TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation the Effect of Fumaria Parviflora L. on Uremic Pruritus of End-stage Renal Disease Patients: A Randomized Double- Blind Placebo-controlled Clinical Trial
Brief Summary: The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.


Options:
A: Change from Baseline in Detailed score proposed by Duo for pruritus (Change from Baseline in Detailed score at 1months)
B: The changes in pruritus symptoms assessed by VAS (Week0, week1-12, Week 14)
C: Severity of Pruritis as measured by a visual analogue scale (VAS) (3 months)
D: pruritus (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Virtual Reality Based Training on Posture Stability in Individuals With Parkinson's Disease
Brief Summary: The present study is to examine the effects of a virtual reality based balance training using the Kinect sensor on postural stability and functional balance in individuals with Parkinson's disease.


Options:
A: Level of Physical Activity based on the LAPAQ questionnaire (Average of 6, 12, 18 and 24 months)
B: Limits of stability test (Change from Baseline at 8 weeks); One-leg stance test (Change from Baseline at 8 weeks)
C: Parkinson's Disease Quality of Life Questionnaire (PDQL) (8 months); AMC Linear Disability Score (ALDS) (8 months)
D: UNIFIED PARKINSON'S DISEASE RATING SCALE (08/2011 (up to 2 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Simulation-based Education for Managing Stress in ICU Nurses
Brief Summary: I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined as the presence of job strain as defined by Karasek.

II. Main secondary outcomes

* ICU nurses stress at one year
* Burnout
* Intent-to-leave the ICU
* Quality of life

III. Design

Prospective, randomized, open study comparing 2 groups of ICU nurses:

Simulation group and Control group

Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to take into account differences between the ICUs regarding organization, activity, patients...).

This study is observational because nurses can participate to this training when they want. The fact that nurses are in control group delays their participation to this training but does not forbid them to particpate. The nurses from control group will participate to training at the end of study.

IV. Specific measures Control group: none

Simulation group: 5-day specific training with dedicated scenario done by an ICU expert simulation team

V. Study duration 48 months

VI. Ethical aspects - Reglementary concerns

* Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de l'Informatique et des Libertés (CNIL)
* Information to the participants prior inclusion

VII. Study population Job strain evaluated in a French study was 59% . The same rate was observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We therefore hypothesized that the intervention (simulation) should be able to reduce the job strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this study needs to include 185 patients per arm. To take into account few participants who will not complete the study, we aimed to include a total of 400 ICU nurses.

VIII Results An interim analysis will be performed after 200 inclusions


Options:
A: Presence of job stain evaluated by the French version of the Karasek scale (6 months)
B: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
C: Acceptability/Satisfaction of Intervention as assessed by Client Satisfaction Questionnaire (CSQ-8) scores to yield a homogeneous estimate of general satisfaction. (At the end of 12 week intervention)
D: Change in physician burnout from baseline to 6-month follow-up (Will be measured at baseline and 6-month follow-up); Change in physician burnout from baseline to 15-month follow-up (Will be measured at baseline and 15-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System: Multi-site Implementation Study
Brief Summary: This is a multi site experiment to evaluate the impact of various strategies for increasing the use of evidence based screening, assessment and linkage to substance use treatment. All sites collect baseline data and receive a core intervention. Half are then randomly assigned to get an additional year of coaching to facilitate implementation.


Options:
A: Number of Case Management Sessions Completed (6-month follow-up)
B: Primary Outcome Measure (3 years)
C: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
D: Service Cascade: % Referred to Substance Use Treatment (120 weeks); Staff Perception: Value of Evidenced Based Substance Use Treatment (120 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System: Multi-site Implementation Study
Brief Summary: This is a multi site experiment to evaluate the impact of various strategies for increasing the use of evidence based screening, assessment and linkage to substance use treatment. All sites collect baseline data and receive a core intervention. Half are then randomly assigned to get an additional year of coaching to facilitate implementation.


Options:
A: 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)
B: Service Cascade: % Referred to Substance Use Treatment (120 weeks); Staff Perception: Value of Evidenced Based Substance Use Treatment (120 weeks)
C: Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time (1, 3, 6, and 12 months post-release from incarceration); Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form (30 days post-release from incarceration)
D: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient and Provider Engagement and Empowerment Through Technology (P2E2T2) Program to Improve Health in Diabetes
Brief Summary: The overall goal of this proposal is to enhance the supports and resources available to patients with diabetes to assist them to achieve their health goals. The investigators will evaluate an innovative program that uses nurse health coaching, motivational interviewing techniques, wireless sensors and mobile health (mHealth) technology. In this program, patients will receive timely, tailored nurse coaching feedback to facilitate behavior change using mHealth technology, thus bridging bidirectional exchange of meaningful information among patient, nurse coach and provider. The investigators will conduct a randomized controlled trial among patients receiving chronic disease management at the University of California Davis(UC Davis) Primary Care Network. The patients who are eligible for inclusion in the study will be randomized to one of two arms of the trial: 1) Usual care (Care Coordination) administered by UC Davis Health Management and Education; or 2) the Patient and Provider Engagement and Empowerment through Technology (P2E2T2) Program to Improve Health in Diabetes. The hypothesis is that patients in the P2E2T2 arm of the study will be more engaged in identifying and achieving health goals related to their diabetes and will achieve better health outcomes compared to patients receiving usual care.


Options:
A: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
B: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))
C: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
D: Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline (Baseline); Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF) (3 months); Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 9-months (9-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient and Provider Engagement and Empowerment Through Technology (P2E2T2) Program to Improve Health in Diabetes
Brief Summary: The overall goal of this proposal is to enhance the supports and resources available to patients with diabetes to assist them to achieve their health goals. The investigators will evaluate an innovative program that uses nurse health coaching, motivational interviewing techniques, wireless sensors and mobile health (mHealth) technology. In this program, patients will receive timely, tailored nurse coaching feedback to facilitate behavior change using mHealth technology, thus bridging bidirectional exchange of meaningful information among patient, nurse coach and provider. The investigators will conduct a randomized controlled trial among patients receiving chronic disease management at the University of California Davis(UC Davis) Primary Care Network. The patients who are eligible for inclusion in the study will be randomized to one of two arms of the trial: 1) Usual care (Care Coordination) administered by UC Davis Health Management and Education; or 2) the Patient and Provider Engagement and Empowerment through Technology (P2E2T2) Program to Improve Health in Diabetes. The hypothesis is that patients in the P2E2T2 arm of the study will be more engaged in identifying and achieving health goals related to their diabetes and will achieve better health outcomes compared to patients receiving usual care.


Options:
A: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
B: Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline (Baseline); Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF) (3 months); Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 9-months (9-months)
C: Treatment Adherence (10 months)
D: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Web-based Computer-tailored Intervention on Workplace Sitting: a Randomized Controlled Trial
Brief Summary: A theory-driven, web-based, computer-tailored advice to influence sitting at work was developed. The study investigated the effects of this computer-tailored intervention to influence workplace sitting on behavioural measures.


Options:
A: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)
B: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
C: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
D: Incidence of CHD and other lifestyle related diseases after ten years (2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Web-based Computer-tailored Intervention on Workplace Sitting: a Randomized Controlled Trial
Brief Summary: A theory-driven, web-based, computer-tailored advice to influence sitting at work was developed. The study investigated the effects of this computer-tailored intervention to influence workplace sitting on behavioural measures.


Options:
A: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
B: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)
C: Average steps per day (6 weeks)
D: Reduced total time spend sitting at work (1 month); Reduced number of prolonged siting periods (>30 min) (1 month); Increased number of breaks from sitting time (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB
Brief Summary: Cardiac surgery has evolved considerably after the advent of cardiopulmonary bypass (CPB), a feature that allowed more precision and tranquility to the heart surgeon. But their influence on exacerbation of inflammatory response can unbalance the whole homeostasis so happens surgical trauma. The attenuation of the systemic inflammatory response in major surgeries like cardiac surgery for aortic aneurysm appears to represent an important advance in reducing morbidity and mortality of these patients. Some studies suggest that inhaled anesthetics such as sevoflurane appear to play an important role in this control, but the mechanism by which this happens is still unclear. This study has the primary purpose of analyzing from a clinical study sevoflurane inhalation anesthetic can change the inflammatory response induced by CPB, significantly reducing the release of inflammatory markers, especially elastase PMN.


Options:
A: Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb (24h after surgery)
B: Post operative atrial fibrillation detected on continuous ECG monitoring. (Monitoring will commence soon after surgery and will be continued until the end of post operative day 5); Myocardial injury assessed by Troponin release (Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery)
C: Reduction of systemic inflammatory response (Through study completion, an average of 1 year)
D: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation
Brief Summary: The Growing Resilience research leverages reservation-based assets of land, family, culture, and front-line tribal health organizations to develop and evaluate home food gardens as a family-based health promotion intervention to reduce disparities suffered by Native Americans in nearly every measure of health. Home gardening interventions show great promise for enabling families to improve their health, and this study aims to fulfill that promise with university and Wind River Indian Reservation partners. The investigators will develop an empowering, scalable, and sustainable family-based health promotion intervention with, by, and for Native American families and conduct the first RCT to assess the health impacts of home gardens.


Options:
A: Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study (Baseline to two years); Change in Physical Activity (Baseline to two years); Change in Reported Added Sugar Intake (Baseline to two years); Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes) (Baseline to two years); Change in BMI Z-score (Baseline to two years); Change in HOMA-IR (Baseline to two years)
B: Adult BMI change (Change from baseline at 2 years)
C: standardized body mass index (zbmi)
D: Change in Body Mass Index From T1 to T3 (T1 (Baseline) to T3 (9 months-post baseline)); Change in Total Body Weight From T1 to T3 (T1 (baseline) to T3 (9-month post baseline)); Change in Pounds of Body Fat From T1 to T3 (T1 ( Baseline) to T3 (9-months post baseline))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
Brief Summary: This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
B: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
C: Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 (Week 16)
D: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
Brief Summary: This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
B: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
C: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 (At Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 (At Week 16)
D: Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline (Baseline to Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy
Brief Summary: InterFast is a Cohort study with an embedded randomized controlled pilot trial. Study participants will be healthy subjects and subjects who already practice Alternate Day Fasting. The trial will include 100 participants (50 Participants in Alternate Day Fasting group and 50 participants in the control group). Those participants in the control group will be asked to participate in a short randomized controlled trial, where they will be either allocated to an Alternative Day Fasting group or another control visit.


Options:
A: Change in body weight (Baseline and weeks 2, 4 and 8)
B: Insulin Sensitivity (HOMA-IR) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (QUICKI) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (ISI-Index) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (Matsuda-Index) (4 weeks (from Baseline to 4 weeks))
C: Changes in body weight (Kilograms) (Baseline and 16 weeks); Change in insulin resistance (Baseline and 16 weeks)
D: Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months (Every 6 months- baseline, 6 month and 12 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial
Brief Summary: The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment parallel to radiation therapy in oncological patients. The trial is designed as a two-armed trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy, thereafter weekly until the end of radiotherapy; the follow-up visits include clinical workup as well as questionnaires.


Options:
A: Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy (Up to 2 years)
B: proctitis and cystitis (3 years)
C: Effect of Soy Isoflavones on Serum Testosterone Levels. (Two weeks)
D: Quality of Life (6 weeks after completion of radiotherapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
Brief Summary: To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%


Options:
A: Intraocular Pressure (IOP) (Study treatment was administered for 28 days, and outcome measures collected on Day 29)
B: Intraocular Pressure (IOP) (3 months)
C: Change in Intraocular Pressure (IOP) Over Nocturnal Time Period (Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9)
D: Intraocular Pressure (from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Brief Summary: To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.


Options:
A: All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) (1 year)
B: The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access (1 year)
C: All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability (24 months)
D: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)

Answer: A