TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: En Pareja: A Latino Couples Intervention to Help Expectant Fathers Quit Smoking
Brief Summary: Smoking among Latino males living in the U.S. is a significant public health problem, one that can contribute to disparities in life expectancy and increase mortality. Latinos smoke at the same rate as White males but are less likely than Whites to quit. Interventions do not reach Latino smokers because many speak only Spanish and previous interventions have had notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers likely did not participate. Second, cessation effects were short-term only. Third, no program has attempted to boost Latino cessation rates by capitalizing on a "teachable moment", a time when quitting may seem especially relevant. To address these deficits, we propose to conduct a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We will include couples, rather than just men, to sustain intervention effects. We will partner with community leaders to develop an intervention based primarily on Social Cognitive Theory, the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements will be at the individual level to help Latinos quit smoking and others will be couple-based to improve communication and reduce stress in the postpartum relationship. The program will be culturally sensitive to Latino values, such as familismo, valuing of and duty to the family and personalismo, valuing warm personal relationships. We will recruit Latino couples (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking cessation guide, and a couple-based smoking cessation counseling arm.

Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months post-randomization than Latino expectant fathers who receive a self-help smoking cessation guide.

Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion, and self-image, which in turn, will increase cessation rates among Latino expectant fathers.

Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than couples in the Guia arm.


Options:
A: seven-day point prevalence smoking abstinence (28 weeks gestation and 12 months post-randomization)
B: N/A
C: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)
D: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: En Pareja: A Latino Couples Intervention to Help Expectant Fathers Quit Smoking
Brief Summary: Smoking among Latino males living in the U.S. is a significant public health problem, one that can contribute to disparities in life expectancy and increase mortality. Latinos smoke at the same rate as White males but are less likely than Whites to quit. Interventions do not reach Latino smokers because many speak only Spanish and previous interventions have had notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers likely did not participate. Second, cessation effects were short-term only. Third, no program has attempted to boost Latino cessation rates by capitalizing on a "teachable moment", a time when quitting may seem especially relevant. To address these deficits, we propose to conduct a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We will include couples, rather than just men, to sustain intervention effects. We will partner with community leaders to develop an intervention based primarily on Social Cognitive Theory, the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements will be at the individual level to help Latinos quit smoking and others will be couple-based to improve communication and reduce stress in the postpartum relationship. The program will be culturally sensitive to Latino values, such as familismo, valuing of and duty to the family and personalismo, valuing warm personal relationships. We will recruit Latino couples (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking cessation guide, and a couple-based smoking cessation counseling arm.

Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months post-randomization than Latino expectant fathers who receive a self-help smoking cessation guide.

Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion, and self-image, which in turn, will increase cessation rates among Latino expectant fathers.

Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than couples in the Guia arm.


Options:
A: seven-day point prevalence smoking abstinence (28 weeks gestation and 12 months post-randomization)
B: Participants' Smoking Status (around the 32nd week of gestation.); The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. (At the baseline and at the 32nd week of gestation)
C: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
D: Cotinine validated quit rates.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Placebo-controlled Study of Efficacy, Safety and Tolerance of Raloxifene as an Adjuvant Treatment for Negative Symptoms of Schizophrenia in Postmenopausal Women
Brief Summary: Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women.

This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Treatment period of 12 weeks.

The primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. The investigators also found improved response in some aspects of social functioning and neuropsychological functioning.


Options:
A: Most Bothersome Symptom (MBS) Severity (Baseline, Week 4, Week 12)
B: The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
C: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Vaginal pH at Week 12 (Baseline and Week 12); Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12 (Baseline and Week 12); Number of Participants With Adverse Events (From the first dose of study drug up to 14 days after the last dose; 14 weeks)
D: Vascular function (0 and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer
Brief Summary: This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.


Options:
A: Progression-Free Survival (PFS) Determined by an Independent Review Facility (Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months))
B: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
C: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)
D: Time to Progression (every 8 weeks up to a maximum of 36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer
Brief Summary: This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.


Options:
A: Progression-free Survival (Treatment will continue until disease progression or intolerable toxicity, up to 2 years)
B: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
C: Overall Survival (From randomization until death due to any cause (average of 51 weeks)); Overall Survival in All Randomized Participants (From randomization until death due to any cause (average of 51 weeks))
D: Overall Survival Time (OS) (Randomization up to 27.5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer
Brief Summary: This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.


Options:
A: Overall Survival (From randomization until death, up to 26 months)
B: Overall Survival (3 years)
C: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
D: Overall Survival (OS) (2.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer
Brief Summary: This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.


Options:
A: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
B: Overall Survival (Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years)
C: Progression free survival (8 weeks)
D: Overall Survival (OS) (From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Granulocyte-Macrophage Stimulating Factor (GM-CSF) and Mobilization of Progenitor Cells in Peripheral Arterial Disease: A Phase II Randomized Study
Brief Summary: Peripheral arterial disease is a common condition in older adults involving poor arterial circulation in the legs leading to leg pain and debility. The body's own circulating blood vessel stem cells may help to improve circulation. This study will test whether treatment with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms and signs of peripheral arterial disease over placebo after four weeks of therapy. As well this study will examine whether improvements in blood vessel function can be observed. Finally, we will measure blood vessel function and stem cell levels in order to determine whether they can help to predict whether patients wither peripheral arterial disease will suffer further cardiovascular complications.


Options:
A: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)
B: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)
C: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
D: Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Granulocyte-Macrophage Stimulating Factor (GM-CSF) and Mobilization of Progenitor Cells in Peripheral Arterial Disease: A Phase II Randomized Study
Brief Summary: Peripheral arterial disease is a common condition in older adults involving poor arterial circulation in the legs leading to leg pain and debility. The body's own circulating blood vessel stem cells may help to improve circulation. This study will test whether treatment with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms and signs of peripheral arterial disease over placebo after four weeks of therapy. As well this study will examine whether improvements in blood vessel function can be observed. Finally, we will measure blood vessel function and stem cell levels in order to determine whether they can help to predict whether patients wither peripheral arterial disease will suffer further cardiovascular complications.


Options:
A: side effects (3months)
B: Major amputation
C: Ankle brachial index (6 months); Healing (1 year); Amputation rate (1 year)
D: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Granulocyte-Macrophage Stimulating Factor (GM-CSF) and Mobilization of Progenitor Cells in Peripheral Arterial Disease: A Phase II Randomized Study
Brief Summary: Peripheral arterial disease is a common condition in older adults involving poor arterial circulation in the legs leading to leg pain and debility. The body's own circulating blood vessel stem cells may help to improve circulation. This study will test whether treatment with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms and signs of peripheral arterial disease over placebo after four weeks of therapy. As well this study will examine whether improvements in blood vessel function can be observed. Finally, we will measure blood vessel function and stem cell levels in order to determine whether they can help to predict whether patients wither peripheral arterial disease will suffer further cardiovascular complications.


Options:
A: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
B: Therapy Success (6 months)
C: major-amputation-free survival rate (at 6 months)
D: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: US Pilot Safety and Feasibility Study of Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction in Patients With Heterogeneous Emphysema With Upper Lobe Predominance
Brief Summary: To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.


Options:
A: Occurence of adverse events (serious and non-serious) secondary to the BTVA treatment procedure from initiation of treatment through completion of the six-month follow-up period (6 months)
B: Change in Percent Volume of Lung (12 weeks following treatment)
C: Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio (12 Weeks following final treatment)
D: Improvement in pulmonary function (FEV1) 6-minute walking test (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Brief Summary: This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).


Options:
A: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
B: All strokes (fatal and non-fatal) (Duration of trial)
C: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
D: N/A

Answer: A