TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial
Brief Summary: The goal of this research is to improve communication to Veterans. The investigators want to improve how doctors and nurses talk to patients about the risk of heart attack and stroke. The investigators will give everyone in the study information about the risk for heart attack or stroke. The investigators will also provide information on how to reduce this risk. This information will be given in one of two ways. The investigators want to see which way of giving information works better for veterans. The investigators also want to assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of personalized risk communication on medication adherence and blood pressure. The investigators plan to enroll approximately 100 veterans for this study. All veterans will be from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3 months.


Options:
A: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
B: The primary measure of results will be the differences in smoking cessation rates between intervention and control groups (12 months after been conducted the intervention)
C: Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic (Nine months (from recruitment to completion))
D: smoking abstinence: self reported abstinence (12 or more months) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial
Brief Summary: The goal of this research is to improve communication to Veterans. The investigators want to improve how doctors and nurses talk to patients about the risk of heart attack and stroke. The investigators will give everyone in the study information about the risk for heart attack or stroke. The investigators will also provide information on how to reduce this risk. This information will be given in one of two ways. The investigators want to see which way of giving information works better for veterans. The investigators also want to assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of personalized risk communication on medication adherence and blood pressure. The investigators plan to enroll approximately 100 veterans for this study. All veterans will be from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3 months.


Options:
A: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
B: Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
D: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial
Brief Summary: The goal of this research is to improve communication to Veterans. The investigators want to improve how doctors and nurses talk to patients about the risk of heart attack and stroke. The investigators will give everyone in the study information about the risk for heart attack or stroke. The investigators will also provide information on how to reduce this risk. This information will be given in one of two ways. The investigators want to see which way of giving information works better for veterans. The investigators also want to assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of personalized risk communication on medication adherence and blood pressure. The investigators plan to enroll approximately 100 veterans for this study. All veterans will be from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3 months.


Options:
A: Medication adherence; Exacerbation of heart failure; Health-related quality of life
B: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)
C: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
D: Medication Possession Ratio at baseline, 1-6 months, 6-12 months, and 12-18 months. Aggregate adherence categories based on MPR, anti-psychotic blood levels (present/not present) and patient self-report at baseline, 6 months, and 12 months.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Brief Summary: The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.


Options:
A: Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV (From Baseline up to the Final Assessment Visit (FAV) (average of 609 days))
B: Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization (baseline and 12 weeks)
C: Number of Participants With Adverse Events (AEs) (Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period))
D: 6 minutes walking distance

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Brief Summary: The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.


Options:
A: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)
B: Change in 6-minute walk distance (Baseline to End-of-Period 1)
C: Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV (From Baseline up to the Final Assessment Visit (FAV) (average of 609 days))
D: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
Brief Summary: Autism spectrum disorders affect as many as 1 out of 150 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Although effective interventions have been developed for typically developing youth with anxiety disorders, this approach needs to be adapted for children with autism. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with autism spectrum disorders and comorbid anxiety disorder(s).


Options:
A: Changes in dental anxiety (3 months and 12 months from baseline)
B: DSM-IV criteria for Separation Anxiety Disorder (December 2009); Global Success Rating (GSR) (December 2009); Separation Anxiety Inventory for Children (SAI) (December 2009)
C: Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms) (After an average of 16 weeks (Post-treatment))
D: Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis (Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II
Brief Summary: The Clinic Treatment Project tested two alternative methods of delivering evidence-based practices within public community-based mental health clinics, using training and supervision procedures designed for the settings and users.


Options:
A: Brief Problem Checklist (BPC, parent and child forms) (Change over time from Day 1 to Day 267)
B: Clinical Global Impression - Improvement Scale (Measured at Week 12)
C: Score on anxiety diagnostic interview after treatment or waitlist (post-treatment); Score on anxiety rating scale after treatment or waitlist (post-treatment)
D: DSM-IV criteria for Separation Anxiety Disorder (December 2009); Global Success Rating (GSR) (December 2009); Separation Anxiety Inventory for Children (SAI) (December 2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project - Phase II
Brief Summary: The Clinic Treatment Project tested two alternative methods of delivering evidence-based practices within public community-based mental health clinics, using training and supervision procedures designed for the settings and users.


Options:
A: N/A
B: Brief Problem Checklist (BPC, parent and child forms) (Change over time from Day 1 to Day 267)
C: Changes in dental anxiety (3 months and 12 months from baseline)
D: Anxiety Disorders Interview Schedule - Child/Parent Version (Post Treatment (16 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial
Brief Summary: It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.


Options:
A: plasma troponin T level (within the first 7 days after surgery)
B: IL-6 (1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours)
C: Allogenic Blood Product Transfusion Risk (Patients were followed for the duration of hospital stay, an average of 6 days)
D: SOFA Score (24 hours before until day 9 post-surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial
Brief Summary: It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.


Options:
A: The mean peak increase of serum creatinine concentration during day1 and day2.
B: plasma troponin T level (within the first 7 days after surgery)
C: Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control (3 days)
D: To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization) (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial
Brief Summary: It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.


Options:
A: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (Postoperative 6th hours)
B: Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) (up to 5 years)
C: Number of Participants With Acute Kidney Injury (postoperative day 2); Number of Participants With Delirium (while in ICU (about 2 days))
D: plasma troponin T level (within the first 7 days after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial
Brief Summary: Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and 17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of cervical shortening, in the present pregnancy.

Main outcome: Delivery before 37 weeks.

Secondary outcomes: Gestational age at delivery, Delivery \<32, \<35 wks, hospital admissions before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications, congenital neonatal malformations and anomalies.

Allocated treatments will be:

Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical observation

Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics per os. Any treatment will be recorded.

Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will be competitively assigned later. Results are expected 20-24 months from starting.

Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50% (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160 patients/arm, with a total of 480 patients.

Data analysis: Methodological Unit will assign randomized treatment through a web site and it will collect data through the same way.


Options:
A: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))
B: The chance of miscarriage before 20 weeks of gestation (At 20 weeks of gestation)
C: Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. (48 hours); Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. (48 hours)
D: Preterm delivery (37 weeks of gestation) (6 mo. after end of recruitment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.

(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)


Options:
A: Clinical pregnancy (8 weeks after IUI)
B: Ongoing pregnancy rate beyond 20 weeks
C: Ongoing pregnancy rate (12 weeks)
D: Ongoing Pregnancy Rate (10 weeks after treatment start)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.

(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)


Options:
A: Ongoing pregnancy rate (12 weeks)
B: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))
C: The frequency of spontaneous abortion before 28 weeks (14 weeks)
D: The chance of miscarriage before 20 weeks of gestation (At 20 weeks of gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Brief Summary: This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Options:
A: Change in Weight (kg) (52 weeks post-randomization); Proportion Maintaining >= 5% Loss of Initial Weight (52 weeks post-randomization)
B: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
C: change in body weight from baseline to 1 year.
D: Co-primary: Body Weight- Mean Percent Change (Baseline, 56 weeks); Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease (Baseline, 56 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Brief Summary: This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Options:
A: ß score evaluation 6 months after first infusion (group 1 'immediate registration on infusion waiting list') or 6 months after inclusion (group 2: 'delayed registration on infusion waiting list') (6 months after first infusion (group 1) or 6 months after inclusion (group 2))
B: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
C: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
D: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Brief Summary: This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Options:
A: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
B: HbA1c Change From Baseline (Baseline and 12 weeks); Mean 24-hour Systolic Blood Pressure Change From Baseline (Baseline and 12 weeks)
C: Plasma liraglutide concentration (pmol/L) (12 weeks)
D: Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis (From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Brief Summary: This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Options:
A: To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). (52 weeks)
B: Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke (Up to approximately 8 years)
C: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomisation until completion of the planned treatment period, up to 1040 days.)
D: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))

Answer: D