TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Brief Summary: The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.


Options:
A: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)
B: Duration of diarrhea (within the first 72 hours during hospitalization)
C: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
D: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Brief Summary: The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.


Options:
A: Duration of diarrhea (within the first 72 hours during hospitalization)
B: Time to recovery of hemoglobin after blood donation (Up to 24 weeks after blood donation)
C: Anemia (6 months following the start of the intervention)
D: gastrointestinal symptoms (14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Development, Implementation, and Evaluation of Novel Strategies to Reduce Inappropriate Antimicrobial Use in Community and Healthcare Settings
Brief Summary: Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of pneumonia risk among patients with acute cough illnesses. This study will use a cluster randomized trial design within the Geisinger Health System's integrated clinic network to measure the efficacy of an algorithm driven clinical decision support tool to safely reduce the frequency of unnecessary antibiotic prescriptions for adult patients with lower respiratory tract infections.


Options:
A: Biochemically confirmed 7-day point-prevalence abstinence at 6-month (6-month follow-up)
B: a designated health care proxy (12 months after intervention made available); initial bone density scan (12 months after intervention made available); administration of annual influenza vaccine (12 months after intervention started); administration of pneumococcal vaccine (12 months after the start of the intervention)
C: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
D: Intervention acceptance (6 months (May 2010-Nov2010))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Development, Implementation, and Evaluation of Novel Strategies to Reduce Inappropriate Antimicrobial Use in Community and Healthcare Settings
Brief Summary: Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of pneumonia risk among patients with acute cough illnesses. This study will use a cluster randomized trial design within the Geisinger Health System's integrated clinic network to measure the efficacy of an algorithm driven clinical decision support tool to safely reduce the frequency of unnecessary antibiotic prescriptions for adult patients with lower respiratory tract infections.


Options:
A: Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI) (up to 12 months post intervention)
B: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
C: Prescribing rate of antibiotics (up to 03/12)
D: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Development, Implementation, and Evaluation of Novel Strategies to Reduce Inappropriate Antimicrobial Use in Community and Healthcare Settings
Brief Summary: Inappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of pneumonia risk among patients with acute cough illnesses. This study will use a cluster randomized trial design within the Geisinger Health System's integrated clinic network to measure the efficacy of an algorithm driven clinical decision support tool to safely reduce the frequency of unnecessary antibiotic prescriptions for adult patients with lower respiratory tract infections.


Options:
A: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
B: Impact on rates of medication errors (1 year)
C: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia
Brief Summary: Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.


Options:
A: Body Mass Index (6, 12, 24 months); Weight (6, 12, 24 months); Insulin sensitivity (6, 12, 24 months); Fasting insulin levels (6, 12, 24 months); Cholesterol levels (6, 12, 24 months)
B: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants (Baseline, 52 weeks)
C: Change in Weight From Baseline (Baseline and 52 weeks); Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline (52 weeks)
D: Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) (Baseline, Endpoint (Week 6))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Disease Risk Reduction for Persons With HIV Infection: a Polypill Pilot Study
Brief Summary: This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with HIV infection).

Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.


Options:
A: serum LDL-C (at week 12); ALT value
B: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (12 weeks minus baseline)
C: Number of Participants Who Stated (by Self-report) That They Had Side Effects (4 months); Number of Participants Who Took >90% of Their Doses (by Pill Count) (4 months); Change From Baseline to Month 4 in the Framingham Risk Score (FRS) (Change from baseline to 4 months)
D: Total Cholesterol (-2, 0, 4, 6 weeks); LDL Cholesterol (-2, 0, 4, 6 weeks); HDL Cholesterol (-2, 0, 4, 6 weeks); Triglycerides (-2, 0, 4, 6 weeks); C-reactive protein (-2, 0, 4, 6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pioglitazone in Alzheimer Disease Progression
Brief Summary: This study was designed to assess the safety and tolerability of pioglitazone, an approved drug for type 2 diabetes, in non diabetic patients with Alzheimer's disease. It was also designed to generate preliminary information on whether pioglitazone might slow progression of Alzheimer's disease.


Options:
A: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
B: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
C: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)
D: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pioglitazone in Alzheimer Disease Progression
Brief Summary: This study was designed to assess the safety and tolerability of pioglitazone, an approved drug for type 2 diabetes, in non diabetic patients with Alzheimer's disease. It was also designed to generate preliminary information on whether pioglitazone might slow progression of Alzheimer's disease.


Options:
A: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
B: cognitive improvement or maintenance of cognitive performance (within 3 months of treatment)
C: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
D: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pioglitazone in Alzheimer Disease Progression
Brief Summary: This study was designed to assess the safety and tolerability of pioglitazone, an approved drug for type 2 diabetes, in non diabetic patients with Alzheimer's disease. It was also designed to generate preliminary information on whether pioglitazone might slow progression of Alzheimer's disease.


Options:
A: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
B: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
C: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
D: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)
Brief Summary: This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.


Options:
A: Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period (After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64))
B: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory) (Week 0, week 26)
C: N/A
D: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment (Week 0, Week 52); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin (Week 0, Week 106)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism
Brief Summary: A randomised double blind clinical trial, accepted by the Medical Products Agency and registered in the European Clinical Trials Database. Aims to evaluate the prevalence of vitamin D deficiency in a pHPT population in relation to gender and age, the correlation between vitamin D status, pre- and postoperative parathyroid hormone level and bone density and the correlation between vitamin D status, metabolic, cardiovascular risk factors and QoL aspects before and after parathyroid adenomectomy.


Options:
A: postoperative parathyroid hormone level (3 months); ambulatory blood pressure (one year)
B: Decrease in arterial stiffness after parathyroidectomy (3 month)
C: Total sleep time (Before and After Intervention)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous huMAb OX40L (RO4989991) in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Brief Summary: This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by IV infusion for the treatment of allergen-induced asthma.


Options:
A: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 56.)
B: Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) (Day 92)
C: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147); Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Clearance (CL) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Volume of Distribution (Vd) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose (Pre-dose on Day 28); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose (Pre-dose on Day 56); Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose (Day 84); Accumulation Ratio (R0) for CAT-354 (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84)
D: The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo (16 weeks after the first dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous huMAb OX40L (RO4989991) in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Brief Summary: This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by IV infusion for the treatment of allergen-induced asthma.


Options:
A: The prednisone-sparing effect of SB-240563 versus placebo as; indicated by the absolute and percentage dose reduction possible without a clinical exacerbation (as measured by the Juniper ACQ in patients with asthma or by Likert symptom scores +/- FEV1 in patients with eosinophilic bronchitis without asthma).
B: The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo (16 weeks after the first dose)
C: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147); Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Clearance (CL) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Volume of Distribution (Vd) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose (Pre-dose on Day 28); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose (Pre-dose on Day 56); Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose (Day 84); Accumulation Ratio (R0) for CAT-354 (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84)
D: Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures (Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TARGIT: A Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy With Conventional Post-operative Radiotherapy After Conservative Breast Surgery for Women With Early Stage Breast Cancer
Brief Summary: The purpose of this study is to evaluate whether a single fraction of radiotherapy given intra-operatively and targeted to the tissues at the highest risk of local recurrence is equivalent to standard post-operative external beam radiotherapy after breast conserving surgery in women with early stage breast cancer in terms of local relapse within the treated breast.


Options:
A: Local control (5-years, 10 ten-years)
B: ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail. (ongoing throughout study)
C: In-breast tumor recurrence (IBTR) (every 6 months for 5 years; annually thereafter for up to 10 years)
D: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TARGIT: A Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy With Conventional Post-operative Radiotherapy After Conservative Breast Surgery for Women With Early Stage Breast Cancer
Brief Summary: The purpose of this study is to evaluate whether a single fraction of radiotherapy given intra-operatively and targeted to the tissues at the highest risk of local recurrence is equivalent to standard post-operative external beam radiotherapy after breast conserving surgery in women with early stage breast cancer in terms of local relapse within the treated breast.


Options:
A: Ipsilateral Breast Tumor Recurrence (5-year)
B: rate of local recurrence (5 years)
C: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)
D: Local control (5-years, 10 ten-years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C
Brief Summary: The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).


Options:
A: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)
B: Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 (12 weeks after first dose of study drug)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 12 weeks)
D: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)

Answer: B