Clinical trials: Drug Delivery System
Chronic Graft-versus-host-disease
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received…
- Trial name
- AGAVE-201 (NCT04710576)
- Testing
- Axatilimab
- Where
- 121 sites in United States, Australia and 14 more
- Volunteers
- 296 people
- Sponsor
- Syndax Pharmaceuticals
Prader-Willi Syndrome, Hyperphagia
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2)…
- Trial name
- OXT-PWS (NCT02629991)
- Testing
- Intranasal Oxytocin (IN-OXT)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Montefiore Medical Center
Dermatitis, Atopic, Eczema
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine
The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.
- Trial name
- ADvantage (NCT05149313)
- Testing
- Lebrikizumab
- Where
- 48 sites in Austria, Belgium and 6 more
- Volunteers
- 331 people
- Sponsor
- Almirall, S.A.
Asthma
Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
Stress and anxiety can negatively affect children with asthma. Reducing the stress of asthmatic children and their families may lead to improved asthma care and fewer asthma symptoms in the children.
- Trial name
- ASPIRE (NCT00384813)
- Testing
- Project ASPIRE Home-Based Family Intervention, Project ASPIRE Enhanced Treatment As Usual
- Where
- 2 sites in United States
- Volunteers
- 43 people
- Sponsor
- Emory University
Contraception
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
- Trial name
- NCT01181479
- Testing
- AG200-15 (cycles 1-13), Lessina crossover to AG200-15
- Where
- 80 sites in United States
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Migraine
A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment…
- Trial name
- NCT04530110
- Testing
- Fremanezumab
- Where
- 70 sites in United States, Canada and 7 more
- Volunteers
- 499 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Methamphetamine Abuse, Opioid-use Disorder
Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics
The investigators propose to develop and evaluate optimal combinations of evidence-based interventions to improve HIV outcomes and reduce methamphetamine use (hereafter: meth use) among people with opioid use disorder who are in…
- Conditions
- Methamphetamine Abuse, Opioid-use Disorder, HIV Seropositivity
- Trial name
- STAR-OM (NCT04706624)
- Testing
- Contingency management (12 weeks), Contingency management (6 weeks), SMS reminders
- Where
- 4 sites in Vietnam
- Volunteers
- 667 people
- Sponsor
- Hanoi Medical University
Diabetes Mellitus, Type 1
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the…
- Trial name
- TN07 (NCT00419562)
- Testing
- Oral Insulin
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 560 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Peanut Allergy
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing…
- Trial name
- NCT03682770
- Testing
- Dupilumab, AR101
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Regeneron Pharmaceuticals
Hypothyroidism
Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.
- Trial name
- NCT02766283
- Testing
- iodinated contrast agents
- Where
- Israel
- Volunteers
- 843 people
- Sponsor
- Bayer
Insomnia, Traumatic Brain Injury
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).
- Trial name
- NCT03261674
- Testing
- CBT-I, ABT-I
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- VA Office of Research and Development
Asthma
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal Therapy.
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
- Trial name
- NCT00603382
- Testing
- GW685698X
- Where
- 149 sites in United States, Bulgaria and 12 more
- Volunteers
- 599 people
- Sponsor
- GlaxoSmithKline
Fabry Disease, Chronic Kidney Disease, Stage IV (Severe)
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
- Trial name
- NCT00837824
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Genzyme, a Sanofi Company
Appendicitis
Laparoscopic Versus Open Appendectomy? Let the Patient Decide
This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.
- Trial name
- NCT01738750
- Testing
- Cost Information Included
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Utah
Asthma
Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once…
- Trial name
- NCT01122680
- Testing
- Tiotropium bromide
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 105 people
- Sponsor
- Boehringer Ingelheim
Urea Cycle Disorder
Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)
THRIVE is an observational study that will collect information on patients with UCDs. THRIVE will follow enrolled participants for up to 10 years.
- Trial name
- THRIVE (NCT01948427)
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Amgen
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
Epilepsy, Partial
Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.
- Trial name
- NCT00355082
- Testing
- lamotrigine, 300 mg/day, lamotrigine, 250 mg/day
- Where
- 103 sites in United States, Argentina and 6 more
- Volunteers
- 226 people
- Sponsor
- GlaxoSmithKline
Neurofibromatosis Type 1
A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1
The specific aim of this study is to determine whether Lovastatin ™ significantly improves visual spatial learning and/or sustained attention in children with NF1.
- Trial name
- STARS (NCT00853580)
- Testing
- Lovastatin ™
- Where
- 12 sites in United States, Australia
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Food Allergy, Peanut Allergy
Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy
The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind…
- Trial name
- CAFETERIA (NCT03907397)
- Testing
- Peanut Protein, Continued peanut avoidance
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Scott Sicherer
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