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HIV related Myelopathy

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121. The Kiva® System as a Vertebral Augmentation Treatment

Type : Interventional (Clinical Trial) Actual Enrollment : 300 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment Official Title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial Study Start Date : July 2010 Actual Primary Completion Date : May 2013 Actual Study Completion Date : May 2013 Resource links provided by the National Library of Medicine related topics: Arms (...) will be defined as: Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS), Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation

2010 Clinical Trials

122. Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy

Completion Date : July 2014 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Allograft Cervical Spinal Fusion with Allograft Procedure: Allograft Single Dose Allograft Surgical Implantation Other Names: Anterior Cervical Discectomy and Fusion with Allograft Cervical Spinal Fusion Control Experimental: NeoFuse Cervical Spinal Fusion with NeoFuse Biological: NeoFuse Single Dose NeoFuse Surgical (...) for the use and disclosure of personal health information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US]. Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1. Has symptomatic radiculopathy and/or myelopathy correlating to radiographic findings of duration of 6 weeks or greater that had failed to respond to non-operative management Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels

2010 Clinical Trials

123. Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease

Disease Study Start Date : March 2009 Actual Primary Completion Date : February 2013 Actual Study Completion Date : February 2013 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: PDS System Device: PDS System Percutaneous Dynamic Stabilization System Active Comparator: Fusion Device: Fusion Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws Outcome Measures Go to Primary Outcome (...) with Modic 3 bone changes at the target level(s). Spondylolisthesis > Grade 1 and/or spondylolysis at the target level(s). Subjects with myelopathy or cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence). Subjects with fixed motor deficit and/or peripheral neuropathy. Subjects with prior discectomy at the target level(s). Subjects with prior spine surgery, trauma, metastatic disease, or spinal deformity due

2009 Clinical Trials

124. Carmustine, Etoposide, Cytarabine, Melphalan, and Antithymocyte Globulin Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Autoimmune Neurologic Disease That Did Not Respond to Previous Therapy

) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases Study Start Date : June 2008 Estimated Primary Completion Date : March 31, 2020 Estimated Study Completion Date : December 1, 2021 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Treatment (immunosuppressive therapy followed by transplant) Patients receive (...) Deltacortisone Deltadehydrocortisone Deltasone Deltison Deltra Econosone Lisacort Meprosona-F Metacortandracin Meticorten Ofisolona Orasone Panafcort Panasol-S Paracort PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Predniment Prednisonum Prednitone Promifen Servisone SK-Prednisone Procedure: Syngeneic Bone Marrow Transplantation Undergo syngeneic bone marrow transplantation Outcome Measures Go to Primary Outcome Measures : Incidence of grades 4-5 regimen-related toxicity [ Time Frame

2008 Clinical Trials

125. Ciclosporin in HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)

Healthy Volunteers: No Criteria Inclusion Criteria: Early (less than 2 years) HAM Progressing (within past 3 months) HAM Important to study the effect of therapy on disease that is most active as most likely to detect and measure improvement Exclusion Criteria: HIV infection Tuberculosis, strongyloidiasis or other infection related to immune compromise Hepatitis B & C viral infections Malignancy Contacts and Locations Go to Information from the National Library of Medicine To learn more about (...) Ciclosporin in HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP) Ciclosporin in HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before

2008 Clinical Trials

126. Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Treatment FLD Device: FLD Artificial lumbar disc Active Comparator: Control Device: Control Artificial lumbar disc Outcome Measures Go to Primary Outcome Measures : Overall success will be determined by a composite of measures regarding subject self-assessment of function (disability), low back pain, neurological function and device implantation status (...) is a surgical candidate for an anterior approach to the lumbar spine (<3 abdominal surgeries). Back pain at the operative level only (by discogram, if necessary). Leg pain and/or back pain due to disc space settling, with or without radicular symptoms related to foraminal narrowing. Subject must understand and sign the written Informed Consent. Exclusion Criteria: Prior fusion at any lumbar level. Clinical evidence of adjacent lumbar segment disease. Previous trauma to the L3, L4, L5, or S1 levels

2008 Clinical Trials

127. Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients

: A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Study Start Date : May 2008 Actual Primary Completion Date : May 2010 Actual Study Completion Date : October 2011 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Cohort 1.1 100mg ofatumumab then placebo Drug: Ofatumumab 100 (...) =treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2

2008 Clinical Trials

128. Motor Neurone Disease

. There is pain (localised to the neck or radicular) and sensory disturbance. There are no bulbar symptoms and signs. The absence of UMN signs above the LMN signs increases the possibility of this diagnosis. MRI scan of the cervical spine can confirm the diagnosis. Dual pathologies: A cervical myelopathy and a co-existent peripheral neuropathy can present as a mixed upper-lower motor neurone picture. Sensory signs and symptoms and absence of bulbar symptoms help to diagnose this. Neurophysiological assessment (...) with associated . . . . . HIV-associated neuropathy/myopathy/radiculopathy (as one of the complications of HIV). Lepto-meningeal disease - eg, due to carcinomatosis or vascular collagen disease. . (Kennedy's syndrome). Hereditary polyneuropathies - eg, . Focal muscular atrophies (monomelic amyotrophy). Post-radiation myeloplexopathy. Viral plexopathies. (adult form). Investigations [ ] There are no specific investigations that will confirm a diagnosis of MND. A range of investigations is carried out

2008 Mentor

129. Abbreviations

thromboplastin time APT adaptive pacing therapy APUD amine precursor uptake and decarboxylation AR ankle reflex ARB angiotensin receptor blocker ARC AIDS-related complex ARDS acute/adult respiratory distress syndrome ARR absolute risk reduction ART assisted reproduction technique ARVC arrhythmogenic right ventricular cardiomyopathy ASD autistic spectrum disorder ASW approved social worker ASTRAL Angioplasty and Stent for Renal Artery Lesions ATC around the clock ATRA all-trans retinoic acid AVJRT (...) building-related illness BSAP bone-specific alkaline phosphatase BSE bovine spongiform encephalopathy BS MB Bachelor of Surgery and Bachelor of Medicine BSO bilateral salpingo-oophorectomy C1-INH C1-inhibitor antigenic protein Ca carcinoma CA carbohydrate antigen CABG coronary artery bypass graft CAD computer-aided detection CA-MRSA community-acquired MRSA cANCA classical antineutrophil cytoplasmic antibodies CAPD continuous ambulatory peritoneal dialysis CAPS catastrophic antiphospholipid syndrome

2008 Mentor

130. Cervical Spondylosis

of movement (forward flexion, backward extension, lateral flexion and rotation to both sides). Minor neurological changes like inverted supinator jerks (unless complicated by myelopathy or radiculopathy). Poorly localised tenderness. Radiculopathy [ ] Suspect this where there is unilateral neck, shoulder, or arm pain approximating to a dermatome. There may be accompanying changes in sensation or weakness in related muscles. NB : pain or paraesthesia radiating into the arm is a nonspecific sign for nerve (...) sweats. Unexpected weight loss. History of inflammatory arthritis, malignancy, infection, tuberculosis, HIV infection, drug dependency, or immunosuppression. Excruciating pain. Intractable night pain. Cervical lymphadenopathy. Exquisite tenderness over a vertebral body. Features suggestive of a myelopathy include: Insidious progression. Gait disturbance +/- clumsy hands. Loss of sexual, bladder or bowel function (often a late sign). Lhermitte's sign (neck flexion causes 'electric shock'-type

2008 Mentor

131. Complications of HIV Infection

/NEJMoa1011214. ; Drug susceptibility testing and pharmacokinetics question current treatment Int J Antimicrob Agents. 2012 Feb39(2):173-6. Epub 2011 Nov 17. ; Aerosolized amikacin in patients with difficult-to-treat pulmonary nontuberculous Eur J Clin Microbiol Infect Dis. 2011 Dec 25. ; Pattern of HIV-related central nervous system disorders varies by region, evolving alongside access to antiretroviral therapy, 2015. ; Neurological complications in late-stage hospitalized patients with HIV disease. Ann (...) Complications of HIV Infection Complications of HIV Infection information. Patient | Patient TOPICS Try our Symptom Checker TREATMENT RESOURCES Try our Symptom Checker PROFESSIONAL Upgrade to Patient Pro / / Search Complications of HIV Infection Authored by , Reviewed by | Last edited 4 Apr 2015 | Certified by This article is for Medical Professionals Professional Reference articles are designed for health professionals to use. They are written by UK doctors and based on research evidence, UK

2008 Mentor

132. Cost-effectiveness of epoetin and autologous blood donation in reducing allogeneic blood transfusions in coronary artery bypass graft surgery

Expectancy (DEALE) approach. The model was built using the software package DATA 3.5 for Windows (Treeage Software). Outcomes assessed in the review A range of outcome measures was identified and used in the model. The primary measure was quality-adjusted life years (QALYs). Other important measures included perioperative mortality and HIV, HBC and HCV related life expectancy and associated quality-adjusted life expectancy, the effectiveness of epoetin and combined therapy, CABG survival and QALY, acute (...) . Economic study type Cost-utility analysis. Study population A hypothetical cohort of 67 year old men undergoing CABG. The inclusion criteria were based on an experimental protocol proposed by Kyo et al (1992). The authors did not provide any additional details about health status, such as duration and severity of disease or co-morbidity. Setting The setting was secondary care. The authors do not report that the economic analysis was carried out in Italy. Dates to which data relate Effectiveness data

2000 NHS Economic Evaluation Database.

133. Intraoperative autologous transfusion (IOAT) during elective infrarenal aortic reconstruction: a decision analysis model

for hospitalization for acute hepatitis, 0.0055 for liver biopsy, 0.0385 for interferon therapy, 0.90 for symptomatic chronic hepatitis B or C (per year), 0.99 for asymptomatic chronic hepatitis B or C (per year), 0.5 for HIV infection (pre-AIDS, per year), 0.25 for AIDS (per year), 0.9 for HTLV I/II myelopathy (per year). Life expectancy values were as follows: 12.3 for AAA reconstruction, 17.63 for AIOD reconstruction; excess mortality, none for AAA and 0.059 for AIOD reconstruction, 0.0035 for chronic (...) hepatitis; 9 for HIV/AIDS. Measure of benefits used in the economic analysis QALYs and life expectancy were used as the measures of benefits in the economic analysis. Direct costs Direct health service costs were considered: the costs of the CS, allogenic packed red blood cells (PRBC), and transfusion related complications. The cost of CS included the cost of equipment, all disposable items, maintenance and dedicated personnel.1996 prices were used. Costs were reported separately. All costs that were

1997 NHS Economic Evaluation Database.

134. An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

: Interventional (Clinical Trial) Actual Enrollment : 319 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment Official Title: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation Study Start Date : January 2006 Actual Primary Completion Date : May 2014 Estimated Study Completion Date : May 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm (...) characteristics: Arm/shoulder pain, decreased flexes, decreased strength and abnormal sensation Pain level arm/shoulder >4 on 0-10 VAS Pain level neck >4 on 0-10 VAS Neck disability Index >30 Involved discs between C3 and C7 Undergoing anterior cervical fusion at a single level Failed to gain adequate relief from non-operative treatment Able and willing to give consent to participate in study Understand and read English at elementary level Exclusion Criteria: Systemic infection such as AIDS, HIV, and active

2006 Clinical Trials

135. A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis

Title: A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis Study Start Date : December 2004 Actual Study Completion Date : December 2006 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : To investigate (...) infections), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, or syphilis) History of cancer, including solid tumors and hematologic malignancies (except fully resolved and resected cutaneous basal cell and squamous cell carcinomas of the skin) History of alcohol or drug abuse within 6 months

2004 Clinical Trials

136. A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis

of Rituximab in Adults With Primary Progressive Multiple Sclerosis Study Start Date : June 2004 Actual Primary Completion Date : October 2007 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 Drug: rituximab Intravenous repeating dose Placebo Comparator: 2 Drug: placebo Intravenous repeating dose Outcome Measures Go to Primary Outcome Measures : Time to Confirmed Disease (...) , mycobacterial, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds or recurrent herpes zoster or simplex infections) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis) History of cancer, including solid tumors and hematologic

2004 Clinical Trials

137. Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: 2 Subjects randomized to the control arm of the study will have a standard vertebroplasty with any FDA-approved bone cement done in accordance with the usual method employed by the treating physician. Device: standard vertebroplasty standard vertebroplasty Experimental: 1 Subjects randomized to the experimental arm of the study will have a vertebroplasty with the SPACE CpsXL Bone cement (FDA-approved) and SPACE (...) Fractures due osteoporosis Burst fracture Pedicle fracture Neurological deficit associated with the fracture Kyphosis > 30° Translation > 4 mm Instability of posterior wall with symptomatic displacement of fragment into spinal canal or significant canal compromise Intercostal nerve compression Active systemic or local infection at the level(s) to be treated Myelopathy Uncontrolled coagulopathy Cannot temporarily discontinue anticoagulation therapy Known allergy to device materials / PMMA Radiculopathy

2007 Clinical Trials

138. Activ-Lâ„¢ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease

: Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease Study Start Date : January 2007 Actual Primary Completion Date : December 2012 Actual Study Completion Date : January 2017 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Investigational Implantation of the Activ-L Artificial Disc at one level of the lumbar spine (...) Months Relative to Baseline [ Time Frame: 24 months ] Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score. Device Success [ Time Frame: 24 months ] Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months. Absence of Serious Device Related Adverse Events [ Time Frame: 24 months

2007 Clinical Trials

139. Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI

(exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including human immunodeficiency virus [HIV]) or kidney disease; or active malignancy or any other condition as determined by history or laboratory investigation that could cause a neurological deficit including syphilis, myelopathy, clinically relevant polyneuropathy, etc. History of meningitis, meningoencephalitis, epilepsy or life-threatening allergic or immune-mediated reaction. History of or current (...) Start Date : May 2006 Actual Primary Completion Date : September 2011 Actual Study Completion Date : September 2011 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 Drug: ATI355 Outcome Measures Go to Primary Outcome Measures : Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every

2006 Clinical Trials

140. PCM Cervical Disc System

randomly assigned to be treated either with the PCM Cervical Disc or ACDF. Condition or disease Intervention/treatment Phase Radiculopathy Myelopathy Device: Anterior Cervical Discectomy and Fusion (ACDF) Device: PCM Cervical Disc Phase 3 Detailed Description: The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between (...) , or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 494 participants Allocation: Randomized Intervention

2007 Clinical Trials

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