TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Brief Summary: REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.

In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.


Options:
A: All-cause mortality (Day 90); Days alive and not receiving organ support in ICU (Day 21)
B: N/A
C: COVID Ordinal Outcomes Scale at 14 Days (Assessed once on day 14 after enrollment (enrollment is day 0))
D: time to fever control (15 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Brief Summary: REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.

In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.


Options:
A: Time to Recovery (Day 1 through Day 29); Time to Recovery by Race (Day 1 through Day 29); Time to Recovery by Ethnicity (Day 1 through Day 29); Time to Recovery by Sex (Day 1 through Day 29)
B: Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) (Week 52)
C: Survival without needs of ventilator utilization at day 14 (14 days); WHO progression scale ≤ 5 (4 days); Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14 (14 days); Decrease of at least one point in WHO progression scale score (4 days)
D: All-cause mortality (Day 90); Days alive and not receiving organ support in ICU (Day 21)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Brief Summary: REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.

In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.


Options:
A: Transfusion-related Serious Adverse Events (14 days after randomization)
B: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score (Study Day 15)
C: All-cause mortality (Day 90); Days alive and not receiving organ support in ICU (Day 21)
D: Requirement for invasive ventilation (through study completion up to 28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Brief Summary: REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.

In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.


Options:
A: Rate of COVID-19 progression (days 1 to 14.)
B: All-cause mortality (Day 90); Days alive and not receiving organ support in ICU (Day 21)
C: Development of severe respiratory disease defined as a respiratory rate (RR)>30 and/or an O2 sat<93% (From 12 hours post infusion to day 15 post infusion)
D: Proportion of patients remaining free of mechanical ventilation in both groups (Day 7)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?
Brief Summary: To determine if a balloon tamponade catheter filled with cold saline is more effective than a catheter filled with room temperature saline in controlling post partum hemorrhage.


Options:
A: Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes (during hospital stay)
B: Total measured blood loss (time frame is approximately 24 hours, until the balloon catheter is removed from the uterus)
C: Safety of Tampostat as measured by number of serious adverse events in primary PPH management (2 months); Efficacy of Tampostat as measured by number of successful cases in arresting bleeding in Primary PPH (12 months); Comparison of the efficacy of Tampostat as measured by number of successful cases in arresting primary PPH and the time takes to arrest the bleeding with that of the condom catheter tamponade (12 months)
D: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone in Patients With Locally/Regionally Advanced/Recurrent Melanoma: A Randomized Efficacy, Safety and Biomarker Study
Brief Summary: This study plans to test the pathologic complete response (pCR) rate of the combination biotherapy regimen consisting of nivolumab plus ipilimumab versus nivolumab alone in patients with advanced but operable melanoma. Evaluation of the presence of tumor-infiltrating CD8+ T cells as well as that of PDL1 expression and IDO expression will be associated with clinical response (pathologic and/or radiologic). The study will test the radiologic/clinical preoperative response rate, recurrence free survival (RFS) and overall survival (OS). It will evaluate the safety of neoadjuvant nivolumab and neoadjuvant nivolumab-ipilimumab. Up to 66 patients will be randomized in 1:1 ratio.


Options:
A: The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Safety as measured by SUSARs. (12 weeks from baseline); The alteration in breadth of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Feasibility as measured adherence to the timelines in the study protocol. (12 weeks from baseline)
B: Percent of patients who actually become resectable and are resected (Following 18 weeks of combined treatment)
C: Assess the pathologic complete response rate (absence of viable tumor on histologic assessment) (5 years)
D: Ganglioside Expressed by Tumor Cells (GD2) (up to 1 week); Recurrence Free Survival (RFS) (up to 24 months); Overall Survival (OS) (up to 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone in Patients With Locally/Regionally Advanced/Recurrent Melanoma: A Randomized Efficacy, Safety and Biomarker Study
Brief Summary: This study plans to test the pathologic complete response (pCR) rate of the combination biotherapy regimen consisting of nivolumab plus ipilimumab versus nivolumab alone in patients with advanced but operable melanoma. Evaluation of the presence of tumor-infiltrating CD8+ T cells as well as that of PDL1 expression and IDO expression will be associated with clinical response (pathologic and/or radiologic). The study will test the radiologic/clinical preoperative response rate, recurrence free survival (RFS) and overall survival (OS). It will evaluate the safety of neoadjuvant nivolumab and neoadjuvant nivolumab-ipilimumab. Up to 66 patients will be randomized in 1:1 ratio.


Options:
A: Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO) (Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)); Percentage of Participants With Overall Survival (OS) at 12 Months (Month 12)
B: Assess the pathologic complete response rate (absence of viable tumor on histologic assessment) (5 years)
C: Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) (From first treatment through September 27, 2010)
D: Pathological response rate (From baseline to 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)
Brief Summary: This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.


Options:
A: Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) (Week 16); Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) (Week 16)
B: Proportion of Participants Who Had Relapse During the Entire Week 36 Period (Week 36)
C: Percent of Participants Who Were Histologic Responders (Week 16); Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation (Baseline, Week 16)
D: Percent of Participants Who Responded to Therapy (12 weeks after the start of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
Brief Summary: The purpose of this research is to observe the efficacy of Naltrexone and Bupropion combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.


Options:
A: Change From Baseline in Weight at 24 Weeks (baseline and 24 weeks)
B: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
C: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
D: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
Brief Summary: The purpose of this research is to observe the efficacy of Naltrexone and Bupropion combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.


Options:
A: Body Mass Index (BMI) Z-score Change (Change from baseline to 24 weeks)
B: Change in Weight (Measured at each visit from baseline to end of study over a 12 week period)
C: Change From Baseline in Weight at 24 Weeks (baseline and 24 weeks)
D: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks (8 weeks); Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. (8 weeks); Change From Baseline in PANSS Negative Symptom Subscale at Week 8 (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Intensity Weight Loss for Young Adults
Brief Summary: This is a 3-arm randomized controlled trial to test the efficacy of three novel motivational approaches to weight loss with 18-25 year olds. Participants will be 18-25 year olds with a BMI of 25-45 kg/m2, randomized to: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a 6-month behavioral weight loss intervention, followed by a 6-month no-treatment follow up period.


Options:
A: Adherence to the trial (6 months); Adherence to the intervention arms (6 months)
B: Weight Loss (6 Months); Percent Weight Loss (6 Months); Change in Body Mass Index (6 Months)
C: Weight (Baseline to 6-Months)
D: Change in Weight from Baseline to 6 Months (Baseline and 6 Months); Change in Weight from Baseline to 30 Months (Baseline and 30 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: the Sequential Therapy of CD19-targeted and CD20-targeted CAR-T Cell Therapy for Diffuse Large B Cell Lymphoma(DLBCL)
Brief Summary: The main purpose of this study is to explore the sequential therapeutic effect of CD19-targeted and CD20-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Diffuse Large B Cell Lymphoma(DLBCL)


Options:
A: Treatment-related adverse events (AEs) as assessed by CTCAE v4.03 (Up to 730 days after the final JCAR017 infusion); Dose-limiting toxicities of JCAR017 (28 days after first (single-dose schedule) or second (2-dose schedule) JCAR017 infusion); Objective response rate (ORR) (24 months)
B: Overall Response Rate (ORR) (From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
C: Percentage of Participants With Overall Remission Rate (ORR) as Determined by Independent Review Committee (IRC) Assessment. (during the 3 months after tisagenlecleucel administration)
D: Adverse Events That Are Related to Treatment (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
Brief Summary: This study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Improvement of each disease is evaluated between smoking cessation intervention group and non-cessation intervention group.


Options:
A: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
B: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
C: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
D: Pocket depth in peridontitis (Change from baseline at 12 months); Per-implant marginal bone loss (Change from baseline at 12 months); Size reduction of oral mucosal diseases (Change from baseline at 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit)
Brief Summary: This study evaluates the relationship between several genetic variants and the response to a hypocaloric diet, in order to design a genetic test which permits prescribe the more personalized diet for each individual according to her genotype. Half of the participants will assigned to a moderate high protein diet, while the other half will assigned to a high carbohydrate diet.


Options:
A: Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. (After 3 months of intervention)
B: Change in body weight at Week 16 (Baseline and 16 Weeks); Change in body weight at Week 40 (16 Weeks and 40 Weeks)
C: body weight (12 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
Brief Summary: This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.


Options:
A: Change in 30-Second Chair Stand Test (Change from day 0 to day 10)
B: Step Length Symmetry (Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.)
C: Retention Rate (3 months); Dose Goal Attainment (3 months); Acceptability (3 months); Study-Related Adverse Events (3 months)
D: Prosthetic Limb Users Survey of Mobility (PLUS-M) (5-10 minutes); Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (5-10 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
Brief Summary: Primary Objective:

To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.

Secondary Objectives:

Change From Baseline in HbA1c to Week 12

To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:

* Change in Fasting plasma glucose (FPG);
* Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;
* Percentage of participants reaching HbA1c targets \<7% or ≤6.5%;
* Percentage of participants reaching HbA1c targets \<7% or ≤6.5% without severe and/or confirmed hypoglycemia
* Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia.

To assess the safety in each treatment group.

To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).

Percentage of participants requiring rescue therapy.


Options:
A: Change From Baseline in HbA1c to Week 24 (Baseline, Week 24)
B: HbA1c (Recorded at baseline (week 0), week 12, week 24 and week 36)
C: Change in HbA1c (percentage %) (Baseline to 6 Months)
D: Health Assessment, Patient treatment satisfaction and Quality-of-Life (At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Normal Voiding Function After Surgical Repair of Pelvic Organ Prolapse: A Randomized Trial Comparing Day of Surgery Retrograde Void Trials to Standard Postoperative Day One Retrograde Void Trials
Brief Summary: The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.


Options:
A: time to return of normal bladder function (5 days)
B: Re-insertion rate of urinary catheter after removal (after removal of urinary catheter)
C: Post-operative urinary retention requiring re-catheterisation (1 day following urethral catheter removal)
D: all cause mortality (one year)

Answer: A