TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
Brief Summary: Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.

Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration)
B: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)
C: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
D: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response (10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Trial of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L) in Individuals With Schizophrenia or Schizoaffective Disorder at Risk for Treatment Non-adherence and for Homelessness
Brief Summary: Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors.

This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.


Options:
A: Primary Outcome Measure (3 years)
B: A reduction in the use of drugs and alcohol (12 months)
C: Treatment Progress (6 months)
D: Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks (Baseline-25 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Trial of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L) in Individuals With Schizophrenia or Schizoaffective Disorder at Risk for Treatment Non-adherence and for Homelessness
Brief Summary: Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors.

This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.


Options:
A: Post-Release Opioid Relapse (Four weeks post-release)
B: Relapse (6 months)
C: Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks (Baseline-25 weeks)
D: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Miami Healthy Heart Initiative (MHHI) a Randomized Study of Behavioral Risk Factors for Cardiovascular Disease in Latino and Hispanic Patients With Poorly Controlled Diabetes
Brief Summary: A study to examine the effectiveness of a multilevel Community Health Workers intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in Miami.


Options:
A: Change from Baseline in Mean steps/day at 3 months (3 months); Change from Baseline in Mean Steps/day at 1 month (1 month)
B: Glycemic Control (12 months.)
C: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
D: Percent of Participants That Scheduled an Appointment for PrEP Consultation. (3 months); Percent of Participants That Attended an Appointment for PrEP Consultation. (3 months); Percent of Participants That Received a PrEP Prescription. (3 months); Percent of Participants That Filled Their PrEP Prescription. (3 months); Percent of Participants That Initiated PrEP Use. (3 months); Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP (3 months); Percent of Participants That Attended PrEP Follow-up Appointment. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.


Options:
A: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)
B: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment (Baseline and Week 6)
C: Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 (Baseline to Week 8)
D: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment (Baseline and Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double Blind, Exploratory, Parallel-group, Placebocontrolled Clinical Study to Assess Two Dosing Regimens of GSK2402968 for Efficacy, Safety, Tolerability and Pharmacokinetics in Ambulant Subjects With Duchenne Muscular Dystrophy
Brief Summary: The purpose of this study is to determine whether GSK2402968 given as a continuous dose and as an intermittent dose is effective and safe in the treatment of Duchenne muscular dystrophy.


Options:
A: Cardiac Ejection Fraction as Measured by Echocardiogram (12 month visit)
B: To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD (48 weeks)
C: Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging. (6 months compared to baseline)
D: 12-month Change in Myocardial Strain (baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study
Brief Summary: During patients' stay in the hospital, some of the patients may require artificial feeding for various reasons either through a vein or through a tube going directly to the gut. However, the amount of feeding that can be considered 'adequate' is unclear due to lack of research data. The current evidence the investigators have suggests that doctors might be giving patients more than they require, which might carry some risks. This hasn't been proven until now and there is no evidence as yet to show investigators exactly how much the doctors should feed patients.

The aim of the study is to see whether feeding patients less than what they are currently been feed is associated with better outcome.

The patients will be randomly (like tossing a coin) allocated into 2 groups. One group will get 100% of the current amount; the second group will get 60%. The investigators will then compare the groups to decide if feeding patients less than the current practice is associated with better outcomes.


Options:
A: Septic complication (average of one week)
B: Documented Infection Rate (20 days)
C: Sudden cardiac death (12 months)
D: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Double-bind Randomized Trial of Ferric Carboxymaltose With or Without Erythropoietin for the Prevention of Red-cell Transfusion in Hip Fracture Perioperative Period.
Brief Summary: In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture is designed. Required sample size is of 87 patients per arm (87x3 = 261). Primary efficacy variable is the percentage of patients who receive red-cell transfusion during hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. Adverse clinical events and side effects are assessed as safety variables. In addition health related quality of life will be measured at inclusion and after 60 days. A cost-efficacy analysis (by means of incremental cost-efficacy method using as a primary endpoint each patient not requiring transfusion, and as secondary end-point every patient who survived the index admission is performed). The investigators would like to demonstrate a double benefits: optimizing precious resource such as blood products and reducing complications arising from their use.


Options:
A: Hematocrit (Day 7, Day 14, Day 21, Day 28); Serum Iron Concentration (Day 7, Day 14, Day 21, Day 28); Serum Ferritin Concentration (Day 7, Day 14, Day 21, Day 28); Erythrocyte Zinc Protoporphyrin Concentration (Day 7, Day 14, Day 21, Day 28)
B: Risk of blood transfusion or death (From randomisation until 30-days following the index operation); Blood transfusion rate (including repeat transfusions) (From randomisation until 30-days following the index operation)
C: The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.
D: Reduce red-cell transfusion packs (60 days after hospital discharge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Double-bind Randomized Trial of Ferric Carboxymaltose With or Without Erythropoietin for the Prevention of Red-cell Transfusion in Hip Fracture Perioperative Period.
Brief Summary: In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture is designed. Required sample size is of 87 patients per arm (87x3 = 261). Primary efficacy variable is the percentage of patients who receive red-cell transfusion during hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. Adverse clinical events and side effects are assessed as safety variables. In addition health related quality of life will be measured at inclusion and after 60 days. A cost-efficacy analysis (by means of incremental cost-efficacy method using as a primary endpoint each patient not requiring transfusion, and as secondary end-point every patient who survived the index admission is performed). The investigators would like to demonstrate a double benefits: optimizing precious resource such as blood products and reducing complications arising from their use.


Options:
A: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)
B: Reduce red-cell transfusion packs (60 days after hospital discharge)
C: Methodology of the pilot study (up to 30 days)
D: Physical Fatigue (on day 3 postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad
Brief Summary: The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.


Options:
A: Cumulative wasting incidence, hemoglobin concentration (monthly)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
C: Postpartum weight loss between delivery and 28 weeks (between delivery and 28 weeks); Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) (birth to 28 weeks); Exclusive breastfeeding and breastfeeding cessation by 28 weeks (birth to 28 weeks)
D: Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age (Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)); Incidence of serious adverse events during the study period (12 months after enrollment (age 18 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad
Brief Summary: The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.


Options:
A: Cumulative wasting incidence, hemoglobin concentration (monthly)
B: Weight gain during the 12-week follow-up (in grams)
C: Change in Length for Age (Once per month for 6 months, then once after 12 months.)
D: weight-for-height in children 6 to 60 mo of age (8 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Nigeria
Brief Summary: The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.


Options:
A: Dual Sugar Absorption Test (12 weeks); Dual Sugar Absorption Test (24 weeks)
B: "negative nutritional outcome" of a child (6 months follow-up)
C: "negative nutritional outcome" of a child (6 months follow-up)
D: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Brief Summary: This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
C: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
D: Survival free of atrial fibrillation (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Brief Summary: This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
B: Improved metabolic parameters(glucose, lipid, liver enzymes, etc.) (16 weeks)
C: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)
D: Hepatic steatosis (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Brief Summary: This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: Survival free of atrial fibrillation (12 months)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
C: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
D: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Brief Summary: This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
B: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
C: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
D: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)

Answer: C