TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial
Brief Summary: Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).


Options:
A: Cardiovascular events (5 years of follow up)
B: Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan (Week 4)
C: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
D: Hemoglobin A1c (6 months follow up from baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of an Ultrasound Guided Bilateral Transversus Abdominis Plane Block With Dexamethasone and Preperitoneal Instillation of Local Anesthetic With Dexamethasone to a Standard Anesthetic Technique for Analgesic Efficacy and Patient Satisfaction Following a Total Extraperitoneal Bilateral Inguinal Hernia Repair: A Prospective Randomized Single Blinded Study
Brief Summary: Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under direct visualization will be compared it to a standard anesthetic technique (control) following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are hypothesizing that the bilateral TAP block and preperitoneal instillation of local anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction and post-operative pain control when compared to a standard anesthetic technique (no regional technique).


Options:
A: Pain score by numeric rating scale (At 8 hours postoperatively)
B: Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia
C: Prevention of PONV in the 24 hours following end of surgery; Tolerability (24 hours)
D: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair (Post-operatively (Day 1))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Prenatal Short Messages on Maternal and Newborn Health
Brief Summary: It is hypothesized that delivering short messages (SMS) to pregnant women can improve maternal and newborn health outcomes. This pilot offers mothers-to-be in rural China free daily short messages (SMS) via cell phone. The aim is to advise them on (a) good household prenatal practices (GHPP) and (b) care seeking (CS) in order to improve the quality of life for mothers and newborns.


Options:
A: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)
B: Newborn health (the first month after birth)
C: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
D: contraception (past 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years.


Options:
A: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)
B: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)
C: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
D: Point prevalence abstinence at 6 months (6 months after beginning treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Sevoflurane Preconditioning on Tissue Oxygenation of the Tibial Anterior Muscle Measured by Near-infrared Spectroscopy After Clamping of the Femoral Artery for Vascular Surgery
Brief Summary: Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.


Options:
A: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)
B: troponin level (within the 1 day after operation)
C: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
D: Decrease of tissue oxygen saturation below 95 % of baseline (4 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Cognitive Behavioral Therapy for Military Populations
Brief Summary: The primary purpose of this study is to compare the effectiveness of brief cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal ideation and attempts (regardless of Axis I or II diagnosis) among active duty military personnel. The standard null hypothesis will involve tests conducted comparing improvement following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation, intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along with remission of psychiatric diagnoses. Secondary purposes include the prospective investigation of suicide risk factors and warning signs to explore these variables' ability to predict subsequent suicidal behavior following an index attempt.


Options:
A: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
B: Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Service Utilization at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Suicidality at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months)
C: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)
D: suicide/attempted suicide (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Cognitive Behavioral Therapy for Military Populations
Brief Summary: The primary purpose of this study is to compare the effectiveness of brief cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal ideation and attempts (regardless of Axis I or II diagnosis) among active duty military personnel. The standard null hypothesis will involve tests conducted comparing improvement following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation, intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along with remission of psychiatric diagnoses. Secondary purposes include the prospective investigation of suicide risk factors and warning signs to explore these variables' ability to predict subsequent suicidal behavior following an index attempt.


Options:
A: suicidal act frequency (12 months)
B: Repeat Suicide Attempts (1, 3, 6, and 12 months)
C: Beck scale for suicidal ideation (six months)
D: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Cognitive Behavioral Therapy for Military Populations
Brief Summary: The primary purpose of this study is to compare the effectiveness of brief cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal ideation and attempts (regardless of Axis I or II diagnosis) among active duty military personnel. The standard null hypothesis will involve tests conducted comparing improvement following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation, intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along with remission of psychiatric diagnoses. Secondary purposes include the prospective investigation of suicide risk factors and warning signs to explore these variables' ability to predict subsequent suicidal behavior following an index attempt.


Options:
A: Change in Autonomous and Controlled Motivation (From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months))
B: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)
C: Number of suicidal behaviours (12 months)
D: Suicide ideation (12 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use
Brief Summary: The goal of study is to develop and test a parenting-focused version of mindfulness intervention ("Parenting Mindfully") to reduce parent stress and prevent adolescent substance use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that Parenting Mindfully (PM) will decrease prevent adolescent substance use and HIV risk behaviors and intentions. Secondarily, PM will improve parenting, and decrease adolescent stress responses.


Options:
A: Attendance (8 weeks)
B: Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to week 8 (Baseline, week 8)
C: Change in Substance Use from pre-intervention through 12 months after the intervention (Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session); Change in Adolescent Sex Behaviors from Pre-intervention Through 12 months following the intervention (Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session)
D: Change from Baseline in parent-rated self-control of the child (Baseline, 3, 5 and 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Strategies to Increase Testing and Linkages of HIV Positive Individuals to Care and HIV Negative Men to Male Circumcision in Sub-Saharan Africa
Brief Summary: The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision.


Options:
A: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)
B: Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (2 weeks)
C: Exhaled Carbon Monoxide Levels (1 month)
D: Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing (Up to 12 Months); Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits (Up to 9 months); Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral (Up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Strategies to Increase Testing and Linkages of HIV Positive Individuals to Care and HIV Negative Men to Male Circumcision in Sub-Saharan Africa
Brief Summary: The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision.


Options:
A: Measles vaccination coverage (10 months)
B: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
C: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program (up to 1 year)
D: Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing (Up to 12 Months); Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits (Up to 9 months); Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral (Up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: International Latino Research Partnership
Brief Summary: Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and intervention project designed to improve the quality of care for Latino patients with comorbid mental health and substance use problems. We will first test a screening of comorbid problems with patients identified in mental health as well as primary health care. Building on that work, we will test the feasibility, acceptability and efficacy of the "Integrated Intervention for Dual Problems and Early Action" (IIDEA) intervention addressing mental health, substance use, and prevention of HIV, as well as a smoking cessation supplement. The project is being conducted in Massachusetts as well as at two sites in Spain. As such, the proposed ILRP multi-site international project is a critical step towards developing models of integrated care for the large and diverse Latino migrant population and more broadly towards understanding how best to integrate evidence-based assessment and treatments for co-occurring substance and mental health problems and HIV risks.


Options:
A: Mean Number of Alcohol and Drug Use Days Out of Past 30 (30 days previous, assessed at 12-month follow-up)
B: Addiction Severity Index (ASI) - Alcohol (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Addiction Severity Index (ASI) - Drugs (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Change on Urine Drug Test (change) (Baseline, 2 months, 4 months, 6 months, 12 months)
C: Change in pain symptoms (Change from baseline through study completion (9 months post-treatment)); Change in aberrant drug-related behaviors (Change from baseline through study completion (9 months post-treatment))
D: Pain severity, pain functional interference (Baseline, immediately following treatment, and at 3 month follow-up); Opioid craving (Baseline, immediately following treatment, and at 3 month follow-up); Opioid misuse behaviors (Baseline, immediately following treatment, and at 3 month follow-up); Well-being (Baseline, immediately following treatment, and at 3 month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: International Latino Research Partnership
Brief Summary: Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and intervention project designed to improve the quality of care for Latino patients with comorbid mental health and substance use problems. We will first test a screening of comorbid problems with patients identified in mental health as well as primary health care. Building on that work, we will test the feasibility, acceptability and efficacy of the "Integrated Intervention for Dual Problems and Early Action" (IIDEA) intervention addressing mental health, substance use, and prevention of HIV, as well as a smoking cessation supplement. The project is being conducted in Massachusetts as well as at two sites in Spain. As such, the proposed ILRP multi-site international project is a critical step towards developing models of integrated care for the large and diverse Latino migrant population and more broadly towards understanding how best to integrate evidence-based assessment and treatments for co-occurring substance and mental health problems and HIV risks.


Options:
A: Addiction Severity Index (ASI) - Alcohol (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Addiction Severity Index (ASI) - Drugs (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Change on Urine Drug Test (change) (Baseline, 2 months, 4 months, 6 months, 12 months)
B: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)
C: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)
D: Participation in cervical cancer screening (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's Disease
Brief Summary: This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.


Options:
A: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
B: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
C: Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response (Week 10); Maintenance Phase: Percentage of Participants With Clinical Remission (Week 60); Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs) (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With TEAE Related to Body Weight (Weight Decreased) (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With TEAE Related to Vital Signs (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right] (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks))
D: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation (Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sympathetic Renal Denervation Versus Increment of Pharmacological Treatment in Resistant Arterial Hypertension
Brief Summary: Background: In hypertension, a highly prevalent disease, up to 10-15% of hypertensive patients have uncontrolled blood pressure despite a regimen of ≥ 3 drugs, which is known as resistant hypertension (RH). Cardiovascular prognosis in patients with RH is worse than in controlled hypertensives. Efferent renal sympathetic nerves play an important role in volume homeostasis and blood pressure. A novel minimally invasive technique based on the use of selective radiofrequency renal sympathetic denervation has shown promising preliminary results for the treatment of these patients. On the other hand, some patients with RH could improve their blood pressure control by adding spironolactone, an antagonist of aldosterone receptors.

Objective: To evaluate the efficacy of radiofrequency renal sympathetic denervation in patients with RH, as compared with the addition of spironolactone to the therapeutic regimen at baseline.

Method: interventional, prospective, randomized, open study, of a cohort of 50 patients with RH, with office systolic blood pressure ≥ 150 mmHg and also with 24h systolic blood pressure ≥ 140 mmHg, despite treatment with ≥ 3 drugs in adequate doses, one of them a diuretic, and whitout treatment with either spironolactone or eplerenone. Patients will be randomized (1:1) to renal sympathetic denervation treatment or spironolactone (50mg), performing determination of office blood pressure and 24h-ABPM at pre-randomization, 1, 3 and 6 months, as well as laboratory tests, echocardiography, measurement of carotid intima-media thickness and central blood pressure measurement at pre-randomization and after 6 months.


Options:
A: Safety at 6 weeks follow-up (6 weeks); Change in OBP (6 months)
B: Absolute change in office systolic blood pressure(SBP) (at 6 months)
C: Changes in ambulatory 24h-systolic blood pressure (SBP). (From baseline (Visit 0) to Final Examination (6 months).)
D: Change in systolic blood pressure (ABPM mean value) (6 months)

Answer: C