TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy
Brief Summary: This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV anti-pseudomonals.


Options:
A: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
B: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
C: Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 (14 days)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy
Brief Summary: This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV anti-pseudomonals.


Options:
A: Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 (14 days)
B: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
C: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30 (Baseline and End of treatment (Day 28-30))
D: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) (Baseline to168 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy
Brief Summary: This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV anti-pseudomonals.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
D: Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 (14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Aspirin on Renal Disease Progression in Patients With Type 2 Diabetes: a Multicentre Double-blind, Placebo-controlled, Randomised Trial. The LEDA (renaL disEase Progression by Aspirin in Diabetic pAtients) Study.
Brief Summary: The pathophysiology of diabetes is multifactorial. Beyond genetic susceptibility loci, a lot of acquired risk factors are involved in the development and progression of the disease. Chronic complications of diabetes can be divided into vascular and nonvascular. The risk of developing complications increases with the duration of hyperglycemia, and usually become apparent in the second decade of hyperglycemia. Vascular complications are further subdivided into microvascular (retinopathy, nephropathy and neuropathy) and macrovascular (coronary artery disease, peripheral arterial disease, cerebrovascular disease). It is estimated that the annual decline of estimated glomerular filtration rate (eGFR) in diabetic adults is about 2.1-2.7 ml/min.

While there is consolidated evidence about the use of aspirin (ASA) for secondary prevention in diabetic patients, there is no consensus on the use in primary prevention; the use of ASA in these patients is at physician discretion.

ASA is an effective antithrombotic agent that inhibits the production of thromboxane (Tx) A2 and other prostaglandins by blocking cyclooxygenase (COX). In patients treated with aspirin, serum TxB₂ level is the most reliable in vivo indicator of COX-1 inhibition than TxA2, due to its short half-life and artifacts associated with platelet activation ex vivo.

COX are present in the kidney in the macula densa, in the medulla and in the interstitium. Experimental animals models have demonstrated that COX are involved in regulation of renal blood flow. In particular, in a murine animal model, after the administration of COX inhibitors such as aspirin and celecoxib, it was observed an improvement in renal plasma flow and eGFR, suggesting a role for Tx in the progression of renal damage However, data on the relationship between aspirin and renal function in humans are scarce. In a recent work lead on a large cohort of 800 patients with non-valvular atrial fibrillation, ASA use was associated with a reduced progression of eGFR \<45 ml/min during 2 years of follow-up. Furthermore, basal levels of urinary excretion of TxB2, correlated inversely with the use of aspirin and with the decrease of eGFR at follow-up.

The aim of the study is to evaluate the decline in renal function in diabetic patients treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients.


Options:
A: late lumen loss measured by quantitative coronary angiography (9 months)
B: Changes in renal function in diabetic patients treated with aspirin (1 year)
C: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period (Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))
D: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Intervention for Breast Cancer Survivors
Brief Summary: The purpose of this study is to examine the effects of exercise program on health-related physical fitness and biomarkers among breast cancer survivors.


Options:
A: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
B: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)
C: Changes of health-related physical fitness components (1). (Changes from baseline aerobic capacity at 12 weeks); Changes of health-related physical fitness components (2). (Changes from baseline muscular endurance at 12 weeks); Changes of health-related physical fitness components (3). (Changes from baseline muscular strength at 12 weeks); Changes of health-related physical fitness components (4). (Changes from baseline muscular power at 12 weeks); Changes of health-related physical fitness components (5). (Changes from baseline agility at 12 weeks); Changes of health-related physical fitness components (6). (Changes from baseline flexibility at 12 weeks); Changes of anthropometric parameters (1). (Changes from baseline waist circumference at 12 weeks); Changes of anthropometric parameters (2). (Changes from baseline BMI at 12 weeks); Changes of body composition parameters (1). (Changes from baseline body fat mass at 12 weeks); Changes of body composition parameters (2). (Changes from baseline lean body mass at 12 weeks); Changes of body composition parameters (3). (Changes from baseline percentage body fat at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (1). (Changes from baseline serum levels of DKK1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (2). (Changes from baseline serum levels of Sclerostin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (3). (Changes from baseline serum levels of SFRP1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (4). (Changes from baseline serum levels of β-catenin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (5). (Changes from baseline serum levels of WISP-1 at 12 weeks)
D: Feasibility of a planned Nordic life style intervention (Five years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnership for Mental Health Development in Sub-Saharan Africa: COllaborative Shared Care to IMprove Psychosis Outcome
Brief Summary: COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis implemented by complementary alternative providers (traditional and faith healers) and conventional primary health care providers (PHCP) is compared with care as usual in which no formal collaboration takes place between the two groups of health providers. COSIMPO is therefore a test of a complex task sharing approach for the care of patients with severe mental disorders.


Options:
A: SF-12 MCS (6-Month Follow-up)
B: Reduction in symptoms of psychosis (6 months)
C: AMOUNT OF EMPLOYMENT (24 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnership for Mental Health Development in Sub-Saharan Africa: COllaborative Shared Care to IMprove Psychosis Outcome
Brief Summary: COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis implemented by complementary alternative providers (traditional and faith healers) and conventional primary health care providers (PHCP) is compared with care as usual in which no formal collaboration takes place between the two groups of health providers. COSIMPO is therefore a test of a complex task sharing approach for the care of patients with severe mental disorders.


Options:
A: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
B: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)
C: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)
D: Reduction in symptoms of psychosis (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Brief Summary: The purpose of this study is to investigate the effects of an extended behavioral intervention in exercise-based CR for improvement of physical capacity, adherence, psychological and physiological parameters, compared with usual care.


Options:
A: functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. (6 and 12 months)
B: Change from baseline aerobic exercise capacity (watts) at 4 months (4 months)
C: Medication adherence (12 months post-MI); Cardiac rehabilitation completion (12 months post-MI)
D: Maximal oxygen consumption (At baseline and after 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Brief Summary: The purpose of this study is to investigate the effects of an extended behavioral intervention in exercise-based CR for improvement of physical capacity, adherence, psychological and physiological parameters, compared with usual care.


Options:
A: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
B: Change from baseline aerobic exercise capacity (watts) at 4 months (4 months)
C: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
D: Change from Baseline in self-management adherence at 3 and 6 months (3 and 6 months following intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study
Brief Summary: This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.


Options:
A: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)
B: Dietary intake (6 month)
C: Body weight reduction (Month 6)
D: body weight (prior to and after 4, 8, and 12 months of dieting)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study
Brief Summary: This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.


Options:
A: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
B: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
C: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)
D: body weight (prior to and after 4, 8, and 12 months of dieting)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study
Brief Summary: This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.


Options:
A: weight loss
B: Fat mass (Baseline - 12 weeks)
C: N/A
D: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Tobacco Dependence Treatment in the Emergency Department
Brief Summary: The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.


Options:
A: 30 day abstinence (6 months)
B: Tobacco Abstinence (3 months)
C: proportion of smokers in each group who call the Minnesota Quitline, and changes in supportive behaviors among the support persons as measured by the Support Provided Measure. (6 months)
D: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Tobacco Dependence Treatment in the Emergency Department
Brief Summary: The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.


Options:
A: Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment (Change from enrollment to 3 months and 6 months post enrollment)
B: The primary outcome will be self-reported and biologically verified continuous smoking abstinence. (Six month)
C: Tobacco Abstinence (3 months)
D: Smoking cessation (Change in smoking status from baseline at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Tobacco Dependence Treatment in the Emergency Department
Brief Summary: The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.


Options:
A: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)
B: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: Tobacco Abstinence (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Keratin4VLU: A Randomised Controlled Trial of Wool-derived Keratin Dressings for Venous Leg Ulcers
Brief Summary: Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients. Compression bandaging is the main treatment but there are few added treatments for patients with slow healing VLU. About 50% of patients with VLU may be slow healing. Research suggests using keratin dressings as well as using compression may help healing in patients with show healing VLU, but the current evidence is not enough to change clinical practice. The investigators will conduct a randomised controlled trial to test whether using keratin dressings is better than usual care for slow healing VLU.


Options:
A: The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. (Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first)
B: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (Weekly, over 12 Weeks or until wound closure, which ever occurred first)
C: Proportion of patients with complete healing of reference ulcer (24 weeks)
D: Wound Closure (16 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth: a Randomized, Multicentre, Double Blind Placebo-controlled Non Inferiority Trial
Brief Summary: Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. Follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related.

In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose.

Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in Humans.


Options:
A: severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life (48 hours of life)
B: Incidence of respiratory morbidity (72 hours after birth)
C: Respiratory distress syndrome; Intraventricular hemorrhage; Neonatal mortality
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth: a Randomized, Multicentre, Double Blind Placebo-controlled Non Inferiority Trial
Brief Summary: Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. Follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related.

In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose.

Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in Humans.


Options:
A: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
B: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
C: severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life (48 hours of life)
D: Incidence of respiratory morbidity (72 hours after birth)

Answer: C