cyrilzakka/clinical-trials huggingface dataset:
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. CD is a common inflammatory bowel disease (IBD), frequent (150,000 patients in France and 1.5 million in Europe), disabling and incurable. The environmental factors, and in particular diet, play a major role in the pathogenesis of CD. The prevalence of CD is steadily increasing in highly industrialized countries, where the Western diet rich in saturated fats and refined sugars, is blamed for this to explain this true pandemic. On the other hand, enteral nutrition, exclusive or partial, is known to be effective in the initial treatment of CD, especially in pediatrics.

There are a number of evidence in favor of a nutritional management nutritional management of caloric restriction during inflammatory diseases such as psoriasis and rheumatoid arthritis,whose physiopathology is similar to that of IBD.

To date, and despite patient concern, there is no consensus nutritional in the management of CD to influence the natural course of the disease.

The investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric restriction in patients with CD.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 to 65 years old
* Established diagnosis of Crohn's disease with a minimum disease duration of 3 months
* Patient with mild to moderate Crohn's disease defined by a fecal calprotectin ≥ 250 μg/g and a CDAI score between 150 to 300
* Medical treatment of Crohn's disease stable for at least 3 months
* Patient compliant with an intermittent caloric restriction during 16 weeks
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and having signed the informed consent

Exclusion Criteria:

* Patient with a BMI \< 18.5kg/m2
* Patient having a weight loss of 5% the first month and 10% during the first 6 months
* Patient with active ano-perineal lesions
* Patient with an ostomy
* Patient with eating disorders (anorexia, bulimia)
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:

  * Pregnant, parturient or breastfeeding woman
  * Minor person (non-emancipated)
  * Adult person under legal protection (any form of public guardianship)
  * Adult person incapable of giving consent and not under legal protection
* Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Use of N-Acetylcysteine During Liver Procurement

Randomized prospective study on the impact on the post-LT outcome by the infusion of N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).

Anti-oxidant agents have the potential to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT). In this randomized prospective study, we seek to study the impact on the post-LT outcome of the infusion of N-acetylcysteine (NAC) during the liver procurement procedure.

Potential grafts, assigned to adult candidates with chronic liver disease enlisted for first LT, will randomly be included in a one-to-one ratio with a sequential closed envelope single-blinded assignation procedure to either the NAC protocol or in the standard procedure (without NAC).

The NAC protocol comprises: a systemic NAC infusion (30 mg/kg) one hour before the beginning of liver procurement; a loco-regional NAC infusion (300 mg through the portal vein) just before cross-clamping.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive subjects with chronic liver disease undergoing first Liver Transplantation receiving deceased donor livers

Exclusion Criteria:

* recipients with acute liver disease;
* paediatric patients or adult patients receiving a liver from a paediatric donor;
* patients undergoing multiple-organ transplantation;
* patients undergoing re-transplantation of the Liver;
* patients undergoing living donor Liver Transplantation
Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study

The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor.

Comprehensive multiparametric (mp) MRI which includes T2 weighted imaging, dynamic contrast enhanced (DCE) imaging and DWI, was proven to be efficient tool in differentiating benign and malignant bladder lesion. morphological characterization of malignant bladder lesion (mapping/size/morphology/stalk), T stage differentiation and histological grade discrimination.

The application of mpMRI in NMIBC with its added value as non invasive tool for initial staging and after primary resection could be a new helpful method for better diagnosis, risk categorization, refining the indications of second resection and proper determination of adjuvant treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to give informed consent.
2. Patients with primary or recurrent papillary NMIBC.
3. Normal cardiac, hematological, and renal functions.

Exclusion Criteria:

* 1. Patients with history of previous radiotherapy or systemic chemotherapy. 2. Patients suffering from immuno-deficiency or other malignancies. 3. Patients with high serum creatinine (more than 2 mg/dl). 4. Patients with contraindication to MRI (claustrophobia-pacemaker- metallic prosthesis).
Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients

Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients

This study aimed to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients. This prospective, single-blinded study included patients hospitalised for influenza infection aged 1 year to 18 years, at MacKay Children's Hospital, Taiwan, between December 2017 and December 2019. The primary outcomes were respiratory symptom severity and the signs that presented within hospitalisation. The durations of fever and hospital stay were also documented. The secondary outcome measures were serial changes in the virus titres, as detected by real-time polymerase chain reaction. Totally 54 patients were enrolled (28 in the control group and 26 in the combination group). There were no differences in the patients' baseline characteristics between the groups. The time to defervescence was significantly shorter in the combination group than the oseltamivir group (13.2 hours vs 32.1 hours, p=0.002). The decrease in the virus titre was more pronounced from days 1 to 3 (log Δ13) in the combination group than the oseltamivir group.(log Δ13: 39% vs 19%, p=0.001). In paediatric settings, combination therapy may be used selectively among patients with a history of febrile convulsion or families anxious about the discomforts associated with the fever itself.

Eligibility Criteria:
Inclusion Criteria:

- age 1 year to 18 years; body temperature higher than 38 °C; presence of one of the following symptoms-cough, sputum production, sore throat, rhinorrhoea, myalgia, headache, or fatigue presenting within 72 hours from symptom onset; laboratory-confirmed influenza infection (including rapid test or PCR-confirmed influenza A or B); and clinical requirement for hospitalisation. Antiviral treatment was initiated within 48 hours after admission.

Exclusion Criteria:

- a history of allergy or contraindication to the study medications; the administration of medications with macrolides (ex: azithromycin, erythromycin), naproxen or neuraminidase inhibitor use within 72 hours; current use of any antibiotic; and the presence of an immunocompromised state due to steroid use, human immunodeficiency virus infection, chronic kidney disease, renal failure, chemotherapy or radiotherapy in half year, or innate immunodeficiency.
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

The formation of this patient is single-center prospective intervention. It consists of collecting data from patients suspected of pSS from standardized biological clinical data and imaging examination and additional pathology.

* Sjögren patients will be followed at inclusion, 2y, 3y, 4y, 6y, 8y and 10 years. Blood, fluid, sells and urine samples will be collected at inclusion, 4y et 10y.
* Non-Sjögren controls will be followed at inclusion and 4y and samples will be collected at the same visits.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...)
* Patient affiliated with Social Security
* Patient who has signed written informed consent

Exclusion Criteria:

* Refusal to participate
* Pregnant and lactating woman
Improving Asthma Care Through Parental Empowerment

The overall aim of this study will be to perform a prospective randomized clinical trial of an enhanced version of the IMPACT DC intervention involving short-term case management to facilitate PCP follow-up appointments and to provide education for parents about how to communicate more effectively with their children's PCPs as a means (1) to improve the rate of utilization of primary care services for ongoing asthma care and (2) to enhance the self-efficacy of parents in their interactions with their children's provider regarding the child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC Asthma Clinic.

Asthma is the most common chronic disease of childhood, and it disproportionately affects urban, minority, and disadvantaged children. When implemented correctly, existing evidence-based guidelines from the National Heart, Lung, and Blood Institute (NHLBI) improve pediatric asthma care and outcomes. One key component of these guidelines is the importance of longitudinal care as part of a partnership among patient, parents, and a healthcare provider. Such a partnership depends on effective communication of healthcare status by parents to providers. Improving the communication skills of inner-city parents may improve their ability to obtain more effective longitudinal asthma care within their primary care homes and thereby to improve their child's asthma health outcomes. IMPACT DC ("Improving Pediatric Asthma Care in the District of Columbia") is a locally validated emergency department (ED) based intervention that improves multiple measures of asthma care and outcomes through an intensive short-term program of asthma education, medical care, and care coordination. In spite of these successes, achieving increased subsequent contact and partnership with primary care providers (PCPs) for asthma care after the intervention has not been successful. Therefore, for the current study, we propose to assess the effectiveness of an enhanced version of the existing IMPACT DC intervention consisting of short-term case management by trained asthma educators.

Eligibility Criteria:
Inclusion Criteria:

* ages between 12 months and 12 years, inclusive
* prior physician diagnosed asthma
* ability of the parent to identify a specific PCP for their child
* public insurance covering the child
* parent/guardian available for interview

Exclusion Criteria:

* significant medical co-morbidities
* enrollment in another asthma research intervention study
* unavailability for telephone follow-up
* primary language of the caregiver other than English
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial

The purpose of this study is to determine the effect of 10 mg of oral zinc given daily between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of more than 6 mg/dL at 24 ± 6 hours of life on hyperbilirubinemia and phototherapy.

Neonatal hyperbilirubinemia is a common problem occurring in nearly 5-25% neonates.Inhibition of enterohepatic circulation is one of the therapies being tried for neonatal jaundice. Studies have suggested that in a neonate, the postulated enterohepatic pathway is of a magnitude that could be significant in the overall body economy of bilirubin.Zinc has also been investigated for its role in decreasing the STB levels by inhibiting enterohepatic circulation. There have been animal studies which have investigated the role of zinc in decreasing the serum bilirubin levels. The mechanism proposed is that zinc salts precipitate Unconjugated bilirubin from unsaturated micellar solution of bile salts and consequently inhibit the enterohepatic circulation of bilirubin. This is the first study to evaluate the role of zinc in neonatal jaundice.

Study Design: In this randomized placebo controlled clinical trial neonates born at ≥35 wk of gestation and with total serum bilirubin ≥6mg% were given either zinc gluconate (n = 148) or placebo (n = 146) in a dose of 10mg per day between days 2 and 7 of life. Jaundice was assessed clinically and total serum bilirubin estimated using spectrophotometry. Infants were followed up clinically until discharge and then again at day 7 of life. Hyperbilirubinemia was defined as total serum bilirubin ≥15mg%.

Results: Incidence of hyperbilirubinemia was comparable in zinc and placebo groups (OR 0.95, 95% CI 0.50-1.67, p=0.92). The requirement of phototherapy was similar in the two groups (OR 0.81, 95% CI 0.41-1.61, p=0.55). The mean hours of phototherapy in the zinc group were also similar in the two groups (p=0.63). No significant difference with respect to mean levels of bilirubin (mg/dL) at 72±12 hours of age was observed in two groups(zinc 11.3±3.3,placebo 11.5±3.8,p=0.63). No significant adverse effects of zinc were noted.

Conclusion: Twice daily zinc administration in a dose of 10 mg/day does not reduce hyperbilirubinemia in at risk neonates in the first week of life.

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Eligibility Criteria:
Inclusion Criteria:

* Neonates born at ≥35 weeks gestation and with total serum bilirubin ≥ 6 mg/dL at 24±6 h of life.

Exclusion Criteria:

* Rh incompatibility
* Those given exchange transfusion/ phototherapy within 24 h of age.
* Major gross congenital anomaly
* Anticipated to require neonatal intensive care or required neonatal intensive care for more than 24 h.
* Systemic sepsis
Evaluation of the VisuXL® Performance on Ocular Surface Discomfort

VisuXL® is a medical device that is effective in various ocular surface disorders (ocular dryness, changes in the continuity of the corneal and conjunctival surface, environmental stress, exposure to UV and ionizing radiation, prolonged use of videoterminals, etc.). Therefore, the aim of this study is to demonstrate that the clinical benefits and quality of life of the swimmers, exposed for a long time to water added with chlorine, are strongly linked to the unique composition of the long-term VisuXL® medical device.

This is a post-market, monocentric, open-label, randomized study of superiority, with the untreated eye considered as a comparator for the eye treated with VisuXL®, to demonstrate the effectiveness of VisuXL® in professional water-polo athletes exposed to pool water after VisuXL® ocular instillations for 2 months. Considered the category of subjects to study, the study is to be considered a fact-finding pilot study in a particular category of subjects.

The study population will be enrolled only after having signed the informed consent; in each enrolled subject, only one eye will be treated with VisuXL®, while the other no, as will be considered the comparator, so the two randomized groups will be divided by treated eyes:

* Untreated control eye
* Eye treated with VisuXL®

Each enrolled subject will be instructed to instill, TID, 1-2 drops of VisuXL® always in the same eye during the entire study, according to the present modality:

* Morning
* Before training (at least one hour before entering the pool)
* After training (maximum one hour after the end of the activity) Subjects will continue to instil 1-2 drops of VisuXL®, TID, always in the same eye, even in days without training (including weekends).

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged 14 to 33 years
2. Schirmer test I\> 10 mm at 5 '
3. Willingness to participate in the study and possibility to sign the ICF; for athletes aged \<18 years: parents' agreement for the participation of the child in the study
4. Discomfort of the ocular surface

Exclusion Criteria:

1. Pathologies of the anterior segment
2. Diagnosis of autoimmune diseases (eg SEL, Sjogren)
3. Diagnosis of metabolic diseases (eg diabetes, thyroid malfunction/disorder)
4. Entropion
5. Trichiasis
6. Deficiency of androgens sex hormones
7. Taking medications that can interfere with the secretion of the lacrimal gland
8. Connective tissue disease
9. Prior eye surgery
10. Hypersensitivity to the active ingredients contained in VisuXL®
11. Use of artificial tears in the 15 days before the start of the study
Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass

Central and peripheral arterial pressure decoupling occurs in some clinical conditions like sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as the use of catecholamines.

The aim of this study is to evaluate the pulse wave's speed as a marker of central and peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary bypass during cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled patient for coronary or valvular surgery with cardiopulmonary bypass
* Cardiopulmonary bypass is at least 90 minutes
* Written consent is needed

Exclusion Criteria:

* Patient with heart rate disorder
* Patient with aortic dissection
* Dobutamine/milrinone/levosimendan treatment before surgery
* Patient with heart rate due to a pacemaker
Effect of Oral Health Educational Program on the Oral Health Related Quality of Life in a Group of Children with Chronic Kidney Disease

Children with CKD are at higher risk for poor oral health28 due to factors such as compromised immunity, medication side effects, and dietary restrictions. Poor oral health can lead to pain, infection, and difficulties in eating and speaking, which in turn negatively affects their quality of life. This study is designed to address this gap by exploring how an oral health educational program could improve the oral health-related quality of life (OHRQoL) in this group.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-10 years old.
* Diagnosed with Chronic Kidney Disease

Exclusion Criteria:

* Children with other systemic diseases.
* Parents that refuse the participation of their children.
The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).

The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).

The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric cardiac surgery in Boston's Children Hospital since 1994.

There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial was designed to determine the efficiency of the del Nido cardioplegia when compared to multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp times.

For the analysis of two cardioprotection protocols, it is essential to compare groups equal in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp time. The research required elimination of all the unnecessary variables.

The patients undergoing aortic valve replacement procedure were selected as a study population. A group of 150 patients will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).

The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).

Eligibility Criteria:
Inclusion Criteria:

* qualification for isolated aortic valve replacement
* age\>18 years
* given consent for the study

Exclusion Criteria:

* reoperation
* allergy to lidocaine
* coronary artery disease requiring surgical or percutaneous intervention
* pregnancy
* ejection fraction\<30%
* massive aortic calcification ("porcelain aorta")
Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers

The aim of the study was to assess the effect of intraoperative oxygen (O2), which was applied at 30% and 50% concentrations on patients who had undergone septoplasty surgery, on Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Oxidative Stress Index (OSI).


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18-60 years,
* ASA I-II risk class with a minimum operative time of 1.5 hour(s) for whom septoplasty operation under elective conditions

Exclusion Criteria:

* metabolic, endocrine, hepatic, cardiac, or renal diseases,
* malignancies and who used a drug with antioxidant properties such as vitamin E-C
* acetylcysteine in the last 48 hours,
* patients requiring intraoperative 100% O2 inhalation