TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects
Brief Summary: To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.


Options:
A: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis (From Baseline to Week 52)
C: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Mass Media Campaigns Reduce Child Mortality
Brief Summary: A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a comprehensive mass media campaign using local radio stations can change behaviours on a scale large enough to result in measurable and sustainable reductions in under-five child mortality.

It is hypothesised that as a result of the scale and multi-pronged nature of the campaign, reductions of between 10% and 20% in child mortality will be achieved.


Options:
A: Diarrhea in Children Under 5 (one year after the intervention)
B: Post neonatal under-five all cause mortality (1 year)
C: 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)
D: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PETS-D (Parent Education Thru Simulation-Diabetes)
Brief Summary: Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education.


Options:
A: Parent Report Measures (4 years)
B: Change in baseline of Diabetes Knowledge (Baseline and 14 weeks)
C: Parent Report Measures (5 years)
D: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Two Parenting Programs for At-Risk Families
Brief Summary: The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.


Options:
A: Change in Child Behavior Problems (baseline, first follow-up (up to 2 years))
B: child behavior (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child social skills (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child cognition (1 yr, 3 yr, 5 yr); child language/communication (2 yr, 4 yr, 5 yr); child attachment (2 yr); child peer relationships (5 yr); child academics (4 yr, 5 yr); parent-child interaction (6 months, 5 yr)
C: The Parenting Sense of Competence scale (PSOC) (measured when child is 9 months)
D: Parenting behavior (Measured post-intervention and at 6- and 12-month follow-ups); Child disruptive behaviors (Measured post-intervention and at 6- and 12-month follow-ups)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.
Brief Summary: In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.


Options:
A: Angiographic Binary Restenosis (6 months)
B: Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA) (12 months or at Target Lesion Revascularization (TLR) time); Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients (12 months); Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) (6 months)
C: Target Lesion Percent Stenosis (at 1 Year)
D: Angiographic Late Lumen Loss (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.
Brief Summary: In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.


Options:
A: Angiographic Binary Restenosis (6 months)
B: Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) (12 months)
C: Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). (one year)
D: In-Segment Binary Restenosis (12-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Multi-organ Bodily Distress Syndrome. A Double-blinded Placebo Controlled Trial of the Effects of Imipramine (Stress-3)
Brief Summary: The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in patients with longlasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing both pain and other symptoms of bodily distress for patients with BDS. Control conditions are pill placebo. Study duration is 19 weeks for each of the 140 patients. End point is 13 weeks, i.e. after 10 weeks of 25-75 mg study drug.


Options:
A: MRI-derived Percentage Brain Volume Change (PBVC). (2 years)
B: Global Clinical Improvement Scale (After 13 weeks)
C: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score (Baseline, Week 14)
D: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Red Wine Polyphenols on Microvascular Dysfunction
Brief Summary: Rationale:

Epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. Beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. Experimental studies with mixed or separate Red Wine Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. Most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce

Objective:

To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.

Study design:

Randomized controlled trial (double blind).

Study population:

Obese (BMI \>30); n=30, men or women, aged 18-60 years.

Intervention:

Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.


Options:
A: insulin sensitivity as determined by euglycemic clamp tests (8 weeks)
B: adherence, HbA1c, Glc
C: Adherence to alcohol intake and MRI examinations (6 months)
D: Glycemic control (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.
Brief Summary: The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).

The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.


Options:
A: To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS. (One year)
B: Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen (4 months)
C: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
D: To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women (twelve months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore
Brief Summary: The WalkMore study will help find out how walking interventions can help overweight/obese postmenopausal women with increased risk of cardiovascular disease lower their blood pressure.


Options:
A: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
B: Resting systolic blood pressure (3 Months)
C: average daily step count (12 weeks)
D: Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 (Baseline, 6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation
Brief Summary: Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.


Options:
A: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)
B: Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability (within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke)
C: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)
D: Subjective Index of Physical and Social Outcome (SIPSO) (baseline and 1 year); Subjective Index of Social Integration (Subscale of SIPSO) (baseline and one year); Subjective Index of Physical Integration (Subscale of SIPSO) (baseline and one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation
Brief Summary: Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.


Options:
A: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)
B: Behavioural Inattention Test (BIT) (Change in BIT score between the baseline sessions average and score measured at week 11)
C: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
D: electromyography (EMG ) activity of Tibialis Anterior Muscle. (1 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
Brief Summary: The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.


Options:
A: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)
B: OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks (Through 8 weeks)
C: Acute Procedural Safety (One Week)
D: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of the Combination of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Patients
Brief Summary: The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied.

Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or stop growing.

Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.


Options:
A: Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study (Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)); Percentage of Participants With Best Overall Response in Phase II of the Study (by Cutoff Date: 31 March 2012 (within 3 years, 4 months))
B: Response (2 months post consolidation)
C: Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines (Start of treatment (Week 0 of Visit 2) until Week 24)
D: Progression Free Survival (PFS) (up to 50 months); Number of Participants With a Response (7 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: What Should be the Best Physiotherapy Early After Stroke ?
Brief Summary: This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.


Options:
A: Wolf Motor Function Test (WMFT) Log-transformed Time (Baseline to 1 year post-randomization); Wolf Motor Function Test Time (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS) Hand Function Subscale Score. (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) (Baseline to 1 year post-randomization)
B: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)
C: Fugl Mayer motor score for upper extremity (4 weeks)
D: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: What Should be the Best Physiotherapy Early After Stroke ?
Brief Summary: This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.


Options:
A: modified Rankin Score (3 months)
B: To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score) (3 months)
C: Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS) (90 days)
D: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: What Should be the Best Physiotherapy Early After Stroke ?
Brief Summary: This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.


Options:
A: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
B: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)
C: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
D: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Training for Patients With Schizophrenia
Brief Summary: This research on cognitive training addresses the following questions:

1. Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses?
2. What are the neurocognitive and non-cognitive factors that predict good outcomes following cognitive rehabilitation? In addition to verbal learning and memory, immediate verbal memory, vigilance, and executive functioning, the cognitive training intervention attempted to improve prospective memory ability (i.e., the ability to remember to do things in the future, such as take medications or attend a doctor's appointment).


Options:
A: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
B: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
C: UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) (3 months)
D: AMOUNT OF EMPLOYMENT (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Brief Personalized Feedback Intervention in University Students
Brief Summary: Excessive alcohol consumption in university students continues for be a serious public health concern with a variety of negative consequences. There have been a number of different brief interventions developed to address this issue among university students. The current project will add to this literature by evaluating the use of a personalized feedback intervention (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine whether providing access to the CYDU will result in short-term reductions in drinking. This issue is important as use of these interventions is not a mandatory requirement for university students so the issue is whether making materials of this type available leads to any reductions in risky drinking. It is hypothesized that students provided access to the CYDU will display greater reductions in drinking at a six-week follow-up as compared to students who were not provided access to the CYDU.


Options:
A: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
B: Change in estimated Blood Alcohol Concentration (eBAC) (7 weeks)
C: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care (5 months); Number of brief interventions for excessive alcohol consumption delivered in primary health care settings (5 months)
D: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)

Answer: D