View clinical trials related to Bone Marrow Diseases.
Filter by:To use advanced imaging techniques, including MRI Brain and Spinal Cord, and MRI/PET Spinal Cord to provide an assessment of Degenerative Cervical Myelopathy to improve understanding of the pathophysiology and natural history of DCM.
Proprioceptive deficits in degenerative cervical myelopathy (DCM) is a progressive neurological deficits in somatosensory and motor function which affects the body balance and motor control. DCM usually presents with body incoordination, hand clumsiness and gait disturbance associated with proprioceptive dysfunction that hinders the physical performance and functions. In this study, a non-invasive assessment protocol on proprioception will be developed for detecting subtle proprioceptive deficits at the early stage of disease through simple Physical Performance Tests for population older than 45. By adopting the physical performance tests as the diagnostic predictors of DCM, we aim to avoid the development of devastating consequences and disabilities.
Metastatic disease to the bone is a common cause of pain. External beam radiation therapy (EBRT) is the standard palliative treatment BUT pain improvement is observed in 60% to 80%. Combination of hyperthermia (HT) with radiation is strongly compelling. MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases.
The characteristic of axial pain and EEG analysis of patients after laminoplasty
The purpose of this study is to compare the efficacy, safety and imaging outcomes between Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament.
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
Background: Degenerative cervical myelopathy (DCM) is characterized by neck pain, neck stiffness, weakness, paresthesia, sphincter disturbance and balance disorder. The mean age for symptoms is 64 years and more men than women, 2.7:1, are affected. The most common level is C5-C6. DCM is the predominant cause of spinal cord dysfunction in the elderly worldwide. Surgical options include stand-alone laminectomy, laminectomy and fusion and laminoplasty. The preferable surgical approach is though, a matter of controversy. The objective of this study is to compare stand-alone laminectomy to laminectomy and fusion. Methods/Design: This is a multicenter randomized, controlled, parallel group non-inferiority trial. A total of 300 adult participants are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason within 5 years of follow-up. Sample size and power calculations were performed by estimating the reoperation rate after laminectomy to 3.4% and after laminectomy with fusion to 7.9% based on data from the Swedish spine registry (Swespine) on patients with DCM. Secondary outcomes are the patient derived modified Japanese orthopaedic association (P-mJOA) score, Neck disability index (NDI), European quality of life five dimensions (EQ-5D), Numeric rating scale (NRS) for neck and arm pain, Hospital anxiety and depression scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA) and, death. Clinical and radiological follow-up is performed at 3, 12, 24 and 60 months after surgery. The main inclusion criteria is 1-4 levels of DCM in the subaxial spine, C3-C7, with or without deformity. The REDcap will be used for safe data management. Data will be analyzed in the per protocol (PP) population, defined as randomized patients who are still alive without having emigrated or left the study after five years. Discussion: This will be the first randomized controlled trial comparing two of the most common surgical treatments for DCM; the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the MyRanC study will provide surgical treatment recommendations for DCM. This may result in improvements in surgical treatment and clinical practice regarding DCM.
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 12 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy. Participating subjects will be randomly assigned to one of two treatment groups: 1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation. 2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation). For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm. At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 12 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
This is a multicenter，randomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone metastases from solid tumors.