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NCT ID: NCT03936634 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)

INNODIA
Start date: November 14, 2016
Phase:
Study type: Observational [Patient Registry]

INNODIA is a global consortium linking 26 academic institutions, 4 industrial partners, a small to medium enterprise (SME), and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu). The project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking (https://www.imi.europa.eu/projects-results/project-factsheets/innodia) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium. The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families. One of the objectives of INNODIA is to develop a new European clinical research network with standardized protocol based on repeated measures of C-peptide (including home measurements) and comprehensive collection of appropriate biological samples for 'omics', immune, viral and microbiome studies in new onset T1D patients and high-risk auto-antibody positive subjects. A protocol for the harmonization of sample collections in newly diagnosed type 1 diabetic patients and first degree relatives of patients with type 1 diabetes was developed following extensive preliminary work involving partners from across all specialities. Core laboratories with experience in their respective field were set up for analysis of auto-antibodies, fresh immune cells, handling of frozen immune cells, C-peptide measures. A series of standard operating procedures for sample collections and analysis were agreed. Sample tracking between clinical centres and central laboratories was included into a purposely designed electronic case report form (eCRF) into which all clinical and laboratory data collected are captured.

NCT ID: NCT03930953 Recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Start date: May 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

NCT ID: NCT03921931 Recruiting - Clinical trials for Primary Open-angle Glaucoma

Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

It has been shown that reactions of human retinal photoreceptors to a light stimulus can be measured with custom-made, research prototype optical coherence tomography (OCT) systems. This can be used as a biomarker for the function of the photoreceptors. Due to the high technical demands on the system, however, the technique is currently not available for clinical purposes. In this pilot study a protocol to measure changes in retinal photoreceptor layer thickness before and after light stimulation shall be developed based on a commercial OCT system and newly developed algorithms. Other variables, such as circadian processes shall be investigated as well. After measurements in healthy volunteers, the protocol is planned to be applied in patients with primary open angle glaucoma (POAG) and age-related macular degeneration (AMD) to test for feasibility of the method in these patient groups.

NCT ID: NCT03921762 Recruiting - Cataract Clinical Trials

Comparison of a New EDOF-IOL With a Standard-EDOF-IOL

Start date: October 29, 2018
Phase: N/A
Study type: Interventional

Comparison of the new extended depth of focus (EDOF) intraocular lens (IOL) ARTIS ACTIVE, which is designed as a twinset of IOLs, with the standard EDOF IOL AT Lara .

NCT ID: NCT03911700 Recruiting - Clinical trials for Open Midline Laparotomy

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

PREVENT
Start date: December 12, 2019
Phase: N/A
Study type: Interventional

This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.

NCT ID: NCT03908983 Recruiting - Clinical trials for Mitral Valve Regurgitation

OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation

Start date: November 20, 2019
Phase: N/A
Study type: Interventional

KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques. The KALIOS device is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of KALIOS is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3 The primary objective of this clinical investigation is to assess the safety and effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) The secondary objectives are to investigate the effects of KALIOS for the surgical treatment of Mitral Regurgitation on cardiac function and on patient functional status This clinical trial is prospective, non-randomized, single arm, multicentric & international. Up to 100 patients are expected to be enrolled to obtain 62 evaluable patients at one year,presenting with primary (degenerative) or secondary (functional) mitral valve regurgitation and who are candidate to a mitral valve repair.

NCT ID: NCT03899155 Recruiting - Cancer Clinical Trials

Pan Tumor Rollover Study

Start date: August 9, 2019
Phase: Phase 2
Study type: Interventional

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

NCT ID: NCT03897153 Recruiting - Stroke, Acute Clinical Trials

Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke

Start date: February 12, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device.

NCT ID: NCT03897127 Recruiting - Clinical trials for Acute Myeloid Leukemia

Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics

Start date: September 4, 2019
Phase: Phase 3
Study type: Interventional

The trial is a randomized, open-label phase III study comparing CPX-351 vs conventional intensive induction and consolidation chemotherapy in patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification. Overall survival (OS) in the restricted set of de novo patients will be the primary endpoint.

NCT ID: NCT03884907 Recruiting - Hallux Valgus Clinical Trials

Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure

Start date: March 21, 2018
Phase:
Study type: Observational [Patient Registry]

This observational study is to document the application of a human bone graft in the surgical repair of hallux valgus deformity and its subsequent healing process.