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NCT ID: NCT05031234 Completed - Colectomy Clinical Trials

Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery

AGORA
Start date: December 17, 2020
Phase: N/A
Study type: Interventional

Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

NCT ID: NCT05031182 Recruiting - Laparoscopy Clinical Trials

Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

VLAP
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

NCT ID: NCT05031013 Not yet recruiting - Dialysis Clinical Trials

Trace Elements Concentration in Dialysis

EMTDialyse
Start date: September 2021
Phase:
Study type: Observational

In hemodialysis population the study team finds high concentrations of toxic trace elements (2 times higher than the general population for cadmium 4 to 13 times for lead). Several recent studies suggest a role of chronic exposure to cadmium in the loss of residual renal function, osteoporosis, graft failure, arteriosclerosis, as well as in excess cardiovascular mortality. Moreover, in hemodialysis population, a deficit of certain essential trace elements (manganese, selenium, zinc) is observed. For example, in the population undergoing chronic hemodialysis, a zinc deficiency is found in 40 to 78% of cases. Zinc is a cofactor of more than 70 enzymes. In this observational cohort, the study team seeks to understand the impact of HD and HDF on the serum concentrations of heavy metals and also oligometals, by studying their concentrations in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

NCT ID: NCT05030805 Recruiting - Ovarian Cancer Clinical Trials

Transcriptional Map of Ovarian Cancer at the Single Cell Level

Ova-seq
Start date: May 1, 2022
Phase:
Study type: Observational

In 2020, epithelial ovarian cancer (EOC) accounts for 313,959 new cases and 207,252 deaths worldwide. The standardized 5-year net survival of a woman with EOC is 44% for cases diagnosed between 2005-2010. This is because 2 out of 3 cancers are found at an advanced stage with invasion beyond the ovaries to the entire peritoneum or distant metastasis. Treatment of EOC is currently based on platinum-based chemotherapy combined with paclitaxel and maximal cytoreduction surgery. Newer combination therapies may be introduced such as bevacizumab and oral poly ADP-ribose polymerase (PARP) inhibitors. Despite the combination of different therapeutic modes, the 5-year survival has not progressed much since the 1980s. The development of new and more effective therapies is essential but requires a better understanding of cancer heterogeneity and the identification of new therapeutic targets. Cancer heterogeneity results from genetic and transcriptional variations between tumors but also between cells of the same tumor. This heterogeneity has an impact on the development of the tumor and its resistance to treatment. One of the methods to study this heterogeneity is single cell RNA sequencing (scRNAseq) which allows to analyze individually and simultaneously the gene expression (transcriptomics) of thousands of cells. Studies on EOC using this technique have already been performed but they were based on small numbers with very different tumor types and stages. The objective of this protocol is to characterize by scRNA-seq the architecture and microenvironment of primary and secondary tumors of 50 patients with EOC at the single cell level and to correlate the data with the clinical characteristics of the patients, especially during recurrence and/or chemoresistance, in order to identify the molecular parameters allowing tumor cells to acquire survival, invasion, metastasis and chemoresistance capacity as well as to carry out the inventory of cell populations within the different sites of EOC. We will also analyze the interaction between tumor cells and the microenvironment, by studying on the one hand the involvement of immune cells in the antitumor response and on the other hand how tumor cells modulate the microenvironment to make it permissive to the development of the EOC. We will compare the data obtained for each patient with healthy tissue (from the same patient) in order to determine the common and specific tumor molecular signatures in EOC, the latter point allowing us to evaluate the intra and inter-patient variability. Similarly, the comparison of the transcriptomic profile of the same tumor subtype in several patients will allow us to determine if certain transcriptional perturbations are ubiquitous. The identification of these common pathways would allow the discovery of potential therapeutic targets. Furthermore, the molecular processes leading to chemoresistance are still unknown. We will investigate whether known chemoresistance markers are present in tumor cells from primary sites and whether their presence correlates with the response to treatment in patients. We will also study the molecular mechanisms of resistance to treatment in our patients which will ultimately allow the development of new therapies. We will also try to find new prognostic markers which is made possible by the clinical follow-up of the patients. The existence of this heterogeneity will be confirmed by complementary genetic analyses of the genome and exome (search for mutations, variation in gene copy number or chromosome copy number, epigenetic effects) by different molecular biology techniques (qPCR, NGS sequencing) and the markers that will be identified can be confirmed by histochemical analysis.

NCT ID: NCT05030740 Active, not recruiting - Clinical trials for Dissection of Thoracic Aorta

French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft

Start date: December 18, 2014
Phase:
Study type: Observational

Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in terms of surgical mortality and severe morbidity. However, the data concerning the long-term fate of these stents are insufficient. For this reason, the French National Health Authority (HAS) requests a 5-year follow-up in relation to the renewal of insurance reimbursement for these stent-grafts. Therefore, this long-term observational study has been set up.

NCT ID: NCT05030701 Recruiting - Cancer Clinical Trials

Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not

MYCATRES
Start date: July 13, 2021
Phase:
Study type: Observational

Non-tuberculous mycobacteria (NTM) are increasingly common and have a poor prognosis: 5-year mortality can reach 40 to 50%, depending on the type of mycobacteria and the immune system of the host involved. Cancer patients are at higher risk of infectious morbidity and mortality, which may be due to disease-related immune dysfunction, immunosuppressive effects of chemotherapy, or long-term placement of a vascular catheter. However, data on the treatment of NTM species that cause infections and the disease characteristics of these pathogens in cancer patients are limited despite the growing cancer population worldwide. Recently, M. avium infections have been described in patients suffering from cancers (hematological or not), in particular in patients receiving checkpoint inhibitors. Although the proportion of M. avium pneumonia in retrospective series is low (0.8-2%), it has been shown that this population is younger, suffers less from sub-pulmonary pathology. (indicating immunosuppression in these patients) but are therefore treated less than non-cancerous subjects. This retrospective study in CHU Amiens is searching on the number of side effects of NTM treatment in two groups (cancerous and no cancerous) to assess the cause of the decrease of NTM treatment in cancerous patients.

NCT ID: NCT05030428 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

VICTORION-2P
Start date: November 23, 2021
Phase: Phase 3
Study type: Interventional

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

NCT ID: NCT05030389 Recruiting - Healthy Aging Clinical Trials

Vestibular Stimulation, Exercise and Light Optimization for Circadian Clock Enhancement (Velocce)

velocce
Start date: January 25, 2021
Phase: N/A
Study type: Interventional

This study investigates the effects of remote interventions based on the exposure to one or more zeitgebers (i.e. adapted physical activity alone or combined with bright light exposure, or galvanic vestibular stimulation) performed several times a week during three months on older adults' sleep and quality of life.

NCT ID: NCT05030311 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

REMIX-1
Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

NCT ID: NCT05030155 Recruiting - Clinical trials for Eosinophilic Granulomatosis With Polyangiitis

Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With Eosinophilic Granulomatosis With Polyangiitis (E-merge)

E-merge
Start date: May 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare mepolizumab-based regimen to conventional therapeutic strategy for remission induction in patients with Eosinophilic Granulomatosis with Polyangiitis.