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NCT ID: NCT05099172 Recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

Start date: October 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment, BAY2927088, is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC. The main purpose of this study is to learn: Escalation, Backfill, and Expansion Part: - How safe is BAY2927088 for the participants? - What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants? - How does BAY2927088 move into, through, and out of the bodies of the participants? For this, the researchers will measure the followings: - The number of participants with medical problems, also called adverse events and serious adverse events, and their severity - The number of participants who discontinue study treatment due to an adverse event. - The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088 - Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level - The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY 2927088 - The (average) highest level of BAY 2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part - How well does BAY 2927088 work in participants? For this, the researchers will measure the following: • Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor. This study has 4 parts: - The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive. - The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY 2927088 that work well and are safe to be tested in the next part. - The expansion part aims to determine the dose of BAY2927088 to be tested in further studies. - The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well. The participants in this study will take the study treatment BAY2927088 in 3-week periods called "cycles". They will in general take BAY2927088 once or twice daily as a liquid/tablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle. During the study, the study team will: - take blood and urine samples, - check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans, - check the participants' overall health and heart health, - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is considered "serious" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.

NCT ID: NCT05099068 Recruiting - Glioblastoma Clinical Trials

Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)

PLANET
Start date: November 16, 2021
Phase: N/A
Study type: Interventional

The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

NCT ID: NCT05098873 Completed - Intelligence Clinical Trials

Study on Boredom in High Potential Adolescents

ESchAHP
Start date: February 1, 2022
Phase:
Study type: Observational

The research focuses on "High Potential" (HP) in adolescence, in a link with the professional practice of the investigators. Furthermore, supported by scientific literature and professional clinical practice, this research is interested in school boredom, regularly expressed by the consulting adolescents, in its relation with a depressive syndrome. The objective of the research is to know if school boredom is a precursor of a depressive episode in high school students with HP compared to high school students without HP.

NCT ID: NCT05098704 Recruiting - Systemic Sclerosis Clinical Trials

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

PSSIT
Start date: June 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.

NCT ID: NCT05098405 Terminated - Clinical trials for Advanced Malignant Solid Tumor

First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

Start date: October 11, 2021
Phase: Phase 1
Study type: Interventional

This study is investigating a new experimental therapy, MP0317, a DARPin® drug candidate targeting fibroblast activation protein (FAP) and CD40. Preclinical studies suggest that MP0317 may provide benefit for the treatment of tumors known to express high levels of FAP and for which approved therapies have been exhausted. This is the first study of MP0317 in humans and its main purpose is to test its safety and tolerability in patients with advanced solid tumors. This study will also examine the blood levels of MP0317 at several increasing dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity.

NCT ID: NCT05098314 Completed - Clinical trials for Wound Healing Disorder

Impact of Personalized Interventions to Raise Teleconsultation Awareness in EHPAD

Start date: September 1, 2018
Phase:
Study type: Observational

The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. This cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each EHPAD on the use of this network.

NCT ID: NCT05098301 Completed - Diabetes Clinical Trials

Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration

GLUCAL3
Start date: November 30, 2021
Phase:
Study type: Observational

A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm

NCT ID: NCT05098093 Completed - Healthy Clinical Trials

Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

Scientific research on the beneficial effects of botanical extracts has led to a better understanding of the role of its bioactive compounds, but the bioavailability in human remains largely unknown. Indeed, the most of publications investigated the bioavailability of metabolites of spices in in vitro cells model or animal experiments but few clinical studies have been conducted. Therefore, the aim of this study is to characterize and quantify in blood, the main metabolite compounds of a botanical extract, following its administration by different routes (oral or sublingual) and with different preparations (extract or powder), in quantity equivalent to those having demonstrated biological properties.

NCT ID: NCT05097898 Recruiting - Clinical trials for Chronic Heart Failure

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

CHF-COV-P
Start date: August 10, 2022
Phase: N/A
Study type: Interventional

Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation. The main objective of the CHF-COV Preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with preserved left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.

NCT ID: NCT05097742 Completed - Epilepsy Syndrome Clinical Trials

Cognitive Impairments in Children With Epilepsy

Start date: October 15, 2021
Phase:
Study type: Observational

Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments through the taking of specific tests. The general objective of this study is to observe possible oral language and attention disorders in children with epilepsy, by age and etiology of epilepsy. The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.