cyrilzakka/clinical-trials huggingface dataset:
A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension

The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary arterial hypertension (PAH) belonging to the nice 2013 updated classification group 1
* PAH diagnosis confirmed by historical right heart catheterization where in the absence of pulmonary vein obstruction and/or significant lung disease pulmonary artery wedge pressure (PAWP) can be replaced by left atrium pressure (LAP) or left ventricular end diastolic pressure (LVEDP) (in absence of mitral stenosis) assessed by heart catheterization
* World Health Organization (WHO) functional class (FC) I to IV
* PAH-specific treatment-naïve participants or participants on PAH-specific treatment
* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) test at screening and a negative urine pregnancy test at the first administration of study intervention
* A female participant must not get pregnant and must agree not to donate eggs during the study and for a period of up to 4 weeks following the end of study

Exclusion Criteria:

* Participants with PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis, and persistent pulmonary hypertension of the newborn
* Participants with the following diseases: pulmonary vein stenosis; bronchopulmonary dysplasia
* Severe hepatic impairment, example, Child-Pugh Class C, at screening
* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 weeks after the last dose of study intervention
* Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
* Participant with PAH associated with open shunts, with congenital cardiac abnormalities such as univentricular heart, with pulmonary hypertension due to lung disease, and renal dysfunction
Pantoprazole on Insulin Secretion in Diabetes

The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.

Type 2 diabetes mellitus (T2DM) has become a major health problem worldwide with a high prevalence and related mortality, and a high rate of disability in the economically active. In Mexico the prevalence was 14.4% reported one of the highest in Latin America and estimated a cost of $ 778 million allocated for this disease in 2010, i.e., the tenth place worldwide. Within its pathophysiology are alterations in the secretion and insulin action, qualitatively and quantitatively, which implies a challenge for long-term metabolic control with the pharmacological arsenal available today. Since the function of pancreatic β cell decreases as a function of time and lack of control is essential metabolic find drugs that can preserve pancreatic cell mass and even promote neogenesis, with the aim of restoring the physiological secretion of insulin have been lost in the early stages of type 2 diabetes to achieve optimal glycemic control sustained over time to avoid complications and reduce the costs associated with the disease.

Have been evaluated in animal models with promising results Proton Pumps Inhibitors (PPI) for the restoration of glucose and the preservation of pancreatic cell function, including promoting its growth through increased levels of gastrin, which appears to act as a growth factor. However, at present no such mechanisms have been evaluated in humans, it would be interesting to assess the effect of administration of a PPI such as pantoprazole is, on the phases of insulin secretion in patients with T2DM recent diagnosis.

Material and Methods: Randomized, double-blind, placebo controlled clinical trial. Population: 14 drug-naive adults patients with T2DM and obesity. Hyperglycemic-hyperinsulinemic clamp to assess the phases of insulin secretion. Intervention for 45 days: pantoprazole 40mg or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Drug-Naive
* No complications
* HbA1c 7 to \< 9%
* Fasting plasma glucose \< 210mg/dl
* Body mass index 30.0 to 39.9 and body weight stable for at least 3 months before the study
* Non smokers
* Blood pressure \< 130/80

Exclusion Criteria:

* Diabetes complications
* Women pregnant or stage of lactation
* Hepatic, renal, autoimmune disease
* Take drugs with effects on insulin secretion
* Zollinger-Ellison disease
* Gastric or pancreatic tumor.
Global Positioning Satellite and Accelerometry to Assess Human Locomotion (ACTI GPS)

The aim of the study is to validate the association of the GPS and accelerometer tools in order to assess the humain locomotion during exercises.

The hypotheses are:

1. GPS and accelerometer together can assess the human locomotion
2. GPS and accelerometer together can assess the energy expenditure during exercises

The assessment of the physical activity (PA) and the energy expenditure (EE) is very important to estimate the morbi-mortality. However, each of these tools has its advantages and disadvantages but none of them provides a measure of all components dimensions that characterize the associated PA and EE. The current scientific prospects for measurement of PA tend to associate several measuring devices. To date, these perspectives are facilitated by technological developments and miniaturization of various devices. Thus, the purpose of the study is to evaluate wether GPS associated with accelerometer are able to assess the humain locomotion and energy expenditure during exercises.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18
* Informed consent of the participant
* Able to understand the protocol of the study
* Register to the social health insurance
* No exercise limitation

Exclusion Criteria:

* No informed consent of the participant
* pregnant woman
Erector Spinae Block for Thoracoscopic Surgery

This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.

Sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (ESPB) with levobupivacaine (intervention group) or 0,9% saline (control group). ESPB is performed under general anaesthesia before surgery.

Postoperative pain medication incudes acetominophen, NSAIDs en parenteral morphine (patient controlled analgesia).

Following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. Furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. On the first postoperative day, pain intensity is registered at 8.00 o'cock AM and 8.00 o'clock PM. Opioid consumption is registered as a second parameter of postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thoracoscopic pulmonary sleeve resection or lobectomy
* Age 18 years or older

  * American Society of Anesthesiologists (ASA) health status class I-III
  * Informed consent

Exclusion Criteria:

* Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
* Contraindication for NSAIDs
* Chronic opioid use
* Pregnancy
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CD
* Moderately to severely active CD
* Bodyweight \>= 40 kilogram (kg)
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
* Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
* Diagnosis of short gut or short bowel syndrome
* Presence of an ileostomy, colostomy or ileoanal pouch
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Presence of abdominal or perianal abscess
* Presence of rectovaginal fistulas or perianal fistulas with \>3 openings
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Impact of a Front-of-pack Nutrition Labelling on Food Purchases in Contract Catering

This controlled trial investigates the impact of the implementation of a front-of-pack nutrition label, namely Nutri-Score, on foods and beverages sold in a contract catering in France on the nutritional quality of purchases.

The introduction of front-of-pack nutrition labelling is thought to help consumers making healthier food choices at the point-of-purchase. In 2017, the French government has selected the Nutri-Score as single front-of-pack nutrition label to be applied on food products sold in French supermarkets, on a voluntary basis.

Some studies have found that the Nutri-Score would help consumers making healthier choices. Nevertheless, its impact has been demonstrated in experimental supermarkets and its implementation only concerns products sold in groceries and supermarkets, as it is stated in the official decree. The potential impact of the Nutri-Score in contract catering remains unknown, while this sector represents a growing share of out-of-home catering and that the promotion of the Nutri-Score in this sector is now part of the National Public Health Plan.

Thus, the objective of the present study is to investigate the impact of the implementation of the Nutri-Score in contract catering restaurants on the nutritional quality of food purchases. The trial will be conducted using a quasi experimental before/after design with a comparison group. Data on purchases will be collected regularly through receipts, and the nutritional quality of purchases will be evaluated over time on two pairs of sites. In each pair of sites, one site will receive an intervention (Nutri-Score) and one site will be a control site. Within each pair, the sites will be comparable in terms of food offer and consumers profile.

Eligibility Criteria:
Inclusion Criteria:

* all individuals purchasing in the contract catering restaurants will be included.

Exclusion Criteria:

* No
Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.

The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment.

The metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin. A low value glycosylated hemoglobin indicates a good metabolic control, and has been shown to be associated with a better prognosis regarding diabetic complications. Type 2 diabetes is a disease with a profound genetic component. Peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation, lipid and glucose metabolism. Peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver, kidney, heart, skeletal muscle and adipose tissue.

Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors, members of the super family of ligand activated transcription factors. Specifically, thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism. These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle.

This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone.

Eligibility Criteria:
Inclusion Criteria:

* Fulfills all requirements for treatment with pioglitazone.
* Willing to start treatment with pioglitazone.

Exclusion Criteria:

* Has previously participated in this study.
* Is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.
Multifocal vs Monofocal IOL in Congenital Cataract Surgery

The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs.

PURPOSE: To assess the impact on visual development of multifocal versus monofocal intraocular lenses (IOLs) implantation in children following congenital cataract surgery.

DESIGN: Retrospective interventional consecutive case series. METHODS: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. Corrected distance visual acuity (CDVA), refractive error and ocular motility disorders were evaluated after a follow-up greater than 4 years.

Eligibility Criteria:
Inclusion Criteria:

* unilateral congenital cataract
* bilateral congenital cataract

Exclusion Criteria:

* other ocular pathologies (such as glaucoma, microphthalmia, micro - or megalocornea, persistent fetal vasculature, retinal congenital disease, corneal scar, traumatic cataracts)
* systemic diseases (such as chromosomal abnormalities, prematurity or mental retardation)
Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.

Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* =/\> 18 years of age
* Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary physician
* Prescribed daptomycin as determined by the primary physician
* Informed consent granted

Exclusion Criteria:

* \< 18 years of age
* Allergy to daptomycin
* Patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections
* Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)
* Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
* Inability to obtain informed consent
* Pregnant and/or breastfeeding women
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period

The purpose of this observational study is to examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period before and after rabeprazole treatment in LaryngoPharyngeal Reflux Disease(LPRD) patients.

This clinical study is a multicenter, open-label, prospective, observational study of outpatients who visit the department of otolaryngology (branch of medicine that deals with diagnosis and treatment of diseases of the ear, nose, and throat) under routine practice. This study will examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period (before and after rabeprazole treatment) in patients with LaryngoPharyngeal Reflux Disease(LPRD). Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux, those needing rabeprazole sodium treatment according to the doctor's discretion are eligible for enrollment. This study will explore the correlation between RSI and RFS and will examine major reflux symptoms and types of lesions, to find the most reliable factors in diagnosing LPRD and judging therapeutic effectiveness of treatments. LPRD is a disease with various symptoms and causes lesions by exposing the upper respiratory system to gastric acid and stomach contents. RSI and RFS can be used to diagnose LPRD in a relatively objective manner by scoring items of symptoms and lesions particular to LPRD. Evaluations will be performed four times from baseline to week 12. Observational Study - one tablet of rabeprazole 10 mg or 20 mg once daily for 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux
* Patients who need rabeprazole treatment according to the doctor's discretion
* Patients who have signed an informed consent document indicating that they understand the purpose of and procedures required for the observational study and they agree to provide their information

Exclusion Criteria:

* Patients who took rabeprazole within the past one month
* Patients who are hypersensitive to any of rabeprazole or benzimidazole
* Patients with severe hepatic impairment
* Pregnant or lactating women
Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation

Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years.

Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic, flexible, symptomatic flatfoot
* Patients aged between 8 and 14 years

Exclusion Criteria:

* Joint laxity
* Neuromuscular disorders
* Neurological conditions
* Traumatic sequelae
* Iatrogenic flatfoot
* Congenital flatfoot due to tarsal synostosis
Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders

The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.

Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.

In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a long GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"

Eligibility Criteria:
Inclusion Criteria:

Patients should fulfill the "Bologna criteria" for poor ovarian response

At least two of the following three features must be present:

i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \<7 follicles or AMH \<1.1 ng/ml).

Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).

Exclusion Criteria:

-