cyrilzakka/clinical-trials huggingface dataset:
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants

A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32 weeks' gestation. However, the PREMILOC trial was underpowered to investigate rarer side effects, such as gastrointestinal perforation. This study aims to establish whether the odds of gastrointestinal perforation increase when extremely preterm infants are given prophylactic hydrocortisone in the first ten days of life.

This retrospective cohort study will use routinely collected data from the U.K. National Neonatal Research Database. The investigators will examine the records of all infants born before 28 weeks' gestation and cared for in English and Welsh neonatal units between 2016 and 2023. Infants will be considered exposed if they received hydrocortisone for at least eight consecutive days, beginning on postnatal day 1 or 2. The primary outcome will be gastrointestinal perforation, as recorded in the infant's neonatal unit record. This outcome will be validated with the original care teams for a sample of babies. Data will be analysed using a propensity score matched approach to reduce the impact of confounding.


Eligibility Criteria:
Inclusion Criteria:

Infants who:

* were admitted to a neonatal unit between the 1st January 2016 and 31st March 2023 and
* received any of their care in a NHS neonatal unit in England and Wales (part of UK Neonatal Collaborative and therefore contributing data to the NNRD) and
* were born before 28 weeks' gestation.

Exclusion Criteria:

* They have missing data for principal background variables (gestational age at birth, birth weight, year of birth and date of death for those that died).
* Their recorded birthweight absolute value z score exceeds 4 or is missing.
* They died on postnatal day 1 or 2 .
Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis

The pathophysiology of systemic sclerosis (SSc) is still poorly understood and there are no effective treatments for this disease. SSc is a heterogeneous disease with varying severity. The heterogeneity of fibroblast profiles, observed in other fibrosing pathologies, has never been thoroughly explored in the skin of SSc patients. The immune system, and in particular B lymphocytes, plays a central role in the pathophysiology of SSc. The interactions between B lymphocytes and the cells responsible for excess collagen production, i.e. fibroblasts, are not fully elucidated The main objective is to analyze the heterogeneity of fibroblasts and infiltrating immune cells as well as their molecular signature in the skin of patients with SSc


Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years of age
* With a systemic sclerosis meeting the ACR-EULAR 2013 criteria Having signed an informed consent
* Being insured

Exclusion Criteria:

* Syndrome of overlap with another connective tissue disease according to the international diagnostic criteria
* Immunosuppressive treatment within 12 months
* Dosage of current corticosteroid therapy ≥10mg/d
* Protected minors or adults
* Pregnant or breastfeeding women
* Deprived of their liberty
* Persons in emergency situations
* Persons who have refused or are unable to give informed consent
Swallowing Function, Oral Health, and Food Intake in Old Age

The purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.

The present study aims to investigate the effects on swallowing function of a specific rehabilitation program with oral screen in the elderly population included. The present study is a part of an on-going cross-sectional, descriptive project called SOFIA where approximately 400 elderly individuals, admitted to short-term care (from the five regions/county Dalarna, Gävleborg, Örebro, Värmland and Västerbotten in Sweden), will be included. The purpose of the overall project is to gain a broader understanding of aspects of dysphagia, eating, oral health, and quality of life and care among elderly people in short-term care facilities.

In the present study, 35 elderly individuals identified with dysphagia in the overall project (swallowing capacity \<10ml/sec) and without known dementia will be offered to participate and to undergo oral screen training for 5 weeks. The participants' status regarding swallowing, eating, quality of life and oral health will be assessed before and immediately after the intervention and 6-months post-intervention. A control group (35 people in short-term accommodation included in the overall project, identified with dysphagia but not offered the intervention) will undergo the same assessments (at start, after 5 weeks, and 6-month post-intervention) as the intervention group regarding swallowing, eating, quality of life and oral health status.

Cluster randomisation of short-term accommodation facilities will be made for those patients participating from the five regions/county to either intervention group or control group. Participants will be recruited consecutively to either the intervention- or the control group, depending on which short-term care facility they are staying at.

The investigators hypothesize that oral screen rehabilitation for elderly individuals with dysphagia and with different diagnoses treated in short-term care results in improved swallowing capacity.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65
* Admitted to short-term care facility ≥ 3 days
* Included in the overall project SOFIA and with a swallowing capacity \<10ml/sec

Exclusion Criteria:

* Incapable of making decisions
Marijuana Drug Discrimination and Self-Administration

This study is designed to investigate the associations among marijuana's discriminative stimulus, reinforcing, subjective (e.g. craving) and physiological effects, and to assess the relative ability of oral THC to block these effects.

Volunteers will be asked to live on a research unit for up to twenty-six (26) consecutive nights and will participate in a total of 38 study sessions held on 19 weekdays. Each session will last approximately four hours and there will be two sessions per day, therefore each study day will last approximately eight hours. In addition to these study sessions, an orientation session will be conducted on the Friday prior to admission to the inpatient unit, and a lottery session will be held on the last day of the study.

During each study session participants will be asked to smoke a cigarette. The cigarette may contain marijuana or it may contain placebo (a blank). Participants will also be asked to swallow a capsule 2-hours prior to smoking the cigarette. The capsule could contain placebo (a blank), THC (delta-9 tetrahydrocannabinol, which is the active ingredient in marijuana responsible for its mood effects), or d-amphetamine. We will have participants answer questions about how the drugs make them feel and measure their vitals signs (blood pressure, heart rate, and oxygen saturation) will be measured using a non-invasive (external) vitals monitor.

Eligibility Criteria:
Inclusion Criteria:

* Female and male volunteers must be in generally good health (as indicated by results from medical history, physical exam, electrocardiogram, urine and blood samples at screening and upon arrival at the laboratory (urine samples only).
* Psychiatric examination must meet DSM-IV criteria for Cannabis Dependence.
* Individuals must be legally and mentally competent to provide written informed consent.
* Those who are unable to give their voluntary informed consent will not be accepted.

Exclusion Criteria:

* Current serious Axis I disorder (except Cannabis or Nicotine Dependence), neurologic, cardiovascular, pulmonary or systemic (e.g., renal, hepatic) disease; cognitive impairment; pregnancy (urine test), lactation (self-report), or not using (self-report) medically approved contraceptives.
* Applicants who express interest in treatment will not be accepted for study and will be provided with a treatment referral.
Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration

The investigators are conducting a randomized controlled trial to assess the impact of Resiliency in Stressful Experiences (RISE) - a comprehensive trauma-based program for young men releasing from a southeastern state's prisons. The investigators are assessing whether treating trauma and providing other transitional supports - such as employment assistance - as young men return home will help to improve their community stability and enhance their psychological well-being, in turn, resulting in less likelihood that a person will become incarcerated in the future.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Ages 18-35
* Have experienced at least one lifetime traumatic event
* Released from incarceration to Suwanee, Leon, Duval or Columbia County, Florida.
* Conversational in English
* Being able to cognitively consent

Exclusion Criteria:

* Younger than 18 years old
* Older than 35 years old
* Has not experienced at least one lifetime traumatic event
* Not cognitively able to understand
* Not conversational in English
* Not releasing from incarceration to Suwanee, Leon, Duval or Columbia County, Florida.
Necrotizing Enterocolitis (NEC) Surgical Database

The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet at least one criterion from each of the following three categories:

Historical Factors:

* Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile
* Apneic/bradycardic episodes
* Oxygen desaturation episode not otherwise explained
* Guaiac positive or grossly bloody stools

Physical Examination Findings:

* Abdominal distention recorded by practitioner
* Capillary refill time greater than 2 seconds
* Abdominal wall discoloration
* Abdominal tenderness

Radiographic Findings:

* Pneumatosis intestinalis
* Portal venous gas
* Ileus
* Dilated bowel
* Pneumoperitoneum
* Air/fluid levels
* Thickened bowel walls
* Ascites or peritoneal fluid
* Free intraperitoneal air

Exclusion Criteria:

Patients will be excluded for any of the following:

* Major gastrointestinal anomaly
* Prior abdominal operation
* Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).
Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis

To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease.

Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive \& psychological evaluations, and flow cytometry for B cell markers.

This open-label phase I study will be conducted in MS Clinic of Sina and Shariati Hospital of Tehran province .

In this study, diagnosis and management of MS patients will be performed based on McDonald's criteria and Iran's diagnostic and treatment protocols.

The patients will be received a single injection of PLMSCs through the intravenous cannula.

The proposed study will assess safety and short efficacy endpoints of PLMSCs administered to 5 patients with SPMS.

The primary objective of the trial is freedom from treatment associated adverse events at 1,3 and 6 months' post treatment. Secondary objective will be efficacy as assessed at baseline, at 1,3 and 6 months and will be based on the following: EDSS, cytokines, DTI, fMRI, cognitive \& psychological evaluations, and flow cytometry for B cell markers.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

* Age between 17-45 years Patients with SPMS .
* Must be able to Sign informed consent .
* Currently taking Rituximab.
* Disease duration of more than 2 and less than 16 years.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) disease.
* Using cytotoxic agents within 3 months prior to the study.
* Severe anemia (hemoglobin\< 8 mg/dl), coagulation disorders.
* history of malignancy .
* liver disorders .
* significant cardiac, renal or hepatic failure .
* Active or chronic infection.
* Life-threatening organ dysfunction.
* Unable to give written informed consent .
* Current treatment with an investigational therapy.
Adapting Diet and Action for Everyone (ADAPT+)

The purpose of this study is to refine and optimize an obesity intervention with rural underserved Latino children and their parents that combines a standard family-based behavioral approach, the "gold standard" for pediatric obesity treatment, with a mindfulness approach focusing on stress reduction (now ADAPT+).

Latino youth have the highest prevalence of obesity as compared to Black or White youth, and are at high risk for adult obesity-related complications including cardiovascular disease. Moreover, Latino youth living in rural communities have an increased risk of adult obesity and mortality due to obesity-related chronic disease than Latinos living elsewhere. The investigators synthesized the prior childhood obesity intervention and tailored the evidence informed, theory-based, multi-family behavioral intervention, Adapting Diet and Action for Everyone (ADAPT), to the acculturation status, language, and national origin of the target population - obese, school-aged (8-12 years old) Latino youth and their parents living in rural areas. However, because the role of parent stress on obesity has not been adequately addressed in interventions aimed at reducing obesity in Latino youth, it is argued that mindfulness parent stress reduction strategies may be a key component to improving eating and physical activity (PA) behaviors in both children and their parents. This study proposes a refinement and optimization of the original ADAPT obesity intervention protocol to include mindfulness parent stress reduction strategies (now ADAPT+) and feasibility assessment of ADAPT+ implementation.

Aim 1: Refinement of ADAPT+ (ADAPT + mindfulness parent stress reduction). Aim 1A and Aim 1B were focus groups with promotoras from the target communities and parents. The intervention manual was refined based on the qualitative feedback. Aim 1C further refines the manual via a small one parent-child cohort. Data collected at Aim 1C was used to finalize and optimize a culturally acceptable ADAPT+ evaluated in Aim 2.

Aim 2: Feasibility and Acceptability trial. A randomized trial testing feasibility of ADAPT+ vs. Enhanced Usual Care (EUC) conducted in two rural communities. It is anticipated that compared to EUC, ADAPT+ dyads will have a lower attrition rate and will report greater satisfaction. The investigators also explore whether the eating and stress indices are sensitive to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Child with a BMI %ile of 85 or higher.
* The target parent is at least 18 years old, is the main meal preparer, speaks and reads Spanish at a minimum of a 4th grade reading level (able to follow basic instructions in Spanish), and able to perform simple physical exercises.

Exclusion Criteria:

* A child who has a medical/developmental condition that precludes weight loss using conventional diet and PA methods.
* A child has been on antibiotics or steroids in the previous three months.
* The parent is ineligible if he/she is non-ambulatory, is pregnant, or has a medical condition that may be negatively impacted by PA.
Effects of 6-Week Vibration and Non-Vibration Foam Rolling

This study aims to compare the effects of 6-week vibration and non-vibration foam rolling on neuromuscular control and performance in male soccer players.

The typical warm-up protocol consists of different stretching exercises, sub-maximal aerobic activities, and sports-related activities. However, in recent years, warm-up protocols involving different methods have been applied and recommended.

Foam rolling (FR) via foam roller, one of these methods, has become a common and popular method in many sports settings.

While the popularity and use of the foam rolling method is gradually increasing, in recent years this method has begun to be applied as vibration and included in warming protocols.

The aim of this study is to compare the effects of 6-week vibration and non-vibration foam rolling on neuromuscular control and performance in male soccer players.

Within the scope of initial assessments; knee flexor and extensor muscle strength and Hamstring/Quadriceps muscle strength ratio with the Lafayette manual muscle testing device, flexibility with the sit-and-reach test, dynamic balance with the Y balance test, reaction time with the "Test You Brain Pro System", lower extremity anaerobic power with the Wingate anaerobic power test, agility with the t-test and sprint with the 20-m sprint test will be evaluated.

After the initial assessment, vibration and non-vibration foam rolling methods will be applied to the gluteal, tensor fascia latae, hamstring, quadriceps femoris and gastrocnemius muscles of both lower extremities of the participants in the intervention groups, in addition to the routine warm-up protocol, 3 days a week for a total of 15 minutes a day for 6 weeks. No intervention will be applied to the participants in the control group. This group will continue the routine warm-up protocol.

After the methods applied to the intervention groups for 6 weeks, the initial assessments applied to all participants will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study.
* To regularly participate in team training within the club.
* To have been playing football for at least 1 year in the category.

Exclusion Criteria:

* Having any sports injury involving the lower extremity and/or spine in the last 3 months.
* Having a problem (vertigo, neuropathy, etc.) that may negatively affect balance and coordination.
* Having a musculoskeletal deformity (short limb, etc.) concerning the lower and upper extremities.
* Implementing a training program outside of routine team training
Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law

The goal of this observational study is to establish a predictive model for the clinical use value of fat emulsion as an antidote based on the physical information of fat emulsion on drug diffusion process.

The main question it aims to answer is:

Observing the effect of fat emulsion on the pharmacokinetic changes of overdose drugs; Observe and evaluate the therapeutic effect of long-chain fat emulsion as an antidote; Participants will have their whole blood samples collected for toxicology testing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clear history of acute drug exposure;
* The exposed drug is a lipid soluble drug (with a lipid water distribution coefficient logP\>0);
* Age: 18-85 years old;
* The patient or guardian agrees to participate in this project and signs an informed consent form;

Exclusion Criteria:

* Patients with shock and severe lipid metabolism disorders (such as hyperlipidemia);
* Patients with unclear exposure history;
* Drug exposure time \> 24 hours;
* Exposure to two or more drugs;
* Select patients with specific detoxifying agents;
* Merge patients with severe cardiovascular and cerebrovascular diseases;
* Patients with negative blood toxicity test results or overdose of non-fat-soluble drugs;
* Those who fail to provide complete general information and clinical data;
Interleukin-6 Antagonists in Critically-ill Covid-19 Patients

The emerging SARS-COV2 virus has shed a new light on the cross-talks between the immune and the hemostatic system. In this study we aim to evaluate the dynamic change in coagulation caused by the modulation of the inflammatory response by interleukin-6 antagonist as assessed by viscoelastic methods in critically ill COVID-19 patients. Furthermore we try to draw attention to possible associations between the endothelial cell injury, inflammation and coagulation.

The emerging SARS-COV2 virus has shed new light on the cross-talk between the immune and the hemostatic system. Pathophysiologically in COVID-19 infection the thrombo-inflammatory process is initiated by the host's exaggerated systemic inflammatory response, also called "dysregulated immune response" that activates both the inflammatory and the coagulation cascade directly by inflammatory mediators and indirectly by causing endothelial cell injury. These mechanisms altogether contribute to the imbalance of the hemostasis that is characterized by a procoagulant state.

In this multicenter prospective observational study, we aim to evaluate the dynamic change in coagulation as a result of immunomodulation by interleukin-6 antagonists in critically ill COVID-19 patients. We will assess the hemostatic system by a viscoelastic hemostasis assay (Clotpro, Haemonetics Corporation, Boston). Furthermore, we try to draw attention to possible associations between endothelial cell injury, inflammation, and coagulation. To compare these parameters we will draw blood for analysis before administration of IL-6 antagonist then 24h after, 48h after, and 7 days after.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old)
* Clinical diagnosis of SARS-CoV2 infection with rtPCR confirmation
* Disease severity with the indication of immunomodulation therapy with interleukin-6 antagonist: acute respiratory failure that requires invasive, noninvasive ventilation , or high flow nasal oxygen therapy with the following parameters: FiO2 \> 0,4, flow \> 30L/min and C Reactive Protein \> 75 mg/L

Exclusion Criteria:

* The patient had previously been administered one of the following immunomodulating drug: anakinra, tocilizumab, sarilumab
* Presence of any condition or drug in the medical history that can lead to immunosuppression
* Suspicion of infection (active tuberculosis, bacterial, viral, fungal) or level of procalcitonine higher than 0,5 ng/ml at the enrollment of the patient
* Number of thrombocyte lower than 50 x 109 / L
* More than \>120 hours passed between the admission to the ICU and the administration of interleukin-6 antagonist
* Administration of any of the following drugs the week before or during the study: fibrinolytic therapy, factor products (PCC, ATIII, FVIIa, FXIII), fibrinogen, desmopressin, tranexamic acid, blood products (FFP, thrombocyte concentrate)
* Pregnancy
* The patient or his legal guardian does not sign the consent