TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence
Brief Summary: The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.


Options:
A: Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks (Baseline and up to 10 weeks)
B: Participants Experiencing Collisions During "Surprise Events" in Driving Simulator (6 weeks)
C: Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts (weekly over a period of 4 weeks)
D: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use (weekly for 14 weeks of trial or for length of participation); ADHD Symptoms Based on ADHD Rating Scale (measured once per week for 14 weeks or length of study participation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.


Options:
A: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
B: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
C: The Difference in Responders Between Both Groups (6 Months)
D: Mean pain score

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.


Options:
A: Daily Evening Patient Reported Pain Intensity Scores (Baseline and 6 Weeks)
B: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
C: Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary (each day of Week 8)
D: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (Baseline, Week 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients: Interaction Between Endothelial Progenitor Cells, Reactivity of Micro- and Macrocirculation
Brief Summary: Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial repair. Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa. Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an additive, positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification. Therefore, the researchers propose to perform an investigator-initiated, randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement of endothelial function as measured by flow-mediated dilation (FMD) will be the primary endpoint of this study. The researchers propose to also measure determinants of FMD such as microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the number and function of EPCs in the blood. Importantly, detailed food questionnaires and plasma flavanols/metabolites will help to further support a causal link between flavanol-intake and improved vascular function.


Options:
A: Vascular function (Measured at weeks 4 and 12)
B: Change in blood pressure (Baseline (day 0) and 14, 28, 42 and 56 days after intervention); Change in platelet function (Baseline and 14, 28, 42 and 56 days after intervention); Change in metabolic parameters in blood (Baseline (day 0) and 14, 28, 42 and 56 days after intervention)
C: Augmentation index (Changes in augmentation index at 1 week, according to glycemic index of the breakfast)
D: An improvement of endothelial function as measured by flow-mediated dilation (FMD) (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.


Options:
A: Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) (Month 30)
B: 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)
C: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 (Baseline and Week 52)
D: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-free Observation Period
Brief Summary: The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.


Options:
A: Global Symptom Score (GSS) at Week 12, Primary Efficacy Population (12 Weeks)
B: Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon (one year)
C: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)
D: Percent of Subjects Without Recurrence of Diverticulitis (Up to 104 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Brief Summary: A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. The intervention strategy focuses solely on the promotion of drinking tap water. The study was conducted in 32 elementary schools including about 3000 children in two German cities over 1 school year.


Options:
A: Changes in BMI z-score (Measured at Month 12)
B: Sugar-sweetened beverage consumption (Change from baseline to 6 months); Water consumption (Change from baseline to 6 months)
C: Body mass index (BMI) (Change through 2 years)
D: Overweight (one school year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Brief Summary: A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. The intervention strategy focuses solely on the promotion of drinking tap water. The study was conducted in 32 elementary schools including about 3000 children in two German cities over 1 school year.


Options:
A: N/A
B: Overweight (one school year)
C: Change in BMI z-score (Baseline (0 months) and 9 months)
D: Infant weight for height (One year after study entry)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy
Brief Summary: * Evaluation of the efficacy of an immunosuppressive therapy added to a comprehensive supportive therapy to induce a clinical remission in patients at risk for progressive IgAN
* Investigation of differences between the treatments regarding the number of patients loosing more than 15 ml/min of GFR.


Options:
A: change in the degree of proteinuria (16 weeks)
B: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 (Baseline (Day 1) and at Week 36)
C: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)
D: First occurrence of 40% decrease in eGFR from baseline (Baseline, until the first occurrence or 3 years); First occurrence of progression to continuous renal replacement (Until occurrence or 3 years); Death due to renal disease (Until occurrence or 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy
Brief Summary: * Evaluation of the efficacy of an immunosuppressive therapy added to a comprehensive supportive therapy to induce a clinical remission in patients at risk for progressive IgAN
* Investigation of differences between the treatments regarding the number of patients loosing more than 15 ml/min of GFR.


Options:
A: Change from baseline in urine protein creatinine ratio (9 months)
B: Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio) (Week 0, week 12 and week 16)
C: Progressive kidney failure (1-6 years); primary outcome for low dose cohort (1 year)
D: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema
Brief Summary: The investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.


Options:
A: Treatment success after the one hour study period, defined as all of respiratory rate less than 25 bpm, oxygen saturation greater than 90 %. (One hour)
B: Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2. (48 hours)
C: The rate of Acute Myocardial Infarction
D: Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most) (During the first 3 hours of recruitment); Time Required for Mask Placement (at the initiation of NPPV)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Intervention for DM Guideline Implementation
Brief Summary: This is a multi-site open label randomized controlled study of patients with type 2 diabetes undergoing pharmacist-led group medical visits that include education by a multi-disciplinary personnel, behavioral modification and pharmacotherapy case management vs. usual care


Options:
A: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
B: Clinical inertia (12 month post intervention)
C: Adherence to hypertension guidelines (Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study)
D: Hemoglobin A1c (6 months); Hemoglobin A1c (13 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux
Brief Summary: The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.


Options:
A: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
B: The primary outcome measure was the proportion of patients with a clinical response, defined as a reduction from baseline in the CDAI score of at least 70 points at Day 57 (Days 1-57)
C: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
D: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation (Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux
Brief Summary: The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.


Options:
A: Sustained clinical remission for the precision dosing group vs. the conventional IFX maintenance dosing group (52 weeks)
B: Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease. (12 weeks); Total expenses related to Crohn's disease during the study (inclusion to week 12). (12 weeks)
C: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
D: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux
Brief Summary: The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.


Options:
A: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)
B: N/A
C: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
D: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year (When all participants complete the 1 year visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux
Brief Summary: The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.


Options:
A: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)
B: Number of Subjects Without Mucosal Ulceration at Week 12 (Week 12)
C: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
D: Endoscopic recurrence of disease (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux
Brief Summary: The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.


Options:
A: number of 3-months periods with remission (3 yrs)
B: The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. (12 months)
C: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
D: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux
Brief Summary: The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.


Options:
A: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
B: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
C: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
D: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)

Answer: B