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Diagnoses Disease clinical trials

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NCT ID: NCT06306430 Not yet recruiting - Tuberculosis Clinical Trials

Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis

uLAMTBFIA
Start date: April 2024
Phase:
Study type: Observational

Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).

NCT ID: NCT06225700 Completed - Malaria Clinical Trials

Clinical Validation of Novel Malaria Diagnostic Tools for POC Point-of-Care Testing

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

The aim of this study is to perform a performance evaluation of novel diagnostic tools for detecting malaria in malaria-endemic countries. At the beginning of 2022, FIND launched a call for innovation with the distinct aim to identify malaria innovations that have the potential to address the technical and operational limitations of current malaria RDTs, particularly in view of the emergence of P. falciparum parasites with hrp2/3 deletions, the need for improved tools to identify all Plasmodium species and/or the need for improved surveillance. This study will generate valuable data on the performance of these novel non-HRP2-based tests and inform FIND and developers on technical and operational assay optimization requirements for accelerated access of these tools to market.

NCT ID: NCT06137495 Completed - Diagnoses Disease Clinical Trials

Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in Allergic Rhinitis Patients

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard.

NCT ID: NCT05998486 Recruiting - Diagnoses Disease Clinical Trials

Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity

TREMORHYTHM
Start date: April 3, 2023
Phase:
Study type: Observational

Resting tremors associated with Parkinson's disease (PD) remains difficult to quantify and track during disease progression. This study propose to explore the rhythmicity of distal muscle contractions in the upper limb to characterize resting tremor and discriminate it from cerebellar tremor (CT) based on the frequency spectrum of the EMG signal.

NCT ID: NCT05998473 Active, not recruiting - Parkinson Disease Clinical Trials

Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease

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

This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care.

NCT ID: NCT05604482 Completed - Diagnoses Disease Clinical Trials

CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

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

Giant cell arteritis (GCA) is the most common vasculitis in the elderly. Accurate diagnosis is of utmost importance in order to then initiate the necessary immunosuppressive therapy. For large-vessel GCA (LV-GCA) involving the aorta and its branches, FDG-PET/CT is the standard in imaging for diagnosis and is recommended by the guidelines. However, this only indirectly visualizes inflammation through vessel wall uptake of glucose. A new PET tracer, 68Ga-pentixafor, is used to visualize the chemokine receptor CXCR4. This receptor is expressed by cells of the immune system. In the context of inflammatory processes, upregulation of CXCL12, the ligand of CXCR4, occurs in affected tissues. The chemotactic effect of this ligand leads to the immigration of CXCR4-positive inflammatory cells into the inflamed area, which can be visualized by PET using the CXCR4-specific tracer 68Ga-Pentixafor. The value of CXCR4-PET should therefore be tested in the context of LV-GCA. This study tests the benefit of CXCR4 in therapy-naïve patients with suspected LV-GCA. For this purpose, patients will receive a FDG-PET and a CXCR4-PET for direct comparison. This is an imaging-only study. Therapy will not be affected by the study. The study is single-arm and not blinded.

NCT ID: NCT05600608 Not yet recruiting - Gastric Cancer Clinical Trials

Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome

AVOCADO
Start date: November 2022
Phase: N/A
Study type: Interventional

Nearly 10,000 people die each year in the United Kingdom from cancer of the lower gullet and stomach, known as known as oesophago- gastric adenocarcinoma (OGC). OGC is detected late as symptoms are non- specific and often mistaken for common problems such as heartburn. This translates to fewer than 2 in every 10 patients diagnosed with OGC living longer than 5 years. The breath of people with OGC is enriched with volatile chemicals (VOCs) that indicate cancer. When measured in a breath test, it detects OAC 80 out of 100 times. Whilst encouraging, there is scope to improve the detection rate by giving patients a stimulant drink that amplifies the production of tumour specific VOCs only, to increase their detection in the breath test. The goal of this observational study is to produce an enhanced second-generation breath test with superior ability to detect OGC through augmentation of breath. This will improve long term survival from cancer using an entirely non- invasive test. All participants (cancer and control participants) will consume an oral stimulant drink (OSD) and provide breath samples pre and post consumption of the drink at set time points (maximum 2 hours after consumption of the drink). The investigators will compare the breath VOCs from both groups, before and after consumption of the OSD to see if the OSD has a desired augmentation effect and can improve the accuracy of the OGC breath test. With this second-generation breath test, participants with vague symptoms can undergo a quick, non- invasive test, have samples analysed in a safe and accurate manner and be subsequently stratified based on their risk of having OGC, leading to earlier disease detection and improved clinical outcomes.

NCT ID: NCT05497258 Completed - Clinical trials for Artificial Intelligence

IDEAS-AAP System Diagnoses Acute Abdominal Pain

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

This is a study to validate the effect of the intelligent diagnostic evidence-based analytic system in acute abdominal pain augmentation. Included physicians were randomly assigned into control or AI-assisted group. In this experiment, the whole electronic health record of each acute abdominal pain patient was divided into two parts, signs and symptoms recording (including chief complaint, present history, physical examination, past medical history, trauma surgery history, personal history, family history, obstetrical history, menstrual history, blood transfusion history, drug allergy history) and auxiliary examination recording (including laboratory examination and radiology report). For each case, the control group readers will first read the signs and symptoms recording of electronic health record and make a clinical diagnosis. Then the readers have to decide to either order a list of auxiliary examinations or confirm the clinical diagnosis without further examination. If the readers choose to order examinations, the corresponding examination results will be feedback to the readers, and the readers can then decide to either continue to order a list of auxiliary examinations or make a confirming diagnosis. Such cycle will last until the reader make a confirming diagnosis. For the AI-assisted readers, the physicians were additionally provided with the feature extracted by IDEAS-AAP, a list of suspicious diagnoses predicted by IDEAS-AAP, and corresponding diagnostic criteria according to guidelines. After the readers get the examination results, the IDEAS-AAP will renew its diagnosis prediction

NCT ID: NCT05492227 Completed - COVID-19 Clinical Trials

SARS-CoV-2 Nucleic Acid Detection Kit Clinical Performance Study

CPS CW008
Start date: July 5, 2022
Phase:
Study type: Observational

SARS-CoV-2 Nucleic Acid Detection Kit is an In Vitro Diagnostic (IVD) medical device intended for RNA detection of SARS-CoV-2 in human specimens using multiplex real-time polymerase chain reaction (RT-PCR) technology. The conserved regions of ORF1ab and N genes are used as target sites of the primers and probes according to the indications provided in the Instructions for Use (IFU).

NCT ID: NCT05444790 Completed - Malaria Clinical Trials

Abbott NxTekTM Malaria RDT WHO Prequalification Study

Start date: June 30, 2022
Phase:
Study type: Observational

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. A partnership between Abbott, FIND, PATH, and the Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with improved pLDH detection: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens on a single test line (NxTekTM Malaria P.f plus Rapid Diagnostic Test Device), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen on a second test line (NxTekTM Malaria P.f/P.v. plus Rapid Diagnostic Test Device). These new combo tests with improved pLDH detection may provide added value compared to currently available malaria RDTs, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria. Abbott, PATH, and FIND will conduct a prospective evaluation of NxTekTM Malaria P.f plus and NxTekTM Malaria P.f/P.v plus RDTs in malaria-endemic countries to assess their clinical performance for detection of malaria and usability in their intended-use settings. This is in support of a submission for WHO Prequalification.The purpose of this synopsis is to describe key points of alignment in study design and conduct across the portfolio of studies.