TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Part 1: AVANOVA1 - A Phase I Study to Evaluate the Safety and Tolerability of Bevacizumab-niraparib Combination Therapy and Determine the Recommended Phase 2 Dose (RP2D) in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Part 2: AVANOVA2 - A Two-arm, Open-label, Phase II Randomized Study to Evaluate the Efficacy of Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer.
Brief Summary: Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS)

PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease.

In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone.

The question is:

Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.


Options:
A: Progression free survival (30 months)
B: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)
C: Progression-Free Survival (PFS) (Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months))
D: investigator-determined progression-free survival (every 12 weeks until progression or up to 30 months (whichever occurs first))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Part 1: AVANOVA1 - A Phase I Study to Evaluate the Safety and Tolerability of Bevacizumab-niraparib Combination Therapy and Determine the Recommended Phase 2 Dose (RP2D) in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Part 2: AVANOVA2 - A Two-arm, Open-label, Phase II Randomized Study to Evaluate the Efficacy of Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer.
Brief Summary: Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS)

PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease.

In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone.

The question is:

Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.


Options:
A: MDS/AML reports related to PARPi (from WHO database). (From inception to May 3, 2020); MDS/AML reports related to PARPi (from French database). (From inception to May 1, 2021)
B: PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation (Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose); Continued Supply Phase: To enable patients to continue to receive treatment with AZD2281. Safety and tolerability data will be collected to further determine the safety and tolerability of the capsule formulation of AZD2281 in these patients (every 28 days); Continued Supply Expansion Phase: To compare the safety and tolerability of the tablet and capsule formulation of AZD2281 in all patients: Safety, AEs, Physical Exam, vital signs (at every visit); Dose Escalation Phase of continued supply expansion: To determine safety & tolerability of higher than 200mg bid (to 400mg) of tablet & compare safety & tolerability profile of tablet with 400mg capsule (at every visit); Randomised tablet formulation continued supply expansion phase (Group 8): To determine the safety and tolerability profile of selected tablet dose schedules of the melt-extrusion (tablet) formulation. (at every visit)
C: Progression free survival (PFS) (To assess from the time of randomization until the date of objective disease progression or death (by any cause in the absence of progression) or approximately up to 2.5 years.)
D: Progression free survival (30 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Commitment and Motivation in a Brief DBT Intervention for Self Harm
Brief Summary: Research suggests that individuals with Borderline Personality Disorder (BPD) experience low motivation for change (Skodal, Buckley, \& Charles, 1983). Dialectical Behavior Therapy (DBT; Linehan, 1993) includes commitment strategies that are designed to improve motivation. No studies have examined the effectiveness of these strategies. The proposed study will evaluate the efficacy of a brief DBT intervention consisting of commitment strategies plus skills training for people who self-harm. Participants will be randomly assigned to either a single orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation. Immediately following their orientation session, all participants will be enrolled in a 90 minute group skills training session. Primary outcomes include autonomous motivation and frequency of self harm behaviours. Assessments will be conducted at six time points: baseline, after the initial orientation session, after the skills training group session, and at one week, one month, and three month follow-up


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: 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: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)
D: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Commitment and Motivation in a Brief DBT Intervention for Self Harm
Brief Summary: Research suggests that individuals with Borderline Personality Disorder (BPD) experience low motivation for change (Skodal, Buckley, \& Charles, 1983). Dialectical Behavior Therapy (DBT; Linehan, 1993) includes commitment strategies that are designed to improve motivation. No studies have examined the effectiveness of these strategies. The proposed study will evaluate the efficacy of a brief DBT intervention consisting of commitment strategies plus skills training for people who self-harm. Participants will be randomly assigned to either a single orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation. Immediately following their orientation session, all participants will be enrolled in a 90 minute group skills training session. Primary outcomes include autonomous motivation and frequency of self harm behaviours. Assessments will be conducted at six time points: baseline, after the initial orientation session, after the skills training group session, and at one week, one month, and three month follow-up


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: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation (Baseline, 4 months post baseline, 12 months post baseline)
C: Suicide Events (1 year)
D: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Commitment and Motivation in a Brief DBT Intervention for Self Harm
Brief Summary: Research suggests that individuals with Borderline Personality Disorder (BPD) experience low motivation for change (Skodal, Buckley, \& Charles, 1983). Dialectical Behavior Therapy (DBT; Linehan, 1993) includes commitment strategies that are designed to improve motivation. No studies have examined the effectiveness of these strategies. The proposed study will evaluate the efficacy of a brief DBT intervention consisting of commitment strategies plus skills training for people who self-harm. Participants will be randomly assigned to either a single orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation. Immediately following their orientation session, all participants will be enrolled in a 90 minute group skills training session. Primary outcomes include autonomous motivation and frequency of self harm behaviours. Assessments will be conducted at six time points: baseline, after the initial orientation session, after the skills training group session, and at one week, one month, and three month follow-up


Options:
A: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
B: 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))
C: Repeat suicide attempts (Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion)
D: Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008). (Baseline and 1, 3, and 6 month follow-up assessments)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mechanistic Study to Assess The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF)
Brief Summary: What is heart failure with normal ejection fraction? The heart contracts (pumps) and relaxes with each heartbeat. In some people with heart failure, the heart contracts normally but there is reduced relaxation of the heart. As a result, people notice a feeling of breathlessness, ankle swelling and fatigue especially on exertion.

The investigators feel that patients with reduced or impaired relaxation of the heart have less heart filling time and poor energy utilisation during exercise. Therefore, the investigators are conducting a study to more thoroughly understand the disease condition by giving a drug called ivabradine to reduce the heart rate and hence to increase the heart filling time in these patients.


Options:
A: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))
B: Change in VO2max measured by CPEX (After 2 weeks of intervention)
C: Primary Composite Endpoint (From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimized Chronic Care for Smokers: A Comparative Effectiveness Approach; Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
Brief Summary: The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package. This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4) Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling. These components have strong theoretical and empirical support, but their relative, additive, and interactive effects are unknown.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: 7-Day Point-Prevalence Abstinence (12 months)
C: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
D: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Epanova® Compared to Placebo and Compared to Fenofibrate on Liver Fat Content in Hypertriglyceridemic overwEight subjeCTs; EFFECT I
Brief Summary: This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with over-weight and hypertriglyceridemia.


Options:
A: Serum alanine transaminase level decrease min. 0.3 upper limit of normal (6 months)
B: Reduction in liver and muscle fat (4 months)
C: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo) (Baseline and 12 weeks)
D: Change of intrahepatic triglyceride contents (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
Brief Summary: This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.


Options:
A: The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days (30 days)
B: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)
C: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
D: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
Brief Summary: This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.


Options:
A: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)
B: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
C: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)
D: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of the current study is to evaluate the effects of diets with three levels of dietary fat on weight change and related cardiometabolic risk factors in a 6-month randomized controlled-feeding trial.


Options:
A: Weight loss (2 years)
B: Change in body weight (measured at Year 2)
C: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)
D: Hemoglobin A1c (22 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of the current study is to evaluate the effects of diets with three levels of dietary fat on weight change and related cardiometabolic risk factors in a 6-month randomized controlled-feeding trial.


Options:
A: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)
B: Changes in adipose tissue (Baseline and 3 months and 6 months)
C: Dietary intake (6 month)
D: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Continence in People With Inflammatory Bowel Disease: Active Case Finding and a Randomised Controlled Trial
Brief Summary: Inflammatory Bowel Disease (IBD) affects 250,000 adults in the United Kingdom (UK) and causes bouts of diarrhoea which are hard to control. Over a quarter of patients experience extremely distressing faecal incontinence (FI). Even when the disease is in remission, the majority of patients live in fear of not finding a toilet in time. This curtails their activities and quality of life. The National Institute for Clinical Excellence (NICE 2007) has issued national guidance on actively asking patients about FI and a step-wise care plan for managing FI. However, this has not been evaluated in people with IBD, the vast majority of whom do not ask for help, even when they have frequent FI.

Across six expert centres in the UK, the investigators will perform 3 linked studies: \[1\] The investigators will screen people with IBD, offering the opportunity to obtain help with bowel control. The investigators will compare uptake of a postal approach versus response to a proactive face-to-face asking approach at a physical or telephone clinical appointment. \[2\] The investigators will conduct a randomised controlled trial (RCT) comparing two different approaches (IBD nurse specialist plus self-help booklet versus self-help booklet alone) to see which one produces the best results in terms of reductions in FI, other symptoms, costs and quality of life at 6 months after intervention. Booklet group participants may access the nurse intervention at 6 months if they wish, when the RCT is finished. \[3\] Interviews will be performed at the end of the intervention, gathering patient views and preferences and staff perspectives via Qualitative interviews and free text questionnaire comments, to enable a rich understanding and interpretation of our results.

The investigators will disseminate the results widely to people with IBD and health professionals and take active steps to embed successful interventions in NHS services, having gained sound evidence on how many people want help, whether intervention is effective in improving FI, and patient and staff views on interventions.


Options:
A: Overall length of stay (1 year); Percentage of patients undergoing colectomy (1 year)
B: The St Mark's faecal incontinence score (0-24 scale) (At 6 months from recruitment)
C: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)
D: Harvey Bradshaw Index (12 months); Inflammatory Bowel Disease Questionnaire (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients Continuous Renal Replacement Therapy Patients
Brief Summary: CRRT patients are generally critical ill patients with unstable conditions, such as low blood pressure,severe SIRS,et al. Acute kidney injury(AKI)is especially prevalent,with even two or more organ failure. CRRT serves as an important supportive therapy.Continuous anticoagulation is needed to prevent treatment interruptions due to clotting of the extracorporeal circuit. Unfractionated heparin or low molecular weight heparin both increase the risk of bleeding and heparin induced thrombocytopenia in such cases.However, the problem of CRRT without anticoagulation is the early filter clotting. An alternative method is the use of heparin coated hemofilter. The AN69 ST hemofilter, a surface-treated polyacrylonitrile membrane hemofilter, allows irreversible fixing of heparin to filter membrane, is able to reduce thrombogenic properties of the membrane. In this study, we observe the efficacy and safety of heparin-coated AN69 ST hemofilter in CRRT patients, and compare to the original AN69 membrane hemofilter.


Options:
A: Mortality (Day 28 after ICU admission)
B: the time of 1st membrane exchange (the time of 'filter is clotted')
C: Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF) (Up to 30 days)
D: The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process (6 months); The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter (6 months); The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading (6 months)

Answer: D