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NCT ID: NCT05759299 Not yet recruiting - Clinical trials for Airway Complication of Anesthesia

International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia

STARGATE
Start date: December 2023
Phase:
Study type: Observational

According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major peri-intubation adverse events during anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide. STARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.

NCT ID: NCT05758480 Not yet recruiting - Long COVID Clinical Trials

Characterization of the Immunometabolic Signature in Long COVID-19.

LoCo-ImMet
Start date: April 2023
Phase: N/A
Study type: Interventional

The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC).

NCT ID: NCT05758324 Not yet recruiting - Apnea, Obstructive Clinical Trials

Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea Syndrome

OLIGO-SAS
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSA) is defined by the association of clinical symptoms - drowsiness in particular - and sleep breathing disorders, objectified by measuring the apnea-hypopnea index (AHI). Apneas and hypopneas during sleep are responsible for micro-arousals and hypoxemia. In the short term, these result in daytime sleepiness with reduced alertness, difficulty driving and carrying out tasks (increased risk of road accidents and accidents at work), memory and concentration problems. , mood disorders. These disturbances lead to an impairment of the quality of life. In the long term, severe OSA (AHI > 30 events/hour) increases all-cause mortality and cardiovascular morbidity. The reference treatment is nasal ventilation by Continuous Positive Airway Pressure (CPAP). In practice, the observance and effectiveness of CPAP are limited by the sometimes difficult acceptance of cumbersome equipment, involving noise pollution and requiring the wearing of night-time equipment that some patients find difficult to bear. The alternative treatment is represented by the mandibular advancement orthosis . Lifestyle and dietary measures are always recommended. To date, no pharmacological treatment has demonstrated its effectiveness in OSA. Studies have shown that the antioxidant capacity of the blood is reduced in patients with OSA. It would be secondary to the cycles of hypoxia and reoxygenation which cause a modification of the oxidative balance, leading to an increase in free radicals. It has been observed that the serum levels of trace elements and heavy metals are higher during OSA, by deterioration of the balance of these substances due to oxidative stress and inflammation. Antioxidant therapies have reduced biomarkers of oxidative stress in apneic patients. A new path of research is opening up with the use of antioxidants and trace elements in OSA. To scientifically support the hypothesis of the action of these supplements based on trace metals on OSA, PRONUTRI wish to conduct a comparative, randomized, double-blind study versus placebo evaluating the effect of a specific complex of trace metals in the OSA.

NCT ID: NCT05750836 Not yet recruiting - Oncology Clinical Trials

Assessment and Prevention of Caregiver Burden in Oncology

PREPAC-01
Start date: July 2023
Phase: N/A
Study type: Interventional

The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life. Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month. Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support. The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.

NCT ID: NCT05750485 Not yet recruiting - Orthopedic Disorder Clinical Trials

Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

ALGISAP 2023
Start date: March 6, 2023
Phase:
Study type: Observational

Procedural sedation involves the administration of sedative medications that allow patients to tolerate painful procedures. Procedural sedation has been formally recommended by experts from the French Society of Emergency Medicine (SFMU) since 2010 and procedural sedation using propofol in emergency departments has been recommended by the American College of Emergency Physicians in 2018. Propofol monotherapy is now widely used in emergency medicine (EM) in France as part of procedural sedation for performing painful procedures, however propofol has no analgesic properties per se . Pupilometry makes it possible to study the depth of analgesia by evaluating the body's nociceptive response via the ANS by studying the pupil diameter. This technique would allow the evaluation of the analgesia level in patients sedated by PROPOFOL during the realization of painful procedures. Variations in pupil diameter during painful procedures under procedural sedation in an emergency department will be assesed in this study. Secondly, patients satisfaction following the procedure will also be evaluated by the use of the French version of the "ISAS-F", the Iowa Satisfaction with Anesthesia Scale.

NCT ID: NCT05749965 Not yet recruiting - Knee Disease Clinical Trials

Results of Unicompartmental Knee Arthroplasties in Patients Beyond Historical Indications (PUCIL)

PUCIL
Start date: March 2023
Phase:
Study type: Observational

Primary objective: To compare medial uni compartimental knee arthroplasty between patients who had a limit factor prior to the surgery ans patients who fill thé historical criteria. Secondary objectives 1 to compare survival of medial UKA between patients with one limit factor and those with multiple limits. 2. To identify the prognosis factors of failure in medial UKA in our center during the time of our analysis (2009-2015)

NCT ID: NCT05744102 Not yet recruiting - New MRI Techniques Clinical Trials

Improve MRI Diagnosis

DIAGIRM
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.

NCT ID: NCT05742321 Not yet recruiting - Corneal Dystrophies Clinical Trials

Analysis of the Genotype/Phenotype Relationship in the Fuchs' Corneal Endothelial Dystrophy in France

F3S2
Start date: June 2024
Phase:
Study type: Observational

The pathophysiology of the most common corneal endothelial dystrophies (Fuchs' Corneal Endothelial Dystrophy, FECD) is beginning to be dismembered. There is a significant heterogeneity in the clinical forms and the investigators have just highlighted a great diversity of histological forms that seem to define distinct groups.

NCT ID: NCT05738187 Not yet recruiting - Clinical trials for Recurrent Head and Neck Cancer

Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study

CRYORL
Start date: September 30, 2023
Phase: N/A
Study type: Interventional

In France, squamous cell carcinomas of the head and neck (SCCHN) are the 5th most common cancer. 60% of patients present with locally advanced tumors (stage III/IV), characterized by a poor prognosis (5-year survival not exceeding 60%). The standard treatment consists of either surgical removal followed by adjuvant radiochemotherapy or exclusive radiochemotherapy. In case of locoregional recurrence (about 40% of patients), salvage surgery can be proposed, allowing prolonged survival for less than one third of eligible patients. However, more than half of locoregional recurrences are unresectable. The standard treatment then consists of immunotherapy and/or chemotherapy for palliative purposes with a median survival of no more than 15 months. Stereotactic radiotherapy is another potentially curative option that allows a local control of 30-60% at 1 year, but at the cost of significant toxicity (up to 50% of grade 3-4 toxicities), thus limiting its indication. The issue of salvage treatment also applies to other rarer histological forms, including naso-sinus and salivary gland tumors, for which the probability of overall survival at 5 years does not exceed 65% due to locoregional evolution, despite advances in surgical techniques and the addition of radiotherapy. During the last two decades, minimally invasive interventional radiology techniques have been developed in the field of oncology. Among these techniques, cryotherapy is now commonly used for the treatment of several cancers. The multiplication of its indications is based on numerous clinical advantages (good post-operative analgesia, good toxicity profile, good tumor control). Cryotherapy could thus be a therapeutic alternative in head and neck cancers in recurrence situation in irradiated and unresectable territory, allowing to maintain a curative project in a higher proportion of patients and also to have a more favorable toxicity profile than re-irradiation.

NCT ID: NCT05735925 Not yet recruiting - Clinical trials for Hidradenitis Suppurativa (HS)

The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis

VERIMMUNE
Start date: February 2023
Phase: N/A
Study type: Interventional

Hidradenitis Suppurativa (HS) is a chronic disabling inflammatory skin disorder associated with the development of painful and purulent lesions of the folds (armpits, inguinal folds, sub-mammary glands). HS most often develops in adolescence or young adulthood and is characterized by inflammation of the pilo-sebaceous system, of progressive severity (folliculitis, nodule, abscess, fistula). The pathogenesis of HS is still poorly understood: the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggests that the disease could be due to a dysregulated immune response against microbial skin flora. Unconventional lymphocytes (UL), classically considered being at the interface of innate and adaptive immunity, play an important role in immune protection against microbial flora. But UL dysfunction has also been reported in many autoimmune diseases involving various tissues (joints, digestive tract, skin). The uncontrolled and chronic activation of these UL by skin microbiota could therefore play a role in the pathogenesis of HS.