TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
Brief Summary: Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.


Options:
A: - To measure the impact of zinc and vitamin A on the duration of diarrheal illness (Weekly home visits for 6 months)
B: Incidence of diarrhea (Incidence over the 24-week follow-up period); Change in length-for-age Z score (Measured at enrollment and the end of the 24-week follow-up period)
C: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
Brief Summary: Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.


Options:
A: all cause hospitalizations in comparison to infants receiving placebo. (November 2004 to August 2007); illnesses requiring visits to healthcare providers. (November 2004 to August 2007)
B: Death among children 1-36 months of age
C: To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only (One year)
D: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
Brief Summary: A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.


Options:
A: Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms (For up to 30 months of follow-up); Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms (For up to 30 months of follow-up); Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms (For up to 30 months of follow-up); Person-years of Follow-up of Oral TDF and Oral Placebo Arms (For up to 30 months of follow-up); Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms (For up to 30 months of follow-up); Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms (For up to 30 months of follow-up); Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms (For up to 30 months of follow-up); Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms (For up to 30 months of follow-up); Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms (For up to 30 months of follow-up); Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events (Throughout study, up to 2.5 years)
B: Measured endogenous antimicrobial activity (Throughout study); Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL (Throughout study)
C: Effectiveness (30 months); Safety (30 months)
D: HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. (24 months); All Adverse Events (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Brief Summary: The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia.

The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks.


Options:
A: Time to Relapse of Psychotic Symptoms During 6 Weeks (6 Weeks)
B: 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)
C: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))
D: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Brief Summary: The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia.

The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks.


Options:
A: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
B: Double-blind: Percentage of Participants Who Experienced Relapse (Day 1 up to Month 15 of double blind relapse prevention period)
C: Time to Relapse During the Double-Blind Phase (Approximately Week 60)
D: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Brief Summary: The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia.

The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks.


Options:
A: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
B: Determine comparative efficacy in patients with schizophrenia of non-inferiority of IM olanzapine depot high and low doses versus oral olanzapine based on exacerbation rates after 6 months of maintenance treatment; Determine comparative efficacy in patients with schizophrenia of superiority of IM olanzapine depot low, med and high doses versus very low dose based on time to exacerbation of symptoms of schizophrenia
C: The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.
D: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Single-Blind, Active Control, 18-Week Study to Evaluate the Safety and Efficacy of A New Twice-Daily, Topically Applied LCD Solution vs. Calcipotriol Cream for the Treatment of Adult Subjects With Moderate Plaque Psoriasis
Brief Summary: The purpose of this study is to compare the safety and effectiveness of a new topical LCD solution and a commercially available calcipotriol (Vitamin D) cream in reducing the symptoms of plaque psoriasis and improving the quality of life in adults.


Options:
A: Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8; Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
B: Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) (8 weeks)
C: - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
D: Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms (12 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Extension Trial of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients With Gaucher Disease
Brief Summary: Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is an extension trial to Study NCT00376168 and NCT00712348.


Options:
A: Spleen Volume (Spleen Volume at Baseline and Months 12, 24, and 36)
B: Change From Baseline in Spleen Volume Measured by MRI. (Baseline and 9 months)
C: PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo (PAP Baseline (Day 1), Week 39)
D: Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period (Baseline up to Week 52); Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP (Week 52 up to week 208)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
Brief Summary: In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.


Options:
A: Quality of Life, Heart Failure Disease Biomarkers and Clinical Outcomes (yearly)
B: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)
C: BDI-II score at 6 months (Baseline, 3 months, 6 months, 9 months , 12 months)
D: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
Brief Summary: In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.


Options:
A: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
B: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
C: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)
D: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
Brief Summary: In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.


Options:
A: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
B: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)
C: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)
D: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study Safety & Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients.
Brief Summary: Eligible patients will undergo this open label initial safety and feasibility study investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included with this trial and total subject participation duration of 7-8 weeks. The screening phase will include an initial screening visit and a screening PSG night. After successful screening, subjects will complete a baseline PSG night and undergo a third PSG night to monitor initial safety and compliance with study drug at a dosage of 4.5 g/day of sodium oxybate. Thus the subject will undergo three consecutive nights of PSG in the sleep center. The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6 g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be increased to a dosage of 9 g/day, if tolerated by the patient. The remaining visit will occur at 6 weeks after baseline, with Treatment Visit 3 consisting of two consecutive nights of PSG. Participation will be complete after this visit. Phone follow-up will be made at one week post completion visits to assess any wash-out symptoms. Please refer to Figure for flow of the study design.


Options:
A: Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation (Change from baseline at 2 and 8 weeks)
B: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)
C: Sleep Efficiency (Post-intervention, up to 3 weeks); Sleep Minutes (post-intervention, up to 3 weeks)
D: To evaluate and monitor the safety and tolerability of 6 to 9 g/day sodium oxybate in patients with mild Alzheimer's disease (AD) between the ages of 50 and 65 years. (65 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
Brief Summary: Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.


Options:
A: Spontaneous Delivery Before 34 Completed Weeks (Between 24 and 34 weeks)
B: Frequency of delivery <=32 weeks (18 weeks gestation through delivery)
C: Preterm delivery (Less than 34 weeks gestation)
D: Gestational Latency Achieved Between Cerclage Placement and Time of Delivery (24 weeks)

Answer: A