TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 250mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Low-Dose ICS Therapy
Brief Summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


Options:
A: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
B: Change from baseline methacholine bronchoprotection at 1 hour (baseline versus 1 hour post-treatment)
C: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
D: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)
Brief Summary: The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.


Options:
A: Change in body weight
B: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 (Baseline and Week 52)
C: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
D: Co-primary: Body Weight- Mean Percent Change (Baseline, 56 weeks); Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease (Baseline, 56 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial
Brief Summary: The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.


Options:
A: Quality of life, as measured by a validated enuresis-specific quality of life scale
B: Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition (Baseline and Week 12)
C: voiding frequency (before therapy and at end of therapy)
D: Clinical effects evaluated by home registrations of degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy
Brief Summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


Options:
A: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
B: Maximum heart rate (over 4 hours after dosing.); Blood pressure changes (over 12 hours.); Electrocardiogram changes (over 12 hours.); Change in peak expiry flow rate changes (over 24 hours.); Change in serum cortisol concentration changes (over 24 hours)
C: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
D: Number of Participants With 1 or More Severe Asthma Exacerbations (Baseline to Follow-up (up to 76 weeks of treatment))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy
Brief Summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


Options:
A: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
B: The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)
C: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
D: Time to First Serious Asthma Exacerbation (Up to 21 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Brief Summary: This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.


Options:
A: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))
B: Rate of suicide attempts (Annual)
C: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
D: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Brief Summary: This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
C: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
D: Rate of suicide attempts (Annual)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Brief Summary: This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.


Options:
A: Rate of suicide attempts (Annual)
B: suicide reattempt (6 months)
C: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
D: Reduced Self-harm (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Brief Summary: This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.


Options:
A: Rate of suicide attempts (Annual)
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: Completion of follow-up (End of treatment at 12 weeks); The fraction of eligible participants who consent to inclusion and randomization (End of treatment at 12 weeks); Compliance (End of treatment at 12 weeks); Non-suicidal self-injury as explorative primary clinical outcome (End of treatment at 12 weeks)
D: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Brief Summary: This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.


Options:
A: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)
B: episodes of parasuicide, alcohol intoxication, institutional care (12 months)
C: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
D: Rate of suicide attempts (Annual)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Brief Summary: This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line on the rate of suicide attempts and self-injurious behaviors in borderline patients.


Options:
A: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
B: Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs (Measured post-treatment and at 6- and 12-month follow-ups); Depression, anxiety, and other psychiatric symptoms (Measured post-treatment and at 6- and 12-month follow-ups); PTSD diagnoses and symptom severity (Measured post-treatment and at 6- and 12-month follow-ups)
C: Rate of suicide attempts (Annual)
D: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent an
Brief Summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


Options:
A: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
B: Mean Annual Rate of Moderate or Severe COPD Exacerbations (Up to 54 weeks)
C: Safety：adverse events, vital sign, ECGs, and clinical laboratory test; PK：Cmax, tmax and AUC(0-t)
D: Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period (Baseline and Day 7 of the treatment period (up to Study Day 63))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent an
Brief Summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


Options:
A: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
B: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period (Baseline and Week 12)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808) (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients
Brief Summary: The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.


Options:
A: Percent Weight Loss From Baseline to Week 56 (Baseline to 56 weeks); Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF (Baseline to 56 weeks)
B: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 (Baseline and Week 52)
C: Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis (Baseline up to Month 42); Time From Randomization to First Occurrence of MACE+ (Baseline up to end of study (Month 56))
D: Change in ambulatory blood pressure (50 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Allogeneic Hematopoietic Cell Transplantation With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings
Brief Summary: The present project aims at comparing two nonmyeloablative regimens currently used in 2 major HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy TBI with fludarabine (90 mg/m²) versus the one from the Stanford group combining 8 Gy TLI with ATG.


Options:
A: Incidence of acute GVHD, and chronic GVHD (2 years)
B: Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit (Cycle 7 Day 1 (each cycle was comprised of 4 weeks))
C: Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups (180 days after HCT)
D: Primary: Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation. (100 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
Brief Summary: We are performing a prospective, randomized, controlled trial of dopamine versus norepinephrine for septic shock. The trial will enroll patients with suspected or documented site of infection and having 2 out of the three SIRS criteria. Patients will also be receiving standard of care, early-goal directed therapy including but not limited to fluid resuscitation, appropriate and early antibiotics, source control and evaluation for drotrecogin alpha where deemed appropriate, while being supported for septic shock.


Options:
A: Systemic and regional hemodynamics (during the first 48 hours from the onset of septic shock)
B: Hospital Mortality (prior to discharge or 60 days, whichever comes first)
C: Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock (28 days)
D: 28 Day mortality (28 Day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants
Brief Summary: The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.


Options:
A: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (One month after Poliorix™ booster vaccination.); Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (Before booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3 (One month after Poliorix™ booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3. (Before booster vaccination.)
B: interference and immunugenicity (4 - 6 weeks after vaccination); Safety (up to 10 weeks after first vaccination)
C: Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 31-day (Days 0-30) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (from Day 0 to Month 1))
D: The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination (1 Month Post-vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Youth Suicide in Primary Care: A Family Model
Brief Summary: The purpose of the study is to test the efficacy of a brief family therapy (Attachment-Based Family Therapy) for youth presenting in primary care with suicidal ideation and depressed mood.


Options:
A: N/A
B: N/A
C: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
D: Suicidal Ideation Questionnaire - JR (SIQ-JR) (Baseline, 6 weeks, 12 weels, 24 weeks); Beck Depression Inventory - II (BDI-II) (Baseline, 6 weeks, 12 weeks, 24 weeks); Scale for Suicidal Ideation (SSI) (baseline, 6 weeks, 12 weeks, 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Brief Summary: Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.


Options:
A: Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function (immediately after heart surgery in patients with LVSD)
B: Mortality (90 days)
C: ulcer complication (bleeding/perforation/obstruction) (up to 12 months)
D: The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Brief Summary: Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.


Options:
A: Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function (immediately after heart surgery in patients with LVSD)
B: Incidence of Participants With Diarrhea by Parental Report (14 days)
C: To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. (Up to 40 days)
D: Total Number of Antibiotic-associated Diarrhea Episodes (29 months)

Answer: A