TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Brief Summary: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.


Options:
A: Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
B: Progression-free survival (from randomization till first evidence of progression)
C: Progression-Free Survival (PFS) Time (Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
D: The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma
Brief Summary: This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is \<100 patients.


Options:
A: Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator (From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks))
B: Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) (From first treatment through September 27, 2010)
C: Overall Survival (OS) (24 months)
D: estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D and Genetics in Nutritional Rickets
Brief Summary: The purpose of this study is:

1. To compare the response of rickets to calcium with and without vitamin D.
2. To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.
3. To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2
4. To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh.
5. To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.


Options:
A: Blood 25 Hydroxyvitamin D (25OHD) Concentrations (1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery))
B: Change in vitamin D status (Baseline and 20 weeks)
C: XR healing of rickets (6 months)
D: All-cause mortality and diarrheal morbidity (age 6 weeks to age 24 months)

Answer: C
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 Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Brief Summary: The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.


Options:
A: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (Measured at clinic visits: 1, 4, 8 and 12 weeks)
B: Exacerbation Rate (From randomization to the patients final study visit (up to 12 months))
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (up to week 12)

Answer: A
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 Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Brief Summary: The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.


Options:
A: 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)
B: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (Measured at clinic visits: 1, 4, 8 and 12 weeks)
C: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84))
D: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
Brief Summary: This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.


Options:
A: Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
B: Overall survival and Quality of life (Until death or study completion)
C: Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT (from baseline up to 5 years post radiation); Overall Survival (from baseline up to 5 years post radiation)
D: Time to local recurrence (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage
Brief Summary: Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.


Options:
A: Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours (Every 48 hours until discharge)
B: Rate of ventilator associated pneumonia (30 days)
C: Prevention of ventilator-associated pneumonia (60 days)
D: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage
Brief Summary: Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.


Options:
A: Rate of ventilator associated pneumonia (30 days)
B: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
C: ICU-Ecology (27 months)
D: Main Outcome: Patients With Nosocomial MRSA Clinical Cultures (The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage
Brief Summary: Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.


Options:
A: Rate of ventilator associated pneumonia (30 days)
B: Pneumonia (2.5 years)
C: Pneumonia (Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.)
D: Swallowing function (Baseline, 5 weeks and 6 months post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage
Brief Summary: Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.


Options:
A: Rate of ventilator associated pneumonia (30 days)
B: Nosocomial Infection
C: N/A
D: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Management for Improved Pregnancy Outcomes
Brief Summary: This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention


Options:
A: Change from Baseline in oral glucose tolerance test at variable time frames (1) Baseline (group 1= planning a pregnancy; group 2=at gest.week 10-14); 2) at gest.week 10-14 (group 1) and 3) at gest.week 24-28; 4) 6 weeks and 12 months post partum)
B: Gestational weight gain (36 weeks)
C: Maternal Weight Change (baseline to 2 weeks post partum)
D: Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations (Delivery (when the baby is delivered))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Management for Improved Pregnancy Outcomes
Brief Summary: This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention


Options:
A: Maternal Weight Change (baseline to 2 weeks post partum)
B: 30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts. (30 Months)
C: number of gestational diabetes cases diagnosed with OGTT (24-28th weeks gestation); difference in HOMA values (from first trimester to OGTT)
D: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Management for Improved Pregnancy Outcomes
Brief Summary: This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention


Options:
A: Birth weight as assessed by z-scores (At birth)
B: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
C: Maternal Weight Change (baseline to 2 weeks post partum)
D: Gestational weight gain (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intramyocardial Transplantation of Bone Marrow Stem Cells for Improvement of Post-infarct Myocardial Regeneration in Addition to CABG Surgery: a Controlled, Prospective, Randomized, Double Blinded Multicenter Trial (PERFECT)
Brief Summary: In spite of the fact that the post-myocardial infarction survival rate has improved with recent medical advances, reduced heart function attributed to irreversible loss of viable cardiomyocytes is still a major clinical problem.

The aim of the current study is to determine whether intramyocardial injection of autologous CD133+ bone marrow stem cells yields a functional benefit in addition to coronary artery bypass graft (CABG) surgery in patients with chronic ischemic coronary artery disease.


Options:
A: Improvement in global ejection fraction on LV angiography (4 months)
B: Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment (6 weeks)
C: Left ventricular ejection fraction at rest, measured by MRI (6 months)
D: Change in left ventricular ejection fraction (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer Support, Empowerment and Remote Communication Linked by Information Technology (PEARL): A Multi-Component Program to Improve Community-Based Diabetes Care
Brief Summary: Quality diabetes care requires informed-decisions of motivated care providers and diabetes patients. The investigators aim to use peer support and information technology to facilitate care providers to implement structured care and empower diabetes patients acquire self-management skills in a multi-component program.

The investigators will make use of the following tools: (1) The Joint Asia Diabetes Evaluation (JADE) Program. JADE Program uses a web-based electronic portal to establish a registry and stratify diabetes patients to care protocols based on their risk profiles with features of decision support and data management. (2) The Australasian Telephone Linked Care (TLC) system. TLC system utilizes an automatic, interactive, computer-controlled telephone system to monitor and promote diabetes self-management.

Amongst 600 diabetes patients receiving structured care in Hong Kong through the JADE Program, half of them will be randomized to receive peer support (n=300) including personal coaching by 30 trained mentors (1 mentor to 10 diabetes patients or mentees) through regular phone calls and sharing sessions, and the other half (n=300) will continue the usual diabetes care in their clinic. The 30 mentors are themselves diabetes patients who have good self care and are motivated to support their peers. The mentors will be trained to deliver peer support intervention under supervision by a program manager. The 300 diabetes patients (mentees) randomized to the peer support group are the intervention targets of these 30 mentors. They will be reminded to use the TLC for knowledge enhancement and motivational support.

The investigators will analyse the changes in risk factor control (blood glucose parameters, blood pressure, body weight, lipids), quality of life and cognitive-psychological-behavioral parameters after 12 months. Effects of various components of peer support on these outcomes as well as user acceptability and cost-effectiveness of these programs will be examined.

The investigators will test the hypothesis that in a multi-component program, the use of a peer support program delivered by diabetes patient-mentors, to influence and motivate other diabetes patients receiving structured care made possible through a web-based disease management program, delivered by a doctor-nurse team, will further improve metabolic control, QOL and self care compared to diabetes patients receiving the same standard of care.


Options:
A: N/A
B: Hemoglobin A1c (6 months)
C: Glycemic control (one year); Body weight (one year); Blood pressure (one year); Lipid levels (one year)
D: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration
Brief Summary: This is a pilot interventional study whose aim is to determine the effect of a dietary supplementation with a Crocus Sativus extract, Saffron, on macular cone-mediated function in patients with early age-related macular degeneration (AMD). Pre-clinical evidence ( Maccarone R, Di Marco S, Bisti S. Saffron supplement maintains morphology and function after exposure to damaging light in mammalian retina. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1254-61.) indicates the potential effectiveness of Saffron as a retinal neuroprotectant in animal models of retinal degenerative disorders.The macular function will be tested by visual acuity and macular cone-mediated electroretinogram (focal electroretinogram, FERG) according to a standardized technique (see citations).


Options:
A: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
B: N/A
C: Retinal blood flow (in total 8x on 2 study days)
D: Focal Electroretinogram Amplitude and Phase (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Brief Summary: In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Options:
A: Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound (28 days from randomization)
B: Event free survival for all patients (January 2014); GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) (January 2014)
C: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
D: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Brief Summary: In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Options:
A: Progression Free Survival (during chemotherapy and follow-up)
B: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
C: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
D: Thromboembolic events (during study treatment)

Answer: B