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NCT ID: NCT05536687 Terminated - Healthy Clinical Trials

VALIDITY AND RELIABILITY OF THE 6-MINUTES WALKING TEST EVALUATED BY FEETME® INSOLES

ValiFeet6
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Currently, the guidelines for performing the 6MWT established by the American Thoracic Society and the European Respiratory Society (ATS/ERS) recommend the use of an indoor or outdoor corridor with a 30 m flat surface (6MWT30) for patients with respiratory diseases, which is also a recommendation for healthy adults. However, not all hospitals, nursing homes or clinics have a corridor of sufficient length to properly perform the 6MWT. A simple way to make the test available to more health care professionals would be to reduce the length of the hallway. In times when access to the hospital is difficult, the ability to assess functional abilities at a distance becomes essential. Today, this is becoming possible with tools such as connected watches, accelerometers, connected shoes and insoles. They give access to a quantitative analysis of walking without necessarily requiring large spaces, specialized personnel or even being in a hospital environment. The FeetMe® Evaluation device consists of connected insoles as well as a mobile application allowing the evaluation of standard clinical walking tests. This device allows a better understanding of patients' walking and is transposable in real life. The objective of the present study is to demonstrate the validity and reliability of the measurement of the distance walked during a 6-minute test with connected insoles in standard conditions (6MW30), degraded conditions (6MW10) in a clinic and at home in a healthy population divided into age subgroups. In addition, this study will investigate whether there is a relationship between 6 minutes of uncontrolled walking from real-life walking data and a standard 6-minute test.

NCT ID: NCT05536297 Active, not recruiting - Clinical trials for Age-Related Macular Degeneration

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Start date: September 26, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

NCT ID: NCT05536245 Recruiting - Addictology Clinical Trials

Analysis of the Prevalence of Violence Suffered or Committed by Patients Suffering From Addiction in a Care Facility

APREVIO
Start date: January 14, 2022
Phase:
Study type: Observational

Addictions, whether to a substance or a behavior, are often associated with violence, but their role is not well known. Despite the publication of numerous studies demonstrating the influence of addictions in acts of violence, the exploration of violence in the context of addiction remains very limited. In order to fill this gap, teams members of the Addictopôle Occitanie in collaboration with a regional team are preparing the launch of a concrete longitudinal study to analyze the incidence of violence in populations suffering from addiction, but also to evaluate the need in terms of management of this violence. Hypotheses: To analyze the prevalence of violence in populations suffering from addiction and the need for treatment of such violence using a robust protocol based on an anonymous questionnaire to assess the violence experienced or committed by a patient, taking into account his/her environment. This study would allow us to better understand the effects of addictions on the severity and frequency of violence, but also to implement concrete and adapted solutions in order to limit it. This study could lead to the creation of a regional Observatory of Violence related to Addictions. Translated with www.DeepL.com/Translator (free version)

NCT ID: NCT05536232 Recruiting - Type1 Diabetes Clinical Trials

Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet

KetoDiab
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

Low Carbohydrate Diet (LCD) (< 130 g of carbohydrate per day) and ketogenic diet (< 50 g of carbohydrate per day) are popular among patients with type 1 diabetes (T1D). In most cases, LCD allow a better glycemic control and a important decrease of insulin requirements that cannot, however, be the sole result of low carbohydrate intake. However, due to the increase production of ketone bodies and the decrease of the insulin/glucagon rate, this diet is not without risk in T1D patients and some of them develop ketoacidosis. Type 1 diabetes is a autoimmune disease defined by the destruction of the pancreatic beta cells by the effector T cells, in condition of low regulatory T cells (Tregs). Indeed, some nutrients could regulate the plasticity and the function of Tregs, and be involved in the control of some autoimmune diseases in animals models thanks to a direct effect on immune cells of the digestive tract or an indirect effect by microbiota modulation. The study hypothesises that LCD may be able to restore residual insulin secretion in some patients by modulating immunity. The metabolic mechanisms leading to the effects described in patients with T1D patients under LCD have not been studied : in particular, there is no data on the evolution of the residual insulin secretion and no immunological parameter has been studied on these patients.

NCT ID: NCT05536219 Recruiting - Clinical trials for Severe Respiratory Infections

Impact of the Presence of Anti-interferon Autoantibodies on the Viral Load in Severe Respiratory Infections

INTERFERICUS
Start date: November 8, 2022
Phase:
Study type: Observational

Type I interferons (IFN-I) production is induced by the detection of viral molecules, such as RNA or DNA viral strands, through pattern recognition receptors (PRR) present on many immune cell types. Despite a minimal concentration, IFN-I secretion activate the secretion, by neighbouring cells, of more than 700 proteins with antiviral properties (inhibition of viral replication, destabilization of virus membranes, etc.). IFN-I constitute therefore one of the major first line of defence established by the immune system in response to viral infection. Briefly, during the Coronavirus disease (COVID-19) pandemic, several teams including ours, highlighted a lack of IFN-I response in approximately one in five individuals presenting a severe form of COVID-19. Interestingly, within a large part of them, in vitro investigations revealed the presence of autoantibodies presenting neutralizing capacities against alpha and/or omega interferons This finding confirms the deleterious role of anti-IFN-I autoantibodies on the antiviral immune response and the key role of IFN-I pathway regarding defences against COVID-19 infection. Furthermore, those observations pave the way to interesting research that would allow understanding the underlying pathophysiological mechanisms of severe viral respiratory infection. The research hypothesis are: i) IFN-I deficiency could induce severe forms of viral infections which could lead to intensive care admission ii) IFN-I deficiency could increase viral loads in nasopharyngeal samples, and be associated with protracted viral clearance iii) The frequency of viral co-infections may be higher in case of IFN-I antiviral pathway blockade, iv) severe forms of respiratory viruses' infections could be induced by other anti-cytokine autoantibodies. In addition to confirming research hypotheses recently mentioned, the aim of this clinical protocol will be to assess the impact of antiviral innate immune response alterations in severe respiratory infections.

NCT ID: NCT05536180 Completed - Clinical trials for Coronary Artery Stenosis

Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

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

The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

NCT ID: NCT05536167 Completed - Clinical trials for Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts

Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family

Start date: December 12, 2022
Phase:
Study type: Observational

The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.

NCT ID: NCT05536115 Recruiting - Dry Socket Clinical Trials

Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket

Start date: December 13, 2022
Phase:
Study type: Observational

Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket. ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket. The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .

NCT ID: NCT05535946 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT - Maintenance

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

NCT ID: NCT05535751 Completed - Bacteremia Clinical Trials

Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections

CARBAPENEM
Start date: July 20, 2022
Phase:
Study type: Observational

Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.