This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design.
To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).

Start Date30 Jan 2025

Sponsor / Collaborator

Centre Hospitalier Regional de Metz-Thionville

NCT06469970

/ RecruitingPhase 2IIT

INDICIA: Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults

This is a prospective, observational, monocentric, phase II (exploratory) cohort study aiming to describe the evolutionary profile of the initial volume of glucose distribution (IDVG) during the first four days of management of severely burned patient.

Start Date28 Nov 2024

Sponsor / Collaborator

Centre Hospitalier Regional de Metz-Thionville

NCT06433583

/ RecruitingNot ApplicableIIT

Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation for the Prevention of Non-suicidal Self-injury Recurrence in Adolescents

Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury.
Their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the COVID-19 health crisis, with the prevalence of NSSI rising to 40% in adolescents. Access to psychiatrists is declining. Drug solutions, meanwhile, lack scientific proof in this indication.
The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion.
Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder.
Transcutaneous neurostimulation of the atrial vagus nerve (taVNS) has been studied for some ten years. The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals.
The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI, and thus reduce the frequency of acting out.
Although taVNS is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment.

Start Date28 Nov 2024

Sponsor / Collaborator

Centre Hospitalier Regional de Metz-Thionville

100 Clinical Results associated with Centre Hospitalier Regional de Metz-Thionville

0 Patents (Medical) associated with Centre Hospitalier Regional de Metz-Thionville

Literatures (Medical) associated with Centre Hospitalier Regional de Metz-Thionville

05 Nov 2024·Blood

Minimal Residual Disease-Guided Combination of Ibrutinib and Venetoclax Compared to FCR in Untreated Patients with CLL of Intermediate Risk : Final Results of the Eradic Trial from the Filo Group

Author: Simon, Laurence ; Villemagne, Bruno ; Rouillé, Valerie ; Dilhuydy, Marie Sarah ; Tournilhac, Olivier ; Molina, Lysiane ; De Guibert, Sophie ; Michallet, Anne Sophie ; Fornecker, Luc-Matthieu ; Benbrahim, Omar ; Quinquenel, Anne ; Aurran-Schleinitz, Therese ; Tomowiak, Cecile ; Cartron, Guillaume ; Drenou, Bernard ; Letestu, Remi ; Merabet, Fatiha ; Cahu, Xavier ; Morisset, Stéphane ; Ysebaert, Loic ; Laribi, Kamel ; Carassou, Philippe ; Lepretre, Stéphane ; Guieze, Romain ; Gay, Julie ; Legarff, Magali ; Levy, Vincent ; Roos Weil, Damien ; Nguyen Khac, Florence ; Dartigeas, Caroline ; Ferrant, Emmanuelle ; Dupuis, Jehan ; Hivert, Benedicte ; Feugier, Pierre

With the emergence of targeted therapies, defining the best strategy for first-line treatment in patients with chronic lymphocytic leukemia (CLL) has become challenging. The aim of the ERADIC phase 2 trial (NCT04010968) was to compare the efficacy of a standard fludarabine-cyclophosphamide-rituximab (FCR) regimen to that of a combination of ibrutinib and venetoclax (IV), guided by measureable residual disease (MRD), in fit patients with CLL of intermediate risk defined by either unmutated IGHV status, del(11q) or complex karyotype in the absence of TP53 alteration. MRD was assessed in bone marrow (BM) or peripheral blood (PB) by flow cytometry. After a lead-in phase of ibrutinib as a single agent from month (M)1 to M3, the total duration of treatment with the IV combination was based on M9 BM-MRD. If it was <0.01% (uMRD) at that time, treatment was continued for 6 additional months (M15) then stopped. If M9 BM-MRD was ≥0.01%, IV treatment was continued for 18 additional months (M27). BM-MRD was reassessed at that time-point in both arms. Additionally, PB-MRD evaluation was performed every 6 months.The primary endpoint was the percentage of patients with BM uMRD at M27. Here, the final results of the study are presented.Between September 2019 and February 2021, 120 patients were randomized 1:1 between the 2 treatment arms. Their median age was respectively of 59 [34-72] and 61 [34-74] years in the FCR and IV arms. Patient characteristics were well balanced between the 2 arms in terms of gender (male 72% FCR, 74% IV), PS ECOG 0-1 (59% FCR, 68% IV) and Binet stage (A, B and C 15%, 64%, 21% for FCR ; 8.5%, 59% and 32% for IV). A del(11q) was found in respectively 20% and 24% patients in FCR and IV arms, and all patients but one had unmutated IGHV.With a median follow-up of 42 months [range: 38- 46], 36 serious adverse events occurred in the FCR arm and 34 in the IV arm. Toxicities differed between the 2 arms with more infections and hematological toxicities due to myelosuppression (22%) and infections (40%) in the FCR arm, versus more cardiological events (23%), metabolic disorders (16%) and infections (27%) in the IV arm. Six grade 5 adverse events were reported, respectively 3 in the FCR arm (1 septic shock [M21], 1 acute myeloid leukemia [AML; M13] and 1 myelodysplastic syndrome [MDS; M24]) and 3 in the IV arm (2 sudden deaths [M7 and M12] and one COVID-19-related death at M27). In terms of secondary malignancies, in the FCR arm, squamous cell cancer, MDS, AML, colon cancer, basal cell carcinoma and lung cancer were reported while in the IV arm, liver, invasive skin, prostate, and squamous cell scalp cancers were observed as well as a bronchial carcinoma.Treatment reduction and/or discontinuation involved 11 patients due to cardiac events (ibrutinib) and grade 4 neutropenia (venetoclax).In terms of response (M27), complete response (CR) or CR with incomplete count recovery (CRi) rates were 53% for the FCR arm and 68% for the IV arm (p=0.097).Assessment of MRD in PB showed a statistically significant difference with 67% of PB uMRD for the FCR arm vs. 83% for the IV arm (p=0.056). BM uMRD rates were respectively of 54% and 68%, yet without reaching statistical significance.Superiority for the IV arm was bserved in 3-year progression-free survival (PFS) at 78.5% for the FCR arm and 93% for the IV arm (p=0.029), yet without difference in overall survival (95% for both arms).In conclusion, these final results confirm the superiority of the fixed and maximal duration of 27 months IV combination over chemotherapy, resulting in a very high PB uMRD rate and excellent 3-year PFS. Vigilance remains regarding cardiological toxicity which requires defining the best patient profile for this combination.

05 Nov 2024·Blood

Outcomes By Refractory Status and Prior Therapies Received in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) from the ECHELON-3 Study

Author: Offner, Fritz ; Portell, Craig A. ; Derenzini, Enrico ; Carassou, Philippe ; Bouabdallah, Krimo ; Hahn, Uwe ; Ho, Linda ; Nowakowski, Grzegorz S. ; Wang, Ming-Chung ; Fenton, Keenan ; Chen, Tsai-Yun ; Rustia, Evelyn ; Camus, Vincent ; Kim, Jeong-A ; Patterson, Monica ; Ghesquieres, Herve ; Forward, Nicholas ; Yasenchak, Christopher ; Bartlett, Nancy L. ; Fanale, Michelle ; Chang, Hung

IntroductionPatients (pts) with progressive disease after ≥2 prior lines of systemic therapy are unlikely to derive additional benefit from current salvage immunochemotherapies, and survival declines significantly with each subsequent treatment. Pts with refractory disease following second-line therapy have worse outcomes, with reported overall response rates (ORRs) of 1% to 14% and overall survival (OS) of 5 months (Blood. 2017;130[16]:1800-1808). While chimeric antigen receptor (CAR) T-cell therapy has become a preferred strategy in the second- and third-line settings, pts with R/R disease following CAR-T experience dismal survival, with progression-free survival (PFS) and OS as low as 3 and 5 months, respectively, and no agreed standard of care post CAR-T (Blood. 2022;140[24]:2527-2529). The randomized, global, phase 3 ECHELON-3 study (NCT04404283) was conducted in pts with R/R DLBCL after ≥2 prior therapies who were ineligible for hematopoietic stem cell transplant and/or CAR-T. Here, we present subgroup analyses in pts with 2 prior lines of therapy, refractory disease, or prior CAR-T.MethodsIn these subgroup analyses of ECHELON-3, eligible pts had 2 prior lines of systemic therapy, disease refractory to the last prior therapy, or prior exposure to CAR-T. Pts could qualify for ≥1 subgroup and were analyzed separately. Refractory disease was defined as stable or progressive disease as best overall response to last line of treatment or relapse ≤6 months from the end of treatment. Pts were randomized 1:1 to receive brentuximab vedotin (BV; 1.2 mg/kg) or placebo every 3 weeks (q3w), in combination with rituximab (R; 375 mg/m2) q3w and lenalidomide (Len; 20 mg) once daily. Efficacy was assessed by investigators per Lugano 2014 classification. The primary endpoint was OS, with key secondary endpoints of PFS and ORR. P values are descriptive.ResultsIn total, 230 pts were enrolled in ECHELON-3 from April 2021 to November 2023, with a median follow-up of 16.4 months (range, 0.1-31.5 months). Overall, 94 pts with 2 prior lines of systemic therapy were enrolled and randomized to BV+Len+R (n=48) or placebo+Len+R (n=46). Median OS was 16.3 months (95% CI, 12.6 months-not estimable) with BV+Len+R vs 8.5 months (95% CI, 4.1-15.8 months) with placebo+Len+R (hazard ratio [HR], 0.557; 95% CI, 0.317-0.977; P=.0388). Median PFS was 7.1 months (95% CI, 3.6-12.6 months) with BV+Len+R vs 2.7 months (95% CI, 1.4-4.0 months) with placebo+Len+R (HR, 0.462; 95% CI, 0.279-0.764; P=.0020). ORR was 68.8% (95% CI, 53.7%-81.3%) with BV+Len+R vs 43.5% with placebo+Len+R (95% CI, 28.9%-58.9%; P=.0216); complete response (CR) rate was 52.1% vs 13.0%, respectively. Additional data for pts by lines of therapy received will be presented.In total, 194 pts with disease refractory to the most recent systemic therapy were enrolled and randomized to BV+Len+R (n=98) and placebo+Len+R (n=96). Median OS was 11.7 months (95% CI, 8.8-16.3 months) with BV+Len+R vs 5.5 months (95% CI, 3.7-8.5 months) with placebo+Len+R (HR, 0.566; 95% CI, 0.396-0.808; P=.0015). Median PFS was 4.1 months (95% CI, 2.8-5.4 months) with BV+Len+R vs 1.5 months (95% CI, 1.4-2.6 months) with placebo+Len+R (HR, 0.508; 95% CI, 0.363-0.712; P<.0001). ORR was 59.2% (95% CI, 48.8%-69.0%) with BV+Len+R vs 29.2% (95% CI, 20.3%-39.3%) with placebo+Len+R (P<.0001); CR rate was 34.7% vs 11.5%, respectively.Overall, 67 pts who received prior CAR-T were enrolled and randomized to BV+Len+R (n=32) and placebo+Len+R (n=35). Median OS was 15.6 months with BV+Len+R vs 4.4 months with placebo+Len+R (HR, 0.38; 95% CI, 0.2-0.75). Median PFS was 3.0 months with BV+Len+R vs 1.4 months with placebo+Len+R (HR, 0.41; 95% CI, 0.22-0.76). ORR was 65.6% (95% CI, 46.8%-81.4%) with BV+Len+R vs 25.7% (95% CI, 12.5%-43.3%) with placebo+Len+R (P=.0014); CR rate was 37.5% vs 11.4%, respectively.ConclusionsBV+Len+R demonstrated a clinically meaningful improvement in all key efficacy outcomes, including CR and OS, in pts with 2 prior lines of therapy, disease refractory to prior treatment, or prior CAR-T. This treatment benefit was generally consistent with that observed in the overall ECHELON-3 study population. Therefore, BV+Len+R has the potential to address an unmet need for effective and tolerable therapy in heavily pretreated pts, as described above.

01 May 2024·La Revue du praticien

[Smoking and tuberculosis].

Article

Author: Underner, Michel ; Peiffer, Gérard ; Perriot, Jean

SMOKING AND TUBERCULOSIS. Tuberculosis and smoking are responsible for high mortality worldwide. Tuberculosis causes 9 million incident cases and 1.6 million deaths every year. Smoking increases the risk of infection by Mycobacterium tuberculosis and of severe tuberculosis disease with death or recurrence. Cessation of smoking improves the course of the disease, promoting adherence to anti-tuberculosis treatment and definitive cure. All health-care professionals involved in tuberculosis care must be involved to help smokers with tuberculosis to quit.

100 Deals associated with Centre Hospitalier Regional de Metz-Thionville

100 Translational Medicine associated with Centre Hospitalier Regional de Metz-Thionville

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