TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Phase II Trial of Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy (SMA CARNI-VAL Trial)
Brief Summary: This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes. Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.


Options:
A: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)
B: Safety Labs (-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs); Efficacy, Measured Through Motor Function Assessments (-4wks, 0, 3 mo, 6 mo, 12 mo); Modified Hammersmith Change From Baseline to 6 Months (0 months, 6 months)
C: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (Up to 24 Weeks); Number of participants with clinically significant neurological examination abnormalities (Up tp 24 Weeks); Number of participants with clinically significant vital sign abnormalities (Up to 24 Weeks); Number of participants with clinically significant physical examination abnormalities (Up to 24 Weeks); Number of participants with clinically significant weight abnormalities (Up to 24 Weeks); Number of participants with clinically significant laboratory parameters (Up to 24 Weeks); Number of participants with clinically significant electrocardiograms (ECGs) abnormalities (Up to 24 Weeks); Number of participants who use concomitant medications (Up to 24 Weeks)
D: Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Outcomes After Colon Surgery: Role of Prehabilitation Facilitating the Recovery Process.
Brief Summary: Most patients find that recovering from surgery is difficult particularly after abdominal surgery for cancer or other intestinal disorders. The surgical stress, healing process and concerns if further treatments are required suggest that the post-operative period may not be the best time to get people to exercise to rehabilitate lost functions. Prehabilitation is the process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor, such as surgery, and this study aims to evaluate the effectiveness of prehabilitation for colorectal surgery. Two groups will be formed by a random process and the prehabilitation group will use an exercise cycle and weights to build endurance and strength for a 3-week period prior to surgery. The other group will receive training about exercises that will help them move better after surgery. People who are malnourished prior to surgery will receive nutritional supplements. The results of this trial will be used to inform practitioners and patients alike of the benefits (or risks if any) of exercise in preparing for surgery.


Options:
A: Post operative complications (30 days after surgery)
B: 6 Minute Walk Test (baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks)
C: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
D: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Outcomes After Colon Surgery: Role of Prehabilitation Facilitating the Recovery Process.
Brief Summary: Most patients find that recovering from surgery is difficult particularly after abdominal surgery for cancer or other intestinal disorders. The surgical stress, healing process and concerns if further treatments are required suggest that the post-operative period may not be the best time to get people to exercise to rehabilitate lost functions. Prehabilitation is the process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor, such as surgery, and this study aims to evaluate the effectiveness of prehabilitation for colorectal surgery. Two groups will be formed by a random process and the prehabilitation group will use an exercise cycle and weights to build endurance and strength for a 3-week period prior to surgery. The other group will receive training about exercises that will help them move better after surgery. People who are malnourished prior to surgery will receive nutritional supplements. The results of this trial will be used to inform practitioners and patients alike of the benefits (or risks if any) of exercise in preparing for surgery.


Options:
A: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
B: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)
C: 6 Minute Walk Test (baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks)
D: six minute walk test (baseline, preop, 4 weeks, 8weeks postop)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia
Brief Summary: This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.


Options:
A: Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 (Baseline, Week 48)
B: Overall Response Rate (Assessed at the end of cycle 3)
C: Number of Participants With Objective Response (Response assessed after each 3 cycles (cycle = 30 days))
D: Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose (Baseline and Week 24); Percent Change From Baseline in Total Symptom Score (TSS) as Measured by the Modified Myelofibrosis Symptom Assessment Form (MFSAF) V2.0 Diary at Week 24 by Final Titrated Dose (Baseline and Week 24); Percentage of Participants With Treatment-emergent Adverse Events (TEAE) (Up to Week 156); Percentage of Participants With New Onset Grade 4 Thrombocytopenia Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE V4.03) (Up to Week 156); Percentage of Participants With New Onset Grade 2 or Higher Hemorrhage as Assessed by CTCAE V4.03 (Up to Week 156)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and radiation therapy works in treating patients with malignant pleural mesothelioma.


Options:
A: Complete macroscopic resection (part 1) (After surgery (15 weeks after trial registration)); Loco-regional relapse-free survival (part 2) (From surgery until the first occurrence of loco-regional relapse)
B: Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) (Weeks 24)
C: To determine the objective response (Weeks 24)
D: Feasibility in terms of 90-day progression-free survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Modifying Group Therapy for Bipolar Abusers
Brief Summary: The purpose of this study is to modify Integrated Group Therapy (IGT), which is has been found successful for patients with bipolar disorder (BD) and substance use disorder(SUD), so that it can be more readily adopted by community drug abuse treatment programs. IGT is being reduced from 20 to 12 sessions in this trial, and is being conducted by front-line drug counselors, to test its effectiveness in a more community-based setting. The training has been expanded so that counselors without much psychopathology training or cognitive behavioral therapy experience can conduct IGT.


Options:
A: Addiction severity
B: Global Assessment of Function (9 months and 21 months)
C: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)
D: longest continuous period of cocaine abstinence (Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Brief Marijuana Intervention for Adolescent Women
Brief Summary: The purpose of this study is to examine the efficacy of a brief motivational intervention on marijuana use and sex-risk behavior in young women.


Options:
A: Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score (3 months post-baseline); Hair Testing (3 month post-baseline)
B: the number of joints consumed per month (at 12 months)
C: Use of illicit drugs in the past 30 days (baseline, 3, 6, 9, and 12 months); Enrollment in formal substance abuse treatment (baseline up to 2 years post-intervention); Medical, legal, employment, social, and psychiatric outcomes (baseline, 3, 6, 9, and 12 months)
D: Marijuna use (marijuana use at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
Brief Summary: The purpose of this study is... To assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).


Options:
A: Main Study, Adolescent Drug Use (Number of self reported drug use days from 28 days prior to baseline); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 1-28); Main Study, Adolescent Drug Use (Number of self reported drug use days in days 29-56); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 57-84); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 85-112); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 113-140); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 141 - 168); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 169-196); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 197-224); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 225-252); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 253-280); Main Study, Adolescent Drug Use (Number of self reported drug use from days 281-308); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 309-336); Main Study, Adolescent Drug Use (Number of self reported drug use days from day 337-364); Follow Up Study, Drug Use (Number of self reported drug use days 90 days prior assessment); Follow Up Study, Drug Use (Number of self reported drug use days 90 days prior to assessment)
B: N/A
C: Evaluation of smoking cessation verified by expired air carbon monoxide (12 weeks after baseline)
D: Percentage of Days Used Drugs or Alcohol (intake to delivery, an average of 21 weeks); Percentage of Days Used Drugs or Alcohol (delivery to 3 months post-delivery); Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (intake to delivery, an average of 21 weeks); Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (Delivery to 3 months post-delivery); Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (intake to delivery, an average of 21 weeks); Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol (Delivery to 3 months post-delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Psychotherapies in Recurrent Depression: Study II
Brief Summary: This study will evaluate the effectiveness of maintenance interpersonal psychotherapy (IPT) in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain a remission of depression symptoms.


Options:
A: Paid Work Hours at Week 12 (Week 12); Paid Work Hours at Week Baseline (Baseline)
B: Score on the Hamilton Rating Scale for Depression (measured at Month 24)
C: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients
Brief Summary: The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.


Options:
A: Time to first BPAR episode or treatment failure (6 months)
B: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
C: Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. (6 months)
D: renal function as measured by serum creatinine at 6 months post-transplant

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder
Brief Summary: This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder (ADHD).


Options:
A: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
B: NCBRF-TIQ D-Total Score (Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9)
C: Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment); Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)
D: Scores in the Young Mania Rating Scale (BD); Scores in the SNAP-IV (ADHD); Weight

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder
Brief Summary: This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder (ADHD).


Options:
A: N/A
B: SNAP-IV teacher form score in ORADUR®-Methylphenidate vs. placebo (2 weeks)
C: Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment); Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)
D: Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score. (Last week of 3-week treatment period assessed at Visit 5.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Brief Summary: The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.


Options:
A: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
B: Number of patients with adverse events (Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives)
C: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)
D: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Intima-media Thickness (CIMT), in Overweight Patients With Additional Risk Factors
Brief Summary: Objectives:

* Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness (CIMT)
* Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.


Options:
A: Change in body weight
B: change from baseline in percent atheroma volume (PAV) (Month 18 visit)
C: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
D: Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) (Month 30)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial): Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass?
Brief Summary: The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone.


Options:
A: Death and the composite outcome of death, non-fatal reinfarction or stroke
B: Vein Graft Intimal Area (One year following surgery)
C: The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%)) (1 month)
D: Composite of death or myocardial infarction (at 12 months after randomization (at 24 months after ZEST enrollment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.
Brief Summary: To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.

To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.


Options:
A: Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) (Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))
B: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
C: Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) (Baseline and 8 weeks)
D: The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.; The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.

Answer: D