Clinical trials: Immune System Tolerance
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)
Risk Assessment, Parenting
Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play
Children's risky play is associated with a variety of positive developmental, physical and mental health outcomes, including greater physical activity, self-confidence and risk management skills.
- Trial name
- NCT03374683
- Testing
- RR Digital Tool, RR In-Person Workshop, Position Statement on Active Outdoor Play
- Where
- Canada
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Inherited Epidermolysis Bullosa
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
The purpose of this study was to compare intra-individually the reepithelialization of skin lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size divided in 2 equal halves or 2 comparable…
- Trial name
- NCT01294241
- Testing
- Oleogel-S10, Mepilex® soft silicone faced polyurethane foam dressing
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Birken AG
Hemophilia A
Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies
The primary purpose of this study is to describe the outcome of Immune Tolerance Induction (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with haemophilia A who have failed previous attempts at…
- Trial name
- ReITIrate (NCT03103542)
- Testing
- Recombinant coagulation factor (rFVIIIFc)
- Where
- 12 sites in United States, Canada and 5 more
- Volunteers
- 16 people
- Sponsor
- Swedish Orphan Biovitrum
Obesity, Impaired Glucose Tolerance
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.
- Conditions
- Obesity, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
- Trial name
- NCT00413335
- Testing
- Rosiglitazone
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Yale University
Pediculosis
Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.
- Trial name
- NCT01660321
- Testing
- spinosad
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- ParaPRO LLC
Phenylketonuria
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with…
- Trial name
- SPARK (NCT01376908)
- Testing
- Kuvan®, Phenylalanine (Phe)-restricted diet
- Where
- 22 sites in Austria, Belgium and 7 more
- Volunteers
- 56 people
- Sponsor
- BioMarin Pharmaceutical
Graft vs Host Disease
Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD
The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (Arm 1) or…
- Trial name
- NCT02525029
- Testing
- Pregnyl®
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Prader Willi Syndrome
Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants
The Prader-Willi syndrome (PWS) includes severe neonatal hypotonia with impaired suckling leading to failure to thrive in the most severe cases, subsequently followed by an early onset of morbid obesity with hyperphagia and…
- Trial name
- OTBB2 (NCT02205034)
- Testing
- oxytocin
- Where
- France
- Volunteers
- 18 people
- Sponsor
- University Hospital, Toulouse
Food Hypersensitivity
Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of…
- Trial name
- DEVIL (NCT00932828)
- Testing
- Peanut oral immunotherapy
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- University of North Carolina, Chapel Hill
Pre Diabetes
Diabetes Prevention Program in Youth
The purpose of this study is to test the effectiveness of an out-of-school diabetes prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2 diabetes.
- Trial name
- NCT03042936
- Testing
- Insulin Superheroes Club Curriculum
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University of Tennessee
- Egg Hypersensitivity
Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe IgE-mediated egg allergy and a history of at least…
- Trial name
- EGGSOTI (NCT01379651)
- Testing
- Specific oral tolerance induction
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Ospedale Buon Consiglio Fatebenefratelli
Pediculosis
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older.
- Trial name
- NCT00752973
- Testing
- MALG (malathion) Treatment
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Second Degree Burn
Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®
The primary objective is to compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life) of using foam silver dressing (Mepilex® Ag) to a Silver sulfadiazine 1% cream (Silvadene®) from the…
- Trial name
- NCT00742183
- Testing
- Mepilex, Silvadene
- Where
- 10 sites in United States
- Volunteers
- 100 people
- Sponsor
- Molnlycke Health Care AB
Eczema, Egg Allergy
Persistence of Oral Tolerance to Peanut
ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784). Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment.
- Conditions
- Eczema, Egg Allergy, Food Allergy, Hypersensitivity
- Trial name
- LEAP-On (NCT01366846)
- Testing
- Avoidance of peanut
- Where
- United Kingdom
- Volunteers
- 556 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Attention-deficit/Hyperactivity Disorder
Examining Tolerance to CNS Stimulants in ADHD
Although stimulant medication is a well-established treatment for ADHD, it is often necessary for doctors to increase the dose over time to maintain the benefits of the medication.
- Trial name
- NCT02039908
- Testing
- Methylphenidate
- Where
- United States
- Volunteers
- 267 people
- Sponsor
- Florida International University
Epidermolysis Bullosa
Allogeneic Hematopoietic Stem Cell Transplant For Epidermolysis Bullosa
RATIONALE: In animal models, stem cells have been shown to home to the skin and repair the biochemical and structural abnormalities associated with recessive dystrophic epidermolysis bullosa (RDEB) (collagen 7 deficiency).
- Trial name
- NCT00478244
- Testing
- busulfan, cyclophosphamide, fludarabine phosphate
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Type1 Diabetes Mellitus
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.
- Trial name
- TN-22 (NCT03428945)
- Testing
- Hydroxychloroquine
- Where
- 51 sites in United States, Australia and 4 more
- Volunteers
- 273 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Peanut Hypersensitivity
Peanut Oral Immunotherapy in Children
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children.
- Trial name
- IMPACT (NCT01867671)
- Testing
- Peanut Oral Immunotherapy - Liquid Extract, Peanut Oral Immunotherapy - Peanut Flour
- Where
- 5 sites in United States
- Volunteers
- 146 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Peanut Allergy
Tolerance Following Peanut Oral Immunotherapy
The unifying objective of this project is to determine whether peanut oral immunotherapy (PN OIT) induced clinical tolerance in the context of food allergy is significantly associated with the expansion of a specific regulatory T…
- Trial name
- PNOIT2 (NCT01750879)
- Testing
- Peanut Flour, Oat Flour
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Massachusetts General Hospital