TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-Blinded Evaluation of Oral Everolimus (RAD001) Plus Bevacizumab vs. Oral Placebo Plus Bevacizumab in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: This randomized phase II trial studies how well bevacizumab with or without everolimus works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and everolimus may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without everolimus in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Options:
A: Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) (Cycle 1 (21-days)); Objective Response Rates (ORR) - Part 2 (Phase 2a) (12 months); Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3) (12 Months)
B: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)
C: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)
D: Progression-free Survival (Duration of time from start of treatment to time of progression, approximately 4 years and 6 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women
Brief Summary: The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.


Options:
A: Pain (immediately after LNG-IUS insertion (approx 1 sec))
B: The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale (after IUD insertion)
C: IUD expulsion (1, 3 and 6 months after insertion)
D: Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) (Immediately post IUD insertion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
Brief Summary: The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol


Options:
A: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)
B: success rate of cervical ripening in labor induction (12 hours after intervention)
C: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)
D: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
Brief Summary: The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol


Options:
A: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
B: Uterine Tachysystole (Up to four hours after administration of study drug)
C: success rate of cervical ripening in labor induction (12 hours after intervention)
D: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
Brief Summary: The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol


Options:
A: success rate of cervical ripening in labor induction (12 hours after intervention)
B: Time to Active Labor (from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.)
C: induction delivery time (2 hourly)
D: Time to Delivery (from study entry until delivery- anticipated 3 days); Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications (from study entry until delivery- anticipated 3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Brief Summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).


Options:
A: Overall Survival (From the date of randomization up to 104 weeks (study cut-off))
B: Overall Survival (From randomization (Day 1) up to end of study (Month 60)); Radiographic Progression-free Survival (rPFS) (From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18))
C: Overall Survival (Event-driven timeframe. Final analysis at 331 events.)
D: Overall Survival Time (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder
Brief Summary: The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.

The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.


Options:
A: Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 (Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325))
B: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)
C: Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase (Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182))
D: Hamilton Anxiety Rating Scale (56 weeks); Penn State Worry Questionnaire (56 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extending the Time for Thrombolysis in Emergency Neurological Deficits
Brief Summary: The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.


Options:
A: Modified Rankin Scale (mRS) 0-1 (3 months)
B: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
C: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
D: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extending the Time for Thrombolysis in Emergency Neurological Deficits
Brief Summary: The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.


Options:
A: Favourable outcome (day 90)
B: Modified Rankin Scale (mRS) 0-1 (3 months)
C: Modified Rankin Scale (mRS) 0-1 (3 months)
D: Efficacy (90 day after stroke); Safety (90 day after stroke)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Alternative Treatment of Deep Caries Lesions Based on Biological Evidences
Brief Summary: The aim of this multicenter randomized controlled clinical trial is to evaluate the effectiveness of an alternative treatment for deep caries lesions in Public Health Services. The alternative treatment consists of partial removal of carious dentine followed by restoration. The subjects were assigned to test or control groups: test - carious dentine partial removal and restoration in one session, and control - stepwise excavation. The stepwise excavation consists of partial removal of carious tissue from the cavity floor, indirect pulp capping with calcium hydroxide cement; temporary filling; cavity re-opening after 60 days, removal of the remaining soft carious tissue and filling. Each group was divided according to the filling material: amalgam or resin. The radiological exams are being performed before and after the treatment and then annually. Clinical evaluation of the restorations is performed right after the treatment and then annually (modified USPHS System). All evaluations are performed by calibrated and trained dentists.


Options:
A: Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. (6 months)
B: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. (1year control data for all treatments primo 2008)
C: Pulp sensitivity (Once a year during at least five years)
D: cold pulp test (signalling the nerve of the pulp of the tooth by cold application) (One year follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
Brief Summary: This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).


Options:
A: Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange; Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
B: Six Minute Walk Distance (6MWD) (Baseline and Week 12)
C: 6-minute Walk Distance (6MWD) (Baseline and 16 weeks)
D: Assessment of hemodynamic parameters after single oral dose of ACT-293987. (17 weeks); Proof-of-concept assessment of the efficacy of ACT-293987 in subjects with PAH by measuring the change from baseline in the PVR at Week 17 compared to placebo. (17 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Brief Summary: An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.


Options:
A: Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. (Through 3 years)
B: recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug (1 year)
C: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
D: Office Systolic Blood Pressure Reduction (Baseline to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Brief Summary: An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.


Options:
A: Office Systolic Blood Pressure Reduction (Baseline to 6 months)
B: BP Measurements (6 months)
C: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
D: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention in Uppsala Primary Health Care After Myocardial Infarction, Coronary Artery CABG and PCI. Secondary Prevention After CHD (SUPRIM).
Brief Summary: The purpose of this study is to determine the possible preventive effect of behavioural modification versus standard treatment after hospital discharge in CHD patients.


Options:
A: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)
B: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
C: Admission to hospital for recurrent CHD event (8 years)
D: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention in Uppsala Primary Health Care After Myocardial Infarction, Coronary Artery CABG and PCI. Secondary Prevention After CHD (SUPRIM).
Brief Summary: The purpose of this study is to determine the possible preventive effect of behavioural modification versus standard treatment after hospital discharge in CHD patients.


Options:
A: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)
B: The cumulative incidence of new cardiological events and the occurrence of new medical pathologies (5 years)
C: Stage of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Process of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Decisional balance for coronary heart disease patients with depression (2 - days (T0) before discharge.); Self-efficacy for coronary heart disease patients with depression: scale (2 - days (T0) before discharge.); Hamilton Rating Scale for Depression (2 - days (T0) before discharge.)
D: Admission to hospital for recurrent CHD event (8 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Activities and Exercise on Sleep in Dementia
Brief Summary: The purpose of the study is to determine whether individualized social activities, physical resistance training and walking, and a combination of both are effective in improving nighttime sleep in elders with dementia.


Options:
A: Total sleep time at night and amplitude of the sleep wake rhythm. (7 weeks)
B: N/A
C: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)
D: Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement. (Baseline and Week 4.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Biliopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI > 35 vs. Medical Therapy
Brief Summary: It is generally held that ß-cell function is irreversibly lost already at the time the disease manifests itself and thereafter continues to decline linearly with time. Several studies, however, have documented the possibility that ß-cell function may be restored, at least partially, in type 2 diabetes. Of major relevance to the issue of ß-cell recovery in diabetes are the following findings:

* bariatric surgery in morbidly obese patients with type 2 diabetes can restore euglycaemia, the acute insulin response to glucose and insulin sensitivity;
* recent studies have reported that diabetic subjects return to euglycaemia and normal insulin levels within days after surgery, long before a significant weight loss has occurred; and
* whereas gastric bypass (GBP) improves insulin sensitivity in proportion to weight loss, bilio-pancreatic diversion (BPD) improves insulin action out of proportion to weight loss, i.e., it normalizes it at a time when patients are still markedly obese. Because RYGB is a predominantly restrictive procedure involving the foregut, whereas BPD is a predominantly malabsorptive procedure involving the distal gastro-intestinal (GI) tract, these findings suggest that the control of both insulin action and ß-cell function is influenced by signals originating from the GI tract.

The principal aim of this study is to verify the effect on type 2 diabetes mellitus (T2DM) of GBP and BPD, the two operations which have shown specific actions on glucose homeostasis control, in type 2 diabetic patients with BMI \> 35 kg/m2, and to compare this effect with matched T2DM control patients receiving the standard of medical care.


Options:
A: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. (1 year); Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications (1 year)
B: To assess the efficacy of bariatric surgery in inducing partial or total remission of type 2 diabetes mellitus, as compared to standard medical anti-diabetic care (STC). (10 years)
C: BMI (5 y); Metabolic normalization (5y); Gastro-intestinal side effects (5y)
D: Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. (1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias
Brief Summary: The aim of the study is to establish the impact of a falls screening questionnaire in the adoption of preventive interventions and eventually in the reduction of falls and its consequences in elder people living in nursing homes.


Options:
A: Gait Velocity (Discharge (Average Duration of Hospital Stay is 3 weeks))
B: Number of LTC residents on vitamin D (16 months)
C: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
D: Number of fallers (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Technology-Enhanced Quitline Services to Prevent Smoking Relapse
Brief Summary: The purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit smoking. If successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking.


Options:
A: Smoking abstinence (6 months)
B: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
C: evaluate and provide a model of smoking cessation interventions
D: Participant smoking status. (6 and 12 month follow-up)

Answer: D