TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mentalization-Based Treatment in Groups for Adolescents With Borderline Personality Disorder (BPD) or Subthreshold BPD Versus Treatment As Usual - the M-GAB Randomized Controlled Trial
Brief Summary: Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in adolescents younger than 18 years according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly shown to be effective in treating adult BPD, but in the case of adolescents, only individual MBT have been tested and found to be effective.

Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As Usual (TAU) in treating adolescents with BPD or subthreshold BPD.

Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up will be at three and 12 months.

Discussion: Early intervention is especially important in relation to personality psychopathology and has long-term benefits for patients, their families and society. In addition to being cost effective, using the group modality in the treatment of BPD may have several advantages. This is the first Randomized Controlled Trial (RCT) to test the effectiveness of MBT in groups for adolescents.


Options:
A: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
B: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
C: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)
D: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mentalization-Based Treatment in Groups for Adolescents With Borderline Personality Disorder (BPD) or Subthreshold BPD Versus Treatment As Usual - the M-GAB Randomized Controlled Trial
Brief Summary: Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in adolescents younger than 18 years according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly shown to be effective in treating adult BPD, but in the case of adolescents, only individual MBT have been tested and found to be effective.

Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As Usual (TAU) in treating adolescents with BPD or subthreshold BPD.

Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up will be at three and 12 months.

Discussion: Early intervention is especially important in relation to personality psychopathology and has long-term benefits for patients, their families and society. In addition to being cost effective, using the group modality in the treatment of BPD may have several advantages. This is the first Randomized Controlled Trial (RCT) to test the effectiveness of MBT in groups for adolescents.


Options:
A: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)
B: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)
C: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)
D: Days/skill (Daily measurements up to 1 year. (minimum 8 months.))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aldosterone-induced Microvascular Dysfunction as a Cause of Salt-sensitivity in Obesity?
Brief Summary: Currently, the incidence of obesity and obesity-related disorders is reaching epidemic proportions, which entails an increasing burden for health care systems. The association of obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such as insulin resistance and hypertension, is often referred to as the metabolic syndrome. During recent years, salt-sensitivity of blood pressure has emerged as an additional cardiovascular risk factor that is related to obesity and other key components of the metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a link between insulin resistance and hypertension in obese individuals. In addition, impairment of microvascular function was found to be associated with salt-sensitivity of blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance. Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but was also found to impair endothelial function and thus lower NO-availability, which is characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are associated with both hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism, but also in the general population.

The investigators hypothesize that increased aldosterone levels in obese individuals lead to impairment of microvascular function through reduction of NO-availability. This microvascular dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive hypertension and insulin resistance.


Options:
A: laser Doppler blood flow (8 weeks)
B: Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
C: Difference in capillary recruitment between low- and high sodium diets (One week low-sodium diet; wash-out period of two weeks; one week high-sodium diet; order of respective diets is randomized)
D: 24-h urinary sodium (4.5 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder
Brief Summary: The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.


Options:
A: Clinician Administered PTSD Scale (CAPS) (Up to 7 months)
B: Change in PTSD symptoms and severity - Clinician-Administered PTSD Scale - 5 (CAPS-5) (The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.)
C: Brain Measures (Brain measures are collected on Visit 3, 14 days from baseline (Visit 1) and Visit 4, 15 days from baseline (Visit 1), for approximately 1.5 hours each day); Expectancy Ratings (Collected on Visit 2, 13 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), and Visit 4, 15 days from baseline, during the task. Each day the task lasted approximately 20 minutes.)
D: Primary sedative dose change (24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multifaceted Depression and Cardiovascular Program for Low-Income Patients
Brief Summary: 1. Implement an evidence-based structured care approach that includes screening; acute treatment and relapse prevention follow-up tailored for public sector clinics and low-income and minority patients.
2. Adapt an evidence-based collaborative care model for primary care, implement the adapted model, evaluate and further refine the model based on the pilot experience, and produce and disseminate a detailed manual for use in public sector clinics.
3. Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to determine: its acceptance by patients, medical providers, and organizational decision-makers; patient depression treatment adherence; its direct cost; and the size and variability of change from baseline in the primary outcome measures: depressive symptoms, functional status, quality of life, health service use, and cardiac status at 6 and 12 month follow-up.


Options:
A: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)
B: Depressive symptoms reduction (Measured at months 6 and 12)
C: Brief Pain Inventory (Pain) (1 year)
D: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multifaceted Depression and Cardiovascular Program for Low-Income Patients
Brief Summary: 1. Implement an evidence-based structured care approach that includes screening; acute treatment and relapse prevention follow-up tailored for public sector clinics and low-income and minority patients.
2. Adapt an evidence-based collaborative care model for primary care, implement the adapted model, evaluate and further refine the model based on the pilot experience, and produce and disseminate a detailed manual for use in public sector clinics.
3. Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to determine: its acceptance by patients, medical providers, and organizational decision-makers; patient depression treatment adherence; its direct cost; and the size and variability of change from baseline in the primary outcome measures: depressive symptoms, functional status, quality of life, health service use, and cardiac status at 6 and 12 month follow-up.


Options:
A: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
B: Hemoglobin A1c (6 months)
C: Depressive symptoms reduction (Measured at months 6 and 12)
D: Health-related Quality of Life - Mental Health Component Score (Change from Baseline in Quality of Life at 12-months); Reduced Mood Disorder Symptoms (Change from Baseline in Mood Disorder Symptoms at 12-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Anti-XA Levels in Post-Cesarean Patients With BMI >35 Undergoing Enoxaparin Thromboprophylaxis With Weight Based Dosing Twice Daily Versus Fixed Dose 40 Milligrams Daily
Brief Summary: Pregnant and recently postpartum women are at significantly higher risk of developing a blood clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot in their lungs known as a pulmonary embolism (PE) compared to their non pregnant counterparts. It is estimated that this risk increases anywhere from 4 to 50 times higher in pregnant versus non-pregnant women and further increases almost 11 fold in the post partum period. This risk is almost doubled when the patient undergoes cesarean delivery. In 2011, the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines stating that for patients undergoing cesarean delivery with additional risk factors for clot or thromboembolism, protective (prophylactic) treatment with low molecular weight heparin (LMWH) a type of blood thinner should be considered. However, no specific guidelines about which risk factors should be considered, or what medication doses should be used were provided. The American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines published in 2012 delineated who should be given prophylaxis based on various risk factors, however acknowledged that the recommendations were based on weak quality evidence.

ACOG endorses either once or twice a day dosing for high risk patients after delivery and states that adjustments for obese women should be made on a case by case basis. However, there are limited studies on the dosing of LMWH in specific subpopulations including post operative patients, pregnant patients and obese patients. All of these studies have urged further investigation of the correct dosing for these high risk subjects due to changes associated with pregnancy and the level of medication in the blood that may put these patients at higher risk of venous thromboembolism. Many previous studies have shown that women in these high risk categories do not achieve protective levels of the medication measured with a laboratory test; anti Xa level. The investigators hypothesize that due to their dual risk, obese post-operative recently pregnant women may not be adequately protected with the daily fixed dose and might need more frequent dosing to protect them.

The objective of this study is to assess what proportion of women achieve the desired anti Xa level with the fixed daily dose versus twice daily weight based dosing (0.5 mg/kg).


Options:
A: Anti Xa Level (3.5-4 hours after the third dose of Lovenox (enoxaparin))
B: The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss) (6 weeks post-partum)
C: Feasibility of Recruitment and Trial Operations. (4 months)
D: pregnancy loss (during first 20 weeks of gregnancy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Brief Summary: Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.


Options:
A: Acceptability and feasibility (3 weeks)
B: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
C: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)
D: Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months (1 year); Mean Change in Sitting Time at Work From Baseline to 12 Months (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Brief Summary: Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.


Options:
A: Incidence of CHD and other lifestyle related diseases after ten years (2012)
B: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)
C: non-exercise activity (Measured constantly during the entire control period and measured constantly during the entire intervention period and the two periods were compared to determine change in non-exercise activity)
D: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Brief Summary: Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.


Options:
A: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)
B: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
C: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend (Baseline-6-9-12 and 18 month)
D: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Brief Summary: Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.


Options:
A: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)
B: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
C: Pain intensity (change from baseline to week 10)
D: Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months (12 and 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Individualized treatMent aPproach for oldER patIents: A Randomized, Controlled stUdy in Type 2 Diabetes Mellitus (IMPERIUM)
Brief Summary: The main purpose of this study is to compare the benefits and risks associated with the use of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM. One strategy is based on the use of oral and injectable medications that only reduce blood sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant.


Options:
A: Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia (Baseline to last participant visit (up to 72 weeks))
B: Change in HbA1c From Baseline to Week 26 (Main Study) (Day 1 (Baseline) and Week 26); Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy) (Day 1 (Baseline) and Week 26)
C: HbA1c (after 26 weeks of treatment)
D: Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS)
Brief Summary: PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).


Options:
A: Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90 (Day 90)
B: Composite of Subsequent Stroke or Death (From randomisation (day 1) to visit 3 (day 30-34))
C: Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2) (Day 1 (Baseline) up to follow-up (28 days after Day 90)); Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2) (Day 1 (Baseline) to Day 90); Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2) (Day 7 (Baseline) up to follow up (28 days after Day 90)); Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2) (Day 90)
D: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)

Answer: A