TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
Brief Summary: Although intensive medical treatment of diabetes has clearly been demonstrated to be worthwhile, it has not been a total success in diabetes treatment for a variety of reasons including lack of response to medication. Diabetes has been well demonstrated as a co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base of this observation, we will try to find out the role surgical intervention (gastric bypass \& sleeve gastrectomy) in obese-related diabetes.


Options:
A: effectiveness in terms of weight loss, reduction in co-morbidity and quality of life (5 years)
B: HbA1c < 7.0% (12 Months); Systolic blood pressure < 130 mm Hg (12 Months); LDL cholesterol < 100 mg/dl (12 Months)
C: Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. (1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months)
D: Improvement of co-morbidities (1-year after treatment start)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNTHESIS: a Randomized Controlled Trial on Intra-arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke. Start up Phase.
Brief Summary: The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.


Options:
A: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
B: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
C: Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 (90 days); Incidence of All Serious Adverse Events (90 days)
D: Modified Rankin Score (mRs ) (3 months after treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNTHESIS: a Randomized Controlled Trial on Intra-arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke. Start up Phase.
Brief Summary: The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.


Options:
A: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)
B: Shift in the mRS score, defined by a proportional odds model. (90 days)
C: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
D: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNTHESIS: a Randomized Controlled Trial on Intra-arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke. Start up Phase.
Brief Summary: The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.


Options:
A: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)
B: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
C: Modified Rankin Scale (mRS) 0-1 (3 months)
D: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNTHESIS: a Randomized Controlled Trial on Intra-arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke. Start up Phase.
Brief Summary: The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.


Options:
A: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)
B: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
C: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
D: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation
Brief Summary: The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.


Options:
A: Recurrence of Atrial Fibrillation (One year)
B: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
C: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) (The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.); The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events (Within 7 Days of Ablation Procedure)
D: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation
Brief Summary: The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.


Options:
A: Freedom from AF (18 months)
B: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% (baseline and 6 months); Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) (Baseline); Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months (6 months)
C: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
D: Recurrence of Atrial Fibrillation (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation
Brief Summary: The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.


Options:
A: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) (The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.); The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events (Within 7 Days of Ablation Procedure)
B: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
C: Time to first recurrence of electrocardiographically documented, symptomatic AF or atrial flutter/tachycardia between 3 and 12 months post ablation in the absence of antiarrhythmic drug therapy. (Between 3 and 12 months post ablation)
D: Recurrence of Atrial Fibrillation (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice
Brief Summary: The primary research objective of this observational study is to evaluate treatment compliance over one year in children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the medication at least often.


Options:
A: N/A
B: Treatment emergent adverse events over 12 months. (Weekly)
C: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)
D: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania (First 6 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Comparative, Open-labelled, Randomised, Clinical Study to Assess a Fixed Dose of Oral Pyronaridine Artesunate Granule Formulation vs. Coartem® Crushed Tablets in Infants With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief Summary: The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%.

Secondary objectives of this clinical study are to compare the efficacy (non-inferiority) and safety of the PA granule formulation compared to Coartem® (ie, the combination of artemether/lumefantrine \[AL\]) crushed tablets in a paediatric population and to assess the safety of the PA granule formulation.


Options:
A: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
B: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
C: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
D: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Comparative, Open-labelled, Randomised, Clinical Study to Assess a Fixed Dose of Oral Pyronaridine Artesunate Granule Formulation vs. Coartem® Crushed Tablets in Infants With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief Summary: The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%.

Secondary objectives of this clinical study are to compare the efficacy (non-inferiority) and safety of the PA granule formulation compared to Coartem® (ie, the combination of artemether/lumefantrine \[AL\]) crushed tablets in a paediatric population and to assess the safety of the PA granule formulation.


Options:
A: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
B: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
C: result of PCR (42 day)
D: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Comparative, Open-labelled, Randomised, Clinical Study to Assess a Fixed Dose of Oral Pyronaridine Artesunate Granule Formulation vs. Coartem® Crushed Tablets in Infants With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief Summary: The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%.

Secondary objectives of this clinical study are to compare the efficacy (non-inferiority) and safety of the PA granule formulation compared to Coartem® (ie, the combination of artemether/lumefantrine \[AL\]) crushed tablets in a paediatric population and to assess the safety of the PA granule formulation.


Options:
A: Proportion of patients free of parasites at day 28.
B: Comparison of peak plasma concentration of Dihydroartemisinin in the two studied formulations (DHA plasma samples will be collected on the first day of study drug administration at 20, 30, 40, 60, 100, 200 and 300 minutes post-dose); Comparison of area under the plasma concentration versus time curve of Dihydroartemisinin in the two studied formulations. (DHA plasma samples will be collected on the first day of study drug administration at 20, 30, 40, 60, 100, 200 and 300 minutes post-dose); Comparison of peak plasma concentration of Piperaquine in the two studied formulations (PQP plasma samples will be collected on day 0 of treatment at 40, 80, 280, 720 minutes, then on day 1 at 24 hours and on day 2 at 40, 80, 280, 720 minutes after the last drug administration and then 24, 120, 288 and 456 hours); Comparison of area under the plasma concentration versus time curve of Piperaquine in the two studied formulations. (PQP plasma samples will be collected on day 0 of treatment at 40, 80, 280, 720 minutes, then on day 1 at 24 hours and on day 2 at 40, 80, 280, 720 minutes after the last drug administration and then 24, 120, 288 and 456 hours)
C: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
D: Adherence (Day 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Comparative, Open-labelled, Randomised, Clinical Study to Assess a Fixed Dose of Oral Pyronaridine Artesunate Granule Formulation vs. Coartem® Crushed Tablets in Infants With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief Summary: The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%.

Secondary objectives of this clinical study are to compare the efficacy (non-inferiority) and safety of the PA granule formulation compared to Coartem® (ie, the combination of artemether/lumefantrine \[AL\]) crushed tablets in a paediatric population and to assess the safety of the PA granule formulation.


Options:
A: PCR-Corrected ACPR at Day 28 (Day 28)
B: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
C: Crude Cure Rate on Day 14 (Day 14)
D: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.
Brief Summary: The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.


Options:
A: Urinary markers of bone resorption; measured at the end of each treatment phase (Every 50 days)
B: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population (52 weeks / Endpoint)
C: Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. (Baseline, 6, and 12 months)
D: Mean percent change from baseline in hip trochanter bone mineral density (BMD)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients
Brief Summary: This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.


Options:
A: Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. (Patients followed for 5-8 years with average of 6.5 years follow up)
B: Kidney Volume measured by MRI. (Every year)
C: Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36 (Baseline to Month 36)
D: Study A: Percent Annual Change in Total Kidney Volume (Baseline and 2-, 4- and 5-year follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing
Brief Summary: Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.


Options:
A: Immunogenicity After Dose 3 (1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months))
B: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 (At Month 24); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 (At Month 48); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 (At Month 57); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 (At Month 72)
C: To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047 (208 weeks (4 Years))
D: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)

Answer: D