TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naive Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
Brief Summary: The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)
B: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)
D: Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a (Up to 5 days); Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 (Up to 5 days); Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event (Up to 5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Trial of Irinotecan/Temozolomide With Temsirolimus (NSC# 683864) or Chimeric 14.18 Antibody (Ch14.18) (NSC# 764038) in Children With Refractory, Relapsed or Progressive Neuroblastoma
Brief Summary: This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.


Options:
A: Determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma. (within 12 months of the start of therapy)
B: Percentage of Randomized Patients Who Are Responders (Up to the first 6 cycles of treatment); Percentage of Patients in the Dinutuximab Arm Who Are Responders (Up to the first 6 cycles of treatment)
C: Event Free Survival (R1: MAT therapy) (Up to three years); Event Free Survival (immunotherapy) (Up to three years); Complete metastatic response (R3: Induction therapy) (Up to 95 days); Event free survival (R3: Induction therapy) (Up to three years)
D: Event-Free Survival (EFS) (Three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.


Options:
A: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
B: Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 (Study Baseline, Week 12); Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 (Study Baseline, Week 12)
C: Change in the total weekly number of incontinence episodes (Baseline to Treatment Week 12/Premature Discontinuation)
D: Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. (Baseline and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Evidence-Based Primary Care for Chronic Kidney Disease
Brief Summary: Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary care offices and primary care physicians are generally not familiar with treatment guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently associated with co-morbidities that make effective treatment difficult due to complexity of care. Availability of Clinical Decision Support (CDS) for CKD may help promote effective, evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality improvement and other interventions such as CDS plus practice facilitation may be needed.

Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice guidelines that PCPs may use to enhance the care they provide to a difficult to manage segment of the healthcare population.

Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE model of practice change, versus CDS alone. The study aims to analyze differences in promoting evidence-based care in primary care practices. Thirty-six practices will be recruited for this study. Patient inclusion criteria: adult patients with estimated Glomerular Filtration Rate (eGFR) of \<60 and \>15ml/min/1.73m2 confirmed with repeat testing over three or more months. A process evaluation will be conducted between the CDS practices with facilitation and the CDS only practices to assess clinical outcomes of CKD progression and all-cause mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit ratio of CDS alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to cost per quality adjusted years of life. This study is funded by NIH NIDDK under R01 mechanism starting on 07/01/2011 and ending on 06/30/2016.


Options:
A: Count of Initiating BUP in the ED With Referral for Ongoing MOUD With User-centered CDS Compared With Usual Care (Upon discharge (Up to 1 day))
B: Quality of otitis media care. (18 Months)
C: Degree of evidence-based guideline-concordant care for CKD (up to 3 years)
D: Contraception Use Self-efficacy Scale Score (Aim 1b) (Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)); Contraception Use Self-efficacy Scale Score (Aim 1c) (Baseline, 3 months, 6 months); Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b) (Baseline, 3 months, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial
Brief Summary: A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.


Options:
A: • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain). (2 weeks)
B: 11-point Visual Analog Scale for Pain (1-2 weeks)
C: Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention. (Within 1 week)
D: Maximum Pain Score Over Study Period (Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
Brief Summary: This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.


Options:
A: Average change from baseline through Week 12 for WOMAC pain subscale score. Average change from baseline through Week 12 for WOMAC physical function subscale score. Subject's average global assessment of response to therapy through Week 12.
B: Change in 100mm Pain VAS (baseline throgh week 8)
C: Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score) (Primary: 12months.)
D: Sum of Pain Intensity Difference (SPID) at Hour 48 (Hour 48)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pediatric Behavioral Informatics to Prevent Cancer
Brief Summary: The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.


Options:
A: sugar-sweetened beverages (one time point (baseline only))
B: Change in intake of the target vegetable (Change in intake of the target vegetable from Baseline to day 14)
C: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
D: Change in grams of fruit and vegetables consumed (Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pediatric Behavioral Informatics to Prevent Cancer
Brief Summary: The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.


Options:
A: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)
B: sugar-sweetened beverages (one time point (baseline only))
C: Change in Child Body Mass Index (BMI Z-score) (Change from Baseline at 12 and 21 months)
D: Change in child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Bone Marrow-derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure.
Brief Summary: Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.


Options:
A: Change in left ventricular ejection fraction (baseline and 1 year)
B: increase of the ejection fraction of the left ventricle (1 year)
C: Efficacy between groups post-index procedure (39 weeks post-index)
D: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) (One month post-catheterization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Bone Marrow-derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure.
Brief Summary: Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.


Options:
A: Number of Patients With Serious Adverse Events (12 Months)
B: Changes in left ventricular ejection fraction and dimensions (1 year)
C: Efficacy between groups post-index procedure (39 weeks post-index)
D: Change in global left ventricular ejection fraction (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Management in Obese Pregnant Underserved African American Women
Brief Summary: This project will test a novel lifestyle intervention to help overweight and obese socioeconomically disadvantaged African American women achieve healthy weight control during and after pregnancy and improve the health of their offspring. The treatment will be given through an existing national home visiting program, Parents As Teachers (PAT), which will facilitate sustainability and nationwide dissemination, if effective. We hypothesize that compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine recommendations for gestational weight gain.


Options:
A: Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations (Delivery (when the baby is delivered))
B: 30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts. (30 Months)
C: Maternal Weight Change (baseline to 2 weeks post partum)
D: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Management in Obese Pregnant Underserved African American Women
Brief Summary: This project will test a novel lifestyle intervention to help overweight and obese socioeconomically disadvantaged African American women achieve healthy weight control during and after pregnancy and improve the health of their offspring. The treatment will be given through an existing national home visiting program, Parents As Teachers (PAT), which will facilitate sustainability and nationwide dissemination, if effective. We hypothesize that compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine recommendations for gestational weight gain.


Options:
A: fat tissue (6 months)
B: Postpartum weight loss (12 months after delivery)
C: Weight for Length Body Mass Index (BMI will be assessed at three years of age for the study participants)
D: Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations (Delivery (when the baby is delivered))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the P.L.A.Y. Project Intervention for Autism
Brief Summary: This study is a large, multi-site, randomized controlled NIH trial that evaluates whether The P.L.A.Y. (Play and Language for Autistic Youngsters) Project is effective. The PLAY Project Home Consultation model coaches parents, through monthly home visits and the use of video feedback, to effectively interact with their young child with autism. The aims of the study are 1.) to show that the PLAY Home Consultants show fidelity to the model, 2.) that caregivers can be taught to interact in an engaging way with their child (with causing more stress), 3.) that the child then interacts better, improves his/her language, and has reduced severity of his or her autism.


Options:
A: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
B: Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks (Baseline, 12 weeks)
C: Reduction in autism severity as measured by the Autism Diagnostic Observation Scale (ADOS) (1 year)
D: Number of words used spontaneously during language sample (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Controlled Comparison of an Automated Thermal Pulsation Treatment (Lipiflow ®) and a Standard Lid Hygiene Regime
Brief Summary: Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated thermal pulsation with the Lipiflow® system have been reported in several case reports. In one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However, treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia followed by lid massage and lid margin cleansing over several months. To the best of the investigators knowledge this is the first randomized prospective study to compare automated thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene regime.

The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene regime.


Options:
A: NIBUT (Non-Invasive Break-Up Time) (The difference between the change in NIBUT of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery))
B: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 (Baseline, Month 12)
C: Change of Dry Eye Symptoms (after 3 month compared to baseline value)
D: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Timing on Motor Learning
Brief Summary: The purpose of this research study is to compare different methods for training hand movement at home after stroke. This study involves research because it will test two experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand and arm exercises. The MusicGlove is a glove that measures finger movements and allows its user to play a musical computer game using those movements. The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.


Options:
A: Change in Action Research Arm Test score from baseline (Baseline, after 4 weeks and at 3 months follow-up)
B: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
C: Fugl-Meyer (FM-SEC and FM-WH) (7 months); Motor-Functional Independence Measure (m-FIM) (7 months); Frenchay Arm Test (FA-T) (7 months)
D: Motor and Strength Outcome Measure Using Box and Block Test (From baseline to 1 month post therapy); Motor and Strength Outcome Measure Using Fugl-Meyer Score (From baseline to 1 month post therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan
Brief Summary: To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.


Options:
A: H pylori eradication rate (at least 4 weeks up to 24 weeks after finishing course of antibiotics)
B: Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori (6 months (Feb 2014))
C: Number of Participants With Complete Eradication of Helicobacter Pylori (at the 6th week after the end of anti- H. pylori therapy)
D: To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization. (week 6 post-randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Brief Summary: The aim of this study is to examine whether periodic fasting improves markers of diabetes risk and cardiovascular health, and will compare this to the effects observed with daily dieting by energy restriction, and also with no change in energy intake.

It is hypothesized that periodic fasting, with or without weight loss, will be as effective as daily energy restriction to improve markers of metabolic health and energy metabolism.


Options:
A: Body weight (12 weeks)
B: Insulin sensitivity (8 weeks)
C: Changes in body weight, body fatness and total energy expenditure at baseline, 3, 6, and 12 months of caloric restriction (CR).
D: Body weight (52 days)

Answer: B