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NCT ID: NCT05510479 Completed - Visual Impairment Clinical Trials

Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002)

TIL002
Start date: May 5, 2021
Phase:
Study type: Observational

OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.

NCT ID: NCT05509179 Completed - Clinical trials for Neonatal Phototherapy

Evaluation of the Implementation of Neonatal Phototherapy With BiliCocoon® in Maternity Wards

BiliCocoon
Start date: May 17, 2022
Phase:
Study type: Observational

Free bilirubin jaundice is a common condition in the neonatal period: 80% of newborns have some degree of hyperbilirubinemia within days of birth, but only 5-10% require treatment to prevent complications or to treat the cause of jaundice. The major complication is neurological toxicity, the most severe form of which is kernicterus, a severe and irreversible hyperbilirubinemic encephalopathy involving the basal ganglia. The main treatment for jaundice is phototherapy, which may or may not be combined with exchange transfusion in the most severe forms of jaundice caused by uncontrolled severe hemolysis. Phototherapy acts by interaction of light with bilirubin located in the skin, transforming it into photo-derivatives directly eliminated in the stool and urine. The hepatic stage of bilirubin transformation, limiting its elimination in newborns, is thus short-circuited. The interaction between bilirubin and light on the skin is maximal in the 460-490 nm spectrum. Phototherapy technology has evolved considerably since the discovery of its effectiveness by Dr. Cremer in 1958, with a constant progression in its effectiveness and indications. The light sources used in phototherapy devices are varied and today all use Light Emitting Diode (LED) technology. The models used today in phototherapy directly emit a blue wavelength, whose spectrum between 420 and 490 nm is the most effective. The effectiveness of the treatment also depends on the exposed skin surface, the homogeneity of the light intensity and the distance between the skin and the light source. Other phototherapy equipment is also available, including the BiliCocoon® (Bilicocoon Bag, Eurocare®). This is a so-called "proximity" equipment. Thanks to the routing of the luminous flux by an optical fiber, the terminal light panel is put directly in contact with the baby's skin. This device allows an intensive and homogeneous radiation (35 µW/cm²/nm), and a wide coverage of the body surface (1200 cm²). The Bilicocoon® is a safe and controlled therapy that is performed in the mother's room, thus avoiding any separation, allows, during the treatment, to continue breastfeeding, is easy to install, does not require goggles and therefore no scope or hospitalization and thus reduces the workload of the nursing staff. A continuous treatment of 12 hours is required, interrupted only for the baby's change. Several sessions are sometimes necessary, and in case of failure, the child can be put under intensive phototherapy. The BiliCocoon® was implemented in our maternity hospital in August 2020 to avoid mother-child separations and to limit the number of hospitalizations in neonatology. The objective of our study is to evaluate the impact on the number of hospitalizations in neonatology since its implementation, the failure rate (unchanged or increased bilirubinemia at the end of the Bilicocoon® session requiring a relai by intensive phototherapy) and the average length of stay of neonates treated for jaundice in the NDBS maternity unit of the GHPSJ. The secondary objectives are to evaluate the failure rate of Bilicocoon® : need for intensive phototherapy after a Bilicocoon® session (Bilicocoon® failure is defined by an unchanged or increased bilirubinemia at the end of the 12-hour session) and to evaluate the length of stay of children who had Bilicocoon® alone or intensive phototherapy alone for the same causes.

NCT ID: NCT05507437 Completed - Clinical trials for Acute Kidney Injury Due to Sepsis

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury

Start date: November 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

NCT ID: NCT05505968 Completed - Clinical trials for Lumbar Radicular Pain

Interest of Virtual Reality Headset During Injection in Patients With Back Pain and Sciatica

Epi-RéV
Start date: August 8, 2022
Phase: N/A
Study type: Interventional

For a few years, publications have been published concerning the use of virtual reality headsets in the field of medicine and particularly in various specialities. It has been evaluated in different studies on pain and anxiety in various medical situations. A study has shown a correlation between a decrease in pain in a clinical way during a painful stimulation and a decrease in certain areas of the brain. In this context, the use of the virtual reality headset could then be used in medical interventions that may be painful for the patient. The lumbar radicular pain is a common disease in the world. The epidural injection is one of the treatment of this pathology. He may be performed to reduce the pain but sometimes this act is painful. Most of the time this procedure is performed without premedication. To the knowledge of the investigators, there are currently no studies on the assessment of pain under a virtual reality headset during the performance of an epidural injection in rheumatology. The aim of the study is to demonstrate that the Virtual Reality Headset can reduce the pain and the anxiety during an epidural injection.

NCT ID: NCT05498831 Completed - Acute Pain Clinical Trials

Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room.

SUURGE
Start date: August 9, 2022
Phase:
Study type: Observational

Until now, the Mulhouse emergency department used a protocol for severe pain based on morphine titration. In order to relieve patients' pain more quickly, a new protocol was implemented based on the use of intranasal sufentanil. The primary objective of the study is to prospectively assess the efficacy of the new pain management protocol implemented in the emergency department and based on intranasal sufentanil in combination with paracetamol and codeine for pain of moderate intensity and intranasal sufentanil in combination with paracetamol followed by morphine titration for severe pain. This new pain management protocol has been updated as part of the upcoming French High Authority for Health hospital certification, for which pain management is one of the priority criteria. This research does not change the routine care given to the patient.

NCT ID: NCT05497947 Completed - Swallowing Disorder Clinical Trials

Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

SOAL-VF
Start date: July 3, 2021
Phase:
Study type: Observational

A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

NCT ID: NCT05495607 Completed - Sepsis Clinical Trials

Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants

Start date: December 1, 2018
Phase:
Study type: Observational

Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality. We aim to retrospectively report the first multicenter French experience of CARPEDIEM® use and evaluate the efficacy, feasibility, outcomes, and technical considerations of this new device in a population of neonates and small infant. Compared to adult's device continuous renal replacement therapy with an adapted machine allowed successful blood purification without severe complications even in low birth weight neonates.

NCT ID: NCT05495529 Completed - Neoplasm Metastasis Clinical Trials

Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors

Start date: January 1, 2013
Phase:
Study type: Observational

This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk. Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated. The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process. Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.

NCT ID: NCT05494970 Completed - ORL Cancer Clinical Trials

Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment.

RadioT HBD
Start date: October 13, 2022
Phase:
Study type: Observational

Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy. The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment. Each patient will be followed during 3 months post-radiotherapy (follow-up for up to 12 months post-inclusion).

NCT ID: NCT05493176 Completed - Weightlessness Clinical Trials

A 5-day Dry Immersion Study on 20 Healthy Male Volunteers

VIVALDI2
Start date: August 23, 2022
Phase: N/A
Study type: Interventional

Dry immersion (DI) is a ground-based model of prolonged conditions of simulated microgravity. Dry immersion involves immersing the subject in water covered with an elastic waterproof fabric. As a result, the immersed subject, who is freely suspended in the water mass, remains dry. Within a relatively short duration, the model can faithfully reproduce most physiological effects of actual microgravity, including centralization of body fluids, support unloading, and hypokinesia. The main objective of the present study is to investigate the physiological effects of 5 days of dry immersion in 20 healthy male subjects, and to obtain DI-in-Men Reference Dataset. A set of measurements will assess the changes in the cardiovascular, neuro-ophthalmological, hematological, metabolic, sensorimotor, immune, muscle and bone systems.