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NCT ID: NCT03174522 Terminated - Clinical trials for Diabetes Mellitus, Type 2

The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM

Start date: April 25, 2017
Phase: Phase 3
Study type: Interventional

This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.

NCT ID: NCT03173560 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma

Start date: August 17, 2017
Phase: Phase 2
Study type: Interventional

Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24 weeks [ORR24W]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).

NCT ID: NCT03173300 Active, not recruiting - Clinical trials for Phosphomannomutase 2 Deficiency

Natural History Study Protocol in PMM2-CDG (CDG-Ia)

Start date: January 8, 2018
Phase:
Study type: Observational

Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG) This is a natural history (observational) protocol designed to collect clinical and biological information in patients with PMM2-CDG (CDG-Ia).

NCT ID: NCT03171766 Recruiting - Clinical trials for Postoperative Complications

Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium

Start date: June 15, 2017
Phase: N/A
Study type: Observational

The main goal of the investigation is to identify the incidence of cognitive dysfunction and POD in patients older than 65 years of age undergoing neurosurgical elective surgery and determine if an association between cognitive dysfunction, basal NIRS and POD exists.

NCT ID: NCT03165240 Completed - Clinical trials for Diabetic Nephropathies

This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated

Start date: October 5, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB]. Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].

NCT ID: NCT03165201 Completed - Clinical trials for Liver Transplantation

Non-Invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan

RADIcAL2
Start date: September 18, 2017
Phase:
Study type: Observational

This will be a prospective, multi-centre, biomarker trial comparing the accuracy of a new test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of liver transplant recipients, designed in accordance with the STARD criteria. Study participants are 200 patients with liver transplant, due to undergo liver biopsy as part of serial evaluation of their liver health and to rule out rejection. The whole study will take 3 years with 2 years of recruitment The main aim is to investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.

NCT ID: NCT03164551 Terminated - Infertility Clinical Trials

TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment

TICON
Start date: April 16, 2018
Phase: Phase 4
Study type: Interventional

The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.

NCT ID: NCT03162653 Recruiting - Clinical trials for Infant, Newborn, Diseases

Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome

ALBINO
Start date: March 25, 2018
Phase: Phase 3
Study type: Interventional

Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per year in Europe. Hypothermic treatment became the only established therapy to improve outcome after perinatal hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected children die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective interventions, beside hypothermia, are warranted to further improve their outcome. Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and brain damage in experimental, animal, and early human studies of ischemia and reperfusion. This project aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to near-term infants with HIE in addition to hypothermic treatment.

NCT ID: NCT03161353 Active, not recruiting - Breast Cancer Clinical Trials

Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.

PHERGain
Start date: June 26, 2017
Phase: Phase 2
Study type: Interventional

The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for pathologic complete response (pCR) in the breast and axilla. And also assess 3-year invasive disease-free survival (iDFS) in patients with HER2-positive (HER: human epidermal receptor) breast cancer treated with neoadjuvant trastuzumab and pertuzumab (± endocrine therapy) using a FDG-PET response-adapted strategy.

NCT ID: NCT03155997 Active, not recruiting - Breast Cancer Clinical Trials

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

monarchE
Start date: July 12, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.