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NCT ID: NCT06436027 Completed - Clinical trials for Heart Transplant Rejection

Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.

Nano-Heart
Start date: November 10, 2021
Phase:
Study type: Observational

The goal of this observational study is to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics applicable to formalin-fixed paraffin-embedded endomyocardial biopsies. The primary outcome will be the biopsy-proven rejection, that will be predicted with molecular classifiers (cellular and antibody-mediated rejection scores).

NCT ID: NCT06367049 Completed - Clinical trials for Nasopharyngeal Carcinoma

Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma

Start date: June 1, 2023
Phase:
Study type: Observational

Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer. DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening. There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma. Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer.

NCT ID: NCT06237036 Completed - Skin Diseases Clinical Trials

Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity

COVIDX_EVCDAO
Start date: March 3, 2022
Phase:
Study type: Observational

The goal of this observational prospective and analytical study is to evaluate the effectiveness of the device developed by Legit.Health in remotely monitoring the severity of chronic dermatologic pathologies. Secondly, to assess patient satisfaction with the device for remote monitoring. All this in patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón. The study proceeded as follows: Patient Selection and Recruitment Visit The recruitment period spanned six months, during which investigators identified eligible patients. The Principal Investigator (PI) or designated collaborating investigators explained the study details to potential participants using the Patient Information Sheet. Patients had the opportunity to seek clarification on any aspects of the study. If a patient chose to participate, they provided informed consent and received a study code. Data collection commenced post-consent. During this initial visit, patients used the device under the supervision of the research team to complete questionnaires and capture photographs associated with their pathology. Subsequently, the patient autonomously and remotely continued the data collection process at home, as detailed in the following section. The device was provided at no cost to patients and the research team for the study's duration. Procedures Performed by the Patient at Home Completion of Questionnaires Patients independently reported on their condition from home, following instructions provided by the research team and the "Patient Information Guide" integrated into Legit.Health, in conjunction with photograph submissions. Every two months, patients completed the "Patient Satisfaction Questionnaire" addressing general user experience aspects. Additionally, they completed the System Usability Scale (SUS) Questionnaire at the same frequency Image capture Patients simultaneously took photographs of the affected areas while completing questionnaires through the app. These photographs were captured using the patient's smartphone from their homes in an autonomous manner. The frequency of photograph submission was determined by the consulting specialist. No specialized camera equipment was required; patients used the camera available on their smartphones. Patients then transmitted these photographs to the research team through a web app Both patients and members of the medical team possessed access credentials. The manufacturer did not have access to patient accounts or information. Data transfer and photograph storage adhered to the European Regulation 2016/679 of 27 April on the protection of natural persons with regard to the processing of personal data and the free movement of such data, as well as the Organic Law 3/2018 of 5 December on the Protection of Personal Data and guarantee of digital rights.

NCT ID: NCT06227819 Completed - Heart Failure Clinical Trials

BVA-200 vs BVA-100 Validation Study

Start date: May 23, 2023
Phase:
Study type: Observational

The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an FDA medical device submission.

NCT ID: NCT06157944 Completed - Diagnosis Clinical Trials

Physician Reasoning on Diagnostic Cases With Large Language Models

Start date: November 29, 2023
Phase: N/A
Study type: Interventional

This study will evaluate the effect of providing access to GPT-4, a large language model, compared to traditional diagnostic decision support tools on performance on case-based diagnostic reasoning tasks.

NCT ID: NCT06118125 Completed - Advanced Cancer Clinical Trials

Delay to Diagnosis in Digestive Cancerology by the General Practitioner Related to Covid-19 Pandemic Confinement

Start date: June 1, 2019
Phase:
Study type: Observational

Objective: the pre-hospital management of cancers is little known in General Medicine. The first lockdown related to the COVID-19 pandemic led to the closure of health facilities. Investigators were interested in the diagnosis and care pathway of digestive cancers in post-confinement in General Medicine in Nouvelle-Aquitaine.

NCT ID: NCT06103747 Completed - Fed Conditions Clinical Trials

Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet®

Start date: February 21, 2023
Phase: Phase 1
Study type: Interventional

The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (850 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by SAIPH versus the reference product Galvumet® tablets (850 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis. This study also aims to monitor the safety of the subjects. This study is an open-label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing. Eighteen (18) Tunisian subjects will be enrolled in this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height & weight and meeting the selection criteria for this study

NCT ID: NCT06063031 Completed - Clinical trials for Post-COVID Condition

Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition

ARACOV-02
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Once the acute phase of the disease has passed, about 40% of the people who discharged continue to have symptoms, and of these, between 50 and 70% present them up to three months later. These persistent symptoms include physical aspects such as fatigue and dyspnea, but also cardiac such as palpitations, cognitive such as mental confusion, and psycho-emotional such as depression, anxiety, and stress. SARS-CoV-2 infection is associated with a hyperinflammatory state, including excessive inflammatory cell infiltration, inflammasomes activation. In this context, omega-3 metabolites (Special Pro-resolving Mediators-SPMs) restore the balance in nutritional and molecular levels of eicosanoids. A more direct and targeted way to increase SPMs levels is Omega3 Essential Nutrition with natural SPMs taken by mouth. Today, there are dietary supplements containing SPMs (LIPINOVA®), made from fish oil through a fractionation process. LIPINOVA® is a nutritional supplement patented by Solutex GC S.L., obtained through several fractionation stages (extraction, purification, separation, concentration) from rich-in-omega-3 fish oil (without additives). Each capsule contains 498 mg of fish oil and 2 mg of tocopherols. This represents a variable quantity from 50 to 150 mg of EPA (20%), a variable quantity from 100 to 225 mg of DHA (30%), as well as the following quantities of EPA and DHA active metabolites, obtained from a pool of natural lipid mediators contained in omega-3 oil: 40-200 mcg of 17-HDHA, 25-200 mcg of 18-HEPE and 20-100 mcg of 14-HDHA. In addition to this, the appearance of this new health condition, post-COVID condition, has once again led physiotherapists to update themselves in search of the best evidence to guide the examination and necessary rehabilitation interventions in this type of patient. Studies have shown how physiotherapy sessions that include a multimodal program could be the most indicated for this type of patients. Patients with this condition present an increase in fatigue, dyspnea and a decrease in their functional capacity and, therefore, a decrease in their quality of life, due to various pathogenic mechanisms that include chronic hyperinflammation. These patients could obtain greater health improvements in terms of their quality of life if a therapeutical exercise and education program based on tele-rehabilitation is implemented together with a natural nutritional supplement that generates a systemic anti-inflammatory effect through SPMs (omega- 3).

NCT ID: NCT05950308 Completed - Multiple Sclerosis Clinical Trials

Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies

Start date: January 5, 2022
Phase:
Study type: Observational

Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by activation-induced marker expression.

NCT ID: NCT05930626 Completed - Cancer Clinical Trials

Biomarkers of Acrylamide, Glycidol, POPs, PFAS and Disease Outcomes and OMICs Signatures

Start date: January 1, 1997
Phase:
Study type: Observational [Patient Registry]

The aim of the project is to assess the associations between biomarkers of acrylamide and glycidol exposure and disease outcomes in a case-cohort study based on two prospective cohorts with biobanks. The investigators also aim to assess the exposure-affected OMICS signatures and molecular pathways underlying disease development (specifically cardiovascular diseases such as myocardial infarction and stroke and cancer such as breast-, endometrial and colorectal cancer) for these exposures along with persistent organic pollutants (POPs) and per- and polyflouroalkyl substances (PFAS) using a prospective cohort study utilizing and integrating various 'OMICs' technologies.