TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
Brief Summary: This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.


Options:
A: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants (Up to 36 months); Number of Participants With Serious Adverse Events (SAEs) (Up to 36 months)
B: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years); HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years)
C: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
D: HIV Infection (Cumulative HIV infection between enrollment and 52 weeks); Confirmed Grade 2 or Higher Serum Creatinine Toxicity (cumulative toxicity through 52 weeks of product use and 4 weeks post product); Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration (10-26 months per site); Confirmed Grade 3 or Higher Reduction in Phosphorus (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher ALT Elevation (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher AST Elevation (Through 52 weeks on product and 4 weeks post-product)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain
Brief Summary: The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back, in comparison with placebo and Oxycodone Controlled Release (CR).


Options:
A: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
B: Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. (Baseline and 12 weeks)
C: Number of Participants That Responded to Treatment (6 weeks)
D: Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. (Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psychosis Patients Aged 15 to 25 Years.
Brief Summary: The purpose of this study is determine the minimal effective dose and the impact on:

1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
2. the final maintenance doses
3. the use of other medications
4. the amount of changes to other antipsychotic medication
5. the number of hospitalization days


Options:
A: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
B: 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)
C: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)
D: Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomised, Clinical Study to Examine the Effects of a Single Bolus Erythropoietin on Left Ventricular Function in Patients With an Acute Myocardial Infarction
Brief Summary: The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.


Options:
A: Left ventricular ejection fraction measured by magnetic resonance imaging (4-6 months)
B: Magnetic resonance imaging (MRI) determination of infarct size (12 weeks)
C: Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography (6 weeks)
D: mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection (4 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Brief Summary: The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB. Also safety and tolerability will be evaluated.


Options:
A: • To compare the culture-conversion rate at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen (8 weeks)
B: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)
C: Efficacy: Percentage of relapses by 24 months following treatment cure; Safety: Percentage of adverse events
D: Proportion of Patients With Sterile Sputum Cultures (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Brief Summary: The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB. Also safety and tolerability will be evaluated.


Options:
A: The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. (8 weeks)
B: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)
C: To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy. (Week 8); To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens. (Weekly or more frequent)
D: Efficacy: Percentage of relapses by 24 months following treatment cure; Safety: Percentage of adverse events

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis
Brief Summary: To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis


Options:
A: Rate of clinical remission
B: Clinical and Endoscopic Remission. (8 weeks)
C: Number of Participants Who Achieved Clinical Remission at Day 56 (Baseline up to Day 56)
D: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis
Brief Summary: To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis


Options:
A: Clinical and Endoscopic Remission. (8 weeks)
B: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))
C: Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1 (12 weeks)
D: Rate of clinical remission

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis
Brief Summary: To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis


Options:
A: To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. (Day 3 (after colonoscopy and CCE-2))
B: Rate of clinical remission
C: Change in Mayo score at Day 57 compared with Screening (Day 57)
D: Disease Activity Index score (baseline, week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease
Brief Summary: A randomized control trial is planned to evaluate an interactive voice response (IVR) mediated follow-up and triage system, against usual care, to help smokers hospitalized with Coronary Heart Disease (CHD) to quit smoking. The investigators hypothesize that compared to usual care, participants in the IVR group will; a) have a significantly higher 7-day point prevalence abstinence rate at 26 and 52 weeks after hospital discharge, b) will have a higher rate of continuous abstinence at 26 and 52 weeks after hospital discharge, c) will use a greater number of proven effective interventions over time, and d) will develop greater self-efficacy with respect to smoking cessation, over time.


Options:
A: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
B: Smoking Abstinence for 7 Days at Last Contact (6-12 months)
C: Biochemically confirmed 7-day point prevalent smoking abstinence (52 weeks)
D: 7-day Point Prevalence Abstinence From Cigarettes (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Brief Summary: This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Coefficient of Fat Absorption (CFA) (5 days)
C: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
D: Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) (Open label baseline, end of 6 day double blind treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness
Brief Summary: The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplementation and risk of infection.


Options:
A: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 (Baseline (Day 1) through Week 5)
B: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL (Any time between baseline and the end of study or time to intervention)
C: Hematocrit (Day 7, Day 14, Day 21, Day 28); Serum Iron Concentration (Day 7, Day 14, Day 21, Day 28); Serum Ferritin Concentration (Day 7, Day 14, Day 21, Day 28); Erythrocyte Zinc Protoporphyrin Concentration (Day 7, Day 14, Day 21, Day 28)
D: Haemoglobin and Hematocrit values (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis
Brief Summary: The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.


Options:
A: Hemoglobin Level in blood (Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months)
B: Mean Hb Change Level During the Last Four Weeks of Treatment (Week 22 to week 26); Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment (Week 22 to week 26)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks (Baseline and 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Facilitating Informed Decisions for MSI Testing
Brief Summary: RATIONALE: The use of a CD-ROM may help patients with colorectal cancer or a family history of colorectal cancer make informed decisions about undergoing microsatellite instability (MSI) testing.

PURPOSE: This randomized clinical trial is studying an educational CD-ROM to see how well it works compared with standard informed consent to assist decision-making about MSI testing in patients with colorectal cancer or a family history of colorectal cancer.


Options:
A: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))
B: Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing (2 weeks after enrollment)
C: Decision Self Efficacy (post intervention)
D: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
Brief Summary: This study will evaluate the impact of a brief psychosocial intervention delivered to children or adolescents who are hospitalized for an unintentional injury. The intervention is designed to promote psychological recovery and enhance functional outcomes after injury. The study will also provide preliminary data concerning cost-effectiveness of the intervention.

The core study hypotheses are that children receiving the intervention will (1) have lower severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2) show greater adherence to discharge instructions and better health-related quality of life at follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury, compared to those receiving usual care.


Options:
A: PTSD Symptoms in Children 6 Weeks Post-injury (6 weeks); PTSD Symptoms in Children 6 Months Post-injury (6 months)
B: PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder (pre-treatment, 1 month post, 6 months follow up)
C: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
D: Feasibility of the Coping Coach Online Intervention (6 weeks); Mean Time Spent Using the Intervention (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Induction of Labor With a Foley Catheter Balloon: A Randomized Trial Comparing Inflation With 30ml and 60ml
Brief Summary: The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter placement is a common method used for labor induction in women with an unfavorable cervical assessment. There are several studies using various volumes of Foley balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no studies replicating the findings of the largest study comparing 2 different volumes in the balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml in a Foley balloon catheter for women undergoing induction of labor with an unfavorable cervix. The investigators will observe the following outcomes: rate of delivery within 24 hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.


Options:
A: induction delivery interval (time from starting induction to delivery) (48hours)
B: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
C: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)
D: Rate of vaginal delivery within 24 hours (within 24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Induction of Labor With a Foley Catheter Balloon: A Randomized Trial Comparing Inflation With 30ml and 60ml
Brief Summary: The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter placement is a common method used for labor induction in women with an unfavorable cervical assessment. There are several studies using various volumes of Foley balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no studies replicating the findings of the largest study comparing 2 different volumes in the balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml in a Foley balloon catheter for women undergoing induction of labor with an unfavorable cervix. The investigators will observe the following outcomes: rate of delivery within 24 hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.


Options:
A: Rate of vaginal delivery within 24 hours (within 24 hours)
B: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)
C: caesarean section rate (1 year)
D: Cesarean Birth Rate (39 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison
Brief Summary: Lifestyle intervention and certain medications have been shown to be effective for antipsychotic-induced weight gain, but no controlled studies have compared psychological and pharmacological therapies. We conducted a randomized, placebo-controlled study to test the efficacy of lifestyle intervention and metformin alone and in combination for antipsychotic-induced weight gain.


Options:
A: To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
B: body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index
C: Change from baseline in weight at week eight (Baseline and week eight)
D: Number of Participants With All-cause Mortality (As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months); Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation (As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months)

Answer: B