TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicentric, Open Label, Parallel Group Trial to Compare the Efficacy of 6-months Versus 3-months Therapy With Prednisolone for the First Episode of Idiopathic Nephrotic Syndrome in Children Younger Than 4 Years
Brief Summary: This study is a multicentric, randomized, parallel group, open label controlled trial of children age 1 year up to 4 years with new onset, idiopathic nephrotic syndrome. It is designed to test the initial duration of steroid therapy of either 3 month or 6 month total duration. Participants will be randomized to either extend their pre-trial 3 months (12 weeks) of standard of care corticosteroid therapy to add an additional 12 weeks of therapy or to stop therapy. Pre-trial standard of care corticosteroids will include 60 mg/m2/day for 6 weeks followed by 40 mg/m2/day every other day for 6 weeks of prednisolone or equivalent. The trial intervention will therefore be an additional 12 vs 0 weeks of corticosteroids in these children with idiopathic nephrotic syndrome.


Options:
A: complete remission (within 4 weeks)
B: Remission (4 to 16 weeks)
C: Relapse of nephrotic syndrome during 12 months after randomization (12 month period following randomization)
D: Nephrotic Syndrome Remission (3 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
Brief Summary: This study will measure if five minutes of vibration to the upper back neck muscles, prior to standard of care treatment, will improve symptoms of spatial neglect and/or activities of daily living function for patients who have had a stroke.


Options:
A: Change score in Behaviorial Inattention Test (BIT) - Chinese version (Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment)
B: Behavioral Inattention test (Day 0)
C: Change from Baseline: behavioral Inattention Test (BIT) (up to 21 days post baseline and up to 90 days follow-up)
D: Distance walked (machine-reported) (Week 2); Lower Extremity Functional Index (Week 2); Lower Extremity Functional Index (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Child Mental Healthcare in Low-Resource Settings
Brief Summary: Background: Mental health problems cause a disproportionate burden of disability among children and youth compared to adults. Primary care plays an important role in efforts to prevent and intervene early in the course of child and adolescent mental health problems. While research with adults has shown the feasibility of integrating mental health care into primary care settings, there have been few studies among children and youth. Evidence remains lacking that integration is feasible in diverse settings, that it improves outcomes, and that methods can be developed to address the mixed symptoms of emerging child/youth problems and their overlap with developmental and parental disorders.

Goals: The purpose of this project is to test the effectiveness of adding a child/youth mental health component into an existing collaborative care program for adult mental health problems. The work will refine a framework for efficient cultural adaption and tailoring of an existing child/youth primary care mental health intervention and then test whether the tailored intervention results in improved child and parent outcomes. The work will also provide evidence about the mechanisms by which those outcomes are achieved and what factors influence uptake of the child/youth component by general practitioners (GPs). These results should be generalizable to low and middle income countries and to underserved areas of the US where there are minimal child mental health resources and family physicians provide the bulk of medical care for children and youth.

Methods: The planned work involves the adaptation/tailoring process followed by a trial with 45 GPs already engaged in collaborative care for adults; the trial will study adding collaborative care for children ages 5-15. GPs will be randomly assigned in groups to begin 6-month control periods involving child mental health screening and referral. They will then receive child/youth training and begin second 6-month periods of screening plus ongoing coaching and booster sessions and collaborative management. Primary outcomes will be measured by recruiting and following for 6 months two cohorts of children/youth and their parents (one control, one collaborative care). Data collected from GPs, parents, youth, and the collaborative care data system will allow measurement of key factors that determine the program's success in helping children and families.


Options:
A: Depression, PTSD (Change from 0-12 weeks, 12-24 weeks and 24-36 weeks)
B: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
C: Timeline Followback alcohol use (percent drinking days) (longitudinal alcohol use from baseline (past 30 days) to 9 month post-intervention follow up)
D: Change in child mental health-related symptoms (6 months post enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Arterial Catheterization by Ultrasound: Impact on Success Rates and Complications in Patients Hospitalized in Resuscitation
Brief Summary: Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended


Options:
A: Success rate of the radial artery cannulation at first attempt (intraoperative)
B: Time Needed to Correctly Insert the Arterial or Midline Catheter. (Immediately following intervention (within 2 hours))
C: Only one attempt at arterial puncture was necessary (yes/no) (Day 0 - end of procedure)
D: Success rate of arterial or femoral catheter placement (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Arterial Catheterization by Ultrasound: Impact on Success Rates and Complications in Patients Hospitalized in Resuscitation
Brief Summary: Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended


Options:
A: Success rate (at first attempt, as average 5 min)
B: First successful central venous catheterization rate (Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes)
C: success rate of radial artery cathertrization (postoperate 72 hours)
D: Success rate of arterial or femoral catheter placement (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Arterial Catheterization by Ultrasound: Impact on Success Rates and Complications in Patients Hospitalized in Resuscitation
Brief Summary: Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended


Options:
A: First-pass success rate (Within 10 min from the start time of arterial cannulation using an angiocath)
B: Successful rate without extra vascular damage (Through study completion, an average of 1 year.)
C: Time to Successful Radial Arterial Catheterization (up to 5 minutes)
D: Success rate of arterial or femoral catheter placement (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Midwifery Model in Palestine - Usage and Quality
Brief Summary: To validate a model of Continuity of Midwifery Care implemented in the region of Nabuls and Jericho in Palestine in 2013, register data from the Palestinian Ministry of Health will be analyzed for the following indicators related to usage and quality.

Changes in these variables before and after the implementation will be compared between the 16 clinics where the model was implemented and all comparable clinics in the region.


Options:
A: Expectant mothers satisfaction of prenatal care (36 weeks)
B: Hospitalization, length of stay (LOS) (2 weeks post-partum)
C: Parenting self-efficacy (Up to 24 months of age, from 6 weeks after birth until 24 months of age); Parenting self-efficacy (Up to 24 months of age, from 6 weeks after birth until 24 months of age)
D: Antenatal visits (0-9 months before delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BetaLACTA® Test-guided Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections Diagnosed in Intensive Care Unit - BLUE¬-CarbA Study
Brief Summary: The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems, particularly in the most fragile patients such as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of carbapenem resistance mechanisms. Moreover, several preliminary results suggest that carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of carbapenem exposure is widely desired both by national and international antibiotic plans. Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce inappropriate exposure to carbapenems could be a relevant solution. Due to its good diagnostic performance, the betaLACTA® test could meet these objectives.

Experimental plan :

Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic medical device (close to a phase III study), comparing two parallel groups:

* Experimental group: early carbapenems de-escalation since the second dose, guided by results of the betaLACTA® test performed directly on the bacterial pellet from the microbiological sample positive on direct examination.
* Control group: carbapenems de-escalation guided by definitive results of the antibiotic susceptibility test obtained 48 to 72h after microbiological sampling (reference strategy).


Options:
A: Hours to First Antibiotic Modification (72 hours after randomization)
B: Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis. (After fourteen days of antimicrobial treatment)
C: mortality at D90 and infection recurrence during the ICU stay (Day 90)
D: Duration of Antimicrobial Therapy (Hours) (Approximately 4 days after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.
Brief Summary: The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion


Options:
A: Success rate of abortion (24 hours); Interval to abortion (24 hours)
B: complete miscarriage (10 days)
C: mean duration from the initial misoprostol dose until complete fetal expulsion (24 hours)
D: Percentage of patients with complete abortion (success rate). (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial
Brief Summary: When to start anticoagulation in patients with an acute ischaemic stroke and atrial fibrillation (AF) is a relevant unanswered question in clinical practice. Direct oral anticoagulants (DOACs) are highly effective for secondary stroke prevention in these patients, but DOACs were never initiated \<7 days after stroke onset in recent trials. The ELAN trial will determine the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF.

The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF.

The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation.


Options:
A: Composite outcome of the combined incidence of:recurrent symptomatic ischaemic stroke,symptomatic intracranial haemorrhage and systemic embolism (At 90 days from randomisation)
B: Rate of symptomatic hemorrhagic transformation (within 5 weeks of treatment initiation)
C: Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period (Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).); Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period ("Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).)
D: Composite of major bleeding, recurrent ischaemic stroke, systemic embolism and/or vascular death (30 ± 3 days after randomisation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol Versus Expectant Management in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial
Brief Summary: Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated abdominal pain and cramping . The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold standard management' for miscarriage to remove the retained placental tissue. It is quickly performed and removed almost all the retained products of conception. However, the routine surgical evacuation of the uterus associated with higher rate of morbidity and mortality and should be limited for special indications.

Many studies compared the effectiveness of medical treatment compared to surgery in management of incomplete abortion. There is only one study compared the curettage with expectant management in those women after medical therapy.However; none of them, looked at the effectiveness of the second chance of medical treatment in management of incomplete abortion in trial to avoid the surgical intervention after failure of previous medical treatment. So we think that the immediate evacuation using surgical intervention is truly unnecessary in most cases of failed medical abortion and the patients may get benefit from another trial of medical treatment.


Options:
A: Preoperative cervical width in centimeters (intraoperative)
B: The number of patients with complete miscarriage at 1 week. (1 week)
C: doxycycline side effects (24 hours)
D: complete abortion (14-28 days post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.
Brief Summary: A triad of exhaustion, depersonalization and inefficacy, physician burnout is an epidemic among trainees associated with delivering poor quality care. Training programs are desperate for evidence-based programs that can prevent burnout during residency. Mindfulness training programs can reduce burnout among primary care physicians, but have not been tested during physician training. Pilot testing of a novel mindfulness curriculum during pediatric internship was found to be feasible to implement.

The primary objective of this study is to determine if implementing a novel 6-month mindfulness curriculum comprised of seven 1-hour sessions can reduce physician burnout and increase mindfulness practice and empathy. A multicenter cluster randomized controlled trial will be conducted among interns training in programs of various sizes and regions to address this objective. The investigators hypothesize that completing a mindfulness curriculum during internship will reduce interns' levels of physician burnout and increase their mindfulness practice and empathy.

Within pairs in pediatric residency programs matched on size (a proxy for burnout), clusters of interns in each program will be randomized to experience either the mindfulness curriculum over a 6-month period (intervention) or receive the usual educational curriculum (control). During a 15-month study period, burnout, mindfulness and empathy will be assessed using validated measures at baseline, 6- and 15-month follow-up. The impact of the intervention will be determined by comparing physician burnout, empathy and mindfulness scores between interns in the intervention and control groups. This methodologically rigorous multi-center cluster RCT will determine if implementing an innovative 6-month mindfulness curriculum reduces pediatric interns' burnout and improves empathy and mindfulness practice.


Options:
A: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
B: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)
C: Presence of job stain evaluated by the French version of the Karasek scale (6 months)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin
Brief Summary: The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for patients with amputation after vascular etiology. the secondary aim are to measure the impact of the mirror therapy on quality of life, sleep disorders, and predictive factors for effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric. There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include 40 patients. The length of the study is 20 months.


Options:
A: Numerical Rating Scale (NRS) (Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months)
B: Change from Baseline in Knee Joint Symmetry at 6 weeks (Baseline and at 6 weeks); Change from Baseline in Gait Speed (m/s) at 6 weeks (Baseline, at 3 weeks and at 6 weeks); Change from Baseline in Gait Variability at 3 weeks and 6 weeks (Baseline, at 3 weeks and at 6 weeks); Change from Baseline in Trunk Lean on the Prosthetic versus Non-Prosthetic Side of the Body (measured in degrees) at 6 weeks. (Baseline and at 6 weeks)
C: Pre-intervention:10 Meter Walk Test (10MWT) (Week 12-13); Pre-intervention: 6 Minute Walk Test (6MWT) (Week 12-13); Pre-intervention: Berg Balance Scale Test (Week 12-13); Post-intervention:10 Meter Walk Test (10MWT) (Week 24-25); Post-intervention: 6 Minute Walk Test (6MWT) (Week 24-25); Post-intervention: Berg Balance Scale Test (Week 24-25); Delayed post-intervention:10 Meter Walk Test (10MWT) (Week 40-41); Delayed post-intervention: 6 Minute Walk Test (6MWT) (Week 40-41); Delayed post-intervention: Berg Balance Scale Test (Week 40-41)
D: Change from baseline of the phantom limb pain using a VAS (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
Brief Summary: The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.


Options:
A: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
B: Change in Child Abuse - Parent Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up); Change in Child Abuse - Child Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up); Change in Parenting Behaviour - Adult Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up); Change in Parenting Behaviour - Child Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up)
C: Retention in care in care 6 months post-transfer (6 months); Retention in care 12 months post-transfer (12 months); Retention in care 24 months post-transfer (24 months)
D: Implementation - Reach (From baseline to 6 months); Clinical Effectiveness - AUDIT (From baseline to 6 months)

Answer: C