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161. Patient Modesty: Volume 88

to the interrogations regarding same gender care for males who dare to speak up and declare their rights as a human! When a female worker even “just” rolls her eyes when a male asks for same gender care is a form of abuse and here’s where lawyers are our friends! If as a male (or female) I state I want only same gender care for intimate care, exams, surgeries, etc. then I should not be interrogated or made to explain my choices. My body, my mind, my choice. This choice should be entered in my medical records (...) to the topic of Volume 88. Cont. due to word length -- EO At , Anonymous said... There is no saving the present mak’emsick industry. Let’s see – we already know that drug studies are fraudulent and that physicians seem to be entirely ignorant of this fact. But, writing scripts is about all most of them can do. Super hyped “screening” tests do more harm than good. EBM (Evidence Based Medicine) is essentially a scam as it also relies on fraudulent studies. We’ve seen that the mak’emsick industry is founded

2018 Bioethics Discussion Blog

162. Patient Dignity (Formerly: Patient Modesty): Volume 92

women are concerned. Today, when a man with modesty concerns goes for a male specific intimate exam, test, or procedure, he is faced with the real possibility of being intimately exposed and handled by a gauntlet of women he neither knows, nor wants to be exposed in front of. To a modest man, this kind of exposure being forced upon him can have devastating results. Effects that some gentlemen never recover from. Men don't go around making fun of women for wanting a female nurse or aid

2018 Bioethics Discussion Blog

163. Patient Modesty: Volume 89

; basically what the average physician in the area would have done. If the physician documented a reason for denial (including it is my right to), attempted to educate the patient (gave him ACS pamphlet on recommended screening), periodically revisited the topic (and noted refusal again), and did not ignore the patient's request for alternative testing (FOBT vs colonoscopy), then the physician did everything possible and has a defensible position. That does NOT mean the physician will be dismissed from (...) the patient's former occupation and possible asbestos exposure. ..Maurice. At , Anonymous said... Maurice Pleural effusion can also be attributable to CHF, renal disease or a fall. I shudder to think people coming to a diagnosis with occupation first in mind. That the diagnosis could be arrived at after some investigation clinically or after a series of diagnostic tests. I might mention that prior to Hipaa laws in 1995 much of patient information from medical offices was placed in dumpsters. With names

2018 Bioethics Discussion Blog

164. Understudy Gene Offers Hope for Spinal Muscular Atrophy

. Various “rating scales” are used to evaluate response in children with SMA (infants require different tests). Some are used for several neuromuscular conditions, such as the to assess number of steps taken on a treadmill in that time. Children who can’t walk take the (ULM) test, tweaked for SMA. Tailored to evaluating SMA is the (HFMSE) test. It assesses the best that a patient can do on a particular day, such as how long it takes to roll over and how long a child can hold a position, like sitting (...) and pediatrics, Columbia University Medical Center. “Some children approaching three years of age who had been treated since infancy are showing increases in muscle function scores and are meeting development milestones that are not predicted for infants with SMA, like sitting up, rolling over, and head control,” said Amy Williford, PhD, associate director, corporate communications for Isis . (Dept. of Energy) OTHER TREATMENTS Most genes don’t have shadow copies to manipulate, but other approaches

2015 PLOS Blogs Network

165. Trifluridine/tipiracil hydrochloride (TAS102) (Lonsurf)

and a 3% per year loss to survival follow-up. No interim analyses were planned. The primary analysis of OS included follow-up data (including death events) through the date of the 571st death. The difference in survival between the two treatment arms was assessed in the ITT population using the stratified log-rank test (Score statistic from PHREG and ties=Breslow) from a Cox proportional hazards (CPH) model including treatment and the 3 stratification factors in the model. Survival for each arm (...) Special Animal and/or In Vitro Testing 66 7.2.4 Routine Clinical Testing 66 7.2.5 Metabolic, Clearance, and Interaction Workup 66 7.2.6 Evaluation for Potential Adverse Events for Similar Drugs in Drug Class .. 67 7.3 Major Safety Results 67 7.3.1 Deaths 68 7.3.2 Nonfatal Serious Adverse Events 72 7.3.3 Dropouts and/or Discontinuations 75 7.3.4 Significant Adverse Events 75 7.3.5 Submission Specific Primary Safety Concerns 80 7.4 Supportive Safety Results 80 7.4.1 Common Adverse Events 80 7.4.2

2015 FDA - Drug Approval Package

166. Orkambi - lumacaftor / ivacaftor

. The application submitted is composed of administrative information, complete quality data, non-clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain tests or studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/0337/2014 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0337 (...) into a secondary container for storage and shipping. The LDPE is compliant with EU Regulation 1183/2012, and the European Pharmacopoeia Monograph 3.1.3 “Polyolefins”. Specification The control strategy for lumacaftor consists of the specifications of the active substance starting materials, reagents and solvents, the active substance synthesis design spaces, the in-process controls and the active substance specification. The active substance specification includes tests for: appearance (visual inspection

2015 European Medicines Agency - EPARs

167. Keytruda - pembrolizumab

for this study was strictly controlled at 2.5% (one-sided) with 0.5% allocated to PFS at the second interim analysis and 2% allocated to OS. PFS was only be tested at the second interim analysis. The Bonferroni method was used for testing the two null hypotheses on PFS at the second interim analysis with each tested at 0.25%. If any of the two null hypotheses was rejected, the corresponding alpha level was rolled into the overall OS hypothesis (i.e., the OS hypothesis tested Page 54/160 at 2%, 2.25% and 2.5 (...) no pembrolizumab arms would be dropped earlier. Between-treatment comparison of OS was tested using stratified log-rank test, the hazard ratio and its 95% confidence interval was estimated using the stratified Cox model with efron’s tie handling. OS curve is estimated using Kaplan-Meier (KM) method in each treatment group. Results Participant flow Table 17: Disposition of subjects (ITT population) At the time of this interim analysis, 86 SOC chemotherapy subjects had crossed over to the pembrolizumab treatment

2015 European Medicines Agency - EPARs

168. Hetlioz - tasimelteon

that tasimelteon was considered to be a new active substance. The application submitted is composed of administrative information, complete quality data, non-clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain tests or studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision(s) P/0141/2014 on the agreement of a paediatric investigation plan (...) . Tasimelteon is a white to off-white crystalline powder, it is non hygroscopic, soluble in water across relevant pH values and freely soluble in alcohols, cyclohexane, and acetonitrile. Conducted in vivo studies demonstrate that tasimelteon is highly permeable substance. Photostability testing and testing on stress conditions demonstrated that the active substance degrades in light. Tasimelteon exhibits stereoisomerism due to the presence of two chiral centres. Active substance is manufactured as a single

2015 European Medicines Agency - EPARs

169. Cresemba - isavuconazole

alkaline phosphatase ALT alanine transaminase AST Aspartate transaminase AmB amphotericin B AML acute myeloid leukemia ANC absolute neutrophil count AST aspartate transaminase AUC area under the concentration time curve BAL4815 isavuconazole BAL8557 isavuconazonium sulfate (prodrug) BAL8728 Inactive cleavage product of isavuconazonium sulfate ß-HCG urine or serum pregnancy test b.i.d. twice daily BLQ below the limit of quantification BMI body mass index BMT bone marrow transplant bpm beats per minute (...) /MSG European Organisation for the Research and Treatment of Cancer/Mycoses Study Group ESCMID European Society of Clinical Microbiology and Infectious Diseases EUCAST European Committee on Antimicrobial Susceptibility Testing FDA US Food and Drug Administration FLU fluconazole FU follow-up period GCP Good Clinical Practice GGT gamma glutamyl transpeptidase GM galactomannan GMR GTI geometric mean ratio Genotoxic Impurity h hour HIV human immunodeficiency virus HSCT hematopoietic stem cell

2015 European Medicines Agency - EPARs

170. Dinutuximab (Unituxin)

% of patients in Study 3: nasal congestion (20%) and wheezing (15%). Table 7 provides the per-patient incidence of laboratory abnormalities in Study 3. Table 7: Per-Patient Incidence of Selected (= 5% Grade 3-4) Laboratory Abnormalities in Study 3 Laboratory Test 1 Grade 2 All Grades % Grades 3-4 % HEMATOLOGY Anemia 100 46 Neutropenia 99 63 Thrombocytopenia 98 49 CHEMISTRY Hypoalbuminemia 100 8 Hypocalcemia 97 7 Hyponatremia 93 36 Hyperglycemia 87 6 Aspartate Aminotransferase Increased 84 8 Alanine (...) (dinutuximab) Page 44 of 50 6.2 Immunogenicity As with all therapeutic proteins, patients treated with Unituxin may develop anti-drug antibodies. In clinical studies, 52 of 284 (18%) patients from Study 2 and 13 of 103 (13%) patients from Study 3 tested positive for anti-dinutuximab binding antibodies. Neutralizing antibodies were detected in 3.6% of patients who were tested for anti- dinutuximab binding antibodies in study 2 and study 3. However, due to the limitations of the assay, the incidence

2014 FDA - Drug Approval Package

171. Moventig - naloxegol

cardiovascular event MedDRA Medical Dictionary for Regulatory Activities meu Morphine equivalent units mHS Modified Himmelsbach scale MI Myocardial infarction MMRM Mixed model for Repeated Measures MTP Multiple Testing Procedure Naloxegol Also known as NKTR-118, PEG-naloxol, NKT-10018, as naloxol 6a- Assessment report EMA/CHMP/738815/2014 Page 7/120 methoxyhepta(ethylene glycol) ether, also known as a-6-mPEG7-O-naloxol. Naloxegol oxalate salt International Union of Pure and Applied Chemistry (IUPAC) name (...) to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The applicant indicated that naloxegol was considered to be a new active substance. The application submitted is composed of administrative information, complete quality data, non-clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain test(s) or study(ies). Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006

2014 European Medicines Agency - EPARs

172. Entyvio - vedolizumab

to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The applicant indicated that vedolizumab was considered to be a new active substance. The application submitted is composed of administrative information, complete quality data, non- clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain test(s) or study(ies). Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901 (...) the circulation to enter antigen-containing tissues. An essential step in this migration process is the adhesion of circulating lymphocytes to the endothelium of post capillary venules, which is a multistep process. In the first step, which is mediated by selectins or integrins, lymphocytes are captured (“tethering”) and poorly interact with the endothelial cells (“rolling”). Once they are rolling, they can undergo “activation,” which is usually mediated by chemokines presented on the venular endothelium

2014 European Medicines Agency - EPARs

173. Triumeq - abacavir sulfate / dolutegravir sodium / lamivudine

after an interruption of Triumeq therapy”). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing (see section 4.4 and 4.8)”. The legal basis for this application refers to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The application submitted is composed of administrative information, complete quality data, non- clinical (...) and clinical data based on applicants’ own tests and studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/0287/2012 on the agreement of a paediatric investigation plan PIP. At the time of submission of the application, the PIP P/0287/2012 was not yet completed as some measures were deferred. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000

2014 European Medicines Agency - EPARs

174. Policy options to attract nurses to rural Liberia. Evidence from a discrete choice experiment

provided additional modeling flexibility if the current job is treated as a third possible choice. The questionnaire was pilot tested and revised twice. The first pilot stage consisted of a convenience sample of 12 nurses and certified midwives in two large facilities within Monrovia. This first pilot phase led to significant changes in wording and sequencing of questions. It also provided an estimate of time requirements to complete the questionnaire which was needed for planning the full roll out (...) of Warwick & Consultant, The World Bank, Washington DC., USA c University of Aberdeen & Consultant, The World Bank, Washington DC., USA d Ministry of Health and Social Welfare, Monrovia, Liberia This work was partially funded by the Government of Norway and the Global Alliance for Vaccines and Immunization. Abstract: There is major geographic variation in nurse staffing levels in Liberia with the largest shortages in rural areas. A discrete choice experiment (DCE) was used to test how nurses

2010 Health Economics Research Unit

175. WHO guidelines on drawing blood: best practices in phlebotomy

events. A log book or register should be established with accurate details of the incident, possible causes and management of adverse events (27). 2.1.4 Quality care for patients and health workers Several factors can improve safety standards and quality of care for both patients and health workers, and laboratory tests. These factors, discussed below, include: Availability of appropriate supplies and protective equipment Procurement of supplies is the direct responsibility of the administrative (...) and control, safety equipment and best practice 69 Annex C: Devices available for drawing blood 71 Annex D: Managing occupational exposure to hepatitis B, hepatitis C and HIV 73 Annex E: Training course content for phlebotomists 77 Annex F: Explaining the procedure to a patient 79 Annex G: Disassembly of needle from syringe or other devices 81 Annex H: Blood spillage 83 Annex I: Modified Allen test 85 Annex J: Cochrane review 87 Annex references 103 Glossary 105 v Tables Table 2.1 Elements of quality

2010 World Health Organisation Guidelines

176. Caring For People with a Learning Disability in General Hospital Settings

be required or any risks that may need to be managed. This information should direct subsequent care planning. 4. Each hospital ward should gather resources that can help when a person with a learning disability is admitted and ensure that this is accessible to all staff. For example, information regarding the contact points of local learning disability services, easy read information about the ward, the hospital and certain procedures such as blood tests and x-rays. 5. An up to date list of key contacts

2010 Regulation and Quality Improvement Authority

177. Early intervention in psychosis: how long is long enough?

phase are not maintained once the EI intervention ends (Gafoor et al., 2010). Given that three year EI service models have been rolled out on a large scale (at least in my experience of UK services), I was surprised that this new study (Chang et al, 2015) is actually the first to formally test the EI model extended beyond two years of treatment (though there are ongoing trials assessing five year EI models in Denmark and Canada). In an area of mental health in which policy implementation has often (...) preceded the evidence base, this trial is important in understanding the optimal duration of EI services in order to inform policy and ensure best possible outcomes for young people with psychosis. In addition, much of the evidence base for EI to date has come from western populations and service systems, thus this study is important in providing RCT level data from a non-western country. Three year early intervention programmes are quite commonplace in the UK and elsewhere, but RCTs testing the model

2015 The Mental Elf

178. Pharmacotherapies for reducing cannabis dependence

) sought to identify trials that have tested whether pharmacotherapies can be effective in reducing the effects of cannabis withdrawal and promoting abstinence or reduced use. At present, there are no guidelines recommending pharmacotherapies to help people with dependence on cannabis. Method To identify papers for inclusion in the review the authors searched databases, electronic sources of ongoing trials, reference lists and conference proceedings, and contacted experts in the field. They searched (...) ) Atypical antidepressants: bupropion (Carpenter 2009; Penetar 2012) Anxiolytics: buspirone (McRae-Clark 2009) Selective norepinephrine reuptake inhibitor: atomoxetine (McRae-Clark 2010) A supplement promoting glutamate release and modulating N-methyl-D-aspartate (NMDA) receptor: N-acetylcysteine (Gray 2012) The primary outcomes for the review were abstinence, intensity of withdrawal, adverse effects and completion of the treatment regime. Due to the range of medications tested and the outcomes reported

2015 The Mental Elf

179. Integrated treatment for first episode psychosis: media hype versus reality

through the media spin: what is this paper really about? Schizophrenia is a devastating affliction. We know that early treatment is the best strategy, and that certain interventions, like medication, talking therapy, psychoeducation and employment support can help. But there have only been a few trials testing some of these aspects rolled together into one treatment package. The Early Treatment Programme (ETP), part of the NIMH’s Recovery After an Initial Episode of Schizophrenia (RAISE) initiative (...) as a control group’ changed, or are you being selective in the application of your opinions? Alex Langford replied: View Thanks for the comment – a really good one. In response, no, I haven’t softened in my views of psychotherapy trials that use TAU as a control, but I see this trial as something else. It’s not testing the efficacy of the individual interventions as such – that should have been done already – it’s testing how well they can be packaged up, taught to clinical staff and rolled out

2015 The Mental Elf

180. Psychotherapy for UK military veterans: demographics and clinical outcomes

to identify those at greatest risk following their discharge. The UK’s IAPT programme was rolled out nationally in 2007. It was originally specific to the improvement of access of psychological therapies for adults suffering with depression and anxiety. Its inception was based on economic (getting people back to work and increasing productivity) and clinical (implementing the National Institute for Health and Clinical Excellence’s guidelines). The IAPT model has now been expanded to cover other common (...) (as determined by the Work and Social Adjustment Scale – WSAS). The data was statistically analysed using SPSS version 20. Demographic characteristics and clinical changes were assessed using frequency distributions. Independent t -tests were employed to assess the means of clinical data and chi tests used to examine the demographic characteristics between subgroups. Changes in outcome scores were reported for all patients who experienced 2 or more sessions and were assessed using effect sizes. IAPT services

2015 The Mental Elf

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