TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery
Brief Summary: This study will be a retrospective study. The patient data from the electronic medical records and existing database will be collected and analyzed. Primary endpoints will be postoperative mortality (within 30 days) and overall complications and length of hospital stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia, ischemia, stroke, neurological complications, length of ICU stay, re-admission rate, infections, pulmonary complications, length of intubation time, length of ventilation time, and acute renal failure.


Options:
A: N/A
B: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
C: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
D: hemodynamic changes (In hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: INTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders
Brief Summary: Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. In this view, stressful experiences are conceptualized as person-environment transactions, whose result is dependent on the impact of the external stimulus. This is mediated by the person's appraisal of the significance of the stimulus, of the personal, social and cultural resources available and of the efficacy of the coping efforts.

Extreme levels of stress can have a negative influence on one's professional life and can disrupt both the social and personal life of an individual. Stress can also cause different physiological and psychological disorders such as anxiety, chronic headaches, depression, withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.

Stress Management Therapy can help to overcome counter effects of stress. Usually various techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated approach covering both stress management and stress treatment is the Cognitive Behavioral Therapy (CBT) approach.

The trouble with stress is that it is very personal. Thus, stress-related disorders depend a great deal on how the person experiencing a stressor is put together -psychologically and physically. So the focus for assessment, prediction and treatment has to be the person's situated experience.

To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging physical and virtual world.

From the clinical point of view the INTERSTRESS solution may offer the following innovations to current traditional protocols for stress management:

* Objective and quantitative assessment of user's stress level using biosensors and behavioral analysis;
* Provision of warnings and motivating feedbacks to improve self awareness, compliance and long term outcome;
* Decision Support System (DSS) for treatment planning through data fusion and detection algorithms.


Options:
A: Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI) (five weeks); quality of life questionnaire (5 weeks); psychophysiological measures (heart rate and heart rate variability indexes) (5 weeks)
B: Rate of participant recruitment (1 year); Rate of retention (1 year); Completeness of data entry (1 year); Cost of interventions (1 year); Unexpected costs (1 year)
C: change in self reported Stress symptoms (Baseline, 1 month, 3 months)
D: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Screening, Brief Intervention, and Referral to Treatment for Offenders
Brief Summary: The purpose of the study is to determine whether SBIRT is an effective intervention with inmates and to estimate the costs of providing SBIRT to this population.


Options:
A: A reduction in the use of drugs and alcohol (12 months)
B: Number of Case Management Sessions Completed (6-month follow-up)
C: Service Cascade: % Referred to Substance Use Treatment (120 weeks); Staff Perception: Value of Evidenced Based Substance Use Treatment (120 weeks)
D: Graduation from juvenile drug court (Collected once at 12 months from intake/baseline.); Change in substance use (Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline); Change in delinquency (Baseline, and then at 6, 12, 18, and 24 months after baseline); Change in Mental health symptoms (Baseline, 6, 12, 18 and 24 months after baseline); Change in Family functioning (Baseline, 6, 14, 18, and 24 months after baseline); Length of treatment (Collected once, at 12 months after baseline); Change in arrests (12 months before intake through 24 months after intake); Change in substance use (Intake, 6, 12, 18, 24 months after intake); Change in substance use (Intake, 6, 12, 18 and 24 months after intake)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Screening, Brief Intervention, and Referral to Treatment for Offenders
Brief Summary: The purpose of the study is to determine whether SBIRT is an effective intervention with inmates and to estimate the costs of providing SBIRT to this population.


Options:
A: Acceptability (Study months 21 through 34)
B: A reduction in the use of drugs and alcohol (12 months)
C: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)
D: Relapse (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 Followed by MVA85A in BCG Vaccinated Adults (TB032)
Brief Summary: This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their ability to stimulate an immune response within the body. It is hoped that when these two vaccines are given in sequence, the combined immune response is even better than when each vaccine is used individually.


Options:
A: Safety of MVA85A (Six months)
B: Percentage of Participants With Adverse Events (Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.)
C: Safety of AERAS-402 followed by MVA85A (3 months after final vaccination)
D: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each immunisation (and after 7 days).

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up : the "INCARD" Study
Brief Summary: Treatment of chronic heart failure requires multidisciplinary approaches with a recognized role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional, decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of this disease. After recovery from the acute phase of cardiac infarction, patients admitted to the rehabilitation center will follow the usual rehabilitation program during the hospitalization period. This step precludes outpatient follow-up period in our day hospital, in accordance with their physicians and cardiologists who manage the monitoring. The study INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the benefits of a sustainable rehabilitation heart failure on patients treated optimally and educated during a follow-up period of 24 months. The main objective of the study will be to compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients for each evaluation time point, periodically recorded


Options:
A: Change in VO2max every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change in Left ventricular ejection fraction every 6 months over the 24 months of outpatient follow-up (every 6 months over the 24 months of outpatient follow-up); Change on 6-min walk test every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on Minnesota index of quality of life every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on heart rate every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on systolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on diastolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on body mass index every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on creatine clearance every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up)
B: functional capacity (6 months)
C: Exercise Capacity (20 weeks)
D: change in 6 minute walk test (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on the Effect of Sino-implant (II) Use on Condom Use Among Women in Kingston, Jamaica
Brief Summary: This unblinded, randomized controlled trial (RCT) among women to determine:

1)if unprotected sex as measured prostate-specific antigen (PSA) will be more among women who receive a contraceptive implant immediately at baseline during three months of follow up compared to women who receive the implant at the three month follow-up visit.


Options:
A: LNG Steady State at Baseline and Then Post-randomization (baseline (2 months) and post-randomization (4 months))
B: Prostate-specific antigen (PSA) (3 months)
C: Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS (Participants will receive counseling before admission and at 12 months after)
D: insulin resistance (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone
Brief Summary: The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth.

In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone.

The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group.

In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.


Options:
A: Parenting practices (One month and six months post-intervention)
B: Change in Child Protection (Baseline, 12 months, 24 months); Change in Exposure to Child Abuse (Baseline, 12 months, 24 months)
C: 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)
D: Percent of Participants Who Develop Major Depression and Anxiety Disorders (One year); General Health Questionnaire (GHQ) Scores (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone
Brief Summary: The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth.

In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone.

The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group.

In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.


Options:
A: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)
B: score on Harvard Trauma Questionnaire (at the main study) (before and after the treatment,an expected average of 7 weeks of EMDR treatment); Impact of Event Scale Revised (at the pilot study and the main study) (pre- and post treatment)
C: 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)
D: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone
Brief Summary: The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth.

In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone.

The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group.

In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.


Options:
A: PTSD symptoms (Measured before and after treatment and Months 6 and 12 of follow-up); Anxiety (Measured before and after treatment and Months 6 and 12 of follow-up); Depression (Measured before and after treatment and Months 6 and 12 of follow-up); Behavior (Measured before and after treatment and Months 6 and 12 of follow-up)
B: Change in adolescent mental health symptoms (baseline, 4 month followup, and 12 month followup); Change in parent mental health symptoms (baseline, 4 month followup, 12 month followup); Change in parent-child conflict (baseline, 4 month followup, 12 month followup); Change in parent-child relationship quality (baseline, 4 month followup, 12 month followup)
C: 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)
D: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone
Brief Summary: The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth.

In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone.

The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group.

In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.


Options:
A: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
B: depression (pre, post and 6 months post treatment)
C: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone
Brief Summary: The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth.

In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone.

The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group.

In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.


Options:
A: Mental health symptoms (6 weeks); Idiographic problems (6 weeks)
B: 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)
C: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
D: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women
Brief Summary: As intrauterine contraception is an increasingly popular form of contraception the objective of our study is to examine if uterine size or posture affects the insertion or use of intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.


Options:
A: The effect of uterine size or posture on IUD insertion. (Day 1)
B: Mean Pain Score During IUD Insertion (Day 1)
C: Change in Pain From Baseline to IUD Insertion (change in pain score from baseline (before IUD insertion) to time of IUD insertion)
D: Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) (Immediately post IUD insertion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.
Brief Summary: The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.


Options:
A: Number of Participants With Procedural Success (30 Days)
B: Hierarchical Composite of Stroke, Myocardial Infarction, and Death (30-day post-procedure)
C: Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. (0 to 365 days)
D: Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. (30 days and 4 years)

Answer: B