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NCT ID: NCT02428231 Terminated - Multiple Sclerosis Clinical Trials

Tecfidera Slow-titration Study

TITRATION
Start date: April 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF)-related gastrointestinal (GI) Adverse Events (AEs) in subjects with Multiple Sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of dimethyl fumarate treatment in this study population.

NCT ID: NCT02425683 Terminated - Clinical trials for Colorectal Neoplasms

Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX

Start date: March 26, 2015
Phase: Phase 2
Study type: Interventional

This study, for patients who have Stage IIIC colorectal cancer and who underwent 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to see if regorafenib given after the completion of FOLFOX improves treatment, compared to standard of care (SOC), which is no further treatment.

NCT ID: NCT02425306 Terminated - Melanoma Clinical Trials

Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma

Mel63; CHAMP
Start date: May 12, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.

NCT ID: NCT02424734 Terminated - Late-onset Sepsis Clinical Trials

Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Start date: August 4, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days

NCT ID: NCT02423954 Terminated - Pancreatic Cancer Clinical Trials

Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)

NivoPlus
Start date: April 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Determine Phase 2 dose of study drug

NCT ID: NCT02423330 Terminated - Anal Fistula Clinical Trials

A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula

Start date: September 2014
Phase: Early Phase 1
Study type: Interventional

This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.

NCT ID: NCT02423083 Terminated - Multiple Sclerosis Clinical Trials

Oral Guanabenz for Multiple Sclerosis

Start date: April 21, 2015
Phase: Phase 1
Study type: Interventional

Background: - People with multiple sclerosis (MS) get lesions in their brain and spinal cord. These cause neurological symptoms and sometimes disability. Researchers want to see if a blood pressure drug called guanabenz can repair lesions and help people with MS. Objective: - To see if guanabenz is safe and well tolerated in people with MS. Eligibility: - People 18 55 years old with MS who have taken glatiramer acetate for the past year. Design: - Participants will be screened in a separate protocol. For 2 months, they will be examined and have magnetic resonance imaging (MRI) scans. This will decide if they are in the Stable or Active MS study group. - The study will last 5 months. There will be up to 11 visits, 5 overnight. - Visit 1: overnight stay at the clinic: - Medical history and physical exam. - Health questionnaire - Bladder ultrasound scan - Brain MRI - Electrocardiogram (EKG) to measure heart electrical activity - Blood will be drawn through an intravenous (IV) line. - Participants may have tests of strength, muscle tone, and movement. - They will get their first dose of the study drug, a tablet taken once a day. - Participants will take the study drug at home and keep a medicine diary. - The dose will slowly increase. Each time, participants will stay overnight at the clinic. They will have a physical exam, EKG, MRI, and IV blood draw. - Visit 6: Participants will have a physical exam, MRI, and blood drawn. They will get a schedule to slowly lower their drug dose and stop taking guanabenz. - Participants will have 2 final visits. They will have a physical exam, EKG, MRI, and IV blood draw.

NCT ID: NCT02422940 Terminated - Clinical trials for Post-ischemic Stroke

Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.

MILESTONE?
Start date: April 2015
Phase: Phase 3
Study type: Interventional

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

NCT ID: NCT02422524 Terminated - Tuberculosis Clinical Trials

Pretomanid in Adults With Hepatic Impairment

Start date: December 11, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects. There will be approximately 36 total subjects, adult males and females, 18 to 70 years of age, inclusive. The study will be conducted at 2 sites, study duration is approximately 24 months, and subject participation duration is approximately 5 weeks (including screening). Primary objective: To evaluate the pharmacokinetics of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects.

NCT ID: NCT02422446 Terminated - Clinical trials for Coronary Artery Disease

Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

Start date: April 2015
Phase: Phase 3
Study type: Interventional

This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.