TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
Brief Summary: Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction).

This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).


Options:
A: To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion. (8 weeks)
B: To evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. (8 and 16 hours)
C: change in body weight, change in serum sodium (within 14 days)
D: Change in Serum Sodium From Baseline to 6 Hours (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
B: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
C: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
D: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
B: Number of cigarettes smoked per day (End of 6 week intervention)
C: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
D: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
B: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
B: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
C: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
D: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
B: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
C: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
D: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
B: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.
D: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)
C: Continuous Nicotine Abstinence (8 weeks)
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial
Brief Summary: The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.


Options:
A: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
B: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
C: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Probiotics for the Prevention of Sepsis and NEC in Premature Infants in Colombia. A Randomized Double-Blind, Multicenter Trial
Brief Summary: This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infections and the development of a severe inflammatory disease of the bowel called necrotizing enterocolitis. The investigators propose that premature infants not given probiotics will colonize their gut with bad bacterias and develop infection.


Options:
A: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)
B: Weight (g) (From 4 to 6 weeks after inclusion)
C: The primary outcome measurement was death or NEC (≧stage 2) (From April 1, 2005 to May 30, 2007)
D: Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. (2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Probiotics for the Prevention of Sepsis and NEC in Premature Infants in Colombia. A Randomized Double-Blind, Multicenter Trial
Brief Summary: This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infections and the development of a severe inflammatory disease of the bowel called necrotizing enterocolitis. The investigators propose that premature infants not given probiotics will colonize their gut with bad bacterias and develop infection.


Options:
A: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
B: The primary outcome measurement was death or NEC (≧stage 2) (From April 1, 2005 to May 30, 2007)
C: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)
D: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (at D14 and D21.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.


Options:
A: Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) (Day 1 of Period 1, Day 43 of Period 1)
B: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes (Baseline (Week 3) and Week 8 (5 weeks post-vaccination))
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: ACR 20% response (Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.


Options:
A: ACR 20% response (Week 14)
B: Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.
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: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.


Options:
A: ACR 20% response (Week 14)
B: Percentage of patients with ACR 20 response (Week 24)
C: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
B: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
C: Percentage of patients with ACR 20 response (Week 24)
D: ACR 20% response (Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.


Options:
A: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)
B: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
C: Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline to Week 12); Part B: Percentage of Participants Achieving ACR20 Response at Week 24 (Baseline to Week 24); Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 (Baseline, Week 16); Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 (Baseline, Week 52)
D: ACR 20% response (Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exercise Intervention to Prevent Recurrent GDM
Brief Summary: Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the United States. GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes and thus provides an excellent opportunity to intervene years before the development of this disorder. It is well recognized that acute as well as chronic physical activity reduce fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. Recent studies have suggested that women with higher levels of physical activity have reduced risk of GDM. Therefore, we will test the hypothesis that an exercise intervention is an effective tool for preventing GDM among women with a history of GDM.


Options:
A: 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)
B: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
C: Gestational diabetes diagnosis assessed through glucose tolerance test. (28 weeks gestational age)
D: Serum fasting glucose values. (Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation))

Answer: C