TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs).


Options:
A: Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) (Baseline, Week 6)
B: Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) (Baseline up to Week 16 (End of Study (EoS])); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) (Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) (Baseline, Week 8 (2 Weeks of Follow Up))
C: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and week 12 to 16)
D: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)


Options:
A: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)
B: Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) (Baseline (Day 1) and Week 24 to Week 28)
C: Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period (Pre-treatment; Week 6)
D: Maximum change in hemoglobin by Week 9 from baseline (Week 9)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)


Options:
A: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to 176 weeks)
B: Summary of Hemoglobin (Hgb) Concentration at Week 24 (Week 24)
C: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants (Weeks 40 to 52)
D: Rate of rise in Hb (Hemoglobin) level (g/dL/week) (Up to 8 weeks); Responder rate: proportion of responders among the subjects (Week 21 to 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study Testing Nivolumab and Ipilimumab Versus a Carboplatin Based Doublet in First Line Treatment of PS 2 or Elderly (More Than 70 Years Old) Patients With Advanced Non-small Cell Lung Cancer
Brief Summary: Lung cancer is the most common cancer in the world and the leading cause of cancer-related deaths in Western countries. Unfortunately, at the time of diagnosis, the majority of patients already have metastatic disease and a systemic, palliative treatment is the primary therapeutic option.

Guidelines for PS 2 patients or older than 75 years old patients at the time of diagnosis recommend for fit patients a carboplatin doublet chemotherapy.

Nivolumab has proven efficacy in 3rd line squamous cell lung carcinoma and is superior to chemotherapy in 2nd line treatment of squamous and non-squamous lung cancer in term of overall survival.

In 1st line, nivolumab failed to show superiority compared to a platin based doublet in terms of progression free survival and overall survival in tumors ≥ 5% PD-L1 expression. The association Nivolumab plus Ipilimumab showed encouraging results in first line setting in phase 1 study.

The investigators think that with regard to the manageable toxicity of nivolumab in lung cancer population and the possibility to obtain long responses, this association could be a valid option for this population of elderly and/or PS2 patients in term of overall survival.


Options:
A: Overall survival (From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 3 years maximum)
B: Length of survival
C: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy
Brief Summary: 1. Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months
2. Identify the most effective cash transfer size to increase the proportion of people living with HIV infection (PLHIV) retained in care and with suppressed viral load (\<1000 copies/ml) after 6 months. (This amount will be further evaluated in a cluster randomized trial in Phase 2).


Options:
A: Employment (36 months)
B: HIV viral suppression at 6 months (6 months)
C: HIV Viral Suppression (12 months)
D: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy
Brief Summary: 1. Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months
2. Identify the most effective cash transfer size to increase the proportion of people living with HIV infection (PLHIV) retained in care and with suppressed viral load (\<1000 copies/ml) after 6 months. (This amount will be further evaluated in a cluster randomized trial in Phase 2).


Options:
A: Receipt of two or more home visits from an FLW in the final trimester of pregnancy and delivery at a facility (versus home birth), using maternal survey response (2 year follow-up); Receipt of any postnatal home visits from an FLW (in the first 24 hours at home after delivery and in first month following delivery), using maternal survey response (2 year follow-up); Any complementary feeding of solid or semisolid food for infants aged 6-11 months, using maternal survey response (2 year follow-up); Immunizations (2 year follow-up); Receipt of iron-folic acid tablets by month 4 and consumption of at least 90 tablets, using maternal survey response (2 year follow-up); Clean Cord Care (2 year follow-up); Kangaroo Mother Care (skin to skin care) (2 year follow-up); Delayed Bath (2 year follow-up); Initiation of Breastfeeding (2 year follow-up); Nothing applied to cord or umbilicus (2 year follow-up); Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact (2 year follow-up); First bath delayed by two or more days (2 year follow-up); Breastfed child within one hour of birth (2 year follow-up)
B: HIV viral suppression at 6 months (6 months)
C: In-hospital case-fatality
D: Change in recovery rate of acute malnutrition in children below five years old over two years (26 months from baseline; endline survey in December 2016); Difference in prevalence of acute malnutrition among children aged 6-23 months between Dec 2014 and Dec 2016 (Two years from baseline; endline survey in December 2016)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ACTonHEALTH Study Protocol: Promoting Psychological Flexibility With Activity Tracker and mHealth Tools to Foster Healthy Lifestyle for Obesity and Other Chronic Health Conditions
Brief Summary: Obesity and overweight are growing steadily and becoming a global epidemic. Recent researches report a 64% of the adult population as overweight. The social and economical impact is increasing and the most of the rehabilitation programs, while effective in the short term, do not produce long lasting results. From a behavioral perspective an explanatory model can describe the phenomena with the lack of sources of reinforcement related to healthy habits in the daily-life context. The goal of this project, combining Acceptance and Commitment Therapy and Wearable Technology, is to develop an effective intervention, efficient and sustainable, which continues after ending of the hospitalization, providing adequate contingencies of reinforcement in the natural environment, integrating systematic measurements, continuous feedbacks and individualized, values-based objectives. Related goal-setting show a shift from results linked with weight loss towards action connected with healthy life-style.


Options:
A: Change in weight (6 and 12 months)
B: Weight change (kg) (Baseline, 4, 8, 12 weeks); Waist circumference change (cm) (Baseline, 12 weeks); BMI change (kg/m^2) (Baseline, 4, 8, 12 weeks); Physical activity change (self-reported - IPAQ-SF, MET-hours/week) (Baseline, 12 weeks); Physical activity change (automatically tracked - steps/week) (Baseline, 4, 8, 12 weeks); Dietary caloric intake change (Baseline, 12 weeks)
C: Physical Activity directly measured by wearable devices Daily STEPS Count (Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -)
D: Changes from baseline BMI (At baseline (0 years) and followed for 2 years); Changes from baseline Fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Free-fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Muscular Mass (At baseline (0 years) and followed for 2 years); Changes from baseline Corporal Water (At baseline (0 years) and followed for 2 years); Adherence to dietary pattern will be also measured through personal interview (At baseline (0 years) and followed for 2 years); Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire) (At baseline (0 years) and followed for 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BRCA Founder OutReach (BFOR) Study
Brief Summary: The purpose of this study is to learn how to provide BRCA gene testing to a larger number of people as well as to make testing part of a person's regular medical care.


Options:
A: Proportion of respondents who will complete the 3-month follow-up (Finish all telephone survey by Jan 2018)
B: Response rate (up to 10 weeks after receiving the questionnaire)
C: Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing (Up to 1 year); Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff (Up to 1 year); Psychosocial impact of genetic population screening utilizing a digital health solution (Up to 1 year); Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process (Up to 1 year); Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication (Up to 1 year)
D: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
Brief Summary: There are difficulties in the progress of the study and cancel the plan. The purpose of this study is to evaluate the postoperative pain control using non - opioidal analgesics in children. The investigators will investigate the effect of single use and combination of caldorol(ibuprofen) compare to denogan(propacetamol) in children.

Participants who receive the laparoscopic inguinal hernia repair between 6 months and 6 years old are divided 3 groups(caldolor, denogan, combination). Each groups are received a medication by protocol during surgery. After operation patient's pain score and use of additional analgesics are recorded in postanesthesia care unit and general ward.


Options:
A: Pain Severity (Average pain score will be collected for preoperative visit (the day before surgery)); Pain Severity (Average pain score was collected for postoperative day 1); Pain Severity (Average pain score will be collected for postoperative day 2); Pain Severity (Average pain score will be collected for postoperative day 3); Pain Severity (Average pain score will be collected for postoperative day 4); Pain Severity (Average pain score will be collected for postoperative day 5); Pain Severity (Average pain score will be collected for postoperative day 6); Pain Severity (Average pain score will be collected for postoperative day 7); Medication Log (Postoperative day 1 to 7)
B: additional administration of analgesics (during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour)
C: Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. (6 hours)
D: Post-ERCP Pancreatitis (2 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial
Brief Summary: This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.


Options:
A: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
B: Overall Survival (OS) (From date of randomizationrandomization to date of death from any cause assessed up to 40 months); Progression-free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months)
C: Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) (3 years)
D: Phase I Primary Objective: MTD (4 months); Phase II Primary Objective: PFS (from the date of randomization to the date of documented progression disease, recurrence or death (whichever occurs first), assessed up to 64 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of A New Crosslinked Hyaluronan Gel in the Prevention of Postoperative Intrauterine Adhesion After Dilatation and Curettage in Women With Delayed Miscarriage: A Prospective, Randomized, Controlled Trial
Brief Summary: Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.


Options:
A: Complete abortion (14 days)
B: Incidence of intrauterine adhesion (3 months after dilatation and curettage)
C: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)
D: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study
Brief Summary: To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.


Options:
A: Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment (16 weeks (end of treatment)); Change in the Severity of Depression Symptoms Between Intake and End of Treatment (16 weeks (end of treatment))
B: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
C: Deliberate Self-Harm Inventory Youth version (DSHI-Y) (Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended)
D: suicide/attempted suicide (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study
Brief Summary: To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.


Options:
A: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
B: Delay of recurrence of suicide attempt (6 months)
C: Suicide Attempts (Assessed bimonthly)
D: Deliberate Self-Harm Inventory Youth version (DSHI-Y) (Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Nutrition-Based Approach to Reduce Heart Disease Risk Among Overweight African Americans: Use of Soul Food Plant-Based or Omnivorous Diets to Address Cardiovascular Disease
Brief Summary: This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in:

1. Risk factors for CVD, including LDL cholesterol and blood pressure; and
2. Body weight.

   Secondary Aim
3. Examine long-term changes in CVD risk factors and body weight at 24 months.


Options:
A: Cardiovascular Disease Prevention based on dietary approach. (Two years)
B: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)
C: Gut microbiome composition measured by 16S rRNA gene sequencing (Week 0 and week 4 of each intervention); 75g OGTT derived plasma glucose iAUC (Week 0 and week 4 of each intervention)
D: Percent Change in Postprandial Glucose Levels (12 weeks); Percent Change in Fasting Glucose Levels (12 weeks); Percent Change in Body Weight (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Nutrition-Based Approach to Reduce Heart Disease Risk Among Overweight African Americans: Use of Soul Food Plant-Based or Omnivorous Diets to Address Cardiovascular Disease
Brief Summary: This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in:

1. Risk factors for CVD, including LDL cholesterol and blood pressure; and
2. Body weight.

   Secondary Aim
3. Examine long-term changes in CVD risk factors and body weight at 24 months.


Options:
A: body weight (prior to and after 4, 8, and 12 months of dieting)
B: Physical function (Baseline, 4, 6, and 9 months); Lean Mass (Baseline, 4, 6, and 9 months)
C: Hemoglobin A1c (Change from baseline to 3 months)
D: Cardiovascular Disease Prevention based on dietary approach. (Two years)

Answer: D