cyrilzakka/clinical-trials huggingface dataset:
Trans-pulmonary Pressure in ARDS

Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. The challenge is to carry out these objectives in a patient-centered approach based on individual characteristic of lung pathophysiology. Recently, it has been proposed to set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is obtained from the difference between airway pressure and measured esophageal pressure (Pes). Measured Pes values have been found positive in the supine position in ARDS patients, leading to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under investigation. Prone position ventilation significantly improves survival in severe ARDS as demonstrated by meta-analyses and a recent multicenter randomized controlled trial.

The purpose of present project is to investigate Ptp at end-expiration in the prone position in severe ARDS. The project is centered on the question about what are the values of measured Pes in prone position. The hypothesis is that they are lower than in the supine position due to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional recruitment by using electrical impedance tomography. will be assessed in supine then in the prone position across two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.


Eligibility Criteria:
Inclusion Criteria:

* ARDS
* intubated
* indication of proning
* no contra-indication of proning

Exclusion Criteria:

* contra-indication to proning
* contra-indication to esophageal balloon
* proning before
* end of life decision
* legal protection
* pregnancy
* ECMO
A Treatment Extension Study of Mucopolysaccharidosis Type IIIB

The primary objectives of this study are to evaluate the long-term safety and tolerability of AX 250 administered to subjects with MPS IIIB by an implanted ICV reservoir and catheter and to evaluate the impact of long-term AX 250 treatment on cognitive function in patients with MPS IIIB as assessed by developmental quotient (DQ).


Eligibility Criteria:
Inclusion Criteria:

* Must have completed 48 weeks in Part 2 of Study 250-201 and enter 250-202 within 8 weeks of study completion
* Written informed consent from parent or legal guardian and assent from subject, if required
* Has the ability to comply with protocol requirements, in the opinion of the investigator
* Males and females who are of reproductive age should practice true abstinence, defined as no sexual activity, during the study and for 6 months after the study has been completed (or withdrawal from the study). If sexually active and not practicing true abstinence, males and females of reproductive age must use a highly effective method of contraception while participating in the study.
* If female with childbearing potential, must have a negative pregnancy test at the Screening visit and be willing to have additional pregnancy tests during the study.

Exclusion Criteria:

* Has both (1) a cognitive AEq score ≤ 18 months, and (2) a DQ score ≤ 20
* Would not benefit from enrolling in the study in the opinion of the investigator
* Has received stem cell, gene therapy or ERT (other than AX 250) for MPS IIIB
* Has contraindications for neurosurgery (eg, congenital heart disease, severe respiratory impairment, or clotting abnormalities)
* Has contraindications for MRI scans (eg, cardiac pacemaker, metal fragment or chip in the eye, or aneurysm clip in the brain)
* Has a history of poorly controlled seizure disorder
* Is prone to complications from intraventricular drug administration, including patients with hydrocephalus or ventricular shunts
* Has received any investigational medication other than AX 250 within 30 days prior to the Baseline visit or is scheduled to receive any investigational drug during the course of the study
* Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with protocol requirements, the subject's well-being or safety, or the interpretability of the subject's clinical data.
* Is pregnant at any time during the study
TechCare: Mobile-AssessmenT and ThErapy for PsyCHosis: An Intervention for Clients Within the EArly InteRvention SErvice

The aim of the project is to conduct a feasibility study of the mobile phone application "TechCare" for individuals with psychosis in the North West of England.

This feasibility study will follow the NIHR guidance on feasibility study design (NIHR, 2014) and will consist of both qualitative and quantitative components. The study will run across three strands as follows 1) Qualitative work \& Systematic review 2) Test run and Intervention refinement 3) Feasibility trial.

Eligibility Criteria:
Inclusion Criteria:

* Each client must be accepted into the Psychosis Group of the Lancashire Early Intervention Service.
* Ages 18 - 35 years
* Medication stable for previous two months
* Clients must be currently stable-The Lancashire Early Intervention Team uses a traffic light system to indicate current symptomatology and risks of each client. For this study we will use only clients with a Green Light, signifying that they are currently stable.
* A score of 3 or more on positive symptoms on the PANSS
* Minimum score of 1 on the Calgary depression scale.

Exclusion Criteria:

* Drug induced psychosis
* An acquired brain injury or learning disability
* Clients who are undergoing assessment, not formally diagnosed and accepted into the service.
* Lacking capacity for informed consent.
* Ultra High Risk of Developing Psychosis Group (i.e. Prodromal, not first episode)
Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.

Intra-articular hip injections are commonly used for diagnostic and therapeutic purposes but are often associated with patient anxiety and fear. The disparity between anticipated and experienced pain during these injections, as well as the role of pre-injection local anesthesia in pain modulation, remains unclear.

This study investigates the difference between anticipated and experienced pain during intra-articular hip injections. In addition, the study examines the impact of pre-injection local anesthesia in 60 prospectively recruited patients, some of whom received pre-injection local anesthesia while others did not. These study findings provide valuable insights into experienced pain during intra-articular hip injections, which can be applied to improve patient experiences and treatment compliance.

1. Identification of patients in the outpatient clinic and completion of the questionnaires will be carried out by the principal investigator and sub-investigators in the clinic.
2. Data processing will be conducted by physicians holding an MD certification.
3. The type of study is prospective.
4. Data collection will be performed using the medical records of Tel Aviv Medical Center Hospital only, covering the years 2021 and 2022.
5. Demographic data will be collected, including gender, year of birth, age, diagnosis, indication for injection, and previous treatments. Clinical data will include underlying diseases, side of injection, complications, indications, and follow-up time.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a first-time intra-articular hip injection as indicated by an orthopedic surgeon.
* Indications for injection include:
* Diagnostic purposes (e.g., lidocaine test, arthrography)
* Therapeutic purposes (e.g., steroid injection for osteoarthritis)
* Participants must be 18 years of age or older.
* No previous hip joint injections.
* Ability to fill in the survey questionnaire.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients with a known history of hypersensitivity or allergy to the injectant material (e.g., local anesthetics, steroids).
* Patients lacking the ability to sign informed consent or complete a survey questionnaire.
* Patients with previous hip joint injections, due to the potential for recalling prior pain experienced.
Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients

This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.


Eligibility Criteria:
Inclusion Criteria:

* 60 years old or older
* Scheduled to undergo left ventricular assist device implantation at Thomas Jefferson University

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unable to complete baseline frailty assessment
Stem Cells Therapy for Fecal Incontinence in Children After Posterior Sagittal Ano-rectoplasty

The problem of the incontinence imposes considerable strain on the child and their parents. These patients suffer from a long-life handicap and they need support and follow-up. The cost associated with these diseases has clearly been illustrated to be a major component in the healthcare spending picture, may be adding hundreds of thousands of dollars to healthcare cost, as well as loss of productivity in the work force. Fecal incontinence treatment has been a difficult challenge for surgeons for several generations until now the current traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may represent a new attractive treatment option for anal sphincter lesions. Moreover, experimental injury of muscle of anal sphincter in rats has been successfully treated with stem cells injections. In this study, the investigators will shed more light on the ability of Mesenchymal Stem Cells to induce myogenesis and regenerate anal Sphincter of patients with fecal incontinence. It will be very useful to many Egyptian patients.

A stem cell is capable of forming various tissue under definite signals received from the body. Stem cell research in animals has been an ongoing program in the west with fruitful results. Current challenges with the use of stem cells in clinical practice will be solve the many unanswered queries. To study the potential therapeutic effects of local Mesenchymal Stem cell injection in children presenting with fecal incontinence (FI) after posterior sagittal ano-rectoplasty (PSARP) operation for high imperforate anus. Children whom suffering from FI after PSARP for high imperforate anus will included in this study. Autologous MSC from the upper posterior iliac crest bone marrow sample will be extracted from patients under general anesthesia, in a suitable clean operation room. Will be Cultured and injected into the external anal sphincter defect using direct pena stimulator or ultra sound guidance. Then followed up for 180 days post injection, to assess the ability of mesenchymal stem cells to induce myogenesis of the anal Sphincter of patients with FI after PSARP.

Eligibility Criteria:
Inclusion Criteria:

Male Childern Ages: above 2 Years old.

Patient with FI. After PSARP repair of high imperforate anus.

Absence of parasitic and infective bacterial growth after Stool analysis and stool culture.

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Exclusion Criteria:

Any degree of Spinal cord injury, systemic, neuronal paralysis or sacral agenesis.

Absence of muscle activity detected by EMG.

Ano-rectal disorders such as tumors, fissures, anal or rectal prolapse, and rectocele.

Positive stool culture resistant to preoperative oral antibiotic therapy.

Previous injection of bulking agents at the level of sphincter.

Immunocompromise patient.

Previous adverse reaction to anesthesia.
Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma

This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.

The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 6 years and \< 18 years
* History of physician diagnosed asthma
* Presenting to ED with breathing difficulty or cough
* Initial FEV1 25%-70% predicted
* Parent or guardian speaks English or Spanish.

Exclusion Criteria:

* Pediatric Asthma Score of 0
* Pregnancy or breast-feeding
* Immediate resuscitation required
* Chronic lung disease (other than asthma)
* Congenital heart disease
* Neuromuscular disease
* Suspected intrathoracic foreign body
* Allergy or other contraindication to study medication
Examination of Gastric Emptying in Children

* Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre.
* Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children.
* Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.


Eligibility Criteria:
Inclusion Criteria:

* age 6 - 12 years
* ASA I or II

Exclusion Criteria:

* gastrointestinal pathology
* claustrophobia
* implants like pacemaker, ventriculoperitoneal shunt etc
* symptomatic or relevant cardiac, renal or metabolic disease
Iron Deficiency and Anemia in Cardiac Surgery

Anemia and preoperative iron deficit in cardiac surgery are associated by an increased volume of transfusion and an increase in complications and/or mortality. Recent studies have shown that EPO and iron administration the days preceding the operation results in a reduction of perioperative transfusion for patients with preoperative anemia.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cardiac surgery
* With iron deficiency with or without anemia

Exclusion Criteria:

* Anemia without iron deficiency
* Iron overload
* Jehovah's witnesses
* Endocarditis
* Treating neoplasia
* Uncontrolled hypertension
* With infection
* Alfa-epoetin hypersensitivity
* Hypersensitivity of hamster's protein
* Erythroblastopenia induced by erythropoietin
* Ferinject or mannitol allergy
Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures

Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Diagnosis of single or multiple stable thoracolumbar fracture(s)

  * Level T10- L3
  * Type AO A3 or A4
  * Radiologically confirmed by Rx or CT
* Fracture induced kyphotic deformity lower or equal to 20-35 degrees
* Definitive treatment (surgical or conservative) within 10 days after injury
* American Spinal Injury Association (ASIA) Impairment Scale = E (normal )
* Ability to understand patient information / informed consent form
* Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)
* Signed informed consent

Exclusion Criteria:

* Open fracture
* Polytrauma
* Pathologic fracture
* Disruption of the posterior ligamentous complex between T10 and L3
* Clinically evident osteoporosis as assessed by the investigator
* Spinal luxation
* Associated severe lesions as assessed by the investigator
* Spinal lesion due to gun or projectile
* Pre-existing spinal column deformity
* Prior spinal surgeries
* BMI \> 40 kg/m2
* Any severe medically not managed systemic disease
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Klinefelter Syndrome and Testosterone Treatment in Puberty

The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).

The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.

Participants will be randomized to two years treatment with testosterone or placebo.

Klinefelter syndrome (KS, 47,XXY) is the most frequent sex chromosome disorder with a prevalence of 1:660 boys. Patients with KS are hypogonadal due to a progressive testicular destruction starting already in childhood. Consequently, the adult male with KS is characterized by small testes, signs of incomplete virilization (e.g. lack of voice deepening, sparse face and body hair, gynecomastia, low muscle mass, reduced penile length), hypergonadotropic hypogonadism, infertility and increased risk of metabolic syndrome, diabetes, cardiovascular disease, osteoporosis and psychosocial and neurodevelopmental challenges. Adults with KS have a poor health and a prevention of the major co-morbidities associated with KS and thereby an improvement in the general health would have an enormous impact on the life of a large cohort of males worldwide.

Sufficient testosterone is not only important in the adult but also during puberty and adolescence for a normal virilization and to improve body composition and body proportions, as well as to maximize peak bone mass acquisition. It has therefore been internationally accepted and makes biological sense to consider testosterone replacement therapy (TRT) during puberty in KS. However, there are no evidence based recommendations, and during recent years TRT in puberty has been questioned and is no longer recommended in some countries. There is a need on an international level for evaluating the effect of this treatment. We therefore aim at evaluating the effect of 2 years TRT during early puberty in boys with KS aged 10 to 14 years in this national, multi-center, randomized, double-blind, placebo-controlled intervention study. The primary endpoint is to evaluate the effect on body fat mass. The secondary endpoints are to evaluate effects on lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.

Eligibility Criteria:
Inclusion Criteria:

* 47,XXY Klinefelter syndrome
* Age 10-14 years at inclusion
* Luteinizing Hormone \> +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay
* Free Testosterone\<+2 standard deviations
* Signed consent from parents

Exclusion Criteria:

* Previous or ongoing T treatment except for TRT because of micropenis
* Contraindications to testosterone treatment known hypersensitivity to testosterone or to any other constituent of the gel known or suspected prostatic cancer or breast carcinoma
* Participation in any other clinical trial
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke

The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.


Eligibility Criteria:
Inclusion Criteria:

1. Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.

Exclusion Criteria:

1. Known etiology of TIA or stroke.
2. Untreated hyperthyroidism.
3. Myocardial infarction less than 1 month prior to stroke or TIA.
4. Coronary bypass grafting less than 1 month prior to stroke or TIA.
5. Valvular disease requiring immediate surgical intervention.
6. History of AF or atrial flutter.
7. Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).
8. Permanent indication for OAC at enrollment.
9. Permanent contra-indication for OAC.
10. Included in another clinical trial.
11. Life expectancy less than 1 year.
12. Pregnant.
13. Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
14. Not fit, unable or unwilling to follow the required procedures of the protocol.