TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination Therapy
Brief Summary: Prospective, non-randomized multicenter study on the safety and efficacy of combination therapy with bendamustine and rituximab for chronic cold agglutinin disease.


Options:
A: LDH (From baseline to 26 weeks)
B: Frequency of complete and partial responses (CR/PR) (6 months)
C: Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb) (Up to Week 20 of the double-blind period)
D: overall response (month +2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.


Options:
A: 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)
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: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
D: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.


Options:
A: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
B: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)
C: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
D: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) (Week 16); Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) (Week 44)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.


Options:
A: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
B: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)
C: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
D: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Incentivizing Behavior Change Skills to Promote Weight Loss
Brief Summary: The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.


Options:
A: Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Adjusting Amount Task) (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Monetary Choice Questionnaire) (Phase II baseline to 2 months and 4 months (end of treatment))
B: Weight Loss (Omron Weight Balance) (12 weeks)
C: Weight maintenance 12 months after weight loss intervention (15 months)
D: Weight Change From Baseline to 24 Weeks (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Incentivizing Behavior Change Skills to Promote Weight Loss
Brief Summary: The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.


Options:
A: Proportion of participants who receive an HIV test at a community health campaign between intervention groups (6-8 weeks after enrollment; annually); Proportion of participants with HIV RNA <400 copies/mL between intervention groups (6 months after enrollment); Proportion of participants randomized to loss aversion trial who make a deposit (At enrollment); Proportion of participants who complete all HIV retest visits at study venue (6 months)
B: HIV viral suppression at 6 months (6 months)
C: Weight Change From Baseline to 24 Weeks (24 weeks)
D: HIV Incidence (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause
Brief Summary: This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.


Options:
A: Vaginal Dryness (6 months)
B: Prolapse symptom score (POP-SS) (7 months)
C: Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. (baseline and 2-12 weeks after treatment (at time of surgery))
D: Vaginal Wall Composition: Epithelium (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Epithelium (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Muscularis (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Muscularis (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); hCOL1A1, Per-Protocol (Time of surgery, i.e. after 6-8 weeks of intervention); Total Collagen Content in Vaginal Muscularis, (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Degradative Activity, Muscularis, MMP-9 (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Lamina Propria (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Lamina Propria (Per-Protocol) (Time of surgery, i.e. 6-8 weeks of intervention); hCOL3, (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Lysyl Oxidase (LOX) (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); LOXL1 (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Tropoelastin (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); TGFB1 (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Degradative Activity, Mucosa, MMP-9 (Time of surgery, i.e. after 6-8 weeks of intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause
Brief Summary: This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.


Options:
A: Vascular function (0 and 6 months)
B: Relief of vaginal symptoms (following 12 weeks of treatment.)
C: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)
D: Vaginal Dryness (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Same Day Community-based ART Initiation Versus Clinic-based Pre-ART Assessment and Counselling for Individuals Newly Tested HIV-positive During Community-based HIV Testing in Rural Lesotho - a Randomized Controlled Trial
Brief Summary: The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural Lesotho. Participants who were tested HIV-positive during community-based HIV testing and counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1 with parallel assignment.

Participants in the control arm follow the standard of care after a community-based HIV test result: They are referred to the nearest clinic where they will receive baseline laboratory testing and adherence counseling. After at least 2 clinic visits for adherence counseling they can start anti-retroviral therapy (ART). After ART-initiation they have to attend monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention arm are proposed same day community-based ART initiation combined with less frequent follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression at 12 months after having tested HIV-positive during the community-based HIV testing and counseling campaigns.


Options:
A: Proportion non-pregnant subjects virally suppressed at routine six-month viral load (10 months after study enrollment); Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery (Up to 9 months after study enrollment)
B: Uptake of initial and repeat HIV counselling and testing (Feasibility phase) (14 months); Uptake of ARV treatment among HIV-infected individuals (Feasibility phase) (14 months); HIV infection incidence (4 years after enrolment initiation)
C: Percent of Participants Who Survived Without AIDS Progression. (Through week 48)
D: Linkage to care (90 days); Viral suppression (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Accessibility and Utility of HIV-related Point of Care Diagnostic for Maternal Health in Rural South Africa
Brief Summary: Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South Africa during the last 10-15 years. The investigators sought to determine the existing availability, current usage and future need of POC tests among rural primary healthcare (PHC) clinics in South Africa's KwaZulu-Natal Province.


Options:
A: The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection (up to 6 months); the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up. (3 months after treatment initiation)
B: Proportion of infants tested at birth (0-4 weeks); Proportion of infants tested at 6-weeks (4-12 weeks postpartum)
C: Accessibility and availability (Three months)
D: Specificity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID); Sensitivity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults
Brief Summary: The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting and reducing total sitting time. The goal of the study is to find out if a sitting time reduction intervention reduces sitting time compared with a control group.


Options:
A: Body Fat (36 Months)
B: Change in sedentary behavior during the workday (Baseline - week 8)
C: Incidence of CHD and other lifestyle related diseases after ten years (2012)
D: Change in Hours of Sitting Time (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults
Brief Summary: The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting and reducing total sitting time. The goal of the study is to find out if a sitting time reduction intervention reduces sitting time compared with a control group.


Options:
A: Change in Hours of Sitting Time (12 weeks)
B: Number of myPAtHS exercise sessions. (12 weeks & 24 weeks); Time spent doing the myPAtHS exercise programme. (12 weeks & 24 weeks)
C: Change in objective total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in objective sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months))
D: Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth) (Assessed post-study-endpoint (up to month 18)); Intervention adherence to goals (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is cancelled or delayed for too long (Assessed post-study-endpoint (up to month 18)); Retention rates (% of participants randomised who provide data at follow-up) (Assessed post-study-endpoint (up to month 18)); Acceptability of intervention for participants (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Practicality of intervention for participants (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Participant satisfaction with the study (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Patient perception of the safety of the study as assessed by questionnaire (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.


Options:
A: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))
B: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
C: 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)
D: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke (Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Brief Summary: Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.


Options:
A: Number of Participants With Surgical Site Infection (30 days)
B: Number of Subjects with post cesarean endometritis (48 hours)
C: rates of endometritis (2.5 years)
D: Bacterial Load (Immediately Post-operative prior to exit from operating room)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Mobile Phone-based Text Message Interventions ('Happy Quit') for Smoking Cessation in China
Brief Summary: The primary objective of this proposed three-year (January 01, 2016 to December 31, 2018) project is to assess whether a program of widely accessed mobile phone-based text message interventions ('Happy Quit') will be effective at helping people in China who smoke, to quit. Based on the efficacy of previous studies in smoking cessation, it is hypothesized that 'Happy Quit' will be an effective, feasible and affordable smoking cessation program in China.


Options:
A: Quit smoking status (1, 3, and 6 month follow up)
B: Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (12-weeks post-quit day)
C: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)
D: The primary outcome will be self-reported and biologically verified continuous smoking abstinence. (Six month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Baduanjin Exercise Prevents Post-Myocardial Infarction Left Ventricular Remodeling (BE-PREMIER Trial)
Brief Summary: Left ventricular (LV) remodeling following myocardial infarction (MI) is an established prognostic factor for adverse cardiovascular events and the leading cause of heart failure. Empirical observations suggests that Baduanjin exercise, an important component of traditional Chinese Qigong, exert potential impacts on cardiopulmonary function. However, the impact of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. The aim of this trail is to evaluate whether Baduanjin exercise would prevent the maladaptive progression to adverse LV remodeling in patients following MI.


Options:
A: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)
B: Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test (Functional capacity measured by walked distance in the ISWT at 6 months)
C: the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi) (baseline and 6 months)
D: Medication adherence (12 months post-MI); Cardiac rehabilitation completion (12 months post-MI)

Answer: C