TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection
Brief Summary: The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
C: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial
Brief Summary: Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but throughout the world. There are no large-scale (n\>100), prospective, randomised studies comparing paracetamol with ibuprofen in the management of acute soft tissue injury.

As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness. Previous comparative studies on NSAIDS have been done in this unit and have suggested equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were modest.

Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in pain control for acute soft tissue injuries in an ED setting

Design: Prospective, double-blind, randomised controlled trial with three arms: oral paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in combination

Participants: 783 subjects having sustained isolated soft tissue limb injury without significant fracture presenting to the ED of Prince of Wales Hospital

Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective of the healthcare provider


Options:
A: Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores (2 hours)
B: Decrement of the pain on VAS (Baseline and 60 minutes)
C: analgesic efficacy both at rest and with movement (72 hours)
D: Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm (60 minutes post-analgesia)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a School Based Hand Sanitizer Program on Asthma
Brief Summary: Asthma is a common, serious illness among children in the United States. Improving hand cleanliness and hygiene may prevent the spread of viruses that can cause asthma exacerbations. This study will evaluate the effectiveness of a school-based hand sanitizer program at reducing the frequency of exacerbations in children with asthma.


Options:
A: Asthma exacerbations (Measured at Years 1 and 2)
B: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
C: Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) (90 Day outcome period); Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) (90 Day outcome period)
D: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.


Options:
A: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)
B: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 (Baseline and Day 337); Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (During actual study treatment period (planned Day 1 to Day 337))
C: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
D: Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks (40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy
Brief Summary: Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.


Options:
A: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours (0 to 72 hours)
B: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefits (Wound closure to Day 30)
C: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4 (0 to 96 hours)
D: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (LOS) (Wound closure at time hospital discharge order is written or Day 30, whichever is sooner)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine the Efficacy and Safety of Pravastatin 80 mg Administered Once Daily to Hypercholesterolemic Subjects With Chronic, Well Compensated Liver Disease
Brief Summary: To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.


Options:
A: Total Cholesterol (-2, 0, 4, 6 weeks); LDL Cholesterol (-2, 0, 4, 6 weeks); HDL Cholesterol (-2, 0, 4, 6 weeks); Triglycerides (-2, 0, 4, 6 weeks); C-reactive protein (-2, 0, 4, 6 weeks)
B: serum LDL-C (at week 12); ALT value
C: Combined incidence of all-cause mortality, MACE and/or end-stage renal disease (4 years)
D: Number of Participants Who Stated (by Self-report) That They Had Side Effects (4 months); Number of Participants Who Took >90% of Their Doses (by Pill Count) (4 months); Change From Baseline to Month 4 in the Framingham Risk Score (FRS) (Change from baseline to 4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Organisational Changes to Promote Smoking Cessation
Brief Summary: The Department of Family Practice at Michigan State University partnered with BCBSM with a grant from the Robert Wood Johnson Foundation to recruit primary care practices for a 3 year study designed to assess smoking cessation referral rates by primary care physicians in Michigan.


Options:
A: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)
B: Continuous Abstinence (Measured at Year 1)
C: N/A
D: evaluate and provide a model of smoking cessation interventions

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.


Options:
A: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)
B: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)
C: success rate of cervical ripening in labor induction (12 hours after intervention)
D: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.


Options:
A: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
B: success rate of cervical ripening in labor induction (12 hours after intervention)
C: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)
D: Uterine Tachysystole (Up to four hours after administration of study drug)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.


Options:
A: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
B: Time to Delivery (from study entry until delivery- anticipated 3 days); Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications (from study entry until delivery- anticipated 3 days)
C: success rate of cervical ripening in labor induction (12 hours after intervention)
D: induction delivery time (2 hourly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture vs. Traditional Treatment of Pain With Opioids
Brief Summary: Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.


Options:
A: Pain scores at rest (45 minutes after the injection)
B: Respiratory complications (During hospital stay, up to 1 month)
C: Opiate Requirements (72 hours)
D: Consumption of opioids

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Eight Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension
Brief Summary: This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.


Options:
A: To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment. (after 4 weeks of treatment)
B: Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8); Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8); Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8)
C: Percentage of Participants With Colonic Pathology (54 weeks); Summary of the End of Study Colonoscopy Results (54 weeks)
D: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) (Baseline to 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol
Brief Summary: The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.


Options:
A: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
B: Androgen secretion (0, 3, 6 months); Glucose metabolism (0, (3), 6 months)
C: Serum testosterone
D: Brachial Artery Flow-mediated Dilation (FMD) (baseline and 6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol
Brief Summary: The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.


Options:
A: Observations of all modifications on semen quality after 5 months of atorvastatin treatment (at month 5); Observations of all modifications on semen quality after 5 months of atorvastatin treatment and after 3 months after its withdrawal (at month 8)
B: LVEF (Left Ventricular Ejection Fraction) (baseline and three months); Muscle Sympathetic Nerve Activity (by Sympathetic Microneurography) (Baseline and three months)
C: Brachial Artery Flow-mediated Dilation (FMD) (baseline and 6 weeks)
D: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Effectiveness and Acceptability of Three Alternative Regimens for Malaria Seasonal Intermittent Preventive Treatment in Senegal
Brief Summary: The purpose of this trial is to compare the acceptability, efficacy and safety of three alternative drug regimens for use for seasonal Intermittent Preventive Treatment to prevent malaria in children. Children aged 2 months to 5 years will be randomized to receive IPT with one of three regimens during the transmission season: sulfadoxine-pyrimethamine (SP) plus amodiaquine, show to be highly effective for IPT in a recent trial; SP plus piperaquine, used for malaria prophylaxis in China for many years; or Duocotexcin (a combination of piperaquine with an artemisinin).


Options:
A: Risk of Parasitaemia (Unadjusted by Genotyping) (after 42 days of follow-up)
B: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
C: Incidence of clinical malaria (2008-2009)
D: Incidence of malaria (Four months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Effectiveness and Acceptability of Three Alternative Regimens for Malaria Seasonal Intermittent Preventive Treatment in Senegal
Brief Summary: The purpose of this trial is to compare the acceptability, efficacy and safety of three alternative drug regimens for use for seasonal Intermittent Preventive Treatment to prevent malaria in children. Children aged 2 months to 5 years will be randomized to receive IPT with one of three regimens during the transmission season: sulfadoxine-pyrimethamine (SP) plus amodiaquine, show to be highly effective for IPT in a recent trial; SP plus piperaquine, used for malaria prophylaxis in China for many years; or Duocotexcin (a combination of piperaquine with an artemisinin).


Options:
A: Incidence of malaria (Four months)
B: Mean Hb at the end of the high transmission season.
C: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life
D: Prevalence of anaemia (Hb <112g/L) (March 2006)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy
Brief Summary: For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.


Options:
A: The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks (Baseline to 8 weeks)
B: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)
C: Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) (Week 8)
D: anatomical success rate (absence or obliteration of GSV on US examination) (3 months, 1 and 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy
Brief Summary: For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.


Options:
A: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)
B: cumulative probability of recurrent varicose vein within 24 months after treatment (24 months)
C: Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). (5 years)
D: anatomical success rate (absence or obliteration of GSV on US examination) (3 months, 1 and 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya
Brief Summary: The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya


Options:
A: To compare PCR corrected cure-rates on day 14 and 28 (1 year)
B: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
C: 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)
D: Adherence (Day 4)

Answer: A