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NCT ID: NCT03580304 Recruiting - Mental Fatigue Clinical Trials

Evaluation of Physical and Cognitive Industrial Workload

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In this stage of the project, a study analysing the physical and mental load during occupational work will be carried out. High risk tasks will be identified in the field and simulated in lab-setting to analyse physical and mental load using physiological and biomechanical data.These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front of, to the side of, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. Important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.

NCT ID: NCT03616665 Recruiting - Clinical trials for Persistent Depressive Disorder

Feasibility and Effectiveness of a Personalized Inpatient Program for Persistent Depressive Disorder

PePsy
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The major objective of this study is to evaluate a new conceptualized personalized concept of Cognitive Behavioral Analysis System of Psychotherapy (CBASPersonalized) in the treatment of patients with persistent depressive disorder (PDD), childhood maltreatment and a high rate of comorbidity. Patients receive a two-phase-treatment-program (six-weeks inpatient-treatment and six-to-twelve-weeks blended-online-aftercare) in combination with standardized pharmacotherapy in a routine clinical inpatient setting. This study addresses the primary research question: Is an intensive six-week inpatient CBASPersonalized treatment feasible and effective in a clinical sample of PDD patients? In addition, moderator, process and long-term analyses will be conducted for differential insights.

NCT ID: NCT03620292 Recruiting - Clinical trials for Hilar Cholangiocarcinoma

Fluorescence Image Guided Surgery in Cholangiocarcinoma

COUGAR
Start date: April 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Cholangiocarcinoma is an epithelial cell malignancy arising from varying locations within the biliary tree and is difficult to diagnose due to the often-silent clinical nature. The best chance of long-term survival and potential cure is surgical resection with negative surgical margins, but many patients are unresectable due to locally advanced or metastatic disease at diagnosis. Because cholangiocarcinoma is difficult to diagnose at an early stage and extends diffusely, most patients have unresectable disease at clinical presentation, and prognosis is very poor (5-year survival is 0-40% even in resected cases) There is a need for better visualization of tumor tissue, lymph nodes and resection margins during surgery for perihilar cholangiocarcinoma (PHCC). Optical molecular imaging of PHCC associated biomarkers is a promising technique to accommodate this need. The biomarkers Vascular Endothelial Growth Factor (VEGF-A), Epidermal Growth Factor Receptor (EGFR) and c-MET are all overexpressed in PHCC versus normal tissue and are proven to be valid targets for molecular imaging. Currently, tracers that target these biomarkers are available for use in clinical studies. In previous studies with other tumor types, the investigators tested the tracer bevacizumab-IRDye800CW for the biomarker VEGF-A with very promising results. Since all markers show roughly similar expression in ex vivo studies, the initial study will be performed with bevacizumab-IRDye800CW as the investigators have the most experience with this tracer. The investigators hypothesize that the tracer bevacizumab-IRDye 800CW accumulates in PHCC tissue, enabling visualization using a NIR intraoperative camera system and ex vivo NIR endoscopy. In this pilot study, the investigators will determine if it is possible to detect PHCC intraoperatively and by ex vivo NIR endoscopy using bevacizumab 800CW, and which tracer dose gives the best target-to-background ratio. The most optimal tracer dose will be selected for a future phase II trial.

NCT ID: NCT03667027 Recruiting - Respiratory Failure Clinical Trials

Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant

DIASPORA
Start date: April 1, 2019
Phase:
Study type: Observational

This study is designed to characterize the changes in diaphragm structure, function and biology during bridging to lung transplant by mechanical ventilation or extracorporeal life support.

NCT ID: NCT03685890 Recruiting - Melanoma Clinical Trials

Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion

NivoILP
Start date: April 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms. In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3 months. An independent data safety monitoring board (DSMB) will continuously review safety and judge the seriousness of the events and also recommend the study to stop if necessary. If the DSMB do not find safety issues, the trial will continue as a phase II trial.

NCT ID: NCT03697395 Recruiting - Clinical trials for Chronic Rejection of Lung Transplant

Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue in patients after lung transplant. This study is a registry-forming study with concurrent tissue banking from surveillance bronchoscopy in addition to extra tissue sampling of blood and urine. Patients will be characterized by usual clinical phenotyping and the latest imaging methods so that diseased condition underlying CLAD can be better understood.

NCT ID: NCT03702322 Recruiting - Presbylarynx Clinical Trials

Improving Voice Production for Adults With Age-related Dysphonia

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. The central hypothesis is that targeted therapy tasks will improve voice, and that severity will determine the extent of improvement.

NCT ID: NCT03727997 Recruiting - Acute Kidney Injury Clinical Trials

Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)

InSEA-RRT
Start date: April 1, 2019
Phase:
Study type: Observational

Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.

NCT ID: NCT03732703 Recruiting - Clinical trials for Relapsed Refractory Multiple Myeloma

Myeloma-Developing Regimens Using Genomics (MyDRUG)

MyDRUG
Start date: April 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 25% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 25% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).

NCT ID: NCT03733041 Recruiting - Clinical trials for Executive Dysfunction

Neuromodulation for Exercise Adherence

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

Lack of adherence to an exercise program is a major problem for older Veterans. Several fall prevention programs fail in the home setting due to lack of adherence. Exercise adherence is dependent on brain function among other factors. Magnetic stimulation of the front part of the brain improves brain function necessary for planning and following-through. The investigators propose a three-phase study in 106 sedentary older Veterans. Everyone will be trained on use of the exergame, Nintendo Wii-Fit, that the investigators' team has found beneficial in improving balance and gait. They will be asked to exercise using Wii-Fit at home for 45 minutes daily five days/week for 12-weeks. Those that exercise less than recommended dose and those that exercise adequately but have low executive function will receive either real or sham magnetic stimulation to the front part of their brain over ten sessions paired with exercise training. All subjects will further complete 24-weeks of Wii-Fit home exercises. Adherence, executive function, balance and gait, self-efficacy, delay discounting, and falls will be measured periodically.