TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass - a Randomized Control Clinical Trial
Brief Summary: The great saphenous vein is the most commonly used material in coronary vascular bridging operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the incision open groin to ankle. This operation may damage the lymphatic, cause lymph circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around hematoma and other a series of symptoms.Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following Stripping saphenous vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC application on postoperative complications and wound healing after Stripping saphenous vein in Coronary bypass in comparison to conventional suction drain.


Options:
A: Early Complications of Vascular Zone (2 weeks)
B: Groin Wound Complication (30 days)
C: Number of Participants With Wound Complications (Four weeks after cesarean section)
D: Surgical Site Infection (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass - a Randomized Control Clinical Trial
Brief Summary: The great saphenous vein is the most commonly used material in coronary vascular bridging operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the incision open groin to ankle. This operation may damage the lymphatic, cause lymph circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around hematoma and other a series of symptoms.Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following Stripping saphenous vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC application on postoperative complications and wound healing after Stripping saphenous vein in Coronary bypass in comparison to conventional suction drain.


Options:
A: Post-operative Seroma Formation (Two weeks following drain removal)
B: Number of Participants With Wound Complications (Four weeks after cesarean section)
C: Early Complications of Vascular Zone (2 weeks)
D: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia
Brief Summary: This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for patients with schizophrenia. The aim of this innovative mental health center-based team intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients with poorly controlled type 2 diabetes. The study will be conducted in two phases over the 2-year grant period.

Phase 1. Development of the adapted TEAMcare intervention and training of team members.

Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients at Harborview Mental Health Services with schizophrenia and poorly controlled type 2 diabetes. The intervention involves the management of subjects' diabetes, hypertension, and hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).

The primary aim of this pilot research grant is to evaluate the feasibility of implementing this complex intervention, in order to guide the design of a larger scale efficacy study (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month follow-up visits for the 40 subjects enrolled in this feasibility trial.


Options:
A: Glycemic control (one year); Body weight (one year); Blood pressure (one year); Lipid levels (one year)
B: Pt. 1 Dilated Fundus Exam (DFE) (6-month follow-up assessment)
C: Hemoglobin A1c (6 months)
D: Pre- to post-implementation change in HbA1c. (Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia
Brief Summary: This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for patients with schizophrenia. The aim of this innovative mental health center-based team intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients with poorly controlled type 2 diabetes. The study will be conducted in two phases over the 2-year grant period.

Phase 1. Development of the adapted TEAMcare intervention and training of team members.

Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients at Harborview Mental Health Services with schizophrenia and poorly controlled type 2 diabetes. The intervention involves the management of subjects' diabetes, hypertension, and hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).

The primary aim of this pilot research grant is to evaluate the feasibility of implementing this complex intervention, in order to guide the design of a larger scale efficacy study (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month follow-up visits for the 40 subjects enrolled in this feasibility trial.


Options:
A: The Work Behavior Inventory (Ten months)
B: Blood pressure (One year)
C: Systolic and Diastolic Blood Pressure (SBP, DBP) (24 months); Total Cholesterol (24 months); Physical Health-related Quality of Life Score (24 months)
D: Hemoglobin A1c (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
Brief Summary: This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The plan is to expand the trial shortly as a multi-center project. The patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC defined as the resumption of sustained perfusing cardiac activity.

The primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.


Options:
A: Number Alive at Hospital Discharge (at hospital discharge)
B: Number of Participants With Death or Poor Neurologic Outcome at 6 Months (Six months)
C: Mortality (180 days)
D: Neurological outcome assessed with Cerebral Performance Category scale (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy
Brief Summary: To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.

* Randomized controlled arm : Placebo versus Ramosetron injection
* Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery


Options:
A: pain during coughing (day 1)
B: Pain 6 hours postoperatively (6 hours postoperatively); Pain 3 hours postoperatively (3 hours postoperatively); Pain 24 hours postoperatively (24 hours postoperatively); Pain (2-7 days postoperatively)
C: Incidence or intensity of PONV (during postoperative hospital stays (2 days))
D: Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively (3 days - post operative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
Brief Summary: This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.


Options:
A: Framingham heart risk score (1 year)
B: 12-month systolic blood pressure (SBP) change (Baseline, 12 months)
C: The proportion of high-risk individuals that have been assessed for cardiovascular risk (12 months after intevention); The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease (12 months from intervention)
D: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Pregnancy Failure Management Regimens
Brief Summary: The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.


Options:
A: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
B: Percentage of patients with complete abortion (success rate). (1 week)
C: Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. (Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done); Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 (Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)); Gestational Sac Expulsion by the 30-day Telephone Call (30 Days); Uterine Asperation (30 Days)
D: Incidence of intrauterine adhesion (3 months after dilatation and curettage)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Pregnancy Failure Management Regimens
Brief Summary: The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.


Options:
A: Success rate of abortion (24 hours); Interval to abortion (24 hours)
B: Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. (Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done); Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 (Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)); Gestational Sac Expulsion by the 30-day Telephone Call (30 Days); Uterine Asperation (30 Days)
C: Number of surgical evacuation in each group (during de study)
D: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Pregnancy Failure Management Regimens
Brief Summary: The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.


Options:
A: Complete abortion (14 days)
B: Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. (Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done); Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 (Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)); Gestational Sac Expulsion by the 30-day Telephone Call (30 Days); Uterine Asperation (30 Days)
C: Complete abortion (30 days)
D: feasibility (3 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MemoTV: Epigenetic, Neural and Cognitive Memories of Traumatic Stress and Violence in Former Offenders of the Townships of South Africa
Brief Summary: Escalating violence is omnipresent in South African townships and can be traced back to two core mechanisms: a trauma-related hyper-arousal and a positive rewarding perception of violence. In the past, there was no therapeutic intervention available addressing both, trauma and the so-called appetitive aggression. The University of Konstanz has developed a culturally sensitive and scientifically based short-term intervention for the treatment of traumatized patients, the Narrative Exposure Therapy (NET), that has proven its effectiveness in various randomized clinical studies in different war-affected populations. Recently, the NET has been adapted for the forensic offender rehabilitation (FORNET) by also addressing the perpetration of violence related to a self-rewarding perception of the exposure with violence. It has shown to be effective in reducing the number of committed offenses in a perpetrator sample in Burundi and to reduce PTSD symptoms in a perpetrator sample in the Democratic Republic of the Congo. In this study, we investigated the therapeutic efficiency of FORNET in a randomized clinical control trial with a sample of former offenders of the townships of Cape Town. In addition to the previous studies, we specifically addressed the context of ongoing stress and linked our findings to epigenetic markers of stress and violence. Participants were followed over a period of up to 25-months post-treatment. The FORNET was also disseminated to local staff of our collaboration partners from the South African Universities and an organization working in the townships to warrant sustainability of the therapeutic intervention.


Options:
A: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
B: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
C: Teachers' knowledge (At the end of 3 days workshop)
D: Change in PTSD symptom severity with the PSS-I the Post-traumatic Stress Disorder Scale- Interview (PSS-I) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Attraction to violence with the Appetitive Aggression Scale (AAS) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Methylation Pattern of the Glucocorticoid Receptor promoter region via saliva samples (8, 18 and 25- month follow-up); Change in Self-committed violence with the AAS offense list (8, 18 and 25- month follow-up); Influence of Social Acknowledgement with Social Acknowledgement Questionnaire (SAQ) (8, 18 and 25- month follow-up); Influence of drug abuse related to violence on number of offenses with the offense checklist (from the AAS) (8, 18 and 25- month follow-up); Change in Epigenetic Markers (methylation patterns) of violence in the androgen receptor promoter region via saliva samples (8, 18 and 25- month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents.


Options:
A: Executive function accuracy (Up to 8 months)
B: Fitness (Day 0, Day 120)
C: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
D: Change in knowledge score (One school year); Change in dietary habits (One school year); Change in self-efficacy score (One school year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Brief Summary: A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.


Options:
A: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)
B: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 Through Safety Follow-up (up to Day 61 for Part 1, Day 85 for Part 2 and Day 57 for Part 3)); Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline Through Day 29)
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Brief Summary: A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.


Options:
A: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)
B: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)
C: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)); Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs (Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21 (Cohort 1: Day 14, Day 21); Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56 (Cohort 2 and 3: Day 28, Day 56); Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 (Cohort 4: Baseline, Day 56)
D: Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (On Study Day 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Brief Summary: A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.


Options:
A: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 Through Safety Follow-up (up to Day 61 for Part 1, Day 85 for Part 2 and Day 57 for Part 3)); Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline Through Day 29)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 (Baseline, Through Week 12)
C: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
D: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)

Answer: D