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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: 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: 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.

NCT ID: NCT05422820 Completed - Colorectal Cancer Clinical Trials

The Argentina Brief Colonoscopy Difficulty Score (ABCD)

ABCD
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

Colonoscopy completion by caecal intubation seldom represents a significant effort for the endoscopist. In this situation, additional techniques are necessary to achieve this goal: patients' manual abdominal compression, postural changes, and endoscopist relay. To date, no tool allows colonoscopy technical difficulty grading. This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

NCT ID: NCT05346523 Completed - Emergencies Clinical Trials

Digitalized Differential Diagnosis Broadening in Emergency Rooms

DDX-BRO
Start date: June 9, 2022
Phase: N/A
Study type: Interventional

10 to 35% of patients admitted to an emergency department receive an incorrect diagnosis. Not surprisingly, given the wide variety of health conditions encountered in emergency medicine, physicians often do not consider, remember, or know all possible diagnoses that fit the patient's symptoms. Nowadays, computer software (CDDS) is able to support physicians with a list of possible diagnoses by matching entered patient data to a large database with diagnoses. However, it is still unclear how the use of such a CDDS actually affects the diagnostic quality and workflow in 'real world' ER routine care. Therefore, the aim of this cluster-randomized cross-over trial is to evaluate the consequences of CDDS usage on diagnostic quality, patient outcomes and diagnostic workflow within the ER. Four ER's will provide a CDDS to the diagnosing physicians for specific periods (randomly and alternatingly allocated) in which physicians will be asked to use it for all included study patients. Outcomes between periods with and without the CDDS will be compared. Primary outcome is a diagnostic quality risk score composed of unscheduled ER revisits, unexpected hospitalization (both within 14 days), unexpected intensive medical care unit admission if hospitalized and diagnostic discrepancy between the ER discharge diagnosis and the current diagnosis after 14 days. In total, 1'184 patients will be included.

NCT ID: NCT05211258 Completed - Diagnoses Disease Clinical Trials

A Novel Portable Upper Gastrointestinal Endoscopy System

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

The application of conventional endoscopy in remote and outdoor areas lacking facilities remains challenges. Thus, the investigators developed a novel portable upper gastrointestinal endoscopy system that has the same functions as conventional endoscopy. A total of 24 participants from a medical unit on a remote island in China underwent endoscopy with the portable system between March and June 2021. The portable system packed into a suitcase is 68 × 42 × 32 cm in size, weighing less than 35 kg, and comprises a disposable sheathed system.

NCT ID: NCT05120167 Completed - Cervical Cancer Clinical Trials

Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy

Start date: September 29, 2021
Phase: N/A
Study type: Interventional

cervical cancer is the fourth most frequent cancer in women worldwide and in Brazil, it occupies the third position for the triennium 2020/2022, with a high mortality rate and maintained in the last 10 years. It is associated with persistent human papillomavirus (HPV) infection. Primary prevention can be accomplished through vaccines that prevent HPV infection of the epithelial cells of the cervix. Secondary prevention in screening for precursor lesions through periodic repeat cervical sampling in a population of asymptomatic women. Women with abnormal cytology are more likely to have pre-invasive or invasive lesions and are referred for further testing, colposcopy. Colposcopy identifies suspicious areas and guides the best site for biopsy. In the situation of negative colposcopy and abnormal cytology, suspicion for high-grade lesion (HSIL). It recommends further investigation of the endocervical canal before the possible excisional procedure and obtaining an additional canal sample by brushing or curettage. However, to date, there is no consensus and studies lack consistent results on which is the best method for further investigation of the endocervix. Objectives: To compare the performance of additional strategies in the investigation and detection of precursor or invasive lesions in the endocervical canal in women with abnormal cytology (ASC H+) and with initial colposcopy without suspicious images.