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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Combined therapy with renin-angiotensin system and calcium channel blockers in type 2 diabetic hypertensive patients with proteinuria: effects on soluble TWEAK, PTX3, and flow-mediated dilation. Soluble TNF-like weak inducer of apoptosis (sTWEAK) and long pentraxin-3 (PTX3) concentrations have been associated with endothelial function in patients with chronic kidney disease (CKD). This study tested the hypothesis that the improvement in endothelial function after initiation of angiotensin II receptor blocker (valsartan), calcium channel blocker (amlodipine) therapy, or a combination of both is directly linked to the normalization of sTWEAK and PTX3. One-hundred-eight diabetic CKD stage I patients with hypertension (56% men, 46.7+/-5.3 years) were allocated to a 12-week intervention with amlodipine (10 mg/d), valsartan (160 mg/d), or their combination. Plasma levels of sTWEAK, PTX3, and flow-mediated dilation (FMD) were studied during the interventions. All treatment strategies effectively increased FMD and reduced proteinuria, confirming a more prone reduction with the combined therapy. These improvements were followed by significant PTX3 reductions. Valsartan alone and in combination with amlodipine achieved significant incremental raises in sTWEAK plasma levels. More importantly, the changes observed in sTWEAK (beta=0.25, P=0.006) or PTX3 (beta=-0.24, P=0.007) plasma levels were independently associated with the improvement in ultrasonographically measured FMD. This study shows that treatment with antihypertensive drugs improves FMD and normalizes proteinuria, PTX3, and sTWEAK in diabetic CKD stage I patients with hypertension. The improvement in FMD was independently associated with PTX3 and sTWEAK normalization. Two surrogate biomarkers of endothelial function are therefore identified with potential as therapeutic targets. The study was registered in clinicaltrials.gov as NCT00921570. Output: | {'conditions': 'Diabetes|Hypertension|Proteinuria', 'interventions': 'Drug: Amlodipine|Drug: Valsartan'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A cell culture (Vero)-derived H5N1 whole-virus vaccine induces cross-reactive memory responses. Novel strategies are required to provide rapid vaccine coverage in the event of an influenza pandemic. A phase I/II dose finding/formulation study was performed with a whole-virus H5N1 clade 1 A/Vietnam vaccine (2-dose priming regimen) to evaluate safety and immunogenicity. Seventy-seven of 141 subjects in this study received a booster (12-17 months after priming) with a 7.5-microg dose of a clade 2.1 A/Indonesia vaccine. The prime-boost regimen resulted in antibody responses against clade 1, 2.1, 2.2, and 2.3 viruses that were significantly higher than those after the priming regimen. These findings demonstrate that a prime-boost regimen may alleviate vaccine supply constraints in a pandemic. Output: | {'conditions': 'Influenza', 'interventions': 'Biological: H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effects of the new dual PPAR α/δ agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. We evaluated the metabolic effects and tolerability of GFT505, a novel dual peroxisome proliferator-activated receptor α/δ agonist, in abdominally obese patients with either combined dyslipidemia or prediabetes. The S1 study was conducted in 94 patients with combined dyslipidemia while the S2 study was conducted in 47 patients with prediabetes. Participants were randomly assigned in a double-blind manner to GFT505 at 80 mg/day or placebo for 28 (S1) or 35 (S2) days. Primary efficacy end points were changes from baseline at week 4 in both fasting plasma triglycerides and HDL cholesterol in the S1 group and 2-h glucose upon oral glucose tolerance test in the S2 group. In comparison with placebo, GFT505 significantly reduced fasting plasma triglycerides (S1: least squares means -16.7% [95% one-sided CI -∞ to -5.3], P = 0.005; S2: -24.8% [-∞ to -10.5], P = 0.0003) and increased HDL cholesterol (S1: 7.8% [3.0 to ∞], P = 0.004; S2: 9.3% [1.7 to ∞], P = 0.009) in both studies, whereas LDL cholesterol only decreased in S2 (-11.0% [ -∞ to -3.5], P = 0.002). In S2, GFT505 did not reduce 2-h glucose (-0.52 mmol/L [-∞ to 0.61], P = 0.18) but led to a significant decrease of homeostasis model assessment of insulin resistance (-31.4% [-∞ to 12.5], P = 0.001), fasting plasma glucose (-0.37 mmol/L [-∞ to -0.10], P = 0.01) and fructosamine (-3.6% [-∞ to -0.20], P = 0.02). GFT505 also reduced γ glutamyl transferase levels in both studies (S1: -19.9% [-∞ to -12.8], P < 0.0001; S2: -15.1% [-∞ to -1.1], P = 0.004). No specific adverse safety signals were reported during the studies. GFT505 may be considered a new drug candidate for the treatment of lipid and glucose disorders associated with the metabolic syndrome. Output: | {'conditions': 'Impaired Glucose Tolerance|Abdominal Obesity', 'interventions': 'Drug: GFT505 80mg|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Reduced cognitive and psychomotor impairment with extended-release oxymorphone versus controlled-release oxycodone. Opioids provide effective pain control, yet have risks including adverse events (AEs) (e.g., constipation, nausea/vomiting, sedation) and cognitive/psychomotor effects. To compare cognitive and psychomotor effects of oxymorphone extended release (OM-ER) versus oxycodone controlled release (OC-CR). Randomized, double-blind, 5-way crossover Single inpatient research unit Nondependent recreational opioid users were administered single intact oral tablets of placebo, OM-ER (15 and 30 mg), and OC-CR (30 and 60 mg), separated by a 7- to 21-day washout. The divided attention (DA) test measured psychomotor impairment (e.g., manual tracking [e.g., percentage over road], target accuracy [e.g., target hits], reaction time [hit latency]). Visual analog scales measured alertness/drowsiness, agitation/relaxation, and dizziness. Sedative, stimulant, and dysphoric effects were measured using the Addiction Research Center Inventory Pentobarbital-Chlorpromazine-Alcohol (PCAG), Benzedrine Group (BG), and Lysergic Acid Diethylamide (LSD) scales, respectively. Comparisons were made between equianalgesic doses (OM-ER 15 mg vs OC-CR 30 mg; OM-ER 30 mg vs OC-CR 60 mg), within active drug doses, and between active drugs and placebo using least squares (LS) mean difference of the peak maximum (Emax) or minimum (Emin) effect using linear mixed model analysis of covariance. Thirty-five participants received all 5 treatments. Peak cognitive and psychomotor impairment (LS mean [SE]) was less with OM-ER than equianalgesic doses of OC-CR for reaction time (Emax hit latency, longer if impaired; 571.2 [13.4] vs 588.1 ms [13.4], P=0.03 for OM-ER 15 mg vs OC-CR 30 mg, respectively; 572.4 [13.4] vs 604.3 ms [13.4], P=0.03 for OM-ER 15 mg vs OC-CR 30 mg, respectively; 572.4 [13.4] vs 604.3 ms [13.4], P<0.001 for OM-ER 30 mg vs OC-CR 60 mg, respectively); tracking accuracy (Emin percentage over road, lower if impaired; 71.4 [2.4] vs 65.3 [2.4], P=0.007; 69.9 [2.4] vs 59.4 [2.4], P<0.001), and target accuracy (Emin target hits percentage, lower if impaired; 81.0 [3.1] vs 74.5 [3.1], P=0.02; 79.4 [3.1] vs 66.1 [3.1], P<0.001). Several other DA measures showed that OC-CR, especially 60 mg, produced more psychomotor impairment than equianalgesic OM-ER. Compared to OM-ER, OC-CR produced more dizziness (Emax, P<0.001 for OM-ER 15 mg vs OC-CR 30 mg and for OM-ER 30 mg vs OC-CR 60 mg), drowsiness (Emax, P<0.001 for both equianalgesic dose groups), relaxation (Emin, P=0.003 for OM-ER 15 mg vs OC-CR 30 mg; P=0.001 for OM-ER 30 mg vs OC-CR 60 mg), dysphoria (Emax LSD, P<0.001 for both equianalgesic dose groups), and sedation (Emax, PCAG; P<0.001 for both equianalgesic dose groups) and less stimulation (BG, Emin; P=0.01 for OM-ER 15 mg vs OC-CR mg; P<0.001 for OM-ER 30 mg vs OC-CR 60 mg). Several AEs occurred more commonly with OC-CR than OM-ER (e.g., euphoria, nausea, somnolence, vomiting, dizziness). Participants were young, healthy volunteer nondependent recreational drug users, and only single doses were evaluated. The effects of tampering or higher doses were not assessed. Single oral intact low and high doses of OM-ER produced less cognitive and psychomotor impairment plus less sedation than equianalgesic OC-CR in this exploratory study. ClinicalTrials.gov registration NCT00955110. Output: | {'conditions': 'Healthy', 'interventions': 'Drug: Oxymorphone ER|Drug: Oxycodone CR|Drug: Placebo|Drug: Hydromorphone'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial. In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain. We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance. This study was registered at ClinicalTrials.gov. # NCT00279513. Output: | {'conditions': 'Post Hallux Valgus Repair Pain', 'interventions': 'Drug: Traumeel S'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:FGF-23 as a predictor of renal outcome in diabetic nephropathy. Fibroblast growth factor 23 (FGF-23) has emerged as a new factor in mineral metabolism in chronic kidney disease (CKD). An important regulator of phosphorus homeostasis, FGF-23 has been shown to independently predict CKD progression in nondiabetic renal disease. We analyzed the relation between FGF-23 and renal outcome in diabetic nephropathy (DN). DN patients participating in a clinical trial (enalapril+placebo versus enalapril+losartan) had baseline data collected and were followed until June 2009 or until the primary outcome was reached. Four patients were lost to follow-up. The composite primary outcome was defined as death, doubling of serum creatinine, and/or dialysis need. At baseline, serum FGF-23 showed a significant association with serum creatinine, intact parathyroid hormone, proteinuria, urinary fractional excretion of phosphate, male sex, and race. Interestingly, FGF-23 was not related to calcium, phosphorus, 25OH-vitamin D, or 24-hour urinary phosphorus. Mean follow-up time was 30.7±10 months. Cox regression showed that FGF-23 was an independent predictor of the primary outcome, even after adjustment for creatinine clearance and intact parathyroid hormone (10 pg/ml FGF-23 increase = hazard ratio, 1.09; 95% CI, 1.01 to 1.16, P=0.02). Finally, Kaplan-Meier analysis showed a significantly higher risk of the primary outcome in patients with FGF-23 values of >70 pg/ml. FGF-23 is a significant independent predictor of renal outcome in patients with macroalbuminuric DN. Further studies should clarify whether this relation is causal and whether FGF-23 should be a new therapeutic target for CKD prevention. Output: | {'conditions': 'Macroalbuminuric Diabetic Nephropathy', 'interventions': 'Drug: enalapril|Drug: losartan'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A prospective, randomized, single-blind comparison of laparoscopic versus open sigmoid colectomy for diverticulitis. The aim of this study was to compare open and laparoscopic sigmoid resection for diverticulitis with the patient and the nursing staff blinded to the surgical approach. A total of 113 patients scheduled for an elective sigmoidectomy were randomized to receive either a conventional open (54 patients) or a laparoscopic (59 patients) approach. Postoperatively, an opaque wound dressing was applied and left in place for 4 days, and patients from both groups were managed similarly. The primary endpoints for analysis were (1) postoperative pain; (2) duration of postoperative ileus; and (3) duration of hospital stay (ClinicalTrials.gov, number NCT 00453830). The median duration of procedure was 165 minutes (range, 90-285) in the laparoscopy group and 110 minutes (range, 70-210) in the open group (P < 0.0001). The median delay between surgery and first bowel movement was 76 (range, 31-163) hours in the laparoscopy group versus 105 (range, 53-175) hours in the open group (P < 0.0001). The median score for maximal pain (assessed by a visual analog scale) was 4 (range, 1-10) in the laparoscopy group and 5 (range, 1-10) in the open group (P = 0.05). Finally, the median duration of hospital stay was 5 days (range, 4-69) in the laparoscopy group versus 7 days (range, 5-17) in the open group (P < 0.0001). Laparoscopic sigmoid resection is associated with a 30% reduction in duration of postoperative ileus and hospital stay; by comparison, benefits in terms of postoperative pain appear less impressive, when the patient is blinded to the surgical technique. Output: | {'conditions': 'Diverticulitis', 'interventions': 'Procedure: laparoscopic sigmoid resection'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis. Spleen tyrosine kinase (Syk) is an important modulator of immune signaling. The objective of this phase 2 study was to evaluate the efficacy and safety of R788, an oral inhibitor of Syk, in patients with active rheumatoid arthritis despite methotrexate therapy. We enrolled 457 patients who had active rheumatoid arthritis despite long-term methotrexate therapy in a 6-month, double-blind, placebo-controlled trial. The primary outcome was the American College of Rheumatology (ACR) 20 response (which indicates at least a 20% reduction in the number of both tender and swollen joints and improvement in at least three of five other criteria) at month 6. R788, at a dose of 100 mg twice daily and at a dose of 150 mg once daily, was significantly superior to placebo at month 6 (ACR 20 response rates of 67% and 57%, respectively, vs. 35%; P<0.001 for the comparison of both doses with placebo). It was also significantly superior with respect to ACR 50, which indicates at least a 50% improvement (43% and 32% vs. 19%; P<0.001 for the comparison of the 100-mg dose with placebo, P=0.007 for the comparison of the 150-mg dose with placebo) and ACR 70 (28% and 14% vs. 10%; P<0.001 for the comparison of the 100-mg dose with placebo, P=0.34 for the comparison of the 150-mg dose with placebo). A clinically significant effect was noted by the end of the first week of treatment. Adverse effects included diarrhea (in 19% of subjects taking the 100-mg dose of R788 vs. 3% of those taking placebo), upper respiratory infections (14% vs. 7%), and neutropenia (6% vs. 1%). R788 was associated with an increase in systolic blood pressure of approximately 3 mm Hg between baseline and month 1, as compared with a decrease of 2 mm Hg with placebo; 23% of the patients taking R788 vs. 7% of the patients receiving placebo required the initiation of or a change in antihypertensive therapy. In this phase 2 study, a Syk inhibitor reduced disease activity in patients with rheumatoid arthritis; adverse events included diarrhea, hypertension, and neutropenia. Additional studies will be needed to further assess the safety and efficacy of Syk-inhibition therapy in patients with rheumatoid arthritis. (Funded by Rigel; ClinicalTrials.gov number, NCT00665925.) Output: | {'conditions': 'Rheumatoid Arthritis', 'interventions': 'Drug: Fostamatinib disodium (R935788)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Laboratory staff who work with meningococcal isolates are at increased risk for developing invasive disease relative to the general population. This was the first study of laboratory workers who received both a conjugate vaccine against meningococcal serogroups A, C, W-135, and Y (Men ACWY-CRM, Menveo) and an investigational multicomponent vaccine against serogroup B containing factor H binding protein, neisserial adhesin A, Neisseria heparin binding antigen, and New Zealand strain outer membrane vesicles (4CMenB). Healthy adults (18 to 50 years of age) received three doses of 4CMenB at baseline, 2 months, and 6 months followed by a single dose of MenACWY-CRM 1 month later. Immunogenicity was assessed via serum bactericidal assay using human complement (hSBA) at 1 month postvaccination; solicited reactogenicity and adverse events were monitored. Fifty-four participants enrolled. Bactericidal immune responses were evident after each dose of 4CMenB, as assessed by hSBA geometric mean titers and percentages of subjects with hSBA titers of ≥4 against the test strains or a 4-fold rise in titer over baseline. At 1 month postvaccination, most MenACWY-CRM recipients had hSBA titers of ≥8 against serogroups A, C, W-135, and Y. Few participants discontinued due to an adverse event or vaccine reaction. Rates of solicited reactions were lower after MenACWY-CRM than after 4CMenB administration. Sequential administration of 4CMenB and MenACWY-CRM provided robust evidence of an immune response against serogroups A, B, C, W-135, and Y in laboratory workers routinely exposed to meningococcal isolates. Output: | {'conditions': 'Meningococcal Disease', 'interventions': 'Biological: Men ACWY CRM|Biological: 4CMenB'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. Eosinophilic inflammation, which may be a consequence of interleukin-5 action, is a characteristic feature of some forms of asthma. However, in three previous clinical trials involving patients with asthma, blockade of this cytokine did not result in a significant improvement in outcomes. We studied the prednisone-sparing effect of mepolizumab, a monoclonal antibody against interleukin-5, in a rare subgroup of patients who have sputum eosinophilia and airway symptoms despite continued treatment with prednisone. Secondary objectives were to examine its effect on the number of eosinophils in sputum and blood, symptoms, and airflow limitation. In this randomized, double-blind, parallel-group trial involving patients with persistent sputum eosinophilia and symptoms despite prednisone treatment, we assigned 9 patients to receive mepolizumab (administered in five monthly infusions of 750 mg each) and 11 patients to receive placebo. There were 12 asthma exacerbations in 10 patients who received placebo, 9 of whom had sputum eosinophilia at the time of exacerbation. In comparison, only one patient who received mepolizumab had an asthma exacerbation, and this episode was not associated with sputum eosinophilia (P=0.002). Patients who received mepolizumab were able to reduce their prednisone dose by a mean (+/-SD) of 83.8+/-33.4% of their maximum possible dose, as compared with 47.7+/-40.5% in the placebo group (P=0.04). The use of mepolizumab was associated with a significant decrease in the number of sputum and blood eosinophils. Improvements in eosinophil numbers, asthma control, and forced expiratory volume in 1 second were maintained for 8 weeks after the last infusion. There were no serious adverse events. Mepolizumab reduced the number of blood and sputum eosinophils and allowed prednisone sparing in patients who had asthma with sputum eosinophilia despite prednisone treatment. (ClinicalTrials.gov number, NCT00292877.) Output: | {'conditions': 'Asthma', 'interventions': 'Drug: SB-240563 (Mepolizumab)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Residual vessel length on magnetic resonance angiography identifies poor responders to alteplase in acute middle cerebral artery occlusion patients: exploratory analysis of the Japan Alteplase Clinical Trial II. It remains unknown whether the effects of 0.6 mg/kg alteplase differ with occlusion site of the middle cerebral artery (MCA). We therefore evaluated the effects of 0.6 mg/kg intravenous alteplase in patients with different sites of MCA occlusion. An exploratory analysis was made of 57 patients enrolled in the Japan Alteplase Clinical Trial II (J-ACT II), originally designed to evaluate 0.6 mg/kg alteplase in Japanese patients with unilateral occlusion of the MCA (M1 or M2 portion). The residual vessel length (in mm), determined by pretreatment magnetic resonance angiography, was used to reflect the occluded site. The proportions of patients with valid recanalization (modified Mori grade 2 to 3) at 6 and 24 hours and a modified Rankin Scale (mRS) score of 0 to 1 and of 0 to 2 at 3 months were compared between the groups dichotomized according to length of the residual vessel. Multiple logistic-regression models were generated to elucidate the predictors of valid recanalization, mRS 0 to 1, and mRS 0 to 2. Receiver operating characteristics analysis revealed that 5 mm was the practical cutoff length for dichotomization. In patients with an M1 length < 5 mm (n = 12), the frequencies of valid recanalization at 6 and 24 hours (16.7% and 25.0%) were significantly lower compared with those (62.1% and 82.8%, respectively) of the 45 patients with a residual M1 length ≥ 5 mm and an M2 occlusion (P = 0.008 for 6 hours, P < 0.001 for 24 hours). The proportions of patients who achieved an mRS of 0 to 1 and an mRS of 0 to 2 were also lower for those with an M1 length < 5 mm (8.3% and 16.7%, respectively) compared with the other group (57.8% and 68.9%, respectively; P = 0.003 for mRS 0 to 1, P = 0.002 for mRS 0 to 2). In logistic-regression models, the site of MCA occlusion (< 5 mm) was a significant predictor of valid recanalization at 6 and 24 hours and of an mRS of 0 to 1 and of mRS of 0 to 2. In patients with acute MCA occlusion, a residual vessel length < 5 mm on magnetic resonance angiography can identify poor responders to 0.6 mg/kg alteplase. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412867. Output: | {'conditions': 'Stroke', 'interventions': 'Drug: Alteplase'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Ranolazine improves angina in women with evidence of myocardial ischemia but no obstructive coronary artery disease. We conducted a pilot study for a large definitive clinical trial evaluating the impact of ranolazine in women with angina, evidence of myocardial ischemia, and no obstructive coronary artery disease (CAD). Women with angina, evidence of myocardial ischemia, but no obstructive CAD frequently have microvascular coronary dysfunction. The impact of ranolazine in this patient group is unknown. A pilot randomized, double-blind, placebo-controlled, crossover trial was conducted in 20 women with angina, no obstructive CAD, and ≥ 10% ischemic myocardium on adenosine stress cardiac magnetic resonance (CMR) imaging. Participants were assigned to ranolazine or placebo for 4 weeks separated by a 2-week washout. The Seattle Angina Questionnaire and CMR were evaluated after each treatment. Invasive coronary flow reserve (CFR) was available in patients who underwent clinically indicated coronary reactivity testing. CMR data analysis included the percentage of ischemic myocardium and quantitative myocardial perfusion reserve index (MPRI). The mean age of subjects was 57 ± 11 years. Compared with placebo, patients on ranolazine had significantly higher (better) Seattle Angina Questionnaire scores, including physical functioning (p = 0.046), angina stability (p = 0.008), and quality of life (p = 0.021). There was a trend toward a higher (better) CMR mid-ventricular MPRI (2.4 [2.0 minimum, 2.8 maximum] vs. 2.1 [1.7 minimum, 2.5 maximum], p = 0.074) on ranolazine. Among women with coronary reactivity testing (n = 13), those with CFR ≤ 3.0 had a significantly improved MPRI on ranolazine versus placebo compared to women with CFR > 3.0 (Δ in MPRI 0.48 vs. -0.82, p = 0.04). In women with angina, evidence of ischemia, and no obstructive CAD, this pilot randomized, controlled trial revealed that ranolazine improves angina. Myocardial ischemia may also improve, particularly among women with low CFR. These data document approach feasibility and provide outcome variability estimates for planning a definitive large clinical trial to evaluate the role of ranolazine in women with microvascular coronary dysfunction. (Microvascular Coronary Disease In Women: Impact Of Ranolazine; NCT00570089). Output: | {'conditions': 'Myocardial Ischemia', 'interventions': 'Drug: Ranolazine|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Vaginal pH-balanced gel for the control of atrophic vaginitis among breast cancer survivors: a randomized controlled trial. To estimate the effects of vaginal pH-balanced gel on vaginal symptoms and atrophy in breast cancer survivors treated with chemotherapy or endocrine therapy. This was a randomized, double-blind, placebo-controlled study. Breast cancer survivors who experienced menopause after chemotherapy or endocrine therapy were voluntarily enrolled and randomly administered vaginal topical pH-balanced gel or placebo three times per week for 12 weeks. Vaginal dryness and dyspareunia were measured by visual analog scale, vaginal health index, and vaginal pH. The endometrium and ovary were evaluated by transvaginal ultrasonography. Among 98 enrolled women, 86 completed the treatment (n=44 and n=42 for the pH-balanced gel group and placebo group, respectively). Vaginal dryness and dyspareunia improved more in the pH-balanced gel group than in the placebo group (baseline mean 8.20 compared with end-point mean 4.23 [P=.001] and 8.23 compared with 5.48 [P=.040], respectively). Vaginal pH-balanced gel reduced the vaginal pH (gel: baseline mean 6.49 compared with end-point mean 5.00; placebo: 6.22 compared with 5.69 [P<.001]), and enhanced vaginal maturation index (gel: 45.5 compared with 51.2; placebo: 46.4 compared with 47.9 [P<.001]) and vaginal health index (gel: 15.8 compared with 21.1; placebo 14.3 compared with 16.98 [P=.002]). There was no significant difference in adverse effects between the two groups except for mild irritation at the early time of pH-balanced gel administration. Vaginal pH-balanced gel could relieve vaginal symptoms and improve vaginal health in breast cancer survivors who have experienced menopause after cancer treatment. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00607295. I. Output: | {'conditions': 'Breast Cancer|Vaginal Atrophy', 'interventions': 'Drug: clino-san vaginal lubricant'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Pharmacokinetics and 48 week efficacy of low-dose lopinavir/ritonavir in HIV-infected children. Lopinavir/ritonavir is a common protease inhibitor (PI) used for second-line regimens in children. Several studies have shown higher plasma concentrations of antiretroviral agents in Thai adults than in Caucasians, suggesting that lower doses may be used. An open label study in 24 HIV-infected children between the age of 2 and 18 years, naive to PIs, randomized to receive either the WHO-recommended dose of lopinavir/ritonavir or a low dose (70% of the standard dose) twice daily in combination with zidovudine and lamivudine. A 12 h pharmacokinetic study was done at 4-6 weeks after starting treatment. Treatment outcomes were evaluated at week 48. The clinical trial number of the study is NCT00887120. The medians [interquartile ranges (IQRs)] of age, body surface area, percentage CD4 and plasma HIV RNA were 9.5 years (7.0-12.3), 0.9 m(2) (0.8-1.1), 17% (11%-24%) and 4.6 log(10) copies/mL (4.1-4.9), respectively. The median (IQR) lopinavir dose was 279 mg/m(2)/dose (263-294) and 194 mg/m(2)/dose (176-206) in the standard and low-dose arms, respectively. Median (IQR) AUC(0-12) and C(trough) of lopinavir were 117.6 mg.h/L (74.0-128.5) and 4.9 mg/L (2.7-8.0) for the standard arm and 83.8 mg.h/L (56.0-112.9) and 3.4 mg/L (2.7-5.4) for the low-dose arm. One child in the low-dose arm had a lopinavir pre-dose level of <1.0 mg/L. At week 48, the median percentage CD4 was 22% (15%-28%) and 27% (21%-31%) in the standard and low-dose arms, respectively, while 50% and 83% of children had HIV RNA <50 copies/mL, respectively (P = 0.19). Low-dose lopinavir displayed adequate pharmacokinetic parameters and good efficacy as compared with standard-dose lopinavir in Thai children. A larger study to investigate the efficacy of low-dose lopinavir is warranted. Output: | {'conditions': 'HIV Infections', 'interventions': 'Drug: Lopinavir/ritonavir standard dose According to WHO simplified dosing table|Drug: Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Patients infected with hepatitis C virus (HCV) genotype 1, body weight ≥85 kg, and high baseline viral load respond poorly to standard doses of pegylated interferon (peginterferon) and ribavirin. We evaluated intensified therapy with peginterferon alfa-2a plus ribavirin. This double-blind randomized trial included HCV genotype 1-infected outpatients from hepatology clinics with body weight ≥85 kg and HCV RNA titer ≥400,000 IU/mL. Patients were randomized to 180 μg/wk peginterferon alfa-2a for 48 weeks plus 1200 mg/day ribavirin (standard of care) (group A, n = 191) or 1400/1600 mg/day ribavirin (group B, n = 189). Additional groups included 360 μg/wk peginterferon alfa-2a for 12 weeks then 180 μg/wk peginterferon alfa-2a for 36 weeks plus 1200 mg/day ribavirin (group C, n = 382) or 1400/1600 mg/day ribavirin (group D, n = 383). Follow-up lasted 24 weeks after treatment. Sustained virologic response rates (HCV RNA level <15 IU/mL at end of follow-up) in groups A, B, C, and D were 38%, 43%, 44%, and 41%, respectively. There were no significant differences among the 4 groups or between pooled peginterferon alfa-2a regimens (A + B vs C + D: odds ratio [OR], 1.08; 95% confidence interval [CI], 0.83-1.39; P = .584) or pooled ribavirin regimens (A + C vs B + D: OR, 1.00; 95% CI, 0.79-1.28; P = .974). In patients infected with HCV genotype 1 who are difficult to treat (high viral load, body weight ≥85 kg), a 12-week induction regimen of peginterferon alfa-2a and/or higher-dose ribavirin is not more effective than the standard regimen. Output: | {'conditions': 'Hepatitis C, Chronic', 'interventions': 'Drug: peginterferon alfa-2a|Drug: Ribavirin|Drug: peginterferon alfa-2a|Drug: Ribavirin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial). To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol. Institutional review board approval and patient informed consent were obtained. One hundred sixty-two women (mean age, 52.8 years ± 12.3 [standard deviation]) enrolled at 17 sites in Europe and China between July 2007 and May 2009 underwent at least one breast MR imaging examination at 1.5 T by using three-dimensional spoiled gradient-echo sequences. Of these, 151 women received both contrast agents in randomized order in otherwise identical examinations separated by more than 2 but less than 7 days. Images, acquired at 2-minute or shorter intervals after contrast agent injection, were evaluated independently by three blinded radiologists unaffiliated with enrollment centers. Histopathologic confirmation was available for all malignant lesions (n = 144), while benign lesions were confirmed either by using histopathologic examination (n = 52) or by at least 12-month diagnostic follow-up (n = 20) with mammography and/or ultrasonography. Determinations of malignant lesion detection rates and diagnostic performance (sensitivity, specificity, accuracy, positive predictive value [PPV], and negative predictive value [NPV]) were performed and compared (McNemar and Wald tests). A full safety assessment was performed. Significant superiority for gadobenate dimeglumine was noted by readers 1, 2, and 3 for malignant lesion detection rate (91.7%, 93.1%, 94.4% vs 79.9%, 80.6%, 83.3%, respectively; P ≤ .0003). Readers 1, 2, and 3 reported significantly superior diagnostic performance (sensitivity, specificity, and accuracy) for breast cancer detection with gadobenate dimeglumine (91.1%, 94.5%, 95.2% vs 81.2%, 82.6%, 84.6%; 99.0%, 98.2%, 96.9% vs 97.8%, 96.9%, 93.8%; 98.2%, 97.8%, 96.7% vs 96.1%, 95.4%, 92.8%, respectively; P ≤ .0094) and significantly superior PPV (91.1%, 85.2%, 77.2% vs 80.7%, 75.5%, 60.9%, respectively; P ≤ .0002) and NPV (99.0%, 99.4%, 99.4% vs 97.8%, 98.0%, 98.1%, respectively; P ≤ .0003). No safety concerns were noted with either agent. Gadobenate dimeglumine is superior to gadopentetate dimeglumine for breast cancer diagnosis. © RSNA, 2010 Clinical trial registration no. NCT00486473 (http://www.clinicaltrials.gov/). http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100968/-/DC1. Output: | {'conditions': 'Breast Cancer', 'interventions': 'Drug: Multihance|Drug: Magnevist'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide. Primary objective was to assess whether oral analgesia with oxycodone offers superior pain relief after cesareans than patient controlled analgesia (PCA). Secondary outcomes were additional pain medication, time to first mobilization, therapeutic side effects, postoperative restrictions, overall satisfaction and costs. Randomized controlled trial at a University Hospital conduct between July 2009 and November 2009. Of the 1,112 patients, 257 met the inclusion criteria and 239 agreed to participate. Patients were randomly assigned to either receive intravenous piritramide PCA (2 mg piritramide/ml 0.9 % saline) or oral oxycodone (20 mg). Pain was assessed on a visual analog pain scale (VAS) at 2, 12, 24, 32, 40, 48 and 72 h after cesarean. No differences in VAS scores were observed within the general study population. Pain scores of oxycodone versus PCA were comparable at 24 h. Patients randomized to PCA demonstrated increased demand for rescue medication 48 h after cesarean (p = 0.057). In the PCA group, patients with previous cesarean had increased operative times, a trend towards increased VAS scores after 48 h (p = 0.081) and increased VAS scores in comparison to patients who did not have cesarean before (p = 0.044). For this subgroup, no difference was seen in the oxycodone patients (p = 0.883). General satisfaction with both treatment regimes was high. The results support the potential use of oral pain regimes and emphasis the importance of a multimodal approach to treat post-cesarean pain. Oral oxycodone is a not expensive, convenient and comparable analgesic to PCA devices with opioids after cesarean. Trial registration at clinicaltrials.gov identifier: NCT 01115101. Output: | {'conditions': 'Pain', 'interventions': 'Drug: Oral Oxycodon|Drug: Piritramid|Device: intravenous PCA device'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. Methylnaltrexone has been shown to be effective for treating opioid-induced constipation (OIC) in chronic settings, but its effects on acute OIC have not been studied. To assess safety and efficacy of subcutaneous methylnaltrexone in patients with acute OIC after orthopedic procedures. Double-blind, randomized, parallel-group, placebo-controlled, hypothesis-generating phase 2 study. Sixteen US hospitals and rehabilitation facilities. Adult patients with acute OIC after orthopedic surgical procedure, expected to require opioids for at least 7 days postrandomization. Patients received once-daily subcutaneous methylnaltrexone 12 mg or placebo for up to 4 or 7 days. All endpoints were exploratory and included the percentage of patients achieving laxation within 2 and 4 hours of first dose and time to laxation. Thirty-three patients received at least 1 dose of study drug (methylnaltrexone, n = 18; placebo, n = 15). Within 2 and 4 hours, significantly more patients receiving methylnaltrexone achieved laxation (2 hours: 33.3% vs 0%, P = 0.021; 4 hours: 38.9% vs 6.7%, P = 0.046) compared with placebo. Time to laxation was significantly shorter with methylnaltrexone (median = 15.8 hours) versus placebo (median = 50.9 hours), P = 0.0197. The most common adverse events related to the gastrointestinal tract. Pain scores remained stable and were similar to those of placebo, and signs and symptoms of opioid withdrawal did not emerge in patients receiving methylnaltrexone. Methylnaltrexone was generally well tolerated and was active in inducing laxation in this study of patients experiencing acute OIC following orthopedic surgery. Output: | {'conditions': 'Opioid-induced Constipation', 'interventions': 'Drug: Methylnaltrexone bromide|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Pharmacokinetics and 48-week efficacy of nevirapine: 400 mg versus 600 mg per day in HIV-tuberculosis coinfection receiving rifampicin. We aim here to determine the appropriate dose of nevirapine (NVP) in Thai HIV-tuberculosis (TB)-coinfected patients receiving rifampicin. Thirty-two HIV-infected adults with CD4+ T-cell counts <200 cells/mm3 and active TB, receiving rifampicin for 2-6 weeks were randomized to receive either NVP 400 mg (NVP400) or 600 mg (NVP600) per day plus two nucleoside reverse transcriptase inhibitors; a 2-week NVP lead-in was performed at 200 mg once daily (OD) and 200 mg twice daily, respectively. Plasma NVP levels were determined at weeks 2, 4 and 12. Twelve-hour pharmacokinetics (PK) were obtained (n=20) at week 4. Baseline body weight was comparable. There were more patients with NVP plasma concentration at 12 h (C12) <3.1 mg/l at week 2 in NVP400 than in NVP600 (79% versus 19%, respectively; P=0.002). However, the proportions were comparable at weeks 4 and 12. From week 4, 12 h PK studies showed that NVP400 had lower median NVP area under the plasma concentration-0-12 h (AUC0-12 h, maximum concentration in plasma (Cmax) and C12 than NVP600 (P<0.05). Four patients in NVP600 developed NVP hypersensitivity. At week 48, the median CD4+ T-cell count rise and proportion with viral load <50 copies/ml (intention-to-treat analysis 56% versus 50% and as-treated analysis 75% versus 89%) were comparable. In rifampicin-treated patients, 200 mg NVP OD lead-in led to a significant short-term suboptimal NVP C12 level, while NVP 400 mg lead-in then 600 mg/day was associated with a high rate of NVP hypersensitivity. Forty-eight week efficacy was comparable. Thus, NVP 600 mg/day in rifampicin-treated patients is not recommended. Output: | {'conditions': 'HIV Infections|Tuberculosis', 'interventions': 'Drug: HAART containing nevirapine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. LCZ696 is a first-in-class inhibitor of the angiotensin II receptor and neprilysin. We aimed to establish whether the dual actions of LCZ696 lead to further lowering of blood pressure, compared with the angiotensin-receptor blocker valsartan. 1328 patients aged 18-75 years with mild-to-moderate hypertension were randomly assigned (double-blind) to 8 weeks' treatment in one of eight groups: 100 mg (n=156 patients), 200 mg (n=169), or 400 mg (n=172) LCZ696; 80 mg (n=163), 160 mg (n=166), or 320 mg (n=164) valsartan; 200 mg AHU377 (n=165); or placebo (n=173). The primary endpoint was the mean difference across the three single-dose pairwise comparisons of LCZ696 versus valsartan (100 mg vs 80 mg, 200 mg vs 160 mg, and 400 mg vs 320 mg) in mean sitting diastolic blood pressure during the 8-week treatment period. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00549770. 1215 patients completed the 8-week treatment period. The average reduction in mean sitting diastolic blood pressure across the doses of LCZ696 versus the appropriate comparator dose of valsartan showed significantly greater reductions with LCZ696 (mean reduction: -2.17 mm Hg, 95% CI -3.28 to -1.06; p<0.0001). The reduction in mean sitting diastolic blood pressure was significantly different for 200 mg LCZ696 versus 160 mg valsartan (-2.97 mm Hg, 95% CI -4.88 to -1.07, p=0.0023) and for 400 mg LCZ696 versus 320 mg valsartan (-2.70 mm Hg, -4.61 to -0.80, p=0.0055). LCZ696 was well tolerated and no cases of angio-oedema were reported; only three serious adverse events occurred during the 8-week treatment period, of which none was judged to be related to the study drug, and no patients died. Compared with valsartan, dual-acting LCZ696 provides complementary and fully additive reduction of blood pressure, which suggests that the drug holds promise for treatment of hypertension and cardiovascular disease. Novartis. Output: | {'conditions': 'Hypertension', 'interventions': 'Drug: LCZ696|Drug: Valsartan|Drug: AHU377|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Docosahexaenoic acid supplementation increases prefrontal cortex activation during sustained attention in healthy boys: a placebo-controlled, dose-ranging, functional magnetic resonance imaging study. Emerging evidence suggests that docosahexaenoic acid (DHA, 22:6n-3), the principal omega-3 (n-3) fatty acid in brain gray matter, positively regulates cortical metabolic function and cognitive development. However, the effects of DHA supplementation on functional cortical activity in human subjects are unknown. The objective was to determine the effects of DHA supplementation on functional cortical activity during sustained attention in human subjects. Healthy boys aged 8-10 y (n = 33) were randomly assigned to receive placebo or 1 of 2 doses of DHA (400 or 1200 mg/d) for 8 wk. Relative changes in cortical activation patterns during sustained attention at baseline and endpoint were determined by functional magnetic resonance imaging. At 8 wk, erythrocyte membrane DHA composition increased significantly from baseline in subjects who received low-dose (by 47%) or high-dose (by 70%) DHA but not in those who received placebo (-11%). During sustained attention, both DHA dose groups had significantly greater changes from baseline in activation of the dorsolateral prefrontal cortex than did the placebo group, and the low-dose and high-dose DHA groups had greater decreases in the occipital cortex and cerebellar cortex, respectively. Relative to low-dose DHA, high-dose DHA resulted in greater decreases in activation of bilateral cerebellum. The erythrocyte DHA composition was positively correlated with dorsolateral prefrontal cortex activation and was inversely correlated with reaction time, at baseline and endpoint. Dietary DHA intake and associated elevations in erythrocyte DHA composition are associated with alterations in functional activity in cortical attention networks during sustained attention in healthy boys. This trial was registered at clinicaltrials.gov as NCT00662142. Output: | {'conditions': 'Healthy|Attention', 'interventions': 'Dietary Supplement: docosahexaenoic acid'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Telephone depression care management for Latino Medicaid health plan members: a pilot randomized controlled trial. The objective of this pilot study was to provide a preliminary test of feasibility, acceptability, and efficacy of telephone depression care management among Latino Medicaid health plan members. Thirty-eight depressed primary care patients were enrolled in a pilot randomized trial of telephone depression care management + treatment as usual (TAU) versus TAU only. Bilingual care managers conducted care management for 3 months following an antidepressant prescription. For 1 year, research staff attempted to contact 929 potentially eligible members and enrolled 38. Qualitative analyses suggested that, of the participants we interviewed, most expressed satisfaction with the program. Participants suggested ways to improve recruitment, such as face-to-face contact. When compared with the group receiving TAU, there was a trend for the intervention group to experience less depression in time. This pilot study suggests that this program may be promising; however, there is need to investigate ways to better reach those who might find the program helpful. Output: | {'conditions': 'Depression', 'interventions': 'Behavioral: telephone depression care management'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Immunogenicity and safety of a two-dose regimen of a combined measles, mumps, rubella and varicella live vaccine (ProQuad(®)) in infants from 9 months of age. Vaccination against measles, mumps, rubella and varicella (MMRV) is currently recommended in developed countries for infants from 12 months of age. However, measles vaccination at 9 months of age is recommended by the WHO in the Expanded Program on Immunization (EPI) schedule and it is therefore possible that MMR or MMRV vaccines might also be given at this age. This open-label, randomised, comparative study evaluated the immunogenicity and safety of a 2-dose schedule of ProQuad(®) (MMRV vaccine) given at a 3-month interval in healthy infants aged ≥9 months. For measles, the non-inferiority of the response rate post-Dose 2 was reached when Dose 1 was administered at 11 months (98%) compared with 12 months (99%) but was not reached when Dose 1 was administered at 9 months (95%). The response rate to measles post-Dose 1 increased with age, from 73% to 88% and 90% at 9, 11 and 12 months, respectively. For mumps, rubella and varicella, response rates were not different after Dose 1 (>95%) or Dose 2 (>99%) regardless of whether Dose 1 was administered at 9, 11 or 12 months of age. In conclusion, the age of administration of the first of a two-dose regimen of ProQuad may be lowered to 11 months. Dose 1 may be administered at 9 months if early protection is required, but it should be recognised that a second dose is required promptly with a minimum of 3-month interval between doses. Output: | {'conditions': 'Measles|Mumps|Rubella|Varicella', 'interventions': 'Biological: ProQuad® manufactured with recombinant Human Albumine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Human leukocyte death after a preoperative infusion of medium/long-chain triglyceride and fish oil parenteral emulsions: a randomized study in gastrointestinal cancer patients. Parenteral lipid emulsions (LEs) can influence leukocyte functions. The authors investigated the effect of 2 LEs on leukocyte death in surgical patients with gastrointestinal cancer. Twenty-five patients from a randomized, double-blind clinical trial (ID: NCT01218841) were randomly included to evaluate leukocyte death after 3 days of preoperative infusion (0.2 g fat/kg/d) of an LE composed equally of medium/long-chain triglycerides and soybean oil (MCTs/LCTs) or pure fish oil (FO). Blood samples were collected before (t0) and after LE infusion (t1) and on the third postoperative day (t2). After LE infusion (t1 vs t0), MCTs/LCTs did not influence cell death; FO slightly increased the proportion of necrotic lymphocytes (5%). At the postoperative period (t2 vs t0), MCTs/LCTs tripled the proportion of apoptotic lymphocytes; FO maintained the slightly increased proportion of necrotic lymphocytes (7%) and reduced the percentage of apoptotic lymphocytes by 74%. In the postoperative period, MCT/LCT emulsion increased the proportion of apoptotic neutrophils, and FO emulsion did not change any parameter of apoptosis in the neutrophil population. There were no differences in lymphocyte or neutrophil death when MCT/LCT and FO treatments were compared during either preoperative or postoperative periods. MCT/LCTs altered the expression of 12 of 108 genes related to cell death, with both pro- and antiapoptotic effects; FO modulated the expression of 7 genes, demonstrating an antiapoptotic effect. In patients with gastrointestinal cancer, preoperative MCT/LCT infusion was associated with postoperative lymphocyte and neutrophil apoptosis. FO has a protective effect on postoperative lymphocyte apoptosis. Output: | {'conditions': 'Surgery', 'interventions': 'Dietary Supplement: Fish oil lipid emulsion|Dietary Supplement: MCT/LCT'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair. Chronic pain may be a long-term problem related to mesh fixation and operative trauma after Lichtenstein hernioplasty. The aim of this study was to compare the feasibility and safety of tissue cyanoacrylate glue versus absorbable sutures for mesh fixation in Lichtenstein hernioplasty. Lichtenstein hernioplasty was performed under local anaesthesia as a day-case operation in one of three hospitals. The patients were randomized to receive either absorbable polyglycolic acid 3/0 sutures (Dexon(®); 151 hernias) or 1 ml butyl-2-cyanoacrylate tissue glue (Glubran(®); 151 hernias) for fixation of lightweight mesh (Optilene(®)). Wound complications, pain, discomfort and recurrence were identified at 1 and 7 days, 1 month and 1 year after surgery. A total of 302 patients were included in the study. The mean(s.d.) duration of operation was 34(12) min in the glue group and 36(13) min in the suture group (P = 0·113). The need for analgesics was similar during the first 24 h after surgery. Five wound infections (3·4 per cent) were detected in the glue group and two (1·4 per cent) in the suture group (P = 0·448). The recurrence rate at 1 year was 1·4 per cent in each group (P = 1·000). The rates of foreign body sensation, acute and chronic pain were similar in the two groups. Logistic regression analysis showed that the type of mesh fixation did not predict chronic pain 1 year after surgery. Mesh fixation without sutures in Lichtenstein hernioplasty was feasible without compromising postoperative outcome. NCT00659542 (http://www.clinicaltrials.gov). Output: | {'conditions': 'Inguinal Hernia', 'interventions': 'Procedure: cyanoacrylate glue'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:QT response after a test dose and during maintenance therapy with AZD1305 in patients with atrial fibrillation: a double-blind, randomized, placebo-controlled trial. AZD1305 is an investigational antiarrhythmic agent that prolongs refractoriness through combined potassium and sodium channel inhibition. This study aimed to explore the utility of a test dose in predicting QT interval corrected according to Fridericia's formula (QTcF) during subsequent maintenance treatment with AZD1305. This was a randomized, double-blind, parallel-group, placebo-controlled trial carried out at multiple hospital cardiac facilities in Denmark, Norway, Poland, Slovakia, and Sweden. Patients with documented atrial fibrillation (AF) but currently in stable sinus rhythm for ≥2 hours and ≤90 days were eligible for inclusion. Patients were randomized in a 1 : 1 : 1 ratio to receive AZD1305 extended-release or matching placebo tablets as follows: group A - test dose 250 mg, evening dose 125 mg on day 1, maintenance dose 125 mg twice daily; group B - test dose 500 mg, placebo evening dose, maintenance dose 125 mg twice daily; placebo group - placebo test and maintenance dose. Maintenance dosing was for 9 days. QTcF >550 ms at any time during the in-patient phase or >500 ms after discharge (day 4) were predefined study drug discontinuation criteria. The main outcome measure was the relationship between QTcF following the test dose and during maintenance treatment. Sixty-five patients were randomized (n = 21, 22, and 22 in group A, group B, and the placebo group, respectively). AZD1305 dose-dependently increased QTcF. There was a positive, linear correlation between the change in QTcF during the first 6 hours after the test dose and during the maintenance phase. Three patients, all from group B, discontinued treatment on day 1 due to QTcF >550 ms. All other patients completed the study without events related to QT prolongation. There was a trend for reduced AF recurrence with AZD1305 compared with placebo. In this exploratory study a test dose predicted the QT response during maintenance treatment with AZD1305 and may thus be employed in further studies. [ClinicalTrials.gov Identifier: NCT00643448]. Output: | {'conditions': 'Atrial Fibrillation', 'interventions': 'Drug: AZD1305|Drug: AZD1305|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers. Ciclesonide, an intranasal corticosteroid, is administered as a prodrug and is converted to the active metabolite, desisobutyryl ciclesonide, in the upper and lower airways. Previous studies have assessed systemic exposure with the ciclesonide hydrofluoroalkane metered dose inhaler (CIC HFA-MDI) and the ciclesonide aqueous nasal spray (CIC-AQ) formulations. However, systemic exposure with ciclesonide HFA nasal aerosol (CIC-HFA) developed for the treatment of allergic rhinitis has not been investigated. This study compared the systemic exposure of ciclesonide and desisobutyryl ciclesonide after administration of ciclesonide formulated as an aqueous nasal spray, an HFA nasal aerosol, or as an orally inhaled HFA-MDI. Healthy adults (aged 18-60 years) were randomly assigned in an open-label, singledose, 3-period crossover design to CIC-AQ 300 microg, CIC-HFA 300 microg, or CIC HFA-MDI 320 microg. Serum samples were collected before study drug administration and at 5, 15, and 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 18, 22, and 24 hours after dosing. The primary pharmacokinetic parameters were AUC(0-infinity) and C(max) of desisobutyryl ciclesonide. Adverse events were elicited by direct questioning of participants throughout the study. Thirty volunteers were randomly assigned. Most of the volunteers were male (63% [19/30]) and white (83% [25/30]); the mean age was 36 years and mean weight was 68 kg. Concentrations of desisobutyryl ciclesonide were quantifiable (lower limit of quantitation [LLOQ] = 10 ng/L) in the serum samples of only 5 volunteers (of 30) receiving CIC-AQ, and the highest C(max) value of desisobutyryl ciclesonide was 26.7 ng/L (mean C(max), 15.2 ng/L). The AUC(0-infinity) of desisobutyryl ciclesonide for CIC-AQ was below the LLOQ of the bioanalytic assay. Mean C(max) and AUC(0-infinity) of desisobutyryl ciclesonide were 59.1 ng/L and 397.5 ng . h/L, respectively, for CIC-HFA; and 586.2 ng/L and 2685.0 ng . h/L, respectively, for CIC HFA-MDI. Concentrations of the parent compound, ciclesonide, were below the LLOQ in serum samples after administration of CIC-AQ; they were detectable up to 2 hours after administration of CIC-HFA and up to 4 hours after administration of CIC HFA-MDI. Treatment-emergent adverse events occurred with a low frequency in all 3 treatment groups (30% [9/30] overall) and were mild in intensity as determined by the study investigator. In this study, compared with that of CIC HFA-MDI, the systemic exposure of desisobutyryl ciclesonide was 10-fold lower after administration of CIC-HFA and at least 40-fold lower after administration of CIC-AQ. All treatments were well tolerated. Output: | {'conditions': 'Allergic Rhinitis', 'interventions': 'Drug: Ciclesonide'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Multicenter, placebo-controlled trial of lorcaserin for weight management. Lorcaserin is a selective serotonin 2C receptor agonist that could be useful in reducing body weight. In this double-blind clinical trial, we randomly assigned 3182 obese or overweight adults (mean body-mass index [the weight in kilograms divided by the square of the height in meters] of 36.2) to receive lorcaserin at a dose of 10 mg, or placebo, twice daily for 52 weeks. All patients also underwent diet and exercise counseling. At week 52, patients in the placebo group continued to receive placebo but patients in the lorcaserin group were randomly reassigned to receive either placebo or lorcaserin. Primary outcomes were weight loss at 1 year and maintenance of weight loss at 2 years. Serial echocardiography was used to identify patients in whom valvulopathy (as defined by the Food and Drug Administration) developed. At 1 year, 55.4% of patients (883 of 1595) receiving lorcaserin and 45.1% of patients (716 of 1587) receiving placebo remained in the trial; 1553 patients continued into year 2. At 1 year, 47.5% of patients in the lorcaserin group and 20.3% in the placebo group had lost 5% or more of their body weight (P<0.001), corresponding to an average loss of 5.8+/-0.2 kg with lorcaserin and 2.2+/-0.1 kg with placebo during year 1 (P<0.001). Among the patients who received lorcaserin during year 1 and who had lost 5% or more of their baseline weight at 1 year, the loss was maintained in more patients who continued to receive lorcaserin during year 2 (67.9%) than in patients who received placebo during year 2 (50.3%, P<0.001). Among 2472 patients evaluated at 1 year and 1127 evaluated at 2 years, the rate of cardiac valvulopathy was not increased with the use of lorcaserin. Among the most frequent adverse events reported with lorcaserin were headache, dizziness, and nausea. The rates of serious adverse events in the two groups were similar. In conjunction with behavioral modification, lorcaserin was associated with significant weight loss and improved maintenance of weight loss, as compared with placebo. (Funded by Arena Pharmaceuticals; ClinicalTrials.gov number, NCT00395135.) Output: | {'conditions': 'Obesity', 'interventions': 'Drug: lorcaserin|Drug: matching placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Comparison of natamycin and voriconazole for the treatment of fungal keratitis. To conduct a therapeutic exploratory clinical trial comparing clinical outcomes of treatment with topical natamycin vs topical voriconazole for fungal keratitis. The multicenter, double-masked, clinical trial included 120 patients with fungal keratitis at Aravind Eye Hospital in India who were randomized to receive either topical natamycin or topical voriconazole and either had repeated scraping of the epithelium or not. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months. Other outcomes included scar size, perforations, and a subanalysis of BSCVA at 3 months in patients with an enrollment visual acuity of 20/40 to 20/400. Compared with those who received natamycin, voriconazole-treated patients had an approximately 1-line improvement in BSCVA at 3 months after adjusting for scraping in a multivariate regression model but the difference was not statistically significant (P = .29). Scar size at 3 months was slightly greater with voriconazole after adjusting for scraping (P = .48). Corneal perforations in the voriconazole group (10 of 60 patients) were not significantly different than in the natamycin-treated group (9 of 60 patients) (P >.99). Scraping was associated with worse BSCVA at 3 months after adjusting for drug (P = .06). Patients with baseline BSCVA of 20/40 to 20/400 showed a trend toward a 2-line improvement in visual acuity with voriconazole (P = .07). Overall, there were no significant differences in visual acuity, scar size, and perforations between voriconazole- and natamycin-treated patients. There was a trend toward scraping being associated with worse outcomes. Application to Clinical Practice The benefit seen with voriconazole in the subgroup of patients with baseline visual acuity of 20/40 to 20/400 needs to be validated in a confirmatory clinical trial. Trial Registration clinicaltrials.gov Identifier: NCT00557362. Output: | {'conditions': 'Fungal Keratitis', 'interventions': 'Drug: Natamycin 5%|Drug: Voriconazole|Procedure: Corneal de-epithelialization'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Antiproliferative and antiosteoclastic activity from preclinical models show potential for dasatinib, an oral SRC and SRC family kinase inhibitor, as a targeted therapy for patients with prostate cancer. This phase II study investigated the activity of dasatinib in patients with metastatic castration-resistant prostate cancer (CRPC). Chemotherapy-naive men with CRPC and increasing prostate-specific antigen were treated with dasatinib 100 or 70 mg twice daily. Endpoints included changes in prostate-specific antigen, bone scans, measurable disease (Response Evaluation Criteria in Solid Tumor), and markers of bone metabolism. Following Prostate Cancer Working Group 2 guidelines, lack of progression according to Response Evaluation Criteria in Solid Tumor and bone scan was determined and reported at 12 and 24 weeks. Forty-seven patients were enrolled and received dasatinib (initial dose 100 mg twice daily, n = 25; 70 mg twice daily, n = 22), of whom 41 (87%) had bone disease. Lack of progression was achieved in 20 (43%) patients at week 12 and in 9 (19%) patients at week 24. Of 41 evaluable patients, 21 (51%) patients achieved > or =40% reduction in urinary N-telopeptide by week 12, with 33 (80%) achieving some level of reduction anytime on study. Of 15 patients with elevated urinary N-telopeptide at baseline, 8 (53%) normalized on study. Of 40 evaluable patients, 24 (60%) had reduction in bone alkaline phosphatase at week 12 and 25 (63%) achieved some reduction on study. Dasatinib was generally well tolerated and treatment-related adverse events were moderate. This study provides encouraging evidence of dasatinib activity in bone and reasonable tolerability in chemotherapy-naive patients with metastatic CRPC. Output: | {'conditions': 'Prostate Cancer', 'interventions': 'Drug: dasatinib|Drug: dasatinib'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. One influenza pandemic preparedness strategy involves priming a population with a pre-pandemic subtype-specific vaccine and boosting the immunological response at the time of the pandemic with a strain-matched vaccine. In the current study, adults (n=469) randomised 15 months previously to receive an A/Indonesia/5/2005 (H5N1) influenza vaccine (3.75 μg haemagglutinin antigen [HA]) administered alone or in combination with an oil-in-water emulsion based Adjuvant System containing 11.86 mg (AS03(A)) or 5.93 mg (AS03(B)) tocopherol per dose, received one booster dose of A/turkey/Turkey/1/2005 (H5N1) vaccine (3.75 μg HA) with or without AS03(A). An anamnestic antibody response that met US regulatory acceptance criteria was observed 15 months after priming. Although superior immunogenicity of AS03-adjuvanted compared to unadjuvanted priming was not demonstrated, higher antibody titres which persisted longer were seen when both priming and boosting regimens were adjuvanted. This may affect duration of response or heterologous immunity. The booster vaccines had a clinically acceptable safety/reactogenicity profile after adjuvanted or unadjuvanted priming. This study has been registered at www.clinicaltrials.gov NCT00771615. Output: | {'conditions': 'Influenza Disease Caused by an Influenza A Virus With Pandemic Potential, Sub-type H5N1', 'interventions': 'Biological: GSK influenza virus H5N1 vaccine 1557484A'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Gene delivery of AAV2-neurturin for Parkinson's disease: a double-blind, randomised, controlled trial. In an open-label phase 1 trial, gene delivery of the trophic factor neurturin via an adeno-associated type-2 vector (AAV2) was well tolerated and seemed to improve motor function in patients with advanced Parkinson's disease. We aimed to assess the safety and efficacy of AAV2-neurturin in a double-blind, phase 2 randomised trial. We did a multicentre, double-blind, sham-surgery controlled trial in patients with advanced Parkinson's disease. Patients were randomly assigned (2:1) by a central, computer generated, randomisation code to receive either AAV2-neurturin (5·4 × 10¹¹ vector genomes) injected bilaterally into the putamen or sham surgery. All patients and study personnel with the exception of the neurosurgical team were masked to treatment assignment. The primary endpoint was change from baseline to 12 months in the motor subscore of the unified Parkinson's disease rating scale in the practically-defined off state. All randomly assigned patients who had at least one assessment after baseline were included in the primary analyses. This trial is registered at ClinicalTrials.gov, NCT00400634. Between December, 2006, and November, 2008, 58 patients from nine sites in the USA participated in the trial. There was no significant difference in the primary endpoint in patients treated with AAV2-neurturin compared with control individuals (difference -0·31 [SE 2·63], 95% CI -5·58 to 4·97; p=0·91). Serious adverse events occurred in 13 of 38 patients treated with AAV2-neurturin and four of 20 control individuals. Three patients in the AAV2-neurturin group and two in the sham surgery group developed tumours. Intraputaminal AAV2-neurturin is not superior to sham surgery when assessed using the UPDRS motor score at 12 months. However, the possibility of a benefit with additional targeting of the substantia nigra and longer term follow-up should be investigated in further studies. Ceregene and Michael J Fox Foundation for Parkinson's Research. Output: | {'conditions': "Idiopathic Parkinson's Disease", 'interventions': 'Genetic: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])|Procedure: Sham Surgery'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Symptomatic effects of chondroitin 4 and chondroitin 6 sulfate on hand osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial at a single center. To evaluate the symptomatic effects of highly purified chondroitin 4 and chondroitin 6 sulfate (CS) therapy in patients with osteoarthritis (OA) of the hand. This investigator-initiated, single-center, randomized, double-blind, placebo-controlled clinical trial included 162 symptomatic patients with radiographic evidence of hand OA (American College of Rheumatology criteria). Inclusion criteria included patient's assessment of global spontaneous hand pain of at least 40 mm on a 0-100-mm visual analog scale (VAS) and functional impairment of at least 6 (0-30 scale) on the Functional Index for Hand OA (FIHOA) in the most symptomatic hand. Patients received either 800 mg of CS (n = 80 patients) or placebo (n = 82 patients) once daily for 6 months and were analyzed in an intent-to-treat approach. The two primary outcomes were the change in the patient's assessment of global spontaneous hand pain and in hand function (by FIHOA score) from baseline to month 6. Secondary outcomes were improvement in grip strength, duration of morning stiffness, acetaminophen consumption, and the investigator's global impression of treatment efficacy. There was a significantly more pronounced decrease in the patient's global assessment of hand pain in the CS group than in the placebo group (difference VAS scores -8.7 mm; P = 0.016). Hand function improved significantly more in the CS group than in the placebo group (difference in FIHOA scores -2.14; P = 0.008). There was a statistically significant between-group difference in favor of CS for the duration of morning stiffness and for the investigator's global impression of treatment efficacy. Changes in grip strength, acetaminophen consumption, and safety end points were not significantly different between the two groups. This study demonstrates that CS improves hand pain and function in patients with symptomatic OA of the hand and shows a good safety profile. Output: | {'conditions': 'Osteoarthrosis', 'interventions': 'Drug: Chondroitin 4&6 sulfate (Condrosulf)|Other: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and acceptability of lanreotide Autogel® 120 mg at different dose intervals in patients with acromegaly previously treated with octreotide LAR. To assess the efficacy of different dosing intervals of lanreotide, Somatuline Autogel® (Lan-ATG) 120 mg in patients with acromegaly, previously treated with octreotide, long-acting release (Oct-LAR). Patients previously on Oct-LAR 10, 20, or 30 mg were switched to 6 repeated deep subcutaneous injections of Lan-ATG 120 mg at intervals of 56, 42, or 28 days, respectively. After the third injection, dose intervals were adjusted on the basis of insulin-like growth factor 1 (IGF-1) levels. The ITT (Intention To Treat) population comprised 35 patients who received at least one dose of study medication and at least one post-baseline efficacy assessment. Overall, 62.9% (n=22) of patients had normalised IGF-1 levels with Lan-ATG at study end (one injection interval after the 6 (th) injection of Lan-ATG), which was similar to the proportion at baseline (60.0% [n=21]). QoL did not change from baseline to study end. Patient preference for Lan-ATG was highest in the 56-day dosing interval group: 71%, 54% and 41% of the patients in the 56, 42 and 28 day groups, respectively, expressed a preference for treatment with Lan-ATG (preference for Oct-LAR: 29%, 9% and 35%, respectively, while the remainder had no preference). Lan-ATG 120 mg injected at intervals of 56, 42 and 28 days provided equivalent hormonal control and QoL to Oct-LAR 10, 20 and 30 mg injected every 28 days, respectively. The proportion of patients preferring Lan-ATG treatment was greater in the longer injection interval groups. Output: | {'conditions': 'Acromegaly', 'interventions': 'Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Lower atovaquone/proguanil concentrations in patients taking efavirenz, lopinavir/ritonavir or atazanavir/ritonavir. HIV-infected travellers frequently use atovaquone/proguanil as malaria prophylaxis. We compared atovaquone/proguanil pharmacokinetics between healthy volunteers and HIV-infected patients taking efavirenz, lopinavir/ritonavir or atazanavir/ritonavir. The geometric mean ratio (95% confidence interval) area under the curve (AUC)0-->t for atovaquone relative to the healthy volunteers was 0.25 (0.16-0.38), 0.26 (0.17-0.41) and 0.54 (0.35-0.83) for patients on efavirenz, lopinavir/ritonavir and atazanavir/ritonavir, respectively. Proguanil plasma concentrations were also significantly lower (38-43%). Physicians should be alert for atovaquone/proguanil prophylaxis failures in patients taking efavirenz, lopinavir/ritonavir or atazanavir/ritonavir. Output: | {'conditions': 'HIV Infections|Malaria', 'interventions': 'Drug: Atovaquone / Proguanil'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. There are safety issues associated with propofol use for flexible bronchoscopy (FB). The bispectral index (BIS) correlates well with the level of consciousness. The aim of this study was to show that BIS-guided propofol infusion is safe and may provide better sedation, benefiting the patients and bronchoscopists. After administering alfentanil bolus, 500 patients were randomized to either propofol infusion titrated to a BIS level of 65-75 (study group) or incremental midazolam bolus based on clinical judgment to achieve moderate sedation. The primary endpoint was safety, while the secondary endpoints were recovery time, patient tolerance, and cooperation. The proportion of patients with hypoxemia or hypotensive events were not different in the 2 groups (study vs. control groups: 39.9% vs. 35.7%, p = 0.340; 7.4% vs. 4.4%, p = 0.159, respectively). The mean lowest blood pressure was lower in the study group. Logistic regression revealed male gender, higher American Society of Anesthesiologists physical status, and electrocautery were associated with hypoxemia, whereas lower propofol dose for induction was associated with hypotension in the study group. The study group had better global tolerance (p<0.001), less procedural interference by movement or cough (13.6% vs. 36.1%, p<0.001; 30.0% vs. 44.2%, p = 0.001, respectively), and shorter time to orientation and ambulation (11.7±10.2 min vs. 29.7±26.8 min, p<0.001; 30.0±18.2 min vs. 55.7±40.6 min, p<0.001, respectively) compared to the control group. BIS-guided propofol infusion combined with alfentanil for FB sedation provides excellent patient tolerance, with fast recovery and less procedure interference. ClinicalTrials. gov NCT00789815. Output: | {'conditions': 'Flexible Bronchoscopy', 'interventions': 'Device: Bispectral index guide propofol infusion|Drug: Clinical-judged midazolam administration'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Upper airway muscle function plays a major role in maintenance of the upper airway patency and contributes to the genesis of obstructive sleep apnea syndrome (OSAS). Preliminary results suggested that oropharyngeal exercises derived from speech therapy may be an effective treatment option for patients with moderate OSAS. To determine the impact of oropharyngeal exercises in patients with moderate OSAS. Thirty-one patients with moderate OSAS were randomized to 3 months of daily ( approximately 30 min) sham therapy (n = 15, control) or a set of oropharyngeal exercises (n = 16), consisting of exercises involving the tongue, soft palate, and lateral pharyngeal wall. Anthropometric measurements, snoring frequency (range 0-4), intensity (1-3), Epworth daytime sleepiness (0-24) and Pittsburgh sleep quality (0-21) questionnaires, and full polysomnography were performed at baseline and at study conclusion. Body mass index and abdominal circumference of the entire group were 30.3 +/- 3.4 kg/m(2) and 101.4 +/- 9.0 cm, respectively, and did not change significantly over the study period. No significant change occurred in the control group in all variables. In contrast, patients randomized to oropharyngeal exercises had a significant decrease (P < 0.05) in neck circumference (39.6 +/- 3.6 vs. 38.5 +/- 4.0 cm), snoring frequency (4 [4-4] vs. 3 [1.5-3.5]), snoring intensity (3 [3-4] vs. 1 [1-2]), daytime sleepiness (14 +/- 5 vs. 8 +/- 6), sleep quality score (10.2 +/- 3.7 vs. 6.9 +/- 2.5), and OSAS severity (apnea-hypopnea index, 22.4 +/- 4.8 vs. 13.7 +/- 8.5 events/h). Changes in neck circumference correlated inversely with changes in apnea-hypopnea index (r = 0.59; P < 0.001). Oropharyngeal exercises significantly reduce OSAS severity and symptoms and represent a promising treatment for moderate OSAS. Clinical trial registered with www.clinicaltrials.gov (NCT 00660777). Output: | {'conditions': 'Obstructive Sleep Apnea', 'interventions': 'Behavioral: Deep breathing, bilateral alternate chewing, nasal lavage|Behavioral: Oropharyngeal exercises'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:CPAP for acute cardiogenic pulmonary oedema from out-of-hospital to cardiac intensive care unit: a randomised multicentre study. Continuous positive airway pressure (CPAP) is a useful treatment for patients with acute cardiogenic pulmonary oedema (CPE). However, its usefulness in the out-of-hospital setting has been poorly investigated and only by small and single-centre studies. We designed a multicentre randomised study to assess the benefit of CPAP initiated out of hospital. A total of 207 patients with CPE were randomly allocated by emergency mobile medical units to receive either standard treatment alone or standard treatment plus CPAP. CPAP was maintained after admission to the intensive care unit (ICU). Inclusion criteria were orthopnoea, respiratory rate greater than 25 breaths/min, pulse oximetry less than 90% in room air and diffuse crackles. The primary end point was assessed during the first 48 h and combined: death, presence of intubation criteria, persistence of either all inclusion criteria or circulatory failure at the second hour or their reappearance before 48 h. Absence of all criteria defined successful treatment. CPAP was used for 60 min [40, 65] (median [Q1, Q3]) in the pre-hospital setting and 120 min [60, 242] in ICU and was well tolerated in all patients. Treatment was successful in 79% of patients in the CPAP group and 63% in the control group (p = 0.01), especially for persistence of inclusion criteria after 2 h (12 vs. 26%) and for intubation criteria (4 vs. 14%). CPAP was beneficial irrespective of the initial PaCO(2) or left ventricular ejection fraction. Immediate use of CPAP in out-of-hospital treatment of CPE and until CPE resolves after admission significantly improves early outcome compared with medical treatment alone. Output: | {'conditions': 'Pulmonary Edema|Dyspnea|Paroxysmal|Congestive Heart Failure', 'interventions': 'Procedure: Continuous Positive Airway Pressure (CPAP)|Procedure: usual care of acute pulmonary oedema'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Comparative immunogenicity of recombinant influenza hemagglutinin (rHA) and trivalent inactivated vaccine (TIV) among persons > or =65 years old. Alternative substrates for influenza vaccine production are needed to ensure adequate supplies. We evaluated the relative safety and immunogenicity of recombinant hemagglutinin (rHA) or trivalent inactivated vaccine (TIV) among 869 > or =65-year-old subjects in a randomized clinical trial. Virologic surveillance for influenza-like illness (ILI) was conducted during the 2006-2007 epidemic. Vaccines were well tolerated. Seroconversion rates vs. influenza A/H1N1 and H3N2 antigens were superior in the rHA group, but were inferior vs. influenza B; however, results for influenza B are confounded since the vaccine antigens were different. ILI frequencies were low and similar in both groups. Studies assessing relative immunogenicity of vaccines using identical B Ags are warranted. Output: | {'conditions': 'Influenza', 'interventions': 'Biological: Influenza Vaccination'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomized clinical trial of ischaemic preconditioning in major liver resection with intermittent Pringle manoeuvre. Vascular inflow occlusion is effective in avoiding excessive blood loss during hepatic parenchymal transection but may cause ischaemic damage to the remnant liver. Intermittent portal triad clamping (IPTC) is superior to continuous hepatic pedicle clamping as it avoids severe ischaemia-reperfusion (IR) injury in the liver remnant. Ischaemic preconditioning (IPC) before continuous Pringle manoeuvre may protect against IR during major liver resection. This RCT assessed the impact of IPC in major liver resection with intermittent vascular inflow occlusion. Patients undergoing major liver resection with intermittent vascular inflow occlusion were randomized, during surgery, to receive IPC (10 min inflow occlusion followed by 10 min reperfusion) or no IPC (control group). Data analysis was on an intention-to-treat basis. The primary endpoint was serum alanine aminotransferase (ALT) level on the day after surgery. Eighty four patients were enrolled and randomized to IPC (n = 41) and no IPC (n = 43). The groups were comparable in terms of demographic data, preoperative American Society of Anesthesiologists grade and extent of liver resection. Intraoperative morbidity and postoperative outcomes were also similar. ALT levels on the day after operation were not decreased by IPC (mean(s.d.) 537·6(358·5) versus 525·0(400·6) units/ml in IPC and control group respectively; P = 0·881). Liver biochemistry tests in the week after operation showed the same pattern in both groups. IPC did not reduce liver damage in patients undergoing major liver resection with IPTC. NCT00908245 (http://www.clinicaltrials.gov). Output: | {'conditions': 'Ischaemic Type Biliary Lesion', 'interventions': 'Procedure: Control|Procedure: Preconditioning ischemia'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial. Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) possesses anti-inflammatory effects, attributed to the main constituent andrographolide proposed as alternative in the treatment of autoimmune disease. A prospective, randomized, double blind, and placebo-controlled study in patients with rheumatoid arthritis (RA) was performed. Tablets (Paractin) made of an extract of A. paniculata (30% total andrographolides) were administered three times a day for 14 weeks, after a 2-week washout period to 60 patients with active RA. The primary outcomes were pain intensity measured using a horizontal visual analog pain scale (VAPS). In addition, ACR, EULAR, and SF36 clinical parameters were recorded. The intensity of joint pain decreased in the active vs placebo group at the end of treatment, although these differences were not statistically significant. A significant diminishing for week in tender joint -0.13 95% confidence interval (CI; -0.22 to 0.06; p = 0.001), number of swollen joints -0.15 95%CI (-0.29 to -0.02; p = 0.02), total grade of swollen joint -0.27 95%CI (-0.48 to -0.07; p = 0.010), number of tender joints -0.25 95%CI (-0.48 to -0.02; p = 0.033), total grade of swollen joints -0.27 95%CI (-0.48 to -0.07; p = 0.01), total grade of tender joints -0.47 95%CI (-0.77 to -0.17; p = 0.002) and HAQ -0.52 95%CI (-0.82 to -0.21; p < 0.001) and SF36 0.02 95%CI (0.01 to 0.02; p < 0.001) health questionnaires was observed within the group with the active drug. Moreover, it was associated to a reduction of rheumatoid factor, IgA, and C4. These findings suggest that A. paniculata could be a useful "natural complement" in the treatment of AR; however, a larger trial and a more extended period of treatment is necessary in order to corroborate these results. Output: | {'conditions': 'Arthritis, Rheumatoid', 'interventions': 'Drug: FANG(30)|Drug: Specific Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with measles-mumps-rubella-varicella vaccine in children aged 12 to 16 months. A booster dose of pneumococcal conjugate vaccine may be administered at the same age as measles-mumps-rubella-varicella (MMRV) vaccination. This study examined the safety, reactogenicity, and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with MMRV vaccine. In this open, controlled study, 325 healthy children aged 12 to 14 months were randomized to 1 of 3 groups: the first group (N = 110) received PHiD-CV and MMRV vaccine followed 6 to 8 weeks later by MMRV and DTPa-HBV-IPV/Hib vaccines; the second group (N = 101) received DTPa-HBV-IPV/Hib and MMRV vaccines followed 6 to 8 weeks later by PHiD-CV and MMRV vaccine; the third group (N = 114) received PHiD-CV and DTPa-HBV-IPV/Hib vaccine during 1 vaccination visit. Immune responses were assessed with GlaxoSmithKline's 22F-inhibition enzyme-linked immunosorbent assay (for PHiD-CV), commercial enzyme-linked immunosorbent assay (for MMR), or indirect immunofluorescence assay (for varicella). Adverse events were recorded by the parents/guardians. After the first vaccination, 2 peaks in fever (rectal temperature > or =38 degrees C) were observed; at days 0 to 2, related to PHiD-CV and DTPa-HBV-IPV/Hib vaccination, and at days 4 to 12, related to MMRV vaccination. Booster responses to pneumococcal antigens and protein D and seroconversion rates for all MMRV vaccine components were high. PHiD-CV and MMRV vaccine can be coadministered without compromising the safety and immunogenicity profiles of either vaccine. Output: | {'conditions': 'Pneumococcal Disease', 'interventions': 'Biological: 10 valent pneumococcal conjugate (vaccine)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. The aims of this article were to perform a detailed evaluation of the healing of extraction sockets covered with a resorbable collagen membrane 12 weeks following exodontia and to determine if this device had ossifying properties. Ten consecutive subjects in need of extraction of maxillary premolars were recruited. Each subject had a hopeless maxillary premolar extracted with minimal trauma. Sockets were then covered with a collagen barrier membrane alone. At 12 weeks, reentry surgery was performed, clinical measurements were repeated, and bone core biopsies were obtained prior to dental implant placement for histologic and microcomputed tomography (micro-CT) analysis. Study sites showed mean bone regeneration horizontally of 7.7 mm (buccopalatally) and 4.6 mm (mesiodistally). Vertical bone repair showed a mean gain of 10.9 mm. Subtraction radiography showed a mean apical shift of the crestal bone at the center of the socket of 2.1 mm (range, 0.7 to 4.3 mm). Micro-CT and histology revealed formation of well-mineralized tissue at 12 weeks, with a mean percentage of vital bone of 45.87% ± 12.35%. No signs of membrane ossification were observed. A detailed analysis of tissue neogenesis in extraction sites protected by this barrier membrane has demonstrated that adequate bone formation for implant placement occurs as early as 12 weeks following exodontia, with minimal changes in alveolar ridge dimensions. No evidence of membrane ossification was observed. Output: | {'conditions': 'Tooth Extractions', 'interventions': 'Device: OSSIX-Plus'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:The effects of tibolone in older postmenopausal women. Tibolone has estrogenic, progestogenic, and androgenic effects. Although tibolone prevents bone loss, its effects on fractures, breast cancer, and cardiovascular disease are uncertain. In this randomized study, we assigned 4538 women, who were between the ages of 60 and 85 years and had a bone mineral density T score of -2.5 or less at the hip or spine or a T score of -2.0 or less and radiologic evidence of a vertebral fracture, to receive once-daily tibolone (at a dose of 1.25 mg) or placebo. Annual spine radiographs were used to assess for vertebral fracture. Rates of cardiovascular events and breast cancer were adjudicated by expert panels. During a median of 34 months of treatment, the tibolone group, as compared with the placebo group, had a decreased risk of vertebral fracture, with 70 cases versus 126 cases per 1000 person-years (relative hazard, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001), and a decreased risk of nonvertebral fracture, with 122 cases versus 166 cases per 1000 person-years (relative hazard, 0.74; 95% CI, 0.58 to 0.93; P=0.01). The tibolone group also had a decreased risk of invasive breast cancer (relative hazard, 0.32; 95% CI, 0.13 to 0.80; P=0.02) and colon cancer (relative hazard, 0.31; 95% CI, 0.10 to 0.96; P=0.04). However, the tibolone group had an increased risk of stroke (relative hazard, 2.19; 95% CI, 1.14 to 4.23; P=0.02), for which the study was stopped in February 2006 at the recommendation of the data and safety monitoring board. There were no significant differences in the risk of either coronary heart disease or venous thromboembolism between the two groups. Tibolone reduced the risk of fracture and breast cancer and possibly colon cancer but increased the risk of stroke in older women with osteoporosis. (ClinicalTrials.gov number, NCT00519857.) Output: | {'conditions': 'Osteoporosis', 'interventions': 'Drug: Tibolone|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Homozygous familial hypercholesterolaemia is a rare genetic disorder in which both LDL-receptor alleles are defective, resulting in very high concentrations of LDL cholesterol in plasma and premature coronary artery disease. This study investigated whether an antisense inhibitor of apolipoprotein B synthesis, mipomersen, is effective and safe as an adjunctive agent to lower LDL cholesterol concentrations in patients with this disease. This randomised, double-blind, placebo-controlled, phase 3 study was undertaken in nine lipid clinics in seven countries. Patients aged 12 years and older with clinical diagnosis or genetic confirmation of homozygous familial hypercholesterolaemia, who were already receiving the maximum tolerated dose of a lipid-lowering drug, were randomly assigned to mipomersen 200 mg subcutaneously every week or placebo for 26 weeks. Randomisation was computer generated and stratified by weight (<50 kg vs >/=50 kg) in a centralised blocked randomisation, implemented with a computerised interactive voice response system. All clinical, medical, and pharmacy personnel, and patients were masked to treatment allocation. The primary endpoint was percentage change in LDL cholesterol concentration from baseline. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00607373. 34 patients were assigned to mipomersen and 17 to placebo; data for all patients were analysed. 45 patients completed the 26-week treatment period (28 mipomersen, 17 placebo). Mean concentrations of LDL cholesterol at baseline were 11.4 mmol/L (SD 3.6) in the mipomersen group and 10.4 mmol/L (3.7) in the placebo group. The mean percentage change in LDL cholesterol concentration was significantly greater with mipomersen (-24.7%, 95% CI -31.6 to -17.7) than with placebo (-3.3%, -12.1 to 5.5; p=0.0003). The most common adverse events were injection-site reactions (26 [76%] patients in mipomersen group vs four [24%] in placebo group). Four (12%) patients in the mipomersen group but none in the placebo group had increases in concentrations of alanine aminotransferase of three times or more the upper limit of normal. Inhibition of apolipoprotein B synthesis by mipomersen represents a novel, effective therapy to reduce LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia who are already receiving lipid-lowering drugs, including high-dose statins. ISIS Pharmaceuticals and Genzyme Corporation. Output: | {'conditions': 'Lipid Metabolism, Inborn Errors|Hypercholesterolemia, Autosomal Dominant|Hyperlipidemias|Metabolic Diseases|Hyperlipoproteinemia Type II|Metabolism, Inborn Errors|Genetic Diseases, Inborn|Infant, Newborn, Diseases|Metabolic Disorder|Congenital Abnormalities|Hypercholesterolemia|Hyperlipoproteinemias|Dyslipidemias|Lipid Metabolism Disorders', 'interventions': 'Drug: ISIS 301012 (mipomersen sodium)|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials. Study objectives were to assess the efficacy, safety, and tolerability of AFQ056 in Parkinson's disease patients with levodopa-induced dyskinesia. Two randomized, double-blind, placebo-controlled, parallel-group, in-patient studies for Parkinson's disease patients with moderate to severe levodopa-induced dyskinesia (study 1) and severe levodopa-induced dyskinesia (study 2) on stable dopaminergic therapy were performed. Patients received 25-150 mg AFQ056 or placebo twice daily for 16 days (both studies). Study 2 included a 4-day down-titration. Primary outcomes were the Lang-Fahn Activities of Daily Living Dyskinesia Scale (study 1), the modified Abnormal Involuntary Movement Scale (study 2), and the Unified Parkinson's Disease Rating Scale-part III (both studies). Secondary outcomes included the Unified Parkinson's Disease Rating Scale-part IV items 32-33. The primary analysis was change from baseline to day 16 on all outcomes. Treatment differences were assessed. Fifteen patients were randomized to AFQ056 and 16 to placebo in study 1; 14 patients were randomized to each group in study 2. AFQ056-treated patients showed significant improvements in dyskinesias on day 16 versus placebo (eg, Lang-Fahn Activities of Daily Living Dyskinesia Scale, P = .021 [study 1]; modified Abnormal Involuntary Movement Scale, P = .032 [study 2]). No significant changes were seen from baseline on day 16 on the Unified Parkinson's Disease Rating Scale-part III in either study. Adverse events were reported in both studies, including dizziness. Serious adverse events (most commonly worsening of dyskinesias, apparently associated with stopping treatment) were reported by 4 AFQ056-treated patients in study 1, and 3 patients (2 AFQ056-treated patient and 1 in the placebo group) in study 2. AFQ056 showed a clinically relevant and significant antidyskinetic effect without changing the antiparkinsonian effects of dopaminergic therapy. © 2011 Movement Disorder Society. Output: | {'conditions': "Parkinson's Disease", 'interventions': 'Drug: AFQ056|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. The risk for major depressive disorder (MDD) increases during the menopausal transition. Nonetheless, no large, placebo-controlled studies have prospectively assessed the efficacy of antidepressants in perimenopausal or postmenopausal women. This randomized, double-blind, placebo-controlled trial evaluated the short-term efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) in perimenopausal and postmenopausal women with DSM-IV-defined MDD. 387 depressed perimenopausal and postmenopausal women aged 40 to 70 years were randomly assigned to placebo or desvenlafaxine (100 or 200 mg/d at the discretion of the investigator) in an 8-week, flexible-dose trial conducted from September 2006 to June 2008. The primary efficacy variable was change from baseline in 17-item Hamilton Depression Rating Scale (HDRS(17)) total score, analyzed using a mixed-effects model for repeated-measures analysis. Safety data were collected throughout the trial. The reduction in adjusted HDRS17 total scores from baseline to week 8 (mean daily dose after titration, 162 to 176 mg/d) was significantly greater for desvenlafaxine (-12.64) compared with placebo (-8.33; P < .001). Statistical separation from placebo was observed at week 1 and was sustained through week 8. Both the perimenopausal and postmenopausal subgroups achieved significant reductions in HDRS(17) total scores with desvenlafaxine treatment (perimenopausal, P = .003; postmenopausal, P < .001). Response (58.6%) and remission (38.2%) rates were significantly higher for desvenlafaxine compared with placebo (31.6% [P < .001] and 22.4% [P = .008], respectively). In all, 19/256 (7.4%) desvenlafaxine-treated patients and 4/125 (3.2%) placebo-treated patients discontinued due to adverse events. Treatment-emergent adverse events were reported by 94/125 (75.2%) placebo-treated patients and 218/256 (85.2%) desvenlafaxine-treated patients. Short-term treatment with desvenlafaxine was effective and generally well tolerated in perimenopausal and postmenopausal women with MDD. clinicaltrials.gov Identifier: NCT00369343. Output: | {'conditions': 'Depression|Depressive Disorder|Depressive Disorder, Major', 'interventions': 'Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Prophylactic human papillomavirus (HPV) vaccines are now available and vaccination programs are being widely implemented, targeting adolescent girls prior to sexual debut. Since the risk of HPV exposure persists throughout a woman's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. We report the long-term efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine (Cervarix (®) ) up to 8.4 y after the first vaccine dose. In an initial placebo-controlled study performed in US, Canada and Brazil, women aged 15-25 y with normal cervical cytology, HPV-16/18 seronegative by ELISA, DNA-negative for 14 oncogenic HPV types by PCR, received either the HPV-16/18 vaccine or placebo (n = 1,113). Subjects were followed up to 6.4 y after the first dose (n = 776). We report an additional 2-y follow-up for women enrolled from the Brazilian centers from the initial study (n = 436). During the current follow-up study (HPV-023, NCT00518336), no new infection or lesions associated with HPV-16/18 occurred in the vaccine group. Vaccine efficacy over the entire follow-up (up to 8.4 y) was 95.1% (84.6, 99.0) for incident infection, 100% (79.8, 100) for 6-mo persistent infection, 100% (56.1, 100) for 12-mo persistent infection and 100% (< 0, 100) for CIN2+ associated with HPV-16/18. All women in the vaccine group remained seropositive to both HPV-16/18, with antibody titers for total and neutralizing antibodies remaining several-folds above natural infection levels. The safety profile was clinically acceptable for both vaccine and control groups. This is, to date, the longest follow-up study for a licensed cervical cancer vaccine. Output: | {'conditions': 'HPV-16/18 Infections|Cervical Neoplasia', 'interventions': 'Procedure: Blood sampling|Procedure: Collection of cervical specimen'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial. The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain. In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0-100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported. The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief. ClinicalTrials.gov NCT00567736. Output: | {'conditions': 'Chronic Low Back Pain', 'interventions': 'Drug: Disci/Rhus toxicodendron comp.®|Drug: placebo solution'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial. To evaluate lactogenesis after early postpartum insertion of the etonogestrel contraceptive implant. Healthy peripartum women with healthy, term newborns who desired the etonogestrel implant for contraception were randomly assigned to early (1-3 days) or standard (4-8 weeks) postpartum insertion. The primary outcomes, time to lactogenesis stage II and lactation failure, were documented by a validated measure. The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 8 additional hours. Secondary data (device continuation and contraceptive use, breast milk analysis, supplementation rates, side effects, and bleeding patterns) were collected at periodic intervals for 6 months. Sixty-nine women were enrolled. Thirty-five were randomly assigned to early insertion and 34 to standard insertion. There were no statistically significant differences between the groups in age, race, parity, mode of delivery, use of anesthesia, or prior breastfeeding experience. Early insertion was demonstrated to be noninferior to standard insertion in time to lactogenesis stage II (early: [mean±standard deviation] 64.3±19.6 hours; standard: 65.2±18.5 hours, mean difference, -1.4 hours, 95% confidence interval [CI] -10.6 to 7.7 hours). Early insertion was also demonstrated to be noninferior to standard insertion in incidence of lactation failure (1/34 [3%] in the early insertion group, 0/35 [0%] in the standard insertion group [risk difference, 0.03, 95% CI -0.02 to 0.08]). Use of formula supplementation was not significantly different between the groups. Milk composition at 6 weeks was not significantly different between the groups. Breastfeeding outcomes were similar in women who underwent early compared with standard postpartum insertion of the etonogestrel implant. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00847587. Output: | {'conditions': 'Complications; Contraceptive|Female Lactation', 'interventions': 'Drug: Etonogestrel contraceptive implant|Drug: Etonogestrel contraceptive implant'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:The safety, tolerability, and efficacy of a liquid formulation of deferiprone in young children with transfusional iron overload. Limited data are available on the use of deferiprone in children younger than 10 years of age. This study evaluated the safety and efficacy of a new liquid formulation of deferiprone for the treatment of transfusional iron overload in children 1-10 years old. One hundred children (91 thalassemia major, 8 Hb E-β thalassemia, and 1 sickle cell disease) were enrolled for a 6-month treatment with deferiprone (50 to 100 mg/kg/d). The safety profile was similar to or better than that reported in earlier studies with deferiprone tablets in older children and adults. No unexpected adverse reactions were observed. Gastrointestinal intolerance (GI) was observed in 11% and an increased serum ALT in 12% of the children. Both events were transient. Mild neutropenia, observed in 6% of patients, did not progress to agranulocytosis and resolved despite continuous deferiprone treatment. Two patients experienced agranulocytosis that resolved without complications upon discontinuation of therapy. Deferiprone use was associated with a significant decline in mean serum ferritin level from 2532±1463 μg/L at baseline to 2176±1144 μg/L (P<0.0005). The results of this study show a favorable benefit/risk ratio of deferiprone oral solution for the treatment of young children with transfusional iron overload. Output: | {'conditions': 'Iron Overload', 'interventions': 'Drug: Deferiprone'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial. In recent studies, the combination of azithromycin and artesunate has proven to be a promising alternative for the treatment of uncomplicated falciparum malaria. We conducted a randomized, controlled clinical trial assessing the efficacy of azithromycin-artesunate combination therapy. The study was conducted involving 228 patients aged 8-65 years. Patients were randomized to 1 of 2 cohorts at a ratio of 2:1, receiving either azithromycin-artesunate once daily for 3 days (30 mg/kg per day of azithromycin plus 4 mg/kg per day of artesunate) or an adult dose of 80 mg of artemether plus 960 mg of lumefantrine (4 tablets Coartem or the equivalent for children weighing <35 kg) twice daily for 3 days. The 42-day cure rate by Kaplan-Meier analysis was 94.6% (95% confidence interval [CI], 89.38%-97.44%) in the azithromycin-artesunate arm and 97.0% (95% CI, 89.45%-99.40%) in the control arm. Fever clearance times and parasite clearance times did not show any differences between the 2 arms (P=.59 and .95, respectively). No serious adverse events were seen, but the percentage of patients who developed any adverse event was higher in the control group (P=.03). Our data suggest that azithromycin-artesunate is an efficacious and well-tolerated treatment for patients with uncomplicated falciparum malaria in Bangladesh. Output: | {'conditions': 'Uncomplicated Falciparum Malaria', 'interventions': 'Drug: azithromycin plus artesunate|Drug: Artesunate'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. To evaluate the efficacy and safety of guanfacine extended release (XR, Intuniv; Shire Development Inc., Wayne, PA, USA) in the treatment of oppositional symptoms in children aged 6-12 years with a diagnosis of attention-deficit hyperactivity disorder (ADHD) and the presence of oppositional symptoms. In this randomized, double-blind, placebo-controlled, multicentre, flexible-dose, dose-optimization study, children aged 6-12 years were randomized to receive guanfacine XR (1-4 mg/day) or placebo for 9 weeks. Screening and washout periods were followed by a 5-week dose-optimization period, a 3-week dose-maintenance period and a 1-week tapering period. The primary efficacy measure was change from baseline to endpoint in the oppositional subscale of the Conners' Parent Rating Scale-Revised: Long Form (CPRS-R:L) score. Change in ADHD Rating Scale IV (ADHD-RS-IV) total score was a secondary efficacy measure. Safety assessments included adverse events (AEs), vital signs, ECG readings and laboratory studies. A total of 217 children were enrolled: 138 were randomized to receive guanfacine XR and 79 to receive placebo. Least-squares mean reductions from baseline to endpoint in CPRS-R:L oppositional subscale scores were 10.9 in the guanfacine XR group compared with 6.8 in the placebo group (p < 0.001; effect size = 0.59). A significantly greater reduction in ADHD-RS-IV total score from baseline to endpoint was also seen in the guanfacine-treated group compared with the placebo group (23.8 vs 11.5, respectively; p < 0.001; effect size = 0.92). A post hoc correlation analysis between percentage reduction from baseline to endpoint in CPRS-R:L oppositional subscale and ADHD-RS-IV total scores indicated that the decreases in oppositional symptoms and ADHD symptoms were highly correlated (r = 0.74). The most commonly reported, treatment-emergent AEs (TEAEs) in the guanfacine XR group were somnolence (50.7%), headache (22.1%), sedation (13.2%), upper abdominal pain (11.8%) and fatigue (11.0%) and most were mild or moderate in severity. TEAEs of sedation, somnolence or hypersomnia were experienced by 62.5% of subjects in the guanfacine XR group. These events were most common during the dose-titration period but most (63.5%) resolved prior to the taper period. TEAEs of fatigue, lethargy and asthenia were reported in 11.0%, 3.7% and 0.0% of subjects in the guanfacine XR group, respectively. Most subjects receiving guanfacine XR demonstrated modest changes in blood pressure, pulse rate and ECG readings that were not considered clinically significant. In this population of children aged 6-12 years with ADHD and the presence of oppositional symptoms, significant reductions in CPRS-R:L oppositional subscale and ADHD-RS-IV total scores were observed with guanfacine XR treatment compared with placebo. Treatment with guanfacine XR at optimized doses was associated with mostly mild or moderate TEAEs. The findings of this study support the efficacy of guanfacine XR in the treatment of children with ADHD and the presence of oppositional symptoms. NCT00367835. Output: | {'conditions': 'ADHD', 'interventions': 'Drug: SPD503 (Guanfacine hydrochloride)|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Eosinophilic esophagitis (EoE) is caused by immunologic reactions to ingested/inhaled allergens. The diagnosis is considered if >or=15 eosinophils per high-powered field (eos/hpf) are detected in mucosal biopsies. Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB). Children with EoE were randomly assigned to groups that were given OVB (n=15) or placebo (n=9). Patients<5 feet and >or=5 feet tall received 1 mg and 2 mg OVB daily, respectively. All patients received lansoprazole. Duration of treatment was 3 months, followed by repeat endoscopy and biopsies. Patients were classified as responders if their peak eosinophil counts were <or=6 eos/hpf, partial responders were 7-19 eos/hpf, and nonresponders were >or=20 eos/hpf. Baseline and post-treatment symptoms and endoscopic and histologic features were scored. Thirteen (86.7%) children given OVB (P<.0001) and none who received placebo (P=.3) were classified as responders. Mean pre-/post-treatment peak eosinophil counts were 66.7 and 4.8 eos/hpf, respectively, in the group given OVB (P<.0001); they were 83.9 and 65.6 eos/hpf, respectively, in the group given placebo (P=.3). In the group given OVB, there were significant reductions from baseline values in proximal (P=.002), mid (P=.0003), and distal (P=.001) esophageal eosinophilia. After OVB therapy, compared with baseline, the mean symptom (P=.0007), endoscopy (P=.0005), and histology scores improved (P=.0035) significantly. OVB is an effective treatment of pan-esophageal disease in children with EoE. OVB improves symptoms and endoscopic and histologic features. Proton pump inhibitor single therapy did not significantly improve esophageal eosinophilia or symptoms of EoE. Output: | {'conditions': 'Eosinophilic Esophagitis', 'interventions': 'Drug: Budesonide plus Prevacid|Drug: placebo plus Prevacid'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and safety of the long-acting muscarinic antagonist GSK233705 delivered once daily in patients with COPD. GSK233705 is a recently developed inhaled anticholinergic being investigated for the potential treatment of chronic obstructive pulmonary disease (COPD). This dose-ranging, parallel-group, double-blind study compared the bronchodilator efficacy, safety and pharmacokinetics of GSK233705 with placebo in patients with moderate-to-severe COPD. Patients were randomised to receive 12.5 µg, 25 µg, 50 µg, 100 µg or 200 µg of GSK233705 or placebo once daily for 28 days. The primary endpoint was change from baseline in trough forced expiratory volume in 1 s (FEV(1)) on day 29. The intent-to-treat population consisted of 576 patients (mean predicted FEV(1) 51%; mean age 62 years). Treatment with GSK233705 produced statistically significant improvements in pulmonary function compared with placebo. Only the 200 µg dose exceeded the predefined target threshold of 130-mL difference compared with placebo for the primary endpoint of change from baseline in trough FEV(1) on day 29. No clear pattern of dose response was observed for the other doses. Serial FEV(1) (0-24 h) showed a peak effect around 2 h postdose and tended to decline to clinically insignificant levels compared with placebo at 23 and 24 h. Each dose of GSK233705 was well tolerated. The incidence of adverse events was low and similar across all treatment groups. There were no clinically significant effects on laboratory parameters, vital signs or electrocardiograms. All doses of GSK233705 demonstrated bronchodilatory activity and were well tolerated. Although the onset of bronchodilation was rapid, it was not sustained over 24 h making it unsuitable for once-daily dosing. Output: | {'conditions': 'Pulmonary Disease, Chronic Obstructive', 'interventions': 'Drug: GSK233705 12.5mcg|Drug: GSK233705 25mcg|Drug: GSK233705 50mcg|Drug: GSK233705 100mcg|Drug: GSK233705 200mcg|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. There are various regimens for thromboprophylaxis after hip replacement. Low-molecular-weight heparins such as enoxaparin predominantly inhibit factor Xa but also inhibit thrombin to some degree. Orally active, specific factor Xa inhibitors such as apixaban may provide effective thromboprophylaxis with a lower risk of bleeding and improved ease of use. In this double-blind, double-dummy study, we randomly assigned 5407 patients undergoing total hip replacement to receive apixaban at a dose of 2.5 mg orally twice daily or enoxaparin at a dose of 40 mg subcutaneously every 24 hours. Apixaban therapy was initiated 12 to 24 hours after closure of the surgical wound; enoxaparin therapy was initiated 12 hours before surgery. Prophylaxis was continued for 35 days after surgery, followed by bilateral venographic studies. The primary efficacy outcome was the composite of asymptomatic or symptomatic deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause during the treatment period. Patients were followed for an additional 60 days after the last intended dose of study medication. A total of 1949 patients in the apixaban group (72.0%) and 1917 patients in the enoxaparin group (71.0%) could be evaluated for the primary efficacy analysis. The primary efficacy outcome occurred in 27 patients in the apixaban group (1.4%) and in 74 patients in the enoxaparin group (3.9%) (relative risk with apixaban, 0.36; 95% confidence interval [CI], 0.22 to 0.54; P<0.001 for both noninferiority and superiority; absolute risk reduction, 2.5 percentage points; 95% CI, 1.5 to 3.5). The composite outcome of major and clinically relevant nonmajor bleeding occurred in 129 of 2673 patients assigned to apixaban (4.8%) and 134 of 2659 assigned to enoxaparin (5.0%) (absolute difference in risk, -0.2 percentage points; 95% CI, -1.4 to 1.0). Among patients undergoing hip replacement, thromboprophylaxis with apixaban, as compared with enoxaparin, was associated with lower rates of venous thromboembolism, without increased bleeding. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00423319.). Output: | {'conditions': 'Deep Vein Thrombosis|Pulmonary Embolism', 'interventions': 'Drug: Enoxaparin + Placebo|Drug: Apixaban + Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. NovoTTF-100A is a portable device delivering low-intensity, intermediate frequency electric fields via non-invasive, transducer arrays. Tumour Treatment Fields (TTF), a completely new therapeutic modality in cancer treatment, physically interfere with cell division. Phase III trial of chemotherapy-free treatment of NovoTTF (20-24h/day) versus active chemotherapy in the treatment of patients with recurrent glioblastoma. Primary end-point was improvement of overall survival. Patients (median age 54 years (range 23-80), Karnofsky performance status 80% (range 50-100) were randomised to TTF alone (n=120) or active chemotherapy control (n=117). Number of prior treatments was two (range 1-6). Median survival was 6.6 versus 6.0 months (hazard ratio 0.86 [95% CI 0.66-1.12]; p=0.27), 1-year survival rate was 20% and 20%, progression-free survival rate at 6 months was 21.4% and 15.1% (p=0.13), respectively in TTF and active control patients. Responses were more common in the TTF arm (14% versus 9.6%, p=0.19). The TTF-related adverse events were mild (14%) to moderate (2%) skin rash beneath the transducer arrays. Severe adverse events occurred in 6% and 16% (p=0.022) of patients treated with TTF and chemotherapy, respectively. Quality of life analyses favoured TTF therapy in most domains. This is the first controlled trial evaluating an entirely novel cancer treatment modality delivering electric fields rather than chemotherapy. No improvement in overall survival was demonstrated, however efficacy and activity with this chemotherapy-free treatment device appears comparable to chemotherapy regimens that are commonly used for recurrent glioblastoma. Toxicity and quality of life clearly favoured TTF. Output: | {'conditions': 'Recurrent Glioblastoma Multiforme', 'interventions': 'Device: NovoTTF-100A'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial. Vasomotor symptoms and bone loss are complications frequently induced by adjuvant treatment for breast cancer. Tibolone prevents both side-effects, but its effect on cancer recurrence is unknown. The aim of this study was to show non-inferiority of tibolone to placebo regarding risk of recurrence in breast-cancer patients with climacteric complaints. Between July 11, 2002, and Dec 20, 2004, women surgically treated for a histologically confirmed breast cancer (T(1-3)N(0-2)M(0)) with vasomotor symptoms were randomly assigned to either tibolone 2.5 mg daily or placebo at 245 centres in 31 countries. Randomisation was done by use of a centralised interactive voice response system, stratified by centre, with a block size of four. The primary endpoint was breast-cancer recurrence, including contralateral breast cancer, and was analysed in the intention-to-treat (ITT) and per-protocol populations; the margin for non-inferiority was set as a hazard ratio of 1.278. This study is registered with ClinicalTrials.gov, number NCT00408863. Of the 3148 women randomised, 3098 were included in the ITT analysis (1556 in the tibolone group and 1542 in the placebo group). Mean age at randomisation was 52.7 years (SD 7.3) and mean time since surgery was 2.1 years (SD 1.3). 1792 of 3098 (58%) women were node positive and 2185 of 3098 (71%) were oestrogen-receptor positive. At study entry, 2068 of 3098 (67%) women used tamoxifen and 202 of 3098 (6.5%) women used aromatase inhibitors. The mean daily number of hot flushes was 6.4 (SD 5.1). After a median follow-up of 3.1 years (range 0.01-4.99), 237 of 1556 (15.2%) women on tibolone had a cancer recurrence, compared with 165 of 1542 (10.7%) on placebo (HR 1.40 [95% CI 1.14-1.70]; p=0.001). Results in the per-protocol population were similar (209 of 1254 [16.7%] women in the tibolone group had a recurrence vs 138 of 1213 [11.4%] women in the placebo group; HR 1.44 [95% CI 1.16-1.79]; p=0.0009). Tibolone was not different from placebo with regard to other safety outcomes, such as mortality (72 patients vs 63 patients, respectively), cardiovascular events (14 vs 10, respectively), or gynaecological cancers (10 vs 10, respectively). Vasomotor symptoms and bone-mineral density improved significantly with tibolone, compared with placebo. Tibolone increases the risk of recurrence in breast cancer patients, while relieving vasomotor symptoms and preventing bone loss. Schering-Plough (formerly NV Organon, Oss, Netherlands). Output: | {'conditions': 'Breast Cancer|Climacteric Symptoms', 'interventions': 'Drug: tibolone|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Mailed intervention to promote sun protection of children: a randomized controlled trial. Sun exposure, especially during childhood, is the most important preventable risk factor for skin cancer, yet few effective interventions to reduce exposure exist. To test the effectiveness of a partially tailored mailed intervention based on the Precaution Adoption Process Model, delivered in the spring over 3 years to parents and children. RCT, with data collection through telephone interviews of parents and skin exams of children at baseline (Summer 2004) and annually (Summer 2005-2007). The control group received no intervention. Families recruited in the Denver CO area, through private pediatric clinics, a large MCO, and community settings. Children born in 1998 were approximately 6 years of age at baseline; 867 children met inclusion criteria; analysis is reported for 677 white, non-Hispanic participants at highest risk for skin cancer. Primary outcomes were parent-reported child sun protection behaviors. Secondary outcomes included parents' risk perception, perceived effectiveness of and barriers to prevention behaviors, stage of change, reported sunburns, and observed tanning and nevus development. The longitudinal mixed-model analysis was conducted between 2008 and 2011. The intervention group reported more use of sunscreen, protective clothing, hats, shade-seeking, and midday sun avoidance; fewer sunburns; more awareness of the risk of skin cancer; higher perceived effectiveness of sun protection; higher stage of change; and lower perception of barriers to sun protection (all p<0.05). The intervention group had fewer nevi ≥2 mm in 1 year of the study, 2006 (p=0.03). No differences were found in tanning or nevi <2 mm. The level of behavior change associated with this single-modality intervention is not likely sufficient to reduce skin cancer risk. However, the intervention shows promise for inclusion in longer-term, multicomponent interventions that have sufficient intensity to affect skin cancer incidence. Output: | {'conditions': 'Skin Cancer', 'interventions': 'Behavioral: Semi-tailored newsletter intervention for parents and children'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. Randomized, multicenter trial conducted between January 2006 and October 2008. Ten sites serving a total catchment area of approximately 2.8 million inhabitants. A total of 400 patients with unresectable distal malignant biliary obstruction. ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. Time to stent failure, survival time, and complication rate. The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). Randomization was not blinded. There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents. Output: | {'conditions': 'Bile Duct Obstruction|Pancreatic Cancer|Gallbladder Cancer|Bile Duct Cancer', 'interventions': 'Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study. Patients with biliary tract cancer have a poor prognosis, and, until recently, no standard palliative chemotherapy has been defined. We aimed to investigate the efficacy and safety of cetuximab in combination with gemcitabine and oxaliplatin (GEMOX) for first-line treatment of biliary tract cancer. From Oct 1, 2006, to July 26, 2008, patients with unresectable locally advanced or metastatic biliary tract cancer were sequentially enrolled and treated at one centre in Austria. All patients received intravenous infusions of 500 mg/m(2) cetuximab on day 1, 1000 mg/m(2) gemcitabine on day 1, and 100 mg/m(2) oxaliplatin on day 2, every 2 weeks for 12 cycles. The primary outcome was overall response rate. Analysis was by intention to treat. Adverse reactions were assessed according to National Cancer Institute Common Toxicity Criteria. The study is completed and registered with ClinicalTrials.gov, number NCT01216345. 30 patients with median age of 68 years (IQR 62-73) were enrolled and included in the analysis. Objective response occurred in 19 patients (63%; 95% CI 56·2-69·8), of whom three (10%; 3·2-16·8) achieved complete response, and 16 (53%; 46·2-59·8) achieved partial response. Nine patients underwent potentially curative secondary resection after major response to therapy. Grade 3 adverse events were recorded in 13 patients: skin rash (n=4), peripheral neuropathy (n=4), thrombocytopenia (n=3), nausea (n=1), diarrhoea (n=1), and neutropenia (n=1); no grade 4 adverse events were recorded. Cetuximab plus GEMOX was well tolerated and had encouraging antitumour activity, leading to secondary resection in a third of patients. These findings warrant further study of cetuximab plus GEMOX in a large randomised trial. Output: | {'conditions': 'Unresectable|Locally Advanced|Metastatic', 'interventions': 'Drug: Cetuximab + Gemcitabine + Oxaliplatin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. A 2-year, randomized, double-blind, placebo-controlled study in men with osteoporosis demonstrated that treatment with risedronate 35mg once a week significantly decreased bone turnover markers (BTMs) and increased bone mineral density (BMD). This study was extended to include a 2-year, open-label extension to continue to assess the safety and efficacy of risedronate in men with osteoporosis. In the open-label extension, all patients received risedronate 35mg once a week, and 1000mg elemental calcium and 400 to 500IU vitamin D daily for up to 2 years. The safety of risedronate was evaluated based on adverse events, laboratory data, vital signs, and physical examination results. BMD, BTMs, and the incidence of new vertebral fractures were also assessed. A total of 218 (of 284) patients enrolled in the open-label extension. Risedronate continued to produce significant increases in lumbar spine BMD from baseline (7.87%) in the group of patients who took it for 4 years. Risedronate produced significant increases in lumbar spine BMD from baseline (6.27%) in the former placebo group who took it for 2 years during the open-label extension. Few new vertebral and clinical fractures occurred during the study. There were no significant differences in BTMs between the two groups at months 36 and 48. Incidences of any upper GI adverse events during the extension were low and similar in the two groups; however, the percent of moderate to severe events were higher (8% versus 2%) in the group that received placebo prior to the extension. Safety results continued to show that risedronate was well-tolerated in men with osteoporosis. Patients who received risedronate 35mg once a week for 2years in the open-label extension study showed similar safety and efficacy results compared with those who received risedronate treatment in the first 2 double-blind years of the study. Patients who received risedronate for 4 years in total showed similar safety and efficacy to that observed in women with postmenopausal osteoporosis treated with risedronate for 4 years. (ClinicalTrials.gov Identifier number: NCT00619957). Output: | {'conditions': 'Other Osteoporosis', 'interventions': 'Drug: Placebo tablet|Drug: Risedronate'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. An adjuvanted recombinant varicella zoster virus (VZV) subunit vaccine is being developed for the prevention of herpes zoster and its complications. In a phase I/II, open-label, randomized, parallel-group study, older adults (50-70 years) received 2 doses 2 months apart of an adjuvanted recombinant glycoprotein E vaccine (HZ/su; n = 45), a live attenuated Oka strain VZV vaccine (OKA; n = 45), or HZ/su and OKA administered concomitantly (n = 45). To evaluate safety prior to administration in older adults, young adults (18-30 years) were vaccinated with 2 doses 2 months apart of HZ/su (n = 10) or OKA (n = 10). Safety and immunogenicity were assessed up to 42 months for older adults immunized with HZ/su and up to 12 months for all others. Few grade 3 events and no severe adverse events were reported. Fatigue, myalgia, headache, and injection site pain were the most common solicited reactions for HZ/su and occurred more frequently than with OKA. CD4(+) T-cell and humoral immune responses were much higher with HZ/su than with OKA and remained elevated until 42 months. Addition of OKA to HZ/su did not increase immunogenicity. In this study, HZ/su adjuvanted subunit vaccine was well tolerated and more immunogenic than a live attenuated VZV vaccine. Clinical Trial registration. NCT00492648 and NCT00492648. Output: | {'conditions': 'Herpes Zoster (Shingles)', 'interventions': 'Procedure: Blood sampling for assay of persistence of immunogenicity'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Tobacco dependence is a chronic, relapsing condition that may require extended treatment. To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers. Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156) Academic center. 568 adult smokers. In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks). The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence. At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment. The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected. Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy. National Institutes of Health. Output: | {'conditions': 'Tobacco Use Cessation', 'interventions': 'Drug: Standard Patch Treatment|Drug: 24-weeks of nicotine patch'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Once-daily fluticasone furoate is efficacious in patients with symptomatic asthma on low-dose inhaled corticosteroids. Fluticasone furoate (FF) is an inhaled corticosteroid (ICS) with 24-hour activity in development as a once-daily treatment for the long-term management of asthma. To assess the efficacy and safety of 4 doses of once-daily FF administered using a dry powder inhaler in patients (≥12 years) with moderate asthma, uncontrolled on low-dose ICS (fluticasone propionate [FP] 200 μg/day or equivalent). This double-blind, placebo-controlled, dose-ranging study randomized 622 patients to 1 of 6 treatments: FF (100, 200, 300, or 400 μg) once daily in the evening, FP 250 μg twice daily (active control), or placebo for 8 weeks. The primary endpoint was the change from baseline in predose evening forced expiratory colume in 1 second (FEV1) at week 8. At week 8, relative to placebo, all doses of FF once daily and FP twice daily demonstrated significantly (P < .001) greater increases from baseline and greater than 200-mL increases in predose FEV1. There was no evidence of a dose-response relationship between FF doses. Improvement with once-daily FF was similar to or greater than that for twice-daily FP. Secondary efficacy endpoint findings generally supported the efficacy of FF 100 to 400 μg once daily, although statistically significant improvements versus placebo in symptom-free 24-hour periods were only reported for FF 400 μg. There were few withdrawals due to lack of efficacy. Oral candidiasis was reported in 0 to 4% of patients; 24-hour urinary cortisol excretion ratios were similar across active treatment groups and not significantly different from placebo. FF 100 to 400 μg once daily in the evening is effective and well tolerated in patients with asthma uncontrolled on low-dose ICS, with 100 μg and 200 μg, considered the most applicable doses in this asthma population. clinicaltrials.gov Identifier: NCT00603278. Output: | {'conditions': 'Asthma', 'interventions': 'Drug: GW685698X|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Population pharmacokinetics of ganciclovir after intravenous ganciclovir and oral valganciclovir administration in solid organ transplant patients infected with cytomegalovirus. A population pharmacokinetics analysis was performed after intravenous ganciclovir and oral valganciclovir in solid organ transplant patients with cytomegalovirus. Patients received ganciclovir at 5 mg/kg of body weight (5 days) and then 900 mg of valganciclovir (16 days), both twice daily with dose adjustment for renal function. A total of 382 serum concentrations from days 5 and 15 were analyzed with NONMEM VI. Renal function given by creatinine clearance (CL(CR)) was the most influential covariate in CL. The final pharmacokinetic parameters were as follows: ganciclovir clearance (CL) was 7.49.(CL(CR)/57) liter/h (57 was the mean population value of CL(CR)); the central and peripheral distribution volumes were 31.9 liters and 32.0 liters, respectively; intercompartmental clearance was 10.2 liter/h; the first-order absorption rate constant was 0.895 h(-1); bioavailability was 0.825; and lag time was 0.382 h. The CL(CR) was the best predictor of CL, making dose adjustment by this covariate important to achieve the most efficacious ganciclovir exposure. Output: | {'conditions': 'Cytomegalovirus Infection', 'interventions': 'Drug: Single arm (ganciclovir and valganciclovir)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to conjugated estrogens on dopamine and serotonin brain systems and may be a better option since it lacks the possible negative effects of estrogen on breast and uterine tissue. In this study, we assess the utility of raloxifene as an adjunctive treatment for negative symptoms and other psychotic symptoms in postmenopausal women with schizophrenia. This was a 12-week, double-blind, randomized, placebo-controlled study. Patients were recruited from both the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Barcelona, Spain, and Corporació Sanitària Parc Taulí, Sabadell, Spain. Thirty-three postmenopausal women with schizophrenia (DSM-IV criteria) who exhibited prominent negative symptoms were randomized to either adjunctive raloxifene (16 women; mean age = 60.14 years, SD = 6.41 years) or adjunctive placebo (17 women; mean age = 62.66 years, SD = 4.54 years) for 12 weeks. The period of recruitment lasted from January 2005 through June 2009. Psychopathological symptoms were assessed at baseline and weeks 4, 8, and 12 by means of the Positive and Negative Syndrome Scale. The addition of raloxifene (60 mg/d) to regular antipsychotic treatment significantly reduced negative (P = .044), positive (P = .031), and general psychopathological (P = .045) symptoms during the 12-week trial as compared with women receiving placebo. Raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia who exhibit prominent negative symptoms appears to be useful in improving negative, positive, and general psychopathological symptoms. If more extensive and longer-term studies confirm and expand upon these positive results, the use of raloxifene could be recommended in postmenopausal patients with schizophrenia. clinicaltrials.gov Identifier: NCT01041092. Output: | {'conditions': 'Schizophrenia', 'interventions': 'Drug: raloxifene'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Diabetes control with reciprocal peer support versus nurse care management: a randomized trial. Resource barriers complicate diabetes care management. Support from peers may help patients manage their diabetes. To compare a reciprocal peer-support (RPS) program with nurse care management (NCM). Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00320112) 2 U.S. Department of Veterans Affairs health care facilities. 244 men with hemoglobin A(1c) (HbA(1c)) levels greater than 7.5% during the previous 6 months. The primary outcome was 6-month change in HbA(1c) level. Secondary outcomes were changes in insulin therapy; blood pressure; and patient reports of medication adherence, diabetes-related support, and emotional distress. Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals, receive peer communication skills training, and be paired with another age-matched peer patient. Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact. These patients could also participate in optional group sessions at 1, 3, and 6 months. Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager. Of the 244 patients enrolled, 216 (89%) completed the HbA(1c) assessments and 231 (95%) completed the survey assessments at 6 months. Mean HbA(1c) level decreased from 8.02% to 7.73% (change, -0.29%) in the RPS group and increased from 7.93% to 8.22% (change, 0.29%) in the NCM group. The difference in HbA(1c) change between groups was 0.58% (P = 0.004). Among patients with a baseline HbA(1c) level greater than 8.0%, those in the RPS group had a mean decrease of 0.88%, compared with a 0.07% decrease among those in the NCM group (between-group difference, 0.81%; P < 0.001). Eight patients in the RPS group started insulin therapy, compared with 1 patient in the NCM group (P = 0.020). Groups did not differ in blood pressure, self-reported medication adherence, or diabetes-specific distress, but the RPS group reported improvement in diabetes social support. The study included only male veterans and lasted only 6 months. Reciprocal peer support holds promise as a method for diabetes care management. Output: | {'conditions': 'Diabetes', 'interventions': 'Behavioral: Peer-support telephone calls|Behavioral: group outpatient counseling visits'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial. To estimate whether a gel containing the spermicide C31G was noninferior to a commercially available product containing nonoxynol-9. Participants were healthy, sexually active women aged 18-40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. The primary study outcome was contraceptive efficacy. Sample size was calculated at a 2.5% significance level using a one-sided test based on assumed 6-month pregnancy probability of 15% in the nonoxynol-9 group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher. Nine hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized patients with at least one episode of coitus (modified intent-to-treat group), 6-month pregnancy probabilities were 12.0% (95% confidence interval [CI] 9.3-14.7%) and 12.0% (95% CI 8.7-15.3%) for C31G and nonoxynol-9,respectively. Twelve-month pregnancy probabilities were 13.8% (95% CI 7.6-20%) for C31G and 19.8% (95% CI 10.9-28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product and neither occurred in the C31G group. Three fourths of users in either group reported that they liked their assigned study product. Approximately 40% of patients discontinued prematurely for reasons other than pregnancy with 11% lost to follow-up. C31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9. C31G may provide another marketable option for women seeking spermicidal contraception. ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00274261. Output: | {'conditions': 'Pregnancy', 'interventions': 'Drug: C31G|Drug: nonoxynol-9 (N-9)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. To evaluate the efficacy and safety of saxagliptin vs. placebo in patients with type 2 diabetes mellitus (T2DM) and renal impairment. In this multicentre, randomized, parallel-group, double-blind, placebo-controlled study, patients with glycated haemoglobin (HbA1c) 7-11% and creatinine clearance <50 ml/min were stratified by baseline renal impairment (moderate, severe or end-stage on haemodialysis), and randomized (1 : 1) to saxagliptin 2.5 mg once daily or placebo for 12 weeks. Oral antihyperglycaemic drugs and insulin therapy present at enrolment were continued throughout the study. The absolute change in HbA1c from baseline to week 12 (primary efficacy end-point) was analysed using an analysis of covariance model with last observation carried forward methodology. A total of 170 patients were randomized and treated. The adjusted mean decrease from baseline to week 12 in HbA1c was statistically significantly greater in the saxagliptin group than in the placebo group; the difference between treatments was -0.42% (95% confidence interval: -0.71 to -0.12%, p = 0.007). Adjusted mean HbA1c decreases from baseline to week 12 were numerically greater with saxagliptin than with placebo in the subgroups of patients with moderate (-0.64 vs. -0.05%) and severe (-0.95 vs. -0.50%) renal impairment. HbA1c reductions were similar between saxagliptin and placebo in the subgroup with end-stage renal disease on haemodialysis (-0.84 vs. -0.87%). Saxagliptin was generally well tolerated; incidences of adverse events and hypoglycaemic events were similar to placebo. Saxagliptin 2.5 mg once daily is a well-tolerated treatment option for patients with inadequately controlled T2DM and renal impairment. Output: | {'conditions': 'Type 2 Diabetes', 'interventions': 'Drug: Saxagliptin|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:APCAP--activated protein C in acute pancreatitis: a double-blind randomized human pilot trial. Previous human studies have shown low activity of protein C (APC) in severe acute pancreatitis (SAP). This, together with the findings in animal models, suggests that activated protein C (APC) may protect against pancreatic injury and ameliorate the disease. We, therefore, evaluated its effect on multiple organ dysfunction (MOD) measured by the SOFA (Sequential Organ Failure Assessment) and on organ-failure-free days, and the safety of APC in SAP. A prospective double blind randomized pilot study was use. The study occurred in one university hospital tertiary intensive care unit (ICU) with eight beds. The patients were chosen according to the following inclusion criteria: 1) Those admitted to the hospital < 96 h from the onset of pain, 2) Those who had a three-fold increase in serum amylase over normal upper range or/and in whom computed tomography (CT) verification of SAP was noted, 3) Those who had one or more organ dysfunction (OD), and 4) Those in whom less than 48 hours had passed since their first OD. Of a total of 215 adult patients with SAP screened between June 2003 and August 2007, 158 fulfilled the study inclusion criteria. After exclusions 32 patients were randomized to the study. The intervention consisted of APC (N = 16) administered intravenously for 96 hours with a dose of 24 μg/kg/hour or placebo (N = 16) with a similar infusion rate. The sample size for the study was calculated according to the primary end-point: the change in SOFA during study drug infusion (Days 0 and 5). Comparisons between the study groups were performed using patient-related changes and calculation of difference in means (DIM, 95% CIs) and regarding categorical variables with Fisher's exact test. For all comparisons P < 0.05 was considered significant. No serious bleeding was detected clinically or by CT scans in either group. No significant difference in SOFA score change between the APC and placebo groups was found (difference in means (DIM) +2.3, 95% CI -0.7 to +5.3). Treatment with APC was associated with an increase in serum levels of both total and conjugated bilirubin. No differences in ventilator-free days, in renal replacement therapy-free days, in vasopressor-free days, or in days alive outside the hospital were detected. No serious bleeding or differences in the evolution of MOD were detected between APC and the placebo. Instead we found an increase in serum bilirubin in the APC group compared to the placebo group in patients with SAP. ClinicalTrials.gov NCT01017107. Output: | {'conditions': 'Acute Pancreatitis', 'interventions': 'Drug: Activated protein C'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Comparison between intermittent mandatory ventilation and synchronized intermittent mandatory ventilation with pressure support in children. To compare intermittent mandatory ventilation (IMV) with synchronized intermittent mandatory ventilation plus pressure support (SIMV+PS) in terms of time on mechanical ventilation, duration of weaning and length of stay in a pediatric intensive care unit (PICU). This was a randomized clinical trial that enrolled children aged 28 days to 4 years who were admitted to a PICU between October of 2005 and June of 2007 and put on mechanical ventilation (MV) for more than 48 hours. These patients were allocated to one of two groups by drawing lots: IMV group (IMVG; n = 35) and SIMV+PS group (SIMVG; n = 35). Children were excluded if they had undergone tracheotomy or had chronic respiratory diseases. Data on oxygenation and ventilation were recorded at admission and at the start of weaning. There were no statistical differences between the groups in terms of age, sex, indication for MV, PRISM score, Comfort scale, use of sedatives or ventilation and oxygenation parameters. The median time on MV was 5 days for both groups (p = 0.120). There were also no statistical differences between the two groups for duration of weaning [IMVG: 1 day (1-6) vs. SIMVG: 1 day (1-6); p = 0.262] or length of hospital stay [IMVG: 8 days (2-22) vs. SIMVG: 6 days (3-20); p = 0.113]. Among the children studied here, there was no statistically significant difference between IMV and SIMV+PS in terms of time on MV, duration of weaning or time spent in the PICU. ClinicalTrials.govID: NCT00549809. Output: | {'conditions': 'Respiratory Failure', 'interventions': 'Procedure: Intermittent mandatory ventilation (IMV) and synchronous IMV'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Indacaterol is a novel, inhaled, once-daily ultra long-acting β(2)-agonist (ultra-LABA) for the treatment of COPD. This study investigated the effect of indacaterol on exercise endurance, and on lung hyperinflation during exercise and at rest in patients with moderate-to-severe COPD. In this double-blind, placebo-controlled, two-period crossover study (3-week treatment, 3-week washout between treatments), patients were randomized to receive indacaterol 300 μg once-daily or matching placebo. The primary efficacy variable was exercise endurance time after 3 weeks of treatment, measured through constant-load cycle ergometry testing performed at 75% of the peak work rate in a screening incremental exercise test. Of 90 patients randomized (mean age: 62.8 years; post-bronchodilator FEV(1): 61.2% predicted and FEV(1)/FVC: 51.6%), 74 completed the study. Pre-treatment exercise tolerance averaged 459 s. Improvement in exercise endurance time was higher with indacaterol 300 μg than with placebo both after the first dose (treatment difference: 101 s; p < 0.001) and after 3 weeks (treatment difference: 111 s; p = 0.011). In addition, indacaterol increased end-exercise inspiratory capacity (IC) versus placebo after 3 weeks (0.28 L, p = 0.002). Significant improvements were also observed in resting IC (0.17 L, p = 0.001), FEV(1) (0.25 L, p < 0.001) and FVC (0.26 L, p < 0.001) with indacaterol compared with placebo at 75 min post-dose after 3 weeks. In conclusion, indacaterol treatment improved the ability of patients with COPD to exercise. In addition, the improvements observed in resting and end-exercise IC indicate reductions in lung hyperinflation after 3 weeks treatment (ClinicalTrials.gov registration number: NCT00620022). Output: | {'conditions': 'Chronic Obstructive Pulmonary Disease', 'interventions': 'Drug: Indacaterol 300 μg|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial. Artemisinin-based combination therapies (ACTs) are the mainstay for the management of uncomplicated malaria cases. However, up-to-date data able to assist sub-Saharan African countries formulating appropriate antimalarial drug policies are scarce. Between 9 July 2007 and 19 June 2009, a randomized, non-inferiority (10% difference threshold in efficacy at day 28) clinical trial was carried out at 12 sites in seven sub-Saharan African countries. Each site compared three of four ACTs, namely amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL), or chlorproguanil-dapsone-artesunate (CD+A). Overall, 4,116 children 6-59 mo old with uncomplicated Plasmodium falciparum malaria were treated (1,226 with AL, 1,002 with ASAQ, 413 with CD+A, and 1,475 with DHAPQ), actively followed up until day 28, and then passively followed up for the next 6 mo. At day 28, for the PCR-adjusted efficacy, non-inferiority was established for three pair-wise comparisons: DHAPQ (97.3%) versus AL (95.5%) (odds ratio [OR]: 0.59, 95% CI: 0.37-0.94); DHAPQ (97.6%) versus ASAQ (96.8%) (OR: 0.74, 95% CI: 0.41-1.34), and ASAQ (97.1%) versus AL (94.4%) (OR: 0.50, 95% CI: 0.28-0.92). For the PCR-unadjusted efficacy, AL was significantly less efficacious than DHAPQ (72.7% versus 89.5%) (OR: 0.27, 95% CI: 0.21-0.34) and ASAQ (66.2% versus 80.4%) (OR: 0.40, 95% CI: 0.30-0.53), while DHAPQ (92.2%) had higher efficacy than ASAQ (80.8%) but non-inferiority could not be excluded (OR: 0.35, 95% CI: 0.26-0.48). CD+A was significantly less efficacious than the other three treatments. Day 63 results were similar to those observed at day 28. This large head-to-head comparison of most currently available ACTs in sub-Saharan Africa showed that AL, ASAQ, and DHAPQ had excellent efficacy, up to day 63 post-treatment. The risk of recurrent infections was significantly lower for DHAPQ, followed by ASAQ and then AL, supporting the recent recommendation of considering DHAPQ as a valid option for the treatment of uncomplicated P. falciparum malaria. ClinicalTrials.gov NCT00393679; Pan African Clinical Trials Registry PACTR2009010000911750 Output: | {'conditions': 'Fever|Malaria', 'interventions': 'Drug: amodiaquine-artesunate (ASAQ)|Drug: dihydroartemisinin-piperaquine (DHAPQ)|Drug: artemether-lumefantrine (AL)|Drug: Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. The progression-free and median survival of patients with advanced ovarian cancer has not appreciably improved over the last decade. Novel targeted therapies, particularly antiangiogenic agents, may potentially improve clinical outcomes in patients with ovarian cancer. This phase II, open-label study evaluated oral pazopanib monotherapy in patients with low-volume recurrent ovarian cancer. Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with complete CA-125 response to initial platinum-based chemotherapy and subsequent elevation of CA-125 to ≥ 42 U/mL (> 2 × ULN) were treated with pazopanib 800 mg once daily until PD or unacceptable toxicity. This Green-Dahlberg study required 2 CA-125 responses in stage I (20 patients) to proceed to stage II (15 patients). The primary endpoint was CA-125 response (≥ 50% decrease from baseline, confirmed ≥ 21 days after initial evaluation). Eleven of 36 patients (31%) had a CA-125 response to pazopanib, with median time to response of 29 days and median response duration of 113 days. Overall response rate was 18% in patients with measurable disease at baseline. The most common adverse events leading to discontinuation of study drug were grade 3 ALT (8%) and AST (8%) elevation. Only 1 grade 4 toxicity (peripheral edema) was reported. Pazopanib monotherapy was relatively well tolerated, with toxicity similar to other small-molecule, oral angiogenesis inhibitors, and demonstrated promising single-agent activity in patients with recurrent ovarian cancer. Further studies evaluating the potential role of pazopanib in patients with ovarian cancer are ongoing. Output: | {'conditions': 'Malignant Tumor of Peritoneum|Ovarian Cancer|Neoplasms, Ovarian|Fallopian Tube Cancer', 'interventions': 'Drug: GW786034'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. Tuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to the timing for the initiation of antiretroviral therapy (ART) in relation to the start of antituberculosis therapy. We tested the hypothesis that the timing of ART initiation would significantly affect mortality among adults not previously exposed to antiretroviral drugs who had newly diagnosed tuberculosis and CD4+ T-cell counts of 200 per cubic millimeter or lower. After beginning the standard, 6-month treatment for tuberculosis, patients were randomly assigned to either earlier treatment (2 weeks after beginning tuberculosis treatment) or later treatment (8 weeks after) with stavudine, lamivudine, and efavirenz. The primary end point was survival. A total of 661 patients were enrolled and were followed for a median of 25 months. The median CD4+ T-cell count was 25 per cubic millimeter, and the median viral load was 5.64 log(10) copies per milliliter. The risk of death was significantly reduced in the group that received ART earlier, with 59 deaths among 332 patients (18%), as compared with 90 deaths among 329 patients (27%) in the later-ART group (hazard ratio, 0.62; 95% confidence interval [CI]; 0.44 to 0.86; P=0.006). The risk of tuberculosis-associated immune reconstitution inflammatory syndrome was significantly increased in the earlier-ART group (hazard ratio, 2.51; 95% CI, 1.78 to 3.59; P<0.001). Irrespective of the study group, the median gain in the CD4+ T-cell count was 114 per cubic millimeter, and the viral load was undetectable at week 50 in 96.5% of the patients. Initiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower. (Funded by the French National Agency for Research on AIDS and Viral Hepatitis and the National Institutes of Health; CAMELIA ClinicalTrials.gov number, NCT01300481.). Output: | {'conditions': 'HIV Infections|Tuberculosis', 'interventions': 'Drug: Antiretroviral therapy (ARV)|Drug: Tuberculosis (TB) treatment'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Neurotrophic bone marrow cellular nests prevent spinal motoneuron degeneration in amyotrophic lateral sclerosis patients: a pilot safety study. The objective of this article is to assess the safety of intraspinal infusion of autologous bone marrow mononuclear cells (BMNCs) and, ultimately, to look for histopathological signs of cellular neurotrophism in amyotrophic lateral sclerosis (ALS) patients. We conducted an open single arm phase I trial. After 6 months observation, autologous BMNCs were infused into the posterior spinal cord funiculus. Safety was the primary endpoint and was defined as the absence of serious transplant-related adverse events. In addition, forced vital capacity (FVC), ALS-functional rating scale (ALS-FRS), Medical Research Council scale for assessment of muscle power (MRC), and Norris scales were assessed 6 and 3 months prior to the transplant and quarterly afterward for 1 year. Pathological studies were performed in case of death. Eleven patients were included. We did not observe any severe transplant-related adverse event, but there were 43 nonsevere events. Twenty-two (51%) resolved in ≤2 weeks and only four were still present at the end of follow-up. All were common terminology criteria for adverse events grade ≤2. No acceleration in the rate of decline of FVC, ALS-FRS, Norris, or MRC scales was observed. Four patients died on days 359, 378, 808, and 1,058 post-transplant for reasons unrelated to the procedure. Spinal cord pathological analysis showed a greater number of motoneurons in the treated segments compared with the untreated segments (4.2 ± 0.8 motoneurons per section [mns per sect] and 0.9 ± 0.3 mns per sect, respectively). In the treated segments, motoneurons were surrounded by CD90+ cells and did not show degenerative ubiquitin deposits. This clinical trial confirms not only the safety of intraspinal infusion of autologous BMNC in ALS patients but also provides evidence strongly suggesting their neurotrophic activity. Output: | {'conditions': 'Amyotrophic Lateral Sclerosis', 'interventions': 'Procedure: Laminectomy and bone marrow stem cells transplantation|Procedure: Autologous bone marrow cells collection'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. This double-blind trial investigated the efficacy and safety of estradiol valerate/dienogest (E(2)V/DNG) for the treatment of heavy menstrual bleeding without recognizable organic pathology. Otherwise healthy women with idiopathic heavy, prolonged or frequent menstrual bleeding, confirmed during a 90-day run-in phase, were randomized (2:1) according to a permuted-block, computer-generated schedule to E(2)V/DNG or placebo for 196 days at 34 centres in Europe and Australia. The primary efficacy end-point was the proportion of women with a 'complete' response (i.e. a return to 'menstrual normality') during a 90-day efficacy phase. Secondary end-points included changes in measured menstrual blood loss (MBL) and iron metabolism parameters. The intention-to-treat population comprised 231 women. The E(2)V/DNG response rate was much higher than with placebo (P < 0.0001). The mean reduction in MBL volume in E(2)V/DNG recipients was 69.4% (median 79.2%) versus 5.8% (median 7.4%) in placebo recipients. The between-treatment difference in MBL volume was 373 ml in favour of E(2)V/DNG (95% confidence interval 490, 255 ml; P < 0.0001). Significant improvements in iron metabolism parameters were observed with E(2)V/DNG but not placebo. Overall, 14 women (9.7%) treated with E(2)V/DNG and 5 (6.2%) treated with placebo prematurely discontinued treatment because of adverse events, headache being the most prevalent. Serious adverse events occurred in both the E(2)V/DNG and placebo groups (each n = 2). E(2)V/DNG is an effective treatment in women with heavy and/or prolonged menstrual bleeding without organic pathology. Further study of E(2)V/DNG compared with an active comparator is warranted. ClinicalTrials.gov identifier: NCT00307801. Output: | {'conditions': 'Metrorrhagia', 'interventions': 'Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Responses to adalimumab in patients with active psoriatic arthritis who have not adequately responded to prior therapy: effectiveness and safety results from an open-label study. To evaluate the effectiveness and safety of adalimumab in patients with active psoriatic arthritis (PsA) and an inadequate response to prior therapy. Patients were treated with subcutaneous injections of adalimumab 40 mg every other week in addition to their standard antirheumatic therapies in a 12-week, open-label study. Effectiveness evaluations at Week 12 included American College of Rheumatology (ACR) and Psoriasis Area and Severity Index (PASI) response rates, Psoriatic Arthritis Response Criteria (PsARC), active dactylitis, enthesitis, and target lesion assessment. Physical function was evaluated using the Health Assessment Questionnaire Disability Index (HAQ-DI). A total of 127 patients were enrolled. At Week 12, patients achieved ACR20, ACR50, and ACR70 response rates of 78.0%, 55.9%, and 21.3%, respectively. PASI50 and PASI75 response rates were 64.7% and 47.1%. A PsARC response was experienced by 70.1% of patients. Between baseline and Week 12, clinically and statistically significant reductions occurred in the mean total plaque score of the target lesion as well as in the percentages of patients with active dactylitis and enthesitis. A mean improvement in HAQ-DI was also observed (-0.44; p < 0.001). Three serious adverse events were reported, but none was considered related to adalimumab therapy. Adalimumab-treated patients achieved significant improvements in both skin and joint manifestations of PsA, as well as in physical function. Adalimumab was well tolerated and had a safety profile similar to that observed in other clinical trials of adalimumab for the treatment of PsA. ClinicalTrials.gov identifier: NCT00427362. Output: | {'conditions': 'Psoriatic Arthritis', 'interventions': 'Drug: Adalimumab'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomised clinical trial: the efficacy and safety of propionyl-L-carnitine therapy in patients with ulcerative colitis receiving stable oral treatment. Ulcerative colitis (UC) is characterised by impaired fatty-acid oxidation; l-carnitine has a key role in fatty-acid metabolism and short-chain fatty acids such as butyrate and propionate are important energy source for intestinal epithelial cells. To evaluate efficacy and safety of colon-release propionyl-L-carnitine (PLC) in patients with mild-to-moderate UC receiving stable oral aminosalicylate or thiopurine therapy. In a multicentre, phase II, double-blind, parallel-group trial, patients were randomised to receive PLC 1 g/day, PLC 2 g/day or placebo. Main inclusion criteria were as follows: age 18-75; disease activity index (DAI) score 3-10 inclusive, be under oral stable treatment with aminosalicylate or thiopurine. The primary endpoint was clinical/endoscopic response, defined as a decrease in DAI score ≥ 3 points or remission, defined as a DAI score ≤ 2 with no individual sub-score > 1. Of 121 patients who were randomised, 57 of 79 (72%) patients receiving PLC (combined 1 g and 2 g cohort) had a clinical/endoscopic response vs. 20 of 40 (50%) receiving placebo (P = 0.02). Specifically, in PLC 1 g/day group, 30 of 40 (75%) patients had clinical/endoscopic response (P = 0.02 vs. placebo) and 27 of 39 (69%) in the PLC 2 g/day group (P = 0.08 vs. placebo). Rates of remission were 22/40 (55%), 19/39 (49%), 14/40 (35%) in the PLC 1 g, PLC 2 g, and placebo groups, respectively. PLC had a similar safety profile to placebo; the most common adverse events were gastrointestinal. Propionyl-L-carnitine 1 g/day should be investigated further as a co-treatment for mild-to-moderate ulcerative colitis (NCT-01026857). Output: | {'conditions': 'Ulcerative Colitis', 'interventions': 'Drug: Propionyl-L-Carnitine|Drug: Propionyl-L-Carnitine|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Long-term evaluation of sumatriptan and naproxen sodium for the acute treatment of migraine in adolescents. To evaluate the long-term safety, tolerability, effectiveness, impact on quality of life, and medication satisfaction of sumatriptan/naproxen sodium in the acute treatment of migraine headache in adolescents. This 12-month, multicenter, open-label, safety study was conducted in adolescents (aged 12-17 years) with an average of 2-8 migraines/month typically lasting >2 hours untreated for >6 months prior to initiation. Subjects were instructed to treat migraines as early as possible and were allowed to rescue 2 hours post dose with a single dose of a naproxen-containing product, over-the-counter pain reliever, or anti-emetics. Subjects were advised not to take a second tablet of sumatriptan/naproxen sodium without at least a 24-hour headache-free period. Safety evaluations included adverse events, laboratory tests, and vital signs and electrocardiogram evaluation. Other evaluations included freedom from pain, quality of life, and medication satisfaction. Of the 656 subjects enrolled, 622 (95%) treated at least 1 migraine with sumatriptan/naproxen sodium, of which 435 (70%) and 363 (58%) completed 6 and 12 months of the study, respectively. Overall, there were 12,927 exposures to sumatriptan/naproxen sodium: on average 2.5 tablets were taken per month per subject. The most common treatment-related adverse events were nausea (7%), dizziness (3%), muscle tightness (3%), and chest discomfort (3%). There were no deaths; 4 subjects had 5 serious adverse events (suicide attempt, hemolytic anemia and syncope, suicidal ideation, spontaneous abortion) unrelated to sumatriptan/naproxen sodium and resolved without sequelae. Seven percent of subjects discontinued participation in the study because of an adverse event; 5% of subjects discontinued due to lack of efficacy. Overall, 42% of the migraine attacks were pain-free within 2 hours of treatment with sumatriptan/naproxen sodium, subjects reported improvements from baseline in 2 of 3 quality of life domains over time, and were generally satisfied with the efficacy and overall treatment at the end of the study. In adolescent migraineurs, after up to 12 months and over 12,000 exposures to sumatriptan/naproxen sodium, there were no new or clinically significant findings in the safety parameters, including the frequency and nature of adverse events, as compared to the individual components or to the adverse event profile in adults. In addition, sumatriptan/naproxen sodium provided freedom from pain over time, improvements in quality of life and medication satisfaction. Output: | {'conditions': 'Migraine Disorders', 'interventions': 'Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Enhanced efficacy of pegylated interferon alpha-2a over pegylated interferon and ribavirin in chronic hepatitis C genotype 4A randomized trial and quality of life analysis. The therapy of chronic hepatitis C genotype 4 (HCV-4) has not been optimized yet. This randomized, prospective, parallel-group clinical trial compared the efficacy and safety of pegylated interferon α-2a (PEG-IFN α-2a) plus ribavirin and PEG-IFN α-2b plus ribavirin and assessed the health-related quality of life (HRQOL) in patients with chronic HCV-4. Eligible patients with proven chronic HCV-4 were randomized to receive either a weekly dose of PEG-IFN α-2a (180 μg) or PEG-IFN α-2b (1.5 μg/kg) and a daily dose of ribavirin (1000-1200 mg) for 48 weeks with 24 weeks post-treatment follow-up. The primary end point was sustained virological response (SVR) defined by undetectable HCV RNA 24 weeks after treatment. The Short form-36 Health Survey version 2 (SF-36v2) and the Chronic Liver Disease questionnaires (CLDQ) were assessed before, during and after therapy. The overall SVR rate of the entire cohort was 59.9%. The SVR rates were significantly higher in patients treated with PEG-IFN α-2a and ribavirin (Group A; n=109) compared with those treated with PEG-IFN α-2b and ribavirin (Group B; n=108, 70.6 vs. 54.6%, respectively; P=0.017). The relapse rates were 5.1% for PEG-IFN α-2a and 15.7% for PEG-IFN α-2b (P=0.0019). The SF-36v2 and CLDQ were low during therapy and improved significantly after therapy successful therapy. Pegylated interferon α-2a plus ribavirin was significantly more effective than PEG-IFN α-2b and ribavirin therapy in the treatment of chronic HCV-4 patients. The tolerability and adverse events were comparable between the two regimens. The HRQOL improved significantly after successful PEG-IFN α-2a plus ribavirin therapy. Output: | {'conditions': 'Hepatitis C', 'interventions': 'Drug: Pegylated interferon alpha 2a|Drug: Ribavirin|Drug: Pegylated interferon alpha 2 b plus ribavirin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study. Since current treatment options for patients suffering from active rheumatoid arthritis (RA) remain inadequate, especially for those unresponsive to disease-modifying antirheumatic drugs (DMARDs), new and improved medication is needed. This study evaluates the safety and efficacy of masitinib (AB1010), a potent and selective protein tyrosine kinase inhibitor of c-KIT, in the monotherapy treatment of DMARD-refractory RA. This was a multicentre, uncontrolled, open-label, randomised, dose-ranging, phase 2a trial. Masitinib was administered orally to 43 patients who had inadequate response to DMARDs, at initial randomised dosing levels of 3 and 6 mg/kg per day over a 12-week period. Dose adjustment was permitted based upon tolerability and response criteria. Efficacy was assessed via American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) responses, disease activity score using 28 joint counts (DAS28), index of improvement in RA (ACRn) and C-reactive protein (CRP) improvement, relative to baseline at week 12. Improvement was observed in all efficacy endpoints, including ACR20/50/70 scores of 54%, 26% and 8%, respectively, and a reduction in CRP level by greater than 50% for approximately half the population. This improvement was sustainable throughout an extension phase (> 84 weeks) and was also independent of initial DMARD resistance (anti-tumour necrosis factor-alpha and/or methotrexate). A relatively high patient withdrawal rate (37%) required the use of last observation carried forward (LOCF) data imputation. Incidence of adverse events was high (95%), although the majority were of mild or moderate severity with a considerable decline in frequency observed after 12 weeks of treatment. Two nonfatal serious adverse events were reported. Dose-response analyses tentatively indicate that an initial dosing level of 6.0 mg/kg per day administered orally in two daily intakes is the most appropriate, based upon potency and tolerability trends. Treatment with masitinib improved DMARD-refractory active RA. Following an initial high incidence of mostly mild to moderate side effects during the first 12 weeks of treatment, masitinib appears to be generally well tolerated. This, together with evidence of a sustainable efficacy response, suggests that masitinib is suitable for long-term treatment regimens. Since this was the first study of masitinib in a nononcologic pathology, the relatively high patient withdrawal rate observed can be partly attributed to a highly cautious response to adverse events. There is sufficient compelling evidence to warrant further placebo-controlled investigation. ClinicalTrials.gov NCT00831922. Output: | {'conditions': 'Rheumatoid Arthritis', 'interventions': 'Drug: masitinib (AB1010)|Drug: masitinib (AB1010)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Long-term leucine supplementation does not increase muscle mass or strength in healthy elderly men. It has been reported that the blunted muscle protein synthetic response to food intake in the elderly can be normalized by increasing the leucine content of a meal. The objective was to assess the effect of 3 mo of leucine supplementation on muscle mass and strength in healthy elderly men. Thirty healthy elderly men with a mean (+/-SEM) age of 71 +/- 4 y and body mass index (BMI; in kg/m(2)) of 26.1 +/- 0.5 were randomly assigned to either a placebo-supplemented (n = 15) or leucine-supplemented (n = 15) group. Leucine or placebo (2.5 g) was administered with each main meal during a 3-mo intervention period. Whole-body insulin sensitivity, muscle strength (one-repetition maximum), muscle mass (measured by computed tomography and dual-energy X-ray absorptiometry), myosin heavy chain isoform distribution, and plasma amino acid and lipid profiles were assessed before, during, and/or after the intervention period. No changes in skeletal muscle mass or strength were observed over time in either the leucine- or placebo-supplemented group. No improvements in indexes of whole-body insulin sensitivity (oral glucose insulin sensitivity index and the homeostasis model assessment of insulin resistance), blood glycated hemoglobin content, or the plasma lipid profile were observed. Long-term leucine supplementation (7.5 g/d) does not augment skeletal muscle mass or strength and does not improve glycemic control or the blood lipid profile in healthy elderly men. This trial was registered at clinicaltrials.gov as NCT00807508. Output: | {'conditions': 'Sarcopenia|Atrophy|Aging', 'interventions': 'Dietary Supplement: placebo|Dietary Supplement: leucine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab versus epirubicin, cyclophosphamide, vinblastine, prednisone and rituximab for the initial treatment of elderly "fit" patients with diffuse large B-cell lymphoma: results from the ANZINTER3 trial of the Intergruppo Italiano Linfomi. We conducted a prospective study to compare epirubicin, cyclophosphamide, vinblastine, prednisone and rituximab (R-miniCEOP) with cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab (R-CHOP) for the treatment of "fit" elderly patients with diffuse large B-cell lymphoma (DLBCL). Patients over the age of 65 with stage II-IV DLBCL were screened with a comprehensive geriatric assessment. Patients were randomized to receive six courses of R-miniCEOP (n = 114) or R-CHOP (n = 110). Overall, the rate of complete remission was 70% (p = 0.466). After a median follow-up of 42 months, 5-year event-free survival (EFS) rates were 46% and 48% for R-miniCEOP and R-CHOP, respectively (p = 0.538). Patients older than 72 years and with low-risk disease had a better outcome when treated with R-miniCEOP (p = 0.011). Overall R-CHOP and R-miniCEOP are similarly effective for elderly "fit" patients with DLBCL. The less intense R-miniCEOP may be an acceptable option for the treatment of relatively older patients with low-risk disease. Output: | {'conditions': 'Elderly Patients (>65 Years)|Diffuse Large B Cell Lymphoma (DLBCL)', 'interventions': 'Drug: Cyclophosphamide|Drug: Cyclophosphamide|Drug: Doxorubicin|Drug: Vincristine|Drug: Prednisone|Drug: Prednisone|Drug: Epirubicin|Drug: Vinblastine|Drug: Rituximab|Drug: G-CSF'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A randomized trial comparing the effect of two phone-based interventions on colorectal cancer screening adherence. Early-stage diagnosis of colorectal cancer is associated with high survival rates; screening prevalence, however, remains suboptimal. This study seeks to test the hypothesis that participants receiving telephone-based tailored education or motivational interviewing had higher colorectal cancer screening completion rates compared to usual care. Primary care patients not adherent with colorectal cancer screening and with no personal or family history of cancer (n = 515) were assigned by block randomization to control (n = 169), tailored education (n = 168), or motivational interview (n = 178). The response rate was 70%; attrition was 24%. Highest screening occurred in the tailored education group (23.8%, p < .02); participants had 2.2 times the odds of completing a post-intervention colorectal cancer screening than did the control group (AOR = 2.2, CI = 1.2-4.0). Motivational interviewing was not associated with significant increase in post-intervention screening. Tailored education showed promise as a feasible strategy to increase colorectal cancer screening. Output: | {'conditions': 'Colorectal Cancer Screening', 'interventions': 'Behavioral: Tailored counseling|Behavioral: Motivational Interview|Behavioral: control'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomized comparison of eptifibatide versus abciximab in primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: results of the EVA-AMI Trial. The aim of this study was to compare eptifibatide and abciximab as adjuncts to primary percutaneous coronary intervention (PCI). The glycoprotein (GP) IIb/IIIa receptor inhibitor abciximab as adjunct to primary PCI in patients with ST-segment elevation myocardial infarctions has been shown to reduce ischemic complications and improve clinical outcomes. So far, no trial has been performed to compare the efficacy of another GP IIb/IIIa receptor inhibitor, eptifibatide, and abciximab in primary PCI. A total of 427 patients with ST-segment elevation myocardial infarctions <12 h and planned primary PCI were randomized to double-bolus eptifibatide (n = 226) followed by a 24-h infusion or single-bolus abciximab (n = 201) followed by a 12-h infusion. In this noninferiority trial, the primary end point was the incidence of complete (> or =70%) ST-segment resolution (STR) 60 min after PCI, a measure of myocardial reperfusion. The assumption was a 60% complete STR rate in the abciximab group. The noninferiority margin was set to 15%. The incidence of complete STR at 60 min after PCI in the intention-to-treat analysis was 62.6% after eptifibatide and 56.3% after abciximab (adjusted difference: 7.1%; 95% confidence interval: 2.7% to 17.0%). All-cause mortality 6.2% versus 4.5% (p = 0.50); reinfarction 0.4% versus 3.5% (p = 0.03); target vessel revascularization 4.4% versus 6.5% (p = 0.40); the combined end point of death, nonfatal reinfarction, and target vessel revascularization 10.6% versus 10.9% (p = 0.90); stroke 0.5% versus 0.5% (p = 1.00) after 6 months; and Thrombolysis In Myocardial Infarction major bleeding complications 4.0% versus 2.0% (p = 0.20) after 30 days were observed after eptifibatide and abciximab, respectively. Eptifibatide as an adjunct to primary PCI is equally as effective as abciximab with respect to STR. (Efficacy of Eptifibatide Compared to Abciximab in Primary Percutaneous Coronary Intervention [PCI] for Acute ST Elevation Myocardial Infarction [STEMI]; NCT00426751). Output: | {'conditions': 'Infarction, Myocardial', 'interventions': 'Drug: Abciximab|Drug: Eptifibatide'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Twenty-four-hour ambulatory blood pressure monitoring (ABPM) has been shown to be more reliable than conventional measurements for hypertension assessment and the associated increased risk of cardiovascular events. Olmesartan/hydrochlorothiazide combination therapy has demonstrated increased blood pressure lowering over 24 hours compared with the component monotherapies. This prespecified pooled analysis of data from two trials investigated the effects of olmesartan/hydrochlorothiazide combination therapy and olmesartan monotherapy on 24-hour blood pressure control in patients with moderate-to-severe hypertension. After 8 weeks' open-label olmesartan 40 mg monotherapy, uncontrolled patients (mean trough seated blood pressure 90-115/140-180 mmHg and 24-hour mean ambulatory diastolic blood pressure ≥80 mmHg with ≥30% of daytime ambulatory diastolic blood pressure readings >85 mmHg) were randomised to 8 weeks' double-blind treatment with olmesartan 40 mg or olmesartan/hydrochlorothiazide 20/12.5, 40/12.5 or 40/25 mg (Study 1) or olmesartan/hydrochlorothiazide 20/25 or 40/25 mg (Study 2). This prespecified analysis of ambulatory blood pressure was performed on patients from the full analysis set of pooled studies 1 and 2, restricted to patients who provided at least one valid ABPM measurement at baseline. After 8 weeks' double-blind treatment, reductions in 24-hour, daytime and night-time blood pressure from baseline were observed for all treatment groups. These reductions were dose-dependent, with olmesartan/hydrochlorothiazide 40/25 mg demonstrating the greatest reductions in 24-hour blood pressure from baseline to Week 16 versus olmesartan monotherapy: -14.0/-8.8 vs -2.7/-2.0 mmHg, respectively; p < 0.0001. Adding hydrochlorothiazide to olmesartan provides more effective 24-hour blood pressure control versus olmesartan monotherapy in patients with moderate-to-severe hypertension. Study 1: EudraCT Number: 2006-003876-37; ClinicalTrials.gov identifier: NCT00430508; Study 2: EudraCT Number: 2006-003876-28; ClinicalTrials.gov identifier: NCT00430950. Output: | {'conditions': 'Essential Hypertension', 'interventions': 'Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo|Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets|Drug: olmesartan medoxomil/hydrochlorothiazide tablets|Drug: olmesartan medoxomil/hydrochlorothiazide tablets'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. 7-Valent pneumococcal conjugate vaccine (PCV7 [Prevnar, Wyeth Pharmaceuticals Inc, Philadelphia, PA], serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) is effective in preventing vaccine-serotype pneumococcal disease. 13-Valent pneumococcal conjugate vaccine (PCV13) (PCV7 serotypes plus 1, 3, 5, 6A, 7F, and 19A) was designed to provide broader pneumococcal disease coverage. We evaluated the immunogenicity and safety of PCV13 compared with PCV7. Infants received PCV13 or PCV7 at ages 2, 4, 6, and 12 to 15 months with routine pediatric vaccinations. Pneumococcal anticapsular polysaccharide-binding immunoglobulin G responses and functional antipneumococcal opsonophagocytic activity were assessed 1 month after dose 3, before the toddler dose, and 1 month after the toddler dose. Safety and tolerability were also assessed. For the 7 common serotypes, PCV13-elicited immunoglobulin G titers were noninferior to those elicited by PCV7, although PCV13 responses were generally somewhat lower. PCV13 also elicited functional opsonophagocytic activity comparable with that elicited by PCV7. For the 6 additional serotypes in PCV13, PCV13 elicited binding and functional antibody levels notably greater than those in PCV7 recipients. After PCV13 immunization, concordance between antipolysaccharide and opsonophagocytic responses was noted for all 13 serotypes. The PCV13 toddler dose resulted in higher immune responses compared with infant-series doses. Safety and tolerability were comparable; reactogenicity was generally mild. PCV13 will be as effective as PCV7 in the prevention of pneumococcal disease caused by the 7 common serotypes and could provide expanded protection against the 6 additional serotypes. The PCV13 safety profile was comparable to that of PCV7. Output: | {'conditions': 'Vaccines, Pneumococcal', 'interventions': 'Biological: 13 valent pneumococcal conjugate vaccine|Biological: 7vPnc pneumococcal conjugate vaccine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Tanezumab for the treatment of pain from osteoarthritis of the knee. Increased expression of nerve growth factor in injured or inflamed tissue is associated with increased pain. This proof-of-concept study was designed to investigate the safety and analgesic efficacy of tanezumab, a humanized monoclonal antibody that binds and inhibits nerve growth factor. We randomly assigned 450 patients with osteoarthritis of the knee to receive tanezumab (administered at a dose of 10, 25, 50, 100, or 200 μg per kilogram of body weight) or placebo on days 1 and 56. The primary efficacy measures were knee pain while walking and the patient's global assessment of response to therapy. We also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety. When averaged over weeks 1 through 16, the mean reductions from baseline in knee pain while walking ranged from 45 to 62% with various doses of tanezumab, as compared with 22% with placebo (P<0.001). Tanezumab, as compared with placebo, was also associated with significantly greater improvements in the response to therapy as assessed with the use of the patients' global assessment measure (mean increases in score of 29 to 47% with various doses of tanezumab, as compared with 19% with placebo; P≤0.001). The rate of response according to the OMERACT-OARSI criteria ranged from 74 to 93% with tanezumab treatment, as compared with 44% with placebo (P<0.001). The rates of adverse events were 68% and 55% in the tanezumab and placebo groups, respectively. The most common adverse events among tanezumab-treated patients were headache (9% of the patients), upper respiratory tract infection (7%), and paresthesia (7%). In this proof-of-concept study, treatment with tanezumab was associated with a reduction in joint pain and improvement in function, with mild and moderate adverse events, among patients with moderate-to-severe osteoarthritis of the knee. (Funded by Rinat Neuroscience; ClinicalTrials.gov number, NCT00394563.). Output: | {'conditions': 'Osteoarthritis', 'interventions': 'Drug: RN624 (PF-04383119)|Drug: RN624 (PF-04383119)|Drug: RN624 (PF-04383119)|Drug: RN624 (PF-04383119)|Drug: RN624 (PF-04383119)|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Three generic nevirapine-based antiretroviral treatments in Chinese HIV/AIDS patients: multicentric observation cohort. The purpose of this study was to evaluate the efficacy and safety of three nevirapine-based antiretroviral treatments for adult antiretroviral-naïve Chinese patients with HIV-1 infection. This was a prospective, multicenter study. 198 antiretroviral-naïve HIV-1 positive subjects with CD4 lymphocyte counts between 100/ul and 350/ul and plasma HIV-1 RNA levels more than 500 copies/ml were randomized to start three NVP-based antiretroviral treatments: group A, NVP+AZT+ddI; group B, NVP+3TC+d4T; group C, NVP+AZT+3TC. Viral responses, immunologic responses, adverse events and drug resistance were monitored at baseline and the end of week 4, 12, 24, 36, 52. Viralogical response and immunological response were also compared in different strata of baseline CD4 T lymphocyte counts and plasma HIV-1 RNA concentrations. At baseline, the plasma HIV-1 RNA was 4.44+/-0.68, 4.52+/-0.71 and 4.41+/-0.63 lg copies/ml in group A, B and C respectively (p = 0.628). At the end of the study, the plasma viral load reached 2.54+/-1.11, 1.89+/-0.46 and 1.92+/-0.58 lg copies/ml in group A, B and C respectively (p<0.001). At week 52, suppression of plasma HIV-1 RNA to less than 50 copies/ml was achieved in more patients in group B and C than in group A (68.2%, 69% vs. 39.7%; p<0.001). In planned subgroup analyses, the decrease of viral response rate was seen in group A when CD4 cell count >200/ul (subgroup H). But in subgroup L, viral response rate of three groups has no significant statistic difference. There were no statistically significant differences among three groups in immunological response within any of the CD4 or pVL strata. 3 out of 193 patients with available genotype at baseline showed primary drug resistant. Of 26 patients with virologic failure, 17 patients showed secondary drug resistant, 16 subjects in group A and 1 subject in group B. Logistic regression analysis indicated that presence of hepatotoxicity was associated with HCV-Ab positive (OR = 2.096, 95%CI: 1.106-3.973, P = 0.023) and higher CD4 baseline (CD4 count >250/ul) (OR = 2.096, 95%CI: 1.07-4.107, P = 0.031). Our findings strongly support the use of 3TC+d4T and 3TC+AZT as the nucleoside analogue combination in NVP-based antiretroviral therapy. The regimen of AZT+ddI+NVP produced poor virological response especially in the stratum of CD4 count more than 200/ul. More patients showed secondary drug resistant in this arm too. Patients with HCV-Ab+ and CD4 count >250/ul appear to have significantly high risk of hepatoxicity. ClinicalTrials.gov NCT00618176. Output: | {'conditions': 'HIV Infections', 'interventions': 'Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)|Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)|Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Cell culture technologies have the potential to improve the robustness and flexibility of influenza vaccine supply and to substantially shorten manufacturing timelines. We investigated the safety, immunogenicity and efficacy of a Vero cell culture-derived seasonal influenza vaccine and utilized these studies to establish a serological correlate of vaccine protection. Two multicenter, randomized, double-blind phase III trials were undertaken in the US during the 2008-2009 Northern hemisphere influenza season, in young (18-49 years) and older (50-64 years and ≥ 65 years) adult subjects. 7250 young adults were randomized 1:1 to receive either Vero-derived vaccine or placebo. 3210 older adult subjects were randomized 8:1 to receive either Vero-derived vaccine or a licensed egg-derived vaccine. Serum hemagglutination inhibition antibody titers were assessed 21 days post-vaccination. Vaccine efficacy in preventing cell culture-confirmed influenza infection was determined for the young adult population. Local and systemic adverse events were recorded in both studies. The Vero-derived vaccine was safe and well tolerated in both young and older adults. All US and European immunological licensing thresholds were comfortably met in both populations. Vaccine efficacy in young adults was 79% against A/H1N1 viruses antigenically matching the corresponding vaccine strain and 78.5% for all antigenically matched influenza viruses. A hemagglutination inhibition antibody titer of ≥ 1:15 provided a reliable correlate of protection for the Vero-derived influenza vaccine, with no additional benefit at titers >1:30. Bridging of the correlate of protection established in the young adult population to the older adult immunogenicity data demonstrated the likely effectiveness of the Vero-derived vaccine in the older adult population. A Vero cell culture-derived seasonal influenza vaccine is safe, immunogenic and protects against infection with influenza virus. The novel vaccine technology has the potential to make a substantial contribution to improving influenza vaccine supply. The studies are registered with ClinicalTrials.gov, numbers NCT00566345 and NCT00782431. Output: | {'conditions': 'Influenza', 'interventions': 'Biological: Vero cell derived, trivalent, seasonal influenza vaccine|Biological: Licensed egg-derived, trivalent seasonal influenza vaccine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age. The goal was to evaluate the hypnotic efficacy of zolpidem at 0.25 mg/kg per day (maximum of 10 mg/day), compared with placebo, in children 6 through 17 years of age who were experiencing insomnia associated with attention-deficit/hyperactivity disorder. An 8-week, North American, multicenter, double-blind, placebo-controlled, parallel-group study was conducted. Patients underwent stratification according to age (6-11 years [N = 111] or 12-17 years [N = 90]) and were assigned randomly to receive treatment with the study drug or placebo (in a 2:1 ratio). The primary efficacy variable was latency to persistent sleep between weeks 3 and 6. Secondary efficacy variables also were assessed, and behavioral and cognitive components of attention-deficit/hyperactivity disorder were monitored. Safety was assessed on the basis of reports of adverse events, abnormal laboratory data, vital signs, and physical examination findings. The potential for next-day residual effects also was assessed. The baseline-adjusted mean change in latency to persistent sleep at week 4 did not differ significantly between the zolpidem and placebo groups (-20.28 vs -21.27 minutes). However, differences favoring zolpidem were observed for the older age group in Clinical Global Impression scores at weeks 4 and 8. No next-day residual effects of treatment were associated with zolpidem, and no rebound phenomena occurred after treatment discontinuation. Central nervous system and psychiatric disorders were the most-frequent treatment-emergent adverse events (>5%) that were observed more frequently with zolpidem than with placebo; these included dizziness, headache, and hallucinations. Ten (7.4%) patients discontinued zolpidem treatment because of adverse events. Zolpidem at a dose of 0.25 mg/kg per day to a maximum of 10 mg failed to reduce the latency to persistent sleep on polysomnographic recordings after 4 weeks of treatment in children and adolescents 6 through 17 years of age who had attention-deficit/hyperactivity disorder-associated insomnia. Output: | {'conditions': 'Attention Deficit Hyperactivity Disorder', 'interventions': 'Drug: Zolpidem (SL800750)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:The POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. The aim of this study was to investigate the efficacy and safety of 10 mg vardenafil orodispersible tablet (ODT) vs. placebo in a general population of men with erectile dysfunction (ED). This was a double-blind, multicentre, randomised, parallel-group, placebo-controlled study conducted at 35 centres in Australia, Canada, Mexico and the United States. Subjects aged > or =18 years, with ED for at least 6 months, were randomised to receive 12 weeks of on-demand treatment with either 10 mg vardenafil ODT or placebo. Each treatment group was stratified such that approximately half of the subjects were aged > or = 65 years. Primary efficacy variables were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3). Secondary variables included SEP diary questions 1, 4, 5 and 6, the patient version of the Treatment Satisfaction Scale (TSS) and the Global Assessment Question (GAQ). Of the 473 men enrolled in the study (51.4% aged > or =65 years), 331 were included in the intent-to-treat population (vardenafil ODT, n = 169; placebo, n = 162). Vardenafil ODT therapy was statistically significantly superior to placebo for all primary (i.e. IIEF-EF, SEP2, SEP3) and secondary efficacy variables (p < 0.0001). Treatment-emergent adverse events were mostly mild to moderate in severity, and comparable in both incidence and type with those of the film-coated tablet formulation. Treatment with 10 mg vardenafil ODT, taken on demand, significantly improved erectile function and was effective and well tolerated in a broad population of men with ED. Output: | {'conditions': 'Erectile Dysfunction', 'interventions': 'Drug: Vardenafil ODT (STAXYN, BAY38-9456)|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Predictive factors of ovarian response and clinical outcome after IVF/ICSI following a rFSH/GnRH antagonist protocol with or without oral contraceptive pre-treatment. Prediction of ovarian response prior to the first controlled ovarian stimulation (COS) cycle is useful in determining the optimal starting dose of recombinant FSH (rFSH). However, potentially predictive factors may be subject to inter-cycle variability and many patients are pre-treated with oral contraceptives (OC) for scheduling purposes. Our objective was to determine predictive factors of ovarian response for patients undergoing COS with rFSH in a gonadotrophin-releasing hormone antagonist protocol and to determine the inter-cycle variability of these factors. In this multinational trial, 442 patients were randomized to receive either OC treatment or no treatment prior to their first COS cycle. For candidate predictive factors, patient characteristics were collected at screening, and endocrine and sonographic data were collected during the early follicular phase of the two subsequent cycles. A treatment regimen of 200 IU rFSH and 0.25 mg ganirelix was applied during the second cycle. Predictive factors of ovarian response and of too low (<6 oocytes) or too high (>18 oocytes) ovarian responses were determined using stepwise linear regression and stepwise logistic regression, respectively. Anti-Müllerian hormone (AMH) and basal FSH were statistically significant predictors of the number of oocytes retrieved and of an excessive ovarian response. For low ovarian response, AMH was the only significant predictive factor. In the non-OC group, the predictive value was higher than in the OC group and higher at the early follicular phase of the stimulation cycle than of the previous cycle. The inter-cycle variation for AMH was low compared with the inter-cycle variation of other hormones. Between the two groups, there were no differences in the number or quality of embryos obtained or transferred, but the implantation rate was significantly lower in the OC group (24.1 versus 30.1%, P= 0.03), resulting in an ongoing pregnancy rate of 26.3% compared with 35.7% in the non-OC group (P= 0.05). The best predictive model of ovarian response was in the non-OC group and included both AMH and basal FSH determined at the early follicular phase of the stimulation cycle. In the proceeding cycle, AMH alone had sufficient predictive value since it was not affected by inter-cycle variability or OC pretreatment. Output: | {'conditions': 'Infertility', 'interventions': 'Drug: Marvelon'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial. To determine the efficacy of intranasal aqueous triamcinolone acetonide in treating the tympanometric signs and symptoms of eustachian tube dysfunction, such as otitis media with effusion and negative middle ear pressure. Randomized, placebo-controlled, double-blind prospective clinical trial. Tertiary referral clinic. Adults (≥18 years) and children (6-17 years) presenting with otitis media with effusion, negative middle ear pressure, or both. The 2 treatment arms consisted of aqueous triamcinolone or matching placebo administered once daily intranasally for 6 weeks. All subjects underwent tympanometry, otologic examination, and completion of a symptom questionnaire before and after treatment. Resolution of abnormal tympanometry and change in symptom scores (severity and frequency). Ninety-one patients presenting from September 1, 2005, through December 31, 2008, with otitis media with effusion or with negative middle ear pressure were enrolled and randomly assigned to treatment or placebo in a double-blind manner. No statistically significant difference in normalization of abnormal tympanometric signs was demonstrated with the active treatment arm compared with placebo on either a per-patient basis (19% vs 32%; P = .18) or a per-ear basis (22% vs 35%; P = .15). There was also no significant difference in the overall poststudy symptom score between the 2 treatment arms, after adjusting for the prestudy overall symptom score in an analysis of covariance model (P = .27). These findings do not support the use of intranasal steroid sprays to treat the manifestations of eustachian tube dysfunction. Trial Registration clinicaltrials.gov Identifier: NCT00279916. Output: | {'conditions': 'Otitis Media, Serous|Negative Middle Ear Pressure|Rhinitis', 'interventions': 'Drug: triamcinolone acetonide|Drug: placebo nasal spray'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:RNOP-09: pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma--a phase II study. Although Temozolomide is effective against glioblastoma, the prognosis remains dismal and new regimens with synergistic activity are sought for. In this phase-I/II trial, pegylated liposomal doxorubicin (Caelyx, PEG-Dox) and prolonged administration of Temozolomide in addition to radiotherapy was investigated in 63 patients with newly diagnosed glioblastoma. In phase-I, PEG-Dox was administered in a 3-by-3 dose-escalation regimen. In phase-II, 20 mg/m2 PEG-Dox was given once prior to radiotherapy and on days 1 and 15 of each 28-day cycle starting 4 weeks after radiotherapy. Temozolomide was given in a dose of 75 mg/m2 daily during radiotherapy (60 Gy) and 150-200 mg/m2 on days 1-5 of each 28-day cycle for 12 cycles or until disease progression. The toxicity of the combination of PEG-Dox, prolonged administration of Temozolomide, and radiotherapy was tolerable. The progression free survival after 12 months (PFS-12) was 30.2%, the median overall survival was 17.6 months in all patients including the ones from Phase-I. None of the endpoints differed significantly from the EORTC26981/NCIC-CE.3 data in a post-hoc statistical comparison. Together, the investigated combination is tolerable and feasible. Neither the addition of PEG-Dox nor the prolonged administration of Temozolomide resulted in a meaningful improvement of the patient's outcome as compared to the EORTC26981/NCIC-CE.3 data. Output: | {'conditions': 'Glioblastoma', 'interventions': 'Drug: Pegylated Liposomal Doxorubicine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. Following a phase II trial in which pemetrexed-platinum demonstrated similar activity to that of historical etoposide-platinum controls, a phase III study was conducted to compare pemetrexed-carboplatin with etoposide-carboplatin for the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Chemotherapy-naive patients with ES-SCLC and an Eastern Cooperative Oncology Group performance status of zero to 2 were randomly assigned to receive pemetrexed-carboplatin (pemetrexed 500 mg/m(2) on day 1; carboplatin at area under the serum concentration-time curve [AUC] 5 on day 1) or etoposide-carboplatin (etoposide 100 mg/m(2) on days 1 through 3; carboplatin AUC 5 on day 1) every 3 weeks for up to six cycles. The primary objective of the study was noninferiority of pemetrexed-carboplatin overall survival with a 15% margin. Accrual was terminated with 908 of 1,820 patients enrolled after results of a planned interim analysis. In the final analysis, pemetrexed-carboplatin was inferior to etoposide-carboplatin for overall survival (median, 8.1 v 10.6 months; hazard ratio [HR],1.56; 95% CI, 1.27 to 1.92; log-rank P < .01) and progression-free survival (median, 3.8 v 5.4 months; HR, 1.85; 95% CI, 1.58 to 2.17; log-rank P < .01). Objective response rates were also significantly lower for pemetrexed-carboplatin (31% v 52%; P < .001). Pemetrexed-carboplatin had lower grade 3 to 4 neutropenia, febrile neutropenia, and leukopenia than etoposide-carboplatin; grade 3 to 4 thrombocytopenia was comparable between arms and anemia was higher in the pemetrexed-carboplatin arm. Pemetrexed-carboplatin is inferior for the treatment of ES-SCLC. Planned translational research and pharmacogenomic analyses of tumor and blood samples may help explain the study results and provide insight into new treatment strategies. Output: | {'conditions': 'Small Cell Lung Cancer', 'interventions': 'Drug: pemetrexed|Drug: etoposide|Drug: carboplatin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study). Etanercept 50 mg a week is approved in the treatment of AS. Increasing the etanercept dose to 100 mg/week improves efficacy in cutaneous psoriasis, a clinical manifestation related to the spondylarthritis family, while maintaining its safety profile. The purpose of this study was to evaluate the efficacy and safety of etanercept 100 vs 50 mg/week in patients with AS. Adult patients with AS were randomized to receive etanercept 50 mg twice a week (biw), or etanercept 50 mg once a week (qw) for 12 weeks. The primary efficacy endpoint was Ankylosing Spondylitis Assessment Study (ASAS20) response at Week 12; secondary endpoints included ASAS40, ASAS50, ASAS70 and ASAS5/6 responses, partial remission and quality of life. Safety was assessed until 15 days after the last visit. A total of 108 patients were randomly selected and treated, 54 in each arm. At 12 weeks, ASAS20 response was achieved by 34 (71%) out of 48 patients of the etanercept 50 mg biw group and by 37 (76%) out of 49 patients of the etanercept 50 mg qw group (not statistically significant differences). Other efficacy variables improved significantly over time, but not between treatment groups. Fifty-six patients experienced at least one adverse event (generally, infections and infestations, gastrointestinal disorders and injection site reactions), most of them mild or moderate. High-dose (100 mg/week) etanercept in the treatment of AS for 12 weeks is as safe as the standard dose (50 mg/week). However, it does not significantly increase its efficacy. Trial Registration. Clinicaltrials.gov, http://clinicaltrials.gov/, NCT00873730. Output: | {'conditions': 'Ankylosing Spondylitis', 'interventions': 'Drug: etanercept|Drug: etanercept/placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study. To evaluate the efficacy and safety of three doses of ciclesonide (with or without spacer) in children with persistent asthma. This was a multicentre, double-blind, placebo-controlled, 12-week study of ciclesonide 40, 80 or 160 μg (once daily pm). Children (6-11 years) were randomised 1:1 to treatment via a metered dose inhaler (MDI) or MDI plus spacer. The primary variable was change from baseline in mean morning peak expiratory flow (PEF). Secondary variables included: time to first lack of efficacy (LOE), asthma control, forced expiratory volume in 1 s (FEV(1)), asthma symptom score and quality of life (QoL). Safety assessments included: adverse events (AEs), urinary cortisol excretion and body height. In total, 1073 children received treatment. At endpoint, mean morning PEF significantly improved with all doses of ciclesonide vs. placebo. There was no difference over placebo in time to first LOE, but ciclesonide was superior to placebo on asthma control, symptom score, FEV(1) and QoL. There were no differences between the spacer or non-spacer subgroups. The incidences of AEs were comparable between treatment groups (approximately 35%) and there were no between-group differences in body height or urinary cortisol. Ciclesonide 40-160 μg once daily is effective and well tolerated in children with persistent asthma; its efficacy and safety are unaffected by the use of a spacer. clinicaltrials.gov registration number: NCT00384189. Output: | {'conditions': 'Asthma', 'interventions': 'Drug: Ciclesonide|Drug: Placebo'} |