TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)
Brief Summary: This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.


Options:
A: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
B: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
C: Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs (Measured post-treatment and at 6- and 12-month follow-ups); Depression, anxiety, and other psychiatric symptoms (Measured post-treatment and at 6- and 12-month follow-ups); PTSD diagnoses and symptom severity (Measured post-treatment and at 6- and 12-month follow-ups)
D: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)
Brief Summary: This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.


Options:
A: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
B: Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs (Measured post-treatment and at 6- and 12-month follow-ups); Depression, anxiety, and other psychiatric symptoms (Measured post-treatment and at 6- and 12-month follow-ups); PTSD diagnoses and symptom severity (Measured post-treatment and at 6- and 12-month follow-ups)
C: Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). (weeks: 0, 2, 4, 6, 8, 10, 12); Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. (0, 6, 12)
D: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Multi-center Randomized Control Trial of Peripheral Prism Glasses for Hemianopia
Brief Summary: The purpose of this study is to evaluate the functional utility for general mobility (walking) of new high power permanent peripheral prism glasses, which provide visual field expansion device for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes). The efficacy of real peripheral prism glasses will be assessed relative to sham peripheral prism glasses.


Options:
A: Total "dose" of intervention received as a proportion of the scheduled time (10 days over a 2 week period)
B: Overall Proportion Saying "Yes" to Real Prism Glasses (Evaluated after 4 weeks of wearing each type of prism glasses)
C: Total score in a neglect test battery (Change from baseline at Day 8 (post-treatment)); Functional independence score (Change from baseline at Day 8 (post-treatment))
D: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of Rivaroxaban (BAY59-7939) for the Prevention of Stroke and Non-central Nervous System Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation
Brief Summary: This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).


Options:
A: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)
B: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
C: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
D: Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding (Up to 2 days after the last dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of Rivaroxaban (BAY59-7939) for the Prevention of Stroke and Non-central Nervous System Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation
Brief Summary: This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).


Options:
A: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
B: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
C: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
D: Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding (Up to 2 days after the last dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
Brief Summary: The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients.


Options:
A: Resiliency Scale (At 6 months)
B: To establish the efficacy of a new and unique individual, brief intervention called "Dignity Psychotherapy" in enhancing a sense of meaning, purpose and overall well-being for patients with advanced, end stage cancer (7-10 days)
C: Change in symptoms (Functional Assessment of Cancer Therapy General - FACT-G) (Baseline, week 4, week 8); Change in symptoms (Patient Health Questionnaire - PHQ-9 Item) (Baseline, week 4, week 8); Change in symptoms (Generalized Anxiety Disorder - GAD7 Item) (Baseline, week 4, week 8); Change in symptoms (Quality of Life and Satisfaction Questionnaire - Q-LES-Q) (Baseline, week 4, week 8)
D: The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
Brief Summary: The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients.


Options:
A: Mental condition (from baseline until 6 months)
B: Enhanced goal-consistent care (up to 2 years); PEACE (up to 2 years)
C: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)
D: The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
Brief Summary: The purpose of this study was to confirm the efficacy of NB UVB phototherapy in alleviating uremic pruritus and investigate the association between improvement of pruritus and change of serum parameters, including routine biochemical data, immune profile and dialysis adequacy.


Options:
A: Visual Analogue Scale (VAS) Score for Pruritus (VAS score at baseline and after 6 -week phototherapy)
B: Subjective measurement of reduction in pruritus (3 months)
C: VAS change from baseline (the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10))
D: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
Brief Summary: Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with inhaled corticosteroids often requires periodic adjustments to medication dosing and frequency levels. This study examines whether it is more beneficial to adjust corticosteroid treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical guidelines.


Options:
A: symptom-free days (1 year time frame with visits every 3 months)
B: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
C: Change in FENO (2 weeks)
D: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
Brief Summary: Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with inhaled corticosteroids often requires periodic adjustments to medication dosing and frequency levels. This study examines whether it is more beneficial to adjust corticosteroid treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical guidelines.


Options:
A: Change in FENO (2 weeks)
B: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
C: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
D: symptom-free days (1 year time frame with visits every 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
Brief Summary: Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with inhaled corticosteroids often requires periodic adjustments to medication dosing and frequency levels. This study examines whether it is more beneficial to adjust corticosteroid treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical guidelines.


Options:
A: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
B: Rate of Exacerbations Requiring Systemic Corticosteroids (Measured during the 12-month follow-up period)
C: The proportion of upper respiratory tract infections (URTIs) in each group requiring treatment with systemic corticosteroids as confirmed by review of medical records and pharmacy records of prescriptions dispensed.
D: Time to first severe asthma exacerbation

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Non-inferiority Trial Comparing the Nevirapine-based Antiretroviral Therapy Versus the Standard Efavirenz-based ART for the Treatment of HIV-TB Co-infected Patients on Rifampicin-based Therapy (ANRS 12146 CARINEMO)
Brief Summary: The purpose of this study is to determine whether the use of Nevirapine in HIV patients already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as Efavirenz.


Options:
A: Virological suppression at 48 weeks. (5 years)
B: Viral load measure (Virological failure will be defined after 2 consecutive measures as : More than 1 log10 increase in plasma HIV-1 RNA concentration for patients with detectable viral load (> 50 copies/mL) at the previous dosage.) (3, 6 and 12 months)
C: Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy (Dec 2008)
D: To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups (48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to determine the effectiveness of antibiotic therapy for patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.


Options:
A: Clinical efficacy at the end of treatment
B: Additional antibiotic therapy to study medication during treatment period or until the test of cure visit (at day 30) (up to day 30)
C: Number of exacerbations after 48 weeks of intermittent pulse treatment (After 48 weeks of treatment)
D: Number of Patients Who Were Cured (Day 9-11)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan, Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO)
Brief Summary: The Temprano trial is based on the following assumptions:

* ART initiation at CD4 counts \<800/mm3 could significantly reduce the probability of severe HIV-related morbidity or death in the medium term.
* Tuberculosis and tuberculosis-related deaths are likely to represent a considerable proportion of morbidity and mortality among HIV-infected patients with high CD4 counts in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT) and early ART could enhance each others efficacy.


Options:
A: Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) (30 months); prevalence of HIV resistance (ANRS12253 associated study) (30 month after ARV initiation)
B: Receipt of post-test results and counseling following testing completeness (30 days)
C: Percent of Participants Who Survived Without AIDS Progression. (Through week 48)
D: Linkage to care (90 days); Viral suppression (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients
Brief Summary: Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.

Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.


Options:
A: Medication Adherence (12 months); Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause (12 months)
B: Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization (At 12 months)
C: Change in Systolic Blood Pressure (6 months prior to 6 months after the intervention period)
D: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients
Brief Summary: Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.

Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.


Options:
A: Death and/or ESRD defined as need for dialysis or plasma creatinine 500mmol/l (May 2003 - Dec 2007)
B: Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women) (12 months from start of intervention); For patients with diabetes: blood HbA1c at target level (7% or less) (12 months from start of intervention)
C: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
D: Change in Systolic Blood Pressure (6 months prior to 6 months after the intervention period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients
Brief Summary: Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.

Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.


Options:
A: Change in systolic blood pressure (6 months)
B: Change in Systolic Blood Pressure (6 months prior to 6 months after the intervention period)
C: BP at 6 months (6 months)
D: Blood Pressure Change (Measured at Baseline, and 6,12,18,24, and 30 months post baseline.)

Answer: B