TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Comparative (Double-blind, Double-dummy) Randomised Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients With Acute Vivax Malaria
Brief Summary: The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.


Options:
A: Crude Cure Rate on Day 14 (Day 14)
B: PCR-Corrected ACPR at Day 28 (Day 28)
C: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
D: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Comparative (Double-blind, Double-dummy) Randomised Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients With Acute Vivax Malaria
Brief Summary: The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.


Options:
A: result of PCR (42 day)
B: Crude Cure Rate on Day 14 (Day 14)
C: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)
D: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Comparative (Double-blind, Double-dummy) Randomised Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients With Acute Vivax Malaria
Brief Summary: The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.


Options:
A: Crude Cure Rate on Day 14 (Day 14)
B: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
C: PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR) (Day 56)
D: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Comparative (Double-blind, Double-dummy) Randomised Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients With Acute Vivax Malaria
Brief Summary: The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.


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

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis
Brief Summary: General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes.

Objectives:

Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.

Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.


Options:
A: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit (Up to 98 weeks); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks))
B: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
C: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
D: Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16 (16 Weeks); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to Week 40)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis
Brief Summary: General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes.

Objectives:

Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.

Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.


Options:
A: ITP: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS (ITP: Baseline up to Week 96)
B: Neurofilament light chain in the cerebrospinal fluid (CSF) (0-48 weeks)
C: Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16 (16 Weeks); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to Week 40)
D: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion
Brief Summary: In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.


Options:
A: Difference in HbA1C From Baseline and 6 Months (Baseline and 6 months)
B: Clinical effectiveness: percentage of time spent in euglycaemia (3-6 days)
C: Change in A1c From Baseline to 52 Weeks (Baseline and 52 weeks)
D: Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort) (Baseline and 26 weeks); Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) (Baseline and 26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
Brief Summary: This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.


Options:
A: Change in HIV status compared between arms (tenofovir vs placebo) (Baseline and monthly HIV testing for the duration of the study, an expected average of 18 months)
B: Time to HIV seroconversion during trial participation (evaluated quarterly)
C: Safety of BufferGel and 0.5% PRO 2000/5 Gel (P), as assessed by deep epithelial disruption, other genital symptoms, or other systemic symptoms (Throughout study); HIV infection as measured by seroconversion (Throughout study)
D: Measured endogenous antimicrobial activity (Throughout study); Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL (Throughout study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III: The Study of Acid Reflux in Children With Asthma
Brief Summary: Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a condition in which excess stomach acid flows backwards into the esophagus. This study will evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in improving asthma control and reducing symptoms in children with poorly controlled asthma.


Options:
A: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)
B: Change in Juniper Asthma Control Score (ACS) (Measured at Weeks 0, 4, 8, 12, 24)
C: Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period). (Baseline to 6 months)
D: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
Brief Summary: This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC


Options:
A: Overall survival between the two treatment arms (Probability of 1 year survival (%))
B: Overall survival (1-year)
C: Progression-Free Survival (PFS) (Randomization to PD or death (up to 24 months))
D: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ACTFAST (2): Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration: A Multicenter, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving Low Density Lipoprotein Cholesterol (LDL-C) Target With Atorvastatin Starting Doses Of 10 mg, 20 mg, 40 mg, And 80 mg.
Brief Summary: European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)


Options:
A: N/A
B: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 (Baseline and 6 Weeks)
C: Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 (Baseline (Week 6), Week 12)
D: Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Mosquito Coils to Control Malaria in China
Brief Summary: Although mosquito coils are widely used, there is no robust evidence that their use can provide clinical reduction in malaria. This study will randomise 4 groups of 400 houses, each with 5 people, in rural China and monitor cases of malaria in each group each month for 6 months. The treatment groups will include Coils, Treated bed nets, Coils plus treated bed nets, or no treatment (control). All cases detected will be given prompt appropriate treatment.


Options:
A: Malaria parasite (P. falciparum and/or P. vivax)through microscopic detection
B: Change from baseline in malaria prevalence at 6 months (6 months)
C: Reduction in cases of malaria
D: Malaria cases (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Brief Summary: The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.


Options:
A: Rate of vaginal delivery within 24 hours (within 24 hours)
B: Time from the start of labor induction to delivery
C: Delivery rate (proportion) (Within 24 hours)
D: feasibility of randomised Induction of Labour Trial in Out-patient setting (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Brief Summary: The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.


Options:
A: Average Time in Hours From Insertion of the Catheter Until Delivery (At the end of the study)
B: caesarean section rate (1 year)
C: Time from treatment start to delivery (At delivery)
D: Time from the start of labor induction to delivery

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention (The ABOARD Study)
Brief Summary: Release of troponin evaluated by the peak of troponin during the hospital phase.Because of its sensitivity and specificity as well as its widespread use in routine practice, rise in troponin levels is the main assessment criteria of this study. We plan to demonstrate a significantly altered distribution of the troponin release as evaluated by the peak of troponin for each patient during the hospitalization period (from randomization to cardiologic unit discharge), in the two arms of the trial.


Options:
A: Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. (96 hours after randomization)
B: N/A
C: peak creatine kinase- MB level (5 days)
D: Release of troponin evaluated by the peak of troponin during the hospital phase (during the hospital phase)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications
Brief Summary: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.


Options:
A: major bleeding (up to 48 hours from last injection)
B: Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) (3 months)
C: Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11 (11 days)
D: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications
Brief Summary: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.


Options:
A: Thrombosis Progression and Venous Thromboembolism (VTE) (Day 14); Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months (3 months)
B: To assess the efficacy and safety of low-molecular-weight heparin - dalteparin in patients with ST (3 months); Combined end-point: occurrence of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism or ultrasonographic blood clot progression or relapse of ST (3 months); Clinically relevant bleeding occurring (during treatment)
C: Incidence of confirmed venous thromboembolism at three months. (3 months)
D: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcade in Untreated Patients With Multiple Myeloma More Than 65 Years Old.
Brief Summary: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments


Options:
A: Overall survival
B: Response Rate; Progression Free Survival; Event Free Survival
C: Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria (Up to disease progression, approximately 3 years)
D: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcade in Untreated Patients With Multiple Myeloma More Than 65 Years Old.
Brief Summary: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments


Options:
A: Best Overall Response Rate (ORR) (A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.)
B: Time to Progression (TTP) (Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006]))
C: Rate of CR+nCR to induction treatment (63 days after the start day of either TD or VTD as induction therapy)
D: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
Brief Summary: Severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain. Several interventions have been evaluated for phantom pain prevention, including continuous brachial plexus blockade5, intravenous6 or epidural ketamine administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.


Options:
A: analgesic consumption of level 3 in the two treated groups (24 hours)
B: The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. (24 hours)
C: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
D: 30% decrease in VAS score on mobilization on the day of surgery (patients will be followed during all the duration of hospital stay and 2 months after surgery)

Answer: C