TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Therapy in Primary Care: Treating the Medically Ill
Brief Summary: The current study seeks to test the effectiveness of a talk-therapy intervention designed to better meet the needs of chronically ill Veterans. This project looks to recruit 450 Veterans with either chronic obstructive pulmonary disease (COPD) or heart failure (HF) who also have symptoms of worry, stress, anxiety, or sadness. Participants will be randomly put into either the talk-therapy intervention or enhanced usual care.

The talk therapy intervention will be provided by VA clinicians in the primary care setting and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone meetings. Enhanced usual care participants will receive feedback regarding the assessment findings and educational materials on COPD and/or HF, depression and anxiety.


Options:
A: Re-hospitalizations (During the 30days after discharge)
B: Number of unscheduled hospital days (up to 12 months)
C: Patient Health Questionnaire -9 (PHQ-9) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Beck Anxiety Inventory (BAI) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Chronic Respiratory Questionnaire_Fatigue (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Mastery (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Dyspnea (4 month (post treatment), 8 month follow/up, 12 month follow/up); Kansas City Cardiomyopathy Questionnaire (KCCQ) (4 month (post treatment), 8 month follow/up, and 12 month follow/up)
D: Change in physical activity (Baseline and 12 months follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Therapy in Primary Care: Treating the Medically Ill
Brief Summary: The current study seeks to test the effectiveness of a talk-therapy intervention designed to better meet the needs of chronically ill Veterans. This project looks to recruit 450 Veterans with either chronic obstructive pulmonary disease (COPD) or heart failure (HF) who also have symptoms of worry, stress, anxiety, or sadness. Participants will be randomly put into either the talk-therapy intervention or enhanced usual care.

The talk therapy intervention will be provided by VA clinicians in the primary care setting and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone meetings. Enhanced usual care participants will receive feedback regarding the assessment findings and educational materials on COPD and/or HF, depression and anxiety.


Options:
A: disease-specific health-related quality of life (HRQoL) (two years)
B: Quality of Care (36 months)
C: Patient Health Questionnaire -9 (PHQ-9) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Beck Anxiety Inventory (BAI) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Chronic Respiratory Questionnaire_Fatigue (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Mastery (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Dyspnea (4 month (post treatment), 8 month follow/up, 12 month follow/up); Kansas City Cardiomyopathy Questionnaire (KCCQ) (4 month (post treatment), 8 month follow/up, and 12 month follow/up)
D: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Brief Summary: Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).


Options:
A: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (Up to approximately 27-30 weeks); Event-free Survival (EFS) as assessed by Investigator (Up to approximately 8 years)
B: Comparison of the pCR rates in patients with HER2+/HR+ breast cancer treated by preoperative T-DM1 with or without standard endocrine therapy or trastuzumab with endocrine therapy. (After 12 weeks); Evaluation of dynamic testing (based on proliferation/apoptosis changes in serial biopsy and imaging by MRI) after three weeks of treatment as a surrogate parameter for response. (after 3 weeks of treamtment)
C: disease-free survival (5 year)
D: Disease Free Survival (DFS) of 3 years (3 years after mastectomy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Brief Summary: The central aim of this study is to improve understanding of how metabolic pathways that contribute to adiposity also amplify risks of kidney disease progression and cardiovascular disease in subjects with moderate to severe CKD. In order to achieve this goal, we propose the following aims through a randomized 2x2 factorial design trial in subjects with moderate to severe CKD: (a) To assess the feasibility of implementing aerobic exercise and caloric restriction interventions, and (b) To examine the effects of aerobic exercise and caloric restriction on a metabolic risk profile, including systemic measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction.

Hypothesis: We hypothesize that implementation of caloric restriction and aerobic exercise is feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to severe CKD.

Interim analysis may be performed (no specific plan at this time).


Options:
A: ∆Albuminuria by 24-hour Urine Protein Excretion (changes from week 8 at week 16 (week 8 - week 16))
B: weight loss
C: a change in plasma F-2-isoprostane concentration (baseline and 4 months); a change in VO2 max (baseline and 4 months); a change in weight (baseline and 4 months); a change in absolute fat mass (baseline and 4 months)
D: Time-to-first event of the composite endpoint (Approximately 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Safety Trial of CTX0E03 Drug Product Delivered Intracranially in the Treatment of Patients With Stable Ischemic Stroke
Brief Summary: The study is designed to test the safety of a manufactured neural stem cell line (CTX cells) delivered by injection into the damaged brains of male patients 60 years of age or over who remain moderately to severely disabled 6 months to 5 years following an ischemic stroke. In addition the trial will evaluate a range of potential efficacy measures for future trials. Treatment will involve a single injection of one of four doses of CTX cells into the patient's brain in a carefully controlled neurosurgical operation performed under general anesthetic. The trial is designed to treat 12 patients and measure outcomes over 24 months. Patients will be invited to participate in a long-term follow-up trial for a further 8 years.


Options:
A: Absence of new neurological deficits and adverse effects during the timeframe. (Duration of study)
B: Incidence of adverse events (1 year)
C: Barthel index score (six month post randomization)
D: Functional Independence Measure (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Proof of Concept, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Protective Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in Healthy, HIV-infected Adults
Brief Summary: This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults.

This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity analysis set).


Options:
A: The occurence and severity of local side-effects The occurence and severity of systemic side-effects (1 year)
B: Safety of MVA85A (Six months)
C: To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG (3 months)
D: Percentage of Participants With Adverse Events (Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Cardiovascular and Inflammatory Effects of Statin Therapy in Patients With COPD
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and these patients are at increased risk of heart disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the blood but may also reduce inflammation and lower the risk of heart disease. This study will explore whether simvastatin reduces one of the risk factors in patients with COPD in a short term proof of principle study. The key purpose is to determine whether simvastatin improves the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or blood inflammation and change in breathing ability


Options:
A: Rates of COPD Exacerbations (up to 37 months)
B: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)
C: Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period (Week 0 (start) and week 6 (end))
D: Change in CD45+ cells expression over study period (12 weeks); Change in gene expression over study period (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Brief Summary: The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).


Options:
A: Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
B: Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks
C: Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 (Baseline and Week 12)
D: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study (Baseline - end of study (Week 52 or Last observation carried forward (LOCF))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Multi-centre Placebo Controlled Trial of Dexmedetomidine for Patients With Agitation and Delirium in the Intensive Care Unit
Brief Summary: The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium and agitation who are otherwise pathophysiologically stable (as defined), the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or placebo while receiving all other aspects of standard care.

The null hypothesis assumes no difference in the median number of ventilator-free hours in this ICU admission in the following 7 days, between patients receiving dexmedetomidine and placebo for ICU-associated agitation and delirium.


Options:
A: Ventilator-free hours (7 days following randomisation)
B: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
C: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
D: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Multi-centre Placebo Controlled Trial of Dexmedetomidine for Patients With Agitation and Delirium in the Intensive Care Unit
Brief Summary: The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium and agitation who are otherwise pathophysiologically stable (as defined), the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or placebo while receiving all other aspects of standard care.

The null hypothesis assumes no difference in the median number of ventilator-free hours in this ICU admission in the following 7 days, between patients receiving dexmedetomidine and placebo for ICU-associated agitation and delirium.


Options:
A: decrease in delirium rating scale and clinical global improvement (7 days)
B: Days alive and free of delirium and coma (delirium and coma free days) (enrollment to day 21)
C: Ventilator-free hours (7 days following randomisation)
D: Time from the commencement of treatment to extubation (days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: an Open Parallel Clinical Trial in HBV-GN Patients
Brief Summary: Lamivudine treatment for HBV-DNA negative HBV-GN patients.


Options:
A: N/A
B: Remission Status (24 months after randomization)
C: renal function (serum creatinine); proteinuria; side effects
D: Evaluation of efficacy of Rituximab associated with Non Immunosuppressive Symptomatic Treatment (NIST) in (IMN) in reducing the rate of proteinuria (patients with persistent urinary protein excretion rate ≥3,5g/24 h and albuminemia < 30g/l ) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial
Brief Summary: The aim of this project is to evaluate the efficacy of electronic reminder letters versus postal reminder letters on general practices adherence to clinical quality guidelines regarding Point Of Care Testing (POCT).


Options:
A: The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition (3 months)
B: Total number of split tests performed in study period. (January - April 2011)
C: Short-term adherence to CRC screening (From randomization to the end of 2 years); Long-term adherence to CRC screening (From randomization to the end of 9 years)
D: Number of LTC residents on vitamin D (16 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Point-Of-Care Testing In Danish General Practice: A Randomised Controlled Trial - Part II
Brief Summary: The aim of this project is to evaluate the efficacy of electronic reminder letters versus none on general practices adherence to clinical quality guidelines regarding Point Of Care Testing (POCT). The investigators hypothesize, that electronic reminder letters may increase adherence.


Options:
A: Short-term adherence to CRC screening (From randomization to the end of 2 years); Long-term adherence to CRC screening (From randomization to the end of 9 years)
B: Compliance rates with care guidelines (12 months)
C: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
D: Total number of split tests performed in study period (three periods). (January - April 2011)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.


Options:
A: Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone (Baseline, Week 8)
B: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)
C: Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) (Baseline, 12 weeks)
D: Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Measuring Quality of Decisions About Treatment of Depression
Brief Summary: The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.


Options:
A: Proportion of patients reaching remission (6 months)
B: Penn State Worry Questionnaire-Abbreviated (Week 11)
C: Change in Hamilton Depression Rating Scale-17 Score (Baseline, Week 24 post-intervention)
D: Depression Knowledge (2 weeks, on average)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Considering Patient Diet Preference to Optimize Weight Loss
Brief Summary: Obesity is increasingly common and can lead to decreased quality of life, increased medical and psychiatric illness, high health care costs, and early mortality. The problem of obesity is as great in veterans as it is in the general public. Adherence to dietary therapy for obesity is often inadequate, possibly because patients' food preferences are not considered during dietary counseling. Allowing patients to choose a diet based on their food preferences may increase their motivation to adhere to diet counseling. This, in turn, could enhance their weight loss success and, ultimately, reduce the many health complications and costs of obesity. The proposed study will examine whether assessing a person's food preferences, and then allowing the person to choose from two commonly prescribed diets, results in greater weight loss success.


Options:
A: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
B: weight loss
C: Percent Change in Body Weight From Baseline to 48 Weeks (Baseline, 48 weeks)
D: Change in body weight (measured at Year 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
Brief Summary: Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.

Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response (10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)
B: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration)
C: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)
D: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)

Answer: A