TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Brief Summary: To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Options:
A: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)
B: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
C: Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose (from baseline up to 12 weeks)
D: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital
Brief Summary: The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).


Options:
A: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
B: days alive and out of hospital (up to 2 years)
C: Maximal oxygen consumption (At baseline and after 6 months)
D: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital
Brief Summary: The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).


Options:
A: Maximal oxygen consumption (At baseline and after 6 months)
B: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
C: functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. (6 and 12 months)
D: Controlled Blood pressure (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital
Brief Summary: The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).


Options:
A: CR Program Adherence (6 months)
B: Maximal oxygen consumption (At baseline and after 6 months)
C: Psychologic aspect (8 weeks); Functional capacity (8 weeks); Disability level (8 weeks); Quality of life (8 weeks)
D: Mortality rate (10-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital
Brief Summary: The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).


Options:
A: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
B: Reduction of the SCORE Risk Score (6 months after the intervention)
C: Attendance at the free orientation session for Cardiac Rehabilitation (within 5 weeks of randomized apointment date)
D: Maximal oxygen consumption (At baseline and after 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital
Brief Summary: The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).


Options:
A: Maximal oxygen consumption (At baseline and after 6 months)
B: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)
C: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))
D: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Brief Summary: This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.


Options:
A: Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date (26 Weeks Following Smoking Quit Date (Study week 29)); 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date (52 Weeks Following Smoking Quit Date (Study week 55))
B: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)
C: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
D: Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 (Week 9 - Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Brief Summary: This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.


Options:
A: A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up); A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up)
B: Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (from the first administration of nicotine/placebo patch until delivery)
C: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)
D: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Brief Summary: This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.


Options:
A: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
B: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
C: 6 Month Self-reported Abstinence From Smoking (6 months)
D: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Brief Summary: This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.


Options:
A: N/A
B: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Brief Summary: This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.


Options:
A: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
B: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
Brief Summary: This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.


Options:
A: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)
C: Birth weight as assessed by z-scores (At birth)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
Brief Summary: This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.


Options:
A: Body Mass Index standard deviation score (On average 2.9 years of age)
B: Excessive weight gain during pregnancy (2007-2023)
C: Birth weight as assessed by z-scores (At birth)
D: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
Brief Summary: This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.


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: Number of at risk participants developing GDM during pregnancy
C: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
D: Birth weight as assessed by z-scores (At birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
Brief Summary: This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.


Options:
A: Birth weight as assessed by z-scores (At birth)
B: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
C: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
D: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
Brief Summary: The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.


Options:
A: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
B: N/A
C: 5-Day Sum of Pain Intensity Difference (SPID5) (Day 1 to Day 5); Spontaneous Bowel Movements Per Week (SBMs/Week) (Week 1 to Week 2)
D: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
Brief Summary: The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.


Options:
A: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
B: No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.
C: Change From Baseline to Week 12 in Mean Pain Intensity (Baseline, Week 12 (or final visit))
D: Change in pain intensity from baseline (pre-randomization) to last assessment.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Epidural Etanercept in the Treatment of Sciatica
Brief Summary: Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior. Open-label studies in humans have shown both etanercept and infliximab provide excellent, long-term relief in patients with acute radiculopathy from herniated disc. However, a recent placebo-controlled study failed to demonstrate any significant difference from placebo. The investigators have already established the safety of neuraxial etanercept in a trial that has just been completed (not yet published). The objective of this study is to determine whether small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for LBP caused by nerve root irritation (i.e., radiculopathy).


Options:
A: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
B: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)
C: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year (When all participants complete the 1 year visit)
D: Visual analogue scale pain score, Oswestry disability index, medication intake (7 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation: a Single Center Randomized Controlled Trial
Brief Summary: We hypothesize that the administration of a combination of high numbers of probiotic bacteria will maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Diarrhea following kidney transplantation.


Options:
A: Short Form Health Survey (SF-36) (24 weeks); Adverse Events (24 weeks)
B: To maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Diarrhea following kidney transplantation, utilizing a daily questionnaire, stool cultures and C. Difficile. (5 months)
C: All-cause postoperative mortality (90 days after the date of liver transplantation); Postoperative infection (30 days from the date of liver transplantation)
D: Evaluate the effect of synbiotic on postoperative infection after liver transplantation (15 days)

Answer: B