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NCT ID: NCT05831592 Recruiting - Undernutrition Clinical Trials

Evaluation of the Validity and Reliability of Muscle Ultrasound in the Detection of Undernutrition

SAURON
Start date: February 23, 2023
Phase: N/A
Study type: Interventional

In France, the prevalence of undernutrition in hospitalized patients varies from 30 to 50%. Undernutrition is strongly associated with a decrease in the patient's functional abilities and an increase in morbidity and mortality and healthcare expenses. In 2019, the Global Leadership Initiative on Malnutrition (GLIM) published an international consensus report on diagnostic criteria for undernutrition. The diagnostic criteria are numerous, and include etiological criteria such as reduced food intake; an inflammatory setting; symptoms such as anorexia, fatigue; phenotypic criteria such as weight loss, body mass index (BMI), fat to lean mass ratio, fluid retention, and muscle function. Muscle mass is described as a major diagnostic criterion, since it is on the one hand a direct indicator of protein catabolism related to undernutrition, but also a reflection of functional impairment in the patient, as it is directly associated with functional capacities, autonomy and prognosis. Ultrasound is a reproducible method of muscle assessment. It allows the evaluation of muscle thickness or cross-sectional area of a muscle, the reduction of which, a marker of atrophy, is strongly correlated to its loss of strength and to reference measurements. In addition, ultrasound can be used to assess muscle quality, particularly by evaluating the echogenicity of the muscle. The echogenicity increases when the muscle is altered, linked to the presence of fatty infiltrate and fibrous tissue. The use of ultrasound in the evaluation of the patient's nutritional status, as a tool for assessing muscle function, is developing in the ICU and is associated with an increase in the patient's comorbidities. Studies remain limited to a few patient populations, do not report clear cut-off values to define muscle pathological status, and require more precise definition of ultrasound measurement protocols. The investigators hypothesize that muscle ultrasound is reliable and valid in the evaluation of muscle function during the screening of undernutrition in a population of patients hospitalized in diabetology-obesity, pneumology, oncology and gastro-nutrition, under 70 years old.

NCT ID: NCT05831319 Recruiting - Clinical trials for Peripheral Arterial Disease

Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

BIO-OSCAR SOC
Start date: May 29, 2023
Phase:
Study type: Observational

Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.

NCT ID: NCT05830084 Recruiting - Bone Cancer Clinical Trials

Phase Ib / Regorafenib With Conventional Chemotherapy/Newly Diagnosed Patients/ Multimetastatic Ewing Sarcoma

REGO-EWING
Start date: March 27, 2023
Phase: Phase 1
Study type: Interventional

New drug efficacy in ES has been disappointing in the last decades and no new drugs have been successfully introduced up to now in front line treatment. Among the tested drugs, early clinical data suggest that strategies using multi-targeted tyrosine kinase inhibitors (TKI) with anti-angiogenic activities are among the most efficient and may be beneficial in the treatment of patients with ES. Several TKI have been and are currently being tested as single-agent in patients with relapsed/refractory ES with encouraging results in phase II trials. Regorafenib has shown promising activity in Ewing sarcoma relapse setting, Nevertheless, regorafenib has never been combined with the intensive chemotherapy VDC/IE schedule and therefore this combination needs to be evaluated in order to avoid dose reduction of the current standard treatment and hence its efficacy. The current clinical trial has been therefore designed to test the feasibility of regorafenib with ES conventional chemotherapy. It consists of a phase Ib that will only recruit patients with multi-metastatic (other than lungs/pleura only) ES, that present the highest unmet medical need (2 year EFS: 33%, similar to patients with relapse/refractory ES).

NCT ID: NCT05829993 Recruiting - Cardiac Disease Clinical Trials

Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias

DEEPECG4U
Start date: November 28, 2023
Phase:
Study type: Observational

The objective of this study is to prospectively validate in real life cohorts from various departments of the APHP our artificial intelligence (deep-learning) models allowing for : 1. automatic measurement of various ECG quantitative features, 2. identification and typing of LQT and risk of TdP.

NCT ID: NCT05829733 Recruiting - Osteoarthritis, Hip Clinical Trials

6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis

Start date: April 27, 2024
Phase: N/A
Study type: Interventional

Multicenter, independent study of Synolis VA 80/160 over a period of 6 months

NCT ID: NCT05828979 Recruiting - Clinical trials for Urinary Incontinence,Stress

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter in women

NCT ID: NCT05828511 Recruiting - Multiple Myeloma Clinical Trials

A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

LINKER-MM4
Start date: December 19, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible). The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM. This study consists of 2 phases: - In Phase 1, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2. - In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM. The study is looking at several research questions, including: - What side effects may happen from taking linvoseltamab? - What the right dosing regimen is for linvoseltamab? - How many participants treated with linvoseltamab have improvement of their disease and for how long? - The effects of linvoseltamab study treatment before and after transplant - How much linvoseltamab is in the blood at different times? - Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).

NCT ID: NCT05828459 Recruiting - Solid Tumor Clinical Trials

First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors

Start date: July 10, 2023
Phase: Phase 1
Study type: Interventional

This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.

NCT ID: NCT05827016 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Start date: June 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

NCT ID: NCT05826990 Recruiting - Clinical trials for Complicated Urinary Tract Infection

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

Start date: September 11, 2023
Phase: Phase 2
Study type: Interventional

This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI.