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NCT ID: NCT05501886 Recruiting - Breast Cancer Clinical Trials

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

VIKTORIA-1
Start date: September 30, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

NCT ID: NCT05501873 Active, not recruiting - Atrial Fibrillation Clinical Trials

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

FARADISE
Start date: March 24, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSEā„¢ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSEā„¢ pulsed field ablation System is used per hospitals' standard of care.

NCT ID: NCT05501743 Recruiting - Arthrosis Clinical Trials

Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation (Established Standard Treatment).

AMIPREP-2
Start date: February 17, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II, prospective, comparative, randomized, single-center, open-label, parallel-group therapeutic trial. It is a non-inferiority trial to establish the efficacy of intra-articular injection of autologous microfat and PRP at the wrist in patients suffering from radiocarpal osteoarthritis in reference to wrist denervation.

NCT ID: NCT05501405 Recruiting - Autism Clinical Trials

Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits

FERmarkers
Start date: March 30, 2022
Phase: N/A
Study type: Interventional

Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several diseases. They are notably present in a quasi-systematic way in diseases associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in some genetic syndromes with atypical neurodevelopment. In previous studies, the investigators adopted the FPVS-EEG approach to investigate facial emotion discrimination abilities in typical and atypical developing populations. the investigatorshave shown that, in typical adults, the neural response to facial expressions emerges as emotional intensity parametrically increases. A time-domain analysis revealed three components, with the first two increasing linearly with expressive intensity, and the third (beyond 300 ms) showing categorical sensitivity to increasing expressive intensity. The investigators have already successfully extended this approach to the investigation of patients, such as those with 22q11.2 syndrome. The brain response to facial expression was reduced by approximately 36% in these patients, revealing impaired visual coding of emotional facial signals. In this study, response amplitude was associated with positive symptom severity, indicating a potential endophenotype for psychosis risk. Here, the investigators study the implementation of high-level processes and the top-down effect it should have on the response of occipitotemporal regions to identify altered brain markers in schizophrenic patients, but also in other populations with expression recognition deficits (autistic, 22q11.2, in particular). The implementation of compensatory strategies that should result in an increased exploration of the lower part of the face at the oculometric level will also be studied.

NCT ID: NCT05500833 Recruiting - Clinical trials for Dyspnea and Respiratory Insufficiency in Children

Multidimensional Characterization of Dyspnea in Children

DYSPED
Start date: January 26, 2023
Phase:
Study type: Observational

There is no specific tool existing to describe dyspnea in children in a multidimensional way. It has been shown in adult studies that multidimensional dyspnea evaluation scales are well correlated to quality of life and respiratory function impairments. The investigators hypothesis is that using multidimensional dyspnea evaluation scales could allow for a more systematic and precise evaluation of this symptom in children, thus improving management and follow-up of patients presenting with acute (asthma attack, infectious diseases) and chronic (cystic fibrosis, primary ciliary diskynesia, neuromuscular diseases) respiratory insufficiency.

NCT ID: NCT05500794 Recruiting - Psoriasis Clinical Trials

Meditation in Inflammatory Dermatosis

MediDermIn
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Psoriasis and atopic dermatitis are multifactorial inflammatory dermatoses, with a very high prevalence, reaching more than 120 million patients in the world. Although the physiopathological mechanisms are not yet clearly defined, these inflammatory dermatoses involve an interaction between the immune system and the epidermal cells, severe skin inflammation and often very intense pruritus. The objectives of an effective management should be to treat lesions in order to reduce them, but also to reduce itching and allow the patients to accept and cope with their pathology, without neglecting an improvement in the "Dermatology Life Quality Index" (DLQI) and in the psychological state, sometimes depressive, of the patient. Itching is defined as "a feeling that needs to be scratched urgently" and can cause significant distress along with pain. It severely impacts the quality of life and the quality of sleep. Chronic itching is associated with increased stress, anxiety, and other mood disorders. In turn, stress and anxiety exacerbate the itching, leading to a vicious cycle of pruritus - scratching that affects patient behavior (excessive scratching) and worsens disease prognosis and quality of life. Much research over the past few decades has demonstrated the effect of mindfulness meditation on emotional and cognitive responsiveness, cognitive flexibility, rumination, self-compassion and mindfulness, but also on acute pain, anxiety, stress, depression, cardiovascular disease, eating disorders, cancer and cognitive loss with age. Several studies have shown the impact of mindfulness on brain function and immunity, with evidence for the association between mindfulness and changes in the levels of markers characteristic of immune system activity and inflammation, known to be increased in psoriasis or atopic dermatitis. The objective is to evaluate the effect of mental training in the regulation of stress and emotions through mindfulness meditation in patients with moderate, itchy atopic dermatitis or psoriasis, not treated with systemic agents (e.g.: biotherapies). This project is based on the premise that mental training in the regulation of stress and emotions through meditation would reduce the effects of the infernal itch-scratch cycle, alleviating pruritus, thus improving the well-being and mental health of patients while reducing their inflammatory skin lesions and limiting the appearance of new lesions.

NCT ID: NCT05500391 Recruiting - Glioma Clinical Trials

Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

SUR-CAN
Start date: February 28, 2024
Phase: Phase 2
Study type: Interventional

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

NCT ID: NCT05499611 Recruiting - Clinical trials for Acute Myeloblastic Leukemia

Impact of Optical Genome Mapping in Acute Myeloblastic Leukemia

COALA
Start date: January 27, 2023
Phase:
Study type: Observational

A retrospective study using a new technology will be performed: the Optical Genome Mapping (OGM) on acute myelogenous leukemia (AML) samples stored at the CRB-Cancer of the Bordeaux University Hospital and annotated in the DATAML clinical database. The main objective is to estimate the proportion of AML patients for whom OGM detects at least one additional abnormality compared to conventional techniques. This study will constitute an important step in the validation of COA as a reference technique for cytogenetic analysis in AML, replacing the classical techniques, and could also constitute a first argument for redesigning the prognostic classification of AML.

NCT ID: NCT05499325 Not yet recruiting - Pregnancy Related Clinical Trials

Requests for Medical Termination of Pregnancy for Psychological or Social Maternal Reasons

Start date: August 17, 2022
Phase:
Study type: Observational

When the request for termination of pregnancy is made at a term of less than sixteen weeks of amenorrhea, the patients have complete decision-making autonomy. This is called voluntary termination of pregnancy. On the other hand, when they are made after this term, their requests must be subject to a multidisciplinary assessment. This is called medical termination of pregnancy for maternal indication. Schematically, there are two categories of indications: "organic" (progressive cancer, severe heart disease, etc.) and "psycho-social". In the latter case, and although the recommendations of the CNGOF recommend a formalization of these requests in the centers where the patients are received, strong disparities are observed in practice. In addition, there are few epidemiological and clinical data concerning these medical terminations of pregnancy with a psychological or social maternal indication in the literature. The objective of this work is to describe the demographic characteristics of patients who have made a request for termination of pregnancy after the legal deadline for psychological or social maternal reasons, and to specify the care pathways of these patients.

NCT ID: NCT05499130 Recruiting - Crohn Disease Clinical Trials

A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

RELIEVE UCCD
Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: - To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures - To evaluate the safety and tolerability of the 2 different dose regimens - To evaluate the immunogenicity of the 2 different dose regimens The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.