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Endocrine Manifestations of HIV


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161. Lemtrada - alemtuzumab

Lemtrada - alemtuzumab 27 June 2013 EMA/563018/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Lemtrada International non-proprietary name: ALEMTUZUMAB Procedure No. EMEA/H/C/003718/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail (...) CHMP: Committee for Medicinal Products for Human Use CI: confidence interval CIS: clinically isolated syndrome CMV: cytomegalovirus CT: computed tomography CTD: common technical document CYP: cytochrome P450 DMT: disease-modifying therapies EAE: experimental autoimmune encephalomyelitis EDSS: expanded disability status scale EMA: European Medicines Agency EQ-5D: EuroQoL FIS: Fatigue Impact Scale FS: functional score GA: glatiramer acetate Gd: gadolinium HLT: high level term IC50: half maximum

2013 European Medicines Agency - EPARs

162. Otrexup (methotrexate) auto-injector

--------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- SNEZANA TRAJKOVIC 10/11/2013 TATIANA OUSSOVA 10/11/2013 Reference ID: 3389420 MEDICAL OFFICER - MEMO TO FILE Date: September 26, 2013 Subject: Labeling issues for NDA 204824, Otrexup (methotrexate) for Injection From (...) administered SC in either the abdomen or the thigh and the approved injectable product administered with a needle and syringe either by the SC or IM route. 5. The applicant also performed an actual use labeling study (MTX-11-002) and a labeling and human factors study (MTX-11-004) to support the labeling and use of the proposed product, demonstrating that patients and caregivers could be taught to successfully use the product. These studies were requested by our CDRH colleagues. Labeling Issues Background

2013 FDA - Drug Approval Package

163. Tasimelteon (Hetlioz)

Additional Safety Evaluations 136 7.6.1 Human Carcinogenicity 136 7.6.2 Human Reproduction and Pregnancy Data 137 7.6.3 Pediatrics and Assessment of Effects on Growth 137 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound 137 7.7 Additional Submissions 140 8 POSTMARKET EXPERIENCE 143 9 APPENDICES 143 9.1 Literature Review/References 143 9.2 Labeling Recommendations 144 9.3 Advisory Committee Meeting 144 Reference ID: 3415078Clinical Review Devanand Jillapalli, MD NDA 205677 (Priority (...) . Tasimelteon does not adversely affect other metabolic or endocrine laboratory parameters. Tasimelteon is not associated with adverse changes in electrocardiogram or cardiac-related adverse events. Overall, the potential for an adverse effect of tasimelteon on cardiac repolarization is low based on available data which are sufficient for such a determination. Tasimelteon does not have adverse effects on vital signs. Reviewer’s overall benefit-risk assessment: The efficacy for tasimelteon in the treatment

2013 FDA - Drug Approval Package

165. Realising the potential of stratified medicine

received subsequent approval for use in HER2-positive gastric cancer. HIV Ziagen (abacavir) GSK/viiv Healthcare HLA-B*57:01 screening assay Dec 1998 n/A: unbranded test Jul 1999 n/A: unbranded test Action of HIv's reverse transcriptase enzyme is critical to the replication of the virus. Abacavir is a nucleoside reverse transcriptase inhibitor (nRTI) with activity against Human Immunodeficiency virus Type 1 (HIv-1). Serious and sometimes fatal hypersensitivity reactions have been associated (...) on the findings of the 2007 symposium, which confirmed the advantages of stratified medicine. Stratification represents a more targeted approach to therapy, with the potential for greater efficacy of treatments and minimisation of their side effects. For example, stratification means that the 2–9% of patients who test positive for a particular genetic biomarker of hypersensitivity to Ziagen (abacavir, an HIv nucleoside reverse transcriptase inhibitor) are no longer prescribed this medication. Decreases both

2013 Academy of Medical Sciences

166. Childhood Hodgkin Lymphoma Treatment (PDQ®): Health Professional Version

immunodeficiencies.[ ] The risk of Hodgkin lymphoma increases as much as 50-fold over the general population in patients with autoimmune lymphoproliferative syndrome.[ ] Although it is not an AIDS-defining malignancy, the incidence of Hodgkin lymphoma appears to be increased in HIV-infected individuals, including children.[ , ] Compared with the general population, the risk of Hodgkin lymphoma is increased in recipients of solid organ transplant who are maintained on chronic immunosuppressive medications (...) immunodeficiency. Am J Pediatr Hematol Oncol 9 (2): 189-92, 1987. [ ] Straus SE, Jaffe ES, Puck JM, et al.: The development of lymphomas in families with autoimmune lymphoproliferative syndrome with germline Fas mutations and defective lymphocyte apoptosis. Blood 98 (1): 194-200, 2001. [ ] Biggar RJ, Jaffe ES, Goedert JJ, et al.: Hodgkin lymphoma and immunodeficiency in persons with HIV/AIDS. Blood 108 (12): 3786-91, 2006. [ ] [ ] Biggar RJ, Frisch M, Goedert JJ: Risk of cancer in children with AIDS. AIDS

2017 PDQ - NCI's Comprehensive Cancer Database

167. Management of Stable Coronary Artery Disease

; (iii) those who report symptoms for the ?rst time and are judged to already be in a chronic stable condition (for instance because history-taking reveals that similar symptoms were already present for several months). Hence, SCAD de?nes the different evolutionary phases of CAD, excluding the situations in, which coronary artery thrombosis dominates clinical presentation (acute coronary syn- dromes). However, patients who have a ?rst or recurrent manifestation of angina but can be categorized (...) . Naturalhistoryandprognosis In many patients, early manifestations of CAD are endothelial dys- function and microvascular disease. Both are associated with an increased risk of complications from CAD. 20– 22 Contemporary data regarding prognosis can be derived from clin- ical trials of anti-anginal and preventive therapy and/or revasculariza- tion, although these data are biased by the selected nature of the populations studied. From these, estimates for annual mortality rates range from 1.2–2.4% per annum, 23– 28

2013 European Society of Cardiology

168. Candida - oral

of conditions, including: Haematological cancer (for example acute leukaemia). Chemotherapy and radiotherapy (for the treatment of cancer). HIV infection and AIDS. Recent or concurrent use of drugs that promote candidal growth, particularly broad spectrum antibiotics and inhaled or oral corticosteroids. Diabetes mellitus (types 1 and 2) — chronic hyperglycemia is associated with impaired wound healing and higher susceptibility to infections. Other endocrine disorders or disturbances, including undiagnosed (...) Candida - oral Candida - oral - NICE CKS Share Candida - oral: Summary Candida is a yeast-like fungus which is part of the normal commensal flora of the human gastrointestinal tract. Colonization with Candida is usually asymptomatic. However, if mucosal barriers are disrupted or defences lowered, it can cause infections ranging from non-life threatening superficial mucocutaneous disorders to invasive disseminated disease involving multiple organs. Oral candidiasis is most commonly caused

2017 NICE Clinical Knowledge Summaries

169. Candida - skin

Candida - skin Candida - skin - NICE CKS Share Candida - skin: Summary Candida is a yeast-like fungus which is part of the normal commensal flora of the human gastrointestinal tract and the vagina. It is not part of the normal skin flora, but there may be transient colonization of fingers or body folds. Colonization with Candida is usually asymptomatic. However, if mucosal barriers are disrupted or defences lowered, it can cause infections ranging from non-life threatening superficial (...) mucocutaneous disorders to invasive disseminated disease involving multiple organs. Candida albicans is the most common species that can cause infection in humans. Candidal skin infections are common and are more likely to occur where skin rubs on skin (such as between skin folds) and where heat and moisture lead to maceration and inflammation. The diagnosis of candidal skin infection is usually made as a result of typical presenting clinical features; investigations are usually unnecessary. An underlying

2017 NICE Clinical Knowledge Summaries

170. Corticosteroids - oral

glucocorticoids decrease the synthesis of type I and type III collagen in human skin in vivo, whereas isotretinoin treatment has little effect [ ] and a drug reference database [ ]. Corticosteroids affect the integrity of wounds by inhibiting inflammation, cross-linking of collagen fibres, and collagen synthesis. This delays wound healing [ ]. Impaired tissue repair and immune function can lead to delayed wound healing and susceptibility to infection [ ]. The recommendations for people with other pre-existing (...) , which are: Endocrine — adrenal insufficiency, weight gain, and diabetes mellitus (new-onset, or worsening of blood glucose control in existing diabetes mellitus). Gastrointestinal — peptic ulceration with perforation and haemorrhage, dyspepsia, abdominal distension, and oesophageal ulceration; especially in . Psychiatric — confusion, irritability, delusions and suicidal thoughts early in treatment and especially with high doses. Musculoskeletal — osteoporosis and proximal myopathy. Ophthalmic

2017 NICE Clinical Knowledge Summaries

171. Glybera - alipogene tiparvovec

serotype 2 AMT Amsterdam Molecular Therapeutics bp base pairs BVDV Bovine viral diarrhoea virus, BWP Biotechnology Working Party CAL Cells at limit of or beyond the maximum level used for production cap capsid CAT Committee for Advanced Therapy Medicinal Products CHMP Committee for Human Medicinal Products CM chylomicrons CMV cytomegalovirus CPK creatine phosphokinase CPV Canine Parvovirus CSA ciclosporin A CYP cytochrome P450 DNA deoxyribonucleic acid DP Drug Product DS Drug Substance ELISA Enzyme (...) copies (gc) of alipogene tiparvovec (AAV1-LPL S447X ) in 1ml of a phosphate based formulation buffer containing 5% sucrose. Glybera is to be administered once at multiple sites intramuscularly at a dose of 1 x 10 12 gc per kg body weight. 2.2.2. Active Substance General Information Nomenclature The drug substance is Alipogene tiparvovec. The scientific name of the drug product is recombinant adeno- associated virus serotype 1 (AAV1) vector expressing the S447X variant of the human lipoprotein lipase

2012 European Medicines Agency - EPARs

172. Teriflunomide

. For these reasons, the human data do not, and cannot, be understood to mean that teriflunomide is not teratogenic in people. Therefore, it must still be considered a presumptive significant human teratogen, and should be classified as Pregnancy Category X. The review team has recommended that the sponsor perform several studies as Post Marketing Requirements (PMRS): 1) Pregnancy Registry 2) A drug interaction study with rosuvastatin, because it is a substrate for the transporters BCRP and OAT3, both of which (...) are inhibited by teriflunomide. 3) A Pediatric study required by PREA. I agree that these studies should be requested. For the reasons given above, we recommend that the NDA be approved. Russell Katz, M.D. Reference ID: 3185084 (b) (4)--------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature

2012 FDA - Drug Approval Package

173. Mass Balance Study With MT-7117

at each visit. 7. Has a positive hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) result at Screening. 8. Clinically significant abnormal 12-lead ECG findings, including subjects with corrected QT interval using Fridericia's formula (QTcF) of >450 ms, or presence of atrial fibrillation or other significant arrhythmia at Screening or Day -1, confirmed by repeat assessment. 9. Any surgical or medical (...) and the Investigator, the medication will not interfere with the objectives of the study or compromise the subject's safety (Note: The use of acetaminophen [2 g/day for up to 3 consecutive days] will be permitted from Screening and during the study). 4. Clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic (including Gilbert's syndrome), respiratory, gastrointestinal or renal disease, diabetes mellitus (type I and II), coronary heart disease, hypertension, or significant history

2018 Clinical Trials

174. The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects

screen (including cotinine) at Screening or Check-in, or positive alcohol breath test at Check-in. Positive hepatitis panel and/or positive human immunodeficiency virus test. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing. Use or intend to use any prescription or nonprescription medications/products, including St. John抯 wort, vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations (...) : Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). Fasting blood glucose >110 mg/dL (confirmed with repeat testing). History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee

2018 Clinical Trials

175. Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia

, drug and/or significant active alcohol abuse Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) Known hypersensitivity to GEM333 excipients Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance) Incapability of understanding purpose and possible consequences of the trial Patients who should not be included according to the opinion of the investigator Contacts (...) . Male patients must also practice a highly effective method of birth control. Able to give written informed consent Weight ≥ 45 kg Exclusion Criteria: Acute promyelocytic leukemia (t15;17) Manifestation of AML in central nervous system Leukocytosis > 10 Gpt/L Cardiac disease: i.e. heart failure NYHA III or IV; unstable coronary artery disease (Myocardial Infarction more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

2018 Clinical Trials

176. Effect of BIA 5 1058 on Cardiac Repolarization

mL) of spirits. Positive alcohol breath test result, positive urine cotinine test, or positive urine drug screen (confirmed by repeat) at Screening or Period 1 Check-in. Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects whose results are compatible with prior immunization may be included at the discretion of the Investigator. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior (...) abnormalities in 12-lead ECG rate, rhythm, or conduction at Screening or Period 1 Check-in. Females will not be pregnant (negative pregnancy test at Screening and Period 1 Check in) or lactating, and females of childbearing potential and males will agree to use contraception. Able to comprehend and willing to sign an ICF before any study procedure and to abide by the study restrictions. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic

2018 Clinical Trials

177. Lentiviral Gene Therapy for X-ALD

of the MRI to examine the damage on the CNS. Neurological function score (NFS) ≥ 1 Parent / guardian / patient signing informed consent Patients and their families have a strong willingness to participate in clinical trials, and are willing to bear all the consequences caused by the failure of the trial, and sign an informed consent form Exclusion Criteria: HIV positive patients Stablized condition after statins, Lorenzoas oil, or diet to reduce VLCFA levels Patients who are experiencing severe viral (...) Adrenoleukodystrophy Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Hereditary Central Nervous System Demyelinating Diseases Leukoencephalopathies Demyelinating Diseases Mental Retardation, X-Linked Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Genetic Diseases, X-Linked Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolism, Inborn Errors Peroxisomal Disorders Metabolic

2018 Clinical Trials

178. Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer

, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radiosensitizer WILL be counted as a systemic chemotherapy regimen. Patients are not required to, but may have received a single line of prior hormonal therapy with either an antiestrogen, anti progesterone (or combination) or an aromatase inhibitor. Patients may not have received more than 1 line of endocrine therapy. This will not count toward prior therapy total. Resolution of adverse effects of recent (...) of disease. Patients who have received prior treatment with fulvestrant, everolimus, temsirolimus, ridaforolimus or another mTor inhibitor, or any CDK4 and CDK6 inhibitor. Patients who have received an autologous or allogenic stem-cell transplant. Clinically significant history of liver disease, including cirrhosis and current alcohol abuse. Presence of positive test results for hepatitis B (hepatitis B surface antigen [HBsAGg] and/or total HB core antibody [anti-HBc]) or hepatitis C (hepatitis C virus

2018 Clinical Trials

179. Multicenter Study to Evaluate the Effect of BTI320 on Glycemic Control in Type 2 Diabetes

immunodeficiency virus (HIV) infection, hepatitis, tuberculosis, or other serious infectious disease. History of alcohol addiction or drug abuse (illegal or controlled pharmaceutical substances) within past year prior to randomization. Have planned major surgery within 6 months after randomization. Have a terminal illness. Serum creatinine of >1.4 mg/dL (>124 μmol/L) in women or >1.5 mg/dL (>133 μmol/L) in men or subjects with end-stage renal disease (Estimated Glomerular Filtration Rate calculated by CKD-EPI (...) cotransport-2 inhibitors (SGLT-2). Treatment with any of these drugs should have been stopped at least 3 months before inclusion. Current or recent (within past 30 days) participation in another investigational drug or device study. Have participated in a previous study of BTI320. Have any uncontrolled cardiovascular risk factors (hypertension, hyperlipidemia), past clinical manifestation of coronary artery disease, blood dyscrasias, or significant cerebrovascular disease in the previous year. Any

2018 Clinical Trials

180. Personalized Nutrition for Diabetes Type 2

to amputations. It is also linked to other manifestations, collectively termed the metabolic syndrome, including obesity, hypertension, non-alcoholic fatty liver disease, hypertriglyceridemia and cardiovascular disease . As blood glucose levels are mainly affected by food consumption, the growing number of blood glucose abnormalities is likely attributable to nutrition. Indeed, dietary and lifestyle changes normalize blood glucose levels in 55% -80% of the cases. Therefore, maintaining normal blood glucose (...) of the recommended daily consumption At least 2 reported meals a day Exclusion Criteria: Short-acting insulin treatment Bariatric surgery Antibiotics/antifungal treatment in the last 3 months Use of weight-loss medication for less than 6 months Use of GLP-1 and SGLT-2 for less than 6 months People under another diet regime that is different from the ADA recommended diet Pregnancy or 3 months after giving birth, fertility treatments Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active

2018 Clinical Trials

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