Clinical trials: Delivery Systems
Anaplastic Astrocytoma, Glioblastoma
Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma…
- Trial name
- SAPPHIRE (NCT00761280)
- Testing
- trabedersen, temozolomide, Drug delivery system for administration of AP 12009
- Where
- 68 sites in United States, Argentina and 14 more
- Volunteers
- 27 people
- Sponsor
- Isarna Therapeutics GmbH
Asthma
Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma I
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).
- Trial name
- NCT01172808
- Testing
- tiotropium Respimat® low dose, tiotropium Respimat® high dose, 50 mcg salmeterol HFA MDI
- Where
- 114 sites in United States, Brazil and 9 more
- Volunteers
- 1,071 people
- Sponsor
- Boehringer Ingelheim
Healthy Male Subjects
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and…
- Trial name
- NCT05275010
- Testing
- Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC), Handheld Syringe with Hypodermic Needle, On-Body Delivery System
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Caregiver Burnout, Dementia
Savvy System Project
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program…
- Trial name
- NCT04060355
- Testing
- Savvy program, Semi-structured video interviews
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Emory University
Diabetes Mellitus, Type 1
Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency
This proposed study will test whether measurement of breath acetone (BrAce) can be used for the purpose of identifying ketosis (elevated ketones) in persons with type 1 diabetes (T1D).
- Trial name
- NCT05541484
- Testing
- SGLT2 inhibitor, Biosense Breath Ketone Analyzer
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Washington University School of Medicine
Elevated Intraocular Pressure (IOP)
Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure
This is a pilot, open-label, multi-center clinical study. Each potential subject that has met all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical…
- Trial name
- NCT04962009
- Testing
- Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Mati Therapeutics Inc.
Negative Pressure Wound Therapy, Cesarean Section; Infection
The Invia Motion at Cesarean Study
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
- Trial name
- NCT04365452
- Testing
- Invia Motion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Indiana University
Type 1 Diabetes
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
- Trial name
- NCT04084171
- Testing
- Tandem t:slim X2 with Control-IQ Technology + Dexcom G6
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Virginia
Aggressive Non-Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma
Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma
This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma.
- Conditions
- Aggressive Non-Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma
- Trial name
- NCT03035331
- Testing
- Cryosurgery, Dendritic Cell Therapy, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Mayo Clinic
Diabetic Foot Ulcers
Negative Pressure Wound Therapy as a Drug Delivery System
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous…
- Trial name
- NCT02463487
- Testing
- Cardinal Pro +Simultaneous Irrigation (NPWTi), Cardinal Pro (NPWT) Therapy
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Texas Southwestern Medical Center
Labor Pain
Prostin and Propess in Induction of Labor
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
- Trial name
- NCT01635439
- Testing
- Propess, Prostin E2
- Where
- Saudi Arabia
- Volunteers
- 200 people
- Sponsor
- Ain Shams University
Preterm Birth
Tennessee Connections for Better Birth Outcomes
Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention.
- Trial name
- BBO (NCT00502697)
- Testing
- Targeted Nurse Home Visits, Conventional prenatal/postpartum care
- Where
- United States
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Type2 Diabetes
OP5-005 Using Omnipod 5 in Adults With Type 2
This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.
- Trial name
- SECURE-T2D (NCT05815342)
- Testing
- Omnipod 5 Automated Glucose Control System
- Where
- 21 sites in United States
- Volunteers
- 343 people
- Sponsor
- Insulet Corporation
Delivery Systems, Oral Health
Determining the Viability a Lozenge Dosage for Probiotics
Gingivitis is an oral disease condition affecting 50% to 90% of adults globally. Gingivitis is a reversible inflammatory condition caused by the accumulation of dental plaque and the associated disruption of the host-microbial…
- Trial name
- NCT06819761
- Testing
- Salivarius SALI-10
- Where
- Canada
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Ostia Sciences
Asthma
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.
A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the…
- Trial name
- NCT01498679
- Testing
- GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)
- Where
- 28 sites in China, Philippines and 1 more
- Volunteers
- 311 people
- Sponsor
- GlaxoSmithKline
Intracranial Aneurysm
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial…
- Trial name
- SUNRISE (NCT00486226)
- Testing
- Vascular Reconstruction Device
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- Codman & Shurtleff
Parenting Practices, Self Efficacy
Evaluation Study of Talk Parenting Skills
After development of the prototype Bedtime Routine module of the Talk Parenting program, the investigators will evaluate its feasibility and initial efficacy in a within-subjects pre-post design study.
- Conditions
- Parenting Practices, Self Efficacy, Stress, Child Behavior
- Trial name
- NCT04633434
- Testing
- The Talk Parenting Skill for Alexa
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Glioma, Pilocytic Astrocytoma
Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics…
- Conditions
- Glioma, Pilocytic Astrocytoma, Anaplastic Astrocytoma, Glioblastoma
- Trial name
- NCT02372409
- Testing
- MRI-guided laser ablation, Doxorubicin, Etoposide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Washington University School of Medicine
Severe Combined Immunodeficiency
Gene Transfer for Severe Combined Immunodeficiency, X-linked (SCID-X1) Using a Self-inactivating (SIN) Gammaretroviral Vector
Researchers are working on ways to treat SCID patients who don't have a matched brother or sister. One of the goals is to avoid the problems that happen with stem cell transplant from parents and unrelated people, such as repeat…
- Trial name
- NCT01129544
- Testing
- Gene transfer
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- David Williams