TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
Brief Summary: The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.


Options:
A: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response (Baseline to the end of the retreatment period (up to 7 years, 6 months))
B: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
C: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
Brief Summary: The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
C: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
D: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
Brief Summary: The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.


Options:
A: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
B: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
C: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
D: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Brief Summary: The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.


Options:
A: N/A
B: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)
C: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Brief Summary: The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.


Options:
A: N/A
B: Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age (15 months); Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age (15 months); Incidence of symptomatic P. vivax malaria from 3-15 months of age (!5 months)
C: N/A
D: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) (Three years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Variable-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release OROS® Hydromorphone HCl (NMED-1077) Compared to Placebo in Patients With Chronic Low Back Pain
Brief Summary: This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain.

The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.


Options:
A: Change From Baseline to Week 12 in Mean Pain Intensity (Baseline, Week 12 (or final visit))
B: No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.
C: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
D: Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. (Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
Brief Summary: Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.


Options:
A: International Knee Documentation Committee 'Subjective Knee Form' (3, 6, 12, 24 and 60 months)
B: WOMAC Functional Status - Difference From Baseline (Baseline and 6 months)
C: The Lysholm Knee Score (One year); Pain After Exercise (VAS) (One year); WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) (One year)
D: Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) (2 and 10 years postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
Brief Summary: Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.


Options:
A: WOMAC Functional Status - Difference From Baseline (Baseline and 6 months)
B: The Lysholm Knee Score (One year); Pain After Exercise (VAS) (One year); WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) (One year)
C: pain ( VAS ) (6 months)
D: Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (24 months follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension
Brief Summary: Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: 6 minutes walking distance
C: Number of Participants With Adverse Events (AEs) (Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period))
D: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 (Baseline and week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Brief Summary: The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).


Options:
A: N/A
B: A composite of healthcare-associated infections (Daily)
C: Bacteremia (participants were followed for the duration of ICU stay, median stay 3 days)
D: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Dose Ascending, 3-cohort Parallel Group Study to Measure the Systemic Cortisol Profile and Evaluate the Safety, Tolerability and Pharmacokinetics of GW870086X, Administered as Single Doses (12mg and 15mg), and Repeat Doses Over 3 Days (6mg, 12mg and 15mg) in Healthy Male Subjects
Brief Summary: GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile.


Options:
A: Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29 (Baseline, Day 29); Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29 (Baseline, Day 29)
B: VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (Baseline to Week 8)
C: Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing (3 days)
D: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID (Baseline and Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial
Brief Summary: Although there is a strong rationale to supplement gravid patients suffering intrauterine growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors, evidence in the literature has been inconclusive. The current study was designed to determine whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth restriction (IUGR).


Options:
A: Intact neonatal survival until term age (Term age, up to 20 weeks after randomization)
B: improvement of the Doppler indices following treatment (9 months)
C: The principal outcome is birth weight at delivery and neonatal morbidity (Crib Score) (6 weeks)
D: compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups (6 weeks after postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Tolerability of Inhaled GSK256066 in Mild to Moderate COPD Patients
Brief Summary: This study will evaluate the safety and tolerability of the cfor the first time in mild to moderate COPD patients.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
B: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
C: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)
D: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Up to follow up (approximately 56 days)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings-ventricular rate (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Number of participants with abnormal (potential clinical importance [PCI]) systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) (Up to Day 27 (Visit 6a)); Number of participants with abnormal (PCI) clinical chemistry (Up to Day 42 (follow up visit)); Number of participants with abnormal (PCI) hematology (Up to Day 42 (follow up visit)); Number of participants with abnormal urinalysis (Up to Day 56 (Visit follow up)); Change from Baseline (Day 0) in lung function parameters: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) (Baseline (Day 0) and up to Day 27 (Visit 6a)); Number of participants with abnormal Holter interpretations (Up to Day 27 (Visit 6a)); Number of participants who withdrawn for exacerbations of chronic obstructive pulmonary disease (COPD) (Up to Day 27 (Visit 6a))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Tolerability of Inhaled GSK256066 in Mild to Moderate COPD Patients
Brief Summary: This study will evaluate the safety and tolerability of the cfor the first time in mild to moderate COPD patients.


Options:
A: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
B: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)
C: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Baseline to Week 24)
D: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Up to follow up (approximately 56 days)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings-ventricular rate (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Number of participants with abnormal (potential clinical importance [PCI]) systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) (Up to Day 27 (Visit 6a)); Number of participants with abnormal (PCI) clinical chemistry (Up to Day 42 (follow up visit)); Number of participants with abnormal (PCI) hematology (Up to Day 42 (follow up visit)); Number of participants with abnormal urinalysis (Up to Day 56 (Visit follow up)); Change from Baseline (Day 0) in lung function parameters: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) (Baseline (Day 0) and up to Day 27 (Visit 6a)); Number of participants with abnormal Holter interpretations (Up to Day 27 (Visit 6a)); Number of participants who withdrawn for exacerbations of chronic obstructive pulmonary disease (COPD) (Up to Day 27 (Visit 6a))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects
Brief Summary: A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme (6 months)
B: Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer (Base study: through Month 36); Overall Study: Incidence of HPV Type 6/11-related Genital Warts (Up to 10 years after the first dose of qHPV vaccine); Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer (Up to 10 years after the first dose of qHPV vaccine); Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer (Up to 10 years after the first dose of qHPV vaccine); Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) (Base study: through Day 5 after any vaccination); Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) (Base study: through Month 36); LTFU (EXT2): Number of Participants With Vaccine-Related SAEs (LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine); LTFU (EXT2): Number of Participants Who Died (LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine)
C: Number of Subjects Reporting Serious Adverse Events (Throughout the study period (up to Month 7)); Number of Subjects Reporting Solicited Local Symptoms (During the 7-day (Day 0-6) period following each vaccination); Number of Subjects Reporting Solicited General Symptoms (During the 7-day (Day 0-6) period following each vaccination); Number of Subjects Reporting Unsolicited Adverse Events (AEs) (Within 30 days (Day 0-29) after any vaccination); Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters (At Month 0 and Month 7); Number of Subjects Reporting Medically Significant Adverse Events (Throughout the study period (up to Month7))
D: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 (At Month 7); Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) (At Month 7)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)
Brief Summary: The purpose of this study is to compare the effects of fluvastatin, pravastatin, pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on coronary plaque volume, serum lipids, and inflammation markers in patients with acute coronary syndrome in Japanese.


Options:
A: the percent change in coronary plaque volume the percent change in integrated backscatter signal obtained by integrated backscatter IVUS (9-11 month)
B: Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. (24 months)
C: Change from baseline in low density lipoprotein cholesterol after 12 weeks
D: Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion (before randomization & 9-12 months after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Talking About Traumatic Events - A Randomized Controlled Dissemination Study of the Treatment of PTSD in an African Refugee Settlement
Brief Summary: The study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in Africa. Treatment was administered by lay counsellors.


Options:
A: Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale (9 months)
B: HSCL 25 (Symptoms were assessed at baseline); HSCL 25 (3-month follow-up); HSCL 25 (Assessment at 12-month-follow-up)
C: Harvard Trauma Questionnaire (Baseline, 12 weeks, 3 months)
D: the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms) (16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study SCA104779, an Evaluation of BW430C (Lamotrigine) Versus Placebo in the Prevention of Mood Episodes in Bipolar I Disorder Patients
Brief Summary: This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder.


Options:
A: Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).; Modified Social Adjustment Scale (SAS II-B; Bauer, 2001); ***Note: all primary outcomes obtained prospectively every 3 months for 18 months
B: Time to Withdrawal From Study (Randomization to Study Withdrawal (up to Week 26))
C: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) (8 Weeks)
D: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) (Eight weeks)

Answer: B