TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventive Primary Care Outreach for High Risk Older Persons
Brief Summary: It is recognized that a significant proportion of seniors over 75 years of age are at risk of functional decline, and thus of institutionalization and death. The investigators at McMaster University Medical Centre, are conducting is a randomized controlled trial of a preventive primary care outreach (PPCO) service provided to high risk seniors living in the community. The goal of this service is to identify unrecognized problems and individuals at increased risk and to link individuals to care. This preventive primary care service is provided by nurse case managers. The investigators have recruited patients through their family physicians who work in primary care networks. The investigators are screening all seniors aged 75 and over within these practices. The sample includes seniors aged 75 and over who are identified to be at risk according to the Sherbrooke Postal Questionnaire. Patients are randomly allocated to intervention and control groups. A research assistant, who is blind to group allocation, will collect data from seniors at baseline, six months, and at the end of one year.

Outcome measures include health-related quality of life (quality adjusted life years \[QALYs\]), health and social service utilization and costs, mortality, institutionalization, functional status, and perceived health status.

Primary Hypothesis:

The intervention compared to usual care will result in higher health-related quality of life.

Secondary Hypotheses:

Compared to usual care, the PPCO intervention will result in:

* the same or lower costs associated with service utilization;
* less functional decline;
* reduced mortality;
* lower rates of institutionalization; and
* better self-rated health.


Options:
A: Health related quality of life (quality adjusted life years [QALYs]) (baseline, 6 months, 12 months)
B: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
C: Functional status; health status; hospitalization and nursing home placement
D: Hospitalizations: rates of first hospitalization, number and reason (Three years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Brief Summary: This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).


Options:
A: Exercise Tolerance Comparison Between QVA149 and Placebo Groups (3 weeks)
B: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
C: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) (baseline (BL), 12 Weeks)
D: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Brief Summary: This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).


Options:
A: All cause mortality at 3 years
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Brief Summary: This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).


Options:
A: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) (Change from Baseline to 12 weeks)
B: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
C: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
D: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Brief Summary: This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).


Options:
A: FEV1 AUC0-24 on Day 29 (Day 29)
B: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
C: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score (12 weeks treatment)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Brief Summary: This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
B: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
C: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment (23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period)
D: All cause mortality at 3 years

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Cardiovascular Events iN Diabetes - A Randomized 2x2 Factorial Study of Aspirin Versus Placebo, and of Omega-3 Fatty Acid Supplementation Versus Placebo, for Primary Prevention of Cardiovascular Events in People With Diabetes
Brief Summary: The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or supplementation with 1 gram daily omega-3 fatty acids or placebo prevents "serious vascular events" (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or death from vascular causes) in patients with diabetes who are not known to have occlusive arterial disease and to assess the effects on serious bleeding or other adverse events.


Options:
A: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
B: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)
C: Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) (Randomized treatment phase during a mean of 7.4 years); Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) (Randomized treatment phase during a mean of 7.4 years)
D: Surgical Arm: Proportion of study SVGs which are totally occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes. (1 year post-operative); Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups. (1-year post-operative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock
Brief Summary: The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.


Options:
A: HbA1c; daily profile of blood glucose
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. (24 hours)
D: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock
Brief Summary: The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.


Options:
A: 28-day mortality (Day 28)
B: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
C: Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis (6 months after injury); Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis (6 months after injury)
D: 28 Day Survival (28 days from time of Emergency Department (ED) arrival)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock
Brief Summary: The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.


Options:
A: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
B: Mortality or dialysis-dependency (90 days)
C: All cause mortality (90 days)
D: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Chronic Ventilatory Support Improve the Outcomes of Rehabilitation in Hypercapnic COPD Patients?
Brief Summary: The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic COPD.


Options:
A: Health related quality of life measured by the Chronic Respiratory Questionnaire
B: Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment (Baseline and Week 4)
C: Quality of Life: Chronic Respiratory Questionaire (8 weeks from the start of the intervention); Daily Physical Activity measured by Actigraph (8 weeks from the start of the intervention)
D: Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) (baseline, week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Chronic Ventilatory Support Improve the Outcomes of Rehabilitation in Hypercapnic COPD Patients?
Brief Summary: The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic COPD.


Options:
A: all-cause mortality (one year)
B: Time to death or repeat AHRF with need of NIV (1 year)
C: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (8 weeks)
D: Health related quality of life measured by the Chronic Respiratory Questionnaire

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial
Brief Summary: A number of major clinical trials have demonstrated the clinical benefits of lowering blood pressure and have indicated that a majority of patients with hypertension will require more than one drug to achieve optimal blood pressure control.

There is little data showing which antihypertensive combination best protects patients from cardiovascular events and which best achieves the target blood pressure with the fewest adverse events.

The COPE trial is planned to investigate, in patients with hypertension, which combination of the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse drug effects.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: Change from baseline in diastolic blood pressure after 26 weeks
C: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)
D: A composite of fatal and non-fatal cardiovascular events. (first event); Achievement of target blood pressure (< 140 mmHg/90 mmHg). (time course)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
Brief Summary: The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients.


Options:
A: Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) (42 days)
B: Assessment of nutritional status with the Mini nutritional Assessment (MNA) (Baseline and every 4 weeks, up to 24 weeks)
C: Protein intake measured on an individual level over 24h (3 days (hospital), 3 weeks (rehabilitation home))
D: Return to hospital or death (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis
Brief Summary: The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.


Options:
A: Proportion of negative appendectomies (During the hospital admission)
B: rate of intra abdominal infections in both therapeutic strategies (30 days)
C: Negative Appendectomy (1 week after surgery)
D: sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. (immediate reading + blinded reading within 48 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis
Brief Summary: The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.


Options:
A: rate of intra abdominal infections in both therapeutic strategies (30 days)
B: Negative Appendectomy (1 week after surgery)
C: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis (Up to 10 years)
D: Negative Appendectomy Rate (1 week after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Place of Low-Dose Naltrexone in Opiate Detoxification
Brief Summary: There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals.


Options:
A: Opiate abstinence
B: Withdrawal intensity (6 days)
C: Opiate abstinence
D: Percentage of patients in each group successfully inducted onto Vivitrol (Completion of 7-day detoxification)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
Brief Summary: A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."


Options:
A: Delivery before than 37 weeks gestation (Up to 37 weeks gestation)
B: Gestational age at delivery (3-6 months)
C: Preterm delivery (Less than 34 weeks gestation)
D: Spontaneous delivery before 34 completed weeks (238 days) of gestation.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
Brief Summary: A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."


Options:
A: Maternal Cortisol Levels (Baseline (pre-stressor)); Maternal Cortisol Levels (20 minutes post-stressor); Maternal Cortisol Levels (45 minutes post stressor); Infant Cortisol Levels (4 months post-partum); Infant Cortisol Levels (4 months post-partum); Infant Cortisol Levels (4 months post-partum)
B: Decreased inflammation during human pregnancy (enrollment (8-16 weeks) to delivery)
C: Delivery before than 37 weeks gestation (Up to 37 weeks gestation)
D: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)

Answer: C