TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of the Efficacy of Analytic Oriented Group Psychotherapy for Psychiatric Outpatients
Brief Summary: A primary goal of this study is to investigate the significance of treatment duration, by comparing change after group psychotherapy of varying lengths. A secondary goal is to investigate the predictive value of selected patient variables on outcome: personality pathology, quality of object relations, presence of personality disorder, degree of initial disturbance, and education. One hundred and twenty patients from 5-6 different study sites (consisting of one coordinator and 3 therapists) will be included. Exclusion criteria are psychosis, substance abuse, and organically based symptoms. Patients are interviewed before treatment and one year after termination, and self-rated outcome measures are filled in at 3-month intervals during treatment and at termination. After an initial evaluation, patients are randomized to one of two manualized psychodynamic group psychotherapies with different treatment lengths (20 and 80 sessions). Each therapist will conduct both a short- and a long-term group, and sessions are taped in order to check treatment integrity.


Options:
A: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))
B: Suicide Attempt Behavior (12-month observation period)
C: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
D: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of the Efficacy of Analytic Oriented Group Psychotherapy for Psychiatric Outpatients
Brief Summary: A primary goal of this study is to investigate the significance of treatment duration, by comparing change after group psychotherapy of varying lengths. A secondary goal is to investigate the predictive value of selected patient variables on outcome: personality pathology, quality of object relations, presence of personality disorder, degree of initial disturbance, and education. One hundred and twenty patients from 5-6 different study sites (consisting of one coordinator and 3 therapists) will be included. Exclusion criteria are psychosis, substance abuse, and organically based symptoms. Patients are interviewed before treatment and one year after termination, and self-rated outcome measures are filled in at 3-month intervals during treatment and at termination. After an initial evaluation, patients are randomized to one of two manualized psychodynamic group psychotherapies with different treatment lengths (20 and 80 sessions). Each therapist will conduct both a short- and a long-term group, and sessions are taped in order to check treatment integrity.


Options:
A: 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)
B: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)
C: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
D: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of the Efficacy of Analytic Oriented Group Psychotherapy for Psychiatric Outpatients
Brief Summary: A primary goal of this study is to investigate the significance of treatment duration, by comparing change after group psychotherapy of varying lengths. A secondary goal is to investigate the predictive value of selected patient variables on outcome: personality pathology, quality of object relations, presence of personality disorder, degree of initial disturbance, and education. One hundred and twenty patients from 5-6 different study sites (consisting of one coordinator and 3 therapists) will be included. Exclusion criteria are psychosis, substance abuse, and organically based symptoms. Patients are interviewed before treatment and one year after termination, and self-rated outcome measures are filled in at 3-month intervals during treatment and at termination. After an initial evaluation, patients are randomized to one of two manualized psychodynamic group psychotherapies with different treatment lengths (20 and 80 sessions). Each therapist will conduct both a short- and a long-term group, and sessions are taped in order to check treatment integrity.


Options:
A: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale (Weeks 1-12)
B: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)
C: Zanarini Scale for Borderline personality disorder (ZAN-BPD) (8 weeks)
D: To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or; equal to 18 years of age, with a diagnosis of BPD as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean last observation; carried forward (LOCF) change in the ZAN-BPD; total score in up to 12 weeks of double-blind treatment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation
Brief Summary: The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.


Options:
A: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
B: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
C: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
D: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation
Brief Summary: The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
B: Maximum Tolerated Dose (MTD) of Eltrombopag (1.5 years)
C: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
D: How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation
Brief Summary: The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.


Options:
A: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
B: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
C: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
D: Bleeding within 24 hours after cvc application; other complications within the first 24 hours

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
Brief Summary: The present study is a randomized, controlled trial that investigates the effects of parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality of life (QoL).


Options:
A: N/A
B: Total sleep time (Before and After Intervention)
C: Decrease in arterial stiffness after parathyroidectomy (3 month)
D: postoperative parathyroid hormone level (3 months); ambulatory blood pressure (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial
Brief Summary: We performed a randomized controlled trial to study the effectiveness of Behavioral graded activity (BGA) in patients with OA of the hip or knee. It was hypothesised that in the long term BGA results in less pain, less limitations in activities, and better patient global assessment (i.e. the effect of treatment perceived by patients themselves), compared to usual care of physiotherapists (UC). UC was operationalized as physiotherapeutic care according to the Dutch physiotherapy guideline for patients with hip and/or knee OA. It was also investigated whether specific subgroups of patients benefited more from BGA and which factors influenced the success of BGA-treatment. Also, it will be investigated whether differences exist in exercise adherence and whether there is a relationship between exercise adherence and long-term effectiveness.


Options:
A: Absolute Value of OA Symptoms at 8 Weeks (8 weeks); Absolute Value of OA Pain at 8 Weeks (8 weeks)
B: Pain (week 0, 13, 39 and 65); Physical function (week 0, 13, 39 and 65); Patient global assessment (week 13, 39 and 65)
C: Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks (between baseline and 12 weeks.)
D: Self-reported pain and function (WOMAC)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial
Brief Summary: The purpose of the ALPHA Trial is to examine the physiologic changes that occur in a woman's body when she begins exercising that may be related to a change in her risk of getting breast cancer.


Options:
A: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)
B: Feasibility of a planned Nordic life style intervention (Five years)
C: Changes in estrone, estradiol and adiposity levels (Up to 12 months)
D: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study
Brief Summary: The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.


Options:
A: Cycloplegic autorefraction (Baseline, 6, 12, 18, and 24 months)
B: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
C: the progression of myopia degree, axial length elongation of eye
D: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (Baseline to 3 years); Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study
Brief Summary: The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.


Options:
A: the progression of myopia degree, axial length elongation of eye
B: Myopia progression, measured by cycloplegic autorefraction (Every 6 months)
C: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
D: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (Baseline to 3 years); Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study
Brief Summary: The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.


Options:
A: Changes in uncorrected visual acuity (Baseline, Month 6, Month 12)
B: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
C: Change in the spherical equivalent refractive error relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Change in axial length relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Measurement of corneal curvature (keratometry)relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Remote Simultaneous Medical Interpretation: Medical Outcomes
Brief Summary: All new patients to the general medicine clinic who were not primarily English speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. Patient charts were followed for one year after enrollment to assess medical outcomes, including patient satisfaction, diabetes management, lipid management, depression screening and management, vaccine administration.

All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit and their knowledge of exit instructions was assessed, as well as their satisfaction with care.


Options:
A: Number of participants linked to medical service for dementia measured by medical record verification (6 months)
B: Adherence with care (one year)
C: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months. (Baseline, 6 months, and 12 months)
D: Systolic Blood Pressure (SBP) (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)
Brief Summary: An implantable cardioverter-defibrillator (ICD) is a small device that is surgically implanted in the chest or abdomen and uses electrical pulses or shocks to help control life-threatening, irregular heartbeats. Increasing aerobic exercise may provide health benefits to people with ICDs. This study will examine the effects of an exercise program on heart and lung function in people who have an ICD.


Options:
A: Cardiopulmonary function (Measured at Week 8)
B: Mental Stress Induced Elevation in "Double Product" by Math Stress Task (Immediate to 6 months post intervention); Mental Stress Induced Elevation in Double Product by Math Stress Task (3 months post intervention); Mental Stress Induced Elevation in "Double Product" by Anger-recall Task (Immediate to 6 months post intervention)
C: Quality of life (3 -6-12 month); Physical capability (3-6-12 month)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Arrhythmic Effects of Exercise After an Implantable Cardioverter Defibrillator (ICD)
Brief Summary: An implantable cardioverter-defibrillator (ICD) is a small device that is surgically implanted in the chest or abdomen and uses electrical pulses or shocks to help control life-threatening, irregular heartbeats. Increasing aerobic exercise may provide health benefits to people with ICDs. This study will examine the effects of an exercise program on heart and lung function in people who have an ICD.


Options:
A: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
B: Cardiopulmonary function (Measured at Week 8)
C: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
D: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Recovery After Cardiac Surgery
Brief Summary: Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of depression, and depression is associated with higher risk of complications and death. Recent discoveries show that depression involves changes in certain molecules in the blood, which are also involved in progressive coronary artery disease (CAD) and its complications. This study will evaluate the effects of cognitive behavioral therapy (CBT) as a treatment for depression on these biological markers among CABG patients.


Options:
A: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)
B: Levels of proinflammatory cytokines (IL-1 and IL-6) (at baseline and after 8 weeks (at the completion of the intervention)); The soluble receptor for IL-6 (sIL-6) (at baseline and after 8 weeks (at the completion of the intervention)); Inflammatory markers c-reactive protein (CRP and sICAM-1) (at baseline and after 8 weeks (at the completion of the intervention))
C: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
D: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)
Brief Summary: "Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.

Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.

One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "


Options:
A: Overall Survival (Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.)
B: Progression free survival (June 2009)
C: Overall Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)
D: Recurrence-Free Survival (RFS) (24 months after last participant was randomized (data cutoff date of 30 April 2019))

Answer: B