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NCT ID: NCT02392234 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation

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

The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.

NCT ID: NCT02392078 Completed - Movement Disorders Clinical Trials

Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

LAANTERN
Start date: October 2015
Phase:
Study type: Observational

The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS has been used in over 2600 procedures conducted at over 70 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 5 years to evaluate safety, QoL, and procedural outcomes including local control failure rate, progression free survival, overall survival, and seizure freedom in up to 1,000 patients and up to 50 sites.

NCT ID: NCT02391948 Completed - Cerebral Palsy Clinical Trials

On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay

Start date: July 1, 2013
Phase:
Study type: Observational

The On Track Study is a large multi-site collaboration involving researchers, therapists, families, and children with cerebral palsy (CP) from across Canada and the United States. The researchers need to better understand how young children who have difficulties with movement activities progress and develop in their balance abilities, fitness, strength, health, range of motion, self-care, everyday play, and activity participation. This study will determine how young children with cerebral palsy or gross motor delays progress in many aspects of their physical development and participation in daily life. The information collected from this study will help therapists and parents monitor if a child is developing as expected in his or her physical development and participation. Then, the health care professionals working with children can use the results of this study, in combination with the previously completed Move & PLAY study results, to provide the services that are most beneficial and meaningful for each child and their family members.

NCT ID: NCT02391779 Completed - Hypertension Clinical Trials

Flaxseed Lignan Supplementation in Elderly Participants With Stage I Hypertension

Start date: May 2015
Phase: Phase 2
Study type: Interventional

Current recommendations today suggest that use of therapeutic lifestyle changes, such as supplementation with specific dietary components and moderate exercise, are appropriate interventions for individuals with borderline high blood pressure. Dietary intervention with natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed to mediate the cardiovascular health benefits following flaxseed consumption (Peterson 2010). Clinical trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax® from Archer Daniels Midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure (Cornish 2009). Furthermore, a recent study in atherosclerosis patients showed significant clinical benefit of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a therapeutic lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the effectiveness of FLC supplementation alone or in combination with moderate exercise merits investigation.

NCT ID: NCT02391506 Completed - Osteoarthritis Clinical Trials

Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis

GRIP
Start date: July 29, 2015
Phase: N/A
Study type: Interventional

This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the CMC joint in the hand.

NCT ID: NCT02391116 Completed - Clinical trials for Diffuse, Large B-Cell, Lymphoma

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Start date: May 8, 2015
Phase: Phase 2
Study type: Interventional

To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

NCT ID: NCT02390102 Completed - Anemia Clinical Trials

Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

EPICURE
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve replacement.

NCT ID: NCT02389946 Completed - Clinical trials for Coronary Artery Disease

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

BIOFLOW-V
Start date: May 2015
Phase: N/A
Study type: Interventional

The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.

NCT ID: NCT02389894 Completed - Stroke Clinical Trials

Neuroprotection in Patients Undergoing Aortic Valve Replacement

Start date: March 2015
Phase: N/A
Study type: Interventional

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

NCT ID: NCT02389868 Completed - Clinical trials for Blood Platelets Proteome

Effects of Lovastatin on Human Platelet Proteome

LovaC
Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims to characterize the biological and inter-individual variation of platelet's proteome as measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of changes induced by Lovastatin on the platelet's proteome may allow the discovery of modifications relative to the effects of statins on hemostasis and the lipid profile.