TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)
Brief Summary: This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.


Options:
A: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory) (Week 0, week 26)
B: Symptomatic nocturnal hypoglycaemia (9 months (3-12) of each treatment period)
C: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (Week 0, Week 26); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 53 + 7 days of follow up)
D: Severe hypoglycaemia (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis
Brief Summary: Objective: assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).

Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.


Options:
A: Delirium (Daily)
B: Hospital Mortality to Day 60. (60 days after randomization)
C: Reduction of ICU delirium duration assessed by ICDSC checklist (during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided)
D: Days alive and free of delirium and coma (delirium and coma free days) (enrollment to day 21)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis
Brief Summary: Objective: assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).

Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.


Options:
A: Compare the adverse events between mesenchymal stem cell treatment and placebo groups (From day 0 at the start of treatment to day 28.)
B: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
C: Hospital Mortality to Day 60. (60 days after randomization)
D: Heart Rate Assessments Upto Day 7 (Part B) (Up to Day 7); Diastolic and Systolic Blood Pressure Assessments Upto Day 7 (Part B) (Up to Day 7); Electrocardiogram (ECG) Parameters, Including PR, QRS, QT, and QTCU and RR Intervals Upto Day 7 (Part B) (Up to Day 7); Hematology Parameters Basophils, Eosinophil, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count Upto Day 7 (Part B) (Up to Day 7); Hematology Parameters Red Blood Cell Count and Reticulocyte Count Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Mean Corpuscle Volume (MCV) Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Mean Corpuscle Hemoglobin (MCH) Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Hematocrit Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Alkaline Phosphatase, Asparatate Amino Transferase, Alanine Amino Transferase, Gamma Glutamyl Transferase Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Albumin and Total Protein Assessment Upto Day 7 (Part B) (Up to Day 7); Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part A) (Up to Day 7); Number of Par With AE and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part B) (Up to Day 7)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Dose-Escalation Study Of A Self Complementary Adeno-Associated Viral Vector (scAAV 2/8-LP1-hFIXco) For Gene Transfer in Hemophilia B
Brief Summary: The purpose of this study is to determine the safety of giving a normal factor IX gene to treat individuals who have an abnormal or no factor IX gene. Recruitment will be limited to adults (≥ 18 years) with a confirmed diagnosis of hemophilia B (HB), resulting from a missense mutation in the coagulation factor IX (FIX) gene or a nonsense mutation that has not been associated with an inhibitor. Only subjects who have no evidence of active hepatitis or anti-hFIX antibodies, and who have been treated/exposed to Factor IX concentrates for at least ten years and have had an average of 3 bleeding episodes per year requiring FIX administration will be enrolled. Patients will be recruited within the United States for treatment at St. Jude Children's Research Hospital, and patients will be recruited in England and other countries for treatment in London by our British collaborators.


Options:
A: Serious and non-serious AEs (4 weeks after infusion with BAX 855 and ADVATE)
B: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)
C: Annualized Bleeding Rate (ABR) (9 months)
D: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings (Baseline up to Week 52); Number of Participants With Clinically Significant Change From Baseline in Vital Signs (Baseline up to Week 52); Number of Participants With Clinical Laboratory Abnormalities Reported as TEAE (Baseline up to Week 52); Number of Participants With Drug -Related TEAEs and Serious Adverse Events (SAEs) (Baseline up to Week 52); Number of Participants With Positive Immune Reponses Against Adeno-associated Virus Vector (AAV) Capsid (Baseline up to Week 52); Number of Participants Who Reached > 150% Vector-derived FIX:C Activity Level After SPK-9001 Infusion (Baseline up to Week 52); Number of Participants With FIX Inhibitor (Baseline up to Week 52); Incremental Recovery of FIX Product (Day 0 and Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Dose-Escalation Study Of A Self Complementary Adeno-Associated Viral Vector (scAAV 2/8-LP1-hFIXco) For Gene Transfer in Hemophilia B
Brief Summary: The purpose of this study is to determine the safety of giving a normal factor IX gene to treat individuals who have an abnormal or no factor IX gene. Recruitment will be limited to adults (≥ 18 years) with a confirmed diagnosis of hemophilia B (HB), resulting from a missense mutation in the coagulation factor IX (FIX) gene or a nonsense mutation that has not been associated with an inhibitor. Only subjects who have no evidence of active hepatitis or anti-hFIX antibodies, and who have been treated/exposed to Factor IX concentrates for at least ten years and have had an average of 3 bleeding episodes per year requiring FIX administration will be enrolled. Patients will be recruited within the United States for treatment at St. Jude Children's Research Hospital, and patients will be recruited in England and other countries for treatment in London by our British collaborators.


Options:
A: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
B: Serious and non-serious AEs (4 weeks after infusion with BAX 855 and ADVATE)
C: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)
D: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
B: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
C: favorable clinical response (day 30)
D: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: Renal composite endpoints [Time to first occurrence of one of the following events:] (2-4 year)
B: Left Ventricular Mass (LVMI, g/m2) changes (1 year)
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) (2 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
B: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)
C: Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90 (Day 90)
D: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)
B: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
C: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (Up to 124 weeks)
D: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
B: N/A
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation (12 months after stent implantation)
B: Platelet activation during and after the intervention (6-12 hours)
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%)) (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: The primary endpoint is death from any cause or incident, dementia or persistent physical disability. (every 6 months)
B: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: Feasibility of Phase III Trial (36 months (24 Months Recruitment + 12 months Follow Up))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Brief Summary: The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.


Options:
A: Any stroke at 90 days; Stroke severity
B: Adjudicated Recurrent Stroke (From randomisation until full follow up period, approximately 43 months.); First Major Bleed (Adjudicated) (Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: Composite of Subsequent Stroke or Death (From randomisation (day 1) to visit 3 (day 30-34))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus
Brief Summary: The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.


Options:
A: blood glucose control (During hospitalization)
B: Mean Fasting Blood Glucose (up to 10 days)
C: Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments (Randomization and 24 hrs after treatment)
D: Mean Blood Glucose Concentration (hospital stay days 2-10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Simulated Diabetes Training for Resident Physicians
Brief Summary: The objective of this translational research is to study the effect of implementing an innovative simulated diabetes learning intervention within primary care residency programs. The intervention uses cognitive behavioral learning theory to provide goal-directed feedback to residents after every encounter over a series of virtual patient-physician encounters. Formulas derived from pharmacokinetic data and the experience of clinical experts model simulated physiologic responses to drug changes, health behaviors, and adherence factors. The online intervention is economical, sustainable, and addresses a number of current obstacles to outpatient diabetes training in primary care residency programs.

In this group trial, we randomly assign about 20 primary care residency programs with up to 700 residents total to either an (a) Early learning program group or (b) Delayed learning program group. We will assess the ability of residents to achieve evidence-based diabetes clinical goals and avoid potential medical safety issues for glycemia, blood pressure, and lipids on simulated assessment cases. Secondary analyses will evaluate the actual use of the tool by residents, direct costs of the program, and resident satisfaction.


Options:
A: Percent of Participants With Improvement in Hemoglobin A1c by 0.5%" (6 months)
B: Treatment according to evidence-based diabetes goals (September 2010 - July 2013); Drug intensification (September 2010 - July 2013); Number of risky prescribing events (September 2010 - July 2013)
C: Change in Hemoglobin A1c (3 months, 6 months, 12 months)
D: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Osteoarthritis is a common disease. The core treatment is often patient education. The aim of this study is therefore to study the effect of a patient education programme for patients with osteoarthritis in primary health care.


Options:
A: Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) from Baseline to 12-months. (Baseline and 12-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 18-months post Baseline. (post Baseline,18-months); Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 24-months post Baseline. (post Baseline, 24-months)
B: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)
C: EQ5D (At baseline and at follow-up after 6 months); Arthritis self-efficacy scale (At baseline and at follow up after 6 months); One-leg rising from sitting to standing (At baseline and at follow up after 6 months); Grip Ability Test (At baseline and at follow up after 6 months)
D: Pain (Baseline and 12-month follow-up)

Answer: C