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Filter by:The study will evaluate the effect of trimetazidine versus placebo in addition to standard pulmonary arterial hypertension regime on right ventricular function in pulmonary arterial hypertension patients.
This phase II study is designed to investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma. The purpose of the study is to show the local recurrence rate after surgical resection and IORT is superior to that of surgical resection alone from the historical control. A total of 42 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.
Freezing of gait (FoG) is a common and debilitating condition in Parkinson's Disease (PD) patients. FoG is described as an episodic inability to walk, which often triggers falls, hospitalization and is an important predictor of poor quality of life. As locomotor regions degenerate in PD, gait automaticity is impaired. Patients compensate by increasing volitional control of gait, however, this adaptation has been found to worsen FoG severity. We hypothesize that increased cortical control of gait is maladaptive, and therapies to improve gait automaticity will not be effective unless cortical control of gait is reduced. The long-term goal of this project is to develop a therapeutic approach for FoG that simultaneously reduces cortical control and increases automaticity of gait. The objective is to determine the locomotor network abnormalities responsible for FoG and demonstrate how neuromodulation and rehabilitation can modulate the network. The rationale of this study is that increased connectivity between brainstem locomotor regions and cortical structures represents increased cortical governance of gait, and it can be reversed by the proposed intervention. We will accomplish this by combining a course of inhibitory rTMS (1Hz) to the cortex (supplementary motor area) with a rehabilitation protocol designed to increase gait automaticity (dual task training). We have designed a study that will carefully assess the locomotor network of freezers with resting state functional, diffusion and interleaved TMS/BOLD MRI studies, before and after intervention. Behavioral measures including gait analysis, cognitive and motor assessments will also be conducted at baseline and post treatment. The study aims to determine the effects of our intervention on the locomotor network (assessed with imaging), as well as on FoG severity as quantified through multiple markers obtained through gait analysis. At the conclusion of the study we expect to have determined the network changes central to the pathophysiology of FoG, the effects of 1Hz rTMS + rehabilitation on this network, and on FoG severity. The relevance of this study to public health is to develop a non-invasive effective therapeutic option for one of the most debilitating and untreatable conditions affecting the lives of one million Americans suffering from PD; freezing of gait.
Background: The prevalence of DM is increasing across both Asian and Western countries, in proportion to the rising aging population. Type 2 diabetic patients are the high-risk group to experience diabetes-related complications that can lead to depression, poor quality of life and even death. In the current face-to-face diabetes counseling, the patients presented with weak comprehension of diabetes knowledge. There is a gap between application of knowledge and self-efficacy behaviors. With the increased patient acuity in the recent years, it has contributed to the shortage of diabetes nurse educators to meet the demands or needs in the outpatient endocrine clinic. Often, the patients have to wait longer for their turn for diabetes education, which can result in a delay in diabetes self-management. The use of mobile health technologies had demonstrated a positive impact on diabetes-related outcomes and better self-efficacy behaviors, all of which are crucial in diabetes management. Aims: This study is to evaluate the effectiveness of Gamification Diabetes Education Program (GDEP) on HbA1c values, self-efficacy, sense of coherence and quality of life among the poorly controlled 2 diabetic patients. Methods: This study adopted a randomized control trial design. Based on Cohen's power analysis, one hundred and forty-eight participants will be recruited through simple random sampling. The recruitment process includes block randomization and allocation concealment. Participants will either be randomized into intervention (GDEP) group or control (current practice) group. The self-efficacy instrument, sense of coherence scale (SOC-13), world health organisation quality of life scale- brief (WHOQoL-BREF) and HbA1c values assessed the outcomes at the same time points: point of enrollment (pre) and two post-time points at 12-week and 24-week. The significance of study: GDEP would bring about awareness on diabetes management and contribute to existing diabetes literature. It addresses the clinical significance of enhancing diabetes knowledge and motivation in self-efficacy behaviors. Hence, GDEP has the potential to close the gap between application of knowledge to self-efficacy behaviors, which in turn would result in better self-efficacy, sense of coherence and quality of life. All of these could reduce their HbA1c values and the global health care expenditure spent on managing diabetes mellitus alone. The development of GDEP is a value-added and innovative-driven packaging to close the gap and address the limitation in the current literature. It serves to transform workforce and redesign patient education process for type 2 diabetic patients.
To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer patients undergoing surgery
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
It is assumed that the reduction of the flap dimension could provide a reduction of surgical time, post surgical complications and patient's discomfort when compared with the traditional surgical approach.
The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with follow-up to 30 days to determine the acute safety, acute device performance and clinical performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries.
The study will consist in an adjustment/adaptation of the "standard EMDR protocol" for cancer disease, and most particulary for women who present a breast cancer and during adjuvant therapy. It will also test the faisability of the research, with a view to adjust the calendar and the ressources to put at disposal for a randomized control trial that follow. This study will also allow to test the need and acceptibility of this new psychotherapy for the patient, and to identify facilitators and obstacles : participation/rejection ratio, inclusion rythm, adhesion of the medical staff about the project
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to manage antidepressant use will be enrolled. Patients of these DFM physicians who are adults with a new prescription for a target antidepressant will also be enrolled.