TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis: Randomized Double-blind Placebo-controlled Trial
Brief Summary: The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.


Options:
A: To demonstrate that a higher proportion of subjects will have an improvement of uveitis on adalimumab versus placebo after 2 months relative to baseline (Final visit could occur at any point up to 78 weeks)
B: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase (Week 16 to Week 48 (32 weeks))
C: Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 (Week 16 through Week 48)
D: ACR Pedi 75 response (54 weeks from baseline (0))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evidence Based Decision Making: Integrating Clinical Prediction Rules Into Electronic Health Records
Brief Summary: Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. The aims of this project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).


Options:
A: The primary outcome of this study will be focused on changes in doctor behavior and the comparison of the number of diagnostic tests ordered (chest x-rays) and antibiotics prescribed per patient encountered per diagnosis. (Comparisons between case and control ordering will be measured after a year of using the EMR tool)
B: Rate of HPV vaccination among girls actively cared for at participating sites (Monthly, up to 1 year)
C: Enhanced goal-consistent care (up to 2 years); PEACE (up to 2 years)
D: Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence (12 months post enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evidence Based Decision Making: Integrating Clinical Prediction Rules Into Electronic Health Records
Brief Summary: Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. The aims of this project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).


Options:
A: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
B: Intervention acceptance (6 months (May 2010-Nov2010))
C: The primary outcome of this study will be focused on changes in doctor behavior and the comparison of the number of diagnostic tests ordered (chest x-rays) and antibiotics prescribed per patient encountered per diagnosis. (Comparisons between case and control ordering will be measured after a year of using the EMR tool)
D: Proportion of clinical failure by day 7 compared among the 3 study arms. (10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults
Brief Summary: The purpose of this study is to analyze and compare the immunogenicity of Bivalent and Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.


Options:
A: Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA) (Day 0, Day 45, Day 180, Day 210 and Day 365)
B: Incident cervical infection with HPV-16 and/or HPV-18
C: 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)
D: The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. (4 weeks post dose 3 injection)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multi-Centre, Randomized Controlled Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel in the Prevention of Human Immunodeficiency Virus Type 1 Infection in Women, and to Examine Effects of the Microbicide on the Incidence of Herpes Simplex Virus Type 2 Infection
Brief Summary: The purpose of the study is to assess the safety and effectiveness of intravaginal 1% tenofovir gel in preventing Human Immunodeficiency Virus (HIV-1) infection and Herpes Simplex Virus (HSV-2) infection in sexually active women.


Options:
A: Effectiveness (30 months); Safety (30 months)
B: Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
C: Measured endogenous antimicrobial activity (Throughout study); Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL (Throughout study)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: IndiaCLEN Multicentric Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children
Brief Summary: The purpose of this study is to determine the safety and efficacy of oral amoxicillin in treating WHO defined severe pneumonia(cough and fast breathing with lower chest indrawing) at home and at hospital using an open labelled multicentric prospective two-arm randomized clinical trial to determine the differences in failure of treatment with a 7 day course of oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent home after enrolment, in children 3 to 59 months old who have severe pneumonia. The investigators developmental hypothesis were to test whether the community/home based oral amoxicillin is efficacious for treating severe pneumonia.


Options:
A: Treatment Failure at 48 Hours (Two Full Days After Enrollment) (48 hours)
B: To assess the efficacy of a 7 day course of oral amoxycillin when administered at Home in comparison to administration of oral amoxycillin for first 48 hours in the hospital (Day of enrollment to Day 7)
C: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end of therapy (EOT))
D: Clinical success (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week, Randomized, Multicenter, Double-blind, Active-controlled, Non-inferiority Study to Compare the Efficacy and Safety of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
Brief Summary: This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.


Options:
A: The change of LDL-C (Baseline to 12 weeks)
B: Androgen secretion (0, 3, 6 months); Glucose metabolism (0, (3), 6 months)
C: change of ApoB/ApoA1 (after 12 weeks' treatment)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week, Randomized, Multicenter, Double-blind, Active-controlled, Non-inferiority Study to Compare the Efficacy and Safety of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
Brief Summary: This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.


Options:
A: Percent Change From Baseline in LDL-C (12 weeks)
B: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (12 weeks minus baseline)
C: Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks (Baseline to 12 weeks)
D: The change of LDL-C (Baseline to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
Brief Summary: Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz) to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation (hereby simply referred to as priming) has been shown to enhance the neurophysiological effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore, this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).


Options:
A: 1.Auditory hallucinations Rating Scale developed by Hoffman and colleagues (2003) 2.SAPS 3.CGI 4.SANS 5.GAF (Prospective)
B: Psychotic Symptoms Rating Scale (PSYRATS) (4 weeks)
C: Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) (105 Days)
D: Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003) (before, after 1 week of treatment and 2 times follow up (1 & 3 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation Powder is safe and effective compared with placebo or no active drug intake, when administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1 (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period (Baseline and Day 8 of each treatment period (up to Study Day 50))
B: Cmax (5 months); tmax (5 months); tlast (5 months); AUC0-t (5 months); t1/2 (5 months); CL/F (5 months); Vd/F (5 months); AUC0-inf (5 months); AUC0-t' (5 months); C τ (5 months); AUC0-τ (5 months); Ro (5 months); RCmax (5 months); DF (5 months)
C: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline and Day 85)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C
Brief Summary: The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.


Options:
A: Body Weight; Lean Body Mass; Functional Performance
B: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)
C: Body weight; Lean body mass; Functional performance
D: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C
Brief Summary: The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.


Options:
A: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)
B: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)
C: Body weight; Lean body mass; Functional performance
D: Body Weight; Lean Body Mass; Functional Performance

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of 30mcg and Levonorgestrel 150 Combined Oral Contraceptive, Etonogestrel-releasing Subdermal Implant and Levonorgestrel-releasing Intrauterine System on Breast-Milk Production and Infant Growth in Fully Breast-Feeding Women
Brief Summary: The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The pairs will then be followed for four weeks. During this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.


Options:
A: Evaluation of infant weight, height and size of the tibial (women and children will be evaluated at time frame from day 42 through day 64 post-partum)
B: Time to Lactogenesis Stage II (5 days postpartum)
C: Number of Participants Who Continued to Breastfeed at 6 Months (Baseline to Week 8, Week 8, 2-6 months)
D: Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Brief Summary: Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?


Options:
A: Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE) (30 days)
B: Composite of arterial access related complications (30 days)
C: Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. (20 minutes, 1 hour and at discharge, pooled)
D: Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC). (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Open-label, Randomized Clinical Trial of Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX) Versus GEMOX Alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma
Brief Summary: This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy.


Options:
A: objective response rate (baseline and every 8 weeks)
B: Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months (4 months)
C: Progression-free survival (Every 8±1 Weeks until PD)
D: Progression-free survival [PFS] (approx. 25 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Structural and Functional Evaluation of the Macula in Patients With Proliferative Diabetic Retinopathy Treated With Panretinal Photocoagulation and Bevacizumab (Avastin ®)
Brief Summary: This is a prospective, randomized and comparative study is to quantify the functional and structural alterations of the macula in patients with proliferative Diabetic Retinopathy submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab as a adjuvant therapy in preventing the adverse events of that procedure. The patients with proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation will be examined by ophthalmologists who will measure the visual acuity and contrast sensitivity, perform slit lamp examination, fundus examination and optic coherence tomography before and after laser photocoagulation. Laser photocoagulation will be performed in both eyes according Early Treatment Diabetic Retinopathy Study that advocate the realization of 3 episodes of laser photocoagulation in 3 weeks. This comparative study analyses the effect of intravitreal bevacizumab one week before laser photocoagulation and one, three and six months after the randomization visit. The fellow eye will be submitted only to laser photocoagulation and will be considered as control. It is estimated a sample of 30 patients. All procedures, purposes and methods will be explained to all patients.


Options:
A: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
B: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)
C: Functional Macular Evaluation (24 weeks)
D: Mean Change in Visual Acuity From Baseline (2-years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Structural and Functional Evaluation of the Macula in Patients With Proliferative Diabetic Retinopathy Treated With Panretinal Photocoagulation and Bevacizumab (Avastin ®)
Brief Summary: This is a prospective, randomized and comparative study is to quantify the functional and structural alterations of the macula in patients with proliferative Diabetic Retinopathy submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab as a adjuvant therapy in preventing the adverse events of that procedure. The patients with proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation will be examined by ophthalmologists who will measure the visual acuity and contrast sensitivity, perform slit lamp examination, fundus examination and optic coherence tomography before and after laser photocoagulation. Laser photocoagulation will be performed in both eyes according Early Treatment Diabetic Retinopathy Study that advocate the realization of 3 episodes of laser photocoagulation in 3 weeks. This comparative study analyses the effect of intravitreal bevacizumab one week before laser photocoagulation and one, three and six months after the randomization visit. The fellow eye will be submitted only to laser photocoagulation and will be considered as control. It is estimated a sample of 30 patients. All procedures, purposes and methods will be explained to all patients.


Options:
A: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
B: Functional Macular Evaluation (24 weeks)
C: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
D: total area of fluorescein leakage from active new vessels (baseline, weeks 1,6,12,24,36,48); Best corrected Visual Acuity (BCVA) (Baseline, weeks 1,6,12,24,36,48); central macular thickness (baseline, weeks 1,6,12,24,36,48)

Answer: B