TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Bioequivalence study of SPARC147609


Options:
A: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
B: 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product (2 cycles)
C: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
D: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Placebo-controlled Clinical Trial Comparing Fesoterodine to Placebo in Women Diagnosed With Urge Urinary Incontinence by the 3 Incontinence Questions (3IQ). Followed by a Multi-center Open Label Clinical Cohort Study of Long-term Effects of Treatment With Fesoterodine.
Brief Summary: Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in the US. All participants who complete the 12-week randomized trial will be offered open-label fesoterodine for an additional 9 months.

The hypothesis of the randomized controlled trial is that among women diagnosed with urge incontinence using the 3IQ, fesoterodine is more effective than placebo in reducing the mean number of urge incontinence episodes per day.


Options:
A: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)
B: Change in Frequency of Urge Urinary Incontinence Episodes at Week 12. (Baseline and Week 12)
C: N/A
D: Change From Baseline in Cognitive Function Composite Score - Power of Attention (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Continuity of Attention (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Speed of Memory (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study
Brief Summary: This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.


Options:
A: Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) (3 years)
B: Progression-Free Survival (The timeframe is from enrollment onto the study up to 3 years following enrollment.)
C: Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.)
D: Median Progression-free Survival (PFS) in each study arm (average of 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study
Brief Summary: This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.


Options:
A: Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.)
B: Progression Free Survival (Time from first dose to date of progression, the longest time frame of 3.9 years)
C: Progression-free survival
D: Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose (Week 12); Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization (Week 12 after randomization.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Duloxetine and Methadone for the Treatment of HIV-Associated Painful Peripheral Neuropathy
Brief Summary: Neuropathy results from damage to the nerves in the feet and legs. It is usually experienced as pain, tingling or numbness. In HIV-infected people, neuropathy can result from the infection itself or be a side effect of antiretroviral treatment. The purpose of this study is to determine whether two different drugs, methadone and duloxetine, reduce neuropathy-associated pain in HIV-infected people. This study will also examine whether utilization of both of these drugs is more effective than treatment with only one.


Options:
A: Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.
B: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)
C: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
D: Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale (During the fourth treatment week of each treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Brief Summary: The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.


Options:
A: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
B: Peak oxygen consumption at cardiopulmonary exercise test (12 months)
C: Acute Procedural Success (APS) (371.4 Minutes (Average)); Freedom From Chronic Treatment Failure (CTF) (12 month follow up period); Treatment Success (12 months); Freedom From Major Atrial Fibrillation Events (MAFEs) (12 Months); Cryoablation Procedure Events (CPEs) (To end of ablation procedure)
D: Recurrence of Atrial Fibrillation (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Brief Summary: The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.


Options:
A: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
B: Recurrence of Atrial Fibrillation (One year)
C: Atrial Fibrillation Burden (AFB) at Baseline (Baseline); Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12 (Baseline; Week 12); Absolute Change From Baseline in AFB by Week 12 (Baseline; Week 12)
D: Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation (3, 6, 12 weeks and 6 months post-procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Brief Summary: The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.


Options:
A: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
B: Treatment Failure (minimum study duration is 6 months (+10 days); maximum is 15 months)
C: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
D: The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial
Brief Summary: 1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
2. Do surgical treatment gain more QALY than conservative treatment after one year?


Options:
A: Constant Shoulder Score (5 years)
B: Change in Constant Score (From baseline to up until 24-Months Post-Operative)
C: Disabilities of the Shoulder, Arm and Hand-Score (DASH) (24 months)
D: Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). (12 and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Administered High Frequency Chest Wall Oscillation Technique for Mucus Clearance in COPD: An Exploratory Pilot Project Using the SMARTVEST Device
Brief Summary: Patients with Chronic obstructive pulmonary disease (COPD) tend to have cough, excess mucus production and breathlessness as cardinal features. The excess mucus production often leads to frequent infections, exacerbations and poor quality of life. Mucociliary clearance may have an impact on improving symptoms, exercise tolerance, quality of life and reduce exacerbations.

High frequency chest wall oscillation(HFCWO) devices use percussion to the chest wall delivered from a pump through a close fitting inflatable vest. This technique has been shown to enhance mucus clearance in patients with cystic fibrosis and Bronchiectasis. This pilot study was designed to explore the feasibility, tolerance and effectiveness of the HFCWO in patients with advanced COPD.


Options:
A: Health related quality of life (St George's Respiratory Questionnaire) (3 months)
B: Weight of sputum expectorated during each airway clearance therapy session (40 minutes); Weight of sputum expectorated 24 hours post each bronchial session (24 hours)
C: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
D: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
Brief Summary: Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.


Options:
A: To investigate the safety, tolerability and feasibility of individual titration of BAY63-2521 according to peripheral systolic blood pressure (3 months); To investigate the long term safety and tolerability of BAY63-2521 (max. 84 months)
B: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.); Number of Participant With Death (From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit))
C: Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12) (Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12))
D: Pulmonary artery mean pressure at rest (Peak change from baseline within 6 hours after a single dose of study drug)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.
Brief Summary: 35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7


Options:
A: Survival at one, three and six months (six months)
B: Overall Survival (6 months)
C: 30 day-survival (30 days); Malondialdehyde serum levels (14 and 30 days)
D: survival rate at 2 months (at 2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
Brief Summary: The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.


Options:
A: Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. (Baseline and Week 14); Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol. (Baseline and Week 14)
B: Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET) (Baseline and Week 8 (or ET))
C: Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score. (Week 8 to Week 14)
D: Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II) (Three months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel-group, Flexible-dose Trial Evaluating the Efficacy and Safety of 12 Weeks of Treatment With Sertindole or Olanzapine in Patients With Schizophrenia in Asia
Brief Summary: The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.


Options:
A: To see if mean extrapyramidal symptoms measure will change significantly from baseline to endpoint for the whole group and if the mean change in EPS measure is significantly different between quetiapine 1200mg daily group and quetiapine 600mg daily group (8 weeks)
B: To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
C: To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia. (12 weeks)
D: Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients (Weeks 0, 3, 4, 6, 8, 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder
Brief Summary: Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults with other anxiety disorders (acrophobia and social phobia) provided support for using a medication called D-Cycloserine (DCS) to enahnce the outcome of exposure-based psychotherapy. Given this, DCS may augment CBT in youth with OCD, an anxiety disorder that is conceptually similar to acrophobia. With this in mind, the investigators are conducting a randomized, double-blind placebo controlled pilot study of DCS to determine whether it had any short-term clinical benefits on CBT in youth with OCD. Forty children and adolescents (ages 8-17) with a primary diagnosis of OCD will be screened and, should they meet relevant criteria, randomly assigned to one of two treatment conditions: (1) CBT plus DCS, or (2) CBT plus placebo. All patients will receive 10 sessions of CBT A rater will assess participants at 3 separate time points.


Options:
A: Acrophobia Questionnaire With Avoidance (AAVQ) (2 months)
B: Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). (Baseline, Mid-Treatment, Post-treatment)
C: significant reduction in panic symptoms after completion of treatment
D: Snake Questionnaire (SNAQ) (2 weeks)

Answer: B