TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
Brief Summary: The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.


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: Peak Concentration (Cmax) (1 day); Time to Peak Concentration (Tmax) Profile (1 day); Disposition Half-life (1 day); Area Under the Concentration-time Curve (AUC) (1 day); Apparent Oral Clearance (CL/F) (1 day); Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration (7 days); Intragastric pH (7 days); Median Intragastric pH (7 days); Percentage of Time Intragastric pH Was >4 (7 days); Mean Intraesophageal pH (7 days); Median Intraesophageal pH (7 days); Percentage of Time That Intraesophageal pH Was <4 (7 days); Normalized Area of Gastric Hydrogen Ion Activity Over Time (7 days); Normalized Area of Esophageal Hydrogen Ion Activity Over Time (7 days)
C: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
D: The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) (12 weeks); The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase) (36 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
Brief Summary: The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.


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: Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. (Week 4); Safety Assessments (Baseline through week 8)
C: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
D: The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) (12 weeks); The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase) (36 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Previously Received BCG
Brief Summary: This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years.


Options:
A: Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.
B: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each immunisation (and after 7 days).
C: Safety of a single intradermal injection of 5 x 107pfu MVA85A (One year)
D: The induction of T-cell responses (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients
Brief Summary: To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.


Options:
A: Equivalence of graft survival at month 12
B: Renal Function (Nankivell Formula) at Month 12 Post Transplantation. (at Month 12 post transplantation)
C: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis (12 months); Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints (12 months)
D: Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH) (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multidisciplinary Approach to Reduce Injury and Alcohol
Brief Summary: The purpose of this study is to determine whether a booster session is needed after a brief intervention upon initial admission to the emergency room (ER) in order to reduce the rate of alcohol-related injury recidivism.


Options:
A: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)
B: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months)
C: Number of Times Used Alcohol (Past 3 months)
D: Alcohol-related Problems (assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multidisciplinary Approach to Reduce Injury and Alcohol
Brief Summary: The purpose of this study is to determine whether a booster session is needed after a brief intervention upon initial admission to the emergency room (ER) in order to reduce the rate of alcohol-related injury recidivism.


Options:
A: Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent. (12 months)
B: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)
C: Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization (Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months)
D: alcohol intake (six months and one year); injury recidivism (six months and one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives
Brief Summary: Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.

The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.


Options:
A: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
B: Serum androgen levels; Lipid profiles; Blood pressure; Cardiovascular performance; Non-classic cardiovascular risk markers; Indexes of insulin secretion and sensitivity
C: serum C-reactive protein (CRP) levels (6 months)
D: Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) (baseline and 3 months); Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) (baseline and 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites
Brief Summary: The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed in the prevention of post-paracentesis circulatory dysfunction


Options:
A: renin-angiotensin-aldosterone activation (4-6 days)
B: Renal failure rate (at 3 months)
C: Mortality (18 months)
D: Mortality or dialysis-dependency (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension
Brief Summary: To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.


Options:
A: Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints (From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron)
B: Annualized Relapse Rate (2 years)
C: Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period (Day 1 to Month 4); Injection-Related Adverse Event Rate Per Year in the Extension Period (Month 5 up to Month 10); Injection-Related Adverse Events in the Extension Period (Month 5 up to Month 10)
D: Proportion of Subjects Relapsed (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
Brief Summary: This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.

The study was designed to detect a 50% improvement in median PFS\[Progression Free Survival\] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.

Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC \[Data Monitoring Committee\]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.


Options:
A: Central Review-based Progression-Free Survival (Up to 3 years)
B: Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
C: Progression Free Survival (PFS) (From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death)
D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)); Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels (Baseline and 12 Weeks); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period (First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Selenoprotein P in Chinese Subjects
Brief Summary: The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects


Options:
A: Cellular and Humoral Immune Response (12 weeks)
B: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
C: Acute Mountain Sickness (AMS) as assessed by Lake Louise Consensus symptom score (Day 2)
D: Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks (40 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Selenoprotein P in Chinese Subjects
Brief Summary: The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
C: Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks (40 weeks)
D: Cellular and Humoral Immune Response (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours
Brief Summary: This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.


Options:
A: Mortality (90 days)
B: The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
C: ulcer complication (bleeding/perforation/obstruction) (up to 12 months)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Site Specific Approaches to Prevention or Management of Pediatric Obesity: Child Health Initiative for Lifelong Eating and Exercise--CHILE
Brief Summary: Child Health Initiative for Lifelong Eating and Exercise (CHILE) is a trans-community multidisciplinary site-specific intervention and evaluation plan for a Head Start and family-based culturally and developmentally appropriate intervention. The primary goals are to increase physical activity and improve dietary intake through increased consumption of fruits, vegetables and whole grain and decrease consumption of sweetened drinks and high-fat foods,decrease television and other screen time, and decrease obesity in three to five year old Hispanic and American Indian children enrolled in Head Start programs in rural New Mexico. The trans-community intervention includes: A classroom curriculum for children; an in-service training program for Head Start teachers and educational aides; a school food service component; a family intervention; a community leader/local health care provider component; and a grocery store component.

Participants include 16 Head Start programs serving Hispanic and Native American children and families from underserved communities in rural New Mexico. This is a randomized trial with an Intervention Condition and Control Condition. One cohort of three-year old Head Start students will be followed and measured for two years. During the two years in Head Start those children, their teachers, and families enrolled in the Intervention Condition will receive a program of activities to modify their dietary, physical activity, and screen viewing behaviors. Also addressed are the Head Start and community environments and policies, local grocery stores, and health care providers.

CHILE uses an ecological framework including social cognitive theory, intervention mapping, environmental and policy changes, developmental theory, and sound educational practices. The approach includes in from the community to ensure acceptability, cultural appropriateness, feasibility, sustainability, and later transferability to similar communities.

The primary outcome measures include changes in physical activity levels, dietary fiber intake, dietary fat intake, intake of sugared drinks, television viewing and other screen time, in BMI. Secondary measures include changes in the Head Start and community environments and policies related to physical activity, school food service, school snacks, and availability of healthful options. We will also examine the role of community leaders, especially health care providers, in raising awareness and creating a supportive and sustainable environment for the prevention of obesity.


Options:
A: Change in glycemic control, change in dietary intake (18 months)
B: Vitamin D plasma concentrations (12 months)
C: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
D: Vegetable Intake in Preschool Children (1 year 11 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Arthroscopic Decompression Versus Diagnostic Arthroscopy Without Subacromial Decompression Versus Supervised Exercise Therapy in Treatment of Subacromial Impingement Syndrome. A Blinded Randomized Controlled Trail.
Brief Summary: pShoulder impingement syndrome is common and number of operations done per year is growing. The aim of this study is to compare the value of arthroscopic subacromial decompression (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The results of treatment are measured at 3 months, 6 months, 12 months, 24 months, 5 years and 10 years. Primary outcome measures are pain at rest and activity (VASs) and secondary outcomes are functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change , quality of life assessment (SF-36 and 15D) and costs. At 10 year follow-up, MRI imaging is obtained and the findings compared to baseline imaging.


Options:
A: Oxford Shoulder Score (6 months post randomisation)
B: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)
C: Pain at rest (2 years (primary)); Pain during activity (2 years (primary))
D: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease
Brief Summary: This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.


Options:
A: Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. (Patients followed for 5-8 years with average of 6.5 years follow up)
B: Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36 (Baseline to Month 36)
C: renal volume measured by high resolution magnetic resolution imaging (1.5 yrs)
D: Kidney Volume measured by MRI. (Every year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years
Brief Summary: This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.


Options:
A: N/A
B: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania (First 6 weeks of treatment)
C: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) (Measured at baseline Week 4 and Week 8)
D: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years
Brief Summary: This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.


Options:
A: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) (Measured at baseline Week 4 and Week 8)
B: Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score (Visit 8 (Day 42))
C: Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. (8-10 weeks); Sleep Duration (8-10 weeks)
D: SKAMP deportment rating scale (Week 8)

Answer: A