Pyeongchon, Korea, Republic of

Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia

A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

The study consists of two phases, called phase I and phase II. Phase I will be conducted in two parts: Part A: Phase I Part A study (dose escalation) is designed to find the dose range showing activity on the tumour that can be tolerated by the participants by testing different doses of IPN01195. Part B: Phase I Part B of the study (dose confirmation) will assess the ability of study drug to prevent, slow down, or stop the growth of tumours (abnormal cell growths that can lead to cancer) and how the body processes and responds to the study drug when administered in a "low dose" or "high dose" and further explore the safety and tolerability. These parts will consist of the following periods: - A period to assess eligibility (screening period). - A treatment period that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at 30 days after the last administration of study drug. An assessment visit will be required every 6 weeks up to Week 24 and every 12 weeks thereafter to measure the tumour again and to assess how it is evolving, whether it is getting bigger, smaller, is stable or has gone away. Based on the results obtained from phase I, a phase II extension study will be included through to an updated study plan, to further evaluate the study drug. In both study phases, participants will undergo blood samplings, urine collections, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.

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.

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

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

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.

The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.

This randomized controlled trial will enroll 154 adults with type 1 diabetes who have suboptimal glycemic control and are treated with multiple daily injections (MDI) of insulin using a pen-based basal-bolus regimen. Subjects must be using a continuous glucose monitor (CGM) as part of their standard care and be telemonitored. The study will be conducted at multiple centres in France, with each subject followed for a total duration of six months. During this period, they will have one in-person visit and two follow-up assessments conducted via phone. Data will be collected through the telemonitoring platform. Subjects will be randomly assigned to either the intervention or control group. The intervention group will use the Hedia Diabetes Assistant in addition to their standard treatment for six months, while the control group will continue with their standard treatment.

Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults

This is a randomized, comparative, multicenter, open-label, phase I/II trial in France evaluating the safety and immunogenicity of a booster dose of an intranasal COVID-19 vaccine (LVt-001) versus a booster dose of a COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers. Phase I dose escalating - Primary Objective: To evaluate the safety of three escalating doses of a boost of an intranasal COVID-19 vaccine (LVT-001) expressing SARS-CoV-2 N/S recombinant protein in healthy volunteers. Phase II superiority trial - Primary Objective: To evaluate, using nasal swabs, the superiority of a booster dose of the selected intranasal COVID-19 vaccine (LVT-001) expressing SARS-COV-2 N/S recombinant protein versus a booster dose of the intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers in term of mucosal humoral immune response at Day 28. Trial population: A total of 36 and 202 healthy volunteers will be enrolled in Phase I and Phase II, respectively. Interventions: Phase I: The investigational medicinal product is the intranasal recombinant protein vaccine LVT-001 administered at Day 0 in each nostril: - Cohort A (12 participants): 20 µg - Cohort B (12 participants): 60 µg - Cohort C (12 participants): 120 µg Phase II: Two investigational medicinal products will be compared: - The selected dose of the intranasal recombinant protein vaccine LVT-001, administered at Day 0 in each nostril. - The intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech), administered as the standard of care booster. Expected Outcomes and Safety Considerations: In Phase I, healthy participants are not expected to benefit directly from the trial aside from the potential theoretical benefit of a mucosal immune response against SARS-CoV-2. Currently, no clinical trial data exist for a nasal protein vaccine in humans. The anticipated risks primarily include local nasal reactions and systemic reactions similar to those observed with other vaccines. Any adverse events following vaccination are expected to be manageable with routine care, as determined by investigators. Given that this is the first human trial of a nasal protein vaccine, the dose-escalation design ensures a safety margin, allowing for careful monitoring before progressing to the next cohort.

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.