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NCT ID: NCT03510897 Terminated - Cardiac Surgery Clinical Trials

QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery

Start date: June 29, 2018
Phase: Phase 3
Study type: Interventional

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

NCT ID: NCT03507881 Terminated - Spine Fusion Clinical Trials

Prospective Study on Ennovate® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients

ENNOVIST
Start date: July 31, 2018
Phase:
Study type: Observational

The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results.

NCT ID: NCT03504501 Terminated - Impaired Cognition Clinical Trials

Synaptic Plasticity and Cognitive Function in RASopathies

SynCoRAS
Start date: March 22, 2019
Phase: Phase 2
Study type: Interventional

The project is targeting cognitive impairment, one of the main health problems of patients with RAS pathway disorders. The aim of this study is to translate findings of animal studies to humans. This has been done by the applicants successfully for Lovastatin in Nf1. This result will be transferred to patients with Noonan Syndrome. lamotrigine is most likely a more effective and promising substance improving synaptic plasticity and consecutive cognitive function. It is expected that both substances are improving synaptic plasticity as well as alertness and changes in alertness may be a precondition for improvement of cognition.

NCT ID: NCT03504410 Terminated - Clinical trials for Relapsed/Refractory Acute Myeloid Leukemia

Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML

Start date: November 12, 2018
Phase: Phase 3
Study type: Interventional

A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.

NCT ID: NCT03503968 Terminated - Safety Clinical Trials

TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms

Start date: March 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an investigational medicinal product (IMP), consisting of patient-derived autologous T cells, persistently transduced with a Preferentially Expressed Antigen in Melanoma (PRAME)-specific human leukocyte antigen (HLA)-A*02:01-restricted T cell receptor (TCR).

NCT ID: NCT03500939 Terminated - Clinical trials for Acute Ischemic Stroke

Penumbral Rescue by Normobaric O2 Administration in Patients With Ischemic Stroke and Target Mismatch ProFile

PROOF
Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

The main objective of the PROOF trial is to investigate efficacy and safety of normobaric hyperoxygenation (NBHO) as a neuroprotective treatment in patients with acute ischemic stroke due to large vessel occlusion likely to receive endovascular mechanical thrombectomy (TBY) in a randomized controlled clinical phase IIb trial.

NCT ID: NCT03496298 Terminated - Clinical trials for Type 2 Diabetes Mellitus

Effect of Efpeglenatide on Cardiovascular Outcomes

AMPLITUDE-O
Start date: April 27, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters: - 3-point MACE. - Expanded CV outcome. - Composite outcome of new or worsening nephropathy. To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.

NCT ID: NCT03494933 Terminated - Clinical trials for Chronic Heart Failure

Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure

RESET-CRT
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for Cardiac Resynchronisation Therapy, the implantation of a pacemaker (index group) is not inferior to defibrillator (control group) with respect to all-cause mortality.

NCT ID: NCT03491150 Terminated - Alzheimer's Disease Clinical Trials

An Open-Label Crenezumab Study in Participants With Alzheimer's Disease

CREAD OLE
Start date: April 11, 2018
Phase: Phase 3
Study type: Interventional

In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.

NCT ID: NCT03486288 Terminated - Clinical trials for Cognitive Impairment

Cognitive Impairment Following Elective Spine Surgery

CONFESS
Start date: February 6, 2018
Phase:
Study type: Observational

Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades. It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.