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HIV related Myelopathy

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121. TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding

hypertension Serious cardiac or pulmonary dysfunction Renal failure Portal vein thrombosis History of organ transplantation History of HIV (human immunodeficiency viruses) infection Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410591 Locations Layout (...) Primary Completion Date : January 2016 Actual Study Completion Date : January 2016 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: 10-mm covered stent group Patients treated with 10-mm covered stent. Device: 10-mm covered stent group Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure. Active Comparator: 8-mm covered stent group Patients treated with 8

2011 Clinical Trials

122. Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases

Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases - 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 adding more. Use (...) of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases (Pentox) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01472263 Recruitment Status : Completed First Posted : November 16, 2011 Last Update Posted : March 18, 2015 Sponsor: Hospital Universitário Professor Edgard Santos Information

2011 Clinical Trials

123. Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis

Update Posted : June 5, 2018 Sponsor: GlaxoSmithKline Information provided by (Responsible Party): GlaxoSmithKline Study Details Study Description Go to Brief Summary: Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab (...) Sclerosis (RRMS) Study Start Date : November 1, 2011 Actual Primary Completion Date : August 23, 2013 Actual Study Completion Date : June 10, 2015 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 Placebo and one dose of Ofatumumab 3mg over 24 weeks Drug: Ofatumumab 3mg 3mg of investigational product Drug: Placebo Placebo Experimental: Cohort 2 Two doses of Ofatumumab

2011 Clinical Trials

124. This Study is to Determine if Degenerative Spinal Pain and Disorders Cause the Levels of Substance P to Change in a Patients Saliva, Blood and/or Cerebrospinal Fluid.

is to determine if degenerative spinal disorders such as acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot study shows a correlation between Substance P levels and pain associated with degenerative spinal disorders, then a larger study will be initiated to determine the feasibility of using Substance P levels in the diagnosis and treatment of degenerative spinal disease. Condition (...) or disease Intervention/treatment Spinal Disease Spinal Radiculopathy Myelopathy Neurogenic Claudication Other: treatment plan Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 53 participants Observational Model: Case-Control Time Perspective: Prospective Official Title: Substance P Neuropeptide Levels in Saliva, Serum and Cerebrospinal Fluid in Patients With Spinal Disease: A Pilot Study Study Start Date : July 2009 Actual Primary Completion Date

2011 Clinical Trials

125. Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine

ISO 14155, where applicable on clinical investigation of medical devices for human subjects and other legal requirements. Condition or disease Intervention/treatment Phase Lower Back Pain Device: Elaspine™ Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 40 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: "Elaspine™ Implant System Post (...) Marketing Clinical Study: A Prospective, Multicentre Study to Evaluate the Safety and Performance of the Elaspine™ System in the Surgical Treatment of Degenerative Lumbar Spine" Study Start Date : August 2010 Actual Primary Completion Date : June 2015 Actual Study Completion Date : June 2015 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Elaspine™ Impantation of Elaspine™ device Device: Elaspine™

2011 Clinical Trials

126. AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors

transplant, including any patient known to have hepatitis C, or human immunodeficiency virus (HIV) will be excluded. Patients with HIV who have adequate CD4 count, not requiring antiretroviral medication, may be enrolled. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. Inability to swallow capsules, since capsules cannot be crushed or broken. Inability to undergo MRI and/or contraindication for MRI examinations following (...) ) Primary Purpose: Treatment Official Title: A Phase I/II Study of the Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor Selumetinib (AZD6244; HYD Sulfate) in Children With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN) Actual Study Start Date : September 21, 2011 Estimated Primary Completion Date : September 10, 2020 Estimated Study Completion Date : July 2, 2024 Resource links provided by the National Library of Medicine related topics: related topics: resources

2011 Clinical Trials

127. 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

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

of spinal instrumentation. Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process. Has a positive screen for human immunodeficiency virus (HIV) antibodies. Has had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 2-year follow-up period. Has been a recipient (...) : March 2013 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: NeoFuse Anterior Cervical Discectomy and Fusion with NeoFuse Procedure: NeoFuse Single Dose NeoFuse Surgical Implantation Other Names: Anterior Cervical Discectomy and Fusion with NeoFuse Cervical Spinal Fusion Adult Stem Cells Active Comparator: MasterGraft Granules Anterior Cervical Discectomy and Fusion with MasterGraft Granules Procedure

2010 Clinical Trials

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

history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process. Has a positive screen for human immunodeficiency virus (HIV) antibodies. has had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 2-year follow-up period. Has been a recipient of prior stem cell/progenitor cell therapy for spinal (...) 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

2010 Clinical Trials

130. 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

131. Cost-effectiveness of transfusion of platelet components prepared with pathogen inactivation treatment in the United States

of being infected (as a result of transfusion) with human immunodeficiency virus, hepatitis B or C, human T-cell lymphotropic virus (HTLV-1) or bacteria. The seven disease outcomes of transfusion-related sequelae in the model were: AIDS-related complex/acquired immune deficiency syndrome, chronic hepatitis, cirrhosis, hepatocellular carcinoma, fulminant hepatitis, adult T-cell lymphoma/HTLV-1 associated myelopathy, and death. Study designs and other criteria for inclusion in the review The review (...) of reducing donor exposures with single-donor versus pooled random-donor platelets. Transfusion 1999;39:925-32. Indexing Status Subject indexing assigned by NLM MeSH Bacterial Infections /prevention & Cost-Benefit Analysis; Health Care Costs; Humans; MEDLINE; Platelet Transfusion /adverse effects /economics /mortality; Risk Assessment; Safety; Sensitivity and Specificity; Sterilization /economics /standards; Treatment Outcome; United States /epidemiology; Virus Diseases /prevention & control /transmission

2003 NHS Economic Evaluation Database.

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 (...) & Feasibility Studies; Health Care Costs; Humans; Male; Models, Theoretical; Preoperative Care /economics; Recombinant Proteins /administration & Safety; Virus Diseases /economics /transmission; dosage /economics /pharmacology; dosage /economics /pharmacology; numerical data AccessionNumber 22000001074 Date bibliographic record published 31/07/2001 Date abstract record published 31/07/2001 NHS Economic Evaluation Database (NHS EED) Produced by the Centre for Reviews and Dissemination Copyright © 2019

2000 NHS Economic Evaluation Database.

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

reconstruction. Outcomes assessed in the review The main health outcomes considered were: operative death, transfusion reaction (fatal, non-fatal), transfusion infections (hepatitis C, B, HIV, Human T cell lymphotropic virus (HTLV) types I/II), transfusion infection outcome (fulminant hepatitis, hospitalisation acute hepatitis, symptom acute hepatitis, hepatitis C resolve, symptomatic chronic hepatitis C, hepatitis B resolve, symptomatic chronic hepatitis B, chronic active hepatitis B or C, interferon (...) 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

1997 NHS Economic Evaluation Database.

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

of encephalopathy or myelopathy (e.g., syphilis, Lyme disease, human T-cell lymphotropic virus type 1 [HTLV-1], herpes zoster myelopathy) Neuromyelitis optica History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, antiphospholipid antibody syndrome, Sjogren�s syndrome, Behcet disease) History or presence of sarcoidosis Relapse within 30 days prior to randomization Previous treatment with rituximab (MabThera(R)/Rituxan(R)) Treatment with any (...) 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

2004 Clinical Trials

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

., cerebral contusion, spinal cord compression) History of intracranial or intraspinal tumor (e.g., meningioma, glioma) History or presence of potential metabolic cause of myelopathy or encephalopathy (e.g., vitamin B12 deficiency, thyroid abnormalities) History or presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-cell lymphotropic virus type 1 [HTLV-1], or herpes zoster myelopathy) History of genetically inherited progressive CNS degenerative disorder (e.g., X-linked (...) 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

2004 Clinical Trials

136. 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

enrolled on this protocol proven by ABO typing, human leukocyte antigen (HLA) typing and variable number tandem repeat (VNTR) analysis to be syngeneic with the patient (e.g. identical twin) DONOR: Willing to undergo multiple apheresis procedures (except donors < 12 years who will undergo bone marrow harvests) Exclusion Criteria: Pregnancy or expressed plans to become pregnant within 1 year of the procedure Patients who are serologically positive for human immunodeficiency virus (HIV) Patients (...) Gait Ataxia with Late age Onset Polyneuropathy (GALOP) Stiff Person Syndrome Chronic Inflammatory Demyelinating Polyneuropathy Myasthenia Gravis Lambert-Eaton myasthenic syndrome Human T-cell lymphotropic virus (HTLV)-1-associated myelopathy (HAM) / tropical spastic paraparesis (TSP) Opsoclonus / myoclonus (anti-Ri) Neuromyelitis optica Multiple sclerosis (only patients with relapsing/remitting multiple sclerosis [MS] will be included) Other central or peripheral nervous system autoimmune diseases

2008 Clinical Trials

137. Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury

mellitus within 6 months of SCI Known immunodeficiency, including human immunodeficiency virus or use of immunosuppressive or cancer chemotherapeutic drugs Body mass index (BMI) of ≥40 kg/m2 at screening (Appendix B includes a table for height and weight to calculate BMI) Contacts and Locations Go to No Contacts or Locations Provided More Information Go to Layout table for additonal information Responsible Party: BioAxone BioSciences, Inc. ClinicalTrials.gov Identifier: Other Study ID Numbers: ALSE-C (...) myelopathy Subjects with moderate to severe traumatic brain injury with a Glasgow Coma Scale score of less than 14 History of multiple sclerosis or other neuromuscular disorder History of an adverse reaction to a fibrin sealant or its human or bovine components Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease History of cancer (except for basal cell carcinoma) Hemophilia or other bleeding abnormality Ankylosing spondylitis Use of insulin therapy to control diabetes

2008 Clinical Trials

138. 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

139. 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

140. 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

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