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NCT ID: NCT05164055 Active, not recruiting - Clinical trials for Glycogen Storage Disease Type II

Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase)

Start date: July 11, 2022
Phase: Phase 4
Study type: Interventional

This long-term open label safety and efficacy study is intended to follow up, and to provide post-trial access to enzyme replacement therapy (ERT) with avalglucosidase alfa to patients with Pompe disease in France who have completed Study EFC14028, LTS13769, or ACT14132, from market authorization until reimbursement of avalglucosidase alfa in France or until December 2024, whichever comes first. - Study visit frequency: every 2 weeks

NCT ID: NCT05159492 Active, not recruiting - Atrial Fibrillation Clinical Trials

Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)

BEAT PAROX-AF
Start date: December 27, 2021
Phase: N/A
Study type: Interventional

BEAT AF is a randomized controlled trial aiming to demonstrate that pulsed field energy is faster, more effective and safer (tissue selectivity) than RF for paroxysmal AF ablation

NCT ID: NCT05157594 Active, not recruiting - Glial Cell Tumors Clinical Trials

hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors

PROGLIO
Start date: February 14, 2022
Phase:
Study type: Observational

PROGLIO is a French mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. Blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hPG80 (circulating progastrin).

NCT ID: NCT05156320 Active, not recruiting - Clinical trials for Neuromuscular Diseases

Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam

SAPPHIRE
Start date: February 24, 2022
Phase: Phase 3
Study type: Interventional

This Phase 3 trial (Study SRK-015-003) is being conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and are receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusinersen or risdiplam), to confirm the efficacy and safety of apitegromab as an adjunctive therapy to nusinersen and evaluate the efficacy and safety of apitegromab as an adjunctive therapy to risdiplam.

NCT ID: NCT05156125 Active, not recruiting - Colitis, Ulcerative Clinical Trials

VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

NCT ID: NCT05155254 Active, not recruiting - Metastatic Melanoma Clinical Trials

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Start date: May 17, 2022
Phase: Phase 3
Study type: Interventional

Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.

NCT ID: NCT05155202 Active, not recruiting - Clinical trials for Hypoxemic Respiratory Failure

Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit

ECRHIN-ICU
Start date: November 15, 2021
Phase:
Study type: Observational

In the context of postoperative hypertension in the intensive care units, or after resusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among those drugs, Nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. Only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance. The aim of this study is to establish the incidence of Nicardipine induced hypoxemia and to compare it to another antihypertensive agent, Urapidil.

NCT ID: NCT05151380 Active, not recruiting - Clinical trials for Genitourinary Syndrome of Menopause

Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy

ATROVENANS
Start date: December 9, 2021
Phase: N/A
Study type: Interventional

Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. These changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. These symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause (GSM). General or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. Non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned. The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM. This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. This simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. It restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with GSM who can benefit of this therapy.

NCT ID: NCT05146375 Active, not recruiting - Clinical trials for Thoracic Aortic Aneurysm

Genes Modulating the Severity of Aortic Aneurysms (MSF1-TGFBR2)

MSF1-TGFBR2
Start date: November 24, 2022
Phase:
Study type: Observational

This project concerns a population at risk of sudden death by dissection of the thoracic aorta. Its interest is to make it possible to recognize the genes that protect or worsen the evolution of aneurysms, to better understand the mechanisms involved, to detect and treat aneurysms of the thoracic aorta, wich is a pathology that is completely silent clinically until life-threatening complications. The variability in the severity of the disease within the same family is related to modifier genes. The objective is to find the modifying factors that account for the variability in the severity of the progression of aneurysms of the thoracic aorta.

NCT ID: NCT05144841 Active, not recruiting - Clinical trials for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)

Start date: January 8, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.