TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2
Brief Summary: To determine the effect of using a robotic exoskeleton to allow walking practice after stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary outcomes.


Options:
A: Change From Baseline in Berg Balance Scale at 4 Weeks (Baseline and 4 weeks from baseline)
B: Change in 10 Meter Walk Test From Baseline in Gait Speed (Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up))
C: Change in 10 meter walk test from baseline in gait speed (session 0 (initial visit); session 11 (at approximately 4 weeks))
D: Walking ability - Functional Ambulation Category (Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) - A Randomized Controlled Trial of Meniscal Tear Treatment in Young Adults
Brief Summary: There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can be caused by either a smaller or larger trauma or be a degenerative age-related tear. Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40 years or younger) in comparison to non-surgical treatments.

The purpose of this study is to determine if a strategy of early arthroscopic meniscal surgery (repair or resection) is superior to a strategy of initial individualized supervised exercise therapy including patient education with the option of later surgery if needed in improving pain, function and quality of life in young patients (18-40 years) with meniscal tears.

The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve more than patients treated with exercise and education.


Options:
A: Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) (2 and 10 years postoperatively)
B: the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (Primary endpoint: Change from baseline to 12 months.)
C: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)
D: KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale (12 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Phase II Clinical Trials of Thalidomide in NTDT
Brief Summary: This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion.15\~30 patients will be enrolled, including type α 5\~13 cases, type β 10\~17 cases.


Options:
A: Clinical effects on heamoglobin changes (6 months)
B: Change in baseline transfusion frequency with increase of pre-transfusion hemoglobin (baseline and 6 month hemoglobin level and transfusion frequency)
C: The level of Hemoglobin (18 months)
D: Hemoglobin(Hb) (Four weeks); Adult hemoglobin(HbA) (Four weeks); Fetal hemoglobin(HbF) (Four weeks); Minor adult hemoglobin(HbA2) (Four weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SMART Weight Loss Management
Brief Summary: The overall objective of this study is to use an innovative experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the delivery of mHealth tools and traditional treatment components in a stepped program of obesity treatments. The SMART approach is a highly efficient strategy for identifying and constructing efficacious adaptive interventions: it accommodates sequential decision-making based on the participant's response to early weight loss treatment components. The proposed treatment package begins with the least expensive components, and for participants identified as treatment non-responders, provides sequential step-up of additional treatment components. By sequentially delivering treatment components based on participant response, SMART permits achievement of the target outcome, weight loss, with least resource consumption and participant burden.


Options:
A: Change in weight (6 and 12 months)
B: Weight change (Baseline - 12 months)
C: Change in weight status (24 months)
D: Change in weight at 6 months (baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Empagliflozin on Cardiac Structure, Function, and Circulating Biomarkers in Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a previous post-marketing clinical trial. The use of empagliflozin to treat patients with diabetes and heart disease has been approved by Health Canada. However, the process by which it may give this beneficial effect remains unclear and needs further investigation. Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic basis by which Empagliflozin could provide its potential cardio-protective effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).


Options:
A: Left Ventricular (LV) mass Changes (6 months)
B: To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). (52 weeks)
C: The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (From randomization until individual day of trial completion, up to 432 weeks)
D: HbA1c Change From Baseline at Week 52 (Baseline and week 52); HbA1c Change From Baseline at Week 104 (Baseline and week 104)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Trial of Avelumab-cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Brief Summary: The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN.


Options:
A: Overall survival (5 years)
B: Progression free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months)
C: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
D: Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT) (within 4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Brief Summary: The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of \>10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.


Options:
A: Absolute Change in Percent Predicted Forced Vital Capacity(FVC) (Baseline to week 72)
B: 6 Minute Walk Distance (The 6-MWD will be measured at 0 and 3 months.)
C: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. (52 weeks)
D: Annual Rate of Decline in Forced Vital Capacity - Overall Population (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)); Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
Brief Summary: Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.


Options:
A: Physical Activity Energy Expenditure (kJ/Day or kcal/Day) (7 days (across 12 weeks) - Primary outcome at week 4)
B: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)
C: change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 0 4 hours); change oral glucose tolerance (week 12 4 hours); change oral glucose tolerance (week 12 4 hours); change oral glucose tolerance (week 12 4 hours); change oral glucose tolerance (week 12 4 hours); change oral glucose tolerance (week 12 4 hours); change oral glucose tolerance (week 12 4 hours); change oral glucose tolerance (week 12 4 hours); change oral glucose tolerance (week 12 4 hours)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based Health Management of COPD Patients
Brief Summary: Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.


Options:
A: Maximal oxygen consumption (Baseline)
B: Quality of Life: Chronic Respiratory Questionaire (8 weeks from the start of the intervention); Daily Physical Activity measured by Actigraph (8 weeks from the start of the intervention)
C: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)
D: Number of exacerbations (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.
Brief Summary: This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).


Options:
A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
B: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
C: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
D: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.
Brief Summary: This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).


Options:
A: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
B: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R (Week 16 of Period R)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
D: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.
Brief Summary: This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).


Options:
A: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)
B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
C: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
D: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial
Brief Summary: Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive, so there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy (NRT) are not effective for many smokers and in many cases provide less nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting success in those who do not respond to a standard dose of NRT (21mg).


Options:
A: Number of Participants With a Quit Attempt (6 months)
B: Rating of urges to smoke 1-week after the target quit (1 week)
C: Short term continuous abstinence (weeks 9 to 12)
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Code Blue Outcomes & Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation
Brief Summary: This multicenter randomized trial will employ in-situ cardiac arrest simulations ("mock codes") to test whether using telemedicine technology to add an intensive care physician as the "copilot" for cardiac arrest resuscitation teams influences chest compression quality, resuscitation protocol adherence, team function, and provider experience.


Options:
A: Change in team cohesion (Change from baseline to 6 months)
B: Goal Setting and Attainment (18 months (3 measurements at 6-month intervals))
C: Fraction of Pulseless Time With no Chest Compressions (From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes))
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mental Health in Adults and Children: Frugal Innovations
Brief Summary: This stepped wedge, randomized controlled trial will test the effectiveness of a Supported Self-Management intervention for depression among adults in Vietnam. The intervention will be delivered at the community level in 8 Vietnamese provinces by primary care providers and social workers. The intervention group will receive the Supported Self-Management intervention, while the control group will receive enhanced treatment as usual. The primary outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional ability and alcohol misuse.


Options:
A: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
B: Self-Reporting Questionnaire 20 (SRQ-20) (Two months)
C: Rate of Maternal HIV Viral Suppression (Two months post pregnancy); Mean Maternal Antiretroviral (ART) Adherence (Past 6 months, assessed at 2 months after the completion of pregnancy); Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention (through study completion, an average of 48 weeks); Rate of Delivery in Health Facility (two months post pregnancy); Rate of Infant Use of ART (First 6 weeks of life)
D: Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo- and Active-controlled Multi-country, Multi-centre Parallel Group Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of 400 mg Ibuprofen and 100 mg Caffeine Compared to Ibuprofen 400 mg and Placebo in Patients With Acute Lower Back or Neck Pain.
Brief Summary: To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet and a placebo tablet.


Options:
A: Change from Baseline in numerical rating scale of back pain (Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)
B: Functional Impairment as Measured on the Roland Morris Disability Questionnaire (1 week)
C: Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) (Baseline and Day 2)
D: Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire (Baseline and one week after discharge from emergency department)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Pragmatic Trial Comparing the Clinical and Cost Effectiveness of Lithium and Quetiapine Augmentation in Treatment Resistant Depression
Brief Summary: LQD is a multicentre randomised clinical trial comparing the clinical and cost effectiveness of lithium versus quetiapine when used as add-on therapies to antidepressant medication for patients with treatment resistant depression. The Lithium versus Quetiapine in Depression (LQD) study will assess patients over 12 months to establish which (if any) treatment is more likely to improve TRD over a long duration of time. Professor Anthony Cleare is the Chief Investigator and recruitment began in November 2016.


Options:
A: MADRS score (weeks 0 (randomization); 8, 9, 10, 12, 14, 16, 18, and 20)
B: Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome (One year)
C: Longitudinal depressive symptom severity (52 weeks); Difference in time to all-cause treatment discontinuation (12 months)
D: Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline (the end of the SSRI/SNRI treatment period), at completion of administration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
Brief Summary: This is a prospective unblinded, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.


Options:
A: The occurrence of a Serious Adverse event (SAE), solicited and unsolicited AE, new gastrointestinal medical condition and diagnoses from FMT treatment or new infection from FMT treatment (up to 1 year); Steroid-free Clinical Remission at week 9 + endoscopic remission or response defined as total Mayo score ≤ 2 with all four sub-scores ≤ 1 and a ≥ 1 point reduction in endoscopy sub-score (8 weeks post initial treatment)
B: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)
C: Safety (up to 6 mo post FMT)
D: Clinical Response (4 weeks following GMT Treatment)

Answer: A