Clinical trials: Immunological Tolerance
Wounds
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)
The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
- Trial name
- BSG-12 (NCT01807650)
- Testing
- Oleogel-S10, non-adhesive wound dressing, Non-adhesive wound dressing only
- Where
- 14 sites in France, Greece and 2 more
- Volunteers
- 112 people
- Sponsor
- Birken AG
Impaired Fasting Glucose, Impaired Glucose Tolerance
D Vitamin Intervention in VA
This study will supplement African American male (AAM) veterans at risk for diabetes and newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps to improve early markers of diabetes.
- Conditions
- Impaired Fasting Glucose, Impaired Glucose Tolerance, Vitamin D Insufficiency
- Trial name
- DIVA (NCT01375660)
- Testing
- 50K vitamin D2
- Where
- United States
- Volunteers
- 205 people
- Sponsor
- US Department of Veterans Affairs
End Stage Renal Disease
Renal Allograft Tolerance Through Mixed Chimerism
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor.
- Trial name
- NCT01780454
- Testing
- MEDI-507, Rituximab, Total Body Irradiation
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Massachusetts General Hospital
Hepatocellular Carcinoma
Phase Ib/2, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Hepatocellular Carcinoma
The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene…
- Trial name
- NCT02314052
- Testing
- DCR-MYC
- Where
- 6 sites in United States, Singapore and 1 more
- Volunteers
- 21 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Cystic Fibrosis, Prediabetes
Prevention of Cystic Fibrosis Diabetes
Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing cells, and thus worsen glucose intolerance.
- Trial name
- Prevent (NCT00967798)
- Testing
- Sitagliptin
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Emory University
Skin Aging
Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles
This research study will test how well a light therapy mask works for women with mild to moderate hyperpigmentation (brown spots) and moderate to severe facial wrinkles, as compared to a "sham" or inactive investigational light…
- Trial name
- NCT03312543
- Testing
- Active Mask
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Old World Cutaneous Leishmaniasis
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing) is more effective than WR279396 without occlusion for once daily treatment.
- Trial name
- NCT01536795
- Testing
- WR279,396 with Tegaderm Dressing, WR 279,396 with Gauze and Tape Dressing
- Where
- Tunisia
- Volunteers
- 48 people
- Sponsor
- U.S. Army Medical Research and Development Command
Hypertension
The Effect of a Peroxisome Proliferator-activated Receptor (PPAR) Alpha Agonist on Cytochrome P450 (CYP) Monooxygenase Activity in Humans
The hypothesis is to test to see if the drug fenofibrate will increase important chemicals in the body and specifically in the kidney, help to rid the body of salt by the kidneys, decrease blood pressure and improve insulin…
- Trial name
- NCT00872599
- Testing
- fenofibrate
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Heart Failure
Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction
The primary objective of this study is to determine whether treatment with aliskiren (300 mg) compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients with heart failure and normal ejection…
- Trial name
- Aliskiren (NCT00982033)
- Testing
- aliskiren
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Wake Forest University Health Sciences
Healthy
Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and…
- Trial name
- NCT02395055
- Testing
- Adalimumab (BCD-057), Adalimumab (Humira)
- Where
- Russia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Biocad
Pulmonary Disease, Chronic Obstructive
Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD
The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination…
- Trial name
- NCT00530842
- Testing
- Tiotropium plus Salmeterol, Fluticasone/Salmeterol
- Where
- 42 sites in Austria, Canada and 5 more
- Volunteers
- 344 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole
Postmenopausal women with hormone receptor positive and negative Her2 tumours. Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs.
- Trial name
- NCT00543127
- Testing
- Fulvestrant, Anastrozole
- Where
- 53 sites in Spain
- Volunteers
- 870 people
- Sponsor
- Spanish Breast Cancer Research Group
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
Hearing Impairment
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful.
- Trial name
- NEATCAP (NCT02744066)
- Testing
- NEATCAP
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Michael Balsan, MD
Angina
Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina
The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo as an add on to stable anti-anginal therapy, on the total exercise time of participants with Chronic Stable Angina.
- Trial name
- NCT01549977
- Testing
- Febuxostat
- Where
- 21 sites in United States
- Volunteers
- 1 people
- Sponsor
- Takeda
Colonoscopy
Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy
- Trial name
- NCT02956057
- Testing
- Polyethylene Glycols, Natrium picosulfate / Magnesium citrate, Polyethylene glycol / Ascorbic acid
- Where
- Czechia
- Volunteers
- 1,044 people
- Sponsor
- Tomas Bata Hospital, Czech Republic
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)
Hematologic Diseases, Secondary Immune Deficiency
Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder
The purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusion related reactions.
- Trial name
- MULTISIM (NCT03250845)
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Prediabetes, Impaired Fasting Glucose
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of progression type 2 diabetes mellitus (T2DM).
- Conditions
- Prediabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance
- Trial name
- NCT02700334
- Testing
- Dapagliflozin
- Where
- Mexico
- Volunteers
- 24 people
- Sponsor
- University of Guadalajara
Burns
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.
- Trial name
- NCT01657292
- Testing
- Oleogel-S10 ointment, Octenilin® wound gel
- Where
- 9 sites in Germany, Sweden and 2 more
- Volunteers
- 61 people
- Sponsor
- Birken AG