TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Pro-Brain Natriuretic Peptide Targeted Therapy to Tailor Medical Management of Patients With Congestive Heart Failure Followed in an Outpatient Setting: the ProBNP Outpatient Tailored CHF Therapy (PROTECT) Study
Brief Summary: Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels may identify a patient at high risk for adverse outcome from their HF, even in periods of apparent stability.

It remains unclear, however, whether treating patients based on their NT-proBNP concentrations would be associated with better outcomes compared to standard HF therapy without measurement of NT-proBNP values.

The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to standard HF therapy without such 'hormone guided' treatment.


Options:
A: CV Death or Heart Failure Hospitalization (24 Months)
B: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
C: Prevalence and severity of LVD (5 year)
D: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Capturing Outcomes of Clinical Activities Performed by a Rounding Pharmacist Practising in a Team Environment (COLLABORATE)
Brief Summary: We, the researchers, propose to link a clinical pharmacist with an internal medicine or family medicine team to provide pharmaceutical care to all patients assigned to the team. The hypothesis is that through this team based approach, pharmacists will act as a resource for providing pharmacotherapeutic advice during the drug therapy decision making process and promote optimal drug use by identifying and resolving actual and potential drug related problems. This study is designed to test this hypothesis, by assessing the impact of this intervention on evidence based, quality of drug therapy indicators, for patients admitted with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).


Options:
A: N/A
B: The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. (2 months)
C: The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm (6 months prior to implementation of intervention to 21 months during intervention)
D: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Capturing Outcomes of Clinical Activities Performed by a Rounding Pharmacist Practising in a Team Environment (COLLABORATE)
Brief Summary: We, the researchers, propose to link a clinical pharmacist with an internal medicine or family medicine team to provide pharmaceutical care to all patients assigned to the team. The hypothesis is that through this team based approach, pharmacists will act as a resource for providing pharmacotherapeutic advice during the drug therapy decision making process and promote optimal drug use by identifying and resolving actual and potential drug related problems. This study is designed to test this hypothesis, by assessing the impact of this intervention on evidence based, quality of drug therapy indicators, for patients admitted with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).


Options:
A: Drug-related readmission (one year after discharge from the cooperating ward)
B: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)
C: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
D: Goal Attainment Scaling at 3 months (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome
Brief Summary: Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for pain control have decreased serum testosterone levels. Indeed, these men complain of decreased libido, erectile dysfunction and impaired quality of life. Animal studies have shown that gonadectomy results in a decrease in pain threshold in rats and repletion of testosterone elevates that threshold. These observations suggest that testosterone may possess analgesic properties. Hence, the investigators hypothesize that hypogonadism developing in men on opioids results in an increased sensitivity to pain and requirement of higher doses of opioids. In this study, the investigators plan to administer testosterone to men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in response to noxious stimuli and changes in the requirement of opioids in response to testosterone administration.

Hypothesis:

Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance, pain perception and quality of life.

Specific aims:

1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance, and pain modulation in men with opioid-induced hypogonadism.
2. To determine the effects of testosterone replacement on health-related quality of life.
3. To determine whether testosterone replacement in hypogonadal men induces changes in the dosage requirements of opioid medications for pain control.

To accomplish our specific aims, the investigators propose a randomized, double blind, placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back pain syndrome on chronic opioids and low testosterone levels (\<300 ng/dl) will be randomized to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in pain tolerance using various external painful stimuli. Secondary outcomes are change in pain sensitivity and modulation, quality of life and opioid requirements.


Options:
A: Change from baseline on the total score of the AMS rating scale (Month 6)
B: Lean body mass (approximately three years)
C: Brief Pain Inventory (BPI) at Week 14 (Week14 after intervention); Algometer-induced Pressure Pain at Week 14 (Week 14 after intervention); Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14 (Week 14 after intervention); Ice Water-induced Cold Pain and Its After-sensation at Week 14 (Week 14 after intervention)
D: Change in the Physical Performance Test (Baseline and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment
Brief Summary: To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Options:
A: To evaluate the efficacy of quetiapine fumarate sustained release; (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
B: Longitudinal depressive symptom severity (52 weeks); Difference in time to all-cause treatment discontinuation (12 months)
C: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Week 4)
D: Montgomery and Asberg Scale for Depression (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium and Vitamin D Malnutrition in Elderly Women
Brief Summary: This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.

* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.


Options:
A: all-type cancer (excluding non-melanoma skin cancers) (4 years)
B: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
C: fractures (4 years)
D: Cardiovascular disease; Cancer

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium and Vitamin D Malnutrition in Elderly Women
Brief Summary: This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.

* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.


Options:
A: 24-hour systolic blood pressure (20 weeks)
B: change of 25-hydroxvitamin D (after 4 and 8 weeks of supplementation)
C: N/A
D: fractures (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium and Vitamin D Malnutrition in Elderly Women
Brief Summary: This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.

* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.


Options:
A: fractures (4 years)
B: Incidence of spontaneous falls. (24 months.)
C: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)
D: Changes in Serum 25-hydroxyvitamin D (25OHD) and parathyroid hormone (PTH) levels (Baseline, 6months,12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium and Vitamin D Malnutrition in Elderly Women
Brief Summary: This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.

* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.


Options:
A: rate of falls compared between treatment arms
B: Mediolateral body sway at 16 weeks. (at 16 weeks)
C: fractures (4 years)
D: Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium and Vitamin D Malnutrition in Elderly Women
Brief Summary: This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.

* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.


Options:
A: fractures (4 years)
B: Incidence of invasive breast cancer; superiority of one of the therapies. (Time from randomization to the occurance of invasive breast cancer.)
C: The primary efficacy parameter was reduction in incident new vertebral fractures assessed by spinal radiographs (anterior-posterior and lateral) (3 years)
D: Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.; Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)
Brief Summary: The goal of this clinical research study is to learn if lenalidomide in combination with prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for the treatment of myelofibrosis will also be studied.


Options:
A: Number of Participants With Adverse Events (AEs) (From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.); Percentage of Participants With Clinical Improvement (CI) Over Time (Week 12, 24, 36, 48 and 60)
B: Overall Response Rate (Assessed at the end of cycle 3)
C: Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement) (6 months)
D: Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 (Baseline and Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Calcium/Vitamin D Supplementation (Caltrate 600+ D) on Body Weight and Fat Loss in Overweight and Obese Individuals on a Weight-Reducing Program.
Brief Summary: The aim of this study was to assess the effect of calcium/vitamin D supplementation (Caltrate 600 +D®) on body weight loss during a weight-reducing program


Options:
A: median time to next exacerbation. (1 year)
B: Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
C: Change in body weight (Baseline and 16 weeks)
D: fractures (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
Brief Summary: In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.


Options:
A: N/A
B: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
C: serum B12 status; serum folate status
D: The primary end point was a composite of; nonfatal myocardial infarction,; fatal myocardial infarction,; nonfatal stroke,; fatal stroke, and; sudden death attributed to coronary heart disease.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
Brief Summary: In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.


Options:
A: Plasma zinc concentration (1 month)
B: serum B12 status; serum folate status
C: red blood cell folate concentration at three time points (baseline, 8th week, 16th week)
D: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
Brief Summary: The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.


Options:
A: Percentage of Days With Subcutaneous Octreotide as Rescue Medication (16-week DB phase)
B: Progression-Free Survival (PFS) (From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year)
C: Central Review-based Progression-Free Survival (Up to 3 years)
D: Progression Free Survival (PFS) (From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Genomics to Combat Resistance Against Antibiotics in Community-Acquired LRTI in Europe: GRACE. Workpackage 8. An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care
Brief Summary: The overall objective of GRACE is to combat the resistance of drugs that kill bacteria and other germs (antimicrobial) through integrating centres of research excellence and using the study of the entire DNA in a cell (genomics) to most appropriately investigate and manage community-acquired LRTI.

Grace-01 is the first study to be undertaken as part of GRACE and the aims of this study are to describe the presentation, diagnosis, investigation, management and outcomes for people with cough / chest infection in general medical practice in 13 primary care networks in 12 countries in Europe.


Options:
A: Change in antibiotic prescription patterns for respiratory infections (1 year)
B: Proportion of clinical failure by day 7 compared among the 3 study arms. (10 months)
C: N/A
D: Total Antibiotic Exposure Days (30 days); Number of Participants With Any Adverse Outcome (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy
Brief Summary: This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: Hemoglobin level
B: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 (Baseline, Month 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy
Brief Summary: This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 (Baseline, Month 15)
B: Cost of Erythropoiesis Stimulating Agent (12 months)
C: Hemoglobin Level in blood (Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months)
D: Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks (Baseline and 24 weeks)

Answer: A