TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Tivozanib as Maintenance Therapy, Post-Chemotherapy, in Patients With Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This research study is evaluating a drug called tivozanib as a possible treatment for ovarian, fallopian tube or primary peritoneal cancer.

Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood supply so that it does not get the blood and nutrients it needs to grow.

In this research study, the Investigators are looking to see whether tivozanib works as a maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in participants who have achieved a complete response following chemotherapy. Maintenance therapy is given after a disease has responded to previous treatment. It is given to help prevent the spread or recurrence of the tumor.


Options:
A: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
B: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment (From randomization of the first patient until 32.5 months later, assessed every 8 weeks)
C: Progression-Free Survival (PFS) Comparison (2 Years)
D: Progression-Free Survival (PFS) (Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder
Brief Summary: The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.


Options:
A: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment). (Baseline, Week 12)
B: Change in Urge Urinary Incontinence (UUI) Episodes (Baseline through 6 months)
C: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours (Baseline and EoT (up to 12 weeks)); Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours (Baseline and EoT (up to 12 weeks))
D: Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)
Brief Summary: Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.


Options:
A: Delivery rate (proportion) (Within 24 hours)
B: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)
C: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
D: induction delivery interval (time from starting induction to delivery) (48hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)
Brief Summary: Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.


Options:
A: Time from treatment start to delivery (At delivery)
B: Time Of Start Of Induction Of Labor To Delivery (Hours)
C: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
D: Time to Delivery (an average of 20 hours, up to 40 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
Brief Summary: To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
C: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) (Post treatment 12 week)
D: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
Brief Summary: To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.


Options:
A: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) (Post treatment 12 week)
B: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) (Week 24 (12 weeks after the end of treatment)); Percentage of Participants Experiencing at Least One Adverse Event (Up to Week 14 (14 days after the Blinded Treatment was completed)); Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event (Up to Week 12 (end of Blinded Treatment))
C: Percentage of Participants Achieving SVR12 (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 16)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (12 Weeks After the Planned End of Treatment (EOT: Week 48))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
Brief Summary: Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.


Options:
A: Change in BMI Percentile (baseline and 12 months)
B: changes in body mass index throughout the intervention
C: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
D: Anthropometric Variables (every two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist-Physician Collaborative Medication Therapy Management Services (MTMS) Demonstration Project
Brief Summary: Patients managed by a newly formed pharmacist-physician medication therapy management team in a university primary care clinic will have better blood pressure control than patients receiving usual care.


Options:
A: Metabolic Syndrome (MetS) (Baseline)
B: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
C: systolic blood pressure (6 months)
D: The primary outcome will be the difference in proportion of patients who receive ≥ 5 of the Arthritis Foundation's quality indicators during the six months of the study. (6 months); (Baseline, months 2 and 6 ) (Months 2 and 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist-Physician Collaborative Medication Therapy Management Services (MTMS) Demonstration Project
Brief Summary: Patients managed by a newly formed pharmacist-physician medication therapy management team in a university primary care clinic will have better blood pressure control than patients receiving usual care.


Options:
A: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg (4 months)
B: systolic blood pressure (6 months)
C: Blood Pressure Change (Measured at Baseline, and 6,12,18,24, and 30 months post baseline.)
D: Anticoagulation-related quality of life (Four months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
Brief Summary: Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times \< 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.


Options:
A: Re-hospitalizations (During the 30days after discharge)
B: The number of ED presentations (1 year after randomization.)
C: Insomnia (Up to 18 weeks)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention
Brief Summary: The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a pilot sample of parents of toddlers and engaging them in a pilot study to test a version of mindfulness-based intervention for parenting stress reduction (PMH), an empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling for parents of preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy eating and physical activity in parent and child; and prevent overweight and obesity in preschoolers with an obese parent.


Options:
A: Change in parental stress (Baseline to end of study (Every 6 weeks for 9 months)); Change in parental depression (Baseline to end of study (Every 6 weeks for 9 months)); Change in parental anxiety (Baseline to end of study (Every 6 weeks for 9 months)); Change in parental mindfulness (Baseline to end of study (Every 6 weeks for 9 months)); Change in parent relationship quality (Baseline to end of study (Every 6 weeks for 9 months)); Change in parental life satisfaction (Baseline to end of study (Every 6 weeks for 9 months)); Change in parental sleep quality (Baseline to end of study (Every 6 weeks for 9 months))
B: Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to week 8 (Baseline, week 8)
C: Attendance (8 weeks)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects.
Brief Summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 70 mg/dL (1.8 mmol/L) or non-HDL-C \>/= 100 mg /dL (2.6 mmol/L).


Options:
A: the change in fibrous cap thickness (9 month)
B: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects.
Brief Summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 70 mg/dL (1.8 mmol/L) or non-HDL-C \>/= 100 mg /dL (2.6 mmol/L).


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--To-Treat (ITT) Analysis (From Baseline to Week 24)
B: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
D: Number of Participants With Adverse Events (52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
Brief Summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 100 mg/dL (2.6 mmol/L) or non-HDL-C \>/=130 mg/dL (3.4 mmol/L).


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) (From Baseline to Week 24)
B: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
C: Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study (From randomization up to 64 months)
D: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
Brief Summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 100 mg/dL (2.6 mmol/L) or non-HDL-C \>/=130 mg/dL (3.4 mmol/L).


Options:
A: Percentage of Participants Who Experienced Adverse Events (AEs) (Up to 10 weeks after last study drug administration (maximum of 86 weeks))
B: Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization (Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.)
C: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
D: Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa
Brief Summary: This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.


Options:
A: Number of Participants Achieving Microfilarial Clearance (12 months)
B: adverse reactions (6 weeks)
C: complete clearance of mf in 80% of the infected (At 13th week (91 days) post therapy)
D: Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) (at 36 months)

Answer: D