TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients


Options:
A: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Week 4)
B: Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17) (Week 4 through Week 16); Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response (Week 4 through Week 16); Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits (Week 4 through Week 16); Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission (Week 4 through Week 16)
C: Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline (the end of the SSRI/SNRI treatment period), at completion of administration)
D: Time to premature discontinuation

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease
Brief Summary: The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).


Options:
A: POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13. (Day 12/13); POC: Safety and tolerability of LFF571 (Day 12/13); POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2). (Day 12/13); Cohort 2: Clinical response rate (clinical cure) of LFF571 in patients with mild and moderate C. difficile infections to different LFF571 dose regimens and total daily doses administered orally for 10 days (Day 12/13); Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571 (Day 12/13); Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients. (Day 12/13)
B: Cure Rate at End of Therapy (Study day 10 (+/- 2 days))
C: Resolution of diarrhea
D: Clinical response (resolution of all symptoms of CDAD) (End of treatment (day 12-14 after beginning treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Oxidative-Stress-Reducing Strategy Consisting of Pravastatin, Vitamin E and Homocysteine-Lowering on Carotid Intima-Media Thickness in Patients With Mild-to-Moderate Chronic Kidney Disease
Brief Summary: The ATIC study is a randomised, double- blind, placebo-controlled trial in which the effects of oxidative stress-lowering treatment on vascular function and structure are studied in patients with chronic non-diabetic renal failure who are free from manifest arterial occlusive disease. Participants in the trial were randomised to active treatment consisting of add-on therapy with pravastatin, vitamin E and homocysteine-lowering therapy, or to placebo. Subjects not using angiotensin converting enzyme inhibitors (ACE-inhibitors) or angiotensin receptor blockers (ARBs) at inclusion were put on ACE-inhibitors for at least two weeks before the baseline measurement and randomisation. Those who were on ARBs continued their ARBs. We excluded individuals with diabetes mellitus (ADA criteria), active vasculitis, nephrotic syndrome (\>3gr/24hr urine protein), renal transplantation, fasting total cholesterol \> 7 mmol/L, cholesterol-lowering therapy within three months prior to inclusion or known ischemic cardiac, cerebrovascular or peripheral arterial disease. Ninety-three patients (out of 118 eligible patients) took part in the study and written informed consent was obtained from all participants.


Options:
A: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: N/A
C: Common carotid artery intima media thickness; Brachial artery flow mediated vasodilatation
D: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial
Brief Summary: The purpose of this study is to evaluate the impact on overall survival of an intensive follow-up protocol (as practiced today at TMH) against a more cost effective follow-up protocol in patients operated for extremity sarcoma.


Options:
A: Percentage of patients with a non removable recurrence (at the end of the study)
B: Overall Survival (Minimum 2 years)
C: Overall survival rate (5 years)
D: To evaluate the time to evaluation of breast cancer or breast cancer treatment-related symptoms, between patients enrolled in a system of symptom-based, patient centered follow-up care (SIS.NET) and patients receiving standard follow up care (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans
Brief Summary: The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that uses tele-health technology to improve outcomes of stroke patients after discharge to home. The primary aim is to determine the effect of TR on physical function, and secondarily to determine the effect on disability, falls-related self-efficacy, and patient satisfaction.


Options:
A: Wolf Motor Function Test (0 to 1 months); Motor Activity Log Quality of Movement Scale (0 to 1 months)
B: Physical Function as Measured by Telephone Version of FIM (6-month)
C: Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy (from the Baseline Visit to the 30 Day Follow Up Visit)
D: ankle range of motion (Measurement at pretest, posttest and followup)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans
Brief Summary: The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that uses tele-health technology to improve outcomes of stroke patients after discharge to home. The primary aim is to determine the effect of TR on physical function, and secondarily to determine the effect on disability, falls-related self-efficacy, and patient satisfaction.


Options:
A: change of infarct size between baseline and day 6 (day 6)
B: Respiratory Events (9 months)
C: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
D: Physical Function as Measured by Telephone Version of FIM (6-month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-Based Tele-Health Stroke Care: A Randomized Trial for Veterans
Brief Summary: The purpose of the proposed study is to examine a Tele-rehabilitation (TR) intervention that uses tele-health technology to improve outcomes of stroke patients after discharge to home. The primary aim is to determine the effect of TR on physical function, and secondarily to determine the effect on disability, falls-related self-efficacy, and patient satisfaction.


Options:
A: Gait speed and Barthel Index (BI) (co-primary endpoint) (3 months post stroke vs baseline)
B: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
C: Aerobic capacity (Baseline,3month)
D: Physical Function as Measured by Telephone Version of FIM (6-month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.


Options:
A: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)
B: Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone (Baseline, Week 8)
C: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis (Baseline and 12 weeks); Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis (Baseline and 12 weeks)
D: Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) (Baseline, 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-assisted Screening for Intimate Partner Violence in Family Practice - a Randomized Controlled Trial
Brief Summary: This study tested the effectiveness of computer-assisted screening for identifying patients at risk of intimate partner violence (IPV) in a Canadian family practice. It was hypothesized that the use of computer-assisted screening among female patients would lead to higher rates of IPV discussion-opportunity and IPV detection during medical consultations, compared to patients receiving standard medical care.


Options:
A: Quality of Life, Physical Health Composite (at one-year follow-up); Quality of Life, Mental Health Composite (past 30 days)
B: Acceptability, perceived safety and ease of administration of each survey method
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data); Detection of partner abuse during physician-patient medical encounter (audio taped data)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-assisted Screening for Intimate Partner Violence in Family Practice - a Randomized Controlled Trial
Brief Summary: This study tested the effectiveness of computer-assisted screening for identifying patients at risk of intimate partner violence (IPV) in a Canadian family practice. It was hypothesized that the use of computer-assisted screening among female patients would lead to higher rates of IPV discussion-opportunity and IPV detection during medical consultations, compared to patients receiving standard medical care.


Options:
A: Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data); Detection of partner abuse during physician-patient medical encounter (audio taped data)
B: Post-Release Opioid Relapse (Four weeks post-release)
C: Time to post release treatment engagement (30 days post release); Reduction of HIV risk behaviors (12 months); Time to relapse (30 days post release); Cost effectiveness (12 months)
D: A reduction in the use of drugs and alcohol (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.
Brief Summary: The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.


Options:
A: Occurrence of RV GE
B: Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
C: Immunogenicity (7 months)
D: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.
Brief Summary: The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.


Options:
A: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (8 weeks post vaccination); Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) (8 weeks post vaccination)
B: Occurrence of RV GE
C: Seroprotection for each polio serotype 1 month after the 3rd dose.
D: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.
Brief Summary: The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.


Options:
A: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)
B: Occurrence of RV GE
C: Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
D: Percentage of subjects with vaccine take (At 2 months post-Dose 2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain
Brief Summary: To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.


Options:
A: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
B: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month after the start of treatment); Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment); Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month from the start of treatment); Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment)
C: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)); Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period))
D: Alteration of pain intensity after treatment (5 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain
Brief Summary: To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.


Options:
A: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
D: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain
Brief Summary: To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.


Options:
A: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
B: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN. (4 weeks)
C: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)); Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period))
D: Alteration of pain intensity after treatment (5 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.


Options:
A: To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis (From day 1 of treatment until end of treatment)
B: Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 (Week 8)
C: Number of Participants With Clinical Response (Week 6)
D: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.


Options:
A: Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 (Week 8)
B: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)
C: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
D: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.


Options:
A: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
B: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)
C: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)
D: Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 (Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Aging on the Isolated Pituitary Response to Gonadotropin Releasing Hormone at Baseline and With Low Dose Estrogen Administration
Brief Summary: The purpose of this study is to study the effects of aging and estrogen on the brain. Specifically, this study will examine how the hypothalamus signals the pituitary gland to secrete reproductive hormones and how that changes with aging.


Options:
A: Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses); Effect of Estrogen on Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses)
B: Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate (One year)
C: Implantation ratio (Six months); Clinical pregnancy ratio (six months); Live birth ratio (six months)
D: clinical pregnancy rate per IUI cycle (by ultrasound at ± 5 to 6 weeks after IUI)

Answer: A