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OBJECTIVE | This is the first-time use of montelukast in post-tonsillectomy pain . | |
METHODS | Double-blind , controlled-randomized study . | |
METHODS | University teaching and research hospital . | |
METHODS | A total of 60 children , aged 5 to 15 years , American Society of Anesthesiologist class I-II , scheduled for elective tonsillectomy were enrolled in this clinical trial study . | |
METHODS | The patients were randomized into 2 groups : the montelukast group ( group M , n = 30 ) and control group ( group C , n = 30 ) . | |
METHODS | Group M recieved an oral montelukast tablet and group C recieved placebo at 2400pm on the morning before surgery . | |
METHODS | Post-tonsillectomy pain was evaluated with the Wong-Baker FACES Scale during the 24 hours after surgery . | |
METHODS | Patients ' intraoperative hemodynamic parameters and intraoperative and postoperative complications were recorded . | |
RESULTS | There were statistically significant differences between group C and group M for Wong-Baker FACES pain rating scale scores ( P < .05 ) . | |
RESULTS | In the 24 hours after surgery , the total number of patients using rescue analgesics was higher in group C than in group M , and the difference was statistically significant ( P < .001 ) . | |
RESULTS | There was no significant difference in demographic parameters ( P > .05 ) . | |
RESULTS | There were no significant differences in postoperative nausea and vomiting , otalgia , trismus , fever , or halitosis between the groups ( P > .05 ) . | |
CONCLUSIONS | Preemptive montelukast can be used safely to reduce the serious pain caused by tonsillectomy in children . | |
OBJECTIVE | Metastatic colon cancer patients are treated with the chemotherapy regimens , FOLFOX and FOLFIRI , in either order . | |
OBJECTIVE | So far , we can not predict the response of chemotherapeutic agent , so it is necessary to find which regimen is adequate before starting chemotherapy . | |
METHODS | Enrolled patients are randomized into either conventional treatment or planned treatment preceded by pretreatment genetic analysis . | |
METHODS | Blood samples of patients in planned treatment group ( N = 53 ) were analyzed for the genetic polymorphism before selection of chemotherapeutic agents . | |
METHODS | Target genes were XPD-751 , GSTP-1-105 , XRCC1-399 for oxaliplatin , UGT1A1 for irinotecan . | |
METHODS | The response was measured by computed tomographic scan after completion of three cycles of chemotherapy . | |
RESULTS | Overall response rate was significantly higher in planned group ( 67.9 % vs. 46.3 % , P = 0.020 ) . | |
RESULTS | In FOLFOX group , response rate was significantly improved in the planned patients ( 77.1 % vs. 50 % , P = 0.018 ) . | |
RESULTS | In FOLFIRI group , the difference did n't reach statistical significance ( 50 % vs. 42.5 % , P = 0.776 ) . | |
CONCLUSIONS | We found significantly improved response rates in the chemotherapy of metastatic colon cancer by pretreatment genetic analysis , especially in FOLFOX group . | |
BACKGROUND | Cardiac arrest causes ischaemic brain injury . | |
BACKGROUND | Arterial carbon dioxide tension ( PaCO2 ) is a major determinant of cerebral blood flow . | |
BACKGROUND | Thus , mild hypercapnia in the 24 h following cardiac arrest may increase cerebral blood flow and attenuate such injury . | |
BACKGROUND | We describe the Carbon Control and Cardiac Arrest ( CCC ) trial . | |
METHODS | The CCC trial is a pilot multicentre feasibility , safety and biological efficacy randomized controlled trial recruiting adult cardiac arrest patients admitted to the intensive care unit after return of spontaneous circulation . | |
METHODS | At admission , using concealed allocation , participants are randomized to 24 h of either normocapnia ( PaCO2 35 to 45 mmHg ) or mild hypercapnia ( PaCO2 50 to 55 mmHg ) . | |
METHODS | Key feasibility outcomes are recruitment rate and protocol compliance rate . | |
METHODS | The primary biological efficacy and biological safety measures are the between-groups difference in serum neuron-specific enolase and S100b protein levels at 24 h , 48 h and 72 h. Secondary outcome measure include adverse events , in-hospital mortality , and neurological assessment at 6 months . | |
CONCLUSIONS | The trial commenced in December 2012 and , when completed , will provide clinical evidence as to whether targeting mild hypercapnia for 24 h following intensive care unit admission for cardiac arrest patients is feasible and safe and whether it results in decreased concentrations of neurological injury biomarkers compared with normocapnia . | |
CONCLUSIONS | Trial results will also be used to determine whether a phase IIb study powered for survival at 90 days is feasible and justified . | |
BACKGROUND | Australian New Zealand Clinical Trials Registry ACTRN12612000690853 . | |
BACKGROUND | For decades thiopental has been considered as the hypnotic drug of choice for intracranial surgery . | |
BACKGROUND | However , total intravenous anesthesia performed with thiopental is associated with delayed recovery , whereas early post-operative neurological evaluation is critical . | |
BACKGROUND | For this reason , target controlled infusion ( TCI ) of propofol is increasingly used for maintenance of anesthesia . | |
BACKGROUND | However , a thiopental TCI has never been assessed for this purpose . | |
BACKGROUND | We tested the hypothesis that a thiopental TCI provides an acceptable way to achieve early recovery compared to a propofol TCI during supratentorial surgery . | |
METHODS | Eighty patients undergoing elective craniotomy for a supratentorial tumor were randomized to receive either a propofol TCI ( group P ) or a thiopental TCI ( group T ) . | |
METHODS | Both groups received a sufentanil TCI and the bispectral index was monitored . | |
METHODS | The primary end-point was time to tracheal extubation . | |
METHODS | Secondary end-points were per - and post-operative hemodynamics as well as respiratory and recovery parameters . | |
METHODS | Assessment of study end-points was performed by an intensive care specialist blinded ( like the patient ) to the received hypnotic . | |
RESULTS | Time to extubation was significantly ( P < 0.0001 ) shorter in group P ( median 149 minutes ; interquartile range 72-250 minutes ) than in group T ( median 453 minutes ; interquartile range 286-813 minutes ) . | |
RESULTS | Similarly , the recovery parameters were significantly better in group P than in group T. | |
RESULTS | There was no difference between groups in terms of patient characteristics and hemodynamic parameters . | |
CONCLUSIONS | Even with TCI and bispectral index monitoring , thiopental is associated with an inappropriate delayed recovery from supratentorial surgery compared to propofol TCI . | |
OBJECTIVE | To investigate the effects of conservative therapy applied before arthroscopic subacromial decompression on the clinical outcome in patients with stage 2 shoulder impingement syndrome . | |
METHODS | Sixty-eight patients having stage 2 shoulder impingement syndrome and treated with arthroscopic subacromial decompression were included in the study . | |
METHODS | We divided these patients into 2 groups , whereby 32 ( 47 % ) patients received conservative therapy before arthroscopic subacromial decompression and 36 ( 53 % ) patients did not receive conservative therapy . | |
METHODS | We compared both groups in terms of the the Constant , UCLA , and VAS scores for shoulder pain before and after arthroscopic subacromial decompression . | |
RESULTS | Constant , UCLA , and VAS scores were statistically significantly improved in both groups after arthroscopic subacromial decompression ( P < 0.001 ) . | |
RESULTS | Constant , UCLA , and VAS scores before arthroscopic subacromial decompression were statistically better in Group 1 than in Group 2 ( P < 0.001 ) . | |
RESULTS | No statistically significant difference was found between the groups in terms of Constant , UCLA , and VAS scores after arthroscopic subacromial decompression ( P > 0.05 ) . | |
CONCLUSIONS | Conservative therapy applied in patients with stage 2 shoulder impingement syndrome before arthroscopic subacromial decompression does not have a positive contribution on the clinical outcome after arthroscopic subacromial decompression . | |
BACKGROUND | Obstructive sleep apnea is associated with considerable health risks . | |
BACKGROUND | Although continuous positive airway pressure ( CPAP ) can mitigate these risks , effectiveness can be reduced by inadequate adherence to treatment . | |
BACKGROUND | We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea . | |
METHODS | Using a multicenter , prospective , single-group , cohort design , we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy . | |
METHODS | The primary outcome measures were the apnea-hypopnea index ( AHI ; the number of apnea or hypopnea events per hour , with a score of 15 indicating moderate-to-severe apnea ) and the oxygen desaturation index ( ODI ; the number of times per hour of sleep that the blood oxygen level drops by 4 percentage points from baseline ) . | |
METHODS | Secondary outcome measures were the Epworth Sleepiness Scale , the Functional Outcomes of Sleep Questionnaire ( FOSQ ) , and the percentage of sleep time with the oxygen saturation less than 90 % . | |
METHODS | Consecutive participants with a response were included in a randomized , controlled therapy-withdrawal trial . | |
RESULTS | The study included 126 participants ; 83 % were men . | |
RESULTS | The mean age was 54.5 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 28.4 . | |
RESULTS | The median AHI score at 12 months decreased 68 % , from 29.3 events per hour to 9.0 events per hour ( P < 0.001 ) ; the ODI score decreased 70 % , from 25.4 events per hour to 7.4 events per hour ( P < 0.001 ) . | |
RESULTS | Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life . | |
RESULTS | In the randomized phase , the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group ( 8.9 and 7.2 events per hour , respectively ) ; the AHI score was significantly higher ( indicating more severe apnea ) among the 23 participants in the therapy-withdrawal group ( 25.8 vs. 7.6 events per hour , P < 0.001 ) . | |
RESULTS | The ODI results followed a similar pattern . | |
RESULTS | The rate of procedure-related serious adverse events was less than 2 % . | |
CONCLUSIONS | In this uncontrolled cohort study , upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea . | |
CONCLUSIONS | ( Funded by Inspire Medical Systems ; STAR ClinicalTrials.gov number , NCT01161420 . ) | |
OBJECTIVE | To identify facilitators and barriers to clinical trial implementation in Aboriginal health services . | |
METHODS | Indepth interview study with thematic analysis . | |
METHODS | Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill ( KGAP ) study , a pragmatic randomised controlled trial that aimed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease . | |
METHODS | 32 health care providers and 21 Aboriginal and Torres Strait Islander patients . | |
RESULTS | A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service . | |
RESULTS | That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients . | |
RESULTS | Enlisting the support of Aboriginal and Torres Strait Islander staff champions who were visible to the community as the main source of information about the trial was particularly important . | |
RESULTS | The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly demanding trial-related procedures . | |
RESULTS | This was partially alleviated by the research team 's provision of onsite support and attempts to make trial processes more streamlined . | |
RESULTS | Although more intensive support was highly desired , there were usually insufficient resources to provide this . | |
CONCLUSIONS | Despite strong community and health service support , major investments in time and resources are needed to ensure successful implementation and minimal disruption to already overstretched , routine services . | |
CONCLUSIONS | Trial budgets will necessarily be inflated as a result . | |
CONCLUSIONS | Funding agencies need to consider these additional resource demands when supporting trials of a similar nature . | |
OBJECTIVE | To compare the effect of incomplete caries removal ( ICR ) and indirect pulp capping ( IPC ) with calcium hydroxide ( CH ) or an inert material ( wax ) on color , consistency and contamination of the remaining dentin of primary molars . | |
METHODS | This double-blind , parallel-design , randomized controlled trial included 30 children presenting one primary molar with deep caries lesion . | |
METHODS | Children were randomly assigned after ICR to receive IPC with CH or wax . | |
METHODS | All teeth were then restored with resin composite . | |
METHODS | Baseline dentin color and consistency were evaluated after ICR , and dentin samples were collected for contamination analyses using scanning electron microscopy . | |
METHODS | After 3 months , restorations were removed and the three parameters were re-evaluated . | |
METHODS | In both groups , dentin became significantly darker after 3 months . | |
RESULTS | No cases of yellow dentin were observed after 3 months with CH compared to 33.3 % of the wax cases ( P < 0.05 ) . | |
RESULTS | A statistically significant difference over time was observed only for CH regarding consistency . | |
RESULTS | CH stimulated a dentin hardening process in a statistically higher number of cases than wax ( 86.7 % vs. 33.3 % ; P = 0.008 ) . | |
RESULTS | Contamination changed significantly over time in CH and wax without significant difference between groups . | |
RESULTS | It was concluded that CH and wax arrested the carious process of the remaining carious dentin after indirect pulp capping , but CH showed superior dentin color and consistency after 3 months . | |
BACKGROUND | In literature there is a general consensus that the use of the mirror improves proprioception . | |
BACKGROUND | During rehabilitation the mirror is an important instrument to improve stability . | |
BACKGROUND | In some sports , such as dancing , mirrors are widely used during training . |
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