La Palta, Argentina

Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty (SCAP-imag)

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

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.

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.

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.

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.

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.

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).

Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.

Evaluation of a Dimensional Adaptation of Good Psychiatric Management (GPM-extended) for the Treatment of Borderline Personality Disorder

Personality disorders (PD) are among the most common psychiatric disorders, the most studied being borderline personality disorder (BPD), a disorder that affects approximately 1.6% of the general population and is characterised by significant difficulties in emotion regulation, identity and interpersonal relationships. Currently, categories of PD are criticised and many authors have highlighted the need for a more dimensional assessment of PD, using the association of a general factor (described as the level of personality functioning, assessed on personal and interpersonal functioning) with several personality traits used to describe specific personality characteristics (negative affectivity, antagonism/dissociality, detachment, disinhibition, anankastia, psychoticism). The two main models are the DSM-5 alternative personality disorder model (AMPD) and the International Classification of Diseases 11th edition personality disorder model (ICD-11). In particular, several works have suggested that the BPD criteria are one of the most important markers of general personality functioning. While these new models offer new and very exciting possibilities in terms of diagnostic assessment, they have struggled to spread across clinical services ; and, to date, no evidence-based treatments have been developed from these models, limiting their usefulness. Furthermore, these models are also limited by the nature of personality traits (Criteria B), as these represent rigid and stable patterns of dysfunction that may be difficult to represent the complex day-to-day fluctuations in internal psychic coherence and interpersonal functioning characteristic of PD. One of the most recent treatments for BPD is Good Psychiatric Management. This has proved as effective as specialist therapies such as dialectical behaviour therapy and has also been developed for other personality disorders (notably narcissistic and obsessional-compulsive PD). Each adaptation is based on a specific conceptualisation designed to represent the main ways in which an individual may dysfunction in the personal and interpersonal domains. According to these conceptualisations, each of these three personality disorders presents a specific trigger for its difficulties: threat to relational dependence with fear of rejection and abandonment for borderline PD, threat to self-esteem for narcissistic PD, threat to ability to control for obsessive PD. Thus, some authors have suggested that the development of an adaptation of the GPM incorporating both the central aspects of the dimensional models, but also each of these different triggers in a non-exclusive manner (as they may be found to a greater or lesser extent in each patient suffering from PD), could be both feasible and useful, in particular to resolve the above-mentioned problems. Indeed, like traditional dimensional models, GPM offers the possibility of a dimensional approach, with personality functioning assessed by the presence or absence of the BPD criteria, and features of personal and interpersonal dysfunction considered holistically using GPM's trigger-based approach. However, unlike traditional dimensional models, GPM has been empirically tested and found to be effective in treating patients who meet the criteria for BPD. In addition, it offers an approach to personality characteristics that is simpler, easier to understand, more accessible to psychoeducation and closer to patients' everyday experience than the personality traits classically used in dimensional models. In addition, although each adaptation of the GPM focuses on different PDs, much of the content remains the same: making and announcing the diagnosis, psychoeducation, case management, recurrent assessment of progress and reassessment if there is no response, multimodal approach including psychodynamic and behavioural psychotherapy, anticipation of crises, and management of symptomatic medication, etc. This may be linked to the fact that, although each disorder has specific triggers/traits, the underlying level of personality functioning is represented by BPD criteria and is therefore expected to be treated by the same psychotherapeutic content. Thus, a dimensional adaptation of GPM seems both relevant and feasible to address the problems of conventional dimensional models, namely the lack of existence of evidence-based treatments associated with these models, and the aspecific nature of personality trait-based approaches. Altogether, we developed a dimensional adaptation of the GPM (GPM-extended), aiming to treat patients fulfilling the criteria for BPD dimensionally by incorporating elements from the adaptations for narcissistic and obsessional personality disorders. In terms of content, GPM-extended takes the common part of the treatment from the three adaptations and uses it as a basis, while also offering the possibility of constructing treatment goals and exposure targets that are much more specific to a given patient, in particular by carrying out an initial assessment and prioritisation of the various triggers. If this adaptation were to be shown to be effective, it would ultimately improve the diagnostic assessment and management of patients fulfilling BPD criteria, by offering treatment that is more tailored to each profile.