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NCT ID: NCT05351697 Not yet recruiting - Clinical trials for Advanced Malignancies

Phase I Clinical Study of BR105 Injection

BR105-I
Start date: April 2022
Phase: Phase 1
Study type: Interventional

A phase 1, dose escalation and dose expansion study of BR105 in patients with advanced malignancies.

NCT ID: NCT05356156 Not yet recruiting - Gastric Cancer Clinical Trials

The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy

Start date: April 2022
Phase: N/A
Study type: Interventional

To compare the incidence of internal hernia, overall survival and short-term surgical safety of routine closure of the surgically created mesenteric defects versus non-closure for patients with adenocarcinoma of the gastric or esophagogastric junction who underwent radical gastrectomy (D1+/D2 lymph node dissection).

NCT ID: NCT04721288 Not yet recruiting - Kidney Transplant Clinical Trials

REmote moBile Outpatient mOnitoring in Transplant 2.0

Reboot
Start date: April 2023
Phase: N/A
Study type: Interventional

This study is designed to determine if an innovative mobile health intervention designed to improve patient-provider communication can reduce unscheduled hospitalizations, and visits to the emergency department and ambulatory clinic in adult heart, liver, and kidney transplant patients.

NCT ID: NCT04986514 Not yet recruiting - Systemic Sclerosis Clinical Trials

Implementation of a Biological Sample Collection in Systemic Sclerosis Patients

SCLERO-BIOBANK
Start date: April 2023
Phase:
Study type: Observational

Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.

NCT ID: NCT05030714 Not yet recruiting - Glaucoma Clinical Trials

Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study

Start date: April 2023
Phase: N/A
Study type: Interventional

This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device will be similar.

NCT ID: NCT05112705 Not yet recruiting - Pulmonary Embolism Clinical Trials

Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

DETECT
Start date: April 2023
Phase: N/A
Study type: Interventional

There is no randomized controlled trial examining surveillance ultrasonography for lower limb DVT in high-risk medical-surgical ICU patients compared to a clinician-directed approach. The DETECT randomized controlled trial addresses the question of whether surveillance ultrasound in critically ill patients by facilitating DVT detection reduces the incidence of PE and lowers all cause 90-day mortality. The primary outcome is 90-day all-cause mortality.

NCT ID: NCT05174741 Not yet recruiting - Asthma Clinical Trials

Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.

Start date: April 2023
Phase: N/A
Study type: Interventional

To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic obstructive pulmonary disease patients.

NCT ID: NCT05237518 Not yet recruiting - Sleep Disorder Clinical Trials

Accuracy Evaluation of EarlySense With Modified Sensor (Smaller Shape Sensor With BLE) at Home Setting Monitoring a Subject While Partner in Bed

Start date: April 2023
Phase: N/A
Study type: Interventional

Accuracy evaluation of EarlySense device, a smaller shape sensor with BLE connection to processing unit (HUB)) for use while two people are in bed ("Home Use" scenario) The EarlySense device is intended for continuous contact-free monitoring of heart rate and respiration rate at home, or in professional healthcare settings. The system is intended for remote monitoring of patients by healthcare professionals and is indicated mainly for elderly population monitoring. The modified version of this product which is the subject of this validation study allows monitoring of subjects when there is a second person in the same bed ("Home scenario" environment). The objective of this study is to evaluate the accuracy of the device in determining Respiration Rate (Br./min) and Heart Rate (BPM) at home environment, while two people are in the same double bed. The study aims to demonstrate that partner presence doesn't affect the monitoring accuracy of the subject that is being measured. The continuous monitoring will last for duration of 90 minutes for each subject, unless the participant requests termination of the experiment or as per the physician's instructions. Subjects admitted to the study will be monitored using both Capnography and ECG- as reference devices. The EarlySense revised sensor will be placed under one of the two-mattress types incorporated into the study. Both mattresses are typical double bed mattresses of 160 X 200 cm with two different internal structure composition. The sensor will be placed directly below the subject's thorax area on one of the mattress sides. The signals collected by the sensor will be communicated via BLE to the processing unit (HUB). Following connecting the subject to the reference devices, both the subject and the partner will be instructed on the actions they should perform through the stages of the experiment. The subject will lie on the mattress side where the EarlySense sensor is located, while the partner will be instructed to enter the other side of the mattress. At this time, the experiment will start, and the clock will start running.

NCT ID: NCT05273112 Not yet recruiting - Gender Dysphoria Clinical Trials

Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.

TRANS'ITION
Start date: April 2023
Phase:
Study type: Observational

Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Currently, the modalities of decision and realization of the care paths are heterogeneous on the territory, little standardized, and are the subject of debates between representatives of users and medical teams. The french national report of IGAS from 2011 warns of the need to argue and legitimize care practices through more numerous, more exhaustive scientific studies, presenting a better level of evidence Since 2011, no prospective study has been carried out on the national and international level, making it possible to assess the relevance of the planned care modalities. This research project, conducted over five consecutive years at the first contact of a transgender people with a care device, aims to correlate a variation in the quality of life of people with the characteristics of the care methods provided. This is a first proposal to assess care practices for transgender people. The results of this study would first allow us to infer the care modalities most suited to the needs of people. Secondly, secondary hypotheses could support new experimental protocols.

NCT ID: NCT05273359 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Immunological Basis for Benralizumab Activity in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 2023
Phase: Phase 2
Study type: Interventional

The current literature suggests that the mode of action of benralizumab is to deplete eosinophils through a mechanism of antibody-dependent cell-mediated cytotoxicity. This direct cellular cytotoxicity may not explain all of the benralizumab effects. The investigators propose a set of studies to systematically examine the spectrum of effects of this drug on the immune system.