Clinical trials: polymerase chain reaction
Metabolic Syndrome, Dyslipidemia
Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism
The purpose of this study is to investigate if daily consumption of barley beta-glucans effect lipid and glucose metabolism and alter intestinal microbiota composition in participants with metabolic syndrome or with high risk for…
- Conditions
- Metabolic Syndrome, Dyslipidemia, Obesity, Abdominal, Hyperglycemia
- Trial name
- NCT02041104
- Testing
- Bread with added beta-glucans
- Where
- 3 sites in Slovenia
- Volunteers
- 51 people
- Sponsor
- Mlinotest Zivilska Industrija d.d.
Non-muscle-invasive Bladder Cancer
A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)
Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years…
- Trial name
- ANTICIPATE X (NCT03664258)
- Testing
- Xpert Bladder Cancer Monitor
- Where
- 13 sites in Austria, Czechia and 7 more
- Volunteers
- 852 people
- Sponsor
- Cepheid
Infectious Gastroenteritis
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious…
- Trial name
- IMPACT (NCT02248285)
- Testing
- FilmArray™ Gastrointestinal (GI) Panel
- Where
- 5 sites in United States
- Volunteers
- 1,545 people
- Sponsor
- BioFire Diagnostics, LLC
Covid19
Gazelle COVID-19 Test Clinical Accuracy Protocol
Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of…
- Trial name
- NCT04987918
- Testing
- Applied Biosystems TaqPath COVID- 19 Combo Kit
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Hemex Health
Upper Respiratory Infections
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories…
- Trial name
- NCT02232711
- Where
- 4 sites in United States
- Volunteers
- 1,082 people
- Sponsor
- BioFire Diagnostics, LLC
Transfusion Transmitted Babesiosis
Babesia Testing in Blood Donors
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection. Two laboratory methodologies will be utilized: 1.
- Trial name
- NCT01528449
- Testing
- B.microti diagnostic blood tests
- Where
- United States
- Volunteers
- 90,116 people, healthy volunteers welcome
- Sponsor
- Imugen
Lung Cancer
OncoSweep Cancer Spotlight and Spectrum Product Line
CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line'
- Trial name
- NCT06261294
- Testing
- OncoSweep Lung Spotligh
- Where
- Taiwan
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Pharus Taiwan, Inc.
Uterine Cervical Neoplasms
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to…
- Trial name
- NCT01944722
- Testing
- BD Onclarity™ HPV assay on BD Viper™ LT, Colposcopy
- Where
- 41 sites in United States
- Volunteers
- 33,858 people, healthy volunteers welcome
- Sponsor
- Becton, Dickinson and Company
Acute Gastroenteritis, Norwalk Virus Infection
Norwalk Vaccine Study
The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.
- Trial name
- NCT00973284
- Testing
- Norwalk VLP vaccine, mannitol and sucrose, Norwalk virus
- Where
- 3 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Takeda
Covid19
Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 (COVID-19) Detection by RT-PCR and ELISA
Nasopharyngeal Swabs (NPS) used to test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection can cause mild to severe discomfort in addition to increasing the risk of transmission.
- Trial name
- NCT04732637
- Testing
- Test At Home's Proprietary "Lollipop" Buccal Cavity Swab
- Where
- India
- Volunteers
- 300 people
- Sponsor
- Datar Cancer Genetics Limited
Possible Fungal Infection
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against…
- Trial name
- IDEA (NCT00150345)
- Testing
- voriconazole (Vfend)
- Where
- 28 sites in Germany
- Volunteers
- 147 people
- Sponsor
- Pfizer
Interstitial Cystitis, Bladder Pain Syndrome
Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms
Real-world clinical practice multicenter study to determine the clinical implications of employing PCR/NGS technology to identify and treat potential urinary pathogens in female participants identified with bladder pain and/or…
- Trial name
- NCT05276466
- Testing
- Polymerase Chain Reaction and Next-Generation DNA Sequencing
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- MicroGenDX
COVID-19
Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19
This is a multicenter, double-blind, randomized, placebo-controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of…
- Trial name
- NCT05679479
- Testing
- Meplazumab for injection, Normal saline
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Influenza
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.
- Trial name
- NCT03248960
- Testing
- iTreat Flu A+B Test, ellume.lab Flu A+B Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- 8 sites in Australia
- Volunteers
- 381 people
- Sponsor
- Ellume Pty Ltd
Chlamydial Infection, Gonococcal Infection
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or…
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Trial name
- NCT04098900
- Testing
- Click Sexual Health Test
- Where
- 5 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- Visby Medical
Varicella
Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
This study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. The results of this study will provide basic scientific information about chickenpox disease.
- Trial name
- NCT00127608
- Testing
- Collection of clinical samples
- Where
- Czechia
- Volunteers
- 36 people
- Sponsor
- GlaxoSmithKline
Upper Resp Tract Infection
TEM-PCR™ Prospective Clinical Utility Study
This is a randomized, open-label, multi-center, prospective study to assess the clinical utility of the TEM-PCR Upper Respiratory Infection (URI) Panel in adult subjects age 65 and older presenting to the primary care clinic with…
- Trial name
- NCT04248361
- Testing
- TEM-PCR URI Panel, SOC/Empiric Diagnosis
- Where
- 4 sites in United States
- Volunteers
- 314 people
- Sponsor
- Diatherix Laboratories, LLC
SARS-CoV-2 Infection, Influenza A
Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test
The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B \& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared…
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT07430410
- Testing
- CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
- Volunteers
- 200 people
- Sponsor
- CorDx, Inc.
Metastatic Colorectal Cancer (mCRC)
DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical…
- Trial name
- NCT06645236
- Testing
- therascreen® KRAS RGQ PCR Kit
- Where
- United Kingdom
- Volunteers
- 600 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Sexually Transmitted Diseases
A Healthcare Economic Study of the Click Sexual Health Test
This is a multicenter study with a minimum of three CLIA-Waived intended operator sites in which prospectively collected vaginal swab specimens will be evaluated with the Click Sexual Health Test as compared to standard of care.
- Trial name
- HERO (NCT04099199)
- Testing
- Click Sexual Health Test
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Visby Medical