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NCT ID: NCT03523572 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

Start date: June 20, 2018
Phase: Phase 1
Study type: Interventional

This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: - Part 1 is to identify the recommended dose to use for treatment. - Part 2 is to find out how well the combination works, and how safe and tolerable it is.

NCT ID: NCT03522025 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.

NCT ID: NCT03520075 Active, not recruiting - Solid Tumor, Adult Clinical Trials

Study of ASTX029 in Subjects With Advanced Solid Tumors

Start date: May 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to subjects with advanced solid malignancies who are not candidates for approved or available therapies.

NCT ID: NCT03519295 Active, not recruiting - Anal Cancer Clinical Trials

A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma

SCARCE
Start date: July 3, 2018
Phase: Phase 2
Study type: Interventional

SCARCE is a non-comparative randomized, 2:1 phase II study. The purpose of this study is to assess the progression-free survival rate at 12 months. (evaluation according with RECISTv1.1 criteria). For all patients, CT scan will be planned at baseline, and every 8 weeks until 12 months from randomization (or disease progression), and every 12 weeks thereafter. PET scan will be performed at baseline, at the end of mDCF treatment, and at 12 months after randomization (in absence of disease progression). CT scan and PET scan will be collected for a centralized review.

NCT ID: NCT03519048 Active, not recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma

SURVEILL'ORL
Start date: January 17, 2018
Phase: Phase 3
Study type: Interventional

Phase III randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2 to 4 months after the end of treatment. The randomization ratio is 1:1.

NCT ID: NCT03518606 Active, not recruiting - Breast Cancer Clinical Trials

Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

MOVIE
Start date: June 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.

NCT ID: NCT03518086 Active, not recruiting - Ulcerative Colitis Clinical Trials

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

NCT ID: NCT03517449 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Start date: June 11, 2018
Phase: Phase 3
Study type: Interventional

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

NCT ID: NCT03508089 Active, not recruiting - Sclerosis, Multiple Clinical Trials

Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis

MS-EYE
Start date: August 22, 2017
Phase: N/A
Study type: Interventional

It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.

NCT ID: NCT03506971 Active, not recruiting - Development, Infant Clinical Trials

Early Childhood : Action Research in the Lunévillois Area (PERL)

PERL
Start date: September 10, 2018
Phase: N/A
Study type: Interventional

The PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI (Protection Maternal Infantile) and the child psychiatry. An innovative prevention device to support the interactions and development of the child will be proposed to about sixty families, randomly recruited into the general population. If the family agrees to participate, their will benefit from regular home visits by a pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from the birth of the child. This home-visits accompaniment, centered on listening and observation, focuses on three areas: baby's development, parenthood and parent-child's interactions. A longitudinal and comparative evaluation will be carried out with a "control" group recruited according to the same conditions and at the same time as the "participants" group. A parallel research on the processes and mechanism will be carried out in partnership with the School of Public Health in order to define and validate the intervention theory (what are the mobilized levers produced and how, what are the mechanisms linking the intervention to its results), to describe the implementation and the processes involved, and to analyze the effects of context, especially social, on processes and results.