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NCT ID: NCT04105803 Enrolling by invitation - Clinical trials for Cardiac Allograft Vasculopathy

Cardiac Mitochondrial Function After Heart Transplantation

ENERGY-HTX
Start date: April 25, 2019
Phase:
Study type: Observational

Studies have shown that cardiac function is affected immediately after heart transplantation (HTx), but seems to recover to some extent over the first year. This immediate effect is associated with lack of oxygen in the tissue and reperfusion injury causing cellular energy depletion, mitochondrial failure and cellular damage. This condition may progress into full blown primary graft failure (PGF), characterized as deterioration of the transplanted heart, which is seen in 3-30 % of HTx patients. In addition to PGF, chronic rejection owing to cardiac allograft vasculopathy (CAV) may develop. PGF and CAV remain the major heart related mortality causes, and additional assessment and treatments are therefore needed. Acute cellular rejection (ACR) is diagnosed based on endomyocardial biopsies (EMB), which are routinely performed to ensure prober immunosuppression in HTx patients. ACR occur in approximately 25% of HTx patients, and is associated with PGF and CAV. However, mitochondrial function and integrity may prove to be a more sensitive marker of allograft rejection than endomyocardial biopsies. Therefore, assessment of mitochondrial function may allow for earlier detection of allograft rejection and dysfunction. This may be of particular importance as emerging treatments are targeting both energy substrate supply for adenosine-triphosphate generation produced by the mitochondria and mitochondrial function in the failing heart. Despite the association between graft rejection and mitochondrial function, it remains unsettled whether mitochondrial function associate with PGF, ACR and CAV. Such findings may be of prognostic importance and even elucidate new treatment targets. Hence, we evaluate the mitochondrial status in HTx patients through four studies designed to assess different aspects of the interplay between cardiac function and mitochondrial integrity and function. Hypotheses: Study 1: Primary graft pump function is correlated to mitochondrial function in the first myocardial biopsy taken from the donor heart during the operation. Study 2: Cardiac mitochondrial function improves over the first 3 months after a heart transplantation. Study 3: Heart transplant patients with moderate to severe coronary graft vasculopathy has impaired mitochondrial function. Study 4: Myocardial external energy efficiency by positron-emission tomography can be used as a marker of mitochondrial function and chronic rejection in HTx patients.

NCT ID: NCT04083430 Enrolling by invitation - Healthy Clinical Trials

Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination

CYF-8
Start date: October 8, 2019
Phase: Phase 4
Study type: Interventional

Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells

NCT ID: NCT04073524 Enrolling by invitation - Depression Clinical Trials

The Wild Man Programme - a Nature-based Rehabilitation Enhancing Quality of Life for Men on Long-term Sick Leave

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

The aim of the present study is to examine whether the nature based 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.

NCT ID: NCT04039347 Enrolling by invitation - Clinical trials for Bronchiolitis Obliterans

Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)

BOSTON-3
Start date: March 12, 2020
Phase: Phase 3
Study type: Interventional

The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

NCT ID: NCT03984591 Enrolling by invitation - Clinical trials for Systolic Heart Failure

A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure

CROWD-ASPECT
Start date: November 1, 2020
Phase: Phase 4
Study type: Interventional

Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction. Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.

NCT ID: NCT03979833 Enrolling by invitation - Clinical trials for Von Hippel-Lindau Disease

Drivers of Hypoxia-induced Angiogenesis in Tumor Development

Start date: June 14, 2019
Phase:
Study type: Observational

The study aims to elucidate hypoxia-induced angiogenesis in tumor development using central nervous system (CNS) hemangioblastoma tumorgenesis as a model. In a pilot-project the investigators will identify genetic drivers of CNS hemangioblastoma progression and associated cyst development using whole genome sequencing and copy number profiling of tumor DNA paired with clinical information about each tumor's growth pattern. The investigators will look for recurrent mutations across tumors to identify common genetic mechanisms involved in early tumorigenesis.

NCT ID: NCT03900247 Enrolling by invitation - Clinical trials for Amyotrophic Lateral Sclerosis

Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

REMAP
Start date: March 18, 2019
Phase: N/A
Study type: Interventional

The current project will aid patients with motor impairment to reduce the need for homecare. Specifically the aim is to develop and implement a robotic exoskeleton and brain computer interface to assist and eventually perform arm and hand movement in patients with the progressive neurodegenerative disease ALS. This proposal brings together state-of-the-art robotic technology, EEG-based brain computer interface (BCI) know-how, clinical expertise, patient perspective and industrial partners to develop and implement a robotic arm/hand device that will adapt, with increasing brain-computer control, based on the need of the patient. In short the BCI will measure electroencephalography (EEG) from the surface of the scalp and recognize signature EEG as the patient intents to move. As the patient loses muscle power the BCI robotic-device will gradually take over and support motor activity, even when the patient is totally paralyzed. As the device supports hand/arm function only, the investigators aim to address ADLs associated to hand function, specifically eating activities.

NCT ID: NCT03891446 Enrolling by invitation - Ocular Hypertension Clinical Trials

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Maia
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

NCT ID: NCT03876197 Enrolling by invitation - Radiation Toxicity Clinical Trials

Mesenchymal Stem Cells for Radiation-induced Xerostomia

Start date: August 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.

NCT ID: NCT03875547 Enrolling by invitation - Haemophilia B Clinical Trials

Post-marketing Surveillance (Use Result Surveillance) With Refixia®

Start date: August 23, 2019
Phase:
Study type: Observational

The participants are invited to take part in this study because they have Haemophilia B. The purpose of this study is to assess the safety and effectiveness of Refixia® about long-term routine use in patients with Haemophilia B. The participants will get Refixia® as prescribed to them by their study doctor. The study will last up to Sep 2025 for the participant. The participants may be asked to fill in the quality of life questionnaires (if they are above age of 15). The blood samples taken from the participants as part of routine clinical practice will also be used to investigate the safety for the long-term use of Refixia®.