Clinical Trials Logo

Filter by:
NCT ID: NCT04420884 Recruiting - Solid Neoplasms Clinical Trials

A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

iintune-1
Start date: July 22, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

NCT ID: NCT04420624 Terminated - Clinical trials for Myocardial Infarction, Acute

COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

COLD-MI
Start date: December 4, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

NCT ID: NCT04420468 Completed - COVID-19 Clinical Trials

Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children

HEART-COVID
Start date: June 10, 2020
Phase:
Study type: Observational

The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

NCT ID: NCT04420338 Recruiting - Clinical trials for Chronic Hemodialysis Patients

SeroCOVIDial Study: Assessment of COVID-19 Seroconversion in Patients on Chronic Hemodialysis and in Their Caregivers, a Cohort Study

SeroCOVIDial
Start date: June 5, 2020
Phase: N/A
Study type: Interventional

Background: The preventive containment measures implemented in the COVID-19 pandemic are not feasible in chronic hemodialysis patients (HD) who need to attend their dialysis sessions 3 times a week. HD patients display frequent comorbidities (such as diabetes and cardiovascular disease), and immune deficiency, which expose them to an increased risk of severe forms of COVID-19. They can be infected in their dialysis center despite the measures taken to limit this risk. Their caregivers are also at risk of infection if patients carry the virus. Dialysis centers face major organizational challenges in terms of patient and caregiver safety. Knowing the viral serological status of HD patients and caregivers, the proportion of asymptomatic forms, and the persistence and effectiveness of immunization over time would be of major interest for patient management and the organization of dialysis care. Research objectives: The primary objective of SeroCOVIDial is to assess the prevalence of SARS-COV2 seroconversion at inclusion (M0) in a cohort of HD patients, using the rapid serological test. Secondary Objectives : 1) assess the prevalence of SARS-COV2 seroconversion in dialysis caregivers at M0, using the same test; 2) assess the proportion of asymptomatic forms of COVID-19 in HD patients and in their caregivers; 3) compare the prevalence of seroconversion and the proportion of asymptomatic forms in HD patients according to their clinical characteristics and co-morbidities; 4) assess the prevalence of SARS-COV2 seroconversion in participants who had a documented COVID-19; 5) evaluate the spread of the epidemic and the kinetics of seroconversion in patients and caregivers by a second test performed at M3; 6) evaluate the predictive value of SARS-COV2 seroconversion at M0 on the risk of developing a symptomatic COVID-19 infection within 6 months, in patients and caregivers; 7) evaluate a posteriori the intrinsic diagnostic performances of the test in comparison with serological gold standards (ELISA and seroneutralization). Methods: Multicenter cohort study, carried out in 4 dialysis facilities in Aix-Marseille. Procedure: collection of clinical data and rapid serological tests carried out at M0 and M3, in patients and caregivers (a systematic screening for COVID-19 symptoms has been carried out in all HD patients in the 4 participating centers since the beginning of the pandemic in France). Number of participants: 800 eligible persons (561 HD patients, and 239 caregivers). Material tested: rapid Biosynex serological test on 1 drop of blood, and 1 tube of frozen serum for patients at M0 and M3. Clinical data will also be collected. Primary endpoint: prevalence of SARS-COV2 seroconversion in HD patients. Maximum duration of participation for each patient: 6 months. Duration of research: 6 months and 2 weeks (inclusions over 2 weeks).

NCT ID: NCT04420312 Completed - Covid-19 Clinical Trials

Prevalence and Characteristics of Pulmonary Embolism on COVID-19 Patients Presenting Respiratory Symptoms

COVID-EP
Start date: March 1, 2020
Phase:
Study type: Observational

Multicentric case-control study that is aims at: - evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for COVID-19 pneumonia into two large university hospitals in Paris, France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges Pompidou (HEGP) - and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.

NCT ID: NCT04420286 Completed - Clinical trials for Coronavirus Infections

Study of the Increase in ICU Beds Capacity During COVID-19 Pandemic in France

FRENCH ICU
Start date: May 6, 2020
Phase:
Study type: Observational

For preventing the overwhelming of ICU beds capacity during COVID-19 pandemic in France, national and regional Health-Care institutions decided to optimize the Intensive Care Unit beds availability by opening new ICU beds in institutions with and without prior ICU. The Present study was design to retrospectively describe the origin of the ICU beds and human resources created during the COVID-19 outbreak in France.

NCT ID: NCT04420052 Withdrawn - Clinical trials for Rhinosinusitis Chronic

Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Chronic Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options. Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by applying several techniques supposed to be related to the autonomic nervous system. Our hypothesis is that these techniques could have beneficial effects on inflammation and head symptoms in CRS. Methods: A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT group or the placebo group. The placebo procedure will consist in using light touch around the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of two visits at day 0 and day 30. A general practitioner will determine the eligibility for the study. The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30 (twice each, before and after treatment) and 180 (once). The two groups will be compared regarding short and long term evolution. The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed effect modelling A Qualitative study will be conducted in the two groups to understand the patients' experiences during care. This protocol has been approved by a french ethic committee (Comité de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).

NCT ID: NCT04420026 Completed - Clinical trials for Hepatocellular Carcinoma

Study of Automatic Image Fusion of a CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors

IAT
Start date: July 6, 2020
Phase: N/A
Study type: Interventional

The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound.

NCT ID: NCT04420013 Not yet recruiting - Colorectal Cancer Clinical Trials

Colorectal Cancer Immunomonitoring Combined With Radiofrequency ablatIon

ColIBRI
Start date: September 2020
Phase:
Study type: Observational

The primary objective of the study aims to compare soluble CD154 (CD40L) levels before and after radiofrequency ablation (RFA) in patients with colorectal cancer (CRC) liver metastases. The secondary objectives aims: - to compare soluble CD154 (sCD40-L) levels before and after treatment by RFA or surgery alone in patients with CRC liver metastases; - to study the feasibility and reliability of soluble CD154 (sCD40-L) levels to detect and quantify the induction of immun response in CRC liver metastases patients after RFA; - to study the impact of surgery on plasma soluble CD154 levels; - to study association between CD154 expression level before and after RFA in CRC liver metastases patients and relapses rate at 1 year.

NCT ID: NCT04419779 Recruiting - Type 2 Diabetes Clinical Trials

Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy

REVITALIZE 1
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled with insulin therapy. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.