TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection
Brief Summary: This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.


Options:
A: Percentage of Participants Achieving SVR12 (Post-treatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
B: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 (Baseline and Day 15)
C: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants (Posttreatment Week 12); Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
D: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection
Brief Summary: This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants (Posttreatment Week 12); Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
C: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 (Baseline and Day 15)
D: Percentage of Participants Achieving SVR12 (Post-treatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan
Brief Summary: Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day


Options:
A: Change in Hb from baseline to the average level (Weeks 7 to 9 inclusive.)
B: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)
C: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and weeks 14 to 17)
D: 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))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Use Of Hydroxyurea in an African Region With Malaria
Brief Summary: Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute painful episodes and reducing the need for blood transfusions in children with sickle cell anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan Africa, the areas with the most children with SCA.

The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for children with SCA in a malaria endemic region within sub-Saharan Africa.


Options:
A: Number of Malaria Episodes (12 months)
B: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
C: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
D: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Use Of Hydroxyurea in an African Region With Malaria
Brief Summary: Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute painful episodes and reducing the need for blood transfusions in children with sickle cell anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan Africa, the areas with the most children with SCA.

The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for children with SCA in a malaria endemic region within sub-Saharan Africa.


Options:
A: Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function (Baseline up to Day 29); Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease (Baseline up to 30 days post last dose on Day 29); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 to 30 days post last dose on Day 29); Number of Participants With Laboratory Test Abnormalities (Baseline up to 30 days post last dose on Day 29)
B: Proportion of children with average hemoglobin ≥9.0 g/dL or average HbF ≥20% (Over 24 month period on study drug)
C: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
D: Number of Malaria Episodes (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Effect of Folic Acid and 5-methyltetrahydrofolate (5MTHF) on Serum Folate and Homocysteine Levels, and Abortion Rates in Women Suffering From Recurrent Abortion
Brief Summary: Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein level more efficiently than folic acid. On the other hand, folic acid is currently an important part of treatment in idiopathic recurrent abortion. There is no study comparing the effectiveness of these supplements in the treatment of recurrent abortion. The aim of this study is to compare the efficiency of these two agents in the treatment of recurrent abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or 5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two groups.


Options:
A: Infant Mortality Through 6 mo of Age (6-months post-birth)
B: Fetal loss, low birth weight and pre-term birth. (Delivery)
C: Recurrence of cleft lip and palate (3 months)
D: ongoing pregnancy on the 20th week of gestational age (20th week of gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Brief Summary: The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS) on patients with low ovarian reserve in an effort to improve success during in vitro fertilization and decrease the time to successful pregnancy.


Options:
A: Implantation ratio (Six months); Clinical pregnancy ratio (six months); Live birth ratio (six months)
B: Live birth rate per initiated cycle (up to 42 days of a live birth)
C: Clinical pregnancy (At 7 - 8 gestational weeks)
D: Delivery rate (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Brief Summary: The objective of this randomised controlled trial (RCT) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers)


Options:
A: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)
B: EPDS (3 and 6 months)
C: Hamilton depression rating Scale (HAM-D) (baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally)
D: incidence of dually diagnosed participants (1 year); anxiety or depression (1 year); blood glucose control (1 year); blood pressure (1 year); cholesterol (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin
Brief Summary: This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.


Options:
A: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)
B: 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 Week 208)
C: 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)
D: Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) (Baseline, Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.
Brief Summary: This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.


Options:
A: Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 (Baseline (Day 1, Week 0) and Week 28 to Week 52.)
B: Summary of Hemoglobin (Hgb) Concentration at Week 24 (Week 24)
C: Percentage of Participants Achieving a Successful Hemoglobin Response (Weeks 19 and 20)
D: Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment (Baseline (pre-dose on Day 1) and up to week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30
Brief Summary: Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.


Options:
A: Scar Quality at 6 Months Postoperative (6 months); Time to Perform Wound Closure (intraoperatively)
B: Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. (4-8 weeks post-surgery)
C: Decrease in wound complications after appendectomy (1-30 days after surgery)
D: Surgical site infection (30 days after the operative procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
Brief Summary: We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.


Options:
A: Time to first ICD shock following LVAD implant (Within 12 months following LVAD implant)
B: To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change. (24 Month)
C: Primary outcome is a composite of all cause total mortality and hospitalization for CHF (Study end)
D: Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. (Median follow-up estimated to be 10.7 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing in Vitro Fertilization Treatment
Brief Summary: Implantation failure remains one of the major factors limiting success in IVF treatment. It was postulated that the local injury to endometrium induces secretions of cytokines and growth factors such as leukemia inhibitory factor, interleukin-11, and heparin-binding EGF-like growth factor which enhance decidualisation and facilitate implantation. It may also up-regulate the gene expressions related to endometrial receptivity and optimize the endometrial development. In stimulated cycles, local injury to the proliferative endometrium has been postulated to delay endometrial development thereby inducing synchronicity between endometrium and embryo stage and facilitate implantation (Zhou et al, 2008; Almog et al, 2010; Gnainsky et al, 2010) The aim of the study is to determine whether endometrial injury by endometrial biopsy in mid-secretory phase of the preceding cycle would improve the on-going pregnancy rate in subfertile women undergoing IVF treatment.


Options:
A: Ongoing pregnancy rate (10-12 weeks gestation)
B: Rate of clinical pregnancy (5 weeks after the embryo implantation in an IVF procedure)
C: Pregnancy Rate (12 weeks)
D: Positive Pregnancy Test (12 to 14 days after embryo transfer); Clinical Pregnancy (5 weeks of pregnancy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MANAGE AT WORK: Evaluation of a Group-based Self-management Program to Address Workplace Discomfort and Fatigue Associated With Chronic Physical Health Conditions
Brief Summary: The specific aim of the study is to evaluate the health benefits of a series of group workshops designed for workers with chronic physical health conditions. The facilitated workshops apply principles of pain and illness self-management to help workers deal with health-related challenges while at work. The workshops address issues of pain management, physical job demands, pacing of work, communication, problem solving, and coping. Half of the participants in the study will be randomly assigned to attend workshop sessions (10 hours total), and all study participants will be followed for one year. The primary hypothesis is that workers who participate in these workshops will show improvements in work engagement and reductions in work limitation in the subsequent 12 months.


Options:
A: Change on Perceived Stress Scale 14 (PSS-14) (Change from baseline on PSS-14 (3 or 6 weeks depending on the study condition)); Change on Perceived Stress Scale 14 (PSS-14) (Change from baseline on PSS-14 (6 months)); Change on Perceived Stress Scale 14 (PSS-14) (Change from baseline on PSS-14 (12 months)); Change on Oldenburg Burnout Inventory (OLBI) (Change from baseline on OLBI (3 or 6 weeks depending on the study condition)); Change on Oldenburg Burnout Inventory (OLBI) (Change from baseline on OLBI (6 months)); Change on Oldenburg Burnout Inventory (OLBI) (Change from baseline on OLBI (12 months))
B: Work limitations (One year); Work engagement (One year)
C: Change in scores on Caregiver Distress (HADS) from baseline (Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].); Change in scores on Caregiver Burden (ZBI-12) from baseline (Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
D: change in self reported Stress symptoms (Baseline, 1 month, 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MANAGE AT WORK: Evaluation of a Group-based Self-management Program to Address Workplace Discomfort and Fatigue Associated With Chronic Physical Health Conditions
Brief Summary: The specific aim of the study is to evaluate the health benefits of a series of group workshops designed for workers with chronic physical health conditions. The facilitated workshops apply principles of pain and illness self-management to help workers deal with health-related challenges while at work. The workshops address issues of pain management, physical job demands, pacing of work, communication, problem solving, and coping. Half of the participants in the study will be randomly assigned to attend workshop sessions (10 hours total), and all study participants will be followed for one year. The primary hypothesis is that workers who participate in these workshops will show improvements in work engagement and reductions in work limitation in the subsequent 12 months.


Options:
A: Change in Hemoglobin A1C (Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.); Change in Patient Health Questionnaires-9 During Intervention (PHQ-9 will be assessed at baseline, 6-, and 12- months.)
B: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
C: Overall functioning (18 months); Incremental cost-effectiveness ratio (ICER) (18 months)
D: Work limitations (One year); Work engagement (One year)

Answer: D