TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Short Course Zinc Therapy (5 vs 10 d) With 20 mg Elemental Zinc Daily in the Treatment of Acute Diarrhoea: A Double-blind Individually Randomized Controlled Community Trial.
Brief Summary: Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc.

The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea.

This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area.

The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure.

Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.


Options:
A: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.
B: Change in length and length-for-age Z-score (12 months); Change in weight and weight-for-age (12 months); Incidence of diarrhea and laboratory-confirmed malaria (12 months); Change in plasma zinc concentration (12 months)
C: Age; Sex; Weight; Body Mass index; Duration of diarrhoea before admission; Stool volume; Dehydration status
D: Death among children 1-36 months of age

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
Brief Summary: The purpose of this study is to determine whether childhood atopic disease decrease or not after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester, followed by infant intake for 6 months after birth.


Options:
A: Effect of VSL#3 probiotic administration on breast milk (2 months)
B: Characterization of gut, oral, vaginal and human milk microbiomes (Monthly for an average of four months)
C: Prevalence of atopic disease in infant (two years)
D: Changes in Body Toxin Levels (Before and after the 25 day intervention period.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
Brief Summary: The purpose of this study is to determine whether childhood atopic disease decrease or not after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester, followed by infant intake for 6 months after birth.


Options:
A: episodes of wheezing, drug use (inhalative steroids and betamimetics), hospital treatment (October 2002 - October 2004)
B: Prevalence of atopic disease in infant (two years)
C: The Effects of probiotics in improving life quality and symptomatic severity (2 years)
D: severity of atopic dermatitis (March 2007 - July 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
Brief Summary: This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12.

Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).


Options:
A: Six Minute Walk Distance (6MWD) (Baseline and Week 12)
B: Peak 6-minute Walk Distance (12 weeks)
C: Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake (Up to 7 days after end of double-blind treatment (maximum: 4.3 years))
D: Six-minute walk distance (Twelve Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
Brief Summary: This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: Six Minute Walk Distance (6MWD) (Baseline and 16 Weeks)
C: Six Minute Walk Distance (6MWD) (Baseline and Week 12)
D: Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange; Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Site Replication of an Inpatient Palliative Care Program
Brief Summary: Palliative care is believed to improve care of patients with life-limiting illnesses. This study evaluated the impact of a multi-center randomized trial of a palliative care team intervention on the quality and cost of care of hospitalized patients. Study subjects were randomized to intervention or usual care. At study end, patients receiving the palliative care intervention reported greater patient satisfaction with their care. Intervention patients also had significantly fewer ICU admissions and lower total costs for care 6 months past their hospitalization. Intervention patients completed more advance directives and had longer hospice stays.


Options:
A: Change in patient's quality of living over time (baseline, 6,12,18,24,36 and every 12 weeks until death or end of study); Quality of end of life care (chart review at time of death and caregiver proxy interview 2-3 months after patient death); Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment (From enrollment until patient death or end of study); Change in caregiver quality of life, burden and grief over time (baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study)
B: Quality and cost of care
C: Quality of life of the patient and his family caregiver at baseline. (at baseline); Quality of life of the patient and his family caregiver at 12 weeks. (at 12 weeks); Quality of life of the patient and his family caregiver, 6-weekly after 12 weeks. (6-weekly after 12 weeks)
D: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.
Brief Summary: A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.


Options:
A: Symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS) (8 weeks)
B: Positive Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12); Negative Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12)
C: Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint ((Week 16) or at time of discontinuation)
D: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of 8 Week Treatment of Rozerem 8 mg (QHS) in Sleep Disturbed, Mild to Moderately Severe Alzheimer's Disease Subjects
Brief Summary: The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance


Options:
A: Age (4 weeks); Gender (4 weeks); Educational level (4 weeks); Cognitive status- Screening (4 weeks); Severe cognitive status- Screening (4 weeks); Cognitive status- Level (4 weeks); Cognitive domains (4 weeks); Depression in Dementia (4 weeks); Mood and behaviour (4 weeks); Agitation (4 weeks); Anxiety (4 weeks); Sleep-disturbed behaviours (4 weeks); Sleep-Actigraphy (4 weeks); Disease severity in advanced stages of dementia. (4 weeks); Mood and behaviour during, preceding and immediately after the sessions (4 weeks); Mean Heart rate (4 weeks); Percentage of Oxygen saturation (4 weeks)
B: Mean Nighttime Total Sleep Time as determined by actigraphy. (Week 1)
C: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (Quarterly over 6 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients
Brief Summary: Chronic Obstructive Pulmonary Disease (COPD) affects over 14 million people in the United States. It is the fourth leading cause of death and the only leading cause of death for which mortality rates are rising. Medical science has developed few effective therapies for COPD. In patients with advanced COPD and chronic hypoxemia, long-term oxygen therapy (LTOT) has been shown to be uniquely beneficial. It is the only available non-surgical therapy demonstrated to prolong survival in these patients. This study will compare the clinical and physiologic benefits of two different oxygen therapy devices among hypoxemic individuals with COPD: a lightweight ambulatory oxygen device versus the standard portable E-cylinder device.


Options:
A: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)
B: Stationary Oxygen Use Daily (6 Months); Ambulatory/Portable Oxygen Use Daily (6 months); Stationary Oxygen Use Daily (Baseline)
C: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
D: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
Brief Summary: The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).


Options:
A: Time to clinical failure (Will be assessed between day 1 (from 1 hour after first drug intake) till day 90 (24 hours after last study drug intake))
B: Inflammatory markers (outcome will be assessed up to two months post initial bronchoscopy)
C: myeloperoxidase in induced sputum (3 weeks)
D: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
Brief Summary: The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).


Options:
A: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
B: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
C: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
D: Occurrence of and time to Pseudomonas aeruginosa pneumonia (daily)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
Brief Summary: The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).


Options:
A: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)
B: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
C: Mean change in the Leicester Cough Questionnaire (LCQ) scores. (2 years)
D: Exacerbation Frequency; Airway Inflammation

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
Brief Summary: The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).


Options:
A: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
B: Presence of malaria parasites on thick blood smear or Rapid Diagnostic Test (RDT) in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of isolates of pneumococcus exhibiting macrolide resistance by nasopharyngeal swabs in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months); Prevalence of macrolide resistance in the stool as determined by genetic determinants or phenotypic testing (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of conjunctival swabs yielding ocular chlamydia in children 1-60 months (24 months); Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Weight for Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months)
C: Reduction in number of exacerbations (1 year)
D: Clinical Attachment Level (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Patient Decision Aid Regarding Natural Health Products for Menopausal Symptoms:a Randomized Controlled Trial
Brief Summary: The aim of this study is to assess the impact of a patient decision aid regarding natural health products for menopausal symptoms on decisional conflict, knowledge and persistence for an option of women aged 45-64 years old. We are expecting a decrease in decisional conflict and an improvement on knowledge level. We are also expecting an intention to use the decision aid in the future and to discuss with the physician or pharmacist about the use, or the intention to use natural health products.


Options:
A: Decisional Conflict Scale (3 months)
B: Decisional conflict (2 weeks)
C: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
D: Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.


Options:
A: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)
B: Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds (12 months)
C: Efficacy (24 months)
D: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment (PEARL STUDY)
Brief Summary: The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Options:
A: Longitudinal depressive symptom severity (52 weeks); Difference in time to all-cause treatment discontinuation (12 months)
B: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Week 4)
C: To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS
D: The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2 (8 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
Brief Summary: This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.


Options:
A: Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively (within 24h after operation)
B: Rates of vomiting and retching (after surgery)
C: Change in incidence of postoperative nausea and vomiting (The incidence was recorded at 1 hour as a baseline and changing incidences from baseline were recorded at 2 hours, 4 hours, and 24 hours.)
D: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair (Post-operatively (Day 1))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: The purpose of this study is to evaluate the long-term safety of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity Disorder (ADHD)


Options:
A: Symptom reduction using ADHD-Clinical Global Impression and ADHD Symptom Checklist Severity scale administered at each visit. (34 weeks)
B: Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis (Baseline, endpoint (42 days or early discontinuation))
C: Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination
D: Number of days of use of cannabis (12 weeks)

Answer: C