Clinical trials: Inflammatory Disorder
Congenital Heart Disease in Children, Inflammatory Response
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass.
- Trial name
- STRESS (NCT03229538)
- Testing
- Methylprednisolone, Isotonic saline
- Where
- 23 sites in United States
- Volunteers
- 1,263 people
- Sponsor
- Kevin Hill
Crohn Disease
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT03467958
- Testing
- Ozanimod
- Where
- 766 sites in United States, Argentina and 47 more
- Volunteers
- 854 people
- Sponsor
- Celgene
Ulcer
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
- Trial name
- NCT00450216
- Testing
- Ibuprofen/famotidine, Ibuprofen
- Volunteers
- 906 people
- Sponsor
- Amgen
Inflammatory Bowel Diseases
Biomarkers of Anti-TNF Treatment in Inflammatory Bowel Disease (IBD)
Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction (primary response) and maintenance of remission.
- Trial name
- NCT01971970
- Testing
- Infliximab, Adalimumab
- Where
- Netherlands
- Volunteers
- 45 people
- Sponsor
- Erasmus Medical Center
Spinal Fusion Acquired, Spinal Stenosis
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects.
- Conditions
- Spinal Fusion Acquired, Spinal Stenosis, Lesions of Lumbosacral Intervertebral Disc, Spinal Diseases
- Trial name
- DEXREDLOS (NCT00808665)
- Testing
- Dexmedetomidine, 0.9% Saline
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Vanderbilt University Medical Center
Colitis, Ulcerative
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral…
- Trial name
- NCT00317356
- Testing
- OPC-6535(Tetomilast)
- Where
- 8 sites in Japan
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Breast Neoplasms
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients…
- Trial name
- NCT01325428
- Testing
- Afatinib once daily (OD), Vinorelbine Weekly
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02065557
- Testing
- Adalimumab
- Where
- 60 sites in United States, Australia and 12 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Immune Reconstitution Inflammatory Syndrome, Leukoencephalopathy, Progressive Multifocal
Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course…
- Trial name
- IRIS (NCT01211665)
- Testing
- Methylprednisolone, Prednisolone
- Where
- 3 sites in United States, Germany
- Volunteers
- 3 people
- Sponsor
- Biogen
Sepsis
Sepsis-Associated Purpura Fulminans International Registry - Europe
Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene.
- Trial name
- SAPFIRE (NCT02238795)
- Where
- 3 sites in Germany
- Volunteers
- 28 people
- Sponsor
- Jena University Hospital
Sepsis, Acute Lung Injury
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS.
- Conditions
- Sepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome
- Trial name
- NCT01438853
- Testing
- TNX-832
- Where
- 7 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Altor BioScience
Crohn's Disease, IBD
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or…
- Conditions
- Crohn's Disease, IBD, Colitis, Inflammatory Bowel Disease
- Trial name
- NCT01369329
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 175 sites in United States, Australia and 21 more
- Volunteers
- 769 people
- Sponsor
- Janssen Research & Development, LLC
Inflammatory Breast Cancer, Stage IIA Breast Cancer
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is inflammatory or has spread from where it started to nearby tissue or lymph…
- Conditions
- Inflammatory Breast Cancer, Stage IIA Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Trial name
- NCT01525966
- Testing
- carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 67 people
- Sponsor
- City of Hope Medical Center
Chronic Kidney Disease, Endothelial Dysfunction
Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the…
- Conditions
- Chronic Kidney Disease, Endothelial Dysfunction, Inflammation, Hypertension
- Trial name
- NCT00428246
- Testing
- paricalcitol
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Indiana University
Spondylitis, Ankylosing
Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes
This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician.
- Trial name
- EMBARK (NCT01258738)
- Testing
- etanercept, Background NSAID
- Where
- 50 sites in Argentina, Belgium and 12 more
- Volunteers
- 225 people
- Sponsor
- Pfizer
Hypovitaminosis D
Cholecalciferol Supplementation for Sepsis in the ICU
Sepsis in a clinical entity that occurs in patients with serious infections. Though the severity of illness may vary, every year, approximately 1.6 million Americans are treated for sepsis.
- Trial name
- CSI (NCT01896544)
- Testing
- Cholecalciferol
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Massachusetts General Hospital
Neonatal Sepsis, Low Birth Weight
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000…
- Trial name
- NCT00947518
- Testing
- Chlorhexidine, Normal saline
- Volunteers
- 60 people
- Sponsor
- All India Institute of Medical Sciences
Hypotension
Efficacy Study of a Facemask Device to Treat Hypotension
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia.
- Trial name
- NCT00256724
- Testing
- Impedance Threshold Device
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Advanced Circulatory Systems
Acute Coronary Syndrome
A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI.
- Trial name
- Solstice (NCT00910962)
- Testing
- GW856553
- Where
- 108 sites in United States, Australia and 7 more
- Volunteers
- 526 people
- Sponsor
- GlaxoSmithKline
Crohn's Disease, Complex Perianal Fistula
A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula
The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula.
- Trial name
- EMPIRE (NCT04118088)
- Testing
- Darvadstrocel
- Where
- 30 sites in Austria, Czechia and 4 more
- Volunteers
- 53 people
- Sponsor
- Takeda
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