TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active Follow-up, a Randomised Controlled Trial. CR-AGE EXTRA Trial
Brief Summary: The goal of this trial is to assess the medium- (6 months) and long-term (12 months) effects of a Home-Based exercise program after in-Hospital comprehensive Cardiac Rehabilitation (CR) - as compared with usual care - on exercise capacity, health-related quality of life and health care services utilization, in patients (pts) older than 75 years after recent acute coronary syndromes or cardiac surgery.


Options:
A: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
B: Escore of combined risk factor control (6 months)
C: functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. (6 and 12 months)
D: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease
Brief Summary: This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD).


Options:
A: Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 (Baseline and Month 15)
B: Sleep and Fatigue (8 weeks)
C: Time "on" defined by tapping speed
D: Canadian Occupational Performance Measure (COPM) (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
Brief Summary: The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety of a larger trial.


Options:
A: To assess the efficacy of bariatric surgery in inducing partial or total remission of type 2 diabetes mellitus, as compared to standard medical anti-diabetic care (STC). (10 years)
B: HbA1c < 7.0% (12 Months); Systolic blood pressure < 130 mm Hg (12 Months); LDL cholesterol < 100 mg/dl (12 Months)
C: weight loss (5 years)
D: Improvement of co-morbidities (1-year after treatment start)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Standard Emergency Department Psychiatric Treatment Compared With Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center.
Brief Summary: Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.


Options:
A: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))
B: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
C: Changes in Stages of Change Questionnaire, which measures motivation (3 months); Changes in Reasons for Living Inventory (3 months); Changes in State Hope Scale (3 months); Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness. (3 months); Changes in Beck Scale for Suicide Ideation (3 months); Suicide Attempt Self-Injury Count (3 months)
D: Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Standard Emergency Department Psychiatric Treatment Compared With Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center.
Brief Summary: Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.


Options:
A: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
B: Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). (2 years)
C: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)
D: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Standard Emergency Department Psychiatric Treatment Compared With Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center.
Brief Summary: Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.


Options:
A: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)
B: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)
C: Suicide ideation (12 month)
D: Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial
Brief Summary: The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.


Options:
A: Brachial artery flow-mediated dilation (Baseline, 8 weeks, 16 weeks)
B: Diet; Physical Activity
C: Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit (nine months)
D: Child body mass standard deviation score (On average 2.9 years of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Cross - Over Design, Single Center Study to Evaluate the Effects of Treatment With Pycnogenol® on Endothelial Function in Subjects With Stable Coronary Artery Disease (Pycno2007-003)
Brief Summary: Pycnogenol® is a proprietary bark extract of the French maritime pine tree (Pinus pinaster ssp. atlantica). Pycnogenol® has prevented pathologic symptoms such as chronic inflammation and increased platelet aggregation, a risk factor for cardiovascular diseases. The endothelium is increasingly recognized not only a target (with vascular remodelling occurring in response to an injury and resulting in atherosclerosis), but also a mediator in the pathogenesis of atherosclerosis. Indeed, endothelial cells play an important regulatory role in the cardiovascular system by the expression of numerous molecules and release of mediators such as nitric oxide (NO), superoxide and endothelin-1 (ET-1). Data from animal studies, as well as human studies indicate that Pycnogenol may improve endothelial function, which is a powerful surrogate for clinical prognosis.


Options:
A: Differences detected on the time evolution of BP both in two arms of intervention (5 weeks)
B: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)
C: The primary objective of this study is to evaluate the effects of treatment with Pycnogenol® on endothelial function in subjects with stable coronary artery disease. (8 weeks)
D: Changes in visual function (At baseline and again at six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin
Brief Summary: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures


Options:
A: Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence (48 hours after administration of study medication.)
B: N/A
C: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures (At delivery)
D: Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Vitamin B12 in Pregnant Indian Women
Brief Summary: This study is a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status. Secondary aims for this trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate.


Options:
A: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)
B: Change in concentrations of biomarkers of vitamin B12 in mother-child pairs (Baseline and 6 months postpartum); Vaccine specific immunity in infants (6 months); Cognitive, Language and Motor Composite Score (12 months); Nuroinflammatory cytokines (12 months)
C: Infant neurodevelopment (9 Month of infant age)
D: Change of Red blood cells (RBC) count in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Hemoglobin (Hgb) concentration in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Hematocrit in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Mean corpuscular volume (MCV) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Mean corpuscular hemoglobin concentration (MCHC) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Mean corpuscular hemoglobin (MCH) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Iron (Fe) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Haptoglobin in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Ferritin in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Total Iron Binding Capacity (TIBC) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Unsaturated Iron Binding Capacity (UIBC) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Vitamin B12 in Pregnant Indian Women
Brief Summary: This study is a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status. Secondary aims for this trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate.


Options:
A: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
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: L:M ratio at 1.5 months (1.5 months)
D: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus
Brief Summary: it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight infants. The likelihood of ductal closure with only one or two doses of treatment is a secondary objective.


Options:
A: Composite of mortality, and/or NEC, and/or BPD (At a postmenstrual age of 36 completed weeks)
B: rate of ductal closure
C: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)
D: 2-year survival without cerebral palsy (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea
Brief Summary: This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.


Options:
A: Apnea-Hypopnea Index (Baseline and 180 Days)
B: proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups (CPAP use was evaluated for 4 months)
C: Acceptance of CPAP treatment (from diagnosis to effective treatment)
D: Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 1); Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea
Brief Summary: This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.


Options:
A: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)
B: Clinical blood pressure (Before treatment, 4 months after treatment)
C: Sympathetic tone (MSNA) (Change from baseline after one month of intervention)
D: Acceptance of CPAP treatment (from diagnosis to effective treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Brief Summary: This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period (EEP (Week 17 to Week 24))
B: Hemoglobin response rate (Weeks 1-24)
C: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range (Week 17 up to Week 24)
D: Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 (Up to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course
Brief Summary: To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.


Options:
A: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
B: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
C: Time to First Relapse (Baseline up to 96 weeks)
D: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course
Brief Summary: To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.


Options:
A: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (Up to Month 24)
B: Time to First Relapse (Baseline up to 96 weeks)
C: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
D: Hazard ratio for relapses (During the first and during the second 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course
Brief Summary: To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.


Options:
A: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
B: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))
C: Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. (Part I (Week 24)); Incidence of treatment-emergent adverse events and serious adverse events (Part II (Up to 4.5 years))
D: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)

Answer: D