cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Endometrial Cavity After Endometrial Ablation

The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy.

The purpose of this study is to evaluate the shape, size and appearance of the inside of the uterus six months following an endometrial ablation procedure. Half of the participants will have their ablation performed with a hydrothermal ablation device and the other half will have their ablation performed with a device that uses radiofrequency energy. Participants are randomly assigned to one or the other device.

A vaginal ultrasound will be performed before the procedure and again at six months post-procedure.

The inside of the uterus will be visualized via hysteroscopy before the procedure and again at six months post-procedure. Measurements will be taken and the investigator will compare photos taken pre-procedure and six months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women Not pregnant and no future pregnancy desired Willing to randomize the device used for the ablation Willing to undergo diagnostic hysteroscopy with office-based anesthesia 6 months post-ablation

Exclusion Criteria:

* Pregnancy or desiring future pregnancy Endometrial hyperplasia Presence of active endometriosis Active pelvic inflammatory disease Previous endometrial ablation procedure
First Complementary Foods and the Infant Gastrointestinal Microbiota

This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.

The introduction of solid foods plays a role in shaping the microbial communities of the gastrointestinal microbiota. This randomized, controlled, single-blinded trial will evaluate the effect of four infant foods (oatmeal cereal, carrot puree, prune puree, beef and gravy puree) on the gastrointestinal microbiota of exclusively human milk fed infants that have not previously consumed solid foods and who are developmentally ready for the introduction of solid foods.

Eligibility Criteria:
Inclusion Criteria:

* Infant was born vaginally
* Infant was born full term
* Infant has no significant gastrointestinal medical issues/diagnoses (e.g., gastroesophageal reflux, malabsorption syndromes, Celiac disease, Crohn's disease, or physician diagnosed or suspected food allergies)
* Infant is at least 5 months old, but not 8 or more months old
* Infant consumes an exclusively human milk liquid diet only
* Infant has not yet begun consuming solid foods
* Infant is developmentally ready to begin consuming solid foods (i.e., has good head and neck control, can sit upright when supported, and has at least doubled their birth weight)
* Infant has not had antibiotics within the past month
* Infant's nursing mother has not had antibiotics within the past month
* Parent/legal guardian is at least 18 years old

Exclusion Criteria:

* Infant is not developmentally ready to begin solid foods
* Infant has a family history of food allergy
Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration

The aim of this research study is to characterize the fermentation of chitin-glucan fiber by assessing the volatile compounds released in the breath. For this purpose, an interventional study with control will be performed. After a single administration of 4.5 g of chitin-glucan fiber, the kinetic of production of exhaled volatile compounds (such as H2, methane, SCFAs,...) will be measured during twelve hours. These results will be compared to the exhaled volatile compounds measured during twelve hours after supplementation with 4.5g of maltodextrin (placebo).


Eligibility Criteria:
Inclusion Criteria:

* Woman or man, aged of 18 to 40 years
* Body mass index (BMI) between 18 and 25 kg/m2
* In good general health as evidenced by medical history and physical examination
* Non-smoker
* Caucasian
* For women: use of highly effective contraception
* H2 - producer as evidenced by the screening test (described in latter section)
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Subjects presenting gastro-intestinal disorders such as ulcers, diverticulitis and inflammatory bowel diseases
* Subject presenting allergy or food intolerance (lactose, gluten,...)
* Subjects with psychiatric problems and/or using antipsychotics
* Current or recent (\< 4 weeks) intake of antibiotics, probiotics, prebiotics, fiber supplement, and/or any products modulating gut transit
* Feeding particular diet such as vegetarian diet or hyper protein diet
* Chronic intake of drug, excepted contraceptive drug
* Pregnant or lactating woman or woman who did not use highly effective contraception
* Subjects who drink more than 3 glasses of alcohol per day (\> 30 g of alcohol per day)
* Subjects having participated to another clinical trial 1 month before the screening test visit
* Subjects presenting an allergy or intolerance to one component of the product tested
The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects

In order to evaluate the effect of CYP3A5\*3 allele on the pharmacokinetics of sildenafil, udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean healthy male subjects whose genotype of CYP3A5 had been determined.

The aim of this study is to evaluate the different effect of the CYP3A5 genotype on the pharmacokinetics(PK) of sildenafil, udenafil, and vardenafil in healthy male subjects. Twenty one healthy male subjects with CYP3A5\*1/\*1, \*1/\*3, or \*3/\*3 were enrolled. An open-label 3-way crossover study was performed with a week washout. A single oral dose of PDE5I (100 mg sildenafil; 200 mg udenafil; 20 mg vardenafil) was administered, respectively. After a single oral dose of phosphodiesterase type 5 inhibitor (PDE5I), plasma levels of the parent and the major metabolite were measured up to 24 or 48 h.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject whose CYP3A5 genotype was determined

Exclusion Criteria:

* Subject whose CYP3A5 genotype was not determined
Adult Outcomes of Children With CAPS

The patients included in this study were followed up in the Internal Medicine and Paediatrics Departments of the Lille CHU, the Paediatric Rheumatology and Immunology Department of the Necker Enfant Malade Hospital in Paris and the Paediatric Rheumatology Department and Internal Medicine of the Bicêtre Hospital in Paris. All patients selected presented one of the 3 CAPS clinical phenotypes (CINCA/NOMID, Muckle-Wells or Cold Urticaria). The mutation and the determination of the variant had to be confirmed by genetic analysis.

Patient data were collected from their medical records, retrospectively. Data collected concern childhood period from appearance of symptoms, adulthood period, in the last year and patients' way of life and quality of life upon the assessment. In addition, we collected demographic data related to the patients' lifestyle (intoxications, living arrangements, level of education) and we conducted individual telephone interviews lasting 15 minutes to complete a quality of life questionnaire including the SF36 questionnaire.

The study aimed to describe the clinical symptoms of patients in adulthood and to assess quality of life. We also wanted to compare the clinical phenotypes of patients according to their genetic variant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FCAS, Muckle-Wells or NOMID/CINCA;
* age \< 16 years at the apparition of the first symptoms of the disease;
* age ≥ 16 years old at inclusion
* follow-up in a CEREMAIA reference or competence center.

Exclusion Criteria:

* Age \< 16 years at inclusion;
* non-consenting patient
Population Pharmacokinetic (PK) Study of Multiple Doses of Cubicin® (Daptomycin) 10 mg/kg in Critical Care Patients Having Bacteremia, Endocarditis or Skin Soft Tissue Infections Due to Gram Positive Bacteria With Various Degrees of Renal Failure

Treatment of infections in critically ill patients remains a significant challenge to intensivists world-wide with persisting high mortality and morbidity. Compelling evidence suggests that source control of the pathogen and appropriate antibiotic therapy remain the most important interventions to improve patients' outcome, the latter including the administration of a suitable molecule at an optimized dosage regimen.

Daptomycin is the first representative of a new family of antibiotics, the cyclic lipopeptides. Its bactericidal effect against Gram-positive bacteria, including meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in critically ill patients having infections due to resistant Gram positive strains.

Unfortunately, no PK study has been performed in infected critically ill patients without renal replacement therapy. A vast array of pathophysiological changes can occur in infected critically ill patients, leading to changes in volume of distribution and clearance of antibiotics in these patients, which may affect the antibiotic concentration at the target site.

It is therefore important to better characterize daptomycin PK in infected patients with various degrees of renal failure in order to define optimal dosing regimens.

This project aims to identify optimal daptomycin administration schemes in critical care patients with various degrees of renal impairment


Eligibility Criteria:
Inclusion Criteria:

* Patients of two sexes aged 18 to 85 years,
* Hospitalized in one of the intensive care unit participating in the study,
* Under mechanical ventilation,
* Having skin or soft tissue infection, bacteremia or endocarditis caused by Gram positivebacteria susceptible to daptomycin,
* Having given written consent to participate to the study.
* Patients with severe sepsis and septic shock will also be included because it's the very population that may benefit from daptomycin treatment and it's important to get data for these patients in order to optimize their treatment.

Exclusion Criteria:

* Pregnant or lactating women
* Obese subjects (body mass index \> 40 mg/m2)
* Patients requiring extrarenal replacement therapy,
* Patients having already received daptomycin during the 21 days prior to inclusion,
* Known hypersensitivity to daptomycin,
* History of myopathy
* creatine phosphokinase \>5 upper limit of normal
* Patients not affiliated to a social security scheme,Patients deprived of their liberty by judicial or administrative decision
Risk Profile for Atrial Fibrillation

The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes (remodeling) in the atrial tissue and which can help to predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, as measured with use of parameters obtained with echocardiography, circulating biomarkers and other relevant clinical data. Ultimately this risk profile can be used to guide type of (rhythm) control therapy in individual patients with atrial fibrillation.

Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of patients with AF that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size or volume could be a useful tool to select patients that will benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.It seems also plausible that recurrent atrial fibrillation within one month after start of rhythm control is associated with a different risk profile than late atrial fibrillation recurrences.During this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy.

Eligibility Criteria:
Inclusion Criteria:

* Short-lasting symptomatic paroxysmal or persistent AF;
* Rhythm control strategy is preferred;
* No contra-indication for oral anticoagulation;
* Age \> 18 years;
* Written informed consent

Exclusion Criteria:

* Total history of heart failure and/ or of severe valvular disease \> 3 years;
* Severe valvular disease;
* Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;
* Post-operative AF.
Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients

Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12, Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is giving to patients with their routine supplements and followed up for 6 months.

Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.

Sun exposure and supplement use questionnaire:

A registered dietitian asked each subject for information on sun exposure, vitamins, medications, and any other supplement usage before each blood sample was taken.

Lab analysis included serum hydroxy vitamin D levels pre and 3 months postoperative.

Descriptive statistics which include both the means and standard deviations were calculated on the study variables. A paired sample t-test was used to determine if there was a significant difference in mean values pre and post vitamin D supplementation. An independent sample t-test was used to assess for significant differences in group (control vs. vitamin D supplement) means. A p-value \< 0.05 was considered statistically significant. Statistical analyses were done using SPSS Version 21 (SPSS, Chicago, III, USA).

Eligibility Criteria:
Inclusion Criteria:

* morbidly obese and eligible for bariatric surgery

Exclusion Criteria:

* under 18 and over 60 years of age
* elevated serum vitamin D and calcium
* pregnant and lactating women
Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation

This study is a single arm, single center, prospective and open exploratory study.

About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.

Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：

1. Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
2. Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
3. Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W

Eligibility Criteria:
Inclusion criteria:

* adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence;
* have not received the first line of standard treatment or have received the first line of standard treatment failure;
* at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2;
* Child-Pugh class A or B (Child-Pugh score ≤7 );
* adequate organ function;
* a predicted life expectancy of at least 3 months.

Exclusion Criteria:

* allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies;
* receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study;
* evident concern of GI bleeding (local active ulcer, Guaic test at least ++) or a history of GI bleeding within the preceding 6 months;
* uncontrolled pleural or peritoneal effusion;
* pulmonary tuberculosis, sarcoidosis, HIV infection, or active HBV or HCV infection;
* uncontrolled cardiac arrhythmia (including QTC interval ≥500 ms);
* hepatic encephalopathy;
* Known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma;
* pregnant or lactating women or women contemplating pregnancy;
* severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators;
* esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.
Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome

OBJECTIVES:

I. Determine whether Cushing's syndrome and stress-induced pseudo-Cushing's syndrome can be differentiated by evaluating endogenous corticotropin-releasing hormone activity.

PROTOCOL OUTLINE: Patients undergo a 30-hour infusion of deuterated cortisol with peripheral and petrosal vein measurements of adrenocorticotropin hormone (ACTH) and corticotropin-releasing hormone (CRH). Patients also have a 2-day, low-dose dexamethasone suppression test.

Patients with ACTH tumors are referred for pituitary surgery as indicated. Patients without Cushing's syndrome are entered as controls. During scheduled radiologic procedures, these subjects undergo ACTH and CRH sampling from the petrosal vein or cavernous sinus following a deuterated cortisol infusion.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Suspected adrenocorticotropin hormone (ACTH)-dependent Cushing's syndrome No pregnant women Effective contraception required of fertile women
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

Visualize surgical needles inserted in the prostate, under the ultrasound modality.

In order to help the surgeon to remove the prostate during a laparoscopic intervention, our goal is to provide an innovative medical device that merges intra-operative ultrasound and endoscopic images.

We have already achieved the proof of concept of a device that merges ultrasound and endoscopic images. The objectives of this clinical trial are to accompany the maturation of the fusion device and to make the initial assessments of its Medical Service.

The main difficulty is to visualize markers (surgical needles) under both modalities , in order to merge them.

Eligibility Criteria:
Inclusion Criteria:

* of-age patient
* patient for whom a radical prostatectomy is planned
* patient with a prostate volume between 30g and 100g
* patient affiliated to the social security or equivalent
* Written informed consent

Exclusion Criteria:

* contraindication
* patient who has undergone a significant prostate resection
* patient who has undergone a prostate irradiation
* patient concerned by the L1121-6 à 8 of the health public code
Cardiotoxicity of Cancer Therapy (CCT)

The objective of this study is to define the clinical significance of mechanistic biomarkers (including Neuregulin-1Beta) and novel echocardiographic measures of cardiac function in predicting the incident risk of cancer therapy cardiotoxicity.

The overall study objectives are:

1. To determine the longitudinal relationships between circulating markers, such as Neuregulin (NRG)-1Beta levels and incident risk of adverse cardiovascular outcomes in patients exposed to anthracycline, trastuzumab, or a combination of the two agents. We hypothesize that a sustained increase in NRG-1Beta, indicative of enhanced cardiac stress with exposure to chemotherapeutic agents, is predictive of an increased risk of cardiac dysfunction and heart failure.
2. To study the single nucleotide polymorphism (SNP)/haplotype variation in pathways of interest, such as the Neuregulin/Epidermal Growth Factor (ErbB) signaling pathway, on incident risk of adverse cardiovascular outcomes. We hypothesize that there will be SNP/haplotypes variations that are associated with incident cardiovascular outcomes.
3. To determine the longitudinal relationships between novel echocardiographic measures, such as strain and strain rate and incident cardiac dysfunction in patients exposed to anthracycline, trastuzumab, or a combination of the two agents. We hypothesize that early declines in strain and strain rate are predictive of an increased risk of future cardiac dysfunction and heart failure.
4. To explore the changes in biomarkers such as NRG-1Beta levels and the relationships with novel echocardiographic measures of cardiac function.
5. To create a biobank as a future resource for additional questions in novel biomarkers and genetics.
6. To determine the long-term effects of cancer therapy cardiotoxicity by following patients yearly for 5 years after their exposure to cancer therapy, with the option to extend up to an additional 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* HER-2 positive breast cancer designated to receive trastuzumab chemotherapy with or without prior exposure to anthracycline-based chemotherapy
* Non-HER-2 positive breast cancer designated to receive treatment with an anthracycline-containing regimen

Exclusion Criteria:

* Other contraindications to trastuzumab or anthracycline chemotherapy.
* Vulnerable populations