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NCT ID: NCT06386107 Not yet recruiting - Cancer Clinical Trials

Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis

CATforCAT
Start date: June 2024
Phase: N/A
Study type: Interventional

Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.

NCT ID: NCT06385691 Not yet recruiting - Gastric Cancer Clinical Trials

Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.

MyDIET
Start date: April 29, 2024
Phase: Phase 2
Study type: Interventional

This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer.

NCT ID: NCT06385054 Not yet recruiting - Infantile Colic Clinical Trials

Effect of Probiotics on Infantile Colic Symptoms

EPIC
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.

NCT ID: NCT06382818 Not yet recruiting - Breast Cancer Clinical Trials

Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability

PROBA
Start date: April 26, 2024
Phase: N/A
Study type: Interventional

Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk.

NCT ID: NCT06381609 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Peer Support in Alcohol Dependence

PEERSIAD
Start date: October 1, 2024
Phase: N/A
Study type: Interventional

Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment. However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome. Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation. Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care. This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome.

NCT ID: NCT06380426 Not yet recruiting - Monogenic Obesity Clinical Trials

Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema)

ObGeSema
Start date: July 1, 2024
Phase:
Study type: Observational

Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways. More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS). The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications. Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches. In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications. GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity. The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity.

NCT ID: NCT06379698 Not yet recruiting - Tumoral Kidney Clinical Trials

Rein 3D PRINT PERSONALIZE

R3DP-P
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers.

NCT ID: NCT06379308 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study

Start date: April 2024
Phase:
Study type: Observational

This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).

NCT ID: NCT06377579 Not yet recruiting - AML, Adult Clinical Trials

OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia

Start date: June 30, 2024
Phase:
Study type: Observational [Patient Registry]

Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis Ivosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML and in front line settings. In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment. In this multicentric retrospective study, sponsor aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML.

NCT ID: NCT06376981 Not yet recruiting - Shoulder Tendinitis Clinical Trials

Hyaluronic Acid in Shoulder Tendinopathy

ACCTE
Start date: May 2024
Phase: Phase 3
Study type: Interventional

Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.