TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Local Ischemic Preconditioning in Patients With Type 1 Diabetes in Vivo
Brief Summary: In this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short period of ischemia that protects against subsequent ischemic exercise). Annexin A5 scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that results from ischemic exercise.

The following hypotheses are tested:

1. Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers.
2. Ischemic preconidtioning is still present in patients with type 1 diabetes. Depending on the validity of hypothesis 2, the effect of short pharmacological interventions are studied on vulnerability to forearm ischemia/reperfusion injury in the absence or presence of local forearm ischemic preconditioning.


Options:
A: Comparison of postoperative PaO2/FiO2 (at 10 minutes after anesthetic induction)
B: Mitochondrial respiration (1 hour)
C: N/A
D: Plasma Creatine Concentration of the Recipients (within the first 3days after the operation); Urinary Output of the Recipients Postoperatively (within the first 3days after the operation); Plasma Concentration of NGAL in the Recipients (within the first 24hours after the operation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
Brief Summary: This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.


Options:
A: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)
B: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
C: N/A
D: diabetes; death

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
Brief Summary: This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.


Options:
A: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. (3 years)
D: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
Brief Summary: This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.


Options:
A: Change from baseline in diastolic blood pressure after 26 weeks
B: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
C: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)
D: All strokes (fatal and non-fatal) (Duration of trial)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
Brief Summary: This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.


Options:
A: BP measurement (Measured at 6 months)
B: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
C: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Brief Summary: This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.


Options:
A: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)
B: Change of intima media thickness of the common carotid artery on the leading side of the neck.
C: Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).
D: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Brief Summary: This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.


Options:
A: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)
B: Change of intima media thickness of the common carotid artery on the leading side of the neck.
C: Change in intima media thickness as measured by carotid ultrasound
D: Anti-factor Xa plasma levels (within 3 days after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Brief Summary: This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.


Options:
A: Change of intima media thickness of the common carotid artery on the leading side of the neck.
B: N/A
C: Intubation rate (Day 28)
D: Time-to-clinical improvement (day 1 until day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-center, Open-label, Controlled, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive (SH T00658ID) as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D00264A) on Plasma Lipids, Hemostatic Variables, and Carbohydrate Metabolism in Healthy Female Volunteers Aged 18-50 Years Over 7 Treatment Cycles, Including the Pharmacokinetics
Brief Summary: The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.


Options:
A: N/A
B: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
C: Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment (Baseline, Cycle 7)
D: Bleeding pattern (7 treatment cycles each consisting of 28 days); Number of unintended pregnancies (7 treatment cycles each consisting of 28 days and follow-up period of 14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.
Brief Summary: The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.


Options:
A: Bleeding pattern (7 treatment cycles each consisting of 28 days); Number of unintended pregnancies (7 treatment cycles each consisting of 28 days and follow-up period of 14 days)
B: Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment (Baseline, Cycle 7)
C: N/A
D: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
Brief Summary: To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor


Options:
A: delivery within 48 hours (48 hours after enrollment)
B: Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence (48 hours after administration of study medication.)
C: Time of Delivery (Delivery)
D: Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial
Brief Summary: Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor


Options:
A: N/A
B: Incidence of delivery within 2 days (48 h) from start of IMP administration (48 hours); Incidence of delivery within 7 days (168 h) from start of IMP administration (168 hours); Incidence of delivery before 37 weeks of GA (Up to 13 weeks from start of IMP administration); Time to delivery measured from start of IMP administration (Up to 17 weeks from start of IMP administration)
C: delaying labor (for more than 48 hours after starting treatment)
D: Achieving 37 weeks gestation (delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
Brief Summary: To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.


Options:
A: gestational age at delivery (8 weeks)
B: N/A
C: Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours (48 hours after the randomization)
D: Gestational age at delivery (before than 42 weeks of gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sports to Prevent Obesity: Feasibility and Pilot RCT
Brief Summary: The purpose of this study is to learn whether overweight children who participate in an after school sports program improve their health as much as overweight children in a more traditional health education program.


Options:
A: N/A
B: Body mass index (Baseline, 3 and 6 months)
C: Change in proportion of children meeting physical activity policy (Baseline, Fall of Year 2, and Fall of Year 3)
D: Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (Baseline, end of intervention (7 months), 1 year after intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sports to Prevent Obesity: Feasibility and Pilot RCT
Brief Summary: The purpose of this study is to learn whether overweight children who participate in an after school sports program improve their health as much as overweight children in a more traditional health education program.


Options:
A: Total Body Bone Mineral Density (TBBMD) (Baseline, 1 year, and 2 years)
B: Daily physical activity > 60 minutes (4 years)
C: Body mass index (Baseline, 3 and 6 months)
D: BMI and aerobic fitness (1 schoolyear)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Acupuncture and Massage for Depression During Pregnancy
Brief Summary: This study evaluates the efficacy of acupuncture and massage for the treatment of depression during pregnancy. The study also examines differential effects of study treatments on delivery outcome and post partum depression.


Options:
A: 17-item Hamilton Depression Rating Scale (8 weeks)
B: Beck Depression Inventory (6 - 8 weeks postpartum)
C: Depression severity and response status after 8 weeks of treatment
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
Brief Summary: In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.


Options:
A: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
B: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
C: 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)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
Brief Summary: In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.


Options:
A: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
B: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
C: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
Brief Summary: In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.


Options:
A: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
B: 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)
C: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
D: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention
Brief Summary: It is known that patients who fracture their legs sometimes develop blood clots (known as deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or they may detach and travel to the lungs producing shortness of breath, chest pain, and sometimes death. Unfortunately, it is not known how frequently these complications occur after leg fractures, or if the use of a blood thinner medication can effectively and safely prevent these clots. Doctors at hospitals across Canada are conducting a study in which patients who have surgery for leg fractures receive either a once-daily injection of a blood thinner, known as low molecular weight heparin, or a placebo injection for up to 14 days after their fractures. Neither the patients nor the doctors know which patient is on the medication and which patient is on placebo. All patients receive an ultrasound examination of their legs at 2 weeks after surgery to monitor for deep vein thrombosis. In addition, all patients are checked for symptoms of leg or lung clots and any side effects of the medication for 3 months. If the blood thinner is shown to be effective at reducing this complication and documented to be safe and cost-effective in this setting it will be recommended for use in such patients. If, on the other hand, the frequency of deep vein thrombosis is too low to justify the cost or inconvenience of taking this medication, this will also be an important finding.


Options:
A: Clinically important venous thromboembolism at 3 months
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
D: To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound (While in ICU to a maximum of 90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Feedback for Effective Cardiac Treatment (EFFECT)
Brief Summary: Randomized cluster trial of cardiac report cards for AMI and CHF. 103 acute care Ontario hospitals/85 hospital corporations participating, randomized to two groups: Group A Early Feedback and Group B Delayed Feedback.

Two phases of retrospective chart review of AMI and CHF separations to assess the impact of the public release of hospital specific performance on a set of Canadian quality indicators.


Options:
A: Hospital rate of permanent colostomy; Hospital rate of local recurrence
B: Change in systolic blood pressure (6 months)
C: EFFECT AMI Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005); EFFECT CHF Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005)
D: decreased of occured of iatrogenic event in ICU (one month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome measures include cognitive batteries, rating scales for activities of daily living and neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for Alzheimer's disease.


Options:
A: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
B: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
C: Cohen-Mansfield (2 weeks)
D: N/A

Answer: D