TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Health Literacy Activation Among the Chronic Obstructive Pulmonary Disease Patients and Designated Support Dyad
Brief Summary: This study investigates whether increasing health literacy among COPD patients and their designated health coach during a hospital admission caused by symptoms exacerbation will lead to better health outcomes including increased health quality, and lower healthcare utilization.


Options:
A: Change in Respiratory Specific Health Related Quality of life (HRQoL) (3 months)
B: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
C: Number of unscheduled hospital days (up to 12 months)
D: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
Brief Summary: Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.


Options:
A: Comparative Duplex Ultrasound (Immediately Post-procedure)
B: Occlusion rate (up to 5 years)
C: Occlusion rate (One year after the treatment); Freedom from reflux (One year after the treatment); Disease-specific quality of life (One year after the treatment); Occlusion rate (three years after the treatment); Freedom from reflux (three years after the treatment); Disease-specific quality of life (three years after the treatment); Occlusion rate (five years after the treatment); Freedom from reflux (five years after the treatment); Disease-specific quality of life (five years after the treatment)
D: Number of Participants With Complete Closure of the Target Vein at 3 Months (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of a Herbal Supplement in the Prevention of Treatment of Post-traumatic Stress Disorder Versus Placebo (PHYTéS Study)
Brief Summary: Psycho-traumatic disorders are a disabling condition whose epidemiological data vary according to the country but also the populations studied and the measuring instruments used. The estimated prevalence of posttraumatic stress disorder (PTSD) appeared to be increasing in recent years, and this appears to be due, among other things, to the improvement of the standardized evaluation procedure. The survey "Mental Health in General Population", conducted in metropolitan France between 1999 and 2003 on more than 36,000 people estimated its instantaneous prevalence (last month) of a full PTSD was 0.7% in the SMPG overall sample, with almost equal frequency between men (45%) and women (55%). This figure is close to that reported in a European population for the ESEMeD study. A very significant psychiatric comorbidity was found in subjects with PTSD, particularly with mood disorders, other anxiety disorders and addictive behaviors. The link with the suicidal risk was clearly established, which is the gravity of this pathology.

The most important publications are made by American teams who have identified and evaluated the treatment of this pathology among veterans of the various wars led by the country.


Options:
A: Change in PTSD symptoms and severity - Clinician-Administered PTSD Scale - 5 (CAPS-5) (The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.)
B: Brain Measures (Brain measures are collected on Visit 3, 14 days from baseline (Visit 1) and Visit 4, 15 days from baseline (Visit 1), for approximately 1.5 hours each day); Expectancy Ratings (Collected on Visit 2, 13 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), and Visit 4, 15 days from baseline, during the task. Each day the task lasted approximately 20 minutes.)
C: 50% diminution or stabilization of CAPS score after 3 and 6 months (after 3 and 6 months of patient's inclusion)
D: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing PharmacoTherapy In the Multimorbid Elderly in Primary CAre: a Cluster Randomized Controlled Trial (the OPTICA Trial)
Brief Summary: The objective of this randomized controlled trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP), put into practice through the STRIP Assistant (STRIPA) and implemented by general practitioners (GPs), will lead to an improvement in clinical and economic outcomes in patients aged 65 or older with multimorbidity and polypharmacy.


Options:
A: number of unplanned hospitalizations (6 months)
B: Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #1: change in the Medication Appropriateness Index (MAI) (12 months); Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #2: change in the Assessment of Underutilization (AOU) (12 months)
C: Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 3 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 6 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 12 months); Change from baseline in fall rate (Change from baseline in fall rate at 3 months); Change from baseline in fall rate (Change from baseline in fall rate at 6 months); Change from baseline in fall rate (Change from baseline in fall rate at 12 months)
D: Health-related quality of life (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Pedometers for the Enhancement of Post Caesarean Mobility in High Risk Patients Using a Personalized Repeated Feedback Approach - a Randomized Controlled Trial
Brief Summary: This is a randomized controlled trial, planned to study the effects of pedometers (digital step counters) on patient mobility following cesarean delivery. The investigators plan to randomize patients at high risk for thromboembolic events to participants with a personalized repeated feedback approach based on pedometer results, versus participants with no feedback to pedometer results.


Options:
A: ongoing intact pregnancy at 24 weeks of gestation (at 24 weeks of gestation)
B: Venous thromboembolism (40 days after delivery)
C: Pregnancy continuation beyond twelve weeks gestation (ONE YEAR)
D: Number of steps (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision Making for Prostate Cancer Screening Among Black Male Patients and Their Providers
Brief Summary: Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a Community Health Worker-led decision coaching program to facilitate Shared Decision Making (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision quality, the decision making process, patient-provider communication and PSA utilization for Black men in the primary care setting.


Options:
A: Decision Self Efficacy (post intervention)
B: The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid. (Month 1-14)
C: Prostate Specific Antigen (PSA) Screening Rates (Up to Month 3); Patient Knowledge Survey Score (Day 1); Decision Quality Score (Day 1); Percentage of Participants Who Make Informed Choice (Day 1)
D: HbA1C (Screening, 3 months post intervention, 6 months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation
Brief Summary: Estimated costs, from thirty days prior to lung transplant up through six months post surgery, exceed 1 million dollars per patient and routine medical costs average approximately fifty thousand dollars per year thereafter. Prior to transplant, lung transplant recipients self restrict activity due to severe respiratory limitations, resulting in reduced muscle mass and qualitative changes in large skeletal muscles. After transplant, despite improved lung function, studies consistently report that lung recipients fail to reach predicted physical function and physical activity. Nearly seventy percent are at risk of developing hypertension within the first five years due to side effects of immunosuppression and an inactive lifestyle worsens this risk. Consequently, full benefits of transplant may not be achieved. Few studies have tested ways to engage lung recipients in self management of exercise and adopt an active lifestyle. Lung Transplant Go LTGO is a behavioral exercise intervention that provides individualized exercise training integrated with behavioral coaching delivered in the recipient's home. Exercise training will focus on assisting lung recipients to learn and practice exercises to reverse muscle conditioning. Behavioral coaching will assist them to develop the skills to self manage physical activity in daily life and maintain this as a sustained habit using strategies that include incremental goal setting, self-monitoring, feedback and problem solving.


Options:
A: Physical Function- Walking: Change in Average Steps Per Day at Month 3 (Baseline and 3 months); Physical Function- Walking: Change in Average Steps Per Day at Month 6 (Baseline and 6 months); Physical Function- Balance: Change in Berg Balance at Month 3 (Baseline and 3 months.); Physical Function- Balance: Change From Baseline to 6 Months (Baseline and 6 months); Physical Function-Lower Body Strength: Change From Baseline to 3 Months (Baseline and 3 months.); Physical Function-Lower Body Strength: Change From Baseline to 6 Months (Baseline and 6 months.); Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months. (Baseline and 3 months.); Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months. (Baseline and 6 months); Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months. (Baseline and 3 months.); Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months. (Baseline and 6 months.)
B: Exercise Shuttle Test (metres completed)
C: maximal exercise capacity (9 months after starting interventions)
D: Change in daily physical activity (Measured for 1 week pre-transplant, measured for 1 week at randomisation (1-2 months post-transplant), 1 week following the 3 month intervention, 1 week at 6 months post randomisation and 1 week at 12 months post-randomisation.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Clinical Trial to Assess the Performance of the Xpert MTB/XDR Assay for INH- and Second-line Resistance Detection
Brief Summary: FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay


Options:
A: Week 73 Efficacy (Week 73 after randomization)
B: Retention in care with viral suppression (48 weeks after HIV testing)
C: Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 6 Months After the End of Treatment. (6 Months post End of Treatment)
D: Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection (Day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease Compared With Alglucosidase Alfa/Placebo
Brief Summary: This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.


Options:
A: Change From Baseline to Week 52 in 6 Minute Walk Distance (6MWD) (Baseline, Week 52)
B: Number of Participants With Adverse Events. (52 weeks)
C: PAP: Change From Baseline in Percent Predicted FVC in Upright Position at Week 49 (Baseline, Week 49)
D: Summary of Patients Reporting Treatment-Emergent Adverse Events (weeks 0-78); Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline (weeks 0, 78); Percent of Predicted Forced Vital Capacity (FVC) (weeks 0, 78); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC) (weeks 0, 12 and 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax) (weeks 0, 12, 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax) (weeks 0, 12, 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: "Make my Day"- Incorporating Healthy Activity Patterns: A Person-centered, Digital Prevention Program to Support Health Among Persons at Risk for Stroke
Brief Summary: The purpose of this study is to evaluate the feasibility of a digital, person-centered stroke prevention program with a focus on primary prevention. The program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke.


Options:
A: Stroke risk score card (Baseline, within a month after the intervention, 1 year follow-up after baseline.); Healthy Activity patterns (PPR profile) (Baseline, within a month after the intervention, 1 year follow-up after baseline.); Questions of Lifestyle habits (Baseline, within a month after the intervention, 1 year follow-up after baseline.); Canadian Occupational Performance Measurement (COPM) (Baseline, within a month after the intervention, 1 year follow-up after baseline.)
B: Glucose area under the curve (0 weeks and 2 weeks)
C: Steps Per Day (Change from Baseline to 3 months (Post)); Steps Per Day (Change from 3 months (Post) to 6 months); Steps Per Day (Change from 3 months (Post) to 12 months)
D: Ambulatory Activity Profile (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation (WeChat), a Randomized Controlled Branch on Antiplatelet of RESCIND Study
Brief Summary: Few studies have attempt to improve DAPT adherence through social media. The investigators will explore the prevalence of DAPT discontinuation and prove the hypothesis that using social media will improve DAPT adherence among patients requiring DAPT following DES implantation.


Options:
A: Adherence (Change in baseline adherence at 3 month and 6 month)
B: Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52. (baseline and after 12 months); Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52 (baseline and after 12 mounth); Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 (baseline and after 12 months)
C: Rate of Discontinuation of Dual Antiplatelet Drug (1 year)
D: Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end. (At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
Brief Summary: "Attempted Suicide Short Intervention Program" (ASSIP) is a brief psychotherapy intervention after suicide attempts in psychiatric patients. The study aims to analyse the efficacy in a controlled trial by comparing number of patients with suicide attempts in a control group with treatment as usual and an intervention group with treatment as usual and ASSIP intervention.

Further, the study aims at indentifying electrophysiological, sociodempgraphical or smartphone-derived parameters for prediction of further suicide attempts.


Options:
A: suicide/attempted suicide (12 months)
B: Suicidal thoughts or attempts (Measured at Year 2)
C: Rate of suicide attempts (Annual)
D: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
Brief Summary: "Attempted Suicide Short Intervention Program" (ASSIP) is a brief psychotherapy intervention after suicide attempts in psychiatric patients. The study aims to analyse the efficacy in a controlled trial by comparing number of patients with suicide attempts in a control group with treatment as usual and an intervention group with treatment as usual and ASSIP intervention.

Further, the study aims at indentifying electrophysiological, sociodempgraphical or smartphone-derived parameters for prediction of further suicide attempts.


Options:
A: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
B: 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)
C: BSSI score (Day 3)
D: suicide/attempted suicide (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
Brief Summary: "Attempted Suicide Short Intervention Program" (ASSIP) is a brief psychotherapy intervention after suicide attempts in psychiatric patients. The study aims to analyse the efficacy in a controlled trial by comparing number of patients with suicide attempts in a control group with treatment as usual and an intervention group with treatment as usual and ASSIP intervention.

Further, the study aims at indentifying electrophysiological, sociodempgraphical or smartphone-derived parameters for prediction of further suicide attempts.


Options:
A: suicide/attempted suicide (12 months)
B: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
C: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6 (Baseline, Week 1, Week 2, Week 3, Week 4, Week 5)
D: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Control Trial of Postpartum Visits at Two or Six Weeks to Evaluate Clinic Attendance and Emergency Department Usage
Brief Summary: The purpose of this study is to determine if shortening the time to initial postpartum visit from six weeks to two weeks can improve clinic visit attendance and decrease usage of the emergency department.


Options:
A: Attendance at one or more routine postpartum visits (8 weeks postpartum)
B: Number of eligible participants who consent and complete study intervention (1-4 days postpartum)
C: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
D: % of mothers who know at last 3 danger signs (2 years); % of VHSG who know 6 danger signs (2 years); % of families who seek care from an appropriate facility (2 years); Time between onset of suspected danger signs and referral to appropriate facility (2 years); Improved hygiene behavior by family (2 years); Improved infection control behavior among HC staff (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Brief Summary: This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.


Options:
A: Group difference in pain intensity (6 weeks after baseline); Change from baseline in intra-network connectivity in the Default Mode Network (6 months after baseline)
B: Responder Rate (3 months post-activation)
C: Visual Analog Scale (VAS) on Back Pain (12 weeks)
D: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Brief Summary: This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.


Options:
A: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
B: Pain intensity according to numeric rating scale (NRS) (3 months after implantation)
C: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
D: Evaluation of pain (28 days)

Answer: A