TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide
Brief Summary: Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month median survival, in the range of the comparable patients in the RPA class V from the EORTC study (Miramanoff, 2006).

Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully published in J Clin Oncol, 2007) a 57 % unexpected response rate using a bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This unusual high response rate, sometimes with major and sustained responses, was confirmed by a cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France, to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM.

The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the Duke University. We believe that an ambitious comparison of the bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a fascinating challenge to improve the treatment of this awful disease.

The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant and adjuvant treatment of chemoradiation with temozolomide for naive unresectable glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide'' has been successfully granted by INCA (Institut National du Fancer, France) through its research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of this program is now starting .


Options:
A: To determine the rate of non-progressive disease at 6 months after inclusion in each arms (after half of each arms has been completed at 6 months of treatment)
B: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
C: Objective response, as determined by the independent review facility (IRF) (Complete response or partial response, determined on two consecutive assessments ≥4 weeks apart); Progression-free survival, as determined by the IRF (6 months)
D: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide
Brief Summary: Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month median survival, in the range of the comparable patients in the RPA class V from the EORTC study (Miramanoff, 2006).

Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully published in J Clin Oncol, 2007) a 57 % unexpected response rate using a bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This unusual high response rate, sometimes with major and sustained responses, was confirmed by a cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France, to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM.

The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the Duke University. We believe that an ambitious comparison of the bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a fascinating challenge to improve the treatment of this awful disease.

The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant and adjuvant treatment of chemoradiation with temozolomide for naive unresectable glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide'' has been successfully granted by INCA (Institut National du Fancer, France) through its research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of this program is now starting .


Options:
A: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
B: To determine the rate of non-progressive disease at 6 months after inclusion in each arms (after half of each arms has been completed at 6 months of treatment)
C: Progression Free Survival (PFS) time (5 years)
D: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)
Brief Summary: This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline.


Options:
A: Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) (Week 16); Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) (Week 16)
B: The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. (13 weeks)
C: Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments. (12 weeks after last dose)
D: Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population) (From baseline to month 11 (end of double blind phase)); Change in Eosinophils/High Power Field at End of Double-blind (DB) (Per Protocol Patients) (Month 11(end of double blind phase))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol
Brief Summary: The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD


Options:
A: Treatment failure defined as: death from any cause; admission to the intensive care unit; readmission to the hospital because of COPD; and the necessity to intensify pharmacologic treatment
B: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (up to week 12)
C: Exacerbation Rate (From randomization to the patients final study visit (up to 12 months))
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol
Brief Summary: The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD


Options:
A: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (up to week 12)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: Rate of healthcare utilisation based exacerbations of COPD
D: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of Pentostatin, Cyclophosphamide, and Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL)
Brief Summary: This phase II trial studies how well giving ofatumumab together with pentostatin and cyclophosphamide works in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies, such as ofatumumab, can block the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ofatumumab together with pentostatin and cyclophosphamide may be a better way to block cancer growth.


Options:
A: Progression-free survival (randomization until disease progression or death)
B: Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study (Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)); Percentage of Participants With Best Overall Response in Phase II of the Study (by Cutoff Date: 31 March 2012 (within 3 years, 4 months))
C: Progression-Free Survival (Randomization to End of Study (up to 60 months))
D: Arm A: Percentage of Complete Responses (7 months); Arm B: Treatment-free Survival at 18 Months (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Active Video Games and Sustainable Physical Activity
Brief Summary: The purpose of this study is to test the effect of active video game play on physical activity of 9-13 year old children in their natural home environments. We observe how much physical activity children engage in after receiving two different active Wii video games and for how long they play. Active video games offer promise of minimizing children's physical inactivity.


Options:
A: Number of months of breast feeding (6 and 12 months)
B: increased physical activity (4 months)
C: body mass index (three years)
D: Change in fruits and vegetables and dairy products (Before and after the intervention (0 and 6 wk))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A(H1N1)v Chez la Femme Enceinte
Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.

Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.


Options:
A: Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine. (Day 21)
B: Incidence of culture confirmed influenza A and/or B during the surveillance period
C: To measure anti-influenza systemic and mucosal antibody responses 4 weeks after administration of influenza vaccine (LAIV) to healthy subjects aged 18-49 and to compare responses in subjects receiving Lactobacillus GG (LGG) versus placebo (4 weeks)
D: Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs) (Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot
Brief Summary: The purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.This research study may lead to a potentially useful treatment for diabetes management when depression is present.


Options:
A: This research study may lead to a potentially useful treatment for diabetes management when depression is present. (6 weeks); HbA1c (3-,6-, and 9-months); Depression (3-, 6- and 9-months)
B: Work limitations (One year); Work engagement (One year)
C: N/A
D: Quick Inventory of Depressive Symptoms (Measured at Month 7)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot
Brief Summary: The purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.This research study may lead to a potentially useful treatment for diabetes management when depression is present.


Options:
A: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
B: Change in patient perception of personal self-efficacy at 6 months (6 months); Change in patient perception of self-management practice at 6 months (6 months); Change in patient perception of health behaviours at 6 months (6 months); Change in patient perception of activation at 6 month (6 months); Change in patient perception of psychological distress at 6 months (6 months)
C: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
D: This research study may lead to a potentially useful treatment for diabetes management when depression is present. (6 weeks); HbA1c (3-,6-, and 9-months); Depression (3-, 6- and 9-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot
Brief Summary: The purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.This research study may lead to a potentially useful treatment for diabetes management when depression is present.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: Participant HbA1c levels (one year); Participant cardiovascular risk index (one year)
C: This research study may lead to a potentially useful treatment for diabetes management when depression is present. (6 weeks); HbA1c (3-,6-, and 9-months); Depression (3-, 6- and 9-months)
D: Glucose Monitoring Adherence at Acute Outcome (Measured at Month 4); Percent Medication Adherence Via MEMS (month 4); Clinician Rated Depression (MADRS) at the Acute Timepoint (month 4); Depression on the CGI at Acute Outcome (Month 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open Label, Parallel Group Phase II Study Comparing the Efficacy and Tolerability of BIBF 1120 Versus Sunitinib in Previously Untreated Patients With Renal Cell Cancer
Brief Summary: Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).


Options:
A: Progression free survival (Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year)
B: Progression-free survival (PFS) rate 1 year (12 months)
C: Disease-free Survival (DFS) (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)
D: Probability Rates of Progression-free Survival at 9 Months (At 9 months after randomisation.); Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) (At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Safety and Access for Physical Activity
Brief Summary: Regular moderate and vigorous intensity physical activity (PA) is inversely related with obesity, however, few adults are successful in incorporating sufficient PA into their daily lives. Minority and lower-income adults have among the highest obesity rates and lowest levels of regular PA. Increasing environmental supports for safe and convenient places for PA is an emerging public health strategy for PA interventions. Preliminary data by Wilson (PI) and colleagues has revealed through focus groups that low-income minority adults would like to increase the safe places for PA (areas free from crime, containment of stray dogs, increased police patrol) and access to PA (sidewalks/trails and expand opportunities for PA) in their community. In addition, the results of the investigators' preliminary studies suggest that African Americans had psychosocial barriers to PA that included lack of self-motivation, cultural body image issues, and lack of time due to family obligations. The present proposal is innovative in that it specifically tests the efficacy of an intervention that includes both patrolled-walking and social marketing elements to increase PA in low-income African Americans. Three communities will be randomized to receive one of three programs: a police patrolled-walking program plus social marketing intervention, a police patrolled-walking only intervention, or no walking intervention (general health education only; N=390; 130/group). The 24-month intervention will focus on increasing safety (training community leaders to serve as walking captains, hiring off-duty police officers to patrol the walking program, and containing stray dogs), increasing access for PA (marking a walking route), and will include a tailored social marketing campaign for increasing PA (in one intervention community). The investigators will collect data for PA (7-day accelerometer estimates, 4-week PA history), body composition, blood pressure, psychosocial measures, and perceptions of environmental supports for safety and access for PA at baseline, 6-,12-,18-, and 24-months. The primary hypotheses are that the patrolled-walking plus social marketing intervention will result in greater increases in moderate and vigorous PA as compared to a patrolled walking only intervention or no-intervention by 12-months and that these effects will be maintained at 18-month and 24-month assessments.


Options:
A: Our outcome measure was reduction of screen time (4 waves of data)
B: Self-Reported physical activity (Baseline, 3 months, and 6 months)
C: Physical Activity (Accelerometer) (0, 6, 12, 18, 24 months)
D: change in physical activity (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: IVR-based Cognitive Behavior Therapy for Chronic Low Back
Brief Summary: The proposed study will test how well an innovative method, interactive voice response (IVR), can be used for delivering an treatment for chronic low back pain. The use of IVR will improve the accessibility of treatment to Veterans. IVR is a computerized interface that allows patients to use their telephone to: 1) obtain pre-recorded didactic information, 2) report data regarding pain-related symptoms and adherence to pain coping skill practice, and 3) receive personalized therapist feedback. Although CBT has been shown to be effective in reducing pain intensity, traditional CBT requires patients to make frequent office visits. The use of IVR will allow Veterans to access CBT from their home via a touch-tone telephone, thereby allowing them to access treatment at their convenience without travel to the VA for an outpatient appointment. Veterans with chronic low back pain will be randomized in equal numbers to receive either standard CBT or IVR-based CBT. Veterans in both conditions will receive 10 session of treatment designed to help them manage their chronic pain using pain coping skills. The primary outcome measure will be pain intensity.


Options:
A: Child BMI
B: Change in Numeric Rating Scale of Pain Intensity (post-treatment (12 weeks), 3 and 6 months post-baseline)
C: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months)
D: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients
Brief Summary: The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.


Options:
A: Evaluation of functional graft (The study is planned to analyze all patients at the end of the fifth year after transplantation. However, an interim analysis will be done at the end of each year.)
B: Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. (Month 12 is Primary, Month 24 secondary)
C: Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens (One year post transplant)
D: Number of Participants With Incidence of Composite Efficacy Failure (12 Months)

Answer: D