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NCT ID: NCT03678727 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Effects of Exercise on VLDL-TG Metabolism

Start date: December 1, 2018
Phase:
Study type: Observational

Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac involvement and the progression from NAFL to NASH are poorly understood but must include altered cardiac and intrahepatic lipid handling. In collaboration with renowned research groups from Oxford, Mayo Clinic and Copenhagen we plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with NAFL and NASH and the relationship with heart function. In addition, we will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. We will address these questions using innovative tracer techniques (11Cpalmitate, 11C acetate, 18FDG glucose PET tracers and TG tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as NMR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. Effects of acute exercise as well as GLP-1 agonist and SGLT-2 inhibitor treatment (alone and in combination) will be assessed. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism and to assess hepatic, adipose and skeletal muscle lipid and substrate utilisation.

NCT ID: NCT03678532 Completed - Clinical trials for Sedation in Critically Ill COPD Patients

Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

the investigators conducted a randomized controlled trial in respiratory intensive care unit (RICU) of Assiut University Hospital. COPD patients admitted to RICU were included. Exclusion criteria include: Marked renal impairment, Liver cell failure, neurological disorders, age <18 or >70 and pregnancy. Patients were randomly allocated to two groups. Midazolam was used for sedation in both groups. Richmond agitation-sedation score (RASS) was used to monitor level of sedation or agitation. Control group received daily interruption of sedation. intervention group managed by no-sedation strategy. Primary outcome measure: changes in PaCO2 Secondary outcome measures include: changes in PH, heart rate, mean arterial blood pressure, respiratory rate, P0.1 and NIF.

NCT ID: NCT03678493 Completed - Clinical trials for Acute Myeloid Leukemia

A Study of FMT in Patients With AML Allo HSCT in Recipients

Start date: September 9, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.

NCT ID: NCT03678454 Completed - Clinical trials for Chronic Myeloid Leukemia

Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

Start date: February 3, 2017
Phase:
Study type: Observational

This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.

NCT ID: NCT03678142 Completed - Clinical trials for Antibiotic Drug Concentration in Sweat

DetectAB - Detecting Antibiotics

DetectAB
Start date: October 1, 2018
Phase:
Study type: Observational

The secretion of different kinds of antibiotic drugs in sweat is investigated. The concentration and pharmacodynamics of antibiotic drugs in sweat and blood will be compared.

NCT ID: NCT03678077 Completed - Education Clinical Trials

Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury

Start date: September 20, 2018
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) accounts for 70-90% of all diagnosed traumatic brain injuries (TBI) affecting approximately 50-300 per 100.000 individuals annually. Persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status. The association between mTBI and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. Previous studies focus on children's academic performance after severe TBI and only few studies include early adulthood and patients with mTBI. Trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. Additionally, all studies have failed to apply a national register based design. Aim The aim of the study is to examine the long-term associations between mTBI and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. The hypothesis was that by 5 years mTBI would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in Denmark. Methods: The study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in Denmark. Population: Patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) were extracted from the Danish National Patient Register between (2003-2007). Patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. Patients who were not resident in Denmark 5 years before and during the inclusion period were also excluded (1998-2007). Data will be retrieved from several national databases, including: the Danish national patient register, Danish Civil Registration System (CRS), the Danish Education Registers, the Income Statistics Register and the Employment Classification Module (AKM). One control of the general population were matched for each case on sex, age and municipality. Outcome measures are: Cohabitation status, Education, income and socio-economic status.

NCT ID: NCT03677934 Completed - Clinical trials for Neovascular Age-Related Macular Degeneration

A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration

Archway
Start date: September 12, 2018
Phase: Phase 3
Study type: Interventional

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

NCT ID: NCT03677869 Completed - Clinical trials for Vitreomacular Traction (VMT)

Effects of Pneumatic Vitreolysis on Macular Hole

Protocol AH
Start date: November 14, 2018
Phase: N/A
Study type: Interventional

Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.

NCT ID: NCT03677726 Completed - Clinical trials for Sleep Initiation and Maintenance Disorders

Improving Sleep Continuity Through Mindfulness Training for Better Cognitive Ageing.

MIST
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Poor sleep quality is a known risk factor for cognitive decline in the elderly. Hearteningly, sleep is also a prime target for behavioral modification. In this study, the investigators propose to test mindfulness-based training (MBT) as an intervention to improve sleep quality by reducing sleep fragmentation, and hypothesize that these improvements will mediate the beneficial effects of MBT on sustained and executive attention. MBT consists of a suite of techniques aimed at enhancing awareness and acceptance of one's internal (e.g., thoughts and feelings) and external experiences in the present moment. Learning these techniques has been shown to improve sleep quality in patients with primary insomnia, and in other conditions associated with sleep disturbance. There is also increasing evidence that mindfulness training enhances multiple facets of cognition, including components of attention. In this study, the investigators will recruit 120 participants in a randomized controlled design, with 60 participants receiving MBT, and 60 receiving a sleep hygiene education and exercise program (SHEEP). Each intervention will last 8 weeks. Before and after the intervention, the investigators will collect objective and subjective measures of sleep quality, resting-state and task-related functional magnetic resonance imaging scans, and performance on standard laboratory tests of attention. The investigators hypothesize that, relative to SHE, MBT will result in significantly greater improvements in sleep quality and attentional metrics. They also predict that the cognitive changes will be mediated by the changes in sleep quality. If a positive result is found, this would indicate the use of MBT as a cost-effective behavioral intervention to stabilize or even improve cognition in the elderly, thus reducing the risk of dementia in this vulnerable population.

NCT ID: NCT03677596 Completed - Leukemia Clinical Trials

A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients

Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refractory ALL who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be evaluated.