TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy.
Brief Summary: The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.


Options:
A: Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases (Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration); Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density (Prior to therapy initiation and 12-15 months from registration)
B: sCTX values (baseline, 1 week post treatment, week 4, week 8, week 12)
C: Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.); Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
D: Time to First Clinical Fracture (From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of CHAM JAM (Previously Known as the Moving Smart) Intervention in Increasing Physical Activity in Bronx Elementary School Students
Brief Summary: The purpose of this study is to determine if the "Moving Smart" program, a daily 10-minute classroom-based exercise program, increases physical activity levels during the school day in Bronx elementary school students.


Options:
A: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)
B: Change from baseline in weekly time in moderate-to-vigorous physical activity at six months (Baseline, end of intervention (6 months), 1 year after baseline); Change from baseline in weekly time in sedentary activity at six months (Baseline, end of intervention (6 months), 1 year after baseline)
C: pedometer-derived step count (baseline and every 3 months)
D: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
Brief Summary: During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies


Options:
A: Duration of Invasive Mechanical Ventilation (up to 8 weeks); Ventilator-free Days (up to 8 weeks); Number of Babies With Reintubation (up to 8 weeks)
B: Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation (within 72 hrs from the beginning of the study mode)
C: Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (Within the first 6 hours after birth)
D: paCO2 at 72 h After Extubation (64 h to 80 h)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
Brief Summary: During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies


Options:
A: Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (Within the first 6 hours after birth)
B: Assessment of respiratory distress (48 hours)
C: Duration of Respiratory Support (every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours)
D: Need for admissions to NICU secondary to TTN (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial
Brief Summary: To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.


Options:
A: Length of Stay (Up to 180 days.)
B: complications until 30 days after surgery according to the zurich classification (30 days postoperative)
C: Mean indexed cardiac output (J1 to J12 (Within the surgical hospital length of stay))
D: Preload independent state (6 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial
Brief Summary: To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.


Options:
A: complications until 30 days after surgery according to the zurich classification (30 days postoperative)
B: Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine. (4 hours)
C: Insulin sensitivity (baseline and postoperatively)
D: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hip Fracture Evaluation With Alternatives of Total Hip Arthroplasty Versus Hemi-Arthroplasty: A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients With Displaced Femoral Neck Fractures
Brief Summary: Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare costs associated with hip fractures are expected to reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a displaced femoral neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip replacement may receive either a total hip replacement, in which the head of the femur and the hip joint socket are replaced, or a partial hip replacement, in which only the head of the femur is replaced. This study will compare the two different hip replacement procedures to determine which one results in better outcomes after surgery in adults aged 50 and older.


Options:
A: Dislocation (1 year after index surgery)
B: hip function score (1 year)
C: Hip related complication rate (2 years); Health-related Quality of Life (2 years)
D: Number of Participants With Revision Surgery (Measured 2 years after original surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hip Fracture Evaluation With Alternatives of Total Hip Arthroplasty Versus Hemi-Arthroplasty: A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients With Displaced Femoral Neck Fractures
Brief Summary: Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare costs associated with hip fractures are expected to reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a displaced femoral neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip replacement may receive either a total hip replacement, in which the head of the femur and the hip joint socket are replaced, or a partial hip replacement, in which only the head of the femur is replaced. This study will compare the two different hip replacement procedures to determine which one results in better outcomes after surgery in adults aged 50 and older.


Options:
A: Number of Participants With Revision Surgery (Measured 2 years after original surgery)
B: Harris Hip Score at 4, 12 and 24 months; Barthel ADL Index at 4, 12 and 24 months; Eq-5d (Euroqol) at 4, 12 and 24 months
C: Revision Surgery (Measured 2 years after original surgery)
D: visual analog scale (36 months); Harris hip score (36 months); Eq-5d index scores (36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized 2 x 2 Factorial Trial of Rabbit Anti-thymocyte Globulin Induction (Single vs. Alternate Day Administration) at Renal Transplantation, With Delayed Calcineurin-inhibitor Withdrawal vs. Minimization
Brief Summary: This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creating 4 study arms; the other half receive the standard treatment. The two potential improvements are:

1. Administering the immunosuppression induction agent rATG ("rabbit anti-thymocyte globulin") in a single dose at the time of transplantation, instead of in the usual series of 4 smaller doses over 6 days.
2. After 6 months, modifying the maintenance immunosuppression used to prevent rejection by replacing the drug tacrolimus with mycophenolate mofetil (MMF).

The two interventions, spaced sequentially six months apart, enable independent analysis of the two treatments so long as it can be shown that there is no synergistic interaction between them.


Options:
A: Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria). (Two years); Average of Renal Function (Two years)
B: Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). (1 year)
C: Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function (During first 7 days after kidney transplantation)
D: Incidence and severity of biopsy-proven acute rejection at 1 year. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled Trial on the Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
Brief Summary: This study will assess whether rhDNase treatment improves ventilation inhomogeneity as assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).


Options:
A: Wet sputum production (45 minutes)
B: The change in LCI from baseline to end of treatment in rhDnase treated patients versus patients receiving placebo (The duration of the patient's involvement in the study (approximately 3 months))
C: Chest CT (48 weeks)
D: Number of Participants Eligible to be Assessed for Sub-study Enrollment (2-week run-in period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled Trial on the Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
Brief Summary: This study will assess whether rhDNase treatment improves ventilation inhomogeneity as assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).


Options:
A: The change in LCI from baseline to end of treatment in rhDnase treated patients versus patients receiving placebo (The duration of the patient's involvement in the study (approximately 3 months))
B: Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches) (day 1, 29, 57 and 85)
C: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
D: FEV1

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled Trial on the Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
Brief Summary: This study will assess whether rhDNase treatment improves ventilation inhomogeneity as assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).


Options:
A: Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches) (day 1, 29, 57 and 85)
B: The change in LCI from baseline to end of treatment in rhDnase treated patients versus patients receiving placebo (The duration of the patient's involvement in the study (approximately 3 months))
C: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
D: FEV1

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Pulmonary Rehabilitation (PR) Following Hospitalisation For Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The principal aim of the study is to evaluate whether attendance at an exercise training and education programme (known as pulmonary rehabilitation) shortly following hospital discharge can lead to a reduction in exacerbations and improvement in exercise capacity and quality of life in patients with chronic obstructive pulmonary disease.


Options:
A: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
B: The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization (Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days))
C: Hospital Readmission (12 months)
D: Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death) (3-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Brief Summary: Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.


Options:
A: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years); HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years)
B: HIV Seroconversion (Monthly follow-up through a median of 1.2 years); Grade 1 or Higher Creatinine Toxicity (Duration of follow-up, median 1.2 years); Grade 3 or Higher Phosphorous Toxicity (The entire follow-up period, median 1.2 years); Grade 2, 3, or 4 Laboratory Adverse Events (Entire follow-up, median 1.2 years); Grade 2, 3, or 4 Clinical Adverse Events (Entire follow-up, median 1.2 years)
C: HIV Infection (Cumulative HIV infection between enrollment and 52 weeks); Confirmed Grade 2 or Higher Serum Creatinine Toxicity (cumulative toxicity through 52 weeks of product use and 4 weeks post product); Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration (10-26 months per site); Confirmed Grade 3 or Higher Reduction in Phosphorus (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher ALT Elevation (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher AST Elevation (Through 52 weeks on product and 4 weeks post-product)
D: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants (Up to 36 months); Number of Participants With Serious Adverse Events (SAEs) (Up to 36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Interventions for Anxious Children
Brief Summary: This study will evaluate the effectiveness of school-based cognitive behavioral therapy with or without parental involvement in treating anxious children.


Options:
A: N/A
B: Pediatric Anxiety Rating Scale. (Post-treatment, which is an average of 16 weeks after Baseline)
C: Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis (Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment)
D: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 14 weeks); Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease
Brief Summary: The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.

Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens.

The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease.

Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.


Options:
A: Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function (immediately after heart surgery in patients with LVSD)
B: Composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, persistent pain with multiple gastric erosions, obstruction or perforation (Anticipated minimum of 48 weeks, up to end of study)
C: ulcer complication (bleeding/perforation/obstruction) (up to 12 months)
D: Mortality (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
Brief Summary: Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival


Options:
A: Overall survival (3 years); Progression free survival (3 years)
B: Progression-Free Survival (PFS) Determined by an Independent Review Facility (Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months))
C: Measure: all cause mortality (5 years)
D: Survival (participants will be followed until death (expected median survival 31 months for surgery group))

Answer: C