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NCT ID: NCT04629443 Completed - Clinical trials for Acute Myeloid Leukaemia

Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

Start date: February 17, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.

NCT ID: NCT04629274 Completed - Clinical trials for Neuromyelitis Optica

In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized NMO

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients. A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease, Neuromyelitis Optica Spectrum Disorders (NMOSD) in this study. The main goal of the study will be to support the selection of Imotopes® (i.e. synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif), and (i) capable of binding with class II HLA antigens of each patient and (ii) causing ex vivo the appearance of epitope -specific cytolytic CD4+ T cells.

NCT ID: NCT04629248 Active, not recruiting - Clinical trials for Primary Membranous Nephropathy

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

MAJESTY
Start date: June 25, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

NCT ID: NCT04629222 Completed - Clinical trials for Infectious Disease of Lung

Tracheobronchitis in Respiratory Involvement on the Lung SPECT/CT Images of Coronavirus Disease (COVID-19) Patients

Start date: March 11, 2020
Phase:
Study type: Observational

Tracheobronchitis signs may be observed on ventilation lung scintigraphy during coronavirus disease (COVID-19) infection. This case report study aimed to analyze the rates and associated factors of such tracheobronchitis in COVID-19 patients referred to ventilation/perfusion lung scintigraphy with shortness of breath, suspected of pulmonary embolism.

NCT ID: NCT04628819 Terminated - Clinical trials for Nosocomial Infection

Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children

EPISODE
Start date: December 29, 2019
Phase: N/A
Study type: Interventional

One of the most common infections acquired in hospital, also known as nosocomial infections, is intestinal infections. These infections can lead to the development of nosocomial diarrhea which can have serious consequences in young / very young children. These infections tend to prolong the average length of hospital stay of this fragile population. Conventional treatment of these infections, in the absence of knowledge of the infectious agent, is purely symptomatic. It is therefore necessary to develop new prevention strategies for this type of disease. In this sense, the administration of probiotic strains in order to prevent the onset of nosocomial diarrhea is a promising avenue and the present study aims to validate the preventive effect of this supplement. The objective of this study is to assess the effect of Babybiane® Imedia or the microbiotic strain Lactobacillus rhamnosus GG LA801 in the preventive nutritional management of nosocomial diarrhea in children aged 1 to 24 months. This evaluation will be made in comparison with a placebo. The tolerance of the product under study will also be assessed.

NCT ID: NCT04628585 Enrolling by invitation - Sickle Cell Disease Clinical Trials

Long-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy

Start date: October 21, 2020
Phase:
Study type: Observational

This is a multi-center, long-term safety and efficacy follow-up study for subjects with sickle cell disease who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After completing the parent clinical study (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in the study.

NCT ID: NCT04628494 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

EPCORE DLBCL-1
Start date: January 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to find out if epcoritamab, also known as EPKINLYâ„¢ and GEN3013, is safe and works well as treatment for patients with diffuse large B-cell lymphoma (DLBCL) that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin [R-GemOx], or bendamustine + rituximab [BR]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT). Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously. Trial details include: - The trial duration will be up to 5 years. - All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death. - The estimated trial duration for an individual subject depends upon the treatment arm assigned: - Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. - Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either: - R-GemOx: On Day 1 (or Day 1 & Day 2), and Day 15 (or Day 15 & Day 16) every 28 days, for up to 4 months; or - BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.

NCT ID: NCT04628416 Recruiting - Violent Trauma Clinical Trials

Evaluation of the PICO® Negative Pressure Dressing System on the Fibula Free Flap Donor Site's Skin Graft.

PICOFLAP
Start date: January 18, 2021
Phase: N/A
Study type: Interventional

A fibula free flap can be used for the reconstruction of a mandible or a maxillar when the lack of bonne exceeds 3cm. This flap is made of the fibula bone, some muscle around, the fibular vascular pedicle and a skin paddle to reconstruct the gum. Once this flap has been taken and transposed on the face, the leg is closed with a split thickness skin graft to replace the skin paddle. But the healing on this site is often a problem: this is partly due to the high rate of early graft's loss due to local devascularization (3 to 55% of loss). The skin grafting is generally improved by the application of a dressing sewn and left in place during 5 to 7 days postoperative (standard method). This study will evaluate the efficiency of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites, compared to the standard method. A prospective randomized evaluation will be done, comparing the PICO® to a conventional dressing. The main aim of the study is the evaluation of the impact of this portative system on the healing of the skin grafted donor site, in terms of rate of skin take, time of healing, complications and medical costs. The patients will be seen preoperatively to decide on their inclusion in the protocol. They will be reviewed at day 10 to evaluate the engraftment and possible local complications on the donor site. They will then be reviewed at day 20 and day 30 and until complete healing. The follow up will be of 12 months maximum. A medical cost evaluation will be done comparing the costs generated by the care on the donor site in the 2 groups.

NCT ID: NCT04628234 Completed - Clinical trials for Hematologic Malignancy

Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site (RESPECT)

RESPECT
Start date: July 4, 2020
Phase:
Study type: Observational

This is a non randomized, monocentric, descriptive, transversal and prospective study. The purpose of this study is to assess the compliance with patient expressed choice regarding subsequent care and death -if occured- site (at hospital or at home) after hospitalisation for terminally ill patients with an onco-hematologic solid tumor in palliative care and to identify reasons for potential non-compliance.

NCT ID: NCT04628091 Recruiting - Clinical trials for Exposure to Environmental Pollution

Characterization of Persistent Organic Pollutants Exposure During Preconception and Preimplantation Development.

TUBPOP
Start date: January 28, 2021
Phase: N/A
Study type: Interventional

In order to evaluate if gametes and preimplantation embryos are in vivo exposed to environmental chemicals, the detection of 6 molecules representative of 3 persistent organic pollutants families will be performed in the mucosa of fallopian tubes obtained after bilateral salpingectomy performed for sterilization purpose in 20 women and compared with concentrations in adipose tissue. This feasibility study is a preliminary step before larger clinical surveys and in vitro studies.