TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Tunneled Dialysis Catheters Versus Non-tunneled Dialysis Catheters for Renal Replacement Therapy in the ICU
Brief Summary: The investigators propose a randomized controlled trial to examine whether tunneled dialysis catheters should be first-line for acute kidney injury requiring renal replacement therapy (AKI-RRT) in the critical care setting, barring any clinical contraindications, compared to non-tunneled access. This randomized controlled trial will include patients admitted to an intensive care unit (ICU) at Brigham and Women's Hospital (BWH). The investigators will randomize all eligible consented incident patients with AKI requiring renal replacement therapy either to tunneled dialysis catheter or non-tunneled dialysis catheter placement. The inclusion criteria encompasses all adult patients in the BWH ICUs with an incident AKI requiring renal replacement therapy. The investigators' hypothesis is that the rate of overall complications is lower with tunneled dialysis catheters compared to non-tunneled catheters.


Options:
A: Rate of complications (Up to 60 days)
B: Survival at 2 weeks after RRT (2 weeks after RRT in follow-up)
C: the time of 1st membrane exchange (the time of 'filter is clotted')
D: mortality (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Brief Summary: To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.


Options:
A: Retention in care with viral suppression (48 weeks after HIV testing)
B: increase TB case detection (6 months)
C: Treatment time (Up to 8 weeks)
D: Time to TB treatment initiation (8 weeks follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Brief Summary: To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.


Options:
A: All-cause mortality (8 weeks)
B: increase TB case detection (6 months)
C: Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. (week 0); Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. (week 0); Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. (week 0)
D: Time to TB treatment initiation (8 weeks follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Brief Summary: To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.


Options:
A: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay (Day 1)
B: TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) (Twelve months after treatment assignment); TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) (Twelve months after treatment assignment); Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen (Regimen 1 2HRZE/4HR) Compared to Experimental Regimens, Regimen 3 (2HPZM/2HPM) and Regimen 2 (2HPZ/2HP) (Safety Analysis Population) (Four months and up to 14 days after last does of after study treatment (Regimen 2 and 3) or Six months and up to 14 days after last does of after study treatment (Regimen 1))
C: increase TB case detection (6 months)
D: Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 6 Months After the End of Treatment. (6 Months post End of Treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Brief Summary: To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.


Options:
A: increase TB case detection (6 months)
B: Time to TB treatment initiation (8 weeks follow up)
C: Rates of TB treatment initiation (48 hours)
D: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Brief Summary: To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.


Options:
A: increase TB case detection (6 months)
B: All-cause mortality 12 weeks after inclusion (12 weeks)
C: Retention in care with viral suppression (48 weeks after HIV testing)
D: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay (Day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Brief Summary: To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.


Options:
A: Treatment time (Up to 8 weeks)
B: Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. (week 0); Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. (week 0); Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. (week 0)
C: increase TB case detection (6 months)
D: Time to TB treatment initiation (8 weeks follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
Brief Summary: To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.


Options:
A: Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS. (Day 1); Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS. (Day 1); Diagnostic yield, with 95% confidence interval, of FujiLAM test among eMRS positive patients and AlereLAM, Smear and Ultra (sputum, urine) as comparators (on Day 1 specimens). (Day 1)
B: Treatment time (Up to 8 weeks)
C: increase TB case detection (6 months)
D: All-cause mortality (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
Brief Summary: In this trial, women with history of recurrent urinary tract infections (UTIs) will be followed over the course of 6 months. The women will be randomized either to D- Mannose or Placebo.

The primary objective of this study is to investigate if treatment with D-mannose reduces the risk for a UTI recurrence compared to treatment with Placebo.

H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same number of recurrent UTIs over the course of 6 months compared to women treated with Placebo.

H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer recurrent UTIs over the course of 6 months compared to women treated with Placebo.


Options:
A: Culture proven, symptomatic urinary tract infection (UTI) (3 months); Recruitment rate (Through study recruitment, an average of 1 year); Retention rate (3 months); Adherence (3 months)
B: Days (168)
C: UTI Recurrence (Variable for each participant over course of up to one year)
D: Frequency of UTIs (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
Brief Summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.


Options:
A: 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)
B: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
C: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
D: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale (Weeks 1-12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
Brief Summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.


Options:
A: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
B: Functioning Assessment Scale Test (FAST) (up to three years)
C: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
D: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
Brief Summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.


Options:
A: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
B: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
C: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
D: Perceived Stress (3 months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER
Brief Summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
C: To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or; equal to 18 years of age, with a diagnosis of BPD as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean last observation; carried forward (LOCF) change in the ZAN-BPD; total score in up to 12 weeks of double-blind treatment.
D: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Brief Summary: Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria


Options:
A: Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP (Baseline and Week 16)
B: Growth of Geographic Atrophy (6 months); Decrease in Drusen Volume (6 Months)
C: N/A
D: Growth rate of geographic atrophy (GA) lesion area from baseline (Month 18)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Addiction Model Based Mobile Health Weight Loss Intervention With Coaching in Adolescents With Overweight and Obesity: Multi-Site Randomized Controlled Trial
Brief Summary: The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching and second as an identical approach phone-coaching alone intervention compared to age matched controls participating in an in-clinic weight management interventions in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18). One hundred and eighty adolescents will be recruited from pediatric interdisciplinary weight management clinics operating out of five different hospital systems in Southern California and through targeted mailing to 40 ethnically, racially and economically diverse neighborhoods in Los Angeles County. The adolescents will be randomized 1:1 via stratified block randomization to either receive 1) interactive addiction model based mobile health (mHealth) weight-loss intervention with personalized phone-coaching (AppCoach), 2) interactive addiction model based mHealth weight-loss intervention alone (App) or 3) Multidisciplinary in-clinic weight management program (Clinic). Assessment of the intervention's effect on zBMI and percent over the 95th percentile (%BMIp95), fasting metabolic parameters, addictive eating habits, executive function, and motivation for change will be obtained at enrollment, 3, 6, 12 and 18 months (1 year post intervention follow up).


Options:
A: %BMIp95 (6 months)
B: Patients' subjective assessment of usability of the PRECIOUS system (At the end of the test (Session 5, week 12)); Satisfaction with the PRECIOUS system (At the end of the test (Session 5, week 12)); User's acceptance of the PRECIOUS system (At the end of the test (Session 5, week 12)); Effectiveness of the PRECIOUS system (At the end of the test (Session 5, week 12))
C: Weight change (Baseline - 12 months)
D: Change in body mass at 12 weeks (12 weeks from baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying
Brief Summary: The purpose of this research study is to conduct a pilot randomized controlled trial of a game-based intervention is able to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the feasibility and acceptability of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors among SGM youth; and (2) Using a randomized controlled trial, test the efficacy of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among SGM youth.


Options:
A: Acceptability: follow-up survey (5 months); Feasibility: recruitment and retention rates (5 months)
B: Drug use (Baseline, 3 months, 6 months)
C: Number of Participants With Changes in Help Seeking Scores (Baseline and 1-month post intervention)
D: Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) (7 months post enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Laid-back Breastfeeding Approach on Breastfeeding Initiation in Hospital Setting. A Randomized Controlled Trial
Brief Summary: The so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF), a new neurobehavioral approach to breastfeeding (BF), has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. BN focuses on facilitating the mother to breastfeed in a relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. This position opens up the mother's body and promotes baby's movements through the activation of 20 primary neonatal reflexes stimulating BF. Neurophysiological studies show that, through this approach, infants instinctively know how to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to instinctively activate the same reflexes.

The main objective of this study is to assess the effectiveness of LB BF compared to standard hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at discharge.


Options:
A: Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey (Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017)
B: Infant Feeding Questionnaire (4 weeks)
C: Breast problems (Within 7 days of birth, at discharge from hospital)
D: proportion of patients with breastfeeding completed at 6 months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
Brief Summary: Background and objective:

There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. The only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. The school is the most appropriate environment for such an intervention. The main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. The project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits.

Methodology:

A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). Participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. The primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score. Secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. Participants will be measured again when they reach 20 years old.

Expected results:

The investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among Spanish adolescents, including obesity/adiposity and metabolic profiles. If successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. Additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.


Options:
A: Change in the prevalence of overweight and obesity (Baseline, Month 9)
B: Improvement of maximal oxygen uptake
C: Change from baseline in physical activity as assessed by Actigraph accelerometer (Baseline, 6 months and 1 year)
D: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)

Answer: D