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NCT ID: NCT06015737 Not yet recruiting - Clinical trials for Cutaneous Lupus Erythematosus

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

LAVENDER
Start date: June 17, 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).

NCT ID: NCT06013150 Not yet recruiting - Clinical trials for Anaphylactic Reaction

Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.

Start date: October 23, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, randomised, double blind placebo controlled 2-part study to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of inhaled DMC-IH1 (epinephrine) and relative bioavailability and carryover effects of Inhaled (DMC-IH1) and Intramuscular(IM) (EpiPen®) Epinephrine in healthy male and female participants.

NCT ID: NCT06009458 Not yet recruiting - Myopia Clinical Trials

Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear

Acuity200OK
Start date: September 2023
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to collect scientifically valid safety and effectiveness data on the Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear. The clinical performance data reported from this study is intended to be submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a new Premarket Application (PMA).

NCT ID: NCT05983159 Not yet recruiting - Clinical trials for Arteriovenous Malformations

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

TARGET-VM
Start date: August 2024
Phase: Phase 2
Study type: Interventional

Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).

NCT ID: NCT05959252 Not yet recruiting - Clinical trials for Extracorporeal Membrane Oxygenation Complication

BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

BLUSH
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support. The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care. Participants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.

NCT ID: NCT05957081 Not yet recruiting - Clinical trials for Advanced or Metastatic Solid Tumors

Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309

MarkV-01
Start date: November 28, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1a/1b, first-in-human (FIH), open label study to evaluate the safety, tolerability, and pharmacokinetics (PK) of PMC-309, a mAb against the human VISTA ligand, in participants with advanced or metastatic solid tumors administered as a monotherapy and in combination with pembrolizumab.

NCT ID: NCT05950841 Not yet recruiting - Iron-deficiency Clinical Trials

Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman

Start date: January 1, 2024
Phase: Phase 3
Study type: Interventional

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in iron-deficient but otherwise healthy premenopausal women over 12 weeks.

NCT ID: NCT05939141 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

An Extension Study to Assess the Long-term Safety of the Genio® System

OLE
Start date: July 17, 2023
Phase:
Study type: Observational

The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation. (Serious) Adverse Device Effects and Device Deficiencies in subjects previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated) will be collected. The main question it aims to answer is: what is the long term safety profile of the Genio System? Participants will be asked to refer back to the site per standard of care and report on any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.

NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

NCT ID: NCT05894707 Not yet recruiting - Autoimmune Disease Clinical Trials

Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers

Start date: June 2023
Phase: Phase 1
Study type: Interventional

The goal of clinical trial is to evaluate the safety and tolerability of SCT650C in healthy participants.