Clinical trials: New Onset
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Acute Cellular Graft Rejection, New Onset Diabetes After Transplant
Budesonide for Liver Transplant Immune Suppression
This is a pilot study that investigates the efficacy and safety of budesonide as an immune suppressing agent for liver transplant recipients in the early post-transplant period.
- Trial name
- NCT03304626
- Testing
- Budesonide 3Mg Capsule, Standard of Care Prednisone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Cincinnati
Type 1 Diabetes Mellitus
Rituximab in New Onset Type 1 Diabetes
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas.
- Trial name
- TN05 (NCT00279305)
- Testing
- Anti-CD20 (rituximab)
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 87 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Acute Graft Rejection, Diabetes
A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
While the incidence of acute rejection and early graft loss have improved dramatically with the advent of newer immunosuppressant medications, improvements in long-term patient and allograft survival after kidney transplantation…
- Trial name
- Astellas (NCT01265537)
- Testing
- Tacrolimus
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of British Columbia
Type 1 Diabetes
Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes
Clinically, the ability to slow or prevent beta cell demise can prevent or improve the course of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent major pathological basis for the disease, has led…
- Trial name
- NCT02218619
- Testing
- Tauroursodeoxycholic Acid (TUDCA)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Robin Goland, MD
Epilepsy
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on…
- Trial name
- NCT02201251
- Testing
- Topiramate, Levetiracetam
- Where
- 41 sites in United States, Argentina and 12 more
- Volunteers
- 63 people
- Sponsor
- Janssen Research & Development, LLC
Type 1 Diabetes Mellitus, New-onset Type 1 Diabetes Mellitus
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the…
- Conditions
- Type 1 Diabetes Mellitus, New-onset Type 1 Diabetes Mellitus, T1DM, T1D
- Trial name
- EXTEND (NCT02293837)
- Testing
- Tocilizumab (TCZ), Standard of Care
- Where
- 19 sites in United States, Australia
- Volunteers
- 136 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes
Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).
- Trial name
- TIDM (NCT00529191)
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Children's Hospital of Philadelphia
Type 1 Diabetes
The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)
The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched…
- Trial name
- NCT02867436
- Testing
- Gluten-free diet
- Where
- 2 sites in Czechia
- Volunteers
- 45 people
- Sponsor
- University Hospital, Motol
Diabetes Mellitus, Type 1
Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab.
- Trial name
- NCT02000817
- Testing
- Otelixizumab
- Where
- 6 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50…
- Trial name
- NCT00495521
- Testing
- 4-Aminosalicylic acid extended release granules
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Jacobus Pharmaceutical
Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia
Lasix for the Prevention of De Novo Postpartum Hypertension
Primary objective: To evaluate whether oral furosemide can help prevent de novo postpartum hypertension (new-onset high blood pressure after delivery) by reducing blood pressure after delivery in high-risk women.
- Conditions
- Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia, Hypertension, Pregnancy-Induced, Hypertension
- Trial name
- LAPP (NCT04752475)
- Testing
- Furosemide
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Columbia University
Diabetes Mellitus, Type 1
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the…
- Trial name
- NCT04270942
- Testing
- teplizumab 1 mg/mL
- Where
- 8 sites in United States
- Volunteers
- 6 people
- Sponsor
- Provention Bio, a Sanofi Company
Diabetes Mellitus, Insulin-Dependent
A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes
The objective of this clinical trial is to investigate whether ladarixin has sufficient activity (preservation of β-cell function and slow-down of the progression of T1D) to warrant its further development (proof of concept…
- Trial name
- NCT02814838
- Testing
- Ladarixin
- Where
- 8 sites in Belgium, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Dompé Farmaceutici S.p.A
Type 1 Diabetes
New Onset Type 1 Diabetes: Role of Exenatide
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps…
- Trial name
- NCT01269034
- Testing
- Exenatide, Rapid and long acting insulin, long acting insulin + rapid acting + 1.25 mcg Exenatide
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
Atrial Fibrillation New Onset
Evaluation Of New Onset Postoperative Atrial Fibrillation
This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation…
- Trial name
- NCT01247974
- Testing
- CorMatrix ECM for Pericardial Closure
- Where
- 16 sites in United States
- Volunteers
- 439 people
- Sponsor
- Elutia Inc.
Parkinson Disease
Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease
- Trial name
- NCT00321854
- Testing
- pramipexole
- Where
- 99 sites in United States, Austria and 8 more
- Volunteers
- 535 people
- Sponsor
- Boehringer Ingelheim
Chronic Graft Versus Host Disease
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
- Trial name
- iNTEGRATE (NCT02959944)
- Testing
- ibrutinib, Prednisone
- Where
- 102 sites in United States, Australia and 13 more
- Volunteers
- 193 people
- Sponsor
- Pharmacyclics LLC.
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Diabetes Mellitus, Insulin-Dependent
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin…
- Trial name
- NCT00357890
- Testing
- Insulin pump therapy, Multiple daily injections using insulin glargine + rapid acting analog
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Nemours Children's Clinic