TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Prehospital Delay in Acute Myocardial Infarction
Brief Summary: This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.


Options:
A: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)
B: change from baseline in perceived health status at six months (baseline and six months)
C: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
D: time from ACS symptom onset to admission to emergency department (two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Prehospital Delay in Acute Myocardial Infarction
Brief Summary: This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.


Options:
A: Change in number of emergency department revisits 90 day pre and 90 days post enrollment. (90 days); Change in the number of hospitalizations (90 days); Change in the length of stay (in days) (90 days); Mortality rate (90 days)
B: Number of Participants Returning to the ED Within 30 Days of the Original ED Visit (30 days after emergency department discharge); Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care (Medical records reviewed for number of participants who followed up within 7 and 30 days, augmented by participant surveys at day 4 and 30 to learn about non-University of Wisconsin hospital visits); Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge (up to 30 days)
C: Rates of stillbirth (36 months)
D: time from ACS symptom onset to admission to emergency department (two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Emergency Department CT Scanning for Appendicitis: IV Contrast vs. IV and Oral Contrast
Brief Summary: The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency department. A secondary purpose will be to design a specific CT for appendicitis protocol at our institution at the conclusion of this study.


Options:
A: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis (Up to 10 years)
B: Negative Appendectomy (1 week after surgery)
C: sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. (immediate reading + blinded reading within 48 hours)
D: rate of intra abdominal infections in both therapeutic strategies (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on Women's Substance Abuse Treatment
Brief Summary: The purpose of this study is to examine the efficacy of a gender-focused addiction treatment model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model (12-Step Facilitation) in a sample of women Veterans with substance use disorder.


Options:
A: Addiction Severity Index Alcohol Composite (Baseline, end of treatment (month 3), 3-month post-treatment follow-up); Addiction Severity Index Drug Composite (Baseline, end of treatment (3 months), and 3-month post-treatment followup); Brief Addiction Monitor (Baseline, end of treatment (month 3), 3-month post-treatment follow-up)
B: The Percentage of Opiate- and Cocaine-negative Urine Samples (1 year); The Percentage of Participants Who Are Employed (1 year)
C: Change in Cocaine Use by Self Report (12 weeks); Change in Cocaine Use by Urine Toxicology Results (12 weeks)
D: Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months (Baseline, 1 month, 3 month and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded Placebo Controlled Clinical Trial
Brief Summary: This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.


Options:
A: Urinary Tract Infections (three weeks post-operative)
B: To assess the effects of maternal obesity on the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery. (6 weeks)
C: Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence (6 weeks); Incidence of Post-operative UTI in Placebo Group (6 weeks); Incidence of Post-operative UTI in Treatment Group (6 weeks)
D: A change in number of cured patients (Up to 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.


Options:
A: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
B: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks (Baseline and 1, 2, 3 and 4 weeks)
C: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)
D: Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase (2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
Brief Summary: Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.


Options:
A: cessation of convulsions within 10 minutes of the initial administration of the study drug and a sustained absence of convulsions for 30 minutes from the initial administration of the study drug. (30 minutes)
B: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given (Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).)
C: Cessation of all clinical seizure activity within 10 min of drug administration (10 min)
D: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Brief Summary: The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.


Options:
A: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)
B: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment (Baseline and Week 6)
C: Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 (Baseline to Week 8)
D: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment. (Baseline and Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Brief Summary: Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.


Options:
A: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) (Week 12); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1) (Week 12); Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) (Up to Week 12); Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) (Up to Week 12)
B: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)
C: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
D: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Brief Summary: Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.


Options:
A: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
B: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
C: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Brief Summary: Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.


Options:
A: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
B: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
C: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Brief Summary: Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 (Week 16)
B: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)
C: Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16 (Week 16)
D: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone-based Intervention for Patients With COPD and Their Caregivers
Brief Summary: This study is an NIH-funded clinical trial conducted at Duke University Medical Center and Ohio State University. The purpose of this study is to examine the effects of a telephone-based, care-giver assisted, coping skills training (CST) program in patients with Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD patients and their caregivers to deal better with the stress of lung disease. This study will test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality of life compared to a Usual Medical Care plus COPD education and symptom management control group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater survival and fewer COPD-related physician visits or hospitalizations) compared to Controls over a follow-up period of up to 4 years; and 3) That improvements in quality of life and survival will be mediated by increased functional capacity and better coping.

This proposed study builds upon our prior research by: a) adapting and refining our CST protocol, which was effective in improving psychosocial adjustment in patients awaiting lung transplantation, to a broader population of patients with COPD who are not immediate candidates for lung transplantation; b) enhancing our intervention to improve functional capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on medical expenditures; and d) including caregivers in an enhanced CST intervention.


Options:
A: Change From Baseline in Inspiratory Capacity (IC) at Isotime (baseline, six weeks of treatment)
B: Proactive tool (clinical visit version) (7 days)
C: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)
D: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone-based Intervention for Patients With COPD and Their Caregivers
Brief Summary: This study is an NIH-funded clinical trial conducted at Duke University Medical Center and Ohio State University. The purpose of this study is to examine the effects of a telephone-based, care-giver assisted, coping skills training (CST) program in patients with Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD patients and their caregivers to deal better with the stress of lung disease. This study will test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality of life compared to a Usual Medical Care plus COPD education and symptom management control group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater survival and fewer COPD-related physician visits or hospitalizations) compared to Controls over a follow-up period of up to 4 years; and 3) That improvements in quality of life and survival will be mediated by increased functional capacity and better coping.

This proposed study builds upon our prior research by: a) adapting and refining our CST protocol, which was effective in improving psychosocial adjustment in patients awaiting lung transplantation, to a broader population of patients with COPD who are not immediate candidates for lung transplantation; b) enhancing our intervention to improve functional capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on medical expenditures; and d) including caregivers in an enhanced CST intervention.


Options:
A: Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition. (6, 12 and 18 months post baseline)
B: We will assess the primary measures of effectiveness (control of blood pressure) in the clinic at baseline and 6 months, for both the usual care plus IVR arm and usual care arm alone. (6 months of follow-up)
C: Participation in exercise (weekly minutes of exercise) at 6 months.
D: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone-based Intervention for Patients With COPD and Their Caregivers
Brief Summary: This study is an NIH-funded clinical trial conducted at Duke University Medical Center and Ohio State University. The purpose of this study is to examine the effects of a telephone-based, care-giver assisted, coping skills training (CST) program in patients with Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD patients and their caregivers to deal better with the stress of lung disease. This study will test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality of life compared to a Usual Medical Care plus COPD education and symptom management control group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater survival and fewer COPD-related physician visits or hospitalizations) compared to Controls over a follow-up period of up to 4 years; and 3) That improvements in quality of life and survival will be mediated by increased functional capacity and better coping.

This proposed study builds upon our prior research by: a) adapting and refining our CST protocol, which was effective in improving psychosocial adjustment in patients awaiting lung transplantation, to a broader population of patients with COPD who are not immediate candidates for lung transplantation; b) enhancing our intervention to improve functional capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on medical expenditures; and d) including caregivers in an enhanced CST intervention.


Options:
A: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
B: Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm (Measured at 6 months post 'index-hospitalization'); Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm (Baseline to 6 months post index-hospitalization)
C: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)
D: Percentage of patients who completed the program (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). (2 years)
B: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
C: CGI scale for use in borderline personality disorder (CGI-BPD) (12 weeks)
D: Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Service Utilization at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Suicidality at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: N/A
B: 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)
C: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
D: Days/skill (Daily measurements up to 1 year. (minimum 8 months.))

Answer: C