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NCT ID: NCT05091424 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Start date: March 7, 2022
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.

NCT ID: NCT05091190 Recruiting - Clinical trials for Metastatic Head and Neck Cancer

Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Lung and Head and Neck Cancers

MADMAS
Start date: October 27, 2021
Phase: N/A
Study type: Interventional

Immunotherapy is widely administrated as anticancer treatment in metastatic setting. Despite a proved efficacy in several cancer types and clinical situations, it exists a wide variability of responses in terms of efficacy and toxicity. The rate of responders depends mostly on the type of pathology, with 40% of responders among melanoma patients, 20-30% among lung and head and neck cancer patients and only 1% of responders among pancreatic cancer patients. Thus, the main challenge today is to be able to select patients for whom the treatment is likely to be effective. Several studies suggested that tumors with a high mutational burden and expressing PD-L1 are better responders to immunotherapy. However, a proportion of PD-L1 negative cancers responds to immunotherapy, suggesting that other parameters have to be considered together with PD-L1 expression. Of that, the immunotherapy clearance seems to have an impact on overall survival, but larger studies, including different molecules and cancer types, are needed to better understand the correlation between the clearance and the response to immunotherapy. Tumor cells released from the primary tumor in the blood circulation (CTCs, for circulating tumor cells) are considered as "liquid biopsies", as they contain the entire genetic and phenotypic information representative of the tumor, including PD-L1 expression. Thus, the variation of PD-L1 expression under treatment can be easily followed-up on blood samples collected during the time. The objective of MADMAS is to study the correlation between the immunotherapy clearance, measured at the different times during treatment, and the variation of the number of CTCs expressing PD-L1 after two cures of treatment. MADMAS will enroll patients with lung or head and neck cancers, treated with an immunotherapy-based therapy. Blood samples will be collected at the baseline and before the first two cures of treatment. The immunotherapy clearance will be measured with an innovative approach of Mass Spectrometry, and PD-L1 expression will be measured on CTCs, purified with a highly sensitive microfluidics technology.

NCT ID: NCT05091164 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

DISE
Start date: February 8, 2021
Phase: N/A
Study type: Interventional

It is proposed to induce in a obstructive sleep apnea syndrome patient, a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways (VAS) the muscle relaxation observed in sleep, at the origin of obstructive apnea and snoring. The collapsibility type obtained, classified according to Kezirian, will allow specific management by OAM in the event of predominant anteroposterior stenosis. There are no risks fort the patient. The Drug Induce Sleep endoscopy (DISE) is a fibroscopy of upper aerodigestive tract.

NCT ID: NCT05090982 Not yet recruiting - Atopic Dermatitis Clinical Trials

Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis

SHADOW
Start date: December 2021
Phase:
Study type: Observational

Hypothesis/Objective : Patient-centered health care and shared decision making are key components of increasing importance which are recommended by the French Haute Autorite de Sante (HAS) and World Health Organization (WHO). In the context of dermatology and atopic dermatitis, European guidelines has promoted an active involvement from both patients and caregivers in therapeutic decisions at all stages to achieve therapeutic success and the Task Force on Atopic Dermatitis (ETFAD) has promoted the setting of treatment goals in a shared decision with the patient. The main objective of this study is to develop and cross culturally validate a tool dedicated to shared-decision in atopic dermatitis that can be used during routine dermatological consultations. The second objective is to better characterize patients seen in this context and to evaluate patients' satisfaction when empowered by shared decision. Method : We aim to develop a SDMt in AD following the recommendations of the International Patient Decision Aid Standards (IPDAS) collaboration. Development will use a multistep approach: 1) identification of priority domains for patients; 2) Selection of domains to be included in the SDMt for AD; and 3) Creation and testing of the SDMt. Participants will be consecutive adult (>18 years old) patients attending consultation for a AD in medical centres in France (Toulouse, Nantes and Créteil). All participants will provide written consent to participate. The study will be submitted for approbation to the local ethics committees of the University Hospital Centres of Paris and will be conducted according to the Declaration of Helsinki. Step 1: Identification of priority domains for patients Step 2: Selection of domains to be included in the SDMt for AD Step 3: Creation and testing of the SDMt

NCT ID: NCT05090969 Recruiting - Febrile Syndrome Clinical Trials

Study of Febrile Syndromes After Tick Bite

FebriTick
Start date: November 30, 2020
Phase:
Study type: Observational

Febrile syndromes after tick bites can be caused by different microorganisms: bacteria (B. miyamotoi, A. phagocytophilum, R. helvetica…), parasites (Babesia spp) and viruses (TBE virus). The clinical picture is not specific but complications may appear depending on the microorganism identified (thrombosis with N. mikurensis, meningoencephalitis with B. miyamotoi and the TBE virus). Thus, in order to provide appropriate treatment and monitoring, the infection should be documented.

NCT ID: NCT05090956 Completed - Healthy Clinical Trials

Developpement of 3T MRI Protocol

(MISAP)
Start date: June 8, 2012
Phase: N/A
Study type: Interventional

Since January 2010, a new magnetic resonance imaging scanner (Philips 3T, Achieva) is installed on the Baudot Building in Toulouse hospital. This tool, is completely dedicated to the research. It was installed with sequences RMN supplied by the manufacturer. Imagers also contain an instrumentation susceptible to evolution and/or to adjustment (antennas radio frequency, sheath of gradients, elements of physiological monitoring (for example control of the breath), regulation of the homogeneity of the magnetic field). This MRI scanner and this instrumentation are used for anatomical examinations or for paradigms of cognitiveresearch (for example of detection of intellectual activations following simple stimuli of fingers movement, visual tasks, or of mental processes). The developpement of this equipment is going to favor the emergence of numerous projects and new themes, up to there adressed by other techniques (psychophysics, EEG). To obtain good quality signals and know the practical limits of this imager, it is thus necessary that the researchers doctors, physicists and engineers, can finalize on volunteers' significant number, all the sequences RMN necessary for the use of these tools for the research. These developments are going to get organized around four main axes: 1 the control of the geometrical distortions (generated by the introduction of an object within the magnetic field) 2 Optimization of the parameters of sequences to improve the contrast and the spatial resolution of the obtained images 3 the development of new sequences 4 the feasibility study of the protocols of functional MRI

NCT ID: NCT05090943 Recruiting - Tic Disorders Clinical Trials

Adult Tic Disorders Registry

RegisTICs
Start date: December 1, 2021
Phase:
Study type: Observational

The purpose of this study is to develop the adult tic disorders registry in order to characterize the relationship between tic severity and tic-related impairment in women compared to men with tic disorders.

NCT ID: NCT05090917 Recruiting - Clinical trials for Cockayne Syndrome, Type I and II

Growth Curves in Cockayne Syndrome Type 1 and Type 2

Curves-CS
Start date: November 1, 2020
Phase:
Study type: Observational

Despite the natural progression of Cockayne's syndrome, affected patients also present with variable neurological and gastrointestinal damage (gastroesophageal reflux, recurrent vomiting, swallowing disorders, etc.) with varying repercussions on their growth. Acute intercurrent events such as seizures, constipation, infections can also interact with their metabolism, food intake and influence their growth. The nutritional deficit potentially involved in this growth retardation can be responsible for many manifestations such as anemia, bone fractures, fatigue, coagulation disorders responsible in total for the reduction in quality and life expectancy. Faced with growth retardation in patients with Cockayne syndrome, medical management is difficult to establish. Is this delay part of the natural course of the pathology?

NCT ID: NCT05090891 Recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva (FOP)

To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

Progress
Start date: May 5, 2022
Phase: Phase 2
Study type: Interventional

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

NCT ID: NCT05090696 Recruiting - Airway Obstruction Clinical Trials

Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly

INEXPA
Start date: December 15, 2021
Phase:
Study type: Observational

The mechanical in-exsufflator (MI-E) is a medical device used to facilitate coughing when the patients' cough is not efficient. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular disorders however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.