TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children with Severe Pneumonia in High Tuberculosis Burden Countries
Brief Summary: Despite progress in reducing tuberculosis (TB) incidence and mortality in the past 20 years, TB is a top ten cause of death in children under 5 years worldwide. However, childhood TB remains massively underreported and undiagnosed, mostly because of the challenges in confirming its diagnosis due to the paucibacillary nature of the disease and the difficulty in obtaining expectorated sputum in children.

Pneumonia is the leading cause of death in children under the age of 5 years worldwide. There is growing evidence that, in high TB burden settings, TB is common in children with pneumonia, with up to 23% of those admitted to hospital with an initial diagnosis of pneumonia later being diagnosed as TB. However, the current World Health Organization (WHO) standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. Hence, TB is often under-diagnosed or diagnosed late in children presenting with pneumonia.

In this context, the investigators are proposing to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra, performed on NPAs and stool samples, to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples.

TB-Speed Pneumonia is a multicentric, stepped wedge diagnostic trial conducted in six countries with high TB incidence: Cote d'Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia.

The sub-study on Covid-19 will assess the prevalence and impact of the Covid-19 in young children hospitalized with severe pneumonia. The sub-study findings are expected to guide policy makers and clinicians on potential specific screening and management measures for these vulnerable groups of children. They are also key to analysing TB-Speed Pneumonia results on mortality in a context of the Covid-19 outbreak and to take into consideration SARS-CoV-2 infection status in the main study analysis.


Options:
A: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
B: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)
C: All-cause mortality 12 weeks after inclusion (12 weeks)
D: All-cause mortality (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children with Severe Pneumonia in High Tuberculosis Burden Countries
Brief Summary: Despite progress in reducing tuberculosis (TB) incidence and mortality in the past 20 years, TB is a top ten cause of death in children under 5 years worldwide. However, childhood TB remains massively underreported and undiagnosed, mostly because of the challenges in confirming its diagnosis due to the paucibacillary nature of the disease and the difficulty in obtaining expectorated sputum in children.

Pneumonia is the leading cause of death in children under the age of 5 years worldwide. There is growing evidence that, in high TB burden settings, TB is common in children with pneumonia, with up to 23% of those admitted to hospital with an initial diagnosis of pneumonia later being diagnosed as TB. However, the current World Health Organization (WHO) standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. Hence, TB is often under-diagnosed or diagnosed late in children presenting with pneumonia.

In this context, the investigators are proposing to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra, performed on NPAs and stool samples, to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples.

TB-Speed Pneumonia is a multicentric, stepped wedge diagnostic trial conducted in six countries with high TB incidence: Cote d'Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia.

The sub-study on Covid-19 will assess the prevalence and impact of the Covid-19 in young children hospitalized with severe pneumonia. The sub-study findings are expected to guide policy makers and clinicians on potential specific screening and management measures for these vulnerable groups of children. They are also key to analysing TB-Speed Pneumonia results on mortality in a context of the Covid-19 outbreak and to take into consideration SARS-CoV-2 infection status in the main study analysis.


Options:
A: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
B: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))
C: All-cause mortality (8 weeks)
D: All-cause mortality 12 weeks after inclusion (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients
Brief Summary: Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.


Options:
A: Proportion of patients reaching remission (6 months)
B: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)
C: Recruitment (From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.); Participation (1-36 hours after family meeting); Retention (3 months)
D: Recruitment Rate (Up to one year from when the study starts enrolling participants)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prediction and Outcome Study in PTSD and (Borderline) Personality Disorders
Brief Summary: The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder (BPD).


Options:
A: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
B: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
C: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
D: Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008). (Baseline and 1, 3, and 6 month follow-up assessments)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prediction and Outcome Study in PTSD and (Borderline) Personality Disorders
Brief Summary: The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder (BPD).


Options:
A: Days/skill (Daily measurements up to 1 year. (minimum 8 months.))
B: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)
C: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
D: CAPS-5 (Clinician Administered PTSD Scale) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prediction and Outcome Study in PTSD and (Borderline) Personality Disorders
Brief Summary: The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder (BPD).


Options:
A: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
B: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)
C: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)
D: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prediction and Outcome Study in PTSD and (Borderline) Personality Disorders
Brief Summary: The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder (BPD).


Options:
A: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
B: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
C: Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale (Weeks 1-12)
D: Symptom Checklist 90

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Stress Management Program on Occupational Stress Among Public Health Centers Nurses in Jordan
Brief Summary: The present study is designed to focus on examining the effectiveness of the stress management program on occupational stress and coping strategies among public health centers nurses in Jordan.

the Specific Objectives that will guide this study are as follow:

1. To assess the level of occupational stress among Jordanian public health nurses who work in comprehensive health care centers.
2. To find out the association between nurses' occupational stress scores and their selected demographic variables.
3. To identify the sources of occupational stress encountered among public health centers nurses in the work setting.
4. To identify the types of coping strategies utilized by Jordanian nurses working in comprehensive health care centers.
5. To evaluate the effectiveness of stress management program on occupational stress mean score among experimental and control groups at baseline, post-test and at two months' follow-up assessment.
6. To evaluate the effectiveness of stress management program on coping strategies mean score among experimental and control groups at baseline, post-test and at two months' follow-up assessment.

This experimental study will examine differential changes in two dependent variables: occupational stress and coping strategies of public health nurses after participation in experiment. Experimental Group will participate in a stress management program and control group will not receive any intervention. The null hypotheses that guide this study are:

1. Null hypothesis (H0_1): There is no significant difference in occupational stress mean score between experimental and control groups at baseline, post-intervention and at two months' follow-up assessment. (µ1 = µ2).
2. Null hypothesis (H0_2): There is no significant difference in coping strategies mean score between experimental and control groups at baseline, post-intervention and at two months' follow-up assessment. (µ1 = µ2).


Options:
A: Changes in subjective symptoms of well-being at work (baseline, 4 weeks, 8 weeks); Changes in subjective symptoms of stress (baseline, 4 weeks, 8 weeks)
B: 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)
C: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
D: Occupational stress will be measured by Nursing stress scale (NSS) "change is being assessed" (Occupational stress will be measured to assess the change between pre-test and up to 2 months post-test); coping skills will be measured by The Brief Coping Orientations to Problems Experienced (COPE) Scale "change is being assesses" (Coping strategies will be measured to assess the change between pre-test- and up to 2 months post-test)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immediate Effects and Safety of High-frequency Chest Wall Oscillation Compared to Airway Clearance Techniques in Non-hospitalized Infants With Acute Viral Bronchiolitis
Brief Summary: Bronchiolitis (BQ) is the acute viral infection of the tract respiratory syndrome in infants that affects the bronchioles of babies under 24 months of age. Respiratory physiotherapy (RF) appears as a treatment measure complementary in the clinical guidelines and consensus on the management of the BQ.


Options:
A: Reduction of Kristjansson Respiratory Score (Baseline; after two weeks of treatment)
B: Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate (obtention)
C: Wang clinical severity scale (12 weeks)
D: Occurrence of chest retractions as a measure of respiratory distress (30 minutes); Occurrence of wheezing as a measure of respiratory distress (30 minutes); Number of nasal bleeding events as a measure of adverse effects (1 day); Number of vomit episodes as a measure of adverse effects (1 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness of Nicotine Patch With Gum Versus Nicotine Patch Alone in Smoking Cessation in Hong Kong Primary Care Clinics
Brief Summary: The prevalence of cigarette smoking has dropped to 10% in Hong Kong (HK) in 2017, however, smoking still kills 5700 persons per year. Studies suggest that abstinence rates are higher with combined NRT than single NRT, although local data on safety and benefits of combined NRT are lacking.

This is a one-year, two-arm, parallel randomized trial in 20 HK public clinics. The aim is to compare the effectiveness of combined NRT with single NRT among HK Chinese. 560 chronic smokers, who smoked ≥10 cigarettes/day for ≥ 1 year, were randomized to either intervention or usual care.

Intervention group received counseling and nicotine patch \& gum. Usual care group received counselling and nicotine patch only. Primary outcome was smoking abstinence rate at 52 weeks. Secondary outcomes included smoking abstinence rate at 4, 12, \& 26 weeks. Crude odds ratio (combined NRT vs. single NRT) and p-value were reported from logistic regression without adjustment; for trend analysis, adjusted odds ratio (AOR) and p-value were reported from Generalized Estimating Equation (GEE) (controlling for time). All AORs were adjusted for age, sex, baseline CO and clusters.


Options:
A: 7-day point-prevalence abstinence rate at 52 weeks after quit date (at 52 weeks after the agreed quit date)
B: Quit Rate (Study weeks 6 through 9)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Two Treatment, Two Period, Chronic Dosing (4 Weeks), Crossover, Multi-center Pilot Study to Evaluate the Effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Brief Summary: This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.


Options:
A: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)
B: Mean Change From Baseline in Post-dose Trough FEV1 (Baseline, 26 weeks)
C: FEV1 AUC0-4 (at Week 24); Change From Baseline in Morning Pre-dose Trough FEV1 (at Week 24)
D: Specific Image-based Airway Volume (siVaw) (Baseline, Day 29); Specific Image-based Airway Resistance (siRaw) (Baseline, Day 29)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Expanded Criteria Donors in Liver and Kidney Transplantation: Protocol of a Randomised Single Center Clinical Trial of Hypothermic Oxygenated Perfusion Versus Static Cold Storage
Brief Summary: With the present study the investigators will evaluate the benefit of end-ischemic HOPE on ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a recently developed machine perfusion (MP) device, from the beginning of back-table procedures till implantation, without increasing CIT. The aim of the study will be demonstrating the ability of HOPE to improve graft function and post-operative outcomes of ECD kidney and liver recipients.


Options:
A: Participants With Early Liver Allograft Dysfunction (EAD) (7 days); Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient (30 days)
B: Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery (Day 7)
C: Early graft injury (During the first week postoperatively (absolute and relative delta))
D: Liver Transplant - Early allograft dysfunction (EAD) (0-30 days after procedure); Kidney Transplant- Delayed graft function (DGF) (0-30 days after procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
Brief Summary: The aim of this study is to

Determine whether cerclage with vaginal progesterone will:

1. Reduce the overall spontaneous preterm birth rate.
2. Prolong pregnancy latency.
3. Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening.

Research question:

Does cervical cerclage reduce the overall spontaneous preterm births in patients with progressive cervical shortening.

Research Hypothesis In this current study, the investigators hypothesize that cervical cerclage reduces spontaneous preterm births in patients with progressive cervical shortening on vaginal progesterone only.


Options:
A: Gestational age at delivery (3-6 months)
B: The frequency of spontaneous abortion before 28 weeks (14 weeks)
C: Gestational age of delivery (<37 weeks)
D: Preterm delivery (Less than 34 weeks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Traditional Technique Peripheral Intravenous [PIV] Catheter Insertion to the Utilization of Ultrasound Guidance for the Development of a Vein Classification System and Difficult IV Insertion Algorithm. A Prospective Observational Study
Brief Summary: Hypothesis The initial use of ultrasound guidance when indicated for difficult peripheral IV access will reduce the number of attempts required to achieve successful peripheral IV insertion and improve patient care and satisfaction.


Options:
A: length of use of the catheter measured in number of days (seven days)
B: Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique (9 months after patient recruitment begins)
C: Length of canalization (Four weeks); Number of punctures (Four weeks); Phlebitis (Four weeks)
D: First pass success (1 day); Number of attempts (1 day); Overall success (1 day); Time to completion (1 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Traditional Technique Peripheral Intravenous [PIV] Catheter Insertion to the Utilization of Ultrasound Guidance for the Development of a Vein Classification System and Difficult IV Insertion Algorithm. A Prospective Observational Study
Brief Summary: Hypothesis The initial use of ultrasound guidance when indicated for difficult peripheral IV access will reduce the number of attempts required to achieve successful peripheral IV insertion and improve patient care and satisfaction.


Options:
A: Duration of IV Survival (30 days)
B: Overall success rate of IV placement (Up to 30 minutes)
C: Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique (9 months after patient recruitment begins)
D: Number of Participants with Successful Securing of Peripheral Vein on First Attempt (60 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis
Brief Summary: FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active Ulcerative Colitis.


Options:
A: Asses Endoscopic Stages of the Colon Pre/Post FMT (2 years); Asses Biologic Inflammatory Markers (2 years); Review and Track Patient reported Outcomes via Validated Questionnaires (2 Years)
B: diversity and steady state of the stool (6 months)
C: clinical remission (12 weeks)
D: Feasibility (Composite Measure) (30 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
Brief Summary: Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan


Options:
A: Intraocular Pressure (from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months)
B: Intraocular Pressure (IOP) (Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90))
C: Intraocular Pressure (IOP) (29 Days)
D: Intraocular Pressure (IOP) (Study treatment was administered for 28 days, and outcome measures collected on Day 29)

Answer: C