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NCT ID: NCT06450548 Not yet recruiting - Clinical trials for Prostate Cancer Metastatic

Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA

PYPET
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe. The PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. The Vision study showed that 177Lu-PSMA-617, combined with standard care, improved survival rates significantly compared to standard care alone.The French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions. Patients must have histologically confirmed mCRPC, be progressive despite treatment, and have PSMA-positive imaging. Imaging assessments include PSMA PET/CT and 18F-FDG PET/CT to identify FDG-positive and PSMA-negative sites, which are associated with a poorer prognosis. Parametric analysis using dynamic PET could improve lesion characterization, aiding in treatment decisions. This is the focus of the PyPET study. The main objective focuses on a comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki, volume of distribution Vd) and static analysis (standard at 1 hour) using 18F-FDG and 68Ga-PSMA PET/CT for diagnosing metastases, especially in the liver, lymph nodes, and bones. It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites.

NCT ID: NCT06449820 Not yet recruiting - Ulcerative Colitis Clinical Trials

Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis

ATTRACT
Start date: May 30, 2024
Phase:
Study type: Observational

Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis. The aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.

NCT ID: NCT06449066 Not yet recruiting - Clinical trials for Obstetrical Neuraxial Anaesthesia

Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia

ANEU-DIP
Start date: June 2024
Phase:
Study type: Observational

The purpose of this study is to evaluate if neuraxial anesthesia (epidural or intradural anesthesia) used during childbirth is associated with more frequent infectious complications in patients with primary immunodeficiencies (PID).

NCT ID: NCT06447506 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

AtDvance
Start date: June 4, 2024
Phase: Phase 2
Study type: Interventional

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

NCT ID: NCT06447480 Not yet recruiting - Acne Vulgaris Clinical Trials

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

ETHNIC
Start date: September 1, 2024
Phase: Phase 3
Study type: Interventional

In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420

NCT ID: NCT06446817 Not yet recruiting - Cataract Clinical Trials

Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

HIGHADD
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.

NCT ID: NCT06446804 Not yet recruiting - Migraine Clinical Trials

Follow-up of Migraine Patients on Eptinezumab

EPTI-CO
Start date: June 1, 2024
Phase:
Study type: Observational

The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment. Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.

NCT ID: NCT06446349 Not yet recruiting - Clinical trials for Benzodiazepine Withdrawal

Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users

BENZ_HALTE
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

We hypothesise that a short-term intervention by dispensing pharmacists is feasible and relatively easy to implement, and that it could have an impact on the deprescribing of BZD/Z in adult patients. Two primary objectives will be evaluated in a sequential hierarchical manner, with two primary endpoints analysed one after the other, without alpha risk adjustment, but the second can only be analysed if the null hypothesis is rejected for the first: 1. Evaluate the impact of brief motivational intervention (BMI) on reducing the daily dose of BZD/Z prescribed at 6 months (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies. 2. Evaluate the impact of BMI on clinical worsening at 6 months (non-inferiority hypothesis) in comparison with the usual practice of dispensing BZD/Z in pharmacies.

NCT ID: NCT06445218 Not yet recruiting - Clinical trials for Musculoskeletal Pain

Observational Study of Musculoskeletal Patients in an Emergency Department in France

SKUAD-P
Start date: June 2024
Phase:
Study type: Observational

The purpose of this study is to estimate the number of patients who come to the emergency department with a musculoskeletal referral, to describe the different types of diagnosis for these patients and their treatment and discharge.

NCT ID: NCT06445179 Not yet recruiting - Endometriosis Clinical Trials

ENDOmetriosis Robotic Assisted Surgery

ENDO-RAS
Start date: June 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the robot-assisted approach with the laparoscopic approach in terms of reducing the rates of intraoperative and postoperative complications in patients undergoing total hysterectomy for DIE and adenomyosis without digestive tract involvement.