TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Kazakhstan: A Study of 600 µg Sublingual Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
Brief Summary: The study will be conducted in 4 sites and will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Kazakhstan. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and sublingual administration of 600 µg misoprostol with gestations through 70 days, as well as the acceptability of this method. Research questions include:

1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by 600 µg sublingual misoprostol and used in gestations of up to 70 days?
2. Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan?
3. Are the side effects associated with sublingual use of misoprostol acceptable to women?
4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?


Options:
A: Proportion of women who select home-use of mifepristone (1-2 weeks); Satisfaction with Method (1-2 weeks)
B: complete abortion rate (5 weeks after treatment)
C: Proportion of participants who would choose outside of center administration of mifepristone again (1-2 weeks); Proportion of participants who would recommend outside-of-center administration to a friend (1-2 weeks)
D: Rate of successful abortion (2 weeks after mifepristone administration)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Extended-release Niacin on Immune Activation in HIV-infected Patients Treated With Antiretroviral Therapy: a Proof-of-concept Study
Brief Summary: There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels and enable HIV-infected individuals to live longer. However, some participants taking anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing AIDS and non-AIDS-related complications.

ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3. Niacin is effective in reducing cholesterol levels in the blood. This drug has been known for a long-time to treat dyslipidemia and it is used to improve favourably all the lipoprotein risk factors for artherosclerotic disease, particularly in HIV-infected patients. Recent scientific research shows that regular consumption of niacin-rich foods may also provide protection against Alzheimer's disease and age-related cognitive decline.

The purpose of this study is to find out:

1. If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could reduce T cell immune activation and enhance CD4 recovery;
2. If ER niacin can improve your quality of life and your neurocognitive functions


Options:
A: To test the efficacy of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to replete vit D status (achieving a minimum serum 25D concentration of 32 ng/mL). (12 weeks); To test the safety of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS as determined by serum calcium. (12 weeks)
B: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)
C: Comparison of the change in CD8CD38 percentage (24 weeks); Comparison of the change in CD8CD38 percentage during the ER niacin + ART period (48 weeks)
D: To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. (Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Neck Pain
Brief Summary: The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.


Options:
A: Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) (3 months)
B: Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) (3 months)
C: Change over time in Catastrophizing (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in (Dis)ability/ pain screening (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in Work ability (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in Functioning (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU)
D: Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30 (From baseline to day 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.


Options:
A: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)
B: change from baseline in percent atheroma volume (PAV) (Month 18 visit)
C: Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis (Baseline up to Month 42); Time From Randomization to First Occurrence of MACE+ (Baseline up to end of study (Month 56))
D: Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) (Month 30)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Low Back Pain
Brief Summary: The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) (3 months)
C: Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30 (From baseline to day 30)
D: Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS) (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
Brief Summary: The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.


Options:
A: The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth (Day 0)
B: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)
C: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374))
D: Percentage of Subjects in Clinical Remission at Week 6 (Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 4-Week, Phase II, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
Brief Summary: This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD). 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. This study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a follow-up visit approximately 4 weeks after completing treatment.


Options:
A: Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
B: Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 (Baseline (Day 1) and Week 4)
C: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)
D: Hemoglobin level (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
Brief Summary: Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response.

Participants: A total of up to 200 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a target of 122 randomized.

Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will generate data for all three Aims


Options:
A: Mean Eosinophil Count (Week 16)
B: Rate of histological remission (2 weeks (LOCF)); Change in the mean numbers of eos (2 weeks (LOCF))
C: Post-Treatment Maximum Eosinophil Count (Aim 1) (8 weeks); Post-treatment Dysphagia Score (Aim 1) (8 weeks)
D: Watson Dysphagia Scale Score (WDS) (Two months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Aerobic Training in Patients With Congenital Myopathies
Brief Summary: Congenital myopathies are clinical and genetic heterogeneous disorders characterized by skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout their life. However, progression of symptoms is rare. There are no specific treatments for congenital myopathies. Training has been shown to benefit several other muscle diseases with weakness, but the defect in congenital myopathies involves contractile proteins of the sarcomere, why the effect of training is uncertain in these conditions. The investigators will therefore investigate the effect cycle-ergometer training for 30 minutes, three times weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital myopathy patients, who do not train, will serve as controls for the trained patients. The study starts and ends with a test day, where efficacy based on VO2max, performance in functional tests and a questionnaire will be assessed.


Options:
A: Aerobic Capacity (Twelve weeks); Muscle strength (Twelve weeks); Quality of life (Twelve weeks)
B: DM1-Activ (Baseline and 10 months)
C: Efficacy based on VO2,max (10 weeks)
D: Hypoxia related metabolites. (At baseline before intervention.); Hypoxia related metabolites. (After 12 weeks of endurance exercise intervention/ non intervention.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.


Options:
A: Pain (3 months)
B: Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale (assessed immediately post IUD insertion)
C: Mean Pain Score During IUD Insertion (Day 1)
D: Pain During IUD Insertion at Various Time Points (See Description for Time Points) (During IUD insertion (see above description for which time points))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Brief Summary: Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).


Options:
A: Time to Death or Disease (IPF) Progression. (Up to 48 months)
B: change from baseline in 6-min-walk distance (6-MWD) (12 weeks)
C: Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD) (From baseline to Week 16)
D: Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. (From baseline to Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Brief Summary: The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.


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 Week 208)
B: Rate of rise in Hb (g/dL/week) at Week 6 (Baseline and at 6 weeks after dosing)
C: Hemoglobin (Hb) Response rate (Up to Week 24)
D: Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy (Baseline to week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mental Health First Aid for College Students: A Multi-campus Randomized Control Trial of a Community Health Intervention
Brief Summary: Most college students with mental disorders do not receive treatment, and over 80% of those who die by suicide have never made contact with campus mental health services. Knowledge, stigma, and other health beliefs represent significant barriers to help-seeking for many of these students. However, there have been no large-scale intervention studies for reducing these barriers to mental health treatment on college campuses. This project will fill this gap by determining whether a community mental health education program, Mental Health First Aid (MHFA), is an effective method to increase number of students who seek mental health services on college campuses. MHFA is an international, 12-hour training program that has been shown to increase knowledge of mental illnesses and their treatments, decrease stigma, and increase helping behaviors in community members. However, it has not been tested in a college setting in the United States. To determine the effectiveness of MHFA in US colleges, the proposed project will involve a randomized control trial of the MHFA training program on 32 campuses representing a range of higher education institutions, from community colleges in rural areas to research universities in large, urban areas. The MHFA training program will be administered to peer supports such as residential advisors. Administrative data from campus mental health services and pre- and post-intervention surveys will be used to collect outcome data on service utilization, knowledge, attitudes, and other measures. Data analyses will focus on identifying changes in students' behaviors, knowledge, and attitudes toward mental illnesses that can be attributed to the MHFA training. In addition to testing a novel and timely mental health intervention for college students, this project will result in improved data collection measures for college populations, and will lay the foundation for stronger connections and future collaborations between diverse campus communities. If the MHFA program is successful in reducing stigma and increasing general on-campus awareness and early treatment of emerging mental health problems, then it may provide a cost-effective means for enabling more students to seek early treatments for developing mental health problems.


Options:
A: Increased confidence in help-giving behaviour as measured by comparing the intervention group after having attended the training course with the control group. (questionnaire) (6 months)
B: Change in Employees' help-seeking behaviour (6, 12 and 24 months.)
C: Change from baseline in help-seeking behavior (Baseline, post-intervention, 3 month follow-up); Change from baseline in help-outreach behavior (Baseline, post-intervention, 3 month follow-up)
D: Changes in mental health service utilization (baseline, 2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific
Brief Summary: Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.


Options:
A: Hemoglobin level (24 weeks)
B: Change from baseline in the average hemoglobin (Hb) (Baseline and Weeks 18 to 24)
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: Percentage of Participants Achieving a Successful Hemoglobin Response (Weeks 19 and 20)

Answer: C
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 (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific
Brief Summary: Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this research.


Options:
A: US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy (Baseline (Day 1, Week 0), Weeks 28 to 52); Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol (Baseline (Day 1, Week 0), Weeks 28 to 36)
B: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) (Weeks 40 to 52)
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: Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) (Baseline, Week 6)

Answer: C