TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunological and Genomic Effects of an Online Mindfulness Program for Stress Management
Brief Summary: This is a prospective parallel non-blinded randomized study with two arms, an intervention group and an active control group.

Sixty healthy, but stressed nurses will be randomly assigned to either participate in a 6-week internet-based mindfulness meditation program produced by the Cleveland Clinic called Stress Free Now for Healers or to listen to relaxing music for at least 5 minutes a day for 6 weeks, and pre-post comparisons will be made for RNA expression profiles, plasma cytokine concentrations, telomerase activity, 6-point salivary cortisol and several self-reported assessments of physical and mental health.


Options:
A: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)
B: Change from baseline quality of Life (8 weeks and 6 months); Change from baseline burnout symptoms (8 weeks and 6 months)
C: Change in Aggression (baseline, post-intervention (week 8), 3-month followup, 6-month followup)
D: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey.
Brief Summary: The aim of this study is to test the clinical effects of a web and mobile application of guided Problem Solving Therapy for depressive symptoms among the general population in Turkey.


Options:
A: Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group. (3 months)
B: Change on Beck Depression Inventory-II (Screening; baseline, 6-8 weeks after baseline and 4 months after baseline)
C: Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors (24-months post-intervention)
D: Recovery from Common Mental Disorder (defined by ICD10) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Knowledge and Attitude of Dental Interns on Child Abuse After Implementation of Two Educational Modules: A Randomized Control Trial
Brief Summary: 1. Knowledge and attitude of dental interns of the pediatric dental department regarding child abuse recognition and reporting will be assessed 2 times before and after attending one of 2 learning modules ( interactive lecture or online module ) assessment through a questionnaire
2. assessment of the learning experience through a written questionnaire


Options:
A: Percentage of "High Quality" reports of suspected child abuse submitted to the State of Maine by childcare providers (48 months)
B: Clinical behaviour on the A&E department, self-efficacy of the nurse in the detection of child abuse and assessment of the individual performance on screening child abuse. (2-3 months)
C: Questionnaire on Knowledge and Attitude of child abuse (2 questionnaires each for 15 minutes before and after the learning module)
D: Change in knowledge regarding reporting suspected child abuse. (48 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
Brief Summary: The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.


Options:
A: Live Birth (1 year)
B: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
C: Ongoing pregnancy with fetal heart beat at 10 weeks (10 weeks post ET day)
D: implantation rate (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ameliorating the Impact of Complications and Errors on Surgeons: Resilience Training for Surgeons.
Brief Summary: The challenges that characterise surgical practice may result in a myriad of stressors that impact upon the personal and professional lives of surgeons. This includes a high likelihood that surgeons will have to deal with adverse patient outcomes due to surgical complications and errors, sometime during their careers. Such stressors can have undesirable effects on the surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of regret), as well as lowered professional confidence and impaired perceptions of professional competence. Furthermore, there is evidence that these kinds of negative impacts can also lead to burnout and depression. As well as the detrimental effects on surgeons and those around them, this in turn may lead to more errors and poorer outcomes for patients. This study will examine the efficacy of an ACT based training intervention to enhance resilience and psychological flexibility.


Options:
A: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Change in scores on Caregiver Distress (HADS) from baseline (Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].); Change in scores on Caregiver Burden (ZBI-12) from baseline (Baseline [T1], Immediately after completion of the intervention/control protocol [T2], One month post intervention/control protocol [T3], Three months post intervention/control protocol [T4], six months post intervention/control protocol [T5].)
C: Patients' unplanned urgent visits to the health care system. (30 days after discharge)
D: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ameliorating the Impact of Complications and Errors on Surgeons: Resilience Training for Surgeons.
Brief Summary: The challenges that characterise surgical practice may result in a myriad of stressors that impact upon the personal and professional lives of surgeons. This includes a high likelihood that surgeons will have to deal with adverse patient outcomes due to surgical complications and errors, sometime during their careers. Such stressors can have undesirable effects on the surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of regret), as well as lowered professional confidence and impaired perceptions of professional competence. Furthermore, there is evidence that these kinds of negative impacts can also lead to burnout and depression. As well as the detrimental effects on surgeons and those around them, this in turn may lead to more errors and poorer outcomes for patients. This study will examine the efficacy of an ACT based training intervention to enhance resilience and psychological flexibility.


Options:
A: 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)
B: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
C: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)
D: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ameliorating the Impact of Complications and Errors on Surgeons: Resilience Training for Surgeons.
Brief Summary: The challenges that characterise surgical practice may result in a myriad of stressors that impact upon the personal and professional lives of surgeons. This includes a high likelihood that surgeons will have to deal with adverse patient outcomes due to surgical complications and errors, sometime during their careers. Such stressors can have undesirable effects on the surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of regret), as well as lowered professional confidence and impaired perceptions of professional competence. Furthermore, there is evidence that these kinds of negative impacts can also lead to burnout and depression. As well as the detrimental effects on surgeons and those around them, this in turn may lead to more errors and poorer outcomes for patients. This study will examine the efficacy of an ACT based training intervention to enhance resilience and psychological flexibility.


Options:
A: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
B: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
C: MHS heavy use (2 years)
D: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ameliorating the Impact of Complications and Errors on Surgeons: Resilience Training for Surgeons.
Brief Summary: The challenges that characterise surgical practice may result in a myriad of stressors that impact upon the personal and professional lives of surgeons. This includes a high likelihood that surgeons will have to deal with adverse patient outcomes due to surgical complications and errors, sometime during their careers. Such stressors can have undesirable effects on the surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of regret), as well as lowered professional confidence and impaired perceptions of professional competence. Furthermore, there is evidence that these kinds of negative impacts can also lead to burnout and depression. As well as the detrimental effects on surgeons and those around them, this in turn may lead to more errors and poorer outcomes for patients. This study will examine the efficacy of an ACT based training intervention to enhance resilience and psychological flexibility.


Options:
A: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
B: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)
C: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
D: Changes in PTSD symptoms(PCL) (Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat); Probable PTSD diagnosis(CAPS) (Four months after combat)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis
Brief Summary: The investigators perform a case-control study to compare preparation before elective colorectal surgery. The first group is a prospective patient - registry in all patients with mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal surgery. The second group is a historic collective of patients with MBP only and colorectal surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical status classification system, BMI, operative procedure and risk factors.


Options:
A: %/type Surgical wound infections rated per infection classifications of NNIS/CDC (with in 30 days post-op)
B: occurrence of any SSI within 30 days after surgery. (30 days after surgery)
C: Surgical Site Infections (30 days (exact 30 days after the Operation date))
D: Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak (Up to 30 days post operation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth
Brief Summary: Despite the need for consistent adherence to medical care, youth living with HIV have low rates of adherence to medications and treatment. There are few interventions to improve adherence to HIV medications and treatment for youth, and there is a great need for novel approaches that are engaging for this age group. The investigators developed an intervention that includes a mobile gaming app that is integrated with a 7-day electronic medication device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small previous project found that the intervention helped youth who were newly starting medications for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This proposed project will test the intervention with larger number of youth (100) who are newly starting HIV treatment and medications in New England, Georgia, and in Mississippi. The investigators want to determine if adherence is improved and viral load is reduced in this larger sample.


Options:
A: Clinic attendance for pills pick up (six months.)
B: LARC uptake (at time of intervention (baseline (0 weeks))
C: Initiation of Long acting reversible contraception method (6 months)
D: Change from Baseline HIV-1 Viral Load at 48 weeks (48 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth
Brief Summary: Despite the need for consistent adherence to medical care, youth living with HIV have low rates of adherence to medications and treatment. There are few interventions to improve adherence to HIV medications and treatment for youth, and there is a great need for novel approaches that are engaging for this age group. The investigators developed an intervention that includes a mobile gaming app that is integrated with a 7-day electronic medication device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small previous project found that the intervention helped youth who were newly starting medications for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This proposed project will test the intervention with larger number of youth (100) who are newly starting HIV treatment and medications in New England, Georgia, and in Mississippi. The investigators want to determine if adherence is improved and viral load is reduced in this larger sample.


Options:
A: Change from Baseline HIV-1 Viral Load at 48 weeks (48 weeks)
B: Change in ART Adherence - Clever Cap (Up to 6 months)
C: Measles - 2 Completion (When the participants reach 2 years of age)
D: Exclusive breastfeeding duration (Six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multisite Randomized Trial of Battle Viro: A Mobile Gaming App to Improve ART Adherence for Youth
Brief Summary: Despite the need for consistent adherence to medical care, youth living with HIV have low rates of adherence to medications and treatment. There are few interventions to improve adherence to HIV medications and treatment for youth, and there is a great need for novel approaches that are engaging for this age group. The investigators developed an intervention that includes a mobile gaming app that is integrated with a 7-day electronic medication device and text messages. During gameplay, youth fight HIV in colorful organ systems. A small previous project found that the intervention helped youth who were newly starting medications for HIV by improving adherence and decreasing HIV virus in their bodies (viral load). This proposed project will test the intervention with larger number of youth (100) who are newly starting HIV treatment and medications in New England, Georgia, and in Mississippi. The investigators want to determine if adherence is improved and viral load is reduced in this larger sample.


Options:
A: Initiation of Long acting reversible contraception method (6 months)
B: Vaccines received (Electronic Health Record) (up to a year of follow up)
C: Rate of Premature birth (before 37 weeks gestation)
D: Change from Baseline HIV-1 Viral Load at 48 weeks (48 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Randomised Phase III Trial Comparing Atezolizumab Plus Bevacizumab and Standard Chemotherapy Versus Bevacizumab and Standard Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma
Brief Summary: The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. The efficacy (whether the treatment works), safety and tolerability (side effects of treatment) of atezolizumab plus bevacizumab in combination with standard chemotherapy versus bevacizumab in combination with standard chemotherapy will be investigated.


Options:
A: Overall Survival (OS) (From date of randomisation until death from any cause, assessed up to 58 months)
B: Effects on Overall Survival (Minimum follow-up is 24 months after randomisation.)
C: Response Rate (approximately 18 months); Overall Survival Phase 3 Interim Analysis (Approximately 18 months); Overall Survival (18 months)
D: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
Brief Summary: To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).


Options:
A: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)
B: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
C: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 (Baseline (Day 1) and at Week 36)
D: Change in 24-h proteinuria from baseline after treatment (Baseline(week 0), week 4, week 12, week 24, week 36, week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients
Brief Summary: People treated for breast cancer often live with an ongoing fear that the cancer will recur. This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc study is a pilot trial of a brief cognitive behavioural communication intervention, designed to reduce fear of cancer recurrence (FCR) in breast cancer patients. This pilot trial aims to determine the acceptability and practicality of introducing the Mini-AFTERc intervention into everyday practice, and inform the development of a full randomised controlled trial.


Options:
A: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)
B: Fear of Recurrence Level-ACCRE FCR (6-8 weeks after treatment)
C: Patient satisfaction with nurse communication during the Mini-AFTERc intervention (1 week post intervention)
D: Change in FACIT-TS questionnaire score (Baseline, 6 months)

Answer: C