TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Brief Summary: The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.


Options:
A: N/A
B: Incidence of spontaneous falls. (24 months.)
C: 25-hydroxyvitamin D3 (25-OHD) (Baseline, 4 weeks and 3 months); Parathyroid Hormone (PTH) (Baseline); Calcium (Baseline, 4 weeks); Phosphate (Baseline); Alkaline Phosphatase (Baseline); Hemoglobin (Baseline); Creatinine (Baseline)
D: Chang in Disposition Index, a Measure of Beta Cell Function (baseline and 4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Brief Summary: The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.


Options:
A: Change in body weight (Baseline and 16 weeks)
B: Body Weight; Body composition; Measures of calcium metabolism; Insulin sensitivity; Muscle strength; Depression score; Blood pressure
C: Chang in Disposition Index, a Measure of Beta Cell Function (baseline and 4 months)
D: AUC for increment in serum 25(OH)D (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 317 in Subjects With Moderate to Severe Asthma
Brief Summary: A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.


Options:
A: Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control (Week 28)
B: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35)
C: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)
D: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 317 in Subjects With Moderate to Severe Asthma
Brief Summary: A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.


Options:
A: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Week 52); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Week 52)
B: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)
C: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)
D: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 317 in Subjects With Moderate to Severe Asthma
Brief Summary: A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.


Options:
A: Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period (Baseline to end of the fixed-dose steroid treatment period (Week 24)); Percentage of Participants With at Least 1 Adverse Event (Baseline to end of the study (Week 68))
B: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils (Baseline and 16 weeks); Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells (Baseline and 16 weeks)
C: Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) (Baseline, 12 Months)
D: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of ATEGE-Fresenius Induction in Liver Transplantation Followed by Tacrolimus Weaning.
Brief Summary: This is a randomized, controlled trial in liver transplantation in which conventional immunosuppressive treatment will be compared with a therapeutic strategy consisting in pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor minimization may promote development of tolerogenic mechanisms allowing the eventual withdrawal of all immunosuppressive therapy.


Options:
A: Recurrence free survival (5 year follow up after last patient in)
B: Proportion of patients who can significantly decrease the doses of tacrolimus 1 year after transplantation (as defined by: tacrolimus administered on alternate days, or daily with trough levels below 5 ng/mL. (1 year)
C: Estimated Glomerular Filtration Rate (GFR) (month 12)
D: Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant (At 6 months posttransplant); Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) (Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)); Number of Participants Who Had AEs of Special Interest During the LTE (Day 1 (randomization) through database lock (20-June-2011)); Number of Participants With Marked Hematology Abnormalities During the LTE (Every 4 weeks from Week 53 to Week 104.); Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE (Every 4 weeks from Week 53 to Week 104.); Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE (Every 4 weeks from Week 53 to Week 104.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomized, Double Blind Clinical Trial.
Brief Summary: Borderline Personality Disorder (BDP) is a serious mental disorder that affects about 1-2% of the general population, and it is characterized by severe psychosocial impairment and a high mortality rate due to suicide. Currently, the most effective treatments for BPD are psychotherapy (cognitive behavior therapy - CBT -) and pharmacotherapy (often as an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms and self-destructive behavior). Nevertheless, although several drugs are used in these patients, these drugs induce an improvement of some symptoms but do not cause the remission of BPD. Thus, identification of novel treatments is needed.

The objective of this study is to examine the efficacy of Omacor® ( a mixture of omega-3-acid ethyl esters: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ) for BDP patients receiving CBT. Patients with BDP will be randomly allocated to the three arms of the study: 1- CBT+placebo, 2- CBT+Omacor 1680 mg/d, 3- CBT+Omacor 3360 mg/d. Follow up will last for 12 weeks. Assessment of affective symptoms, impulsivity and aggressivity will be carried out at baseline and at 2, 4, 6, 8, 10 and 12 weeks.


Options:
A: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))
B: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
C: Self-harm Ideation (pre-treatment (week 0) to post-treatment (end of week 8))
D: Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). (weeks: 0, 2, 4, 6, 8, 10, 12); Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. (0, 6, 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder: a Randomized, Double Blind Clinical Trial.
Brief Summary: Borderline Personality Disorder (BDP) is a serious mental disorder that affects about 1-2% of the general population, and it is characterized by severe psychosocial impairment and a high mortality rate due to suicide. Currently, the most effective treatments for BPD are psychotherapy (cognitive behavior therapy - CBT -) and pharmacotherapy (often as an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms and self-destructive behavior). Nevertheless, although several drugs are used in these patients, these drugs induce an improvement of some symptoms but do not cause the remission of BPD. Thus, identification of novel treatments is needed.

The objective of this study is to examine the efficacy of Omacor® ( a mixture of omega-3-acid ethyl esters: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ) for BDP patients receiving CBT. Patients with BDP will be randomly allocated to the three arms of the study: 1- CBT+placebo, 2- CBT+Omacor 1680 mg/d, 3- CBT+Omacor 3360 mg/d. Follow up will last for 12 weeks. Assessment of affective symptoms, impulsivity and aggressivity will be carried out at baseline and at 2, 4, 6, 8, 10 and 12 weeks.


Options:
A: Parasuicidal behaviour (intermittent)
B: Suicidal behavior and ideation (Weeks 4, 12, and 24)
C: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
D: Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). (weeks: 0, 2, 4, 6, 8, 10, 12); Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. (0, 6, 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Brief Summary: The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.


Options:
A: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
B: Change in average pain according to the Brief Pain Inventory (6 months)
C: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
D: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Atrial Substrate Modification With Aggressive Blood Pressure Lowering to Prevent AF
Brief Summary: Atrial fibrillation (AF) is a very common arrhythmia causing many symptoms resulting in numerous hospitalizations. Catheter ablation is a technique that has evolved significantly to improve symptomatic recurrences, but does not offer a 100% cure rate. We hypothesize that the use of aggressive BP lowering will reduce the rate of recurrent AF after catheter ablation for AF. We plan a randomized clinical trial of aggressive BP lowering versus standard BP control to investigate this.


Options:
A: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
B: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
C: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure (From randomization; for approximately a median of 3.5 years)
D: Time to symptomatic AF/atrial tachycardia (AT)/atrial flutter (AFl) lasting > 30 seconds more than 3 months post ablation. (at least 3 months post catheter ablation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women


Options:
A: decreased dietary fat intake; increased vegetable consumption; increased self-reported leisure physical activity
B: Body fat (At the end of the intervention and at a six month follow-up)
C: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)
D: Change in body weight from baseline (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women


Options:
A: decreased dietary fat intake; increased vegetable consumption; increased self-reported leisure physical activity
B: Development of diabetes (Up to 5 years)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Age 12 Follow-up of Early Preventive Intervention
Brief Summary: To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.


Options:
A: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)
B: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
C: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
D: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Age 12 Follow-up of Early Preventive Intervention
Brief Summary: To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.


Options:
A: Fruit and vegetable intake (Up to one year)
B: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
C: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)
D: Food Intake (9 month posttest, 21 month follow-up, 33 month follow-up); Physical Activity (baseline, 9 month posttest, 21 month posttest, 33 month posttest); Body Mass Index (baseline, 9 month posttest, 21 month posttest, 33 month posttest)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Age 12 Follow-up of Early Preventive Intervention
Brief Summary: To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.


Options:
A: alcohol use, alcohol related consequences (3 -12 month period)
B: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)
C: Increase in parental competence at nine intervals over 39 month study period (birth-3 year postpartum)
D: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Residual Vein Thrombosis (RVT) Establishes the Optimal Duration of Oral Anticoagulants After a First Episode of Deep Vein Thrombosis of the Lower Limbs
Brief Summary: ABSTRACT Background The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain . The present study addressed the possible role of the Residual Vein Thrombosis in assessing the need for a prolonged anticoagulation.

Methods Patients with a first episode of symptomatic unprovoked or provoked proximal Vein Thrombosis (VT) were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein Thrombosis (RVT), ultrasonographically-detected, will be then assessed. Patients without RVT did not continue OAT, whereas those with RVT will be randomized to either stop or continue OAT for 9 more months. Patients were followed-up prospectively focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding over a period of at least 12 months after OAT discontinuation.


Options:
A: Recurrent Venous Thromboembolism; major and minor haemorrhage; death
B: Death due to DVT/PE; Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.; Number of major haemorrhages.
C: The main efficacy outcome is objectively confirmed recurrent thromboembolism from randomization up to completion of 33 months of follow-up. (33 months)
D: Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up; Confirmed major bleeding events at 18 months follow up

Answer: A