TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy
Brief Summary: Primary Objective:

- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy

Secondary Objectives:

* To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
* To assess the safety/tolerability of SAR110894;
* To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
* To explore caregiver time consumption and distress changes.


Options:
A: Change in the Cornell Scale for Depression in Dementia (CSDD) (Week -2, week 0, week 6 and week 13)
B: Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). (Week 4, 12, and 24)
C: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (Quarterly over 6 months)
D: Sleep Disturbance (Change from Baseline (week 0) and intervention (week 4)); Agitation (Change from Baseline (week 0) and intervention (week 4)); Depression (Change from Baseline (week 0) and intervention (week 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma In Situ and Early Invasive Breast Cancer
Brief Summary: This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and have fewer side effects. It is not yet known if hypofractionated RT is more effective than standard RT in treating breast cancer.


Options:
A: Change from baseline in pulmonary function and heart function tests (From end of treatment up to 3 years after treatment)
B: Duration of DFS (Time from registration to first adverse event, assessed up to 15 years)
C: Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis (3 years after completing radiation therapy)
D: Local breast recurrence (Indefinitely)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Baclofen for the Treatment of Alcohol Dependence - BACLAD
Brief Summary: There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.


Options:
A: alcohol consumption (12 weeks)
B: Change in Average Daily Alcohol Consumption (Change from Baseline to 6 Months)
C: Total abstinence from alcohol and cumulative abstinence duration (13-16 weeks (depending on the individually tolerated baclofen dose))
D: Total alcohol abstinence; cumulative abstinence duration (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
Brief Summary: The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.


Options:
A: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)
B: Brief Pain Inventory-Intensity (BPI-Intensity) (Post-treatment (10-weeks) and follow-up (6 months))
C: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
D: Insomnia Severity Index (ISI) (Baseline); Insomnia Severity Index (ISI) (Post treatment- 2 months post baseline assessment); Insomnia Severity Index (ISI) (9 months post baseline assessment); Insomnia Severity Index (ISI) (18 months post baseline assessment); Global Pain Severity-Graded Chronic Pain Scale (Baseline); Global Pain Severity-Graded Chronic Pain Scale (Post treatment-2 mos. post baseline); Global Pain Severity-Graded Chronic Pain Scale (9 months post baseline assessment); Global Pain Severity- Graded Chronic Pain Scale (18 months post baseline assessment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
Brief Summary: The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.


Options:
A: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
B: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
C: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
D: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
Brief Summary: The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.


Options:
A: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
B: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)
C: Pain severity (Week 3)
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq® and Rotarix®
Brief Summary: Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that the body will make enough antibodies to fight infection. The vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12 months. Study procedures include reaction assessment and blood sample.


Options:
A: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
B: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)
C: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
D: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq® and Rotarix®
Brief Summary: Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that the body will make enough antibodies to fight infection. The vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12 months. Study procedures include reaction assessment and blood sample.


Options:
A: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
B: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))
C: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))
D: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq® and Rotarix®
Brief Summary: Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that the body will make enough antibodies to fight infection. The vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12 months. Study procedures include reaction assessment and blood sample.


Options:
A: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)
B: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
C: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
D: 1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BRF113929: An Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain
Brief Summary: This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brain therapy, and subjects in Cohort B will have received prior local therapy for brain metastases. Subjects will continue on treatment until disease progression, death, or unacceptable adverse event.


Options:
A: Progression-free Survival (PFS) - Initial Treatment Period (Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)); Interim Overall Survival (OS) - Initial Treatment Period (Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)); Final Overall Survival (OS) - Initial Treatment Period (Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019))
B: Two-Year Event-Free Survival Rate (2 years)
C: Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator (From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks))
D: Objective Response Rate (ORR) (From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)); Overall Survival (OS) (Up to 96 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The PAC Study: Parents as Agents of Change in Pediatric Weight Management
Brief Summary: The Canadian pediatric obesity epidemic has led to great interest in evaluating weight management care for obese children and families. Investigation is warranted since obesity is linked to risk factors for chronic diseases including type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Over the past 25 years, many interventions have studied the role of healthy lifestyle behaviours to help obese children achieve and maintain a healthy weight. A contemporary view of pediatric weight management interventions includes parents as a fundamental recipient of treatment. These interventions recognize the influence parents have on the lifestyle behaviours of their children. While such parent-based interventions have helped establish the role of education and behavioural theory in facilitating lifestyle changes, we believe an equally important intervention element is a focus on the role of cognitions in helping to interpret behaviour change and change maintenance. Our study incorporates cognitive behaviour theory (CBT) into an intervention for parents of obese children and compares it to a more traditional modality based on psycho-education (PEP).

Hypothesis: Obese 8 - 12 year old children (n=45) whose parents complete a 16-session, group-based, CBT intervention will achieve greater reductions in adiposity as well as improvements in physiological risk factors for T2D, lifestyle behaviours, and psychosocial outcomes at post-intervention as well as 6- and 12-months follow-up versus children (n=45) whose parents complete a 16-session, group-based, psycho-education intervention .

Primary Objective: To compare the impact of two weight management interventions (CBT versus PEP) for parents of obese children on child BMI z-score.

Secondary Objective: To measure a comprehensive set of physiological, behavioural and psychosocial outcomes in obese children and parents pre- and post-intervention.

We expect obese children whose parents complete the CBT intervention will experience greater reductions in BMI z-score vs. children whose parents complete the PEP intervention. We anticipate that improvements in parenting style, family stress, and lifestyle behaviours will be important to improve adiposity, lifestyle behaviours, and risk factors for T2DM and CVD in obese children.


Options:
A: Child BMI
B: Child BMI Z-score (Pre-intervention); Child BMI Z-score (post-intervention); Child BMI Z-score (6-months post-intervention); Child BMI Z-score (12-months post-intervention)
C: Child BMI Percentile (2 years after recruitment)
D: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)
Brief Summary: The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab. The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival, biomarker prediction, and toxicity.


Options:
A: Progression free survival (six months)
B: Progression-free survival (Every 8±1 Weeks until PD)
C: Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months (4 months)
D: objective response rate (baseline and every 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Brief Summary: Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.

Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.

Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.


Options:
A: Renal function (6 days)
B: Treatment failure (5 days)
C: The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach. (For upto 45 minutes from start to end of endoscopy)
D: Mortality at the 45th day (45 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism
Brief Summary: Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.


Options:
A: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. (8 Weeks)
B: Assess the feasability of PTH 1-34 therapy via pump.
C: The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. (Week 24 of dosing)
D: Increase in maximal voluntary knee extension (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial
Brief Summary: Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding.

The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.


Options:
A: Mean daily dialysis delivered dose during intensive care stay (dialysis days during intensive care stay)
B: Survival at 2 weeks after RRT (2 weeks after RRT in follow-up)
C: Filter Life (72 hours)
D: mortality (2 years)

Answer: A