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NCT ID: NCT02174848 Completed - Clinical trials for Pantothenate Kinase-Associated Neurodegeneration

Long-term Deferiprone Treatment in Patients With Pantothenate Kinase-Associated Neurodegeneration

TIRCON-EXT
Start date: June 2014
Phase: Phase 3
Study type: Interventional

Patients with PKAN will be treated with the iron chelator deferiprone for 18 months. Only patients who have completed the earlier study TIRCON2012V1 (NCT01741532), a double-blind placebo-controlled trial in which participants were randomized to receive either deferiprone or placebo for 18 months, are eligible to enroll.

NCT ID: NCT02174276 Completed - Chronic Hepatitis B Clinical Trials

Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment

Start date: July 24, 2014
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.

NCT ID: NCT02173847 Completed - Keratoconus Clinical Trials

Laser Assisted Procedures in Penetrating Keratoplasty

Start date: January 2011
Phase: N/A
Study type: Interventional

Laser- assisted procedures in penetrating keratoplasty (PK) are proposed to improve the surgical outcomes: minimally invasive procedures, improved biomechanical stability of the transplanted flap, reduction of rejection risks, reduction of inflammation, reduction of infections risk, faster healing process. In order to achieve these goals, two different lasers were used during PK surgery: - a femtosecond laser to cut an anvil shaped profile - a diode laser to weld the surgical wound

NCT ID: NCT02173275 Completed - Myocardial Ischemia Clinical Trials

Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

CREDENCE
Start date: May 2014
Phase:
Study type: Observational

The study seeks to determine the accuracy of using anatomic and physiologic information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve. The hypothesis of this proposal is that integrating anatomic plaque features with physiologic fractional flow reserve-CT will optimize identification of coronary lesions that are ischemia-causing by computed tomography .

NCT ID: NCT02173171 Completed - Clinical trials for Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial

Registry Study for Talimogene Laherparepvec

Start date: April 27, 2010
Phase:
Study type: Observational [Patient Registry]

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

NCT ID: NCT02173132 Completed - Work Ability Clinical Trials

Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy

Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress, Work Ability and Work Performance in subjects with Hepatic Encephalopathy.

NCT ID: NCT02173028 Completed - Clinical trials for Congestive Heart Failure

RESynchronizaTiOn theRapy and bEta-blocker Titration

RESTORE
Start date: June 2013
Phase: N/A
Study type: Observational

Patients will be treated according to the clinical practice of the participating centers and to the international guidelines for the treatment of heart failure.The present analysis provides a collection of data about the changes to drug therapy after the "Cardiac Resynchronization Therapy" (CRT) procedure , and any signs and symptoms of intolerance to prescribed medications.

NCT ID: NCT02172950 Completed - Hemophilia A Clinical Trials

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

Start date: October 13, 2014
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

NCT ID: NCT02170714 Completed - Clinical trials for Pediatric Acute Severe Colitis

Efficacy of Infliximab as a Rescue Therapy in Pediatric Acute Severe Colitis

Start date: May 2010
Phase: N/A
Study type: Observational

Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a second line therapy. This study was performed in consecutively observed pediatric patients with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)- European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN) guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical predictors of poor outcome. Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All patients were treated according to the above mentioned guidelines for ASC and received intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy rate and the efficacy of IFX in avoiding colectomy were evaluated.

NCT ID: NCT02170129 Completed - Dental Implants Clinical Trials

SINUS LIFT 100% Anorganic Bovine Bone vs. 50% Anorganic Bovine Bone + 50% Autologous Bone

Start date: February 2013
Phase: N/A
Study type: Interventional

Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase bone height in the atrophic posterior maxilla for dental implant placement. In bone reconstructive surgery, in general, autogenous bone is considered as the gold standard, primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are available that can overcome the limitations of autologous bone due to their osteoconductive properties and biocompatibility. Several studies seem to validate these concepts, but further comparative trials are needed. Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach. Material and Methods: This study was designed as a randomised, controlled, clinical trial. Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses were randomised according to a parallel group design. Sinuses were grafted according to a lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss) and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same surgical procedure a sample of bone was harvested for histomorphometric analysis . All implants were delayed loaded with screw retained temporary crowns 3 months after implants insertion and with screw retained definitive crowns 4 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation.