Clinical trials: Pregnancy Detection
Chronic Kidney Disease
Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound.
- Trial name
- NCT05425719
- Testing
- MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 8 sites in United States, China
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Preeclampsia (PE)
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality.
- Trial name
- iPregnostic (NCT06716242)
- Testing
- Peripheral blood collection
- Where
- 11 sites in Spain
- Volunteers
- 7,473 people
- Sponsor
- iPremom
Streptococcus Agalactiae Infection
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument.
- Trial name
- NCT02718157
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 4 sites in United States, Canada
- Volunteers
- 771 people
- Sponsor
- Meridian Bioscience, Inc.
Down Syndrome, Fetal Aneuploidy
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
- Trial name
- NCT01555346
- Where
- 29 sites in United States, Canada
- Volunteers
- 3,062 people
- Sponsor
- Sequenom, Inc.
Infertility
Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)
The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing…
- Trial name
- NCT02141685
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Progyny, Inc.
Herpes Simplex, HIV Infections
The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.
- Trial name
- NCT00002404
- Testing
- Valacyclovir hydrochloride
- Volunteers
- 30 people
- Sponsor
- Glaxo Wellcome
Pregnancy
Correlation Between PIF Maternal Serum Levels and Pregnancy Outcome
PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta. Except for serum hCG, no pregnancy-complication markers are widely employed to predict the need for medical intervention.
- Trial name
- PIFBlood1 (NCT01805102)
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 500 people
- Sponsor
- BioIncept LLC
Ovarian Cancer
Safety in Ovarian Cancer for Average-Risk Women - Analysis
This study is designed to evaluate the safety, specificity, and downstream diagnostic burden of the Evident™ Ovarian Cancer Screening Test in average-risk postmenopausal women.
- Trial name
- SOARA (NCT07872644)
- Testing
- Blood-Based Ovarian Cancer Screening Test
- Where
- 2 sites in United States
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- Mercy BioAnalytics, Inc.
Adrenal Hyperplasia, Congenital, Congenital Hypothyroidism
Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
The purpose of this study is to assess the agreement of clinical performance between the proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in newborn screening programs for detection of T4…
- Conditions
- Adrenal Hyperplasia, Congenital, Congenital Hypothyroidism, Cystic Fibrosis
- Trial name
- NCT01488721
- Where
- 3 sites in United States
- Volunteers
- 7,462 people, healthy volunteers welcome
- Sponsor
- Luminex Corporation
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Truway Diagnostic Tools in Primary Care
This study evaluates the effectiveness of Truway Health-sourced portable diagnostic devices, including ultrasound and blood glucose monitors, in early detection of chronic conditions in outpatient primary care settings.
- Conditions
- Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, Hypertension, Cardiovascular Disease Acute
- Trial name
- TruDxPC (NCT07209527)
- Testing
- Truway Portable Ultrasound Device, Truway Blood Glucose Monitor, Standard Oral Hypoglycemic Agent
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Truway Health, Inc.
Hematuria, Urothelial Carcinoma
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
- Trial name
- DRIVE (NCT04943380)
- Testing
- Cxbladder
- Where
- 10 sites in United States
- Volunteers
- 682 people
- Sponsor
- Pacific Edge Limited
Adnexal Mass, Germline BRCA1 Gene Mutation
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early…
- Conditions
- Adnexal Mass, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Hereditary Breast and Ovarian Cancer
- Trial name
- OVA360 (NCT04668521)
- Testing
- OVA360
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- Aspira Women's Health
Cervical Cancer, CIN
Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer--ACTN4 and Other Biomarkers in Menstrual Blood
The goal of this clinical trial is 1. To test the sensitivity and specificity of using ACTN4 from menstrual blood for the detection of pre-cervical or/and cervical cancer. 2.
- Trial name
- NCT06261879
- Testing
- Special sanitary pad
- Where
- Hong Kong
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- WomenX Biotech Limited
Down Syndrome, Fetal Aneuploidy
Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
- Trial name
- NCT01429389
- Where
- 14 sites in United States, Canada
- Volunteers
- 2,000 people
- Sponsor
- Sequenom, Inc.
Bladder Cancer
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to…
- Trial name
- NCT00233402
- Testing
- Hexvix, Standard white light cystoscopy
- Where
- 25 sites in United States, Austria and 3 more
- Volunteers
- 789 people
- Sponsor
- Photocure
Cervical Cancer, LSIL
oncoFISH Cervical Test for Detection of 3q26 Region Gain
The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more…
- Trial name
- NCT01416922
- Where
- United States
- Volunteers
- 1,100 people, healthy volunteers welcome
- Sponsor
- Ikonisys, Inc.
Bladder Cancer, Urothelial Carcinoma Bladder
Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results.
- Trial name
- NCT06870253
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Pangea Laboratory LLC
Brain Cancer, Breast Cancer
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types.
- Conditions
- Brain Cancer, Breast Cancer, Bladder Cancer, Cervical Cancer
- Trial name
- CAMPERR (NCT05366881)
- Where
- 17 sites in United States
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- Adela, Inc
Reproduction
Evaluation of EarlySense for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment
The study objective is to collect data to assess the accuracy and reliability of Earlysense fertility cycle monitoring performance vs.
- Trial name
- NCT02634359
- Testing
- EarlySense home device, Vaginal ultrasound, Blood Test
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- EarlySense Ltd.