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NCT ID: NCT06253351 Completed - Adolescents Clinical Trials

Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age With Type 1 Diabetes

BFHado
Start date: March 13, 2024
Phase:
Study type: Observational

The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.

NCT ID: NCT06249659 Completed - Surgery Clinical Trials

Impact of Extubation Location After Surgery on Perioperative Times

Extub_Loca
Start date: September 1, 2020
Phase:
Study type: Observational

The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates.

NCT ID: NCT06249646 Completed - Liver Injury Clinical Trials

Contained Hepatic Vascular Injuries Following Liver Trauma

Start date: January 1, 2022
Phase:
Study type: Observational

Background: For thirty years, a major shift in the management of liver trauma has been seen. Contained hepatic vascular injuries (CHVI), including pseudo aneurysms and arteriovenous fistula, are often feared due to their risk of secondary bleeding. Nonetheless, knowledge of CHVI is scarce and no guidelines on their management have been set. The investigators aimed to validate the risk factors of CHVI, identify associated morbidities, and establish a management protocol. Study Design: A retrospective study on 318 liver trauma from a level 1 trauma center over the last 15 years, comparing the presence or not of CHVI. Univarious and multivarious analyses were performed. A comparison of the management of CHVI was also performed.

NCT ID: NCT06242951 Completed - Clinical trials for Cystic Fibrosis in Children

Cardiopulmonary Fitness in Children With Cystic Fibrosis Compared to Healthy Children

VOmuco
Start date: January 31, 2023
Phase:
Study type: Observational

Cystic fibrosis is the most common severe genetic disease with autosomal recessive transmission in the Caucasian population. Its prognosis has improved considerably since the creation of Cystic Fibrosis centers (CF centers) and the improvement of symptomatic management (nutrition, antibiotic therapy, transplantation, etc.). Thus, the median survival rate is now 46 years, whereas it was 5 years in 1963. The current challenges for cystic fibrosis patients are therefore twofold: to continue to improve their survival, and to improve their quality of life (QoL) to promote "healthy ageing" with this pathology that begins in childhood. In 1980, the World Health Organization (WHO) stated that functional capacity explorations best reflected the impact of chronic disease on health-related quality of life. Impairment of physical activity is common to chronic diseases, as in cystic fibrosis, where respiratory impairment and denutrition have been shown to contribute to reduced exercise tolerance and increased dyspnoea. Measurement of the maximum oxygen consumption (VO2max) by a cardiopulmonary exercise test (CPET) is regarded as the gold standard exercise test in the measurement of aerobic exercise capacity. In 2005 Pianosi et al. found that for children with cystic fibrosis, the rate of decline of VO2max measured by CPET was predictive of poorer quality of life. Continuing to study the determinants associated with impaired aerobic fitness in cystic fibrosis offers the hope of considering appropriate therapies to further improve the quality of life of these patients. In recent years, the arrival and widespread use of CFTR protein modulators in children has been a real turning point and makes it possible to envisage a drastic change in the history of this disease and its prognosis in the long term. Thus, in this study, the investigators aimed to assess the aerobic fitness, assessed by a CPET, of children with cystic fibrosis, and to compare the results with healthy controls. Secondly, investigators wanted to identify the predictive factors of VO2max in children with cystic fibrosis.

NCT ID: NCT06242548 Completed - Diet Habit Clinical Trials

How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude

DIAREAL
Start date: June 2, 2023
Phase: N/A
Study type: Interventional

To date, no study has shown the effects of diets (normoglucidic or ketogenic) on type I diabetes during physical activity (hiking, ski touring) at altitude. The ketogenic diet in the general population is increasingly studied scientifically, but no clinical trial has studied it in type I diabetic patients during physical activity at altitude. Similarly, no study has investigated the effects of this diet on ketone and blood glucose levels in athletes during physical activity at altitude. Therefore, its impact on blood glucose and ketone levels during exercise at altitude is unknown in healthy and type I diabetic subjects. Since the investigators are studying ketonemia at altitude, and since ketonemia depends on insulin and carbohydrate intake, it is necessary to also study a control group with the same diet, in order to analyse whether the results obtained at altitude are related to the diet alone or to the diet in the context of diabetes. In order to avoid certain biases and confounding factors, the type I diabetic group will be compared to a control group of healthy subjects, in which the subjects have the same diet as the diabetic group. This is a pioneering study, of significant interest because the ketogenic diet is recent and rapidly increasing in interest in diabetic patients, with no scientific data for mountain physical activity. Doctors, diabetologists and sports doctors, are still without data to advise their diabetic patients who wish to follow a ketogenic diet on the benefits/risks of this diet, or to explain to them how to react to physical activity in the mountains.

NCT ID: NCT06238557 Completed - Quality of Life Clinical Trials

Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life

PICS
Start date: September 8, 2022
Phase:
Study type: Observational

The goal of this observational study is to show the patient discomfort during their stay in intensive care is directly linked to the occurrence of a post ICU syndrome at 3 months. The main questions it aims to answer are : - Evaluate the value of the IPREA score on quality of life impairment a 3 months ; - Identify the 3 areas of discomfort most associated with progression to a post ICU syndrome at 3 months ; - Define a threshold value for the IPREA score ; - Correlate clinical assessment and psychological follow-up with the to the prediction of a post ICU syndrome ; - Establish a correlation between IPREA score and time to first rise - Establish a correlation between identified factors of post ICU syndrome and IPREA score

NCT ID: NCT06235138 Completed - Malocclusion Clinical Trials

Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery

Start date: May 15, 2017
Phase:
Study type: Observational

Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. A few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. The advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (CAD-CAM) techniques for patient-specific implant (PSI) fabrication has enabled new methods for managing the jawline in orthognathic surgery. The aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.Methods: A virtual simulation of a Le Fort I osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3D) model of each patient's skull using ProPlan CMF software (Materialise, Leuven, Belgium). Computer-assisted osteotomy saw-and-drill guides and patient-specific implants (PSIs, titanium plates and angle implants) were produced and used during the surgery. The investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3D-photographs using the VECTRA H2 3D imagine system (Canfield Scientific, **).

NCT ID: NCT06235073 Completed - Clinical trials for Cochlear Hearing Loss

Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)

ICRobMan
Start date: July 1, 2023
Phase:
Study type: Observational

Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. WThe investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied. This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control.

NCT ID: NCT06234917 Completed - Clinical trials for Chronic Pain Syndrome

Increasing Sensori-Motor Rhythm Activity by EEG-Neurofeedback to Reduce the Impact of Pain on Daily Functioning

SMR-Pain
Start date: January 4, 2021
Phase: N/A
Study type: Interventional

Background: Chronic neuropathic pain associated with peripheral neuropathies cannot be attributed solely to lesions of peripheral sensory axons and likely involves alteration in the processing of nociceptive information in the central nervous system in most patients. Few data are available regarding EEG correlates of chronic neuropathic pain. The fact is that effective cortical neuromodulation strategies to treat neuropathic pain target the precentral cortical region, i.e. a cortical area corresponding to the motor cortex. It is not known how these strategies might modulate brain rhythms in the central cortical region, but it can be speculated that sensorimotor rhythms (SMRs) are modified. Another potent way of modulating cortical rhythms is to use EEG-based neurofeedback (NFB). Rare studies previously aimed at relieving neuropathic pain using EEG-NFB training. Methods/Design: The objective of this single-centre, single-blinded, randomized controlled pilot study is to assess the value of an EEG-NFB procedure to relieve chronic neuropathic pain in patients with painful peripheral neuropathy. A series of 32 patients will be randomly assigned to one of the two following EEG-NFB protocols, aimed at increasing either the low-β(SMR)/high-β ratio (n=16) or the α(μ)/θ ratio (n=16) at central (rolandic) cortical level. Various clinical outcome measures will be collected before and one week after 12 EEG-NFB sessions performed over 4 weeks. Resting-state EEG will also be recorded immediately before and after each NFB session. The primary endpoint will be the change in the impact of pain on patient's daily functioning, as assessed on the Interference Scale of the short form of the Brief Pain Inventory. Discussion: The value of EEG-NFB procedures to relieve neuropathic pain has been rarely studied. This pilot study will attempt to show the value of endogenous modulation of brain rhythms in the central (rolandic) region in the frequency band corresponding to the frequency of stimulation currently used by therapeutic motor cortex stimulation. In the case of significant clinical benefit produced by the low-β(SMR)/high-β ratio increasing strategy, this work could pave the way for using EEG-NFB training within the armamentarium of neuropathic pain therapy.

NCT ID: NCT06234813 Completed - Clinical trials for Glanzmann Thrombasthenia

Targeting TFPI With Concizumab to Improve Haemostasis in Glanzmann Thrombasthenia Patients: an in Vitro Study

GLAT
Start date: April 6, 2023
Phase: N/A
Study type: Interventional

Glanzmann thrombasthenia is a rare genetic disorder caused by the absence or the dysfunction of the main receptor present on the surface of platelets, integrin αIIbβ3 or GPIIb-IIIa. The lack of this protein on the surface of platelets no longer allows these blood cells to bind to each other. This binding corresponds to the process of platelet aggregation. Generally, local measures will control nasal and superficial bleeding whereas platelet transfusions are used to control or prevent life-threatening. The main complication of this treatment is the risk of developing anti-αIIbβ3 antibodies directed against the absent protein and platelet transfusion therapy can become ineffective. Activated recombinant factor VII (rFVIIa) provides an alternative treatment for GT patients who develop such antibodies. However, this therapy has a short duration of efficacy, requiring repeated intravenous administrations every 2 to 3 hours. There is a new treatment, Concizumab, which has not yet been marketed. This treatment acts on TFPI (tissue factor pathway inhibitor). TFPI is a protein that occurs naturally in the body and prevents blood cells from binding to each other. Concizumab works by blocking TFPI, which may allow sufficient clotting to prevent bleeding. This treatment could replace recombinant activated factor VII (rFVIIa) because it has the advantage of a much longer duration of efficacy (about 3 days) and is administered subcutaneously.