TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Brief Summary: This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.


Options:
A: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants (Baseline, Day 7)
B: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 24 weeks)
C: Safety and tolerability: Adverse events, ECG, laboratory parameters (approximately 3 years); Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2 (Days 3-9); Antiviral activity: HCV RNA (COBAS Taqman HCV Test) (from baseline to Day 28)
D: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) (At follow-up Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Protective Effect of Rosuvastatin and Antiplatelet Therapy On Contrast-induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention; PRATO-ACS Trial
Brief Summary: This open-label study, prospective, randomized trial evaluating the acute (in-hospital) pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with acute coronary syndrome


Options:
A: plasma troponin T level (within the first 7 days after surgery)
B: Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control (3 days)
C: An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure (72 h)
D: The mean peak increase of serum creatinine concentration during day1 and day2.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
Brief Summary: This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.


Options:
A: Change of uremic toxins from basal to 1 and 3 months (Baseline, 1 month and 3 months); Change of uremic toxins from basal to 1 and 3 months (Baseline, 1 month and 3 months)
B: Plasma level of p-cresol sulfate (8 weeks)
C: PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid (six months); Changes in BUN, Creatinine and uric acid levels (six months)
D: Hb A1c (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Safety, Efficacy, and Feasibility of Medical Abortion Provided by Physicians and Non-physicians in Nepal: a Randomized Controlled, Equivalence Trial.
Brief Summary: The purpose of the study is to compare the safety, effectiveness, and acceptability of medical abortion provided by doctors and midlevel providers in a developing country where doctors are scarce, such as Nepal. This study is the first to evaluate the independent provision of medical abortion by trained nurses and auxiliary nurse midwives compared to doctors by assessing differences in safety, clinical outcomes, case management decision-making, and acceptability. This study provides scientifically valid data on the administration of medical abortion by midlevel providers working independently in a low-resource, developing country setting. The evidence generated by the study will assist policy makers in developing countries interested in expanding safe abortion services by eliminating the legal requirement limiting prescription of medical abortion to doctors where medical abortion is not restricted by law.


Options:
A: Complete abortion (14 days)
B: feasibility (3 weeks)
C: Complete abortion (30 days)
D: Ongoing pregnancy rates (1-2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Brief Summary: The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.


Options:
A: To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (Baseline); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (8 weeks); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (16 weeks)
B: Menopausal symptoms (6 months)
C: Change in FACIT-TS questionnaire score (Baseline, 6 months)
D: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Brief Summary: The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.


Options:
A: What is the effect of chemotherapy on the fitness of patients prior to cancer surgery? (2 years)
B: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)
C: To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (Baseline); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (8 weeks); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (16 weeks)
D: The change of 6MWD observed between pre-and post radical treatment (12 weeks); between post radical treatment and after a 12 week resistance training (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of FBS0701 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy, With a 72 Week Dosing Extension
Brief Summary: The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in patients with β-thalassemia and other forms of anemia who experience iron overload - iron increases in the body as a result of regularly required blood transfusions. Patients who qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6 months) with a total study duration of up to 33 weeks. These patients will be eligible to participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be up to 96 weeks. The safety of patients will be monitored frequently during the study by physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart, each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the hospital for this study but will need to visit the outpatient clinic up to 28 times over the 96 week period. Patients currently taking an iron chelator will be required to stop for a total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be effective as an iron chelator.


Options:
A: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks (Baseline and 96 weeks)
B: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
C: Heart Failure (1yr); Arrhythmia (1yr)
D: Efficacy of amlodipine in retarding rate of myocardial iron deposition (Assessed by change in T2* times) (At baseline, and then at 6 months and 12 months from the start of the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of FBS0701 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy, With a 72 Week Dosing Extension
Brief Summary: The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in patients with β-thalassemia and other forms of anemia who experience iron overload - iron increases in the body as a result of regularly required blood transfusions. Patients who qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6 months) with a total study duration of up to 33 weeks. These patients will be eligible to participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be up to 96 weeks. The safety of patients will be monitored frequently during the study by physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart, each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the hospital for this study but will need to visit the outpatient clinic up to 28 times over the 96 week period. Patients currently taking an iron chelator will be required to stop for a total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be effective as an iron chelator.


Options:
A: Myocardial T2* values (msec) (6 and 12 months)
B: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
C: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks (Baseline and 96 weeks)
D: Heart Failure (1yr); Arrhythmia (1yr)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Messaging to Improve Adherence to Post-Operative Clinic Appointments and Reduce Early Resumption of Sexual Intercourse After Adult Male Circumcision: A Randomized Controlled Trial
Brief Summary: Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services.

Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners.

To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.


Options:
A: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))
B: Proportion of men failing to return for a post-operative clinic visit at 7 days. (7 days); Proportion of men who report resumption of sexual activity before 42 days post-circumcision. (42 days)
C: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
D: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Messaging to Improve Adherence to Post-Operative Clinic Appointments and Reduce Early Resumption of Sexual Intercourse After Adult Male Circumcision: A Randomized Controlled Trial
Brief Summary: Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services.

Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners.

To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.


Options:
A: Proportion of men failing to return for a post-operative clinic visit at 7 days. (7 days); Proportion of men who report resumption of sexual activity before 42 days post-circumcision. (42 days)
B: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
C: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program (up to 1 year)
D: Vaccines received (Electronic Health Record) (up to a year of follow up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


Options:
A: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)
B: Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set) (16 weeks)
C: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
D: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)

Answer: C