Cities In Argentina, Argentina
Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty (SCAP-imag)
Phase
N/ASpan
109 weeksSponsor
Ramsay Générale de SantéLyon
Recruiting
Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour
Phase
N/ASpan
312 weeksSponsor
Institut Claudius RegaudLyon
Recruiting
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients with Homozygous Familial Hypercholesterolemia
This is a multicenter, international, long-term observational study investigating the real-world impact of lomitapide on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia (HoFH). Study Design: Observational, open-label, retrospective and prospective study Data will be collected from >26 lipid centers across Europe Patients will serve as their own control, with comparisons between pre-treatment (3 years before lomitapide) and post-treatment (first 3 years of lomitapide therapy) periods Study Population: Approximately 72 adult patients (≥18 years) diagnosed with HoFH Patients must have received lomitapide for at least 12 months Availability of 3 years of pre-treatment clinical records Objectives: Primary Objective: Evaluate the incidence of MACE before and after lomitapide treatment Secondary Objectives: Assess changes in LDL-C, total cholesterol, liver function tests (ALT, AST, GGT), and lipid-lowering therapy usage (e.g., discontinuation of LDL apheresis, addition of PCSK9 inhibitors) Endpoints: Primary Endpoint: Change in MACE incidence over the 3-year treatment period Secondary Endpoints: Changes in lipid levels, liver safety markers, and adherence to treatment protocols Safety Considerations: The study follows real-world clinical practice, with monitoring of adverse events, including liver-related safety concerns associated with lomitapide Data will be collected in an electronic Case Report Form (eCRF) and analyzed following Good Clinical Practice (GCP) guidelines This study aims to generate real-world evidence on the cardiovascular impact of lomitapide in HoFH patients, addressing an unmet clinical need for data on long-term outcomes.
Phase
N/ASpan
121 weeksSponsor
Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)Lyon
Recruiting
European Registry of Next Generation Imaging in Advanced Prostate Cancer
This registry is intended to collect real-world data on patient demographics, medical history, clinical endpoints, histological tumour characteristics and imaging explorations of the patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration (conventional, NGI, or their combination) either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment. Stage 1: cross-sectional observation 1. To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria. 2. Assess management prompted by NGI vs. conventional imaging in usual clinical practice. 3. To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria. 4. Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed. 5. Reclassification of HSPC (M0 vs low vs. high volume) based on NGI respect to CI when both imaging modalities are used. Stage 2: longitudinal observation 1. Evaluation of survival outcomes and their relationship with the imaging pathway undertaken (overall and per subgroup of imaging modality). 2. Identification of prognostic factors related to treatment response and disease progression.
Phase
N/ASpan
119 weeksSponsor
Fundacio PuigvertLyon
Recruiting
TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
Cetuximab and panitumumab hae become the standard treatment for patients with metastatic colorectal cancer without RAS gene mutation. Hoever, these EGFR inhbitors induce a broad spectrum of cutaneous toxicities (skin side effects) in 75-90% of patients, including the folliculitis involving the face,upper torso and scalp. The folliculitis appears within 1-2 weeks of anti-EGFR therapy and peaks around 3-5 weeks of treatment. There is no approved treatment to prevent or treat EGFR-induced folliculitis. Tarian Pharma has developed a new topical treatment of EGFRi-induced folliculitis.This study aims to confirm the good safety of TAR-0520 gel in colorectal cancer patients treated with cetuximab or panitmumab and eplore , in the same patients , the effect of TAR-0520 gel on the extent and severity of EGFRi-induced folliculitis. Patients aged 18 years and over with metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections will be included in the study. Participants will be randomly allocated to receive either the topical active TAR-0520 gel or its vehicle.The study will include a 7days treatment period with once daily applications of the test product followed by a treatment free period until the start of the next chemotherapy cycle usually 7 days later.The study will cover 4 complete chemotherapy cycles, thus lasting at least 56 days.
Phase
2Span
89 weeksSponsor
Tarian PharmaLyon
Recruiting
Preventing Burnout Among Caregivers Through Physical Activity
The PACA trial is a pilot, prospective, comparative, randomised (2 arms), controlled, single-centre study. The study population consisted of adult healthcare professionals at the Clinique de la Sauvegarde with a low to moderate level of physical activity and no contraindications to physical activity. Participants will be randomised into two arms (ratio 1:1): - Arm A (intervention): Participants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period. - Arm B (control): Participants will receive the recommendations of the world health organisation for physical activity.
Phase
N/ASpan
68 weeksSponsor
GCS Ramsay Santé pour l'Enseignement et la RechercheLyon
Recruiting
Healthy Volunteers
Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes with Lync
The clinical evaluation demonstrates that the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis are not covered by any clinical data on similar devices. The "LYNC" clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device on 76 cases (feet) when implanted in the toes for the treatment of arthritis and correction of bone misalignments. The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score as primary endpoint. The secondary objectives of the study are: - To confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the reduction in patient pain during the 3-4 month postoperative visit. - To confirm the clinical performance of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the radiographic parameters (bone consolidation) during the 3-4 month postoperative visit. - To confirm the safety of the Lync® device for the treatment of arthritis and the correction of bone alignment default in the toes, by evaluating the occurrence of adverse events, complications and device defects at the various postoperative follow-up visits. The secondary endpoints associated with the secondary objective are: - The change in the VAS score will be evaluated at the postoperative visit at 3-4 months compared to that at the preoperative visit. - The assessment of bone consolidation will be carried out at the post-operative visit at 3-4 months. An additional visit at 6 months, assessing bone union, will be carried out ifbone union has not occurred 3-4 months post-operatively, in accordance with theinvestigators' current practice. - The collection of adverse events and defects will be done throughout the follow-up by the surgeons thanks to questioning of the patient, assessments of clinical and radiographic examinations of the foot.
Phase
N/ASpan
130 weeksSponsor
NovastepLyon
Recruiting
Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa
Infections due to Pseudomonas aeruginosa isolates with acquired resistances to all first-line antipseudomonal beta-lactams and fluoroquinolones (difficult-to-treat isolates - DTR), pose serious therapeutical challenges, especially in critically ill and/or immunocompromised patients. Certain new beta-lactam/beta-lactamase inhibitor combinations (BL/BLI (beta lactamine/ beta lactamase inhibitor) - i.e., ceftolozane-tazobactam, ceftazidime-avibactam, imipenem-relebactam, others) and cefiderocol have shown promising results for the treatment of infections due to DTR P. aeruginosa. However, multicenter data on their real-life utilization in this indication are still scarce. The ADDICT study is a prospective, multicenter cohort study including unselected patients with DTR P. aeruginosa infection requiring definite intravenous antimicrobial therapy. The primary objective of the study is to investigate the clinical efficacy of available options (new BL/BLI, cefiderocol or older agents such as aminoglycosides and colistin) in this population. Secondary objectives are to compare the clinical and microbiological efficacy of available options in infections due to DTR P. aeruginosa with in vitro susceptibility to more than one last-resort drug, to compare the incidence of non-ecological adverse events observed with these drugs, to assess the incidence of resistance emergence under therapy and to elucidate the molecular mechanisms of resistance emergence, to assess the benefits and risks of combination therapy in this indication, to compare the acquisition rates of multidrug-resistant bacteria other than DTR P. aeruginosa, and Clostridioides difficile infection, to compare Day-28 and in-hospital all-cause mortality rates. Patients will be recruited in 60 hospital centers contributing to four French networks of research in infectious diseases and critical care (CRICS-TRIGGERSEP, ReaRezo, OutcomeRéa, RENARCI - PROMISE metanetwork). Clinical variables will be collected through an electronic case-report form. DTR P. aeruginosa isolates will be sent to the National Reference Center of Antimicrobial Resistance in P. aeruginosa for centralized analyses (extended antimicrobial susceptibility testing, MLST, whole-genome sequencing of successive isolates if resistance emergence under therapy).
Phase
N/ASpan
99 weeksSponsor
Centre Hospitalier Régional d'OrléansLyon
Recruiting
Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.
Phase
N/ASpan
87 weeksSponsor
Hospices Civils de LyonLyon
Recruiting
First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma
Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.
Phase
1/2Span
208 weeksSponsor
Adcendo ApSLyon
Recruiting