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NCT ID: NCT03941119 Terminated - Dementia Clinical Trials

Evaluating the Impact of VR-therapy on BPSD and QoL of Individuals With Dementia Admitted to Hospital

VRx-RCT
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Behavioural and Psychological Symptoms of Dementia (BPSD) (such as aggression, restlessness, agitation, wandering, anxiety, depression) are common to most people with dementia at some point during their illness and represent an aspect of dementia particularly difficult to manage. There is growing attention to the therapeutic effects of natural environments on people's health. Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to enhance wellbeing, reduce depression, anxiety and stress levels, and decrease hospital length-of-stay for inpatients. Virtual Reality (VR) is a novel technology that uses a Head Mounted Display (HMD) to generate simulated immersive experiences that elicit perceptions and behaviors similar to those in real life and can make one feel as though they are truly present in another place. Based on scientific research, previous studies, and expert consultation, we created a library of VR experiences depicting calming nature scenes designed specifically for people with dementia. The objectives of this RCT are 1) to evaluate the effects of VR-therapy on BPSD and the hospital care experience of in-patients with dementia and/or delirium admitted to an acute care hospital, 2) to determine the usability, tolerability, and safety of VR-therapy for patients with dementia and/or delirium admitted to acute care, 3) determine the effect of VR-therapy on quality of life for patients with dementia and/or delirium admitted to acute care and 4) to explore a framework for introducing non-pharmacological therapies in acute care hospitals. Our hypotheses are 1) VR-therapy helps manage BPSD (e.g. decrease anxiety, aggression, depression, violent behaviors, incidents of wandering), and may decrease the amount and/or frequency of sedatives and anti-depressant medication administered and/or the number of incidents that require restraints, and the number of falls, in people with dementia and/or delirium admitted to an acute care hospital. 2) VR-therapy will improve the quality of life for individuals with dementia and/or delirium admitted to an acute care hospital (operationalized through conducting a validated instrument to measure quality of life for people with dementia). 3) VR-therapy is safe and feasible to administer to individuals with dementia and/or delirium admitted to an acute care hospital (with assistance from their circle of care members and/or caregivers).

NCT ID: NCT03940677 Terminated - Parkinson's Disease Clinical Trials

Innovative Biomarkers in de Novo Parkinson's Disease

INNOBIOPARK
Start date: April 25, 2019
Phase: N/A
Study type: Interventional

This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.

NCT ID: NCT03939065 Terminated - Clinical trials for Cystic Fibrosis in Children

Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

Start date: June 12, 2020
Phase: N/A
Study type: Interventional

This research proposes a pilot study using the combination of continuous glucose monitor (CGM) and insulin pump therapy, also known as sensor augmented pump (SAP) therapy, for cystic fibrosis related diabetes (CFRD) management in the inpatient setting, with the aim of improving glycemic control.

NCT ID: NCT03938857 Terminated - Clinical trials for Mechanical Ventilation Complication

DOSE Trial of Opioid Sparing Effect

DOSE
Start date: July 18, 2019
Phase: Phase 1
Study type: Interventional

Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children. This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.

NCT ID: NCT03937791 Terminated - Clinical trials for Neoplasms, Squamous Cell

Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions

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

Background: Human papillomavirus (HPV) can cause vulvar high-grade squamous intraepithelial lesions (HSIL). Sometimes, this can become cancer. Researchers want to see if T cell therapy can treat vulvar HSIL. In this therapy, a person s immune cells are genetically modified so they can attack the HPV. Objective: To test if a personalized immune treatment can cure vulvar HSIL. Eligibility: People ages 18 and older with vulvar HSIL that cannot be removed with surgery, or for which surgery has failed Design: Participants will be screened with: Medical history Physical exam HPV testing Venous assessment Chest x-ray Heart and pulmonary tests Participants will have a baseline visit. They may have a vulvar biopsy. Photographs will be taken of their lesions. Participants will have leukapheresis: Blood is removed from a needle in the arm and circulated through a machine that takes out the white blood cells. The other blood cells are returned through a needle in the other arm. The white blood cells will be used to grow treatment cells. Participants will receive the treatment through a tube inserted into an arm, neck, or chest vein. They will recover in the hospital for 1 to 2 days. They will have blood tests and take supportive medications. Participants may have one more treatment. Participants will have 5 follow-up visits in the first 3 months after treatment. They may have more visits if their disease is growing. Visits will include blood tests. They may include vulvar biopsies or leukapheresis. Participants will have an annual physical exam for 5 years after treatment that can be done at home or at the National Institutes of Health (NIH). Then they will have an annual phone or email questionnaire for another 10 years....

NCT ID: NCT03936608 Terminated - Clinical trials for Cardiac Resynchronization Therapy

ECG for Programming in CRT

EPIC
Start date: April 22, 2019
Phase: N/A
Study type: Interventional

Patients with heart failure and left bundle branch block benefit from Cardiac Resynchronization Therapy (CRT) that delivers pacing from right ventricle (RV) and left ventricle (LV) synchronously, resulting in electrical ventricular resynchrony followed by revere structural cardiac remodeling and thereby reduced heart failure symptoms, hospitalizations and death. It is not known if programming an individually optimized RV-LV pacing offset to maximize electrical resynchrony can improve benefit from CRT. The proposed study is a randomized controlled trial in patients undergoing implant of a CRT pacemaker/defibrillator device for clinical indications to evaluate benefit of RV-LV offset programming using electrocardiogram (ECG) vs. standard nominal CRT programming without RV-LV offset. Patients receiving CRT devices will be randomized to either (A) active intervention of programming RV-LV pacing offset to optimize ECG or to (B) active control of nominally programming CRT device without RV- LV offset. The patients will be followed to evaluate change in echocardiogram, quality of life, functional evaluation and a blood marker for heart failure.

NCT ID: NCT03936595 Terminated - Clinical trials for Power Training Exercise Protocols

Recovery of Performance, Muscle Damage and Neuromuscular Fatigue Following Muscle Power Training

PoTrRec
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Muscle power is one of the most important parameters in almost every athletic action, and expresses the ability of the human muscle to produce great amounts of force with the greatest possible speed. Thus, muscle power is critical for high performance in athletic actions such as jumping, throwing, change of direction and sprinting. For enhancing their muscle power, athletes comprise several resistance training programs as part of their training. Muscle power training comprises of eccentric muscle actions, and the magnitude of these actions depend on the emphasis that is given on the concentric or eccentric action, respectively, of the muscles during the exercises. However, eccentric muscle action, especially when unaccustomed, can lead to exercise-induced muscle damage (EIMD), and deterioration of muscle performance. Despite the fact that muscle power training comprises eccentric muscle actions, and consequently can lead to muscle injury and muscle performance reduction during the following days, the recovery kinetics after acute muscle power training have not been adequately studied. However, information regarding the recovery of the muscles after a power training protocol, is critical for the correct design of a training microcycle, and the reduction of injury risk. The aim of the present study is to investigate the muscle injury provoked after acute muscle power training using three different power training exercise protocols. Additionally, we will examine the effect of these protocols on muscle performance and neuromuscular fatigue indices.

NCT ID: NCT03935555 Terminated - Clinical trials for Primary Myelofibrosis (PMF)

Assess the Safety, Tolerability Oral PU-H71 in Subjects Taking Ruxolitinib

Start date: August 12, 2019
Phase: Phase 1
Study type: Interventional

This is a multicenter, Phase 1b study with dose escalation and expansion cohorts designed to assess the safety, tolerability, PK, and preliminary efficacy of PU-H71 in subjects with PMF, Post-PV MF, Post-ET MF, taking stable doses of ruxolitinib.

NCT ID: NCT03933020 Terminated - Clinical trials for Pediatric Onset Multiple Sclerosis (POMS)

Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)

Start date: May 10, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to to determine how implementing a home-based virtual reality video (VR) game exercise program in young people with Multiple Sclerosis(MS) can improve disability outcomes by measuring its impact on cognitive assessments (BICAMS), subjective measures of cognitive, physical and psychosocial disability, and motor assessments (6MWT).

NCT ID: NCT03931746 Terminated - Clinical trials for Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic Surgery

Porcine Xenograft Versus Second Intention Healing

Start date: June 11, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study is to test whether it is better to allow patients with post- operative wounds on the legs to heal on their own without a covering or to use a porcine xenograft (skin graft that is made from pig cells) to cover the wound during healing. It is currently not known which option is better in terms of the appearance, complication rate or the impact on the patient's quality of life during the healing process. In this location, it is common receive either treatment.