Clinical trials: Delivery Systems
Bioavailability
Bioavailability of EPA + DHA in a SMEDS Formulation
This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl…
- Trial name
- NCT03443076
- Testing
- EPA + DHA in SMEDS Formulation, Lovaza (active comparator; already FDA approved)
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Midwest Center for Metabolic and Cardiovascular Research
Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers, SARS CoV-2
mRNA Covid-19 Vaccine Immune Response Comparisons Using Different Delivery Routes
The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using…
- Trial name
- NCT06919796
- Testing
- COMIRNATY®
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- PharmaJet, Inc.
Crohn's Disease, Rheumatoid Arthritis
OTIS Humira Pregnancy Registry
The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live…
- Trial name
- NCT01086059
- Where
- United States
- Volunteers
- 944 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Bariatric Surgery, Type 2 Diabetes
Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery
Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly.
- Trial name
- DRIFTER (NCT06192693)
- Testing
- Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution
- Where
- France
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Message Exposure (Sequence: Regular Then Flavor), Message Exposure (Sequence: Flavor Then Regular)
Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Escalation in Young Adult ENDS Users
180 young adult vapers who are not current smokers will participate in a baseline functional magnetic resonance imaging (fMRI) experiment, prospectively linked to a 1-year randomized controlled trial.
- Conditions
- Message Exposure (Sequence: Regular Then Flavor), Message Exposure (Sequence: Flavor Then Regular), No Message Exposure (Control Condition)
- Trial name
- NCT05447325
- Testing
- Exposure to Anti-Vaping Messages (generic themes then flavor-specific themes), Exposure to Anti-Vaping Messages (flavor-specific themes then generic themes), Exposure to Anti-Vaping Messages (no message exposure)
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Georgia
Alzheimer's Disease
A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
- Trial name
- NCT03438604
- Testing
- Donepezil TDS
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Corium, Inc.
Acute Lymphoblastic Leukemia
Cancer Care Delivery in Adolescent and Young Adult Patients With Acute Lymphoblastic Leukemia
This study investigates cancer care delivery in adolescent and young adult patients with acute lymphoblastic leukemia. Surveying institutions, evaluating delivery of care at the patient level and seeking input from healthcare…
- Trial name
- NCT03204916
- Testing
- Discussion, Medical Chart Review, Questionnaire Administration
- Where
- 482 sites in United States, Puerto Rico
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- Children's Oncology Group
Maternal Depression
Reducing Risk After an Adverse Pregnancy Outcome
This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI).
- Trial name
- NCT01182363
- Testing
- Project Solve Education
- Where
- 4 sites in United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
Gestational Diabetes
Effects of Antenatal Exercises on Clinical Outcomes in Pregnant Females With Gestational Diabetes Mellitus
Gestational diabetes mellitus (GDM) GDM is the most common complication that affects the health of the child and mother during pregnancy.
- Trial name
- NCT04859348
- Testing
- routine physical therapy, routine physical therapy and antenatal exercises
- Where
- Pakistan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Lahore
Premature, Necrotizing Enterocolitis
Intestinal Perfusion After Feeding in Preterm and Term Infants
This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the…
- Trial name
- NCT06319326
- Testing
- Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Obesity
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity.
- Trial name
- ReCharge (NCT01327976)
- Testing
- vBloc (Active Device)
- Where
- 10 sites in United States, Australia
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- ReShape Lifesciences
Extrusion of Tooth
Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children
The aim of this study is to Avoid traditional palatal local injections when extracting upper primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems (permeability enhancer (DMSO), oral patches…
- Trial name
- NCT05187494
- Testing
- Conventional local palatine injection, EMLA cream only, chemical permeability enhancer DMSO with EMLA cream
- Where
- Syria
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Damascus University
Dementia, Hip Fractures
PERFECTED: Caring for Patients With Hip-fracture & Memory Difficulties
This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR) funded research programme.
- Trial name
- PERFECTED (NCT03308123)
- Testing
- Observational study, not interventional
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of East Anglia
Contraceptive Usage
Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception
The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
- Trial name
- Simplify (NCT01140217)
- Testing
- Norethindrone Acetate
- Where
- 53 sites in United States
- Volunteers
- 1,659 people, healthy volunteers welcome
- Sponsor
- Watson Pharmaceuticals
Pain
Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain
This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of…
- Trial name
- NCT03246282
- Testing
- UVL1000 Treatment Station, Normal Saline 0.9% Infusion Solution Bag, Peripheral Catheterization
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- John W. Reeves, MD
Healthy
Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress.
- Trial name
- NCT01150526
- Testing
- CaHMB, HMB Free Acid Gel
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Metabolic Technologies Inc.
Preterm Birth, Low Birth Weight
Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso
The aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying…
- Conditions
- Preterm Birth, Low Birth Weight, Small for Gestational Age at Delivery
- Trial name
- DenBalo (NCT05730569)
- Where
- Burkina Faso
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University Ghent
HIV Infections
Virtual PrEP: Rendering PrEP Delivery More Efficient
Gay, bisexual and other men who have sex with men (GBM) account for over half of new HIV infections in Canada each year, and have a 131-fold higher risk of HIV than other Canadian men.
- Trial name
- VPrEP (NCT05159531)
- Testing
- PrEP, mHealth Model of Care, Standard of Care
- Where
- 5 sites in Canada
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Hypoxemia
Pilot Study to Evaluate the Revoxa™ System in Hypoxic Patients
Patients with COVID-19 may suffer from profound hypoxia, requiring the use of supplemental oxygen at high concentrations and flow rates.
- Trial name
- NCT04699942
- Testing
- Conventional (low flow) oxygen delivery via nasal cannula, Revoxa Oxygen Rebrearther
- Where
- Canada
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Dr. David Maslove
HIV Infections
Safety of and Immune Response to the PENNVAX-B DNA Vaccine With and Without IL-12 in HIV-uninfected Adults
An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using…
- Trial name
- NCT00991354
- Testing
- PENNVAX-B, IL-12 DNA plasmids
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)