365 Clinical Trials for Various Conditions
Degenerative dementias including Alzheimer's Disease (AD), Parkinson's Disease with Dementia (PDD), Dementia with Lewy Bodies (DLB), Frontotemporal Dementias (FTLD), Corticobasal Degeneration (CBD) and Progressive Supranuclear Palsy (PSP) constitute a significant, and growing burden with an estimated cost to the US healthcare system for 2016 of $236 Billion (1). Definitive diagnosis of these dementias is based on pathological criterion upon autopsy, which presents a significant challenge to establish diagnosis in living patients. Although clinical diagnostic criteria have been developed for several of these disorders, including for Alzheimer's Disease (AD) by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) , Parkinson's Disease (PD) by the United Kingdom Parkinson Disease Brain Bank Diagnostic Criteria (UKPDBB) diagnostic criteria for Parkinson Disease(4) and others, the currently available tests, including the use of imaging markers and Cerebrospinal Fluid (CSF) biological markers do not provide a definite diagnosis since this requires the observation of characteristic neuropathological changes in specific regions of the brain.
The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) adverse events of special interest (AESI) in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.
The My Retina Tracker® Registry is sponsored by the Foundation Fighting Blindness and is for people affected by one of the rare inherited retinal degenerative diseases studied by the Foundation. It is a patient-initiated registry accessible via a secure on-line portal at www.MyRetinaTracker.org. Affected individuals who register are guided to create a profile that captures their perspective on their retinal disease and its progress; family history; genetic testing results; preventive measures; general health and interest in participation in research studies. The participants may also choose to ask their clinician to add clinical measurements and results at each clinical visit. Participants are urged to update the information regularly to create longitudinal records of their disease, from their own perspective, and their clinical progress. The overall goals of the Registry are: to better understand the diversity within the inherited retinal degenerative diseases; to understand the prevalence of the different diseases and gene variants; to assist in the establishment of genotype-phenotype relationships; to help understand the natural history of the diseases; to help accelerate research and development of clinical trials for treatments; and to provide a tool to investigators that can assist with recruitment for research studies and clinical trials.
Background: Autosomal recessive bestrophinopathy (ARB) is one of 5 blinding eye diseases caused by mutations in the gene BEST1. These diseases, collectively termed "bestrophinopathies" include ARB, Best vitelliform macular dystrophy (BVMD), adult-onset vitelliform dystrophy (AVMD), autosomal dominant vitreoretinalchoroidopathy (ADVIRC) and retinitis pigmentosa (RP) . Objective: To collect DNA/RNA and skin samples from individuals with ARB or other diseases due to mutations in the gene BEST1. These models will be used to identify and test therapeutic approaches to treating these diseases. Design: Study involves a one time donation of a skin punch biopsy and whole blood. Once the skin biopsy is obtained, skin fibroblasts will be isolated, which will be reprogrammed into iPSCs. RPE cells will be derived from the iPSCs
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.
In this study, the Principal Investigator aim to compare the clinical and radiographic outcomes of patients with degenerative lumbar disease undergoing direct lateral interbody fusion (DLIF) using two different types of lateral interbody cages: PEEK cages combined with rhBMP-2 versus CONDUIT cages. This will be a randomized, prospective, open-label clinical trial. By examining these two groups, the PI hope to determine whether PEEK cages with rhBMP-2 and CONDUIT cages are equally effective for DLIF procedures. The findings from this study will help us optimize the surgical approach for future patients undergoing DLIF.
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.
Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.
The overall objective of this randomized controlled study is to examine the preliminary efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. Patients will be randomized to receive 8 sessions of a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). The Investigator's central hypothesis is that a postoperative telehealth physical activity intervention will lead to greater improvements in objective physical activity (primary outcome) and patient-reported physical function, disability, and pain (secondary outcomes) compared to usual care in patients undergoing lumbar spine surgery.
There is a critical need to target physical activity during postoperative management to optimize long-term recovery after lumbar spine surgery. The overall objective of this study is to conduct a two-group randomized control trial (RCT) to examine the feasibility and acceptability of a physical activity telehealth intervention delivered by a physical therapist for improving disability, physical function, pain, and physical activity compared to usual care after spine surgery for a degenerative lumbar condition. The physical activity intervention will include wearable technology and remote physical therapist support to counsel patients on a realistic progression of physical activity (steps per day). The central hypothesis is that this 8-week physical activity intervention performed at two weeks after surgery will be feasible and acceptable. The results of our randomized trial will be used to support a large multi-site clinical trial to test the effectiveness and implementation of this intervention
To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. Overall a maximum of 600 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in A Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 minutes for two hours. Vital signs (VS), electrocardiograms (ECGs) and clinical laboratory tests of intrernal organ function will be acquired before and at several timepoints after administration of the radiopharmaceutical. Radiation exposures will be estimated with the MIRD Formalism.
This will be a Phase 1, open label study of the pharmacokinetics (PK) and pharmacodynamics (PD) of clonidine, an alpha-2 adrenergic (a2a) agonist, in healthy volunteers. The primary aim is to show that the drug regimen is safe and reasonably well tolerated. The secondary aim is to demonstrate that safety can be monitored with home health devices.
Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.
The overall objective of this study is to conduct a two-group randomized control trial (RCT) to compare which of two treatments provided by telephone - a cognitive-behavioral based physical therapy (CBPT) program focusing on self-management strategies or an education program about postoperative recovery - are more effective for improving patient-centered outcomes in older adults recovering from lumbar spine surgery for degenerative conditions. Our central hypothesis is that the CBPT intervention focusing on self-management will decrease pain and disability and improve general health, physical activity and physical function in community-dwelling adults undergoing spine surgery, through reductions in fear of movement and increases in pain self-efficacy.
The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.
The purpose of this single-center, prospective, randomized study is to determine the fusion rates along with the clinical outcomes of commercially available bone graft substitutes Actifuse mixed with bone marrow aspirate (BMA) versus autograft mixed with demineralized bone matrix (DBM), in subjects who require anterior cervical corpectomy (ACC) spinal fusion in patients experiencing cervical spondylotic myelopathy (CSM).
Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT Cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. Clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will document the clinical outcomes of the radial head.
The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following. Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores. Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay. Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.
This is a multicenter, longitudinal, prospective observational natural history study of subjects with a molecularly confirmed diagnosis of CMT4J. The study will enroll 20 subjects of any age into a uniform protocol for follow-up and evaluations. Subject visits will occur every 12 months + 4 weeks for up to 2 years.
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.
Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.
Immediate family members shoulder the majority of care responsibilities for persons living with dementia. However, due to various societal changes, elder care responsibilities have expanded to extended family members, including grandchildren, siblings, nieces/nephews, siblings, and step-kin. The main objective of this study is to understand the caregiving journeys of various extended family members involved in dementia care. We aim to learn about caregivers' care management strategies; their use of home and community-based services and informal support; and barriers to service usage. We will use the results from the study to help enhance service delivery, alleviate care-related stress, and improve the quality of life of dementia patients and their caregivers. We will use a mixed-methods design to explore the challenges faced by caregivers as well as their service usage for the person living with dementia. Our methodology involves an initial telephone interview (approx. 70 minutes) that includes open-ended questions, standard items, and structured measures, followed by an 8-day semi-structured daily diary interview about daily care responsibilities and experiences with services (15-20 minutes each evening). This study will be conducted with 240 extended family members serving as one of the main caregivers for a person living with dementia in a community setting.
This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK) that is part of incorrect growth signals in histiocytosis cells. Four different groups of patients will be enrolled.
This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.
Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited palliative care (PC) clinical expertise. Secondly, although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The purpose of this study is to compare a culturally-based Tele-consult program to usual hospital care to determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized African American and White older adults with a life-limiting illness.