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NCT ID: NCT04456608 Terminated - Platelet Function Clinical Trials

Genetic and Dietary Predictors of Anti-platelet Response

Start date: August 1, 2016
Phase: Phase 4
Study type: Interventional

This study will investigate differences in platelet aggregation under basal and aspirin-treated conditions in American Indian and Alaska Native people who have extreme levels (low and high) of n-3 polyunsaturated fatty acids (n-3 PUFAs, EPA and DHA) in red blood cell membranes. The study will also determine whether or not platelet aggregation under the different conditions is modified by CYP4A11, CYP4F2, CYP4F11, PEAR1, and ACTN1 gene variation.

NCT ID: NCT04456413 Terminated - COVID-19 Clinical Trials

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

Start date: November 6, 2020
Phase: Phase 2
Study type: Interventional

- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

NCT ID: NCT04454567 Terminated - Chronic Hepatitis B Clinical Trials

A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors

Start date: November 11, 2020
Phase: Phase 2
Study type: Interventional

This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.

NCT ID: NCT04454190 Terminated - Glaucoma Clinical Trials

Development and Validation of a Model to Predict Fast Progression in Glaucoma

Start date: July 20, 2021
Phase:
Study type: Observational

1. The purpose of this study is to obtain genetic data on a well-defined population of patients with glaucoma that had accurate measurements of rates of structural and functional change over time. 2. The investigators aim to recruit 5,000 patients for Phase I and 100 patients for Phase II over a period of 2 years for obtaining blood samples which will be processed for extraction of DNA and genotyping. Phase II also includes eye examination. Patients will be selected from the Duke Glaucoma Registry (DGR) database and will be contacted by phone, mail or email using a standardized script and procedure. 3. Data analysis, based on patient-blind (no personal health information) data will take place at Duke and Genentech. No protected health information (PHI) will leave Duke. Standard statistical methods will be used to analyze the collected data and to develop predictive statistical models for fast progression in glaucoma. Risks from participating in the study are low and include loss of confidentiality and inherent issues related to drawing blood.

NCT ID: NCT04453046 Terminated - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Hemopurifier Plus Pembrolizumab in Head and Neck Cancer

Start date: October 22, 2020
Phase: N/A
Study type: Interventional

This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier to clear immunosuppressive exosomes in combination with pembrolizumab (Keytruda) in the front line setting, in patients with advanced and/or metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT04451382 Terminated - Clinical trials for Overactive Bladder (OAB)

PTNS vs Botox of Refractory OAB

TROOP
Start date: March 2015
Phase:
Study type: Observational

This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.

NCT ID: NCT04450368 Terminated - COPD Clinical Trials

Clinical Feasibility of a Non-invasive Wearable Acoustic Device for Measuring Air Trapping in COPD

Start date: March 1, 2022
Phase:
Study type: Observational

This is a pilot observational study during which the investigators will conduct a longitudinal assessment of air trapping (with up to 2 visits) in 40 patients with COPD and variable degrees of air trapping and 20 healthy controls using ARIA. The investigators will characterize the clinical phenotype of the subjects by administering health and symptom-based questionnaires and obtaining lung function testing at rest and during exertion, and will then correlate and validate the ARIA-based indices with those of the more traditional physiologic measures of static and dynamic air trapping.

NCT ID: NCT04450342 Terminated - Clinical trials for Rotator Cuff Injuries

REGENETEN™ Bioinductive Implant System in Full-thickness Tears

REGENETEN
Start date: December 7, 2020
Phase: N/A
Study type: Interventional

The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.

NCT ID: NCT04450212 Terminated - Vitamin K Status Clinical Trials

Vitamin K Supplementation Study in Healthy Volunteers (Aim 2B)

Start date: August 25, 2017
Phase: N/A
Study type: Interventional

The overall purpose of this study is to determine how variation in the CYP4F2 gene modulates the synthesis of vitamin K-dependent clotting factors. We propose that the CYP4F2*3 gene variant increases short- and long-term vitamin K concentrations in the liver by reducing the efficiency of vitamin K metabolism. The investigators will study the effect of vitamin K supplementation on two biomarkers of hepatic vitamin K concentration in groups with defined CYP4F2*3 genotype. Specifically, the investigators will test for an association between our novel biomarkers of long-term (plasma Factor II proteoforms) and short-term (urinary K-Acid catabolites) hepatic vitamin K concentration and CYP4F2*3 following a 10-day period of vitamin K supplementation in healthy volunteers.

NCT ID: NCT04449835 Terminated - Low Back Pain Clinical Trials

The Intracept Global Registry ( TIGR ) - Pilot Study

Start date: July 31, 2020
Phase:
Study type: Observational [Patient Registry]

The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight. Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.