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NCT ID: NCT06458517 Not yet recruiting - Clinical trials for Head and Neck Neoplasms

Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers

RADIO-PBM
Start date: September 2, 2024
Phase: N/A
Study type: Interventional

The aim of this feasibility, prospective, single-center trial is to compare an intra-oral Photobiomodulation (PBM) via the Caremin650TM device (NeoMedLight) and a transcutaneous PBM via the ATP 38® device (Swiss Bio Innov) in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity. PBM session will be carried out first at the rate of two sessions per week for preventive purposes, and then, in case of occurence of grade 1 mucositis, three sessions per week with curative purpose.

NCT ID: NCT06458504 Not yet recruiting - SARS-CoV-2 Clinical Trials

Viral Infection of HSPC Impacts Hematopoiesis

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

We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis.

NCT ID: NCT06458491 Completed - Clinical trials for Posterior Tibial Nerve Stmulation

Urinary Symptoms After Posterior Tibial Nerve Stimulation

TENSI
Start date: March 1, 2024
Phase:
Study type: Observational

Overactive bladder (OAB) is a common syndrome affecting 7 million people in France, very often of idiopathic origin. Current therapeutic management of OAB primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. However, the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness. In the event of persistent symptoms, the management of OAB is essentially based on the prescription of an anticholinergic medication. The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses. But the side effects of anticholinergics are known and some are very common (particularly dry mouth and constipation). The principle of the posterior tibial nerve stimulation (TNS) by implanted (percutaneous) or adhesive (transcutaneous) electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder. Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session. TNS is also possible transcutaneously (TENS) with daily 20-minute stimulation of the ankle, in the form of a self-administered treatment at home, over a period of 3 months. This treatment modality seems equivalent to the percutaneous approach. Given its numerous advantages, the use of TENS is therefore expanding, and is currently recommended by many learned societies (SIFUD, AFU). In this study, we wish to evaluate the TENSI+ medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder.

NCT ID: NCT06458114 Recruiting - Caregiver Feeling Clinical Trials

Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.

Start date: May 7, 2022
Phase:
Study type: Observational

Introduction : The birth of a child is usually a happy event that caregivers working in delivery rooms share with families. Unfortunately, newborns sometimes need palliative care as soon as birth occurs. In France, neonates who were liveborn under 24+0 weeks amenorrhea (date of last mentrual period) or weighing less than 500 grams) usually have non resuscitation in delivery room [Ancel 2020]. Some of them are considered as viable (referring to World Health Organisation definition : either term ≥ 22 + 0 amenorrhea week or birth weight ≥ 500 grams), others as nonviable (term < 22 AW and birth weight ≤500 grams). In France, legislative development over last two decades have allowed the emergence of palliative care in delivery room. In a French survey in 2016, 83% of maternities were confronted at least once a year with this situation.

NCT ID: NCT06458088 Recruiting - Type1diabetes Clinical Trials

Advanced Glycation Products and Vascular Complications in Type 1 Diabetes

DIABAGE
Start date: January 25, 2023
Phase:
Study type: Observational

DIABAGE (Diabetes Advanced Glycation End products) study was conducted between 2015 and 2017. It included 196 type 1 diabetic patients with more than 10 years of diabetes. It revealed a significant association between the occurrence of vascular complications and tissular Advanced Glycation End products (AGEs) as well as with some circulating AGEs. This protocol is a continuation of that initial research.

NCT ID: NCT06457945 Not yet recruiting - Clinical trials for Idiopathic Hypersomnia

Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions

NARCOWANDERING
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Mind wandering is a state in which attention turns away from the external environment or current task to focus on internal thoughts (past experiences, future events, planned actions...). Humans are thought to spend at least one third of their waking lives in this state. Mind wandering can be assessed experimentally by investigating mental content during well-controlled tasks. In this case, task-unrelated thoughts likely to arise during tasks of varying cognitive demand are studied. Mind wandering (=task-unrelated thoughts) has a deleterious effect on cognitive performance in most paradigms, particularly those requiring sustained attention and executive control. However, this phenomenon could also have cognitive benefits, although knowledge on this issue remains limited. For example, it has been suggested that mind wandering could promote creativity, anticipation of future scenarios and prospective memory. In a recent behavioural study, we investigated the cost and benefit of mind wandering in an implicit visual-motor probabilistic learning task (ASRT - Alternating Serial Reaction Time Task). ASRT distinguishes between two fundamental processes: visuomotor performance and implicit statistical learning. While the former reflects visuo-spatial discrimination efficiency, the latter refers to the unintentional acquisition of probabilistic regularities of external inputs. Reduced visuo-spatial accuracy and faster but less accurate responses have been observed during periods of mind-wandering. On the other hand, mind-wandering was associated with enhanced statistical learning reflecting improved predictive processing. Whereas the study of the neural correlates of mind-wandering is constantly growing, the mechanisms triggering mind-wandering are far from being unravelled, but may involve sleep pressure. Thus, the frequency of mind wandering tends to increase after sleep deprivation or during attention-demanding cognitive tasks, during which neurophysiological markers of local sleep appear. These markers of sleep during wakefulness are frequently observed in hypersomnolence disorders. They are generally defined by the appearance of slow waves (typical of slow wave sleep, SWS). Nevertheless, sleep intrusions during wakefulness may not be limited to non-rapid-eye-movement (NREM) sleep but also concern REM sleep. REM sleep is the sleep state when the most intense forms of dreaming occur, and could therefore be phenomenologically similar to the reverie of mind wandering. Thus, daytime mental wandering could be triggered by intrusions of REM sleep during wakefulness. Patients with narcolepsy type 1 (NT1) exhibit frequent REM sleep onset during daytime wakefulness. The study of ASRT in this population therefore offers a unique opportunity to investigate the role of REM sleep intrusions in mind wandering. The hypothesis is that mind wandering would be observed more frequently during the ASRT task in NT1 patients (with REM sleep intrusions during wakefulness) than in patients with idiopathic hypersomnia (IH) (with NREM sleep intrusions during wakefulness) and patients with subjective hypersomnolence (little or no sleep intrusion). Furthermore, it could be possible that REM sleep-related mind wandering would be associated with impaired visuomotor performance in terms of accuracy, but improved predictive processing (probabilistic learning) compared to NREM sleep intrusions or no sleep intrusion during the task.

NCT ID: NCT06457451 Not yet recruiting - Cystic Fibrosis Clinical Trials

Impact of a Coordinated Dietetic-adapted Physical Activity Program on the Percentage of Lean Body Mass in Adults With Cystic Fibrosis Treated With Elexacaftor-Tezacaftor-Ivacaftor: Multicentre Randomised Controlled Trial

DIAPASOM
Start date: September 2024
Phase: N/A
Study type: Interventional

Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis. Digestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function. In 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion. Elexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities. Adapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS. Our hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.

NCT ID: NCT06457386 Not yet recruiting - Bacteremia Clinical Trials

Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3

VIRSTA-VAL
Start date: December 2024
Phase: N/A
Study type: Interventional

Staphylococcus aureus is the most frequent cause of both healthcare-associated and community-acquired bloodstream infections worldwide. Infective endocarditis (IE) has been detected in 5-17% of cases and is a determinant of poor prognosis. The investigators developed a score (the VIRSTA score) based on patients' characteristics to rule out IE with high confidence (negative predictive value (NPV) above 99%) in patients with SAB. This score, with a cut-off of 3 has been externally validated by two international studies which have also established its high NPV. The 2023 European society of cardiology (ESC) guidelines state that echocardiography should be considered in all patients with Staphylococcus aureus bacteremia (SAB) using risk scores (including VIRSTA score) to guide the use or not of echocardiography. While recommended, the investigators think that VIRSTA score must be evaluated in terms of patients' outcome.

NCT ID: NCT06455904 Recruiting - Breast Cancer Clinical Trials

Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study

PROTECT-07
Start date: May 30, 2024
Phase: N/A
Study type: Interventional

The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. If exercise may be an effective preventive strategy, it seems important to prescribe the most efficient exercise modality. Among them, concentric cycling (i.e., classic cycling) can significantly induce metabolic stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to demonstrate the superiority of a training program based on concentric cycling during chemotherapy compared to standard treatment. The duration of the training program is 15 weeks with one session per week.

NCT ID: NCT06455891 Not yet recruiting - Atopic Dermatitis Clinical Trials

MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement

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

It is an open study, explorative, proof of concept study concerning mycobiota dysbiosis implication in AD patients with head and neck involvement.