Clinical trials: Delivery Systems
Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Melody PB1016 Surveillance Study
Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.
- Trial name
- NCT02347189
- Testing
- Melody Transcatheter Pulmonary Valve PB1016
- Where
- 8 sites in United States, Austria and 2 more
- Volunteers
- 39 people
- Sponsor
- Medtronic Heart Valves
Hypothyroidism
Thyroid Function of Pediatric Subjects Following Isovue® Administration
This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the…
- Trial name
- NCT03779906
- Testing
- Isovue
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Bracco Diagnostics, Inc
Asthma
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat in Adult Patients With Mild Persistent Asthma
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium compared to placebo over 12 week treatment period.
- Trial name
- NCT01316380
- Testing
- tiotropium 2.5 mcg, tiotropium 5 mcg
- Where
- 62 sites in Argentina, Austria and 10 more
- Volunteers
- 465 people
- Sponsor
- Boehringer Ingelheim
HIV/AIDS
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence.
- Trial name
- NCT04199052
- Testing
- LinkPositively
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of California, San Diego
Diabetes Mellitus, Type 1
Tandem Freedom - Feasibility Trial 2
This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a one week run-in…
- Trial name
- NCT06834568
- Testing
- t:slim X2 insulin pump with Tandem Freedom Algorithm
- Where
- New Zealand
- Volunteers
- 10 people
- Sponsor
- Tandem Diabetes Care, Inc.
Cystitis, Interstitial, Dysmenorrhea
Chronic Pain Risk Associated With Menstrual Period Pain
The purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives (OC) can be used to reverse this chronic…
- Conditions
- Cystitis, Interstitial, Dysmenorrhea, Migraine Disorders, Pelvic Pain
- Trial name
- CRAMPP (NCT02214550)
- Testing
- cyclic microgestin 1/20, continuous microgestin 1/20
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Transfer Impairment
Evaluating the CG ASSIST Program for Caregiving Dyads
The CG ASSIST Project is a four-year study for older Veterans with transfer impairments and informal caregivers. CG ASSIST is an in-home training program for dyads designed to teach Veterans how to safely, skillfully, and (when…
- Trial name
- CG ASSIST (NCT02021565)
- Testing
- Immediate Intervention Group, Delayed Intervention Control Group
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Neonatal Brachial Plexus Palsy
NMES Efficacy on Patients With NBPP
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm.
- Trial name
- NCT01999465
- Testing
- Standard NMES device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Michigan
Otitis Media
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
- Trial name
- inVENT2 (NCT02150044)
- Testing
- Acclarent Tympanostomy Tube Delivery System (TTDS).
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of…
- Trial name
- MINORE (NCT04998812)
- Testing
- Ocrelizumab
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
This study will: Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.
- Trial name
- NCT00937157
- Testing
- Copaxone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University at Buffalo
Asthma
Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
The investigators have developed a tool to facilitate asthma self-management in children, the electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new model that is continuous and proactive…
- Trial name
- NCT02409277
- Testing
- Experimental: Standard vs Intensive e-AT Intervention
- Where
- United States
- Volunteers
- 926 people, healthy volunteers welcome
- Sponsor
- University of Utah
Cholestasis
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid…
- Trial name
- NCT02663453
- Testing
- multicomponent lipid emulsion, pure soybean oil lipid emulsion
- Volunteers
- 44 people
- Sponsor
- Thammasat University
Necrotising Enterocolitis
The Efficacy of Symbiotic on Cytokines
The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L.
- Trial name
- NCT01899677
- Testing
- distilled water, symbiotic
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Diabetic Retinopathy
A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab…
- Trial name
- PAVILION (NCT04503551)
- Testing
- PDS Implant Pre-Filled with 100 mg/mL Ranibizumab, Intravitreal Ranibizumab 0.5 mg Injection
- Where
- 65 sites in United States, Puerto Rico
- Volunteers
- 174 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Multiple Sclerosis
Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.
- Trial name
- ENCORE (NCT01167426)
- Testing
- Glatiramer Acetate 20 mg/0.5 mL
- Volunteers
- 148 people
- Sponsor
- Teva Neuroscience, Inc.
Dementia
Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement?
This project is the pilot phase of a pragmatic randomized clinical trial comparing outcomes among older adults with Alzheimer's disease and related dementias (ADRD) receiving home-delivered meals.
- Trial name
- NCT04850781
- Testing
- Bi-weekly frozen meal home delivery, Daily home meal delivery
- Where
- 3 sites in United States
- Volunteers
- 243 people
- Sponsor
- Brown University
Type 1 Diabetes
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
- Trial name
- NCT05204134
- Testing
- Automated Insulin Delivery Settings Initialization and Adaptation Algorithm
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Tandem Diabetes Care, Inc.
Microbicide Delivery System Acceptability
A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users
The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.
- Trial name
- Project-MIST (NCT01334827)
- Testing
- high volume gel, low volume gel, vaginal film
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital