cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Training for Healthcare Providers in Supporting Men Experiencing Suicidal Ideation

The primary objective of this study is to assess how healthcare providers perceive and evaluate the developed e-learning and associated materials (e.g. psycho-education material to use in treatment). The findings will inform potential adjustments to enhance the e-learning and materials as needed.

In a previous study (BUN: B6702024000090), the authors focused on identifying barriers and needs among adult men experiencing suicidal thoughts and their healthcare providers. Findings from this needs assessment indicate a demand for a training (e-learning) to equip healthcare providers with strategies for working effectively with men experiencing suicidal ideation. Additionally, the assessment among individuals with suicidal ideation identified several key recommendations and considerations which healthcare providers should incorporate into their practice. Therefore, an e-learning was developed with integrated psycho-education and the primary objective of this study is to assess how healthcare providers perceive and evaluate the developed e-learning and associated materials (e.g. psycho-education material to use in treatment). The findings will inform potential adjustments to enhance the e-learning and materials as needed.

Participants will be recruited through announcements on the Flemish suicide prevention portal website (www.zelfmoord1813.be) and websites of relevant partners (i.e. VVKP, VVP, Gezond Leven, Psyché, Vivel, Logo's, CGG-SP, Domus Medica,...), as well as via social media (mainly Linkedin, Instagram and Facebook) and newsletters of the Flemish Centre of Expertise in Suicide Prevention and its relevant partner organizations.

Individuals interested in participating will be directed to register online through REDCap, where they will review and approve an informed consent form.After providing informed consent, participants will be asked to provide their email address.

The email address will be used solely for the following purposes:

- Sending a reminder to complete the post-test questionnaire three days later. Once consent is provided, participants will be directed to the online pre-test questionnaire (see Table 1), which takes approximately 10 minutes to complete. Following the pre-test, participants will be directed to the e-learning module, which requires maximum 30 minutes. At the end of the e-learning, healthcare providers will be asked to complete the post-test questionnaire, which is estimated to take 15 minutes. In case a participant does not complete the post-test, a reminder will be sent via e-mail three days later.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare providers (e.g. GP's, psychiatrists, medical doctors, psychologists, psychotherapists, and nurses working in healthcare)
* ≥18y/o
* Access to a smartphone, tablet, or computer with internet connection and proficiency in Dutch

Exclusion Criteria:

* Does not meet the specified inclusion criteria.
Impact of Cannulation Strategy on Neurologic Injury in Infants With Respiratory Failure

There has been increasing use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. This study seeks to leverage the increased use of VA ECMO in this cohort to enrich an evaluation of the differences in rate of intracranial hemorrhage and ischemic stroke between venovenous (VV) and VA ECMO among infants with respiratory failure where clinicians may choose either strategy.

This project is a retrospective review of data in the ELSO registry.

From 2019-2021, there was increased use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. The primary aim is to estimate the average effect on the rate of neurologic injury of VA ECMO versus venovenous (VV) among infants with respiratory failure over the period 2013-2018, during which clinicians could choose either cannulation strategy. This causal effect will be estimated using an inverse propensity weighted (IPW) approach. Secondarily, the investigators will project this estimated treatment effect forward into the period 2019-2021. The beginning of this period roughly corresponds to start of increased use of VA ECMO. Under the assumption of a homogenous treatment effect across both study periods, the rate of neurologic injury that would have occurred in 2019-2021 will be estimated, had the rate of VA ECMO not increased relative to pre-2019 levels. The hypothesis is that the results will point to an increased rate of neurologic injury starting in 2019 due to the increased use of VA ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Patient weighed less than or equal to 10kg at start of ECMO
* Pulmonary support was the indication for ECLS
* Initial cannulation strategy was VV or VA
* The run occurred during the period 2013-2023

Exclusion Criteria:

* Patient had CDH
* Patient was post-cardiotomy
* Non-conventional initial cannulation strategies were employed, such as

  * Central Cannulation (surrogate for inability to achieve peripheral cannulation)
  * Veno-veno-arterial ECMO
  * Initial cannulation approach reported as "other"
* Patient was transported into or out of ELSO center on ECMO support
* Patient had pre-ECLS Cardiac Arrest
* Patient did not have subsequent ECMO runs in the ELSO registry
Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication

The purpose of this study is to see if supplementing calories with Pediasure is effective in maintaining height, weight, and BMI percentiles for young children during 2 years of treatment with ADHD medication.

This is a pilot study evaluating the effect of caloric supplementation on maintenance of growth parameters during two years of open-label atomoxetine treatment in 5 and 6 year old children with ADHD. The study will assess the efficacy of caloric supplementation in maintaining baseline percentiles for height, weight, and body mass index (BMI). Patients will be randomly assigned to receive either PediaSure for caloric supplementation, or no supplementation.

Secondary aims include assessing the tolerability and efficacy of long-term, open-label atomoxetine treatment in 5 and 6 year old children with ADHD, and obtaining adequate pilot data regarding the safety, efficacy, and potential effects of atomoxetine on growth parameters in order to submit a multisite R01 to more adequately assess atomoxetine treatment and its effects in young children with ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Children who participated in the 8 week DBPC trial of atomoxetine (1K23MH066127) who wish to participate in a long-term, open label trial of atomoxetine.
* Parents and patients must be able to attend regular study visits. Visits will be scheduled every 30 days for the first 6 months and then every 60 days for the next 18 months.
* Children who are on alternate medications due to inefficacy or intolerability of atomoxetine may still participate.

Exclusion Criteria:

* Parents who are unwilling to provide informed consent.
A Retrospective Study of the Navio Robotic-assisted Surgical System

A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control

Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.
2. Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.

Exclusion Criteria:

1. Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
2. Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).
3. Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
4. Subject, in the opinion of the Investigator, was morbidly obese.
5. Subject, in the opinion of the Investigator, was contraindicated for UKR.
6. Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.
7. Subject (prospective subjects only) is a prisoner.
Stretching and Strengthening Exercise in Fibromyalgia Patients

Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic exercises are described as an important form to management of symptoms. This study aims to assess strengthening and stretching exercise efficacy in symptoms and quality of life of Fibromyalgia patients. The study is done at General Clinical Hospital of Medicine Scholl of University of Sao Paulo. 63 subjects undergo the study and they are divided into three groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. Patients are evaluated by following instruments: Fibromyalgia Impact Questionnaire, Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire, dolorimetry at tender points by a Fischer dolorimeter, finger-to-tip floor test for muscular flexibility, dynamometer EMG System do Brasil for strength test of extension and flexion of knees and elbows, time to get up and go test, functional reach test, sit-to-stand test. Subjects of 1 strengthening exercise group undergo a global strengthening program and 2 stretching exercise group undergo a global stretching program. All programs have 12 weeks of duration and physical therapy is twice a week. The control group does not do any intervention during 12 weeks and after the second evaluation they enter the common program of physical therapy. Data are being analyzed by descriptive and interferential statistics procedures.

In this study, were included subjects with fibromyalgia diagnosis aged between 30 and 55 years old. We aimed to assess the effect of a physical therapy program on impact of fibromyalgia syndrome and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia diagnosis according to American Rheumatology Criteria
* Aged between 30 and 55 years old

Exclusion Criteria:

* Severe rheumatologic syndromes
* neurologic syndromes
Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease

A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.

Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease, according to the diagnostic criteria established by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 60 to 85 years.
* Patients with a diagnosis of probable or possible Alzheimer's disease according to the NINCDS-ADRDA.
* Patients with mild Alzheimer's disease according to MMSE.
* Patients with ability to ingest oral medication.
* Patients able to undergo a MRI.

Exclusion Criteria:

* Pregnant or breastfeeding women or planning a pregnancy during the study.
* Patients and caregivers unwilling or unable to perform cognitive testing.
* Patients taking part in an interventional clinical trial.
* Patients who have a risk of non-compliance to the study procedures.
* Patients with clinical or significant laboratory abnormalities.
* Patients treated with concomitant treatment or food supplements which could interfere with evaluation criteria.
Save Hearts in Arizona Registry and Education (SHARE) Project

Evaluation of the impact of bystander CPR, prehospital resuscitation protocols, and hospital post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of Arizona.


Eligibility Criteria:
Inclusion Criteria:

* Out of Hospital Cardiac Arrest (loss of spontaneous circulation and EMS attempted resuscitation)

Exclusion Criteria:

* Do Not Resuscitate
Radiomic Analysis for Predicting Treatment Response and Clinical Outcomes in Malignancies

In this study, the investigators aim to undertake a retrospective analysis of CT and MRI scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes.

Imaging in oncology has widespread application with modalities like ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) having a well-established role particularly in diagnosis, staging, assessment of treatment response, and surveillance. With the applications of radiomics in oncology, the potential of imaging as a non-invasive biomarker in treatment response, as well as genotypic characterization, has been recognized. Radiomics has the potential to tailor way towards precision oncology with the development of biomarkers that can guide personalized treatments. In this study, the investigators aim at developing CT and MRI radiomic signatures as potential biomarkers to predict treatment response and clinical outcomes for patients treated with radiation having breast, brain, head and neck, and gynecological malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Breast, head and neck, brain, and gynecological malignancies
* Treated with radiation at Odette Cancer Centre between 2010 and 2019

Exclusion Criteria:

* N/A
Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children

The primary objective of this trial is to investigate the effect of a symbiotic lozenge on dental caries in young children.

The study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group study in healthy children aged 5-8 years. The objective is to investigate the effect of a symbiotic lozenge on caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth.The study will take place in Helsingør and Fredensborg municipality.

The study consists of a baseline visit prior to a 12 months intervention period, followed by a visit after completion. During the intervention period, two to four months after the baseline visit, a saliva sample will be collected.

All guardians to the subjects are encouraged to 1) brush their children's teeth twice daily with the fluoride toothpaste provided, 2) avoid the food provided in appendix D and 3) to continue the subject's dental appointments at local Public Dental Health Service (PDHS). No further specific oral hygiene or dietary instructions/restrictions are provided.

Assuming a dropout rate of 12.5%, 175 children will be included in each treatment group.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children with absence of severe chronic disease
2. Age 5-8 years, both inclusive, at inclusion
3. Ability to cooperate at dental examination
4. Ability to cooperate to a daily intake of a lozenge
5. Parents/legal guarding provided voluntary written informed consent

Exclusion Criteria:

1. Children with severe medical conditions
2. Mentally or physically disabled children
3. Children of parents with language barriers and not able to give written informed consent
Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)

The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.

CIPNM is one of the most frequent clinical problems encountered in a general ICU. Inflicted patients are characterized by generalized muscle weakness, areflexia, delayed weaning from mechanical ventilation and subsequent increased duration of ICU stay. So far, no therapeutic or preventive tool has been proposed for CIPNM.

Electrical muscle stimulation (EMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. The role of EMS in ICU patients has not been evaluated so far.

We designed a randomized intervention study to assess the efficacy of EMS, as a preventive or therapeutic tool in CIPNM. The study consists of two cohorts. In the preventive cohort, patients with Apache II admission score ≥ 13, after stratified (age, gender) randomization, are assigned on the second day after admission to the EMS group or to the control group. In the observation cohort, patients with Apache II \< 13 are followed clinically until interruption of sedation. Patients who regain consciousness and are cooperative are assessed clinically for CIPNM. If they are diagnosed with CIPNM, they undergo stratified randomization (age, gender, diabetes mellitus, malignancy) to EMS group or to the control group. EMS will be applied to both lower extremities of the EMS-group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis. EMS sessions will continue until patient discharge or death. EMS sessions are supplementary to standard physiotherapy practice applied to all ICU patients.

Primary end point is the diagnosis of CIPNM. Secondary end points are 1) the duration of weaning from the ventilator, 2) time to ICU discharge, 3) muscle mass preservation, 4) muscle strength, 5) muscle properties and structure. The primary and secondary endpoints will be assessed as follows: medical research scale (MRC) for clinical evaluation of muscle strength, handgrip dynamometry, muscle mass evaluation with ultra-sonography, muscle biopsies, maximal inspiratory pressure, tissue oxygen saturation assessed with near infrared spectroscopy (NIRS), muscle microdialysis, electromyography (EMG).

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted in ICU of Evaggelismos Hospital

Exclusion Criteria:

* age \< 18 years
* pregnancy
* pre-existing neuromuscular disease (e.g. Gravis)
* connective tissue disease
* fractures or skin lesions that do not allow the implementation of EMS
* BMI \> 35 kg/m2
* brain death
* terminal disease
* length of stay \< 48 hours
* presence of pacemaker
Neurodevelopment After Early Iron Supplementation

Background: Iron deficiency in early childhood may impair neurodevelopment.

Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.

Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.

Children with a birth weight of \< 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor Function Classification Scale (GMFCS) at the age of school entry.

Severe disability was defined as any of the following: any abnormal neurological examination associated with a severely impaired mobility (GMFCS\>1), severe cognitive impairment (mental processing composite (MPC) \<51), hearing loss requiring amplification, or blindness. The absence of disability was defined as normal neurological examination, normal mobility (GMFCS=0), and normal cognitive development (MPC\>85) and the absence of any severe hearing and visual impairment.

Eligibility Criteria:
Inclusion Criteria:

* inborn infants with a birth weight of \<1301g admitted between June 1996 and June 1999

Exclusion Criteria:

* major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent
Intraoperative Fluorescence With Augmented Reality

This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard \& approved intravenous dye and augmented reality.

This is a study investigating a new technique with an approved medication (ICG or indocyanine green) and using that and a near infrared mode on a standard operating room microscope to see the information provided for vascular or neoplastic (tumor related) neurosurgical problems. The technique uses the data from the microscope and using ICG with augmented reality overlaying the data into the microscope view (this is the new process). The technique is called GLOW800.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with a brain lesion requiring surgery and for whom ICG videoangiography would be used

Exclusion Criteria:

* allergy to ICG (indocyanine green)
Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction

The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.


Eligibility Criteria:
Inclusion Criteria:

* Cases : patients who have had a myocardial infarction within one month to one year before the inclusion
* Controls : patients without history of myocardial infarction, free of coronary disease in the view of one of the following tests performed within one year before the inclusion :

Effort test Echocardiographic stress test Myocardial perfusion scintigraphy Coronarography with \>= 2 major cardiovascular risk factors:

1. Treated hypertension,
2. Treated dyslipidemia
3. Current smoking
4. Diabetes mellitus

Exclusion Criteria:

* Infectious disease within one week before the inclusion
* Immunocompromised patients
* Antibiotic treatment within one month before the inclusion
* Chronic viral infection
* Chronic inflammatory intestinal bowel disease
* Renal failure (estimated glomerular filtration rate\< 50 ml/min//1.73 m2)
* Pregnancy