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NCT ID: NCT03345095 Completed - Clinical trials for Newly Diagnosed Glioblastoma

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

MIRAGE
Start date: July 26, 2018
Phase: Phase 3
Study type: Interventional

The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

NCT ID: NCT03345082 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

Start date: November 6, 2017
Phase: Phase 2
Study type: Interventional

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

NCT ID: NCT03345004 Completed - Diabetes Mellitus Clinical Trials

Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes

Start date: December 20, 2017
Phase: Phase 2
Study type: Interventional

The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.

NCT ID: NCT03344653 Completed - Clinical trials for Coronary Artery Disease

A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Onyx ONE
Start date: November 2, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

NCT ID: NCT03344315 Completed - Gingival Recession Clinical Trials

Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap in Class III Recessions

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this multi-center study is to compare the effectiveness of Mucograft versus connective tissue graft in combination with coronal advanced flap for the treatment of Miller class III recessions The connective tissue graft in combination with coronal advanced flap is considered the gold standard for the treatment of gingival recession in terms of percentage of root coverage and complete root coverage. However connective tissue graft harvesting from the palatal mucosa is often associated with increased patient morbidity, prolonged surgical time and is limited supply. To overcome these inconvenients many efforts are made to develop new materials (healing modifiers, barrier membranes and grafts substitutes) Recently a new two-layer , xenogenic collagen matrix (Mucograft: Geistlich Pharma , Wolhusen Switzerland) has been proposed for regenerative therapy involving teeth and implants. The use of this porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects (isolated and multiple recession defects) The mayority of root coverage studies in the literature treats Miller class I and II recession defects .Surgical treatment of class III recesión defects is more challenging due to loss of interproximal bone and soft tissues and complete root coverage may not be expected . But some recent studies demonstrate complete root coverage and high percentage of root coverage in class III recessions. Also a new classification system using the level of interproximal attachment level has been proposed to predict the final root coverage outcome. So ,the soft tissue substitutes should be used also in Miller class III recession, and because of that fact, the investigators are conducting this study, to evaluate the effectiveness of Mucograft in Miller class III recessions compared with connective tissue graft.

NCT ID: NCT03343938 Completed - ART Clinical Trials

Evaluation of a Closed Assisted Reproductive Technology (ART) Station Versus an Open Flow Cabinet

Start date: October 31, 2017
Phase: N/A
Study type: Interventional

There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than individual culture at atmospheric oxygen tension (20% O2) in a conventional incubator. For these reasons, the investigators have decided to continue this research line to evaluate the efficacy of a new ART station with a closed environment in comparison of an open flow cabinet. This new system keeps a controled environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37 degrees. A prospective randomized study will be carried out in which the manipulation of the gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or in a closed station that maintain the CO2 and temperature conditions.

NCT ID: NCT03343275 Completed - Stent Complications Clinical Trials

Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.

Start date: December 13, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effectivity in urinary pH Control and the prevention of calcification in Double J stent using a device combined with the intake of dietary supplements. Every patient will receive hygienic-dietary indications. Patients will also take one out of the three dietary supplements regarded within the study (pH Up, pH Down and Cysteine) to control the adequate pH level, always following medical indications.

NCT ID: NCT03340922 Completed - Catheter Ablation Clinical Trials

MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation

MANIaC-PVC
Start date: June 26, 2018
Phase: Phase 4
Study type: Interventional

Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. This prospective, randomized study analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram, compared with conventional, manual annotation during PVC ablation procedures.

NCT ID: NCT03340844 Completed - Metastasis Clinical Trials

Role of CTC´s Spread During Pancreaticoduodenectomy in Patients With Pancreatic and Periampullary Tumors

CETUPANC
Start date: December 15, 2017
Phase: N/A
Study type: Interventional

This multicentre, prospective and randomized study aims(1:1) to compare the rate of recurrence, metastasis and survival according to the levels of intraoperative circulating tumor cells (CTCs) during cephalic duodenopancreatectomy in patients with pancreatic and periampullary tumors.

NCT ID: NCT03340766 Completed - Clinical trials for Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

HARBOUR
Start date: March 16, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.