TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)
Brief Summary: In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.


Options:
A: Change in PTSD symptom severity with the PSS-I the Post-traumatic Stress Disorder Scale- Interview (PSS-I) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Attraction to violence with the Appetitive Aggression Scale (AAS) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Methylation Pattern of the Glucocorticoid Receptor promoter region via saliva samples (8, 18 and 25- month follow-up); Change in Self-committed violence with the AAS offense list (8, 18 and 25- month follow-up); Influence of Social Acknowledgement with Social Acknowledgement Questionnaire (SAQ) (8, 18 and 25- month follow-up); Influence of drug abuse related to violence on number of offenses with the offense checklist (from the AAS) (8, 18 and 25- month follow-up); Change in Epigenetic Markers (methylation patterns) of violence in the androgen receptor promoter region via saliva samples (8, 18 and 25- month follow-up)
B: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)
C: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)
Brief Summary: In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.


Options:
A: PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder (pre-treatment, 1 month post, 6 months follow up)
B: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)
C: CAPS-CA (10 days, 2 months, 6 months after intervention); CBCL (10 days, 2 months, 6 months after intervention); DIKJ (10 days, 2 months, 6 months after intervention)
D: depression (pre, post and 6 months post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)
Brief Summary: In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.


Options:
A: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
B: Depressive disorder and suicidality (Q3 2016 after an average of 1.5 years of follow-up)
C: Self-Reporting Questionnaire 20 (SRQ-20) (Two months)
D: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
Brief Summary: The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.


Options:
A: Percentage of Subjects in Clinical Remission at Week 6 (Week 6)
B: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
C: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374))
D: The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth (Day 0)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Subjects With Heterozygous Familial Hypercholesterolemia (The ENHANCE Trial)
Brief Summary: The purpose of the study is to determine whether ezetimibe plus simvastatin will be more effective than simvastatin alone in preventing progression of atherosclerosis of the inner layer of the carotid artery.


Options:
A: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) (Baseline, 3 Months)
B: Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis (Measured at baseline and 24 Months)
C: Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. (24 months)
D: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination With Cetuximab in Patients With Advanced Biliary Cancer.
Brief Summary: A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.


Options:
A: Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months (4 months)
B: objective response rate (baseline and every 8 weeks)
C: Progression-free survival [PFS] (approx. 25 months)
D: Progression Free Survival (every 6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania
Brief Summary: This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and trichotillomania.

Trichotillomania is an impulse control disorder. There is growing evidences of the involvement of dopaminergic neurotransmission in the pathophysiology of trichotillomania. Reported increase in the prevalence of ADHD among patients with impulse control disorders, such as pathological gambling as well as trichotillomania, may result from the overlapping pathophisiological background. It is hypothesized that in cases of ADHD comorbid with trichotillomania methtylphenidate treatment will exhibit beneficial effects in both the ADHD and the hair pulling.


Options:
A: Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) (Week 12)
B: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania (First 6 weeks of treatment)
C: Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score (Subjects were followed for their duration of participation in the study (12-weeks))
D: Massachusetts General Hospital Hairpulling Scale (Baseline and final visit after 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania
Brief Summary: This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and trichotillomania.

Trichotillomania is an impulse control disorder. There is growing evidences of the involvement of dopaminergic neurotransmission in the pathophysiology of trichotillomania. Reported increase in the prevalence of ADHD among patients with impulse control disorders, such as pathological gambling as well as trichotillomania, may result from the overlapping pathophisiological background. It is hypothesized that in cases of ADHD comorbid with trichotillomania methtylphenidate treatment will exhibit beneficial effects in both the ADHD and the hair pulling.


Options:
A: N/A
B: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania (First 6 weeks of treatment)
C: NCBRF-TIQ D-Total Score (Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA) (Day 0, Day 45, Day 180, Day 210 and Day 365)
B: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 (4 weeks postdose 3 (Month 7))
C: Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (One month after the third vaccine dose); Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies (One month after the third vaccine dose)
D: Primary Objective Part 1 (Measured after Month 7); Primary Objective Part 2 (At 18, 24 and 36mths post dose 1); Primary Objective Part 2 (Measured at 36 mths)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus (STN) Using the ANS Totally Implantable Deep Brain Stimulation System as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication.
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately controlled with medication.


Options:
A: Assessment of balancing behaviour by sinusoidal translation of the supporting platform. (4 weeks); The Mini-Balance Evaluation Systems Test (4 weeks); Assessment of gait performance by baropodometry (4 weeks); Timed Up and Go Test (TUG) (4 weeks)
B: 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) (Baseline, Week 8); 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) (Baseline, Week1)
C: Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias (90 days)
D: frequency and severity of adverse events, active vs placebo (Every two weeks during dosing (week 0 to week 12) and weekly thereafter for 2 weeks following cessation of dosing); measure of impulse control (rMIDI), active vs placebo (at screening and 4 weeks, 10 weeks, 12 weeks and 14 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes
Brief Summary: The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS).


Options:
A: Release of troponin evaluated by the peak of troponin during the hospital phase (during the hospital phase)
B: Net Adverse Clinical Event (30-day)
C: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
D: Composite of Death, Myocardial (re-) Infarction, or Stroke (180 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Heart Health Program: Randomized, Controlled Trial
Brief Summary: Background: Family members (spouses, siblings, offspring) of patients with coronary heart disease (CHD) may themselves be at increased risk for developing CHD for genetic, biochemical and/or behavioural reasons. Targeted approaches aimed at family members of those with established CHD may be a cost-effective way to identify high-risk persons and link them to effective risk factor modification. During pilot testing we found 29% of family members of patients recently hospitalized at our institution had ≥ 3 CHD risk factors. Encouragingly, they indicated high levels of "readiness" to change underlying risk behaviours such as cigarette smoking and physical inactivity. We have developed a 12-week family heart health program featuring a personal plan for achieving risk factor goals and weekly contact with a heart health educator. This intervention needs to be fully tested.

Research Aims:

In this study, we will:

1. Compare the effects of a targeted family heart health (FHH) screening, counselling and follow-up program versus usual care (UC) for reducing participants total cholesterol/high density lipoprotein (TC/HDL) ratio 52 weeks after program entry, in family members of patients recently hospitalized with CHD;
2. Compare the effects of the FHH program versus UC on modifiable components comprising the Framingham score, including: smoking status; systolic blood pressure; total cholesterol; and high density lipoprotein cholesterol;
3. Compare the effects of the FHH program versus UC on: lifestyle-related factors (dietary patterns, leisure time exercise, body composition); medication use (anti-lipemic medications, anti-hypertensive medications, pharmacotherapies for smoking cessation); and use of healthcare resources (physician visits, hospitalization days, number of laboratory and diagnostic tests and procedures).


Options:
A: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
B: smoking cessation (12 months)
C: Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols (Measured at baseline, 6, 12, and 24 months); Hemoglobin A1c (Measured at baseline, 6, 12, and 24 months)
D: TC/HDL ratio (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of an Antimicrobial Utilization Program on Antimicrobial Use in a Large Public Hospital: A Randomized Controlled Trial
Brief Summary: Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective mechanism for improving antimicrobial use, but data on their efficacy remain limited. The researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a teaching hospital when compared to the standard of care (no AUT intervention).

Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.

Patients: Patients admitted to internal medicine ward teams who were prescribed selected antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the 10month study period.

Intervention: Eight internal medicine ward teams were randomized monthly to academic detailing by the AUT while 8 internal medicine ward teams were randomized indication-based prescription of broad spectrum antimicrobials.

Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).


Options:
A: mortality/survival (28 day)
B: Reduce concomitant orders for warfarin and tmp/smx (7 months)
C: Proportion of Appropriateness of Antimicrobial Prescriptions in each group. (10-month period)
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Brief Summary: A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.


Options:
A: SF-36 (12 months follow-up)
B: Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both (Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months)
C: 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)
D: HbA1c (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Brief Summary: A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.


Options:
A: Rehospitalization rate at 30, 90 and 180 days after index hospitalization.
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: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence
Brief Summary: The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.


Options:
A: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use (weekly for 14 weeks of trial or for length of participation); ADHD Symptoms Based on ADHD Rating Scale (measured once per week for 14 weeks or length of study participation)
B: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
C: Urinalysis negative for cocaine over 10 weeks (10 weeks); Adverse events (10 weeks); Compliance (10 weeks); Retention (10 weeks)
D: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)

Answer: A