cyrilzakka/clinical-trials huggingface dataset:
A Comparative Dissolution and Absorption Study of an Orodispersible Powder, Chewable Tablet and Soft Gel Capsule Vitamin D3 Supplementation

This is an open-labelled, randomized controlled clinical trial aimed to compare the pharmacokinetics of an orodispersible vs a soft gelatin vitamin supplementation in vitamin D deficient healthy adults.

Vitamin D is a fat-soluble vitamin used by the body for normal bone development and maintenance by increasing the absorption of calcium, magnesium, and phosphate. Vitamin D also plays a role in the nervous system, musculoskeletal system and immune system. Vitamin D deficiency has been linked with diverse health conditions including diabetes, cardiovascular diseases, breast, colorectal and prostate cancer, dementia, depression, erectile dysfunction, osteoporosis, and bone disorders. Vitamin D deficiency is a global healthcare challenge. To overcome vitamin D deficiency, a daily vitamin D supplementation of 200-1000 IU or a high dosage from 25000 to 200000 IU for 4-6 weeks, is normally recommended.

Vitamin D supplements are available over the counter in different delivery vehicles (formulations) to reach the circulatory system. In the present study the investigators aim to evaluate the pharmacokinetics of an orodispersible vitamin D supplement vs a conventional oral soft gelatin capsule, in vitamin D deficient healthy adults to assess how different vitamin D supplement formulations can efficiently overcome the vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults aged 18 - 60 years
* Vitamin D deficiency as shown by serum levels of 25 (OH) D3 levels of \< 20 ng/mL
* Able to provide informed written consent

Exclusion Criteria:

* Clinically significant abnormal laboratory parameters (such as complete blood count, CRP, d-dimer, liver enzymes, creatinine) indicative of physical illness, especially hypercalcemia and hypercalciuria
* History of hypersensitivity to vitamin D3 supplements
* History of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, or neurological diseases
* Prior use of medications in general containing calcium, magnesium, or vitamin D3, four weeks before the start of the study
* Participation in the evaluation of any investigational product or blood donations in the last three months before this study
* Any other significant disease or disorder that, in the opinion of the Physician, may either put the participant at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study
The PRO-FUTURE Project

The goal of this observational study is to learn about specific biomarkers of unilateral ureteropelvic junction obstruction (UPJO) in children undergoing surgical intervention for unilateral UPJO compared with controls. The main question it aims to answer are:

* Are Urinary single-cell and extracellular vesicles (EVs) screening useful to stage the intrarenal injury and repair processes in UPJO babies?
* Do babies with unilateral UPJO have a whole blood gene expression profiling (WBGEP) allowing an accurate unilateral UPJO diagnosis?

Congenital anomalies of the kidney and urinary tract (CAKUT) are the main cause of chronic kidney disease in children. UPJO is the most common CAKUT. It is defined as impeded urine outflow from the renal pelvis to the ureter, which may result in progressive kidney damage (KD). Renal imaging is the current diagnostic approach, even if substantial shortcomings are present to reliably determine a significant obstruction. Consequently, a follow up is often needed with the risk of progressive KD. The main hypothesis of this proposal is that biofluids (whole blood and urine) could allow a more precise diagnosis and risk stratification of unilateral UPJO compared with the available diagnostic techniques.

In this project the investigators define the UPJO as an hydronephrosis needing of surgical correction according to 2 of the following criteria: anterior-posterior diameter of the pelvis (APDP) ≥ 30 mm, split renal function (SRF) \< 40% at the Tc99mMag3 scintigraphy (Mag3S), SRF with delta \> 10% at follow-up Mag3S, delayed wash-out, progressive increase of the APDP at follow-up ultrasounds, and 4th degree hydronephrosis.

The investigators will extensively investigate for specific biomarkers of UPJO at different levels. The investigators will focus 1. on the urine by investigating for intrarenal remodeling processes and searching for kidney-specific biomarkers by urinary single-cell and EVs screening (aim 1). Moreover, based on the hitherto revealed capability of blood cells to perceive organ-specific illnesses, 2. the investigators will perform WBGEP of babies with unilateral UPJO to identify early biomarkers of disease progression (aim 2).

For the aims 1 and 2, the investigators will enroll 85 patients aged 0-5 years, 35 with unilateral UPJO and 50 controls without hydronephrosis needing surgical correction for hernia, hydrocele or phimosis.

This project could improve the management of patients with suspect of UPJO -starting from birth- by a better understanding of the pathophysiological mechanisms underlying KD and by the identification of early biomarkers of obstruction, reducing the costs and the complications related to either a tardive or not needed surgical correction and reducing the risk of KD development.

Eligibility Criteria:
Inclusion Criteria:

* unilateral UPJO
* 0-5years of age

Exclusion Criteria:

* bilateral UPJO
* previous surgical intervention on the urinary tract
* bladder or lower urinary tract symptoms or malformations
* nephro- or urolithiasis, vesicoureteral reflux
* urinary tract infections.
Asthma Navigator Intervention to Improve Health Equity in Children

The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:

* To identify the factors related to differential experiences of asthma self-management
* To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.

Despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly Black and Hispanic, being the most affected. These disparities are largely due to social determinants of health (SDOH), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. Children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens.

At Children's Healthcare of Atlanta's Pediatric ICU (PICU), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. Significant barriers to better outcomes include limited provider understanding of SDOH and challenges in asthma self-management. Effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the PICU for asthma

Exclusion Criteria:

* Cystic fibrosis
* Immune deficiency
* Prematurity \<35 weeks
* Gestation and congenital airway deformities
* Non-English speaker
Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).

In this study, we will compare 3 treatments. The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) . The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery . The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray device, an inexpensive delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).

Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain and of opioid requirements in patients undergoing gynecological laparoscopic procedures in one-day surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned for gynaecological laparoscopic interventions on an ambulatory basis.

Exclusion Criteria:

* Less than 18 year old.
* Weight less than 50 kg and more than 80 kg.
* Pregnant.
* Prisoners;
* Allergic to topical anesthetics (Amides specifically).
* Allergic to Opioids as a class.
* Currently or within the last 30 days been prescribed an opiate medication.
* Chronic pain syndrome.
Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children

This randomized controlled study was planned to evaluate the effects of distraction methods, using virtual reality or a stress ball, on the emotional appearance, pain, fear, and anxiety associated with the procedure, during the phlebotomy in children aged 6-12 in a private blood collection unit.

H1: There is a difference between the groups in terms of pain, fear, anxiety and emotional appearance scores related to the intervention during the blood draw attempt.

A standard approach will be applied to all children. Standard approach; giving information about the procedure, the nurse introducing herself, choosing the area together, being with the parent and talking to the child during the procedure, "I'm starting now, I'm cleaning the area, take a deep breath, I'm applying it now, it may hurt a little, you shouldn't move, it will take a very short time, I will cover it with tape " contains.

In the virtual reality glasses group, a tourniquet will be attached to the extremity where the intervention will be performed. By wearing virtual glasses, the video will be started.

In the stress ball group, before the intervention is applied, the other hand will be given a stress ball and asked to squeeze it.

In the control group, communication with the child will continue during the intervention with the questions mentioned above.

When the nurse decides on the area where the PICT will be performed (the minute will be recorded), she will use the words "I am cleaning the area, take a deep breath, now I am applying the injection, it may hurt a little, you should not move, it will be very short".

The intervention will be stopped when the blood draw attempt fails in all groups.

5 minutes after the blood draw attempt, the child will be asked to rate the most painful moment felt during the procedure using the Facial Expressions Rating Scale. The Child Fear Scale (CDS) and Child Anxiety Scale-State (CAS-D) will be given to the child to assess how anxious and frightened he is during the procedure. The child will be asked to mark with a pencil. The Emotional Appearance Scale for Children will be evaluated by the nurse after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* The age range of children is between 6-12
* The child's consent to voluntarily participate in the study
* Parent's willingness to participate in the study voluntarily
* Obtaining consent forms from child and parent

Exclusion Criteria:

* The child has a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.
* fever (\>37.5C) and severe dehydration
* The child takes analgesics before the blood draw
* Wearing glasses
Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer

To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.

The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer;
* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1;
* A leucocyte count of≥4000µl;
* A platelet count of≥100000µl;
* A normal creatinine level;
* Serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal;
* Survival time ≥12 weeks.

Exclusion Criteria:

* Previously treated malignant pleural effusion;
* Pericardial effusion；
* Pregnant；
* Uncontrolled hypertension or diabetes；
* Liver cihrosis.
Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study.

A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.

The objective of this post market surveillance study is to obtain outcome data on the Fitmore Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

The Fitmore Hip Stem is a short and curved uncemented stem that allows preservation of the greater trochanter and of the gluteal muscles.

Indication/Target Population: Patients suffering from severe hip pain and disability requiring total hip arthroplasty.

Study Design: A multi-centre, non-comparative, prospective post-marketing study.

Targeted Number of Subjects: 500. Data Collection: Collection of preoperative, intra-operative and immediate post-operative data; follow-up visits at 6-12 weeks, 1, 2, 3, 5, 7 and 10 years post-operatively.

Recruitment period: 24 months. Clinical Assessments: Evaluations will be made using the Harris Hip Score, the Oxford Hip Score, the SF-12 Physical and Mental Health summary measures, the EQ-5D (EuroQol) and radiographically.

Safety Assessments: Safety will be assessed by appropriate recording and reporting of adverse events throughout the study. The Fitmore Hip Stem is CE marked, commercially available and has been pre-clinically tested.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are capable of understanding the doctor"s explanations, following his instructions and who are able to participate in the follow-up program.
* Patients who have given written consent to take part in the study by signing the "Patient Consent Form".
* 18 years minimum.
* Male and female.
* Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.

Exclusion Criteria:

* Patients who are unwilling or unable to give consent or to comply with the follow-up program.
* Pregnancy.
* Patients who are skeletally immature.
Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)

This phase I/II trial evaluates the efficacy and adverse effects of alpha 1 anti-trypsin (AAT) for the treatment of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation.

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of AAT in patients with steroid non-responsive acute GVHD.

II. Characterize pharmacodynamic effects of AAT on pro-inflammatory cytokines, heparan sulfate, and the spectrum of peripheral blood T cells.

III. Determine clinical responses of GVHD to AAT in patients with steroid non-responsive acute GVHD.

OUTLINE: This is a phase I/II dose-escalation study of AAT.

Patients will receive AAT intravenously (IV) on study days 1, 3, 5, and 7. Patients who experience no toxicity and in whom GVHD is stable or improved after the day 7 dose can continue therapy with AAT on days 9, 11, 13 and 15 for a total of 8 doses.

Eligibility Criteria:
Inclusion Criteria:

* Patients transplanted from related or unrelated, human leukocyte antigen (HLA) matched or mismatched donors
* Patients transplanted with hematopoietic stem cells from any source
* Patients receiving calcineurin inhibitors as part of graft versus host disease (GVHD) prophylaxis
* Patients with acute GVHD grades II-IV developing despite GVHD prophylaxis
* Patients who have not shown a satisfactory response to methylprednisolone-equivalent doses at 2 mg/kg/day, based on adjusted body weight
* Signed and dated informed consent

Exclusion Criteria:

* Patients who have received any systemic agents in addition to steroids for treatment of GVHD
* Patients unable to give informed consent
* Patients with manifestations of classic chronic GVHD
* Patients with evidence of recurrent malignancy
* Patients with acute/chronic GVHD overlap syndrome
* Patients whose GVHD developed after donor lymphocyte infusion (DLI)
* Patients with severe organ dysfunction, defined as

  * On dialysis
  * Requiring oxygen (O2) at more than 2 l/min
  * Uncontrolled arrhythmia or heart failure
  * Veno-occlusive disease (sinusoidal obstruction syndrome)
* Patients with uncontrolled infections
Diagnostic Performance Evaluation of a Novel SARS-CoV-2 (COVID-19) Antigen Detection Test

The current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting

Two nasopharyngeal swab specimens will be concurrently collected on:

* adult patients hospitalized in the Infectious Diseases Department of the Centre Hospitalier Régional d'Orléans (CHRO) for confirmed SARS-CoV-2 infection,
* or symptomatic or asymptomatic subjects voluntarily accessing the COVID-19 Screening Department of the CHRO to perform a diagnostic test. COVID VIRO® diagnostic.

Specificity and sensitivity are assessed in comparison to real-time RT-qPCR results.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old) already having a SARS-CoV-2 RT-qPCR positive result within 5 days
* Adult patients (\>18 years old) requiring a SARS-CoV-2 RT-qPCR on nasopharyngeal swab specimen for any reason

Exclusion Criteria:

* Patients non wishing to participate
* Under guardianship or curatorship or safeguard of justice patients
* Inability to join the hospital other than by public transport
Determining the Most Efficient Screening Cut Off Levels for Phenylketonuria (PKU)

studying the screening of PKU in france with the new tandemMS

Nationwide cohort study of the new pku screening for patient beetwen 180 and 360 µmol/L.

Eligibility Criteria:
Inclusion Criteria:

* having screening in france

Exclusion Criteria:

* refusing neonatal screening
ANC & Malaria Diagnostic in Pregnancy

The program's overall objective is to assess the impact of a package of interventions aimed at reducing malaria-related mortality and morbidity in pregnant women and newborns by ensuring access to a package of interventions designed to optimise the detection and treatment of malaria during pregnancy as well as improving the early detection and treatment of malaria during the third trimester.

This is a cluster-randomised study in which the health facility is the unit of randomisation. 16 health facilities will be randomised to intervention and control. At the community level women will be encouraged to access ANC early in the pregnancy, attend follow-up antenatal visits throughout the pregnancy and deliver at the facility. The current recommended standard of care will be provided to all women attending antenatal and obstetric care. In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (\> 28 weeks of pregnancy), women will be systematically evaluated with selected diagnostic test for whether they have malaria parasites and treated effectively. Skilled birth attendants at the facility will be trained in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low birth weight and external/observable birth defects. In the control area, women will be provided with standard practice of care. In both areas, women will be diagnosed and treated at delivery if they are positive.

Eligibility Criteria:
Inclusion Criteria:

* Located in the geographical location of Dafra \& Do district
* Have a minimum attendance of 200 pregnant women per year

Exclusion Criteria:

* other public health facilities, private clinics and Dafra District Hospital will be excluded from the study.
Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

An observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (RA) receiving filgotinib in real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local standard of care and product label for the first time.
* Patients must be willing and able to use an electronic device to complete the study patient-reported outcome (PRO).

Exclusion Criteria:

- Participation in any other interventional or non-interventional study without prior approval from the Medical Monitor. This does not preclude inclusion of patients enrolled to national registries.