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NCT ID: NCT02642159 Completed - Dyslipidemia Clinical Trials

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

Start date: March 15, 2016
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: - To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density lipoprotein [IDL] particle number). - To assess changes in glycemic parameters with alirocumab vs. usual care treatment. - To demonstrate the safety and tolerability of alirocumab. - To evaluate treatment acceptance of alirocumab. - To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. - To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).

NCT ID: NCT02641548 Recruiting - Clinical trials for Diabetes Complications

Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes

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

This study evaluates the addition of using a sock of silicone to using a heel cream, in the treatment of heel fissures in people with diabetes, aiming at healing the fissures and preventing them from developing into ulcers. Half of the participants will use the silicone sock and a heel cream, the other half will use the cream only.

NCT ID: NCT02641392 Terminated - Crohn's Disease Clinical Trials

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Start date: July 25, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.

NCT ID: NCT02640846 Active, not recruiting - Septic Shock Clinical Trials

Effects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock

SCLM
Start date: December 2015
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate the effects milrinon and levosimandan on n heart function in septic cardiomyopathy and how norepinephrine affects the left and right ventricular function in patients with septick shock using pulmonary artery catheter, conventional and strain echocardiography.

NCT ID: NCT02638792 Completed - Excessive Worry Clinical Trials

Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry

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

The purpose of this study is to examine if an internet-based exposure therapy is more effective in reducing excessive worry amongst patients who suffer from this problem than is internet-based stress management training.

NCT ID: NCT02638636 Completed - Fibromyalgia Clinical Trials

Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.

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

The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.

NCT ID: NCT02637687 Active, not recruiting - Clinical trials for Solid Tumors Harboring NTRK Fusion

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

SCOUT
Start date: December 16, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.

NCT ID: NCT02637635 Active, not recruiting - Breast Neoplasms Clinical Trials

Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant. Our aims are: 1. To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not. 2. Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.

NCT ID: NCT02635776 Completed - Peanut Allergy Clinical Trials

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

PALISADE
Start date: December 22, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

NCT ID: NCT02635685 Active, not recruiting - Stroke Clinical Trials

Clinical Decision Support for Stroke Prevention in Atrial Fibrillation

CDS-AF
Start date: January 11, 2016
Phase: N/A
Study type: Interventional

A cluster randomised study in the primary care setting to evaluate a electronic clinical decision tool for stroke prophylaxis in patients with atrial fibrillation.