TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.


Options:
A: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate
B: Progression free survival (PFS) (5 years)
C: N/A
D: Freedom from first progression at 5 years (After a median of 5 years from start of the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.


Options:
A: Number of Participants With Adverse Events (AEs) (Up to 28.9 months); Complete Remission Rate (Up to 3.42 months)
B: Number of Participants That Experienced Drug Related Grade 3-4 AEs (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants That Experienced Drug Related Grade 3-4 SAEs (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid (Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month); Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants That Experience Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver (approximately up to 4 years); Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid (approximately up to 4 years)
C: Progression free survival (PFS) (5 years)
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.


Options:
A: Progression-free survival
B: Survival (12 years)
C: Progression free survival (PFS) (5 years)
D: Event-free Survival (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease
Brief Summary: The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.


Options:
A: Number of Participants in Population 1 With a Clinical Response at Week 8 (Week 8)
B: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
C: Number of Participants With Clinical Remission at Week 44 (Week 44)
D: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial
Brief Summary: A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.


Options:
A: Change in total volume of weekly active energy expenditure (3 and 6 months)
B: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
C: exercise tolerance (1 year); exercise tolerance (12 weeks)
D: Medication adherence (12 months); Exercise frequency (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial
Brief Summary: A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.


Options:
A: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
B: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
C: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)
D: Controlled Blood pressure (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial
Brief Summary: A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.


Options:
A: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
B: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
C: Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure (4 months)
D: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial
Brief Summary: A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.


Options:
A: 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)
B: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
C: Maximal oxygen consumption (At baseline and after 6 months)
D: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Evidence-based Treatment of Hypertension
Brief Summary: This study examines the use of patient initiated discussions of blood pressure medication in the primary care setting. Additionally, this study examines different levels of patient incentive(s) to initiate discussions with providers including information only, information plus a financial incentive and reimbursement for 6 months of copay, and information/monetary incentive plus a reminder call prior to the index visit. Patient opinions about doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors will be analyzed as well.


Options:
A: Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal (Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.)
B: Proportion of fully immunized children (When the participants reach 2 years of age)
C: Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months (index visit and 6 months)
D: Weight Gain (Day 0-21)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Evidence-based Treatment of Hypertension
Brief Summary: This study examines the use of patient initiated discussions of blood pressure medication in the primary care setting. Additionally, this study examines different levels of patient incentive(s) to initiate discussions with providers including information only, information plus a financial incentive and reimbursement for 6 months of copay, and information/monetary incentive plus a reminder call prior to the index visit. Patient opinions about doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors will be analyzed as well.


Options:
A: Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months (index visit and 6 months)
B: Number of Participants Who Present Children for HIV Testing (2 months); Number of Days Participants Take to Bring Children for HIV Testing (2 months)
C: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)
D: HIV viral suppression at 6 months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Screening and Treatment for PTSD in SUD Patients
Brief Summary: This study proposes a prospective program of research that will identify feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby improving substance abuse treatment outcomes.


Options:
A: Severity of Alcohol Use (ASI Alcohol Composite Scores) (Administered at baseline and 3 months, 6 months and 12 months post baseline.); ASI Drug Composite Score (1 year)
B: Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) (Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)); Drinking Timeline Follow-back Interview (TFBI) (Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up))
C: Alcohol and drug use (3, 6, and 12 months after baseline); Alcohol and drug-related problems (3, 6, and 12 months after baseline); Nights Hospitalized (3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled); Emergency department visits (3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled)
D: Drug abstinence

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2
Brief Summary: PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.


Options:
A: Progression-free survival (PFS) (2 years after last patient in study)
B: Progression-free survival during maintenance therapy (Tumor evaluation every 2 months)
C: Progression-free Survival (PFS) (From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.)
D: Progression-free Survival Time (From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Risk-stratified Therapy for Primary and Secondary AML and MDS. A Randomized Study by AMLCG in Relation to Cytogenetically Defined Prognostic Factors (1) on the Role of High-dose AraC as Part of Double Induction, (2) on G-CSF Priming, and (3) on High-dose Chemotherapy With Stem Cell Transplantation
Brief Summary: The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.


Options:
A: Remission rate, Remission duration,Relapse-free survival, Overall survival, Event-free survival (12-18months)
B: overall survival; relapse-free survival
C: Event-free and absolute survival from the date of diagnosis concerning objective 1 and from the date of randomisation concerning objective 2 (5 years); Concerning objective 3: Disease-free survival from the date of randomisation (5 years)
D: relapse-free survival (two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)
Brief Summary: The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease


Options:
A: serum B12 status; serum folate status
B: The composite of cardiovascular death, myocardial infarction (MI) and stroke
C: N/A
D: The primary end point was a composite of; nonfatal myocardial infarction,; fatal myocardial infarction,; nonfatal stroke,; fatal stroke, and; sudden death attributed to coronary heart disease.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)
Brief Summary: The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease


Options:
A: Cardiovascular disease; Cancer
B: N/A
C: Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events (Up to 6 years (mean 4 years))
D: The primary end point was a composite of; nonfatal myocardial infarction,; fatal myocardial infarction,; nonfatal stroke,; fatal stroke, and; sudden death attributed to coronary heart disease.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Bicentre Open Label Randomised Pilot Study for Proof of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen Bet v 1-FV Versus a Depot Extract of Natural Birch Allergen
Brief Summary: Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV


Options:
A: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment (Last 8 weeks of treatment (Weeks 44 to 52)); Number of Participants Who Experience At Least One Adverse Event (AE) (Up to 54 weeks); Number of Participants Who Discontinue Study Drug Due to an AE (Up to 52 weeks)
B: Pharmacodynamics - Immunological assessments (Pre- and post treatment)
C: N/A
D: Use of inhaled corticosteroid (ICS).

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Kansas University DHA Outcome Study (KUDOS)
Brief Summary: The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.


Options:
A: time of achieving the four gross motor development milestones (4, 8 and 12 months of age)
B: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
C: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
D: Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis (up to three years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Kansas University DHA Outcome Study (KUDOS)
Brief Summary: The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.


Options:
A: Birth size (Birth); Gestational age (Birth); Changes in visual evoked potentials (3 and 6 months of age); Changes in infant weight (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in infant height (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes In infant head circumference (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in auditory evoked potentials (1 and 3 months of age); Changes in child development score (1, 1.5 and 5 years of age); Changes in Hearts and Flowers Stroop Test (5 years of age)
B: Estimated fetal weight (gm) (1 year)
C: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
D: Newborn anthropometry. (At delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Kansas University DHA Outcome Study (KUDOS)
Brief Summary: The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.


Options:
A: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
B: time of achieving the four gross motor development milestones (4, 8 and 12 months of age)
C: change of weight from day 30 to day 120 (postnatal age 30 to 120 days)
D: visual development

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Kansas University DHA Outcome Study (KUDOS)
Brief Summary: The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.


Options:
A: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)
B: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: Birth size (Birth); Gestational age (Birth); Changes in visual evoked potentials (3 and 6 months of age); Changes in infant weight (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in infant height (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes In infant head circumference (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in auditory evoked potentials (1 and 3 months of age); Changes in child development score (1, 1.5 and 5 years of age); Changes in Hearts and Flowers Stroop Test (5 years of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lenalidomide (Revlimid) in Patients With Previously Treated Chronic Lymphocytic Leukemia
Brief Summary: The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to control CLL in patients who have already received standard therapy. The safety of lenalidomide will also be studied.


Options:
A: Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 (Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]).); Final Analysis: PFS Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 (Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]).)
B: Progression-free survival (PFS) based on independent review committee (up to 6 years)
C: Determination of dose limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase two dose (RPTD), and lead-in period regimen (Lead-in period (2-5 weeks) plus 3 weeks of study drug administration at the designated cohort dose (continuous dosing)); Number of subjects with adverse events (First 16 weeks of study drug administration and every 4 weeks thereafter (continuous dosing for an anticipated maximum duration of 9 months)); Determination of plasma peak concentration (Cmax) of ABT-199 (Up to Week 24 for ABT-199); Determination of trough concentration (Ctrough) of ABT-199 (Up to Week 24 for ABT-199); Determination of area under the concentration versus time curve (AUC) of ABT-199 (Up to Week 24 for ABT-199)
D: Number of Patients in Overall Response Categories (Evaluated after three 28-day cycles of lenalidomide.)

Answer: D