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HIV related Myelopathy

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121. Restore CLINICAL TRIAL

Cervical Radiculopathy Actual Study Start Date : May 2014 Estimated Primary Completion Date : June 2019 Estimated Study Completion Date : June 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: M6-C Artificial Cervical Disc Device: M6-C Artificial Cervical Disc Total disc replacement Active Comparator: Anterior Cervical Discectomy and Fusion Device: Anterior plate system with corticocancellous allograft (...) : Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months ] Evaluate the Neck and Arm pain VAS, health-related quality of life SF-36, surgery outcomes, patient satisfaction and quantitative and qualitative radiographic assessments Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision

2012 Clinical Trials

122. C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation

C. Previous serious opportunistic or atypical infections. History of positive serology for hepatitis B. Prior history, or suspicion, of tuberculosis (TB) History of positive serology for HIV. History of clinically significant CNS trauma (e.g. traumatic brain injury, cerebral contusion, spinal cord compression). History or presence of myelopathy due to spinal cord compression by disc or vertebral disease. Past or current history of medically significant adverse effects (including allergic (...) Sponsor: Michael Levy Collaborator: ViroPharma Information provided by (Responsible Party): Michael Levy, Johns Hopkins University Study Details Study Description Go to Brief Summary: The overall objective is to evaluate the tolerability/safety and preliminary efficacy of CINRYZE® (C1 esterase inhibitor [human]) as add-on therapy for treatment of acute optic neuritis and/or transverse myelitis in NMO and NMOSD. Primary Objective: To evaluate the safety and tolerability of 3-5 doses of 1000 - 2000

2012 Clinical Trials

123. Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1

: Laboratoire Cerba Information provided by (Responsible Party): University Hospital Center of Martinique Study Details Study Description Go to Brief Summary: Only 5 to 10% of patients infected with HTLV-1 develop a disease related to infection. The two most serious diseases are adult T-cell leukemia (ATL) and Tropical spastic paraparesis /HTLV-I-associated myelopathy (TSP / HAM). Factors influencing the development of TSP / HAM in the individual HTLV-1 are not yet completely understood. Patients TSP / HAM (...) have a HTLV-1 proviral load (amount of virus) that is 6-10 times higher than seropositive asymptomatic. Various studies have shown that the development of TSP / HAM in the subject HTLV-1 and its rapid evolution is partly attributed to the failure of the immune system that regulates viral replication and expression. It has recently been shown that different versions of Single Nucleotide (human leukocyte antigen) rs12979860, located upstream of the gene for Interleukin 28B (IL28B), influenced

2012 Clinical Trials

124. Proton Radiation for Lymphoma Involving Mediastinum

: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Pilot Study Evaluating the Use of Proton Radiation for Treatment of Lymphoma Involving the Mediastinum Actual Study Start Date : February 2013 Actual Primary Completion Date : October 2016 Actual Study Completion Date : February 2017 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Proton Radiation (...) pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia. Data is shown as the number of participants that experienced the given toxicities. Late Toxicities [ Time Frame: 5 years ] Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers. 6-Month Overall Survival [ Time Frame: 6 Months ] The number of participants surviving six months

2012 Clinical Trials

125. Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS)

Start Date : September 2012 Actual Primary Completion Date : January 2014 Actual Study Completion Date : June 2014 Resource links provided by the National Library of Medicine related topics: related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Intrathecal autologous stem cells Intrathecal stem cells will be administered to patients that fulfill the inclusion criteria. Biological: Intrathecal autologous stem cell Mobilization and collection of stem cells (...) Inclusion Criteria: patients with a confirmed diagnosis of ALS according to El Escorial criteria. Diagnosis-time less than four years. Over 18 years old. Forced vital capacity ≥ 40%. One year of evolution. Adequate nutritional state Exclusion Criteria: Severe bulbar ALS involucre. Inadequate nutritional status. Spondylotic myelopathy, or abnormalities in imaging study. Having concomitant neurological or psychiatric disease. Systemic disease with poor-control. History of treatment with steroids

2012 Clinical Trials

126. Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

gene expression, and sites of viral integration. Condition or disease Intervention/treatment Phase Human T-cell Leukemia Virus Type 1 Infection Drug: Raltegravir Phase 2 Detailed Description: About 5% of HTLV-1 infected individuals develop lymphoma or myelopathy. High levels of virus replication are predictive of disease development. HTLV-1 exhibits lower levels of variation than HIV-1, suggesting that drug resistance is less likely to occur. Raltegravir was shown to inhibit HTLV-1 integration (...) : Merck Sharp & Dohme Corp. Information provided by (Responsible Party): Washington University School of Medicine Study Details Study Description Go to Brief Summary: This is a study of the effect of raltegravir on human T-cell leukemia virus type 1 (HTLV-1) viral load in asymptomatic patients. The study will enroll 14 subjects for a period of 2 months of treatment and 1 month of followup. The study will assess the effect of raltegravir on virus load in peripheral blood lymphocytes, level of virus

2012 Clinical Trials

127. 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

128. 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

129. 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

130. 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

131. 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

132. 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

133. Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)

Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect) Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect) - 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. Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect) (CSM-Protect) 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: NCT01257828 Recruitment Status : Completed First Posted : December 10, 2010 Last Update Posted : November 2, 2018 Sponsor

2010 Clinical Trials

134. 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

135. 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

136. 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

137. 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.

138. 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.

139. 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.

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

=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE. Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml) [ Time Frame: Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104) ] Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure (...) : 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

2008 Clinical Trials

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