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NCT ID: NCT04209855 Active, not recruiting - Clinical trials for Fallopian Tube Cancer

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

MIRASOL
Start date: December 31, 2019
Phase: Phase 3
Study type: Interventional

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

NCT ID: NCT04209140 Active, not recruiting - Bipolar I Disorder Clinical Trials

Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative

R-LiNK
Start date: January 10, 2020
Phase:
Study type: Observational

Bipolar disorder (BD), especially BD type I, is a highly prevalent mental disorder and a is a highly prevalent mental disorder and an important factor for suicide. Lithium is the key treatment for prevention of BD relapse and has a proven suicide prevention effect. Whilst many cases become asymptomatic with lithium treatment, the majority show sub-optimal response. The objectives of this project are to: - improve outcomes of bipolar I disorder (BDI) cases prescribed lithium through the application of stratified approaches - optimize the early prediction of lithium response using a set of multi-modal biomarkers ("blood omics", Magnetic Resonance Imaging and Li7-Magnetic Resonance Spectroscopy derived-markers) - develop a multidisciplinary multinational network of experts to undertake this and future projects on personalized diagnostics and therapeutics and - implement new, powerful technologies to characterize brain lithium distribution and the blood molecular signature of lithium in responders and non-responders. This cutting edge approach will identify the eligibility criteria for treatment with lithium in BD in terms of response, safety and tolerability.

NCT ID: NCT04208178 Active, not recruiting - Clinical trials for Advanced HER2+Breast Cancer

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

EPIK-B2
Start date: July 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.

NCT ID: NCT04206982 Active, not recruiting - Atrial Fibrillation Clinical Trials

MARSHALL PLAN Vs. Pulmonary Veins Isolation Monocentric Trial

PLAN-MARSHALL
Start date: January 22, 2020
Phase: N/A
Study type: Interventional

In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been incorporated in current ablation strategies. The investigators sought to investigate a new ablation strategy that target systematically the vein of Marshall by ethanol infusion. This step is integrated in a new ablation strategy consisting in a global anatomical substrate based ablation including PV isolation and left atrial linear ablation (Marshall-Plan). The main objective of this study is to compare the 12 month freedom from any arrhythmia (Atrial Fibrillation (AF)/Atrial Tachycardia (AT)) between the Marshall-Plan approach and the PV isolation approach.

NCT ID: NCT04206644 Active, not recruiting - Systemic Sclerosis Clinical Trials

Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages

SCLERO JAK
Start date: January 21, 2021
Phase:
Study type: Observational

The Sclero-JAK project aims to assess the impact of a JAK1/2 inhibitor (ruxolitinib) on activation states of monocytes-derived macrophages (MDM) from systemic sclerosis (SSc) patients

NCT ID: NCT04206553 Active, not recruiting - Bullous Pemphigoid Clinical Trials

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

LIBERTY-BP
Start date: October 28, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a "monoclonal antibody". An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60). The study is looking at several other research questions, including: - Side effects that may be experienced by people taking dupilumab - How dupilumab works in the body and affects the body - How dupilumab affects quality of life - How much dupilumab is present in the blood - To see if dupilumab works to wean the patient off oral corticosteroids

NCT ID: NCT04204694 Active, not recruiting - Septic Shock Clinical Trials

Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock

INTERSEP
Start date: July 1, 2020
Phase:
Study type: Observational

Septic shock is the most severe form of a bacterial infection, affecting 24 million patients per year worldwide, with a high mortality (> 30%). Septic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood. Therefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock. Thus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects. Concerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo

NCT ID: NCT04204616 Active, not recruiting - Prurigo Nodularis Clinical Trials

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Start date: January 11, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).

NCT ID: NCT04201262 Active, not recruiting - Clinical trials for Neuromyelitis Optica

An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

Start date: December 13, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

NCT ID: NCT04201093 Active, not recruiting - Parkinson Disease Clinical Trials

Fixed-Dose Trial in Early Parkinson's Disease (PD)

TEMPO-1
Start date: December 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.