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HIV related Myelopathy

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101. Primary CNS Lymphoma (Diagnosis)

30 cells/µL. Virtually all PCNSLs in patients with AIDS express an Epstein-Barr virus (EBV)-related genome. PCNSL is less frequently associated with EBV in patients without AIDS. The overwhelmingly common risk factor for PCNSL related to human immunodeficiency virus (HIV) infection is intravenous (IV) drug abuse. Corboy et al reported that 56% of a group of immunocompetent and immunocompromised patients had human herpes virus 8 (HHV-8) in their tumors. This is the same herpes virus (...) infected with HIV, and the incidence is expected to rise as patients with low CD4 + counts survive longer. Similar trends toward rising frequency of diagnosis of PCNSL are reported internationally. Sex predilection Among immunocompetent patients with PCNSL, males outnumber females by approximately 2:1. Almost 95% of HIV-infected patients with PCNSL are males. Age predilection The median age of immunocompetent patients with PCNSL is 55 years. The median age of HIV-infected patients with PCNSL is 35

2014 eMedicine.com

102. Somatosensory Evoked Potentials: Clinical Applications (Diagnosis)

in the course of the disease, when distal conduction and F-wave studies may be normal Chronic acquired demyelinating neuropathies Infectious causes (eg, HIV) Toxic neuropathies Focal neuropathy The test of choice in focal neuropathy is standard NCSs. Entrapment neuropathies, such as carpal tunnel syndrome, may be found incidentally when SEPs are recorded. The use of SEP for detection of saphenous neuropathy, intercostal neuropathy, and trigeminal neuropathy has been reported. However, standard NCSs (...) fusion and found SSEP to be a highly sensitive and specific test. Data also showed that iatrogenic spinal cord injury resulting in new neurological deficits was 340 times more likely to have changes in SSEP compared to those without any new deficits. [ ] Conditions for which SEPs might be useful See the list below: Subacute combined degeneration and myelopathy , to evaluate the effect of spinal cord compression Hereditary spastic paraplegia Transverse myelitis - Lower-limb SEPs produce a higher yield

2014 eMedicine.com

103. Primary CNS Lymphoma (Treatment)

30 cells/µL. Virtually all PCNSLs in patients with AIDS express an Epstein-Barr virus (EBV)-related genome. PCNSL is less frequently associated with EBV in patients without AIDS. The overwhelmingly common risk factor for PCNSL related to human immunodeficiency virus (HIV) infection is intravenous (IV) drug abuse. Corboy et al reported that 56% of a group of immunocompetent and immunocompromised patients had human herpes virus 8 (HHV-8) in their tumors. This is the same herpes virus (...) infected with HIV, and the incidence is expected to rise as patients with low CD4 + counts survive longer. Similar trends toward rising frequency of diagnosis of PCNSL are reported internationally. Sex predilection Among immunocompetent patients with PCNSL, males outnumber females by approximately 2:1. Almost 95% of HIV-infected patients with PCNSL are males. Age predilection The median age of immunocompetent patients with PCNSL is 55 years. The median age of HIV-infected patients with PCNSL is 35

2014 eMedicine.com

104. Teriflunomide

in the United States 14 2.4 Important Safety Issues with Consideration to Related Drugs 14 2.5 Summary of Presubmission Regulatory Activity Related to Submission 16 2.5.1 May 28, 2004 Clinical Hold of IND 16 2.5.2 November 12, 2004 End of Phase 2 meeting (EoP2) 17 2.5.3 August 2, 2005 Teleconference 18 2.5.4 June 27, 2006 Full Clinical Hold of IND 19 2.5.5 June 5, 2007 Response to sponsor’s questions in lieu of meeting 21 2.5.6 September 28, 2007 Correspondence regarding HIV issue 21 2.5.7 September 1, 2010 (...) a documented increase in LFTs (ALT 10 X ULN, AST 6.4 X ULN, Bili 1.2 X ULN) on Day 141 of treatment with 7 mg/day. Drug was discontinued on Day 143, and she underwent a washout procedure with cholestyramine from Day 147-157. Her LFTs increased to ALT 23 X ULN, AST 12.3 X ULN, and GGT 5.5 x ULN on Day 160. She was also reportedly icteric. She recovered on Day 189; viral serologies were negative. The increased incidence of Blood disorders was primarily related to mild neutropenia (with or without lymphopenia

2012 FDA - Drug Approval Package

105. Raltegravir for HAM/TSP

(NINDS) ) Study Details Study Description Go to Brief Summary: Background: - Human T-cell lymphotropic virus type 1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) is an infection of the spinal cord. The infection is caused by a virus that has been known to cause cancers like leukemia and lymphoma. It causes a weakening of the legs. Researchers want to see if raltegravir, a drug for treating human immunodeficiency virus (HIV), can be used to treat HAM/TSP. They will see if the drug can (...) wish to determine the effects of Raltegravir, a clinically approved HIV-1 integrase inhibitor, on HTLV-1 proviral load (PVL) in patients with HTLV-1 associated myelopathy / tropical spastic paraparesis (HAM/TSP). We will also provide safety and tolerability information on Raltegravir use in this condition and examine the correlation of immune activation markers in HAM/TSP with the effects of Raltegravir on the PVL. Study population: HAM/TSP, a relentlessly progressive and disabling myelopathy

2013 Clinical Trials

106. Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis

Study Start Date : February 2013 Actual Primary Completion Date : September 2014 Actual Study Completion Date : September 2014 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: GSK239512 Arm GSK239512 once daily orally, started at 10 mcg and titrated to the maximum tolerated dose, Up to the highest dose of 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week (...) to AEs [ Time Frame: Up to Week 50 ] Safety and tolerability as assessed by summary of suicide behavior and ideation risk as assessed by the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) [ Time Frame: Up to Week 50 ] Safety and tolerability as assessed by summary of suicide behavior and ideation risk as assessed by Possible Suicidality Related Adverse Event (PSRAE) [ Time Frame: Up to Week 50 ] Safety and tolerability as assessed by change from baseline in clinical chemistry, hematology

2013 Clinical Trials

107. Abnormal Gait and Balance Causes in the Elderly

Administration 4 Abnormal Gait and Balance Causes in the Elderly Abnormal Gait and Balance Causes in the Elderly Aka: Abnormal Gait and Balance Causes in the Elderly From Related Chapters II. Causes: Psychiatric Disorders Disorders III. Causes: Cardiovascular Disorders Arrhythmia IV. Causes: Infectious Disorders Induced (HIV-related ) V. Causes: Metabolic Disorders and VI. Causes: Musculoskeletal Disorders VII. Causes: Neurologic Disorders Cerebellar Degeneration Myelopathy Normal-pressure Vestibular (...) disorders VIII. Causes: Miscellaneous Hearing Medications IX. References Images: Related links to external sites (from Bing) These images are a random sampling from a Bing search on the term "Abnormal Gait and Balance Causes in the Elderly." Click on the image (or right click) to open the source website in a new browser window. Related Studies (from Trip Database) Related Topics in Motor Disorders About FPnotebook.com is a rapid access, point-of-care medical reference for primary care and emergency

2015 FP Notebook

108. 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

109. 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 (...) and replication in culture using concentrations achievable with the approved dose used in HIV-1 infected patients. Currently, no treatment is recommended for asymptomatic infected individuals. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 0 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

2012 Clinical Trials

110. 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 (...) provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: C1-esterase inhibitor (Cinryze) This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2

2012 Clinical Trials

111. 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

112. 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 (...) the severity of infection with hepatitis C and effectiveness of treatment. By analogy with hepatitis C, a Spanish (Treviño et al., 2012) examined this SNP(single nucleotide polymorphism) in 12 patients TSP / HAM and 29 asymptomatic HIV-positive. CT or TT genotype was statistically more frequent in the group TSP / HAM than in asymptomatic patients (80% versus 20%) and was associated with HTLV-1 proviral load higher. We propose a broader group of patients in our population and Afro-Caribbean, to confirm

2012 Clinical Trials

113. 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

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

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™ (...) Implantation of device Outcome Measures Go to Primary Outcome Measures : Safety [ Time Frame: 24 months ] Incidence (including severity) of operative and post-operative complications throughout the first 3 months postoperatively by category (general, operative, post-operative, possibly device related etc.) Performance [ Time Frame: 24 months ] Defined as the incidence of device complications and device malfunctions (including severity), as assessed by radiographic evaluation throughout the first 12 months

2011 Clinical Trials

115. AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors

) 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 (...) that cannot be surgically completely removed without risk for substantial morbidity due to encasement of, or close proximity to, vital structures, invasiveness, or high vascularity of the PN. The PN has to cause (stratum 1) or have the potential to cause (stratum 2) significant morbidity, such as (but not limited to) head and neck lesions that could compromise the airway or great vessels, paraspinal lesions that can cause myelopathy brachial or lumbar plexus lesions that could cause nerve compression

2011 Clinical Trials

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

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 (...) -mm covered stent. Device: 8-mm covered stent group Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure. Outcome Measures Go to Primary Outcome Measures : Incidence of shunt dysfunction. [ Time Frame: 2 years ] Secondary Outcome Measures : Incidence of variceal rebleeding [ Time Frame: 2 years ] Incidence of hepatic encephalopathy [ Time Frame: 2 years ] Survival [ Time Frame: 2 years ] Incidence of hepatic myelopathy [ Time Frame: 2 years

2011 Clinical Trials

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

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 (...) with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML (see Appendix 4, Section 11.4, for PML monitoring algorithm). Subjects whom experience a relapse during the Screening Phase. These subjects may be eligible for re-screening after consultation with GlaxoSmithKline (GSK). History of clinically significant Central Nervous System (CNS) trauma (e.g. traumatic brain injury, cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk

2011 Clinical Trials

118. 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

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

associated myelopathy/ tropical spastic paraparesis (HAM/TSP). Although only 5% of HTLV-infected individuals will develop HAM/TSP, the investigatorts have observed that about 30% have neurological complaints and/or neurogenic bladder associated with HTLV-1. The immunopathogenesis of those diseases is related to the exaggerated immune response with high production of cytokines and induced neurological injury. So far there is not any effective drug against HTLV-1 and modulation of the immune response can (...) limitations. Co-infection with Hepatitis B or C, Syphilis, Chagas Disease or HIV Use of immunossupressive drugs Immune disease Pregnancy 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): NCT01472263 Locations Layout table for location information Brazil

2011 Clinical Trials

120. Complications of Transfusion

circulatory overload Transfusion-related acute lung injury (TRALI) Other complications include Allergic reactions Altered oxygen affinity Delayed hemolytic transfusion reaction Infections Post-transfusion purpura Early recognition of symptoms suggestive of a transfusion reaction and prompt reporting to the blood bank are essential. The most common symptoms are chills, rigor, fever, dyspnea, light-headedness, urticaria, itching, and flank pain. If any of these symptoms (other than localized urticaria (...) When HLA-matched components, excluding stem cells, are transfused Treatment with corticosteroids and other immunosuppressants, including those used for solid organ transplantation, is not an indication for blood irradiation. Transfusion-associated circulatory overload Although transfusion-associated circulatory overload is underrecognized and underreported, recently it has been recognized as the most common cause of transfusion-related deaths reported to the FDA ( ). The high osmotic load of blood

2013 Merck Manual (19th Edition)

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