TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans
Brief Summary: The study was conducted between April 2013 and October 2014. In the parent study, 600 foreign-born Asian American adults 18 years of age and older were drawn from the community in the Baltimore Washington Metropolitan Area. Using a non-probability sampling method, foreign-born Asian American adults, 18 years of age and older, were recruited from the community.

After providing informed consent, all the participants were asked to complete a self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the assistance of a bilingual interviewer when necessary. Then, all of the participants were instructed and given 5 to 10 to minutes to read culturally integrated and linguistically appropriate educational material (e.g., Photo novel) developed and validated for efficacy from a prior study.

All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600 completed the survey and screening. A week later, they received the results of the screening test. Based on the screening results, all participants were categorized into three groups: (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We sent the results by mail to participants who were unprotected and protected. Among those 600 screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335 (55.8%) had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were susceptible to HBV infection (unprotected).

LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were randomly assigned to either the intervention (n=124) or the control (n=108) groups by computer-automated random assignment. Randomization was used to assure equivalence between groups on key factors that may potentially influence the outcome of HBV vaccinations: gender, age, education, length of stay in the U.S.

LHWs conducted phone interventions by reminding participants of a series of vaccinations at months 1, 2, and 5 among those assigned to the intervention group. Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments. Seven months after mailing the results, those unprotected were followed up by phone to ask about their status of the series of vaccinations and about promoters or barriers to vaccinations.


Options:
A: Participant attends cervical cancer screening (Within 7 months of the intervention)
B: Overall Screening Adherence (12 months)
C: Change of Activities of Daily Life (ADL) (change from baseline at 6 months and 1 year); Change of Sense of Coherence (KASAM) (change from basline at 6 months and 1 year)
D: self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records (Seven months after mailing the results)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans
Brief Summary: The study was conducted between April 2013 and October 2014. In the parent study, 600 foreign-born Asian American adults 18 years of age and older were drawn from the community in the Baltimore Washington Metropolitan Area. Using a non-probability sampling method, foreign-born Asian American adults, 18 years of age and older, were recruited from the community.

After providing informed consent, all the participants were asked to complete a self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the assistance of a bilingual interviewer when necessary. Then, all of the participants were instructed and given 5 to 10 to minutes to read culturally integrated and linguistically appropriate educational material (e.g., Photo novel) developed and validated for efficacy from a prior study.

All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600 completed the survey and screening. A week later, they received the results of the screening test. Based on the screening results, all participants were categorized into three groups: (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We sent the results by mail to participants who were unprotected and protected. Among those 600 screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335 (55.8%) had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were susceptible to HBV infection (unprotected).

LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were randomly assigned to either the intervention (n=124) or the control (n=108) groups by computer-automated random assignment. Randomization was used to assure equivalence between groups on key factors that may potentially influence the outcome of HBV vaccinations: gender, age, education, length of stay in the U.S.

LHWs conducted phone interventions by reminding participants of a series of vaccinations at months 1, 2, and 5 among those assigned to the intervention group. Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments. Seven months after mailing the results, those unprotected were followed up by phone to ask about their status of the series of vaccinations and about promoters or barriers to vaccinations.


Options:
A: new immunization doses (within 60 days of reminder notification)
B: self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records (Seven months after mailing the results)
C: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)
D: Receipt of 2nd Dose of the Influenza Vaccine. (by April 30th after receipt of first dose (up to 8 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
Brief Summary: This phase II trial studies how well cabozantinib s-malate, crizotinib, savolitinib, or sunitinib malate work in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib s-malate, crizotinib, savolitinib, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving cabozantinib s-malate, crizotinib, or savolitinib will work better in treating patients with kidney cancer compared to sunitinib malate.


Options:
A: Progression Free Survival (PFS) (From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years)
B: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
C: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
D: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)); Overall Survival (OS) (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectivity of Differences Therapies on Central Nerve System for Pain, Phantom, Disability and Quality of Life in Amputees
Brief Summary: This study evaluates the effectiveness of imagery motor on phantom pain and amputation process


Options:
A: Numerical Rating Scale (NRS) (Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months)
B: Change from Baseline in Knee Joint Symmetry at 6 weeks (Baseline and at 6 weeks); Change from Baseline in Gait Speed (m/s) at 6 weeks (Baseline, at 3 weeks and at 6 weeks); Change from Baseline in Gait Variability at 3 weeks and 6 weeks (Baseline, at 3 weeks and at 6 weeks); Change from Baseline in Trunk Lean on the Prosthetic versus Non-Prosthetic Side of the Body (measured in degrees) at 6 weeks. (Baseline and at 6 weeks)
C: Quality of Life measured of individuals: SF-36 Scale (10 minute); Balance Test (5 minute); Performance Test (6 minute); Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale (5 minute); Gait Parameters (6 minute)
D: 2 Minute Walk to assess walking speed and endurance improvement (Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up); Change in Two Minute Walk Test from baseline (Post-Intervention (1 month from Baseline)); Change in two minute walk test from 1 month assessment (Follow-Up (3 weeks from post-intervention))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Breathe Well Program to Improve Asthma Outcomes
Brief Summary: The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness, cost-effectiveness, and implementation of the Breathe Well intervention, which combines evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care to improve asthma outcomes.


Options:
A: Asthma Exacerbations (12 months)
B: Asthma-related morbidity (Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
C: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
D: Product Evaluation (Once per module (One Evaluation per week for seven weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX)
Brief Summary: MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt (SA), in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter controlled randomized trial (East of France) and there is a funding from the Hospital. The proposal trial will test the hypothesis that adolescent suicide attempters who are receiving SMS (or mail or other new media) from the unit of care in addition to the usual care will do less SA recurrence, than those who are receiving the usual care.

The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.


Options:
A: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
B: Acceptability of Lethal Means Decision Aid (Baseline); Decision Making Quality in Emergency Department (ED) (Baseline); Home Firearm Storage (Baseline and 1 week follow up); Decision Making Quality - Follow up (1 week follow up); Suicidal Ideation and Behavior at One Month (1 month post baseline); Suicidal Ideation and Behavior at Three Months (3 months post baseline); Vital Statistics (Suicide death) (3 months post baseline)
C: Clinical changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neural changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy. (4 months)
D: Delay of recurrence of suicide attempt (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX)
Brief Summary: MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt (SA), in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter controlled randomized trial (East of France) and there is a funding from the Hospital. The proposal trial will test the hypothesis that adolescent suicide attempters who are receiving SMS (or mail or other new media) from the unit of care in addition to the usual care will do less SA recurrence, than those who are receiving the usual care.

The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.


Options:
A: Repeat Suicide Attempts (1, 2, and 3 months)
B: Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Number of Participants With Readmissions (Assessed on a monthly basis for 6 months follow-up.)
C: Delay of recurrence of suicide attempt (6 months)
D: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Dexamethasone and Ibuprofen on Postoperative Pain Prevention and Control Following Surgical Implant Placement: a Double-Blind, Parallel-Group, Placebo-Controlled Randomized Clinical Trial
Brief Summary: Background and aim: Postoperative pain is an adverse effect of oral surgeries and may therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant placement.

Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized clinical trial, 117 dental implants were placed. The groups received three different protocols 1 hour before surgery:

1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or
3. placebo.

Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate scale, hourly for the first 8 hours after surgery and three times a day on the following 3 days.


Options:
A: Number of Participants With Level 3 Postoperative Hemorrhage (Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.)
B: Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) (From 0 hour up to 8 hours post-dose)
C: Change in faces pain score pre and post intervention (48 hours from the time of discharge from hospital.)
D: The visual analog scale (VAS) was used to measures levels of pain. (8 hours-time)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy
Brief Summary: The investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis.


Options:
A: the incidence of Roux stasis syndrome (3 month after surgery)
B: Reflux of bile content (6 months after surgery)
C: The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery); change of potential of hydrogen ( pH) in remnant stomach (1-6 days after surgery); the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery)
D: Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis (0-5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study
Brief Summary: This is a prospective, comparative randomized study. Our study population includes women with pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy.

The two groups will include the study group, who will have their Foley catheter removed 6 hours post-op, and the control group who will have an indwelling Foley catheter overnight. The two groups will be assigned according REDCap randomization system.


Options:
A: Urinary retention (6 hours after discharge from PACU)
B: Number of Participants With Void Trial Failure Rate (post-operative day, about 4 hours post-surgery)
C: time to micturition (first 24 hours after spinal anesthesia)
D: how many patients do need replacement of a catheter because of urine retention in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy (6-8 hours after removal of catheter)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Guided Versus Directed Training in Acute Stroke Rehabilitation
Brief Summary: Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.


Options:
A: Change From Baseline in Performance Quality Rating Scale (PQRS) (A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline))
B: Change in Reintegration to Normal Living Index score (Baseline, average of 14 weeks, and 6 months)
C: The main primary outcome measure is change in the degree of participation measured by the Stroke Impact Scale (SIS, version 2.0.). (At baseline, post intervention and at 3 and 6 months after completion of the intervention period.)
D: Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time (Baseline, rehab discharge, month 3, month 6, month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Inflammatory and Stress Response in the Pathogenesis of Cognitive Dysfunction After Cardiac Surgery
Brief Summary: Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac surgery. This prospective study was conducted to investigate the mechanisms of development of POCD following cardiac surgery taking into account surgical technique (with use or no use of extracorporeal circulation). The investigators focused on the role of inflammatory and stress response to surgical procedure as potential factors involved in the pathogenesis of cognitive dysfunction. Systematic inflammatory response in patients undergoing on-pump or off-pump surgery was analyzed by measuring serum levels of C reactive protein (CRP) and occurrence of systemic inflammatory response syndrome (SIRS). Stress response to surgery was evaluated following cortisol levels and its daily variations. The degree of cognitive dysfunction was assessed based on serum levels of S100β. The effect of dexamethasone on the levels of stress and inflammatory response biomarkers, serum levels of S100β, as well as on the development of POCD was compared with control group that received normal saline.


Options:
A: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
B: Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery. (36 hours)
C: immunologic markers, health care related quality of life, PTSD (one and a half year)
D: Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests (9 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Community Trial of Physical Activity Intervention in Primary Healthcare to Improve Cardiovascular Risk Factors and Health-Related Quality of Life in Older Adults
Brief Summary: Community intervention trial, randomized, to promote regular PA and social and cultural support activities for 9 months in older-adult primary care users and assess their effects on cardiovascular risk factors and health-related quality of life.


Options:
A: Six minute walking distance (3 months); New York Heart Association (NYHA) functional class (3 months)
B: Change of intrahepatic triglyceride contents (12 months)
C: Physical activity level (At the begining of the intervention and after 9 months.); Cardiovascular risk. (At the begining of the intervention and after 9 months); Biochemical analysis. (At the begining of the intervention and after 9 months.); Antropometric measurements. (At the begining of the intervention and after 9 months.); Frequency of food consumption (At the begining of the intervention and after 9 months.); Health related quality of life (At the begining of the intervention and after 9 months.)
D: Resting systolic blood pressure (3 Months)

Answer: C