TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Phone-Based Weight Control for Rural Breast Cancer Survivors
Brief Summary: Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.


Options:
A: Whether the PA and dietary intake targets are met at the end of intervention; (at the end of 12 months of intervention)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: Weight loss maintenance (6 - 18 months)
D: Breast Cancer Recurrence (Lifetime)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.


Options:
A: Number of Transfusions During Hospitalization (From birth to 36 weeks gestational age); Composite Cognitive Score at 18-22 Months Corrected Age (18-22 months)
B: Mental developmental index (Bayley II) and motor, visual and hearing impairment (at age of 24 months corrected for prematurity.)
C: Death or Neurodevelopment Impairment (18-22 Months Corrected Age)
D: The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day). (one month); Time to stop parentral nutrition (one month); Day of onset of weight gain (one month); Duration of hospitalization (2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.


Options:
A: Mental developmental index (Bayley II) and motor, visual and hearing impairment (at age of 24 months corrected for prematurity.)
B: The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day). (one month); Time to stop parentral nutrition (one month); Day of onset of weight gain (one month); Duration of hospitalization (2 months)
C: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function (42-48 months and 66-72 months)
D: Death or Neurodevelopment Impairment (18-22 Months Corrected Age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
Brief Summary: This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.


Options:
A: Abdominal Complications (1 month)
B: Rate of clinically relevant postoperative pancreatic fistula (POPF) (Up to 60 days after Surgery)
C: Surgical Site Infection at D30 (30 days after surgical intervention)
D: 60-day ≥ Grade II Complication Rate (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
Brief Summary: This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.


Options:
A: 60-day ≥ Grade II Complication Rate (60 days)
B: Postoperative pancreatic fistula (30 days postoperatively)
C: Abdominal Complications (1 month)
D: To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo. (60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Brief Summary: The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.


Options:
A: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
B: Percent change from baseline in uterine volume and volume of the largest fibroid. (Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.); Duration of amenorrhea (Day 1 to 1st post treatment menses)
C: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month (Baseline, Final Month (last 28 days of treatment))
D: Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) (Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
Brief Summary: Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated abnormalities.


Options:
A: N/A
B: Changes from baseline in circulating levels of glucose and insulin according to the intervention arm (Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
C: The primary outcome measure is HDL-C (12 weeks and 24 weeks)
D: Metabolic syndrome status (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects With a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention With Incomplete Revascularization
Brief Summary: This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.


Options:
A: N/A
B: Cardiac Magnetic Resonance (CMRs) (4 weeks and 10 weeks)
C: Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization (Baseline through end of study (average 90 weeks))
D: Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function
Brief Summary: The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow, and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.


Options:
A: Intervention Related Adverse Events (90 days)
B: N/A
C: Changes in left ventricular ejection fraction and dimensions (1 year)
D: Improvement in global ejection fraction on LV angiography (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth: A CBPR RCT
Brief Summary: The goal of this project is to evaluate the effectiveness of a family-based tobacco use prevention intervention directed at immigrant Latino parents of middle school aged youth as delivered in partnership with seven community organizations. The primary outcomes of the study are youth susceptibility to tobacco use, and changes in parenting practices among the parents of the youth. The planning, initiation, and delivery of the intervention will occur in collaboration with community organizations that have identified this project as important to the families they serve. Though the collaboratively designed training curriculum has been successfully tested and a study design for the current project established, a substantive development period for this project will allow the research team and collaborating organizations to consider key aspects of design and delivery.


Options:
A: Number of weight management visits/ practitioner Full Time Equivalent(FTE) (Data will be collected monthly and analyzed at 6, 12 and 18 Months); Change in BMI (3,6,12,and 18 month where possible); Change in Self-reported health measures-SF12 (3,6,12 months and 18 months where possible)
B: Proportion of eligible pregnant women who initiate ART for purposes of PMTCT (18 months)
C: Comparison of susceptibility rate differences between the control and intervention groups (6 Months Post Intervention)
D: Change from baseline in the level of patient-centredness at one year (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth: A CBPR RCT
Brief Summary: The goal of this project is to evaluate the effectiveness of a family-based tobacco use prevention intervention directed at immigrant Latino parents of middle school aged youth as delivered in partnership with seven community organizations. The primary outcomes of the study are youth susceptibility to tobacco use, and changes in parenting practices among the parents of the youth. The planning, initiation, and delivery of the intervention will occur in collaboration with community organizations that have identified this project as important to the families they serve. Though the collaboratively designed training curriculum has been successfully tested and a study design for the current project established, a substantive development period for this project will allow the research team and collaborating organizations to consider key aspects of design and delivery.


Options:
A: Comparison of susceptibility rate differences between the control and intervention groups (6 Months Post Intervention)
B: Drug use frequency and quantity at 1-, 3- and 12-months post-intervention. (1 year post treatment)
C: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
D: Self-reported drunkenness (12 months); Self-reported drunkenness (30 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma
Brief Summary: The purpose of this study is to explore the efficacy of bevacizumab combined with radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed glioblastoma in the elderly.

* Trial with medicinal product


Options:
A: median overall survival (1 year)
B: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
C: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months (6 months)
D: Overall Survival (Time to event)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma
Brief Summary: The purpose of this study is to explore the efficacy of bevacizumab combined with radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed glioblastoma in the elderly.

* Trial with medicinal product


Options:
A: N/A
B: median overall survival (1 year)
C: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))
D: Overall Survival (2.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma
Brief Summary: The purpose of this study is to explore the efficacy of bevacizumab combined with radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed glioblastoma in the elderly.

* Trial with medicinal product


Options:
A: Number of Participants With Treatment Related Adverse Events (2 months)
B: median overall survival (1 year)
C: Overall Survival (From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years or 80 deaths have been reported.)
D: Incidence of neuropsychological and neuroendocrine function in the two arms

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D for Sickle-cell Respiratory Complications
Brief Summary: This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month.

Funding Source - U.S. Food \& Drug Administration, Office of Orphan Products Development


Options:
A: Mean Annual Rate of Respiratory Events (Up to 2 years)
B: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
C: Time to first upper respiratory tract infection (One year); Time to first moderate / severe COPD exacerbation (One year)
D: Asthma Control Measured With Asthma Control Test (ACT) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D for Sickle-cell Respiratory Complications
Brief Summary: This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month.

Funding Source - U.S. Food \& Drug Administration, Office of Orphan Products Development


Options:
A: SCORAD score (May - August 2012 (3 months))
B: Blood 25 Hydroxyvitamin D (25OHD) Concentrations (1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery))
C: Mean Annual Rate of Respiratory Events (Up to 2 years)
D: Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form. (21 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)
Brief Summary: To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.


Options:
A: Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. (16 weeks); Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue (Baseline to 16 weeks)
B: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Up to follow up (approximately 56 days)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings-ventricular rate (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Number of participants with abnormal (potential clinical importance [PCI]) systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) (Up to Day 27 (Visit 6a)); Number of participants with abnormal (PCI) clinical chemistry (Up to Day 42 (follow up visit)); Number of participants with abnormal (PCI) hematology (Up to Day 42 (follow up visit)); Number of participants with abnormal urinalysis (Up to Day 56 (Visit follow up)); Change from Baseline (Day 0) in lung function parameters: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) (Baseline (Day 0) and up to Day 27 (Visit 6a)); Number of participants with abnormal Holter interpretations (Up to Day 27 (Visit 6a)); Number of participants who withdrawn for exacerbations of chronic obstructive pulmonary disease (COPD) (Up to Day 27 (Visit 6a))
C: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)
D: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)
Brief Summary: To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.


Options:
A: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.
B: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
C: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)
D: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent) or Travoprost Ophthalmic Solution 0.004%
Brief Summary: Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.


Options:
A: Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. (12 months)
B: Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds (12 months)
C: Efficacy (24 months)
D: Primary outcomes included IOP and reduction in medication use. (15 month)

Answer: A