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NCT ID: NCT03170882 Completed - Clinical trials for Relapsed and/or Refractory Multiple Myeloma

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance. - Ixazomib capsules, given with dexamethasone tablets - Pomalidomide capsules, given with dexamethasone tablets All participants will take their study medicine on specific days during a 28-day cycle. The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home. After treatment, participants will visit the clinic every 12 weeks for a check-up. If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.

NCT ID: NCT03170661 Completed - Surgical Conditions Clinical Trials

Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.

BLISS4
Start date: June 14, 2017
Phase: Phase 4
Study type: Interventional

A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.

NCT ID: NCT03170271 Completed - Asthma Clinical Trials

A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.

ANDHI
Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.

NCT ID: NCT03167580 Completed - Clinical trials for Ventilator-free Days

REstricted Versus Liberal Positive End-Expiratory Pressure in Patients Without ARDS

RELAx
Start date: October 26, 2017
Phase: N/A
Study type: Interventional

The 'REstricted versus Liberal positive end-expiratory pressure in patients without Acute respiratory distress syndrome' (RELAx) trial is a national multicenter, open randomized controlled trial in ICU patients without ARDS at start of ventilation. It will be the first RCT comparing ventilation with the lowest possible positive end-expiratory pressure (PEEP) level with ventilation with the median PEEP level currently practiced in the Netherlands that recruits a sufficient number of patients to test the hypothesis that ventilation with the lowest possible PEEP level is non-inferior to ventilation with a PEEP level of 8 cm H2O with regard to objective and patient-relevant clinical endpoints.

NCT ID: NCT03166735 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH

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

The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.

NCT ID: NCT03165279 Completed - Aneurysm Clinical Trials

ZEnith AlPHa for AneurYsm Repair

ZEPHYR
Start date: December 7, 2016
Phase:
Study type: Observational [Patient Registry]

To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use. To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.

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: NCT03163121 Completed - Malaria Clinical Trials

Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers

Start date: May 12, 2017
Phase: Phase 1
Study type: Interventional

This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically attenuated PfSPZ) in healthy malaria-naïve adult volunteers. This Phase 1 trial is divided into two stages, Stage A and B. Stage A is an open label, single center, dose escalation study in 19 volunteers. Stage B is a multi-center, double blind, randomized, placebo-controlled trial in 48 volunteers. The primary objective of this study is to determine the safety and tolerability of direct venous inoculation (DVI) of PfSPZ-GA1 Vaccine in healthy adults.

NCT ID: NCT03162575 Completed - Psychological Clinical Trials

Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial

Start date: January 18, 2017
Phase: N/A
Study type: Interventional

The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission.

NCT ID: NCT03161288 Completed - Clinical trials for Immune System Diseases

A Study of KY1005 in Healthy Volunteers

Start date: May 29, 2017
Phase: Phase 1
Study type: Interventional

This is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study to evaluate the safety and tolerability of KY1005 in healthy volunteers.