TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin
Brief Summary: This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA \[HCV-RNA\] viral load \>=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with peginterferon plus RBV alone.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (12 weeks after last dose of study drug)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
C: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)
D: Sustained virological response (24 weeks after end of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-17 Follow-up of Home Visiting Intervention
Brief Summary: This study is a longitudinal follow-up of 670 primarily African-American women and their 17-year-old firstborn children enrolled since 1990 in a highly significant randomized controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this program are charged with improving pregnancy outcomes, child health and development, and maternal economic self-sufficiency. This follow-up examines whether earlier program effects on maternal and child functioning lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those at both genetic and environmental risk; and whether program effects replicate those found with whites in an earlier trial.


Options:
A: Number of significantly improved child and maternal outcomes (2 Years)
B: Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old) (baseline, and when the child is 3, 6 and 12 months old); Parental competencies (when the child is 3, 12 and 18 months old) (when the child is 3, 12 and 18 months old); Child mental health (when the child is 18 and 24 months old) (when the child is 18 and 24 months old)
C: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at baseline); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 weeks postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 months postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 6 months postpartum)
D: Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid). (through first child age 18); Cognitive, language, and academic functioning among first-born children. (at youth age 18); Youth depression and anxiety (at youth age 18); Youth gang membership, arrests, convictions, and self-reported antisocial behavior, especially for crimes involving interpersonal violence. (at youth age 18); Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs. (at youth age 18.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High Dose Versus Standard Dose Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Hemostasis: A Prospective Randomized Comparative Study
Brief Summary: The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.


Options:
A: rate of initial hemostasis and the rate of recurrent bleeding (72hr)
B: Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy (one year)
C: recurrent bleeding (within 28 days after the first bleeding event)
D: Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers (30 days after endoscopic therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Brief Summary: The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve strength and function in those who have had extended ICU stays, as well as decrease critical illness myopathy as an etiology of weakness in the critically ill.


Options:
A: VE/VCO2 slope (Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.)
B: Diagnosis of CIPNM (June 2009)
C: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
D: Incremental shuttle walk test (10 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Brief Summary: The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve strength and function in those who have had extended ICU stays, as well as decrease critical illness myopathy as an etiology of weakness in the critically ill.


Options:
A: Diagnosis of CIPNM (June 2009)
B: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
C: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
D: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Brief Summary: The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve strength and function in those who have had extended ICU stays, as well as decrease critical illness myopathy as an etiology of weakness in the critically ill.


Options:
A: ventilator dependent status
B: Diagnosis of CIPNM (June 2009)
C: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
D: mortality

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multifaceted Depression Diabetes Program for Hispanics
Brief Summary: This study will evaluate the effectiveness of culturally adapted depression treatment for reducing depressive symptoms and improving adherence to diabetes self-care regimens in Hispanics with depression and diabetes.


Options:
A: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
B: 20-Item Symptom Checklist Depression Scale (Measured at baseline and after 6 months of treatment)
C: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multifaceted Depression Diabetes Program for Hispanics
Brief Summary: This study will evaluate the effectiveness of culturally adapted depression treatment for reducing depressive symptoms and improving adherence to diabetes self-care regimens in Hispanics with depression and diabetes.


Options:
A: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
B: BSI-12 (Anxiety and Somatization Subscales) (Measured at Month 18)
C: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)
D: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multifaceted Depression Diabetes Program for Hispanics
Brief Summary: This study will evaluate the effectiveness of culturally adapted depression treatment for reducing depressive symptoms and improving adherence to diabetes self-care regimens in Hispanics with depression and diabetes.


Options:
A: global Framingham Risk Score (18 months)
B: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
C: N/A
D: Change in Program Participation (6, 12, 18, and 24 months); Change in Program Fidelity (6, 12, and 24 months); Change in Participant Weight (Baseline, quarterly through 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcomes of Triaged Family Care in Advanced Cancer
Brief Summary: The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.


Options:
A: vaginal dryness score (for 12 weeks)
B: Change in Quality of Life (Baseline, 3 and 6 months)
C: Physical Function (14 months)
D: To evaluate the efficacy of a multicomponent biobehavioral psychosocial telephone counseling (PTC) intervention for cervical cancer survivors, compared to usual care (10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcomes of Triaged Family Care in Advanced Cancer
Brief Summary: The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.


Options:
A: Caregiver Quality of Life Index - Cancer (4 weeks); Perceived Stress Scale (4 weeks); Hospital Anxiety and Depression Scale (4 weeks); Basic Psychological Needs Scale (4 weeks); Healthcare Climate Questionnaire (4 weeks); Perceived Competence Scale (4 weeks); Interpersonal Support Evaluation List (4 weeks); Benefit Finding (4 weeks); Satisfaction and Feedback Questionnaire (4 weeks)
B: Change in Quality of Life (Baseline, 3 and 6 months)
C: Caregiver affect and adjustment (1 year post patient death)
D: Change in Impact of Event Scale (IES) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Hospital Anxiety and Depression Scale (HADS) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Profile of Mood States - Short Form (POMS-SF) (Baseline, 2 weeks post-intervention, 10 months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Attenuation of Second Generation Antipsychotic Induced Weight Gain in Adolescents and Adults Using Betahistine: A Double-Blind, Placebo-Controlled Trial
Brief Summary: The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain.

Hypothesis to be tested:

A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation.

B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation.

C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation


Options:
A: Change in Weight (Measured at each visit from baseline to end of study over a 12 week period)
B: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
C: Changes in body weight (baseline; week-4; week-8; week-12)
D: Weight loss (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infant Study of Inhaled Saline in Cystic Fibrosis
Brief Summary: The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and safe therapy in infants and young children with CF.


Options:
A: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)
B: Change in Lung Clearance Index (LCI) (48 weeks)
C: Chest CT (48 weeks)
D: Interview #1 (to be conducted at the time of enrollment (post SIMPLIFY study)); Interview #2 (to be conducted 4 months following the date of the first interview)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infant Study of Inhaled Saline in Cystic Fibrosis
Brief Summary: The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and safe therapy in infants and young children with CF.


Options:
A: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)
B: Lung Clearance Index (90 minutes post treatment)
C: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)
D: Percent Mucociliary Clearance at 60 Minutes (60 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infant Study of Inhaled Saline in Cystic Fibrosis
Brief Summary: The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and safe therapy in infants and young children with CF.


Options:
A: mucociliary clearance (6 hours)
B: Wet sputum production (45 minutes)
C: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the symptom cough between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of saltiness between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of throat irritation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.)
D: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Infant Study of Inhaled Saline in Cystic Fibrosis
Brief Summary: The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and safe therapy in infants and young children with CF.


Options:
A: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
B: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)
C: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
D: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Economic Evaluation of Rapid Detection of Bacteraemia and Fungemia by Real Time PCR for Cases of Febrile Neutropenia, Suspicion of Endocarditis and Severe Sepsis in Intensive Care Units
Brief Summary: The primary purpose is to improve and quicken the microbial diagnosis in severe infections, since only one third of the cases are documented by blood cultures and adequate anti-infective therapy in the 48 hours reduced mortality and morbidity.

Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive results, which will provide information for an adequate anti-infectious therapy.


Options:
A: Hours to First Antibiotic Modification (72 hours after randomization)
B: Number of Participants With Antibiotic Usage at the Time of the ED Visit (Baseline)
C: Number of bacteraemia and of fungemia - overall - each condition (max Day 30)
D: Duration of Antimicrobial Therapy (Hours) (Approximately 4 days after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass Oral Cholera Vaccination in High-risk Populations in Zanzibar: Assessment of Effectiveness and Herd Protection
Brief Summary: The purpose of this study is to conduct cholera vaccinations in high-risk populations in Zanzibar in order to estimate herd protection conferred by the vaccine,estimate effectiveness of the vaccine, and describe the interaction of vaccination and improved water supply on the burden of cholera and diarrhoeal diseases.


Options:
A: culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility. (1095 days)
B: Number of participants with vaccine related reactogenicity as assessed by study personnel (Within 30 minutes after administration of vaccine); Number of participants with solicited adverse events as assessed by study personnel (Within 7 days after administration of vaccine); Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician (Within 6 months after administration of vaccine); Number of participants showing seroconversion against sero group V. cholerae O1 (7 days after administration of vaccine)
C: Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection (7 days to 6 months)
D: Receipt of 2 complete or nearly complete swallowed doses of oral cholera vaccine (after completion of the vaccination campaign)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Disseminating Effective Habits for Long-Term Weight Loss
Brief Summary: The purpose of the study is to determine whether using a web-based weight loss website can help overweight individuals lose weight.


Options:
A: Body weight (3 months); Blood Pressure Control (3-Months)
B: weight loss (4 and 12 month)
C: 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).)
D: Weight Loss (Measured at Month 18)

Answer: A