TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: HZA106829: A Randomised, Double-blind, Parallel Group, Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder Alone, and Fluticasone Propionate Alone in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.


Options:
A: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
B: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
C: Time to First Serious Asthma Exacerbation (Up to 21 months)
D: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period (Baseline to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HZA106829: A Randomised, Double-blind, Parallel Group, Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder Alone, and Fluticasone Propionate Alone in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.


Options:
A: FEV1, (Forced expiratory volume in the 1st second).
B: FEV1 peak0-3 Change From Baseline (Baseline and 12 weeks)
C: Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)]. (Baseline and 3 months)
D: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone (VTD) Versus Thalidomide-Dexamethasone (TD) for Previously Untreated Multiple Myeloma (MM) Patients Who Are Candidates to Receive Double Autologous Transplantation
Brief Summary: Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as induction therapy in preparation for, and as consolidation after, melphalan-based double autologous stem cell transplantation for previously untreated patients aged ≤65 years with symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of CR plus nCR to double transplantation and subsequent consolidation therapy, time to progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile of both VTD and TD.


Options:
A: Overall survival (from randomistion) of the 2 groups at 5 years
B: N/A
C: To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment
D: Rate of CR+nCR to induction treatment (63 days after the start day of either TD or VTD as induction therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone (VTD) Versus Thalidomide-Dexamethasone (TD) for Previously Untreated Multiple Myeloma (MM) Patients Who Are Candidates to Receive Double Autologous Transplantation
Brief Summary: Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as induction therapy in preparation for, and as consolidation after, melphalan-based double autologous stem cell transplantation for previously untreated patients aged ≤65 years with symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of CR plus nCR to double transplantation and subsequent consolidation therapy, time to progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile of both VTD and TD.


Options:
A: Time to progression
B: Rate of CR+nCR to induction treatment (63 days after the start day of either TD or VTD as induction therapy)
C: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. (2 years)
D: Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation (1 year after randomization of the last patient)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma
Brief Summary: This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.


Options:
A: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
B: Overall Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)
C: Recurrence-free Survival (RFS) (up to 36 months)
D: Recurrence-free Survival (RFS) (Up to ~32.7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma
Brief Summary: This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.


Options:
A: The feasibility of treating patients with unresectable melanoma and palpable lymph node metastases that harbor the BRAF mutation with neoadjuvant vemurafenib. (24 months)
B: Major Pathologic Response (MPR) (54 weeks)
C: Recurrence-Free Survival (1 year)
D: Overall Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Innovative Weight Reduction Strategies for College Students
Brief Summary: Examine the effectiveness of a weight gain prevention intervention to positively affect body mass index in 2-year college students


Options:
A: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
B: Change in Body Mass Index (BMI) (Baseline to 24 Months)
C: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)
D: Change in length of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in frequency of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in minutes spent standing (baseline, 2, 4, and 6 weeks); Change in minutes spent in light intensity physical activity (baseline, 2, 4, and 6 weeks); Change in minutes spent in moderate intensity physical activity (baseline, 2, 4, and 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Multi-Centre Open-Label Randomized Controlled Trial of Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (SIRveNIB)
Brief Summary: The primary objective of this study is to assess the efficacy of SIRT as compared with Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS).

The Study null hypothesis is, there is no difference in overall survival between patients receiving SIRT and those receiving Sorafenib therapy.


Options:
A: Time to progression (TTP) (At 1, 3, 6, 12 months and every 6 months thereafter)
B: Overall Survival (2 years)
C: Median overall survival time (36 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
Brief Summary: For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events. Using a Care Transition conceptual model, the investigators propose developing and evaluating, through a randomized controlled trial, "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention, focused initially on patients hospitalized with heart failure or obstructive lung disease. This trial will test the primary hypothesis that the proportion of patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period will be less in an IVRsupported care transition intervention (e-Coach) compared to a "usual care" comparison group.


Options:
A: Chronic Respiratory Disease Questionnaire (CRQ) (12 weeks)
B: Re-hospitalizations (During the 30days after discharge)
C: Health-Related quality of life (12 months)
D: The number of ED presentations (1 year after randomization.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
Brief Summary: For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events. Using a Care Transition conceptual model, the investigators propose developing and evaluating, through a randomized controlled trial, "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention, focused initially on patients hospitalized with heart failure or obstructive lung disease. This trial will test the primary hypothesis that the proportion of patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period will be less in an IVRsupported care transition intervention (e-Coach) compared to a "usual care" comparison group.


Options:
A: Re-hospitalizations (During the 30days after discharge)
B: Maximum Plasma Concentration at Steady-state (Cmax,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.); Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.)
C: N/A
D: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
Brief Summary: For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events. Using a Care Transition conceptual model, the investigators propose developing and evaluating, through a randomized controlled trial, "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention, focused initially on patients hospitalized with heart failure or obstructive lung disease. This trial will test the primary hypothesis that the proportion of patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period will be less in an IVRsupported care transition intervention (e-Coach) compared to a "usual care" comparison group.


Options:
A: Self-management and Activation (6 Months)
B: Daily number of steps (changes from baseline to 3 months)
C: Re-hospitalizations (During the 30days after discharge)
D: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
Brief Summary: For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events. Using a Care Transition conceptual model, the investigators propose developing and evaluating, through a randomized controlled trial, "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention, focused initially on patients hospitalized with heart failure or obstructive lung disease. This trial will test the primary hypothesis that the proportion of patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period will be less in an IVRsupported care transition intervention (e-Coach) compared to a "usual care" comparison group.


Options:
A: Re-hospitalizations (During the 30days after discharge)
B: Hospital Readmission (12 months)
C: The number of ED presentations (1 year after randomization.)
D: Number of hospital admissions for exacerbations of COPD

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: E-Coaching: IVR-Enhanced Care Transition Support for Complex Patients
Brief Summary: For complex medical patients, the transition from hospital to home-based care is a vulnerable period, placing the patient at high risk for adverse events. Using a Care Transition conceptual model, the investigators propose developing and evaluating, through a randomized controlled trial, "e-Coach," an Interactive-Voice-Response-supported (IVR) Care Transition coaching intervention, focused initially on patients hospitalized with heart failure or obstructive lung disease. This trial will test the primary hypothesis that the proportion of patients with one or more re-hospitalizations during a 90-day post-discharge follow-up period will be less in an IVRsupported care transition intervention (e-Coach) compared to a "usual care" comparison group.


Options:
A: Re-hospitalizations (During the 30days after discharge)
B: Usual Gait Speed (Baseline); Usual Gait Speed (3 month); Usual Gait Speed (12-month); Rapid Gait Speed (Baseline); Rapid Gait Speed (3-month); Rapid Gait Speed (12-month)
C: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
D: Change in body mass index (BMI) (Measured at Year 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sevelamer, FGF-23 and Endothelial Dysfunction in CKD
Brief Summary: Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has not been clarified.

This study was designed to investigate the effect of short-term sevelamer treatment on both serum FGF23 levels concentrations and ED seen in CKD patients.

The researchers investigated the relationship between plasma FGF23 levels and the forearm blood flow response to ischemia in the forearm in a sizable series of incident stage 3-4 CKD patients.


Options:
A: N/A
B: Effect on p-creol levels (3 months)
C: Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) (4 weeks)
D: total phosphate bound per gum piece fasting (15 min, 30 min, 45 min, 60 min post chewing); total phosphate bound per piece of gum post meal (5 min, 15 min, 30 min, 45 minutes post meal)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol SBIRT Implementation in an HMO: Non-Physician Providers Vs Physicians
Brief Summary: The purpose of this study is to determine whether Alcohol Screening, Brief Intervention, and Referral to Specialty Chemical Dependency Treatment (as appropriate) by Non-Physicians versus Primary Care Providers (versus control group) is more likely to be implemented and more effective at reducing unsafe drinking.


Options:
A: Number of patients reported to the Ontario Ministry of Transportation (When participants have completed 500 patient assessments (expected to take approximately 12 months))
B: Proportion of patients screened for alcohol (One year); Proportion receiving Brief Intervention among those who screen positive to screener. (One year.); Proportion of patients referred to treatment (one year)
C: The primary outcome of this study will be focused on changes in doctor behavior and the comparison of the number of diagnostic tests ordered (chest x-rays) and antibiotics prescribed per patient encountered per diagnosis. (Comparisons between case and control ordering will be measured after a year of using the EMR tool)
D: Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge (End of hospital stay (expected average duration of 1 week))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Single Blind Study Comparing a Pulmonary Recruitment Maneuver Versus Intraperitoneal Infusion of Normal Saline to Reduce Shoulder Tip Pain After Gynecologic Laparoscopic Surgery
Brief Summary: Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.

The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to reduce carbon dioxide retention in the pelvic cavity.


Options:
A: the severity and frequency of shoulder-tip pain after laparoscopic surgery (the first 48 hours after the surgery)
B: The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery (The first 48 hours after the surgery)
C: pain scores at varying time points pot operatively (48 hours)
D: Shoulder Pain (within 14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance of Chronic Obstructive Pulmonary disease-a Double Blinded Randomized Placebo Controlled Trial
Brief Summary: This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on reduction of airtrapping and airway resistance in stable COPD patients as well as to study it's effect in reducing exacerbation, improving exercise capacity and quality of life in stable COPD patients.


Options:
A: Changes in objectively measured physical activity (2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4))
B: Airtrapping in COPD patients (At baseline (time 0 week)); Airtrapping in COPD patients (At 16th week); Airtrapping in COPD patients (At 52th Week)
C: Change in physical activity (Baseline and 12 months follow-up)
D: functional capacity of the lower limb muscles (21 - 4 days / +7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicenter, Phase 1b/2 Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
Brief Summary: This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.


Options:
A: Overall survival (2015 (estimated))
B: Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later); Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later)
C: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)
D: Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) (First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)); Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose (First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)); Phase 2: Progression-Free Survival (PFS) (Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months)

Answer: D