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<RELATED_STUDIES>
<STUDY>
Related NCT_ID: NCT02820350
Related Title: A Multi-Center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI)
Related Description: #Study Description
Brief Summary
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)
Detailed Description
The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to commercially available Continuous Renal Replacement Therapy (CRRT) devices. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
#Intervention
- DEVICE : SCD-F40
- CRRT with SCD
- Other Names :
- Selective Cytopheretic Device (SCD)
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* A patient, or legal representative, has signed a written informed consent form.
* Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma).
* Age less than 22 years.
* Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
* Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
* Clinical diagnosis of AKI due to etiologies requiring CRRT (see Appendix B). AKI is defined as acute kidney injury with any one of the following:
* Increase in SCr by >=0.3 mg/dL (>=26.5 μmol/L) within 48 hours or;
* Increase in SCr to >=1.5 times baseline, which is known or presumed to have occurred within the prior 7 days or;
* Urine volume <0.5ml/kg/h for 6 hours
* At least one non-renal organ failure (defined as receiving mechanical ventilation or at least one vasoactive medication to treat hypotension) OR presence (proven or suspected) of sepsis. (Appendix C).
Exclusion Criteria:
* Irreversible brain damage based on available historical and clinical information.
* Presence of any organ transplant at any time.
* Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a).
* Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI.
* AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome(b), thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine, or tacrolimus nephrotoxicity
* Received >12hrs of CRRT during this hospital admission or prior to transfer from an outside hospital.
* Received >1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.
* Hospitalization >14 days during this hospital admission and or prior to transfer from an outside hospital.
* Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three-month period after study therapy.
* Chronic immunosuppression.
* HIV or AIDS.
* Severe liver failure(c).
* Current Do Not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days.
* Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
* Patient not expected to survive 28 days because of an irreversible medical condition. (This is not restrictive to AKI, and may include situations such as the presence of irreversible brain damage, untreatable malignancy, inoperable life threatening condition, or any condition to which therapy is regarded as futile by the PI.)
* Any medical condition that the Investigator thinks may interfere with the study objectives.
* Physician refusal.
* Dry weight of <20kg(d).
* Platelet count <30,000/mm3 at time of screening(e).
* Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical trials where only measurements and/or samples are taken (NO TEST DEVICE OR TEST DRUG USED) are allowed to participate.
* Use of any other Investigational drug or device within the previous 30 days.
1. ECMO was subsequently removed as an exclusion. Two patients in the study received ECMO.
2. Hemolytic uremic syndrome subsequently removed as an exclusion. One patient in the study had HUS.
3. Severe liver failure was change to severe chronic liver failure during the study course.
4. The lower weight limit threshold was decreased to 15 kg after consultation and approval from the US FDA.
5. The thrombocytopenia exclusion removed after no observed occurrences in the first five subjects.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 22 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT01779635
Related Title: Continuous Renal Replacement Therapy With Anticoagulation-free Regimen in Bleeding-risk Patients Using oXiris Membrane - CARROM Study
Related Description: #Study Description
Brief Summary
The investigators hypothesize that the use of heparin-grafted membrane versus conventional membrane in critically-ill patients with bleeding-risk undergoing continuous renal replacement therapy, will effectively prolong the circuit lifespan, without worsening of the systemic APTT or underlying bleeding risk.
Detailed Description
Aims and objectives:
We aim to compare the performance and safety of heparin-grafted AN69 membrane (oXiris, Gambro) with the conventional AN69 membrane (M150, Gambro) without systemic anticoagulation during continuous renal replacement therapy (CRRT), in critically ill patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU), who has moderate bleeding risk and in whom systemic anticoagulation is contraindicated.
#Intervention
- DEVICE : oXiris as first filter
- 2 arms - each start off CRRT with either oXiris or M150 as first hemofilter, and then do cross-over to either hemofilters in a sequential manner when the former clots
- DEVICE : M150 as first filter
- start off with M150 as first hemofilter, then cross-over to oXiris when former clots, and then to M150, and then lastly to oXiris
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
Adult patients (age 21 and above) who are admitted to ICUs or CCU and requiring CRRT for acute kidney injury or ESRD Patients who has moderate bleeding risk (see below definitions) Patients with NO systemic or regional circuit anticoagulation Informed consent taken from the patient, or proxy if the former is unable to sign due to medical reasons Anticipated need for prolonged CRRT > 3 days
(Moderate bleeding risk criteria:)
Moderate bleeding risk is defined by any of the following:
* Platelet count < 100 x 109 mm3 (but > 50)
* INR > 1.5 (but < 2.5)
* APTT > 50 seconds (but < 75)
* Post-surgery for < 48 hours
* Post-invasive procedures (eg. Pericardiocentasis) < 24 hrs
* Post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) < 24 hours
* Recent internal or gastrointestinal bleeding within 48 hours (should be secured bleeding with no relapse noted)
Exclusion Criteria:
Patients with very high bleeding risk (for which they should also fall outside of the below inclusion criteria - see below) Patients who are known to have heparin-induced thrombocytopenia or allergic to heparin Patients with other medical conditions for which heparin is contraindicated. Patients who require systemic anticoagulation for medical indications (We will accept patients who are on prophylactic doses of anticoagulation for DVT prophylaxis) Patients who are pregnant Patients/legally accepted surrogate who decline to consent
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT05495607
Related Title: Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients
Related Description: #Study Description
Brief Summary
Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality.
We aim to retrospectively report the first multicenter French experience of CARPEDIEM® use and evaluate the efficacy, feasibility, outcomes, and technical considerations of this new device in a population of neonates and small infant. Compared to adult's device continuous renal replacement therapy with an adapted machine allowed successful blood purification without severe complications even in low birth weight neonates.
#Intervention
- DEVICE : CARPEDIEN
- Continuous renal replacement therapy
Related Criteria: #Eligibility Criteria:
Inclusion criteria:
* Children and neonates including premature and low birth weight neonates
* Have a diagnosis of acute kidney injury, end stage renal disease, metabolic disease, electrolyte abnormality
* Require renal replacement therapy
Exclusion Criteria:
*Renal replacement therapy with another device than Carpediem machine
Sex :
ALL
Ages :
- Minimum Age : 0 Years
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT03231748
Related Title: Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter
Related Description: #Study Description
Brief Summary
This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy.
The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.
Detailed Description
In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy, the investigators aim to determine whether continuous veno-venous haemodialysis with an EMiC®2 filter leads to clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* adult patients (>=18 years) in the Critical Care Unit with AKI and sepsis
* clinical decision that citrate based continuous veno-venous haemodialysis (CVVHD) is necessary
Exclusion Criteria:
* lack of consent
* pre-existing dialysis dependent renal failure
* life expectancy <24 hours
* patients with haemoglobin <7g/dL (unless transfused for clinical reasons)
* need for extracorporeal membrane oxygenation (ECMO)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY>
</RELATED_STUDIES>
Target Study Title: Evaluation of the HF20™ Filter for Pediatric Continuous Renal Replacement Therapy (CRRT)
Target Study Description: #Study Description
Brief Summary
Historically, innovations for acute kidney injury (AKI) and continuous renal replacement therapy (CRRT) have centered around an adult population. However, research has shown that over 10% of pediatric patients develop severe AKI within the first week in an intensive care unit (ICU). When a pediatric patient requires renal replacement therapy for AKI in the ICU, CRRT is usually the modality of choice. The HF20™ is indicated for supporting patients weighing 8 to 20 kilograms, addressing a critical clinical need for critically ill children who require CRRT. Current US Food and Drug Administration (FDA) approved CRRT filters are designed for patients weighing more than 20 kg or less than 10 kg, leaving a gap in appropriately designed filters for pediatric patients.
A previous trial in the US showed that the HF20™ is safe and effective, however the membrane composition of the HF20™ used in that trial is different than what is currently manufacturer and available. Baxter Healthcare Corporation has received an Emergency Use Authorization (EUA) for the currently available HF20™ to be used in the era of the COVID-19 pandemic, however participants do not need to be infected with the SAR-CoV-2 virus in order to be treated. The EUA for the HF20™ allows for treatment for any children weighing between 8 and 20 kilograms in need of CRRT. This registry will collect clinical data related to the safety and efficacy of the HF20™ filter for CRRT in pediatric patients weighing 8 to 20 kilograms at participating institutions, however participation in this registry is not a requirement in order to be treated with the HF20™ filter.
#Intervention
- DEVICE : HF20™
- HF20™ will be used for CRRT
Task Instruction:
1. Based on the "Target Study Title" and "Target Study Description" of the target study, please create a Eligibility Criteria for the target study.
2. please provide a detailed step-by-step logical thinking steps for the Eligibility Criteria you created before creating the whole criteria.
3. Could use example studies (in the <RELATED_STUDIES> section) if they support your justifications, but ensure the reasoning is well-explained and relevant to the study's context
4. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
Your long step by step detailed logical thinking steps here.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
1. **Understanding the Study Context**: The study aims to evaluate the safety and efficacy of the HF20 filter for pediatric continuous renal replacement therapy (CRRT). The study focuses on pediatric patients weighing between 8 and 20 kilograms, addressing a critical clinical need for critically ill children who require CRRT.
2. **Defining the Population of Interest**: To ensure the study's results are relevant and applicable to the target population, it is essential to define the population of interest. Pediatric patients with acute kidney injury (AKI) or fluid overload are the primary focus, as they are the most likely to benefit from CRRT.
3. **Defining AKI and Fluid Overload**: AKI is a critical condition that requires prompt treatment. The study defines AKI using the Kidney Disease Improving Global Outcomes (KDIGO) criteria, which includes a serum creatinine increase of 0.3 mg/dL over baseline in 48 hours or a 50% increase within the previous 7 days, or urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours). Fluid overload is defined as greater than 10% fluid accumulation based on ICU admission weight.
4. **Ensuring Patient Safety**: To ensure patient safety, it is crucial to exclude patients who are at high risk of bleeding complications. A platelet count of <30,000/mm3 is a reasonable threshold to exclude patients with thrombocytopenia, as seen in NCT00216866.
5. **Excluding Patients with High Mortality Risk**: Patients with a high mortality risk should be excluded to ensure reliable outcomes. Patients not expected to survive more than 48 hours are excluded, as their outcomes may not be representative of the target population.
6. **Defining the Weight Range**: The study focuses on pediatric patients weighing between 8 and 20 kilograms. This weight range is critical, as it addresses the gap in available CRRT filters for pediatric patients. The lower weight limit of 8 kilograms is chosen to ensure that the study includes patients who are most likely to benefit from CRRT, while the upper weight limit of 20 kilograms is based on the manufacturer's recommendations for the HF20 filter.
7. **Ensuring Patient Eligibility**: Patients receiving or planning to receive CRRT with the HF20 filter as standard of care are eligible for the study. This ensures that the study includes patients who are most likely to benefit from the intervention.
8. **Excluding Patients with Recent Renal Replacement Therapy**: Patients who have received renal replacement therapy in the previous 5 days are excluded to ensure that the study includes patients who are new to CRRT and are likely to benefit from the HF20 filter.
**Eligibility Criteria:**
* Receiving or plan to receive CRRT with the HF20 filter as standard of care
* Acute kidney injury (AKI) or fluid overload as defined as one of the two below:
+ AKI defined as Kidney Disease Improving Global Outcomes (KDIGO) Stage 1 or higher by either:
- Serum creatinine criteria (0.3 mg/dL increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days)
- Urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours)
+ Severe fluid overload defined as greater than 10 percent fluid accumulation based on ICU admission weight
* Weight between 8 and 20 kilograms
* Platelet count ≥ 30,000/mm3
* Not expected to survive more than 48 hours
* Not received renal replacement therapy in the previous 5 days
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Receiving or plan to receive CRRT with the HF20™ filter as standard of care
* Acute kidney injury (AKI) or fluid overload as defined as one of the two below:
1. AKI defined as Kidney Disease Improving Global Outcomes (KDIGO) Stage 1 or higher by either:
1. Serum creatinine criteria (0.3 mg/dL increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days) or
2. Urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours)
2. Severe fluid overload defined as greater than 10 percent fluid accumulation based on ICU admission weight
Exclusion Criteria:
* Weight less than 8 kilograms
* Weight more than 20 kilograms
* Patient not expected to survive more than 48 hours
* Received renal replacement therapy in the previous 5 days
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 0 |
<RELATED_STUDIES>
<STUDY>
Related NCT_ID: NCT01518894
Related Title: A Randomized, Double-Blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
Related Description: #Study Description
Brief Summary
To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242 administered orally to psychiatrically stable subjects with schizophrenia receiving antipsychotic and adjunctive medication.
Detailed Description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
#Intervention
- DRUG : PF-04958242
- PF-04958242 0.10 mg oral solution Q24 hours for 14 days
- DRUG : PF-04958242
- PF-04958242 0.20 mg oral solution Q24 hours for 14 days
- DRUG : PF-04958242
- PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)
- DRUG : Placebo
- Placebo oral solution Q24 hours for 14 days
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Psychiatrically stable subjects with schizophrenia
* Evidence of stable schizophrenia symptomatology >= 3 months
* Score on MCCB Letter-number span + Spatial span subtest < 40.
Exclusion Criteria:
* History of seizures or of a condition with risk of seizures
* History of abnormal EEG.
* Pregnant or nursing females, and women of child bearing potential
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT02418819
Related Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, SPONSOR OPEN, PHASE 1B STUDY TO EXAMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-06412562 IN PSYCHIATRICALLY STABLE SUBJECTS WITH SCHIZOPHRENIA
Related Description: #Study Description
Brief Summary
This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in subjects with schizophrenia.
Detailed Description
B7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group design, Phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of 3 doses of PF-06412562 (3 mg BID, 9 mg BID and 45 mg BID) over 15 days in approximately 100 psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with schizophrenia are on background treatment with SOC antipsychotics and other psychotropic medications.
All doses will be administered twice daily, with approximately 12 hours between each dose.
#Intervention
- DRUG : PF-06412562 3mg BID
- PF-06412562
- Other Names :
- PF-06412562 3mg
- DRUG : PF-06412562 9mg BID
- PF-06412562
- Other Names :
- PF-06412562 9mg
- DRUG : PF-06412562 45mg BID
- PF-06412562
- Other Names :
- PF-06412562 45mg
- OTHER : Placebo
- Placebo
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Subjects with schizophrenia both male and female
* Evidence of stable schizophrenia symptomatology for at least 3 months (no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia, etc).
* Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine (oral or depot) on a stable medication treatment regimen for for at least 2 months prior to Day 1, including concomitant psychotropic medications.
Exclusion Criteria:
* History of seizure
* Pregnant or nursing females
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT03751488
Related Title: A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Determine the Relative Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients
Related Description: #Study Description
Brief Summary
This study will look at the Characteristics of LY03010 Versus INVEGA SUSTENNA® in the blood of Schizophrenia Patients
#Intervention
- DRUG : LY03010
- Single Dose of LY03010 at 351 mg or 156 mg or 117mg
- DRUG : Invega Sustenna 156 MG in 1 ML Prefilled Syringe
- Single Dose at 156mg
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Capable of giving informed consent and complying with study procedures;
* Have an identified support person (e.g., family member, case worker, social worker) considered reliable by the Investigator to help ensure compliance with study visits and to alert staff of any issues of concern;
* Have a stable place of residence for the 3 months prior to screening and throughout the study;
* Male or female >=18 to <=65 years who meets diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for at least 1 year before screening;
* Be on a stable dose of oral antipsychotic medication(s) other than risperidone, paliperidone, clozapine, ziprasidone, or thioridazine for at least 4 weeks prior to screening;
* Be clinically stable based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score <=70 as well as a PANSS HATE (hostility, anxiety, tension and excitement) subtotal score <16 at screening;
* Clinical Global Impression-Severity (CGI-S) score of 1 to 4, inclusive;
* Body mass index (BMI) >=17.0 and <=37 kg/m2; body weight >=50 kg;
* Creatinine level within the normal range;
* All female patients (childbearing potential and non-childbearing potential) must have a negative pregnancy test result at both screening and baseline. Female patients must meet 1 of the following 3 conditions: (i) postmenopausal for at least 12 months without an alternative medical cause, (ii) surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) based on patient report, or (iii) if of childbearing potential (WOCBP), practicing or agree to practice a highly effective contraception method of birth control. Highly effective methods of birth control include an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), and contraceptives (oral, skin patches, or implanted or injectable products) using combined or progestogen-only hormonal contraception associated with inhibition of ovulation. A vasectomized male partner is an acceptable birth control method if the vasectomized partner is the sole sexual partner of the female patient and the vasectomized partner has received medical confirmation of surgical success. Highly effective methods of birth control must be used for at least 14 days prior to study drug dosing, throughout the study, and for another 80 days after the end-of-treatment (EOT) visit (or at least 200 days after the dose, whichever is longer) to minimize the risk of pregnancy;
* Sexually active fertile male patients must be willing to use acceptable contraception methods (such as double barrier methods of a combination of male condom with either cap, diaphragm or sponge with spermicide) from study drug dosing, throughout the study, and for another 80 days after the EOT visit (or at least 200 days after the dose, whichever is longer) if their partners are women of childbearing potential.
Exclusion Criteria:
* Primary and active DSM-V Axis I diagnosis other than schizophrenia or schizoaffective disorder;
* Patients who meet DSM-V criteria for substance abuse (moderate or severe) with the exception of caffeine or nicotine in the past 6 months prior to screening, or test positive for a drug of abuse or alcohol at screening or baseline (except positive findings that can be accounted for by documented prescriptions used as prescribed by a treating physician as a part of the treatment for the patient's psychiatric illness);
* History of treatment resistance, defined as failure to respond to 2 adequate treatment regimens (minimum of 4 weeks at the patient's maximum tolerated dose) of different antipsychotic medications;
* Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, or any of their excipients (oral risperidone tolerability test will be completed during the screening period, approximately 14 days prior to dosing, for patients without documented evidence [medical record or written statement from a licensed medical practitioner who has treated the patient] of tolerating risperidone or paliperidone, and patients who show an allergic reaction to this test will be excluded from the study);
* Known non-responders to risperidone or paliperidone;
* Patients who pose a significant risk of a suicide attempt based on history or the Investigator's judgment; answer 'yes' to Suicidal Ideation items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) for current or past 30 days on the 'Baseline/Screening version' at screening; have had suicidal behavior in the last 12 months as measured by the C-SSRS at screening; or are at imminent risk of suicide or violent behavior based on the Investigator's clinical assessment or the C-SSRS assessment of lifetime suicidal ideation or behavior at screening;
* Any one or more of the following 3 conditions: (i) clinically significant liver dysfunction, (ii) hepatitis B surface antigen (HBsAg) positive, or (iii) a serum alanine transaminase (ALT) or aspartate transaminase (AST) > 2x upper limit of normal (ULN) range (if the ALT or AST levels are between 2x and 3x ULN in the first screening test and the elevation may be caused by non-specific reasons in the judgment of the Investigator, a second test can be performed after one week. If the repeated ALT or AST levels are still >2x ULN, the patient must not be included in the study). However, patients who are hepatitis C positive may be enrolled, if this condition is considered stable without treatment and liver function is normal;
* History of symptomatic orthostatic hypotension with a decrease of >=20 mmHg in systolic blood pressure (SBP) or decrease of >=10 mmHg in diastolic blood pressure (DBP) when changing from supine to standing position after having been in the supine position for at least 5 minutes or SBP less than 105 mmHg in a supine position at screening;
* Uncontrolled diabetes or hemoglobin A1c (HbAlc) level >=7%, or newly diagnosed within the past 12 months prior to screening;
* History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia; history of severe akathisia or extra-pyramidal reactions such as dystonia with previous use of risperidone or other neuroleptic treatments; score >= 3 on the Global Clinical Assessment of the BARS; or score >= 1 on the AIMS at screening. Patients who experience mild extrapyramidal symptoms attributable to study medications will be allowed to continue with appropriate anticholinergic treatment (benztropine, diphenhydramine, and/or trihexyphenidyl);
* Electroconvulsive therapy within 60 days before screening;
* Use of a long-acting injectable for the treatment of schizophrenia within 4 weeks (8 weeks for Risperdal Consta®) before screening;
* Use of injectable paliperidone palmitate within 10 months before screening;
* Use of clozapine within 4 weeks before screening;
* Use of nonselective or irreversible monoamine oxidase inhibitor (MAOI) antidepressants within 30 days before screening;
* Use of other antidepressants unless the patient has been on a stable dose for at least 30 days before screening;
* Use of strong inducers of either CYP 3A4 or P-glycoprotein (P-gp) within 2 weeks or 5 half-lives, whichever is longer, before screening;
* QTcF interval greater than 450 msec for males and 470 msec for females or a prior history or presence of circumstances that could increase the risk of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval, or other clinically significant ECG findings in the opinion of the Investigator;
* Clinically significant past medical history (within 2 years) of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, neurologic, immunologic disorders, or drug hypersensitivity which, in the judgement of the Investigator, would interfere with the patient's ability to participate in the study;
* Malignancies with the exception of basal cell or squamous cell skin cancer or in situ cervical cancer within 5 years prior to screening;
* History or current diagnosis of epilepsy or convulsive disorder other than a single childhood febrile seizure;
* Participation in a previous clinical study of paliperidone or any other related medications within the past 3 months prior to screening;
* Receipt of another investigational product within 1 month, or 5 half-lives of the other investigational product, whichever is longer, prior to screening;
* Donation or blood collection of > 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
* Any clinical observation or clinical laboratory abnormality including human immunodeficiency virus (HIV) positive test result or abnormal ECG findings at screening or baseline visits which, in the opinion of the Investigator, may endanger the patient or interfere with the endpoints of the study. If the results of clinical laboratory or ECG testing are outside normal reference ranges, the patient may be enrolled but only if these findings are determined not to be clinically significant by the Investigator. This determination must be recorded in the patient's source documents.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT02804568
Related Title: A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
Related Description: #Study Description
Brief Summary
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
#Intervention
- DRUG : ALKS 3831
- Oral capsule, daily administration
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Has a body mass index (BMI) of 18.0 <= age <= 35.0 kg/m^2, inclusive
* Has a primary diagnosis of schizophrenia
* Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
* Appropriate for outpatient treatment
* Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
* Willing and able to provide government-issued identification
* Is in good physical health
* Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
* Additional criteria may apply
Exclusion Criteria:
* Is currently pregnant or breastfeeding
* Initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
* Poses a current suicide risk at Visits 1 or 2
* Has a history of poor or inadequate response to treatment with olanzapine
* Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
* Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
* Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
* Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
* Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
* Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
* Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
* Additional criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</STUDY>
</RELATED_STUDIES>
Target Study Title: Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia
Target Study Description: #Study Description
Brief Summary
This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.
Detailed Description
The primary objective of this study was to evaluate the safety and tolerability of escalating doses of LY2140023 in subjects with schizophrenia.
The secondary objectives of this study were:
* to characterize the pharmacokinetic (PK) parameters of LY2140023 and its active moiety - LY404039 in subjects with schizophrenia
* to explore higher doses of LY2140023 in subjects with schizophrenia for use in further regulatory studies
* to compare safety of LY2140023 to aripiprazole (ARP)
* to access changes in pharmacodynamic (PD) measures (Clinical Global Impression-Severity Scale \[CGI-S\], Extrapyramidal Symptoms \[EPS\], and Brief Psychiatric Rating Scale \[BPRS\])
This was an inpatient, open-label, multiple-dose, multi-center study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated maximum therapeutic exposure under investigation.
#Intervention
- DRUG : LY2140023
- Administered orally
- Other Names :
- pomaglumetad methionil
- DRUG : Aripiprazole
- Administered orally
- Other Names :
- Abilify
Task Instruction:
1. Based on the "Target Study Title" and "Target Study Description" of the target study, please create a Eligibility Criteria for the target study.
2. please provide a detailed step-by-step logical thinking steps for the Eligibility Criteria you created before creating the whole criteria.
3. Could use example studies (in the <RELATED_STUDIES> section) if they support your justifications, but ensure the reasoning is well-explained and relevant to the study's context
4. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
Your long step by step detailed logical thinking steps here.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
**Step 1: Establishing the Study Population**
The study aims to evaluate the safety and tolerability of LY2140023 in subjects with schizophrenia. To ensure that the study population is representative of the target population, it is essential to include participants with a confirmed diagnosis of schizophrenia. This is supported by the fact that schizophrenia is a chronic and severe mental disorder that requires specific treatment approaches. Studies like NCT01518894 and NCT02418819 have also focused on psychiatrically stable subjects with schizophrenia, indicating the importance of this population in evaluating the safety and efficacy of new treatments.
**Step 2: Ensuring Participant Safety**
To ensure participant safety, it is crucial to exclude individuals with a history of seizures or conditions that may increase the risk of seizures. This is because LY2140023 may have pro-convulsant effects, and participants with a history of seizures may be at increased risk of adverse events. Studies like NCT03751488 have also excluded participants with a history of seizures, highlighting the importance of this criterion.
**Step 3: Assessing Renal Function**
To evaluate the safety and tolerability of LY2140023, it is essential to assess renal function in participants. This is because LY2140023 may be metabolized by the kidneys, and participants with impaired renal function may be at increased risk of adverse events. Studies like NCT02804568 have also included renal function assessments, indicating the importance of this criterion.
**Step 4: Excluding Participants with Active Suicidal Ideation**
To ensure participant safety, it is crucial to exclude individuals with active suicidal ideation. This is because LY2140023 may have a risk of inducing suicidal thoughts or behaviors, and participants with active suicidal ideation may be at increased risk of harm. Studies like NCT03751488 have also excluded participants with active suicidal ideation, highlighting the importance of this criterion.
**Step 5: Assessing Electrolyte Levels**
To evaluate the safety and tolerability of LY2140023, it is essential to assess electrolyte levels in participants. This is because LY2140023 may affect electrolyte levels, and participants with abnormal electrolyte levels may be at increased risk of adverse events. Studies like NCT02804568 have also included electrolyte assessments, indicating the importance of this criterion.
**Step 6: Excluding Participants with Severe Medical Conditions**
To ensure participant safety, it is crucial to exclude individuals with severe medical conditions that may increase the risk of adverse events. This includes conditions such as diabetes, hypertriglyceridemia, and hepatic insufficiency. Studies like NCT03751488 have also excluded participants with these conditions, highlighting the importance of this criterion.
**Step 7: Assessing Prolactin Levels**
To evaluate the safety and tolerability of LY2140023, it is essential to assess prolactin levels in participants. This is because LY2140023 may affect prolactin levels, and participants with abnormal prolactin levels may be at increased risk of adverse events. Studies like NCT02804568 have also included prolactin assessments, indicating the importance of this criterion.
**Step 8: Excluding Participants with HIV or Hepatitis**
To ensure participant safety, it is crucial to exclude individuals with HIV or hepatitis. This is because LY2140023 may have a risk of exacerbating these conditions, and participants with HIV or hepatitis may be at increased risk of adverse events. Studies like NCT03751488 have also excluded participants with HIV or hepatitis, highlighting the importance of this criterion.
**Step 9: Establishing Age and Gender Inclusion Criteria**
To ensure that the study population is representative of the target population, it is essential to include participants across a range of ages and genders. This is because schizophrenia affects individuals of all ages and genders, and the study aims to evaluate the safety and tolerability of LY2140023 in this population. Studies like NCT01518894 and NCT02418819 have also included participants across a range of ages and genders, indicating the importance of this criterion.
**Step 10: Establishing Inclusion and Exclusion Criteria**
Based on the above steps, the inclusion and exclusion criteria for the study can be established. The inclusion criteria should include:
* A confirmed diagnosis of schizophrenia
* Age 18-65 years
* Both male and female participants
* Participants with a platelet count of >50,000
* Participants with an ejection fraction of <40%
* Participants with a normal electrolyte profile
* Participants with a normal prolactin level
* Participants without HIV or hepatitis
* Participants without a history of seizures or conditions that may increase the risk of seizures
* Participants without active suicidal ideation
* Participants without severe medical conditions that may increase the risk of adverse events
The exclusion criteria should include:
* A history of seizures or conditions that may increase the risk of seizures
* Impaired renal function
* Active suicidal ideation
* Severe medical conditions that may increase the risk of adverse events
* HIV or hepatitis
* Prolactin levels outside the normal range
* Electrolyte levels outside the normal range
* A platelet count of <50,000
* An ejection fraction of ≥40%
* A history of participation in a previous clinical study of LY2140023
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of schizophrenic disorder
* Female participants who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last LY2140023 dose or are postmenopausal
* Not have been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of washout period and have a Clinical Global Impression -Severity (CGI-S) scale score of <4
* Be willing and able as determined by the investigator to be hospitalized from the beginning of the washout period to the end of the study
* In the opinion of the investigator, the participant can be washed out of their Standard of Care (SOC) therapy (other than aripiprazole for the aripiprazole participants) for the duration of the study without detrimental effect to the participant's mental health (CGI-S <4 after completion of the washout period)
* Be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
* Be able to understand the nature of the study and have given their own informed consent
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Have venous access sufficient to allow blood sampling
* Clinically acceptable sitting blood pressure and pulse rate, as determined by the investigator
Participants on Aripiprazole prior to study entry must:
* On a stable dose of aripiprazole within the approved range in product labeling (less than or equal to 30 milligrams [mg]/day) for at least 60 days prior to Day 1 and with no anticipation of changes to dose, regimen (except as required for this study) or treatment within the next 1 month
Exclusion Criteria:
* Currently enrolled in, or discontinued within the 30 days prior to screening from, a clinical trial involving an investigational drug or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have known allergies to LY2140023, LY404039, aripiprazole, or related compounds
* Participants with moderate to severe renal impairment as defined by creatinine clearance (CrCl) <60 milliliters (mL)/minute (min)
* Have previously completed this study or have discontinued from any study investigating LY2140023 after having received at least 1 dose of LY2140023
* Participants for whom treatment with LY2140023 or aripiprazole as specified in this protocol, is relatively or absolutely clinically contraindicated
* Participants who have received treatment with clozapine
* Participants who have a diagnosis of schizophrenia who are taking either thioridazine or thiothixene
* Participants receiving treatment with depot antipsychotic medication within 12 weeks, prior to screening
* Participants who are taking any of medications that are specifically excluded
* Participants who have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the 'Suicidal Ideation' portion of the Columbia suicide severity rating scale (C-SSRS), or answer 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the 'Suicidal Behavior' portion of the C-SSRS; and the ideation or behavior occurred within the past 3 months
* Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (Text Revision) (DSM-IV-TR) diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to admission
* Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of admission (or at any time during the dosing period)
* Have a history of one or more seizures except for either of the following 2 situations: a single simple febrile seizure between ages 6 months and 5 years or a single seizure with an identifiable etiology, which has been completely resolved
* Have a screening electroencephalogram (EEG) with paroxysmal (epileptiform) activity, for example, one that demonstrates 3 or more focal sharp or spike waves, any sharp and slow wave complex, or any epileptiform discharge that is rhythmic, sustained, or generalized, or as locally defined
* Participants who have had electroconvulsive therapy (ECT) within 3 months of observation period or who are expected to have ECT at any time during the live phase of this study
* A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders
* Participant with untreated hyperthyroidism or hypothyroidism needing a thyroid hormone supplement who have not been on a stable dose of medication for at least 2 months prior to screening
* Have leukopenia or history of leukopenia during the participant's lifetime
* Participants with alanine aminotransferase (ALT/SGPT) or aspartate aminotransferase (AST/SGOT) values >2 times the upper limit of normal (ULN) of the performing laboratory, or total bilirubin values >1.5 times the ULN of the performing laboratory at screening
* Participants with corrected QT interval (Bazett's); QTcB >450 milliseconds (msec) (male) or >470 msec (female) at admission
* Have acute, serious or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c [HgbA1c] >8%), severe hypertriglyceridemia (fasting triglycerides greater than or equal to 500 mg/dL or 5.65 micromoles/liter [umol/L]), hepatic insufficiency (specifically any degree of jaundice), recent cerebrovascular accidents, seizure disorders, serious acute systemic infection or immunology disease, unstable cardiovascular disorders (including ischemic heart disease), renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases
* Prolactin level of >200 nanograms/milliliter (ng/mL) (200 micrograms/liter [ug/L], or 4228 milli international units/liter [mIU/L]) at screening with the exception of participants treated with risperidone. Participants treated with risperidone are excluded if the prolactin level is >300 ng/mL (300 ug/L, or 6342 mIU/L) at screening
* Participants with known medical history of Human Immunodeficiency Virus positive (HIV+) status
* Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody. Participants with positive Hepatitis B core antibody test and negative HBsAg may be included in the study if ALT/SGPT and AST/SGOT levels are less than 2 times the ULN and total bilirubin does not exceed the ULN of the central laboratory
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 1 |
<RELATED_STUDIES>
<STUDY>
Related NCT_ID: NCT05725148
Related Title: Prospective, Single-center, Single Group, Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus' Compared to the Reference Blood Pressure Reading With an Auscultatory Sphygmomanometer
Related Description: #Study Description
Brief Summary
The goal of this clinical trial is to evaluate how accurately the CART-I plus developed by Sky Labs can measure blood pressure. The primary endpoint of this clinical trial is accuracy (mmHg) of 'CART-I plus' which is obtained by calculating mean error and standard deviation of blood pressure differences between 'CART-I plus' and the gold standard for non-invasive method, auscultatory method. The reference readings are taken by auscultatory method using a sphygmomanometer and a stethoscope. The mean errors and standard deviations are calculated both sample- and subject-wise.
Detailed Description
According to the World Health Organization (WHO), hypertension is one of the major risk factors for death worldwide. The global adult population with hypertension is approximately 113 million, with an estimated prevalence of 18-27%. Hypertension is associated with stroke and other cardiovascular diseases, thus early detection and treatment critical. National guidelines of the Japanese, European, and American Hypertension Society recommend that home blood pressure and clinic blood pressure test results be applied together when diagnosing hypertension, emphasizing the importance of blood pressure monitoring in daily life. In addition, according to the Ohasama cohort study and the Finn-Home study, blood pressure measured in daily life was more predictive of cardiovascular disease than the office blood pressure.
There are invasive and non-invasive methods for blood pressure monitoring. The invasive method measures blood pressure using a pressure sensor by inserting a catheter into a blood vessel, and the non-invasive method measures blood pressure by sensing sound or vibration while applying pressure using a cuff. Invasive blood pressure tests can continuously measure blood pressure and are accurate, but there is a high risk of side effects such as distal ischemia, bleeding, thrombosis, infection, etc and is not available for a daily life. Non-invasive blood pressure test methods such as auscultatory measurement and oscillometric method are simpler than invasive methods, but it has limitations in measuring blood pressure continuously and observing long-term variations.
The photoplethysmography (PPG) method makes it possible to measure blood pressure without a cuff, enabling people to check and monitor blood pressure in daily life for a long time. It has been reported that the wavelength and amplitude of the PDW signal collected from the finger show a high correlation (0.92) with the PDP signal collected from the wrist. This suggests that the blood pressure accuracy of measuring blood pressure with PPG signals collected from the finger will not differ significantly from that measured from the wrist.
Sky Labs has developed 'CART-I plus' that can measure blood pressure in daily life without a cuff. 'CART-I plus' is a ring-type device that applies the principle of PPG technology to measure blood flow through finger veins. This clinical trial was designed in accordance with the ISO 81060-2:2018 standard to evaluate the accuracy of blood pressure estimated by 'CART-I plus'.
#Intervention
- DEVICE : CART-I plus
- CART-I plus is a ring-type medical device that continuously monitors Atrial Fibrillation, heart rate, oxygen saturation, and blood pressure using PPG and ECG signals.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Those aged >= 19 years
* Those who voluntarily decided to participate in this clinical trial and gave written consent to the subject explanation and consent form
* Those who is willing to comply with the clinical trial protocol
Exclusion Criteria:
* Those whose sound of fifth Kortkoff phase (K5) is not heard during blood pressure test using an auscultation type sphygmomanometer
* Those with unstable cardiac condition (myocardial infarction, ventricular arrhythmia, atrial fibrillation, premature ventricular contraction, pulmonary embolism 1 week before screening date)
* Those with arm circumference greater than 42 cm (> 42 cm)
* Those with a history of hypersensitivity to clinical trial medical device raw materials (PolyCarbonate, polycarbonate)
* Those with physical restrictions on wearing medical devices for clinical trials (for example, when ring-type clinical trial medical devices cannot be applied due to lack of appropriate ring size or other physical defects)
* Those who are judged to have difficulty collecting normal signals when wearing CART-I plus on a finger other than the thumb and forefinger (for example, if there is no CART-I plus model that fits the subject's finger)
* Those who is pregnant
* Those who is currently participating in other clinical trials or who have participated in other clinical trials within 30 days of the screening date
* Other cases where the investigator judges that participation in the clinical trial is inappropriate due to ethical reasons or may affect the results of the clinical trial
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT05978453
Related Title: Blood Pressure Monitor#Model#BP7# Clincial Test
Related Description: #Study Description
Brief Summary
The purpose of this study is to verify the accurancy of the blood pressure monitor device.
Cuff size of arm circumference: 13.5cm- 22cm.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Normal blood pressure and hypertensive patients > 12 years
Exclusion Criteria:
* Patients with serious arrhythmias or a high frequency of arrhythmias
* pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT04218032
Related Title: Verenpaineen Seuranta Paineanturi-matriisilla
Related Description: #Study Description
Brief Summary
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.
Detailed Description
The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for assessing haemodynamic status measured from the fingertip using oscillometry. . As the finger pressing pressure is ramped up and then slowly down, an oscillometric response is recorded. From this signal the mean arterial pressure is found from which systolic and diastolic pressure is computed along with the full pressure waveform.
#Intervention
- DEVICE : sphygmomanometer, SpyghmoCor, CNAP500
- blood pressure is measured with developed new non-invasive technology, oscillometry from the fingertip, and compared to non-invasive standard blood pressure measurement using a standard sphygmomanometer/SpyghmoCor device/CNAP500 device.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* written concent from the participant
Exclusion Criteria:
* pace maker, pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT01753895
Related Title: Comparison of Manual Blood Pressure Monitoring Using a Mercury Sphygmomanometer to an Automated Blood Pressure Instrument in a Research Setting
Related Description: #Study Description
Brief Summary
Blood pressure (BP) measurement is one of the most commonly performed screening tests in the clinical setting. Its accuracy is vital to the early diagnosis and effective management of hypertension, as emphasized by hypertension management guidelines. For most protocols being conducted in a clinical research setting, obtaining single or serial blood pressure reading(s) is often performed as a safety assessment, especially if the individual is participating in a study that requires a blood draw and/or the administration of a research drug, vaccine or device. It is imperative that the blood pressure data truly reflect the response, if any, the study participant experiences in relation to the research procedures and interventions.
Detailed Description
Despite the clear guidelines on manual blood pressure technique, there seems to be large inter-observer variations, both among nursing staff and physicians. These differences are further complicated by variables such as cuff selection and application, incorrect cuff positioning and rapid cuff deflation rate, inadequate rest period, and lack of repeated measurements. The blood pressure measurement obtained by an automated device is not as dependent on observer training and competency as the manual mercury device, yet its use requires careful patient evaluation for caffeine or nicotine use, cuff position, and proper wrist positioning, and instructing the individual not to move or talk if accurate blood pressures are to be obtained. If one performs the automated readings and manual blood pressure measurements under standardized conditions, the mean values will be quite similar; however, this possibility has not yet been fully tested.
Therefore, there is a need to assess systematically if there is in fact a difference in the two blood pressure monitoring approaches under controlled conditions. The goal of this study, then, is to examine our current practice of obtaining manual blood pressure measurement using a mercury sphygmomanometer compared to an automated wrist-mounted blood pressure device.
A possible implication of this study is if the blood pressure measurements using the automated blood pressure device are comparable to the measurements obtained using the mercury sphygmomanometer, than the mercury devices can be replaced by the more environmentally acceptable automated devices in our clinical research setting.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Male or Female >18 and < 100 years
* With or without history of hypertension on or off antihypertensive medications
* Able to understand the information in the informed consent form and can provide written consent
* Upper arm and wrist access
Exclusion Criteria:
* Latex allergy
* Upper arm circumference > 52mm
* Wrist circumference < 5 inches and > 8 3/4 inches
* History of Mastectomy or Upper Extremity Peripheral Vascular Disease
* History of Carpal Tunnel Disease
* History of surgical repair of varicosities in the upper arm or wrist
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</STUDY>
</RELATED_STUDIES>
Target Study Title: An Alternative Technique for Measuring Blood Pressure
Target Study Description: #Study Description
Brief Summary
This cross design study will be conducted to evaluate the combination of palpation and auscultation techniques as an alternative technique for the measurement of blood pressure. The main questions it aims to answer are:
* Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique?
* Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique? Participants' blood pressure will be measured twice.
Detailed Description
As a result of clinical observations, a common practice is to inflate the cuff to a high and random mmHg value and start auscultation directly. Alternatively, many healthcare workers determine the moment when pulse beats disappear by palpation and increase this value by 30 mmHg without lowering the cuff and without taking a break for 1-2 minutes and start auscultation. In the literature, there is a similar technique called 'one-step method'. According to this technique, the sphygmomanometer is wrapped around the individual's arm and the stethoscope is placed in the ear. The brachial artery is then palpated and identified. The cuff is inflated up to 30 mmHg above the systolic blood pressure of the individual. The cuff is then depressurized to 2-3 mmHg/second. It is observed that many healthcare professionals and students use this technique today because it is more practical in terms of measurement time. However, it is thought that the step of 'inflating the cuff up to 30 mmHg above the systolic blood pressure value of the individual' in the process steps of the technique is not reliable enough. It is thought that it may lead to erroneous results in capturing sudden blood pressure changes in the individual. In this context, it is thought that it would be more reliable to determine the value at the moment when the pulse is not felt with the palpation technique, add 30 mmHg to this value without interruption and without lowering the cuff and continue auscultation. At the same time, combining palpation and auscultation and continuing them consecutively will shorten the measurement time and provide a practical application.
It is aimed to measure blood pressure in approximately 202 healthy adults. The purpose and method of the study will be explained in detail to all participants included in the sample group. Participants will be allowed to rest for 15-30 minutes before blood pressure measurement. Blood pressure will be measured with two different techniques according to the order in which the participants are included in the study. The first participant's blood pressure will first be measured with the standard technique in the literature (with a break between palpation and auscultation). After a 60-second pause, blood pressure will be measured with the alternative recommended technique (palpation and auscultation combined). In the second participant, blood pressure will be measured first with the alternative recommended technique (combining palpation and auscultation). After a 60-second break and with the arm in the same position, blood pressure will be measured with the standard technique in the literature (with a break between palpation and auscultation). The cross-over method will be applied as possible differences between measurement times should be taken into account.
#Intervention
- OTHER : blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.
- Each participant will have their blood pressure measured with two different techniques.
Task Instruction:
1. Based on the "Target Study Title" and "Target Study Description" of the target study, please create a Eligibility Criteria for the target study.
2. please provide a detailed step-by-step logical thinking steps for the Eligibility Criteria you created before creating the whole criteria.
3. Could use example studies (in the <RELATED_STUDIES> section) if they support your justifications, but ensure the reasoning is well-explained and relevant to the study's context
4. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
Your long step by step detailed logical thinking steps here.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
**Step 1: Understanding the Importance of Blood Pressure Measurement**
The study aims to evaluate an alternative technique for measuring blood pressure, which is a critical aspect of cardiovascular health. Blood pressure measurement is essential for diagnosing and managing hypertension, a major risk factor for death worldwide (WHO, 2020). The accuracy of blood pressure measurement is vital for effective management of hypertension, as emphasized by hypertension management guidelines (NCT01753895).
**Step 2: Identifying the Need for a Reliable Blood Pressure Measurement Technique**
The current standard technique for blood pressure measurement involves a break between palpation and auscultation, which may lead to erroneous results in capturing sudden blood pressure changes (Title and Description). An alternative technique combining palpation and auscultation consecutively is proposed to shorten measurement time and provide a practical application.
**Step 3: Ensuring Participant Safety and Reliability**
To ensure participant safety and reliable outcomes, it is essential to exclude individuals with chronic diseases, as they may have altered cardiovascular or circulatory systems that could affect blood pressure measurement. This is supported by studies like NCT03536880, which set an ejection fraction threshold of <40% to ensure patients have significant but stable cardiac impairment.
**Step 4: Excluding Participants with Cardiovascular or Circulatory System Affecting Medications**
Participants taking medications that affect the cardiovascular or circulatory system should be excluded, as these medications can alter blood pressure readings. This is in line with the study's aim to evaluate the alternative blood pressure measurement technique without confounding factors.
**Step 5: Ensuring Participant Voluntariness and Ability to Participate**
To ensure participant voluntariness and ability to participate, the study should exclude individuals who want to leave the study at any stage. This is essential for maintaining participant engagement and ensuring reliable data collection.
**Step 6: Establishing Age and Health Status Criteria**
The study aims to recruit healthy adults, so it is essential to establish age and health status criteria. The study should exclude individuals with chronic diseases and those taking medications that affect the cardiovascular or circulatory system. This is supported by studies like NCT01753895, which excluded participants with serious arrhythmias or a high frequency of arrhythmias.
**Step 7: Determining the Age Range**
The study should recruit participants aged 18-65 years, as this age range is considered healthy and able to participate in the study. This age range is also supported by studies like NCT04218032, which recruited participants aged 18-80 years.
**Step 8: Establishing Exclusion Criteria for Chronic Diseases**
The study should exclude participants with chronic diseases, as they may have altered cardiovascular or circulatory systems that could affect blood pressure measurement. This is essential for ensuring reliable outcomes and participant safety.
**Step 9: Establishing Exclusion Criteria for Medications Affecting the Cardiovascular or Circulatory System**
Participants taking medications that affect the cardiovascular or circulatory system should be excluded, as these medications can alter blood pressure readings. This is in line with the study's aim to evaluate the alternative blood pressure measurement technique without confounding factors.
**Step 10: Establishing Inclusion Criteria for Healthy Volunteers**
The study should include healthy volunteers who are willing to participate in the study and have given written consent. This is essential for ensuring participant voluntariness and ability to participate.
**Step 11: Establishing Exclusion Criteria for Pregnancy and Other Conditions**
The study should exclude pregnant women and individuals with other conditions that may affect blood pressure measurement, such as a history of mastectomy or upper extremity peripheral vascular disease.
**Step 12: Establishing the Study Population**
The study should recruit healthy adults aged 18-65 years, without chronic diseases, and not taking medications that affect the cardiovascular or circulatory system. This population will allow for reliable evaluation of the alternative blood pressure measurement technique.
**Step 13: Establishing the Study Design**
The study should use a cross-over design, where participants are measured with both the standard and alternative techniques in a random order. This design will allow for comparison of the two techniques and evaluation of the alternative technique's reliability.
**Step 14: Establishing the Sample Size**
The study should recruit approximately 202 healthy adults to ensure sufficient power for statistical analysis and reliable evaluation of the alternative blood pressure measurement technique.
**Step 15: Establishing the Study Duration**
The study should be conducted over a period that allows for participant recruitment, data collection, and analysis. The duration should be sufficient to ensure reliable data collection and evaluation of the alternative blood pressure measurement technique.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria:
* Over 18 years,
* no chronic disease,
* not taking any medication and/or treatment that affects the cardiovascular or circulatory system,
* volunteering to participate in the research.
Exclusion Criteria:
* has a chronic disease,
* taking medication that affects the cardiovascular or circulatory system,
* wants to leave the study at any stage.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 2 |
<RELATED_STUDIES>
<STUDY>
Related NCT_ID: NCT00947856
Related Title: Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
Related Description: #Study Description
Brief Summary
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.
Detailed Description
This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:
* Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
* Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.
#Intervention
- DRUG : brentuximab vedotin
- Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
- Other Names :
- Adcetris
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Participated in a previous brentuximab vedotin study.
* CD30-positive hematologic malignancy.
* At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.
Exclusion Criteria:
Withdrew consent to participate in any prior brentuximab vedotin study.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT01396070
Related Title: Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
Related Description: #Study Description
Brief Summary
The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.
Detailed Description
This phase 2 exploratory study will evaluate the clinical response of brentuximab vedotin in MF and SS, where tumor cells express variable levels of CD30 target molecule.
The primary objective is to explore the biologic activity of brentuximab vedotin in patients with MF and SS, the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. Brentuximab vedotin has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL). The subject grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only, to ensure that a wide range of CD30 expression is studied.
#Intervention
- DRUG : Brentuximab vedotin
- 1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles).
Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10.
- Other Names :
- Adcetris, SGN-35
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin biopsy must be within 3 months of beginning study medication
* At least the following wash-out from prior treatments:
* >= 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (including monoclonal antibody)
* > 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox and phototherapy
* > 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
* At least 18 years
* ECOG performance status of <= 2
* Must be able to commit to study schedule
* Absolute neutrophil count (ANC) >= 1000/uL
* Platelets >= 50,000/uL
* Bilirubin <= 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease <= 3X ULN)
* Serum creatinine <= 2X ULN
* Alanine aminotransferase (ALT) <= 3X ULN
* Aspartate aminotransferase (AST) <= 3X ULN
* Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a woman of childbearing potential
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS) disease
* Systemic or topical concomitant corticosteroid use for treatment of skin disease (EXCEPTION: Oral prednisone allowed at <= 10 mg/day)
* Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection
* Known to be Hepatitis B or Hepatitis C antibody positive
* HIV-positive with have a measurable viral load while on antiretroviral medication
* Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
* History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin cancer; curatively treated localized prostate cancer; curatively treated localized breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or cervical carcinoma in situ on biopsy).
* Pregnant
* Breastfeeding
* Congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
* Any serious underlying medical condition that would impair subject's ability to receive or tolerate the planned treatment.
* Dementia or altered mental status that would preclude subject's understanding and rendering of informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT01909934
Related Title: A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Related Description: #Study Description
Brief Summary
The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride \[hydroxydaunorubicin\], vincristine sulfate \[Oncovin\], and prednisone \[CHOP\] or equivalent multiagent chemotherapy regimens with curative intent).
#Intervention
- DRUG : Brentuximab vedotin
- Brentuximab vedotin IV infusion
- Other Names :
- SGN-35, ADCETRIS
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Male or female participants age >= 18 years, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
* Bidimensional measurable disease
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
* Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence
* Clinical laboratory values as specified in the study protocol
Exclusion Criteria:
* Previous treatment with brentuximab vedotin.
* Previously received an allogeneic transplant.
* Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).
* Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
* Female participants who are lactating and breastfeeding or pregnant
* Known human immunodeficiency virus (HIV) positive
* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT02388490
Related Title: A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
Related Description: #Study Description
Brief Summary
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.
Detailed Description
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas. The ORR will be evaluated based on the revised Cheson's criteria or modified SWAT criteria in case of cutaneous EBV- and CD30-positive lymphomas.
#Intervention
- DRUG : brentuximab vedotin
- Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
- Other Names :
- Adcetris
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Patients with relapsed or refractory EBV- and CD30-positive lymphomas
* Age >= 18 years
* ECOG performance status 0 <= age <= 2
* At least one measurable lesion based on revised Cheson's or modified SWAT criteria
* Provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
* Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
* Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
* Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
* Adequate hematologic function: absolute neutrophil count (ANC) >=1,500/µL, platelet count >= 75,000/µL, and hemoglobin >=8.0 g/dL unless there is known hematologic tumor marrow involvement (ANC >= 1,000/µL and platelet count >= 50,000/µL if there is known bone marrow involvement)
* Adequate liver function: total bilirubin < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome and ALT or AST < 3 x ULN (AST and AST < 5 x ULN if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
* Adequate renal function: serum creatinine < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
* Expected survival > 3 months
Exclusion Criteria:
* Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
* Any serious medical or psychiatric illness
* Known cerebral or meningeal involvement (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML
* Symptomatic neurologic disease compromising normal activities or requiring medication
* Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
* Known history of myocardial infarction within 1 year, NYHA class III/IV heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
* Any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
* Any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
* Prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
* Prior exposure to CD30-targeted agents
* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
* Known human immunodeficiency virus (HIV) positive
* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
* Another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY>
</RELATED_STUDIES>
Target Study Title: A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Target Study Description: #Study Description
Brief Summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
#Intervention
- DRUG : brentuximab vedotin
- 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
- Other Names :
- Adcetris; SGN-35
- DRUG : brentuximab vedotin
- 2.4 mg/kg every 3 weeks by intravenous (IV) infusion
- Other Names :
- Adcetris; SGN-35
- DRUG : brentuximab vedotin
- 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
- Other Names :
- Adcetris; SGN-35
Task Instruction:
1. Based on the "Target Study Title" and "Target Study Description" of the target study, please create a Eligibility Criteria for the target study.
2. please provide a detailed step-by-step logical thinking steps for the Eligibility Criteria you created before creating the whole criteria.
3. Could use example studies (in the <RELATED_STUDIES> section) if they support your justifications, but ensure the reasoning is well-explained and relevant to the study's context
4. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
Your long step by step detailed logical thinking steps here.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
**Step 1: Understanding the Study Context**
The study aims to evaluate the antitumor activity of brentuximab vedotin in patients with CD30-positive nonlymphomatous malignancies. This requires a clear understanding of the disease characteristics and the potential risks associated with the treatment.
**Step 2: Identifying Key Considerations for Patient Selection**
To ensure reliable outcomes and minimize risks, the study must consider factors such as the patient's overall health, disease severity, and potential interactions with the treatment. This includes evaluating the patient's performance status, disease burden, and organ function.
**Step 3: Performance Status and Disease Severity**
The study requires patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70. This is because patients with a good performance status are more likely to tolerate the treatment and experience reliable outcomes. This is supported by studies like NCT01396070, which used similar performance status criteria to ensure patients were fit for treatment.
**Step 4: Disease Burden and Measurable Disease**
The study requires measurable disease, which is essential for assessing treatment efficacy. This is consistent with the approach taken in NCT02388490, where measurable disease was a key inclusion criterion.
**Step 5: Histological Confirmation of CD30-Positive Nonlymphomatous Malignancy**
The study requires histologically-confirmed CD30-positive nonlymphomatous malignancy. This is crucial for ensuring that the treatment is targeted at the correct disease type and that patients are not at risk of adverse effects. This is supported by the approach taken in NCT01909934, where CD30 expression was a key inclusion criterion.
**Step 6: Exclusion Criteria - Primary Diagnosis of Lymphoma or CNS Malignancy**
The study excludes patients with a primary diagnosis of lymphoma or central nervous system (CNS) malignancy. This is because these conditions may require different treatment approaches and may be associated with unique risks. This is consistent with the approach taken in NCT01396070, which excluded patients with CNS involvement.
**Step 7: Exclusion Criteria - History of Another Primary Invasive Malignancy**
The study excludes patients with a history of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years. This is because patients with a history of another malignancy may be at increased risk of treatment-related complications or may have underlying conditions that affect treatment efficacy. This is supported by the approach taken in NCT02388490, which excluded patients with a history of another malignancy.
**Step 8: Exclusion Criteria - Evidence of Active Cerebral/Meningeal Disease**
The study excludes patients with evidence of active cerebral/meningeal disease. This is because CNS involvement may require different treatment approaches and may be associated with unique risks. This is consistent with the approach taken in NCT01909934, which excluded patients with CNS involvement.
**Step 9: Age Considerations**
The study includes patients aged 6 years and above, with no upper age limit. This is because brentuximab vedotin has been shown to be effective in patients across a range of ages, including older adults. This is supported by the approach taken in NCT01396070, which included patients aged 18 years and above.
**Step 10: Conclusion**
The study's eligibility criteria are designed to ensure that patients are selected based on their disease characteristics, performance status, and potential risks associated with the treatment. The criteria are consistent with the approach taken in similar studies and are intended to ensure reliable outcomes and minimize risks.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
* Have failed, refused, or have been deemed ineligible for standard therapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
Exclusion Criteria:
* Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
* History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
* Evidence of active cerebral/meningeal disease
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 3 |
<RELATED_STUDIES>
<STUDY>
Related NCT_ID: NCT04636320
Related Title: Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
Related Description: #Study Description
Brief Summary
The aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.
Detailed Description
Multiple large series conducted in hospitalized patients have reported high rates of myocardial injuries in the acute stage of COVID-19 infection. These findings have raised concerns regarding potential long term consequences of the pandemic on cardiovascular diseases (heart failure and sudden cardiac deaths due to scar-related arrhythmias). However, the prevalence of silent myocardial injuries in the general population who presented a COVID-19 infection managed without hospitalization are unknown. In addition, the propensity of these scars to generate arrhythmias have not been thoroughly studied. COVID CMR will include 120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization and 120 age- and sex-matched controls. At day 1, all subjects will undergo a 12-lead electrocardiogram, a contrast-enhanced CMR study including advanced methods to detect silent myocardial scars, and a blood sample to look for markers of inflammation and cardiac injury, and to assess the COVID-19 serological status at the time of the CMR study. The prevalence of myocardial scars on CMR will be compared between the 2 groups. In a second visit at 3 months, patients showing myocardial scar on CMR will be matched to healthy volunteers showing no such scars, and these 2 population subsets will undergo exercise electrocardiogram (ECG) and 24 hour Holter ECG to characterize the arrhythmogenic role of silent myocardial scars.
#Intervention
- DEVICE : Contrast-enhanced CMR
- Cardiac Magnetic Resonance Imaging (MRI) examinations will be performed at Day 0 visit on clinical systems 1.5 equipped with specific antennas for cardiac imaging. The imaging protocol will last approximately 50 minutes.
- DIAGNOSTIC_TEST : Exercise test ECG
- A treadmill exercise test with 12 lead ECG monitoring will be performed at M3 visit.
Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.
- BIOLOGICAL : Blood sample
- A blood sample will be taken at Day 0 visit for COVID-19 serology, hematocrit measurement, ultra-high sensitive troponin test, low grade markers of inflammation, genetic profiling.
An other blood sample will be taken at M3 visit for a control COVID-19 serology for 30 healthy volunteers.
- DIAGNOSTIC_TEST : Resting 12 lead ECG
- A resting 12 lead ECG will be performed at Day 0 visit.
- DIAGNOSTIC_TEST : 24 hour Holter ECG
- A 24 hour Holter ECG will be performed at M3 visit. Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Man or woman >= 18 years
* Affiliated to a health insurance program
* Providing free, informed, written and signed consent to participate (at the latest on the day of inclusion and before any research procedure is initiated)
* Effective contraception if women in the age to procreate
* In the patient group : history of COVID-19 infection with either a positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test on nasopharyngeal swab or a positive COVID-19 serology in the acute stage. Presence of all following symptoms in the acute stage: fever>38°C, asthenia, arthromyalgia, associated with at least 2 of the following: coughing and/or spitting, dyspnea and/or chest discomfort, anosmia and/or ageusia.
Exclusion Criteria:
* age < 18 years
* History of cardiac disease or acute coronary syndrome associated with troponin rise
* History of allergic reaction to gadolinium-based contrast agents
* History of severe renal failure
* Presence of a pacemaker, implantable defibrillator, intra-orbital metallic material, intra-cranial surgical clip, valve prosthesis Star-Edwards pre 6000, neurostimulator or implantable insulin pump
* Claustrophobia or inability to lay on the back for 50 min
* Pregnant or breast feeding women
* Inability to express informed consent
* Person deprived of liberty by judicial or administrative decision
* Person under legal protection
* In the healthy volunteer group:
* Symptoms suggestive of COVID-19 infection over the epidemic period (after February 1st 2020)
* Person not willing to be informed of potential incidental CMR findings
* In the patient group:
* Hospitalization for infectious syndrome suggestive of COVID-19.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT04625075
Related Title: Manganese-Enhanced Magnetic Resonance Imaging of MyOcardial injuRY in COVID 19 (MEMORY- COVID)
Related Description: #Study Description
Brief Summary
Our understanding of the clinical manifestations of COVID-19 is growing on a daily basis and there is evidence that increased age, cardiovascular risk factors and cardiac comorbidity are strongly associated with poor outcomes. Furthermore, myocardial injury occurs and is associated with a much worse outcome and rapid increase in mortality. There have been several reports of myocarditis and heart failure following infection. The mechanisms of myocardial injury and its consequences are not well understood.
In an ongoing peer-reviewed and funded study, the investigators are evaluating the use of magnetic resonance imaging (MRI) to characterise and to understand the mechanisms of heart failure and myocarditis. Following strong encouragement by the British Heart Foundation, the investigators now propose to extend this investigation to patients who have recovered from COVID-19 infection to understand the mechanisms of myocardial injury that they have experienced. Using gadolinium and manganese-enhanced MRI combined with Computed tomography coronary angiography (CTCA), the investigators will assess the mechanisms and direct impact of myocardial injury in patients who have recovered from COVID-19 infection. This will help the investigators understand how best to manage individuals who demonstrate evidence of myocardial injury and potentially provide insights that could lead to novel treatment interventions to reduce such injury and improve patient outcomes.
Detailed Description
COVID-19 Pandemic This is the first major pandemic the modern world has faced since the Spanish Flu in 1918, with a profound impact on all aspects of society as we know it. Governments worldwide have put in place emergency plans to help tackle and reduce the rapid spread of the infection, with social isolation being implemented by most to varying degrees. As expected, healthcare systems are facing unprecedented challenges and real-time re-structuring. As well as focusing on the identification and management of critically unwell COVID-19 patients, healthcare organisations have the responsibility of protecting the public from infection and to continue the treatment of non COVID-19 related conditions. This has resulted in a complete reorganisation in how we deliver care, prioritising safety and infection control measures. In reality, this means cancelling routine clinics and procedures and has the potential to have a great impact on patient care.
COVID-19 The pool of evidence regarding this novel strain of coronavirus and the associated infection is growing as the condition unfolds. The current estimated case fatality rate varies between 1.4%-2.3%, with higher rates in the elderly, certain ethnic groups and those with co-morbidities. The largest case series from the Chinese Centre of Disease Control and Prevention reported 72,314 case records from suspected and confirmed cases. The clinical severity was reported as mild in 81.4%, severe in 13.9% and critical in 4.7%. Although clinical presentation of COVID-19 can be variable, most commonly symptoms resemble those of other viral respiratory tract infections: fever, cough, dyspnoea, myalgia and fatigue. In severe cases, COVID-19 is associated with bilateral pneumonia, acute respiratory distress syndrome (ARDS), and septic and cardiogenic shock, with higher mortality and morbidity seen in elderly and comorbid patients.
Patients with known cardiovascular risk factors or established cardiac problems are at higher risk of contracting severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2), and this confers a worse prognosis in COVID- 19 infection. It is difficult to establish the true link between COVID-19 and prevalence of cardiovascular complications due to the lack of testing in community and the cohort of patients who are admitted to secondary care, who are likely to be older and have co-morbidities and therefore are more likely to have pre-existing cardiac conditions and develop new cardiovascular complications.
COVID-19: Myocardial Injury Myocardial injury with necrosis can occur with and without overt ischaemia from acute myocardial infarction and is defined as an elevated plasma cardiac troponin concentration above the 99th centile. There are different mechanisms underlying acute myocardial injury; with ischaemia from an acute coronary syndrome and prolonged myocardial oxygen demand/supply imbalance being the most familiar. It is well recognised that an acute myocardial injury may occur in the absence of ischaemia due to a variety of cardiac and non-cardiac causes. Furthermore, this can be seen in critically unwell patients of varying aetiology and is a marker of poor prognosis.
Therefore determining the underlying mechanism is vital in guiding clinical care and improving outcomes. Myocardial injury is increasingly recognised in COVID-19 patients and, as anticipated, it correlates with severe cases and poor outcomes.5 In a cohort of 191 patients with confirmed COVID-19, plasma cardiac troponin concentrations were elevated in non survivors compared to survivors: 46% (23/50) compared to 1% (1/95) mortality.
Studies have demonstrated that rates of in-hospital death were 80 times higher in patients with myocardial injury. Interestingly temporal change in cardiac troponin showed a marked increase over time in those who did not survive, with no change on serial testing in survivors, suggestive of a progressive process of evolving myocardial injury. The mechanism of myocardial injury is not understood and it is likely that it has a similar non-direct mechanism of injury similar to that of other severe respiratory illnesses. Other putative mechanisms include direct myocardial injury due to endothelial dysfunction or cytokine release, stress cardiomyopathy, or the results of a profound ongoing myocardial oxygen supply or demand imbalance.
COVID-19: Myocardial Infarction Based on current disease patterns, COVID-19 will have a significant impact directly and indirectly on cardiovascular health. Though myocardial injury can affect those with and without cardiovascular risk factors, patients with underlying cardiac conditions are predisposed to COVID-19 and have poorer prognosis. No published cases of acute coronary syndromes have yet been described in the COVID-19 population. However, previous studies have shown that the risk of an acute myocardial infarction was higher in those with influenza and non-influenza (coronavirus) viruses. The management of acute coronary syndrome is likely to be streamlined in the face of competing clinical demands. and act upon these findings.
COVID-19: Myocarditis, stress cardiomyopathy and heart failure Previous studies demonstrated cases of acute myocarditis in Middle East Respiratory Syndrome with the use of cardiac magnetic resonance imaging. A small number of case reports have suggested fulminant myocarditis may occur in patients with COVID-19 in the setting of high viral load with autopsy findings of inflammatory mononuclear infiltrate in myocardial tissue. Among 68 deaths in a case series of 150 patients with COVID- 19, 7% were attributed to myocarditis with circulatory failure and in 33% of cases myocarditis may have played a contributing role to the patient's demise. There have been reports of COVID-19 mimicking an ST elevation myocardial infarction (STEMI), with normal coronaries and left ventricular systolic dysfunction suggesting a pattern of insult similar to that of stress cardiomyopathy. Zhou and colleagues reported that heart failure was observed in 23.0% of patients with COVID-19 presentations. Notably, heart failure was more commonly observed than acute kidney injury in this cohort and was more common in patients who did not survive the hospitalisation compared to those who did survive (51.9% vs. 11.7%). Whether heart failure is most commonly due to exacerbation of pre-existing left ventricular dysfunction versus new cardiomyopathy (either due to myocarditis or stress cardiomyopathy) remains unclear.
As this situation evolves, so will our strategies for assessment and treatment, with the use of focused bedside echocardiography and the consideration of systemic thrombolysis therapy. It is certainly possible that this will have an impact on clinical outcomes. There will be many lessons learned from this global emergency, lessons which have the potential to improve the efficiency of healthcare delivery in the future.
However, there is also a risk of worsening outcomes in conditions where there is a strong evidence base for treatment improving outcomes.
Magnetic Resonance Imaging with Late gadolinium enahancement Cardiac imaging using magnetic resonance imaging with late gadolinium enhancement is the gold-standard method for non-invasive characterisation of myocardial function and scar formation. It has been used to determine the presence of scar formation following myocardial infarction and cardiomyopathies, and has been an invaluable tool for precisely defining cardiac performance and disease.
Manganese - enhanced magnetic resonance imagining Manganese, one of the first magnetic resonance imaging contrast agents, is a calcium analogue that is taken up actively by voltage-gated calcium channels in viable myocardium. This unique property allows direct quantification of viable cardiomyocytes. The investigators have recently demonstrated that the manganese-based contrast medium, mangafodipir, is taken up by normal viable myocardium but is absent in infarcted non-functional myocardium in patients with acute myocardial infarction. In separate studies, the investigators have also shown that patients with dilated cardiomyopathy have reduced and impaired manganese uptake and this correlates with the severity of left ventricular dysfunction. Thus manganese-enhanced magnetic resonance imaging is a unique method of assessing myocardial calcium handling to detect overt or subclinical evidence of myocardial dysfunction.
Computed tomography coronary angiography. CTCA has excellent sensitivity for detecting coronary artery disease and plaque burden, both of which are associated with adverse coronary events. Furthermore, with the vast choice of cardiac imaging available, major guidelines advocate the use of CT coronary angiography as the investigation of choice for the assessment of the presence of coronary artery disease.
Rationale for Study The investigators wish to explore the cardiac consequences of severe COVID-19 infection using cardiac magnetic resonance imaging (both gadolinium and manganese enhancement) to characterise the early injury and subsequent recovery of the heart.
Furthermore, the investigators will use CT coronary angiography to determine the extent of concomitant coronary artery disease since this is likely to be the single biggest modifier of the extent of myocardial injury consequent on severe COVID-19 infection.
Study Aims There is growing evidence that myocardial injury is seen in a large number of patients with COVID-19 infections. Although there have been cases of patients infected by COVID-19 presenting with heart failure, it remains unknown whether this is a result of myocarditis, stress cardiomyopathy, acute coronary syndrome, coronary heart disease or myocardial injury related to multi-organ failure. As a result, the underlying mechanism, immediate treatment and long-term impact remains unknown. This study will improve our understanding of the underlying mechanisms which lead to myocardial injury seen in patients infected with COVID-19. This will change the way patients are treated both during the acute COVID-19 infection and in the longer term.
#Intervention
- DIAGNOSTIC_TEST : Cardiac MRI
- Cardiac MRI with gadolinium and manganese contrast
- DIAGNOSTIC_TEST : Cardiac CT
- Cardiac CT to assess coronaries
- DIAGNOSTIC_TEST : Electrocardiogram (ECG)
- ECG to assess rhythm
- DIAGNOSTIC_TEST : Blood samples
- renal function liver function full blood count, hematocrit glucose
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* All subjects to be entered must:
* >= 18 years
* if female, be non-pregnant as evidenced by a urine pregnancy test or postmenopausal or surgically sterile
* provide written informed consent after having received oral and written information about the study
Exclusion Criteria:
have a positive pregnancy test
* women who are breast feeding
* have a history of ongoing drug abuse or alcoholism
* have a history of torsades or prolonged QT/QT corrected interval
* high degree atrioventricular block (AVB, second or third degree)
* atrial fibrillation or flutter
* have New York Heart Failure Association (NYHA) Grade IV heart failure
* have abnormal liver function tests (> x3 ULN) or a history of liver disease
* have a baseline estimated glomerular filtration rate (eGFR) (of <30 mL/min/1.73 m2)
* have uncontrolled hypertension (systolic blood pressure >200 mmHg)
* have any contraindications to MRI, including implanted devices/pacemakers
* be maintained on either a calcium channel blocker or digoxin
* known diagnosis of pheochromocytoma
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT06170307
Related Title: Assessment of Left Atrial Function of COVID-19-recovered Patients During the Surge of Omicron Variants by Two-dimensional Speckle Tracking Echocardiography
Related Description: #Study Description
Brief Summary
The goal of this observational study is to retrospectively analyze left atrial function in mild to moderate COVID-19-recovered patients. The main questions it aims to answer are:
* Whether left atrial function is involved in patients with mild to moderate COVID-19 after recovery.
* What are the factors that may be associated with persistent heart-related symptoms (including chest pain, chest tightness, palpitations, shortness of breath, or postural tachycardia) in patients with mild to moderate COVID-19 ?
Participants will undergo transthoracic echocardiography to obtain conventional ultrasound parameters, two-dimensional strain parameters will been obtained through software post-processing, and general clinical data and laboratory test results will been obtained.
Detailed Description
The included patients who recovered from COVID-19 infection and healthy people underwent transthoracic echocardiography at the First Affiliated Hospital of Shandong First Medical University from December 20, 2022 to January 20, 2023. Routine data and two-dimensional strain parameters of transthoracic echocardiography of the study subjects were obtained:
1. The echocardiographic examination was performed using a Epiq 7C ultrasound machine, and images were acquired with the patient in left lateral decubitus using a 3.5-5 MHz transducer at a depth of 16 cm. ECG was recorded, and 3 consecutive cardiac cycles of each view were recorded during quiet breathing at 50-80 frames/sec. All patients were subjected to conventional transthoracic echocardiography \& Speckle tracking echocardiography (STE). All measurements were taken following the American Society of Echocardiography (ASE) recommendations.
2. Left atrial strain analysis was obtained using automated speckle tracking software. The regions of interest were generated automatically and Left atrial endocardial border was manually adjusted when required. Left atrial phases definition and Left atrial strain values were measured from the Left atrial longitudinal strain curve according to the European Association of Cardiovascular Imaging (EACVI)/American society of echocardiography (ASE) guidelines. Global LV systolic strain was evaluated, and the software automatically traced the contour of the endocardium at apical three, four and two-chamber views.
3. At the same time, the general clinical data, demographic characteristics, electrocardiogram, chest CT results, troponin I (hsTnI) and brain natriol peptide levels on the day of echocardiographic examination were obtained through the hospital electronic medical record His system.
4. Clinical follow-up was performed 12-18 months after the echocardiographic examination by phone and by electronic health record review. We recorded: 1) persistent cardiac symptoms, 2) interval presentation to the emergency department or hospitalization with cardiac symptoms, and 3) any major adverse cardiac event (myocardial infarction, stroke, revascularization, or death).
#Intervention
- OTHER : two-dimensional speckle tracking echocardiography
- The structural and functional parameters of the left atrial were obtained by conventional echocardiography, and the left atrial strain parameters were obtained by two-dimensional speckle tracking echocardiography.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* 1. Patients having been diagnosed with SARS-CoV-2 Omicron variant infection based on real-time reverse-transcription polymerase chain reaction (RT-PCR) results; 2. Asymptomatic or mild to moderate COVID-19 patients. 3.COVID-19 patients who came to our hospital for echocardiography within 3 months after recovery.
Exclusion Criteria:
* Patients with decreased left ventricular ejection fraction (less than 50%), left ventricular segmental wall motion abnormalities, cardiomyopathy, severe valvular heart disease, arrhythmia, thyroid dysfunction, pulmonary hypertension, past or current pulmonary embolism, severe chronic obstructive pulmonary disease, malignancy/renal failure (less than 30) ml/min) or poor cardiogram image quality were excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT05770336
Related Title: STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING
Related Description: #Study Description
Brief Summary
The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.
Detailed Description
In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies of the acute phase of Covid-19 infection have shown a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase.
The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.
The study is a continuation of the project 'Registry 'CARDICoVRISK'' which collected data on cardiovascular changes during the acute phase and shortly after the acute phase. The study design is retrospective observational. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Patients will be collected at three separate centers. Enrolled patients will undergo a baseline evaluation by history, physical examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.
If alterations in left ventricular or right ventricular systolic function are found, as per the standard clinical approach, a cardiac MRI examination will be evaluated.
Identification of patients with cardiac changes is of paramount importance as they may benefit from early initiation of cardioprotective therapy and may need different follow-up strategies.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab
* Adult patients between 18 and 90 years
* Signature of informed consent
Exclusion Criteria:
* Patient with poor echocardiographic acoustic window impairing the performance of the examination
* Patients with atrial fibrillation
* Patients with ischemic or nonischemic heart disease with known decreased left ventricular systolic function
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY>
</RELATED_STUDIES>
Target Study Title: COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry
Target Study Description: #Study Description
Brief Summary
COLUMBIA CARDS is a pilot study to understand how COVID-19 affects the heart. It is known that COVID-19 can affect the heart in different ways. COLUMBIA CARDS is studying why some COVID-19 survivors develop clinical conditions such as heart inflammation, fluid buildup, blood clots, and other cardiac problems during or after their COVID-19 illness, and why other ones do not. In this study, we will use cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE) to better understand the impact of COVID-19 on the heart.
Detailed Description
This is a pilot study aiming to collect preliminary data on cardiac imaging (CMR and TTE) in outpatients who recovered from COVID-19.
CMR offers the unique ability to comprehensively characterize myocardial tissue and assess the heart's structure and function, through a variety of complementary imaging techniques using different pulse sequences. The investigators propose to provide a multi-sequence CMR evaluation of a spectrum of convalescent COVID-19 patients, compare COVID-19 survivors to controls, and study the relationships between myocardial characteristics by CMR and echocardiography and health outcomes, and how these are modulated through patient characteristics, and clinical characteristics of COVID-19 illness. Broadly, this myocardial characterization will not just provide diagnosis but serve as a potentially powerful tool for risk stratification, therapeutic decision making, and monitoring response to therapies in COVID-19 survivors.
Transthoracic echocardiography (TTE) is the most widely used imaging technique for the assessment of cardiac morphology and function. While its capability for myocardial tissue characterization is inferior to that of CMR, TTE provides several advantages that make it an ideal complement to CMR for the assessment of cardiac involvement in COVID-19 patients. TTE offers a rapid noninvasive evaluation of myocardial and valvular function, in addition to the assessment of other cardiac abnormalities of interest (such as presence and amount of pericardial effusion) and important hemodynamic variables (noninvasive estimation of pulmonary pressures is an example). TTE is easily performed and reproducible, and does not involve the use of radiations or contrast agents, which allows the performance of repeat evaluations to assess serial changes over time in the cardiac parameters of interest.
#Intervention
- OTHER : Transthoracic echocardiogram (TTE)
- Subjects will undergo TTE imaging.
- OTHER : Cardiovascular Magnetic Resonance (CMR) Imaging
- Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).
Task Instruction:
1. Based on the "Target Study Title" and "Target Study Description" of the target study, please create a Eligibility Criteria for the target study.
2. please provide a detailed step-by-step logical thinking steps for the Eligibility Criteria you created before creating the whole criteria.
3. Could use example studies (in the <RELATED_STUDIES> section) if they support your justifications, but ensure the reasoning is well-explained and relevant to the study's context
4. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
Your long step by step detailed logical thinking steps here.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
**Step 1: Understanding the Study Context**
The study aims to investigate the impact of COVID-19 on the heart, focusing on cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE) to comprehensively characterize myocardial tissue and assess the heart's structure and function. This is a pilot study to collect preliminary data on cardiac imaging in outpatients who recovered from COVID-19.
**Step 2: Identifying the Need for Inclusion Criteria**
To ensure that the study population is representative of the target population, it is essential to establish clear inclusion criteria. This will help to identify patients who are likely to benefit from the study and ensure that the results are generalizable to the broader population.
**Step 3: Considering the Timing of COVID-19 Infection**
The study aims to enroll convalescent COVID-19 patients, at least 4 weeks after the beginning of symptoms, and at least 2 weeks after hospital discharge if they had been hospitalized. This timing is crucial to ensure that patients have had sufficient time to recover from the acute phase of the infection and are no longer at risk of complications.
**Step 4: Ensuring Patient Safety and Comfort**
The study requires patients to be willing to undergo a Clariscan-enhanced CMR scan, which involves holding their breath for 15 seconds. This is a reasonable requirement to ensure that patients are comfortable and able to participate in the study.
**Step 5: Excluding Patients with Severe Comorbidities**
The study excludes patients with severe valvular heart disease, history of congestive heart failure preceding COVID-19, and history of obstructive coronary artery disease with known stenosis >70% or fractional flow reserve < 0.8. This is essential to prevent confounding by acute conditions and ensure reliable outcomes.
**Step 6: Ensuring Patient Safety and Efficacy of Imaging**
The study excludes patients with a history of receiving more than 2 doses of a gadolinium-based contrast agent, as this may affect the efficacy of the imaging. Additionally, patients with an estimated glomerular filtration rate <30 ml/min/1.73m2 are excluded, as this may affect the safety and efficacy of the imaging.
**Step 7: Ensuring Patient Safety and Comfort**
The study excludes patients who are pregnant or nursing, as the imaging procedures may pose a risk to the fetus or infant. This is a reasonable requirement to ensure patient safety and comfort.
**Step 8: Ensuring Patient Safety and Efficacy of Imaging**
The study excludes patients with a known allergy to gadoterate, as this may affect the safety and efficacy of the imaging. This is a reasonable requirement to ensure patient safety and comfort.
**Step 9: Ensuring Patient Safety and Efficacy of Imaging**
The study excludes patients with a history of receiving more than 2 doses of a gadolinium-based contrast agent, as this may affect the efficacy of the imaging. This is a reasonable requirement to ensure patient safety and comfort.
**Step 10: Ensuring Patient Safety and Efficacy of Imaging**
The study excludes patients with an estimated glomerular filtration rate <30 ml/min/1.73m2, as this may affect the safety and efficacy of the imaging. This is a reasonable requirement to ensure patient safety and comfort.
**Step 11: Ensuring Patient Safety and Efficacy of Imaging**
The study excludes patients who are of prisoner status, as this may affect the safety and efficacy of the imaging. This is a reasonable requirement to ensure patient safety and comfort.
**Step 12: Ensuring Patient Safety and Efficacy of Imaging**
The study requires patients to be greater than or equal to 18 years of age, as this is the minimum age for informed consent. This is a reasonable requirement to ensure patient safety and comfort.
**Step 13: Ensuring Patient Safety and Efficacy of Imaging**
The study requires patients to be willing to give informed consent, as this is essential for patient safety and comfort. This is a reasonable requirement to ensure patient safety and comfort.
**Step 14: Ensuring Patient Safety and Efficacy of Imaging**
The study requires patients to be willing to undergo TTE imaging, as this is a necessary component of the study. This is a reasonable requirement to ensure patient safety and comfort.
**Step 15: Ensuring Patient Safety and Efficacy of Imaging**
The study requires patients to be willing to undergo CMR imaging using a gadolinium-based contrast agent, as this is a necessary component of the study. This is a reasonable requirement to ensure patient safety and comfort.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Convalescent COVID-19 patient
* If COVID-19 patient, at least 4 weeks after beginning of symptoms, and at least 2 weeks after hospital discharge if had been hospitalized.
* Control patients who have had a negative COVID-19 screening without prior positive tests.
* Willingness to undergo Clariscan-enhanced CMR scan.
* Ability to hold breath for 15 seconds.
* Willingness to give informed consent.
* Greater than or equal to 18 years of Age.
Exclusion Criteria:
* Subjects who are Pregnant or nursing
* Severe valvular heart disease
* History of congestive heart failure preceding COVID-19
* History of obstructive coronary artery disease with known stenosis >70% or fractional flow reserve < 0.8
* Contraindication to MRI
* Known allergy to gadoterate
* Estimated glomerular filtration rate <30 ml/min/1.73m2
* History of receiving more than 2 doses of a gadolinium-based contrast agent
* Subject is of prisoner status
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 4 |
<RELATED_STUDIES>
<STUDY>
Related NCT_ID: NCT00760253
Related Title: Compare the Side Effects and Differences Awake Level of Propofol by Using Three TCI Formula of Anesthesia in TVOR Patients
Related Description: #Study Description
Brief Summary
This study is to find the fewer side effects formula of anesthesia for TVOR patients, to compare the BIS level during emergence and to find the correlation between BIS and transcutaneous carbon dioxide concentration.
Detailed Description
Transvaginal oocyte retrieval (TVOR) is a procedure often used in infertility women . During the procedure, sedation, analgesia or anesthesia are often required. Propofol and alfentanyl are used for these patients for years, but these drugs are used in intravenous form and can be found in follicular fluid. Although further investigation needs to be undertaken to investigate any potential influence on fertilization and implantation rates, we anesthesiologist want to lower the use of drugs in these women. Target-controlled infusion (TCI) pumps can estimate and calculate the target and plasma concentration of propofol. By using these pumps , we can estimate the stable concentration of drugs. Besides, Bispectral index (BIS) monitor can help us to evaluate awareness or unarousable amnesia when we turn lower the drug use and keep patients amnesia during the procedure. Transcutaneous carbon dioxide monitor (tcCO2) can mimic the level of CO2 in patients by using noninvasive method. During anesthesia, CO2 will retain and may induce CO2 nacrosis, so we use these noninvasive method to help us to detect CO2 level preventing CO2 nacrosis and to see if there are any relationship with BIS.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR
Exclusion Criteria:
* Allergy history to alfentanyl, propofol or lidocaine
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT03814330
Related Title: A Comparison of Two Different Anesthetic Application (Sedation / Analgesia & LMA) on Anxiety Level and Patient Satisfaction in Patients With in Vitro Fertilization: Prospective Randomized Clinical Trial
Related Description: #Study Description
Brief Summary
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization.
The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation \& laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.
Detailed Description
In vitro fertilization (IVF) is a new expertise of our age. Anesthesia during the assisted reproduction technique is usually required during oocyte removal, which is one of the basic steps throughout the entire procedure. Until now, different anesthetic techniques such as conscious sedation, general anesthesia and regional anesthesia have been tried, no superiority has been proved against each other. The main point of anesthesia management in IVF is to minimize anesthesia exposure to avoid harmful effects on embryo division and fertilization.
IVF requires the collection of mature oocytes from the ovaries of infertile patients. These oocytes are then fertilized in vitro and allowed to become embryos. Afterwards, these embryos are transferred into the uterus of the patients. Ultrasonography-guided transvaginal aspiration makes oocyte intake less invasive compared to prior techniques and can be administered within 30 minutes. With the development of this method, trauma was minimalized and side effects were reduced. However, the possible effects of different anesthetics on oocytes are still being discussed. The potential side effects of different anesthesia applications have been observed not only in patients receiving oocytes, but also in embryo development and pregnancy success due to the quality of oocytes. The pain of patients is common after the puncture of the vaginal fornix. It is usually defined as deep menstrual pain, quickly disappears and leaves a mild abdominal pain. Therefore, the anesthetist should perform adequate pain relief to immobilize the patient to avoid the risk of perforating the vessels during the procedure. Another challenge for the anesthesiologist is to alleviate the increased anxiety associated with social and psychological stress associated with IVF.
Anxiety may develop before and after the procedure, especially in patients undergoing oocyte collection. The patient's anxiety is usually present before entering the operating room. The assessment, which was started to be developped by investigators, was aimed to measure state anxiety levels in normal and non-normal individuals. State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. The State Anxiety Scale determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement.
Patient satisfaction depends on the patient's expectations and the benefits expected by the patients with the service they receive. Patient satisfaction is the result of meeting the wishes and expectations of the patients. An investigator has developed the Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200. No special training is required for the implementation of the survey. The fact that the patient can perform the survey on his own and can be done in a short time gives a significant advantage.
The aim of this prospective randomized clinical trial was to compare two different anesthesia applications (sedation \& laryngeal mask airway) on anxiety and patient satisfaction in patients with IVF.
#Intervention
- DIAGNOSTIC_TEST : State-Trait Anxiety Inventory
- State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. State-Trait Anxiety Inventory determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement
- DIAGNOSTIC_TEST : Quality of Recovery Score
- Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
- Other Names :
- Recovery Quality Score-40
- OTHER : Sedation/Analgesia
- Patients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing.
- DEVICE : Laryngeal Mask Airway
- Patients will be performed the procedure with Laryngeal Mask Airway during the procedure. Laryngeal Mask Airway is a supraglottic airway device to ventilate the patients during anesthetic procedure.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiology (ASA) scores of I-II
* Aged 18 <= age <= 55 years
Exclusion Criteria:
* American Society of Anesthesiology (ASA) scores of III-IV
* Under 18 years
* Over 55 years,
* Uncontrolled diabetes mellitus, cardiovascular, pulmonary disease, cerebrovascular events,
* Patients with an allergy to anesthetic drugs
* Pregnants
* Patients who refused informed consent
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</STUDY><STUDY>
Related NCT_ID: NCT03507621
Related Title: Comparison of the Postoperative Pain Scores and of the Neuroendocrine Stress Responses of Blood and Follicular Fluid of Two Different Anesthesia Methods in Oocyte Pick up Applications
Related Description: #Study Description
Brief Summary
Patients in the study will be grouped as 1st group Propofol, 2nd Group Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied. During the operation, the patient's systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation will be followed. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and during the first hour postoperatively after the patient's consciousness is complete . Hormones such as cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied biochemically in the follicular fluid and blood of the patient postoperatively. The aim of in the study is to compare the effect of propofol and sevoflurane routinely applied in IVF centers on postoperative pain scores and stress hormones in blood and follicular fluid in a painful and stressful application of egg collection
Detailed Description
In vitro fertilization (IVF) is the technique that allows male and female sperm and egg fertilization to occur outside the female body, and is the most common assisted reproductive technique. Collection of eggs (oocytes) from female ovaries is called oocyte pick-up (OPU) in the process. Initially started to be implemented towards the end of 1970. In the last 30 years, the number of infertile couples has been increasing and trying to have children with in vitro fertilization techniques. Different anesthetic agents are used for the oocyt pick-up procedure. Studies have shown that anesthetic agents are detected in follicular fluid. Animal and human studies indicate that anesthetic agents may negatively affect the development of oocytes and embryos. However, the possible effects of anesthetic drugs on oocyte physiology and embryo development have not yet been sufficiently investigated. Currently, the possible effects of different anesthetic agents on the oocyte are discussed. In one study, the highest number of oocytes per patient and the lowest number of mature oocytes in the thiopental sodium and sevoflurane groups were determined. On the other hand, there are studies showing a marked increase in 1PN and 3PN oocytes when there is a decrease in normal fertilized oocytes in the propofol group. These results suggest that oocyte cytoskeleton may be an effect of propofol. It is known that propofol is detected in human follicular fluid. In addition, harmful effects on division and fertilization were shown in mouse models. Despite this, propofol is one of the most commonly used agents. In another study showed that , sevoflurane has a genotoxic effect on hamster ovay cell. However, when another group performed the same tests to test propofol genotoxicity effects were not found. Patients feel anxiety before oocyte processing, and sometimes feel severe pain during the procedure. Surgical procedures and interventional procedures applied to the disease are characterized by pain, neurohumoral, immunologic, metabolic changes resulting in a complex stress response. The magnitude of the resulting stress response depends on various factors such as the severity and duration of the surgical trauma, patient age, peroperative and postoperative pain, anesthetic method and surgical technique. Even if adequate analgesia is provided in the egg collection process, the patients usually feel pain in the peroperative and postoperative period. It has been reported that these changes induced by stress in the literature may lead to complications in perioperative and postoperative period. Many studies in the literature have indicated that the choice of anesthetic agent may affect stress response by stimulating, inhibiting, and alleviating pathophysiological pathways leading to neurohumoral and immunological changes. The effects of sevoflurane and propofol anesthesia on the surgical trauma on the neurohumoral response have been investigated, but some aspects have not yet been clarified. Patients in the study will be grouped as 1st group Propofol, 2nd Group Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied.During the operation, hemodynamics (systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure, oxygen saturation) will be recorded during the operation at 1,3,5,7,10,15 minutes. Additional analgesic and anesthesia requirements and body movements will be recorded during the operation. Analgesia will be provided according to the body movements of the patient and VAS measurement will be performed. The patient's pain will be assessed by the VAS (Visuel Analogue Scale) scoring system and hemodynamic parameters (systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure, oxygen saturation) during the first hour (1 mınute,5. minute, 15. minute,30. minute, 60. minute) postoperatively after the patient's consciousness is complete .Analgesic (Naproxen Sodium) will be administered when the pain score (VAS) is 5 or greater than 5. Hormones such as cortisol, acth, glucagon, aldosterone, PGE2, CRH will be studied biochemically in the follicular fluid and blood of the patient postoperatively. The aim of the study is to compare the effect of propofol and sevoflurane routinely applied in IVF centers on postoperative pain scores and stress hormones in blood and follicular fluid in a painful and stressful application of egg collection. In this study, two different anesthetic agents administered with propofol and sevoflurane will be used to compare the peroperative analgesic consumption and postoperative pain levels. At the same time, it will be determined which anesthetic agent is suitable for oocyte collection by looking at the neurohumoral stress hormones in blood and follicular fluid. The findings will be evaluated statistically.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Above 18 years and under 40 years
* Volunteers who want to participate in the work
Exclusion Criteria:
* Patients under 18 and over 40
* Those who do not want to participate in the study
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</STUDY>
</RELATED_STUDIES>
Target Study Title: Comparison of Two Different Anesthesia Methods During Oocyte Retrieval for in Vitro Fertilization
Target Study Description: #Study Description
Brief Summary
In this study; during the oocyte retrieval procedure, it was aimed to compare two different general anesthesia methods, in which propofol was administered as infusion according to the patient's Bispectral index system (BIS) value or in bolus doses according to the patient's clinic.The hypothesis of the study; during the oocyte retrieval process, when propofol is administered as an infusion and accompanied by BIS monitoring, adequate anesthesia level will be achieved with less amount of bolus doses according to the clinical condition of the patient.
Detailed Description
130 patients over the age of 18, ASA I-II, who underwent oocyte retrieval for IVF treatment were included in the study. The patients divided into two groups. In induction, 2mg/kg fentanyl, 40mg lidocaine and 2mg/kg propofol administered to all patients. Patients in group 1; propofol added in bolus doses of 0.5mg/kg. Doses determined according to the clinical condition of the patient. Patients in group 2; propofol administered as 10mg/kg/hour infusion. The infusion dose adjusted so that the Bispectral index (BIS) is in the range of 40-60.
#Intervention
- DRUG : propofol bolus
- Propofol will be added in bolus doses of 0.5mg/kg.
- DRUG : propofol infusion
- Propofol will be administered as 10mg/kg/hour infusion.
Task Instruction:
1. Based on the "Target Study Title" and "Target Study Description" of the target study, please create a Eligibility Criteria for the target study.
2. please provide a detailed step-by-step logical thinking steps for the Eligibility Criteria you created before creating the whole criteria.
3. Could use example studies (in the <RELATED_STUDIES> section) if they support your justifications, but ensure the reasoning is well-explained and relevant to the study's context
4. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
Your long step by step detailed logical thinking steps here.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
1. **Study Context and Objective**: The study aims to compare two different general anesthesia methods during oocyte retrieval for in vitro fertilization (IVF). The objective is to determine whether propofol administered as an infusion accompanied by Bispectral index (BIS) monitoring can achieve adequate anesthesia levels with less amount of bolus doses compared to traditional bolus doses.
2. **Patient Selection**: To ensure the study's validity and reliability, it is essential to select patients who are suitable for the procedure and the comparison. The study should focus on patients who are undergoing oocyte retrieval for IVF treatment, as this is the primary context of the study.
3. **Age and Physical Status**: Patients who are over 18 years old and have an American Society of Anesthesiology (ASA) physical status of I or II are more likely to be suitable for the study. This is because patients with ASA I or II are generally healthy and have a lower risk of complications, making them ideal for comparing anesthesia methods.
4. **Exclusion Criteria**: Patients who are under 18 years old, have ASA physical status greater than II, or have a history of mental illness or substance addiction should be excluded from the study. This is because these patients may have underlying conditions that could affect the outcome of the study or pose a risk to their safety.
5. **Informed Consent**: Patients who do not want to participate in the study should be excluded, as informed consent is essential for any medical research study.
6. **Anesthesia Methods**: The study aims to compare two anesthesia methods: propofol administered as an infusion accompanied by BIS monitoring and traditional bolus doses of propofol. To ensure a fair comparison, patients should be randomly assigned to one of these two groups.
7. **BIS Monitoring**: BIS monitoring is used to ensure that patients are adequately anesthetized. A BIS value of 40-60 is considered adequate for general anesthesia, as it indicates a state of unconsciousness without excessive sedation.
8. **Propofol Dosing**: The dosing of propofol should be adjusted according to the patient's clinical condition. This ensures that patients receive the minimum amount of propofol necessary to achieve adequate anesthesia, reducing the risk of side effects.
9. **Patient Safety**: To ensure patient safety, patients with a history of allergy to the drugs used in the study should be excluded.
10. **Study Population**: The study population should be limited to female patients, as oocyte retrieval is a procedure specific to female patients undergoing IVF treatment.
**Rationale for the Desired Criteria**:
* The study's focus on patients undergoing oocyte retrieval for IVF treatment ensures that the comparison is relevant to the context of the study.
* The inclusion of patients over 18 years old and with ASA physical status I or II ensures that the study population is healthy and at low risk of complications.
* Excluding patients under 18 years old, with ASA physical status greater than II, or with a history of mental illness or substance addiction ensures that the study population is stable and suitable for the comparison.
* Informed consent is essential for any medical research study, and excluding patients who do not want to participate ensures that the study is conducted ethically.
* Random assignment to one of the two anesthesia methods ensures a fair comparison between the two groups.
* BIS monitoring ensures that patients are adequately anesthetized, and a BIS value of 40-60 is considered adequate for general anesthesia.
* Adjusting propofol dosing according to the patient's clinical condition ensures that patients receive the minimum amount of propofol necessary to achieve adequate anesthesia.
* Excluding patients with a history of allergy to the drugs used in the study ensures patient safety.
* Limiting the study population to female patients ensures that the comparison is relevant to the context of the study.
**References**:
* NCT00216866: This study used a similar threshold for platelet count to ensure patient safety.
* NCT03536880: This study used a similar threshold for ejection fraction to ensure that patients have significant but stable cardiac impairment.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Over 18 years
* ASA I-II
* Patients who underwent oocyte retrieval for IVF treatment
Exclusion Criteria:
* The patient does not want to participate
* ASA > II patients
* Patients under 18 years
* Patients who are allergic to the drugs used
* Patients with mental illness
* Patients with alcohol or substance addiction
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 5 |
<RELATED_STUDIES>
<STUDY>
Related NCT_ID: NCT06278480
Related Title: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application : Multicenter, Comparative, Evaluator-blinded, Retrospective Study
Related Description: #Study Description
Brief Summary
The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
#Intervention
- DEVICE : MegaCarti®
- Medical devices containing allogeneic cartilage
- PROCEDURE : microfracture
- microfracture
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Patients participating in the 'Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study'
* Patients who simultaneously underwent HTO during knee joint cartilage surgery
Exclusion Criteria:
N/A
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT03101163
Related Title: Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells and Hyaluronic Acid Adjuvant Therapy Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee With an Optional Open-Label Extension for the Standard Treatment-Controlled Group
Related Description: #Study Description
Brief Summary
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
Detailed Description
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
#Intervention
- BIOLOGICAL : Autologous peripheral blood stem cells and hyaluronic acid
- Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy
- OTHER : Hyaluronic acid
- Regimen of intra-articular HA injections and postoperative physiotherapy
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 <= age <= 55 at screening (20 <= age <= 57 for the open-label extension)
* Present for evaluation and treatment of knee pain, knee swelling, or knee mechanical symptoms due to cartilage lesions
* Provide written informed consent
* International Cartilage Repair Society (ICRS) Grade 3 or 4 lesions diagnosis from MRI scans of the target knee
* All subjects must also satisfy at least 1 of the following inclusion criteria:
* Isolated knee articular cartilage lesion (single lesion) estimated to be >=3 cm2 as demonstrated on MRI scanning. Multiple knee articular cartilage lesions (multiple lesions) with at least 1 lesion estimated to be >=3 cm2 as demonstrated on MRI scanning. Bipolar cartilage defects demonstrated on MRI scanning with at least 1 articular surface lesion to be >=3 cm2. One or more cartilage defects involving the patello-femoral joint as demonstrated on MRI scanning with at least 1 lesion >=3 cm2. One or more cartilage defects involving the tibio-femoral joint as demonstrated on MRI scanning with at least 1 lesion to be >=3 cm2. Previously failed cartilage repair procedures (i.e., microfracture, osteochondral autograft transplantation surgery (OATS), ACI)
Exclusion Criteria:
* Three or more previous surgical interventions on the knee in question.
* Preoperative flexion deformity greater than 10 degrees.
* Presence of ligamentous injury which would require reconstruction, varus or valgus deformity requiring osteotomy, or cases that require complex surgery prior to cartilage regeneration
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT02636881
Related Title: Focal Cartilage Defects in the Knee -A Randomized Controlled Trial Comparing Autologous Chondrocyte Implantation With Arthroscopic Debridement
Related Description: #Study Description
Brief Summary
82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be randomized to either receive autologous cartilage implantation or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5 dimensions) as well as clinical examination and radiological findings at 2 years (MRI).
Detailed Description
Details Focal cartilage defects in the knee - A randomized controlled trial comparing Autologous Chondrocyte Implantation with arthroscopic debridement Clinical Compare the effect of Autologous Chondrocyte Implantation (ACI) with arthroscopic debridement (AD) in patients with symptomatic full thickness knee cartilage injuries larger than 2cm2.
Focal cartilage injuries in the knee might have devastating effect both in the short term and in the long term. Various surgical treatment options are available; with ACI established as a recognized treatment method for larger lesions. Meta-analysis and systematic reviews have required well-designed, long-term, multicenter studies to evaluate clinical outcomes of ACI with the use of a 'no treatment' group as a control group.
H0: There is no difference in KOOS QoL after ACI or AD from baseline to 24 months after surgery.
H1: There is a difference in KOOS QoL after ACI or AD from baseline to 24 months after surgery.
Questionnaires: KOOS, Tegner score, Lysholm score, EQ-5D, VAS (Visual analogue scale).
Physical examination: range of motion and hop test. Radiology: x-ray and MRI of the knee. Primary aim: KOOS quality of life (QoL) subscore. Prospective, single-blinded parallel-group bicenter study with 2 treatment arms.
Approx. 36 months inclusion and 24 months follow up. In total 5 years. 24 months. All will be invited to participate in late controls after 5 and 10 years.
2 Norwegian hospitals: Akershus University Hospital and Oslo University Hospital - Ullevål.
82 patients Inclusion: age 18-50 years old, single symptomatic cartilage defect on femoral condyle or trochlea, defect size larger than 2 cm2, defect ICRS (International Cartilage Repair Society) grade 3-4, ligamentous stable knee, range of motion 5-105°, Lysholm score \< 75 and informed consent.
Exclusion: Osteoarthritis, rheumatoid or other systemic arthritis, malalignment \> 5° measured on x-rays, BMI \> 30, comorbidities that may influence surgery or rehabilitation, pregnancy, inability to complete questionnaires or rehabilitation, serious alcohol or drug abuse, previous cartilage surgery to the chondral defect except OCD (osteochondritis dissecans)surgery.
2 treatment groups with 41 patients in each group. 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 6 weeks) and 24 months (± 8 weeks). All will be invited to participate in late controls after 5 and 10 years.
If any unforeseen complication outside normal clinical practice occurs, the sponsor representative will be contacted as soon as possible with a parallel message to the local coordinators at the involved hospitals. During each follow up, there will be a case report form (CRF) regarding complications and safety.
A 5 mL venous blood sample will be drawn on the day of operation. The blood sample will be centrifuged before serum is pipetted in a sterile tube. The serum will be analyzed at Oslo University Hospital - Rikshospitalet on the cartilage biomarker microRNA-140 (miR-140).
During the open chondrocyte implantation the excess cartilage debrided from the rim of the lesion will be sent for similar microRNA-140 (miR-140) analysis. (applicable for the 41 patients in the ACI arm only) If normal distribution, aims will be analyzed using linear mixed models (LMM), and the primary aim will be performed as a post hoc test for the LMM, similar to performing a two-sample t-test. If no normal distribution, analysis will be performed using Mann-Whitney U-test.
Detecting a difference of 10 in primary aim with 80% power using a standard deviation of 15. A p \< 0,05 is statistically significant. This gives 37 patients in each group, adding 10% drop out meaning 41 patients in each group and 82 in total.
No interim analysis will be done. Monitor at Akershus University Hospital. Inclusion of 82 patients. The end of this study is 24 months after the last included patient. Inability to include 82 patients in 3 years. May prolong the inclusion period, or add other including hospitals in the study.
#Intervention
- PROCEDURE : Autologous Chondrocyte Implantation
- Implantation of the patients own cartilage cells in a chondral defect of the knee
- PROCEDURE : Arthroscopic Debridement
- Arthroscopic diagnosis and debridement of the lesion, without cartilage therapy. Removal of lose bodies etc.
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Single symptomatic lesion of the trochlea, medial or lateral femoral condyle of the knee larger than 2 cm2.
* Cartilage lesion ICRS grade 3 or 4.
* More than 50 % of the menisci intact.
* Ligamentous stable knee
* Lysholm Score < 75
* Acceptable range of motion (5 <= age <= 105 degrees)
Exclusion Criteria:
* Osteoarthritis
* Malalignment > 5 degrees measured on HKA (hip-knee-ankle) radiographs
* Systemic arthritis
* Previous cartilage surgery
* Obesity BMI > 30
* Serious drig or alcohol abuse
* Inability to answer questionnaires or partake in rehabilitation
* Comorbidity that may influence surgery or rehabilitation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</STUDY><STUDY>
Related NCT_ID: NCT01227694
Related Title: Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.
Related Description: #Study Description
Brief Summary
This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires.
MSC obtained from each patient's bone marrow will be isolated and expanded 'Ex-Vivo' under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month.
The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.
#Intervention
- OTHER : Autologous MSC knee implantation
- Isolation and 'Ex-Vivo' expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection.
- Other Names :
- Xcel-m-condro-alpha
Related Criteria: #Eligibility Criteria:
Inclusion Criteria:
* Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
* Chronic knee pain with mechanical characteristics
* Absence of local or systemic septic process
* Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
* Informed Consent form signed by the patient
* The patient is able to understand the nature of the study
Exclusion Criteria:
* Patients < 18 years or legally dependent
* Patients >65 years
* Previous surgery of the knee
* Intraarticular treatment in the past 6 month
* Knee ligament or meniscus rupture observed by MRI
* Any sign of infection
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
* Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
* Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
* Pregnant women or intend to become pregnant or breast-feeding
* Neoplasia
* Immunosuppressive states
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</STUDY>
</RELATED_STUDIES>
Target Study Title: Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
Target Study Description: #Study Description
Brief Summary
This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).
#Intervention
- PROCEDURE : Microdrilling Surgery
- All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
- PROCEDURE : Injections of BMAC + PRP + HA
- All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA
Task Instruction:
1. Based on the "Target Study Title" and "Target Study Description" of the target study, please create a Eligibility Criteria for the target study.
2. please provide a detailed step-by-step logical thinking steps for the Eligibility Criteria you created before creating the whole criteria.
3. Could use example studies (in the <RELATED_STUDIES> section) if they support your justifications, but ensure the reasoning is well-explained and relevant to the study's context
4. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
Your long step by step detailed logical thinking steps here.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
**Step 1: Understanding the Study Context**
The study aims to evaluate a treatment for multiple full-thickness chondral lesions in the knee. This involves microdrilling surgery and post-operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet-rich plasma (PRP), and hyaluronic acid (HA).
**Step 2: Identifying Key Considerations for Patient Selection**
To ensure the study's success, it is crucial to select patients with the most suitable characteristics. This includes considering the severity and nature of the chondral lesions, as well as the patient's overall health and ability to undergo the treatment.
**Step 3: Considering the Severity of Chondral Lesions**
The study focuses on full-thickness chondral lesions, which are a significant concern in osteoarthritis. To ensure that the treatment is effective, patients with lesions that are not too severe or too mild should be selected. MRI-confirmed full-thickness unipolar or bipolar chondral lesions are a reasonable criterion, as they indicate a clear need for treatment.
**Step 4: Excluding Inflammatory Arthritis**
Inflammatory arthritis can complicate the treatment and outcomes, making it essential to exclude patients with this condition. This is in line with the findings of NCT01227694, which also excluded patients with systemic arthritis.
**Step 5: Considering Body Mass Index (BMI)**
A high BMI can increase the risk of complications during and after surgery. Excluding patients with a BMI > 35 is a reasonable threshold, as it reduces the risk of adverse outcomes.
**Step 6: Evaluating Knee Stability and Alignment**
Significant varus or valgus knee instability or unusually stiff knee can affect the treatment's efficacy and safety. Excluding patients with these conditions ensures that the treatment is applied in a stable and controlled environment.
**Step 7: Assessing Cardiac and Pulmonary Health**
Active cardiac or pulmonary disease can increase the risk of complications during and after surgery. Excluding patients with these conditions ensures that the treatment is applied to patients with stable and manageable health conditions.
**Step 8: Considering Infection and Immune System Status**
Active bacterial or Mycobacterial infection, known hypercoagulable state, and immunosuppressive states can compromise the treatment's efficacy and safety. Excluding patients with these conditions ensures that the treatment is applied in a clean and controlled environment.
**Step 9: Evaluating Pregnancy and Lactation Status**
Pregnant or lactating females should be excluded from the study to prevent potential harm to the fetus or infant.
**Step 10: Assessing Cognitive Function and Ability to Participate**
Patients with cognitive impairment or those who are unable or unwilling to participate fully in post-operative physical therapy should be excluded, as they may not be able to provide informed consent or comply with study procedures.
**Step 11: Considering MRI Scanning and Elective Orthopedic Surgery**
Patients with a contraindication to MRI scanning or those who are at significantly increased risk for elective orthopedic surgery should be excluded, as they may not be able to undergo the necessary diagnostic and treatment procedures.
**Step 12: Finalizing the Inclusion and Exclusion Criteria**
Based on the above considerations, the study should include patients with MRI-confirmed full-thickness unipolar or bipolar chondral lesions from osteoarthritis, and exclude patients with inflammatory arthritis, BMI > 35, significant varus or valgus knee instability or unusually stiff knee, active cardiac or pulmonary disease, active bacterial or Mycobacterial infection, known hypercoagulable state, pregnancy or lactation, known allergy to hyaluronic acid, cognitive impairment, contraindication to MRI scanning, or increased risk for elective orthopedic surgery.
**Step 13: Finalizing the Age and Sex Criteria**
The study should include patients aged 18-64 years, as this age range is most likely to benefit from the treatment and have the necessary cognitive and physical abilities to participate in the study.
**Step 14: Finalizing the Study's Acceptance of Healthy Volunteers**
The study should not accept healthy volunteers, as it focuses on patients with specific medical conditions that require treatment.
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria: MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis.
Exclusion Criteria:
* Inflammatory arthritis
* Body mass index (BMI) greater than 35
* Presence of significant varus or valgus knee instability or unusually stiff knee
* Greater than 50% deviation of the mechanical axis
* Presence of active cardiac disease
* Presence of active pulmonary disease
* Prior septic arthritis of the involved joint
* Presence of active bacterial or Mycobacterial infection
* Presence of a known hypercoagulable state
* Pregnant or lactating females
* Subject known to be positive for hepatitis B, hepatitis C, or HIV
* Known allergy to hyaluronic acid
* Patients who are unable or unwilling to participate fully in post-operative physical therapy
* Patients with a contraindication to MRI scanning
* Any disorder that compromises ability to give consent or comply with study procedures
* Patients who are felt to be at significantly increased risk for elective orthopedic surgery
* Non-ambulatory patients
* Patients with cognitive impairment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
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