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141. Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update

of characteristics of this systematic review on treatment of patients with early rheumatoid arthritis Population Key Inclusion Criteria: Adult outpatients, 19 years of age or older, with an early RA diagnosis, defined as 1 year or less from disease diagnosis Key Exclusion Criteria: Adolescents and adults with RA greater than 1 year from diagnosis ES-2 Drug Therapies Approved by FDA for RA Included in the Review Corticosteroid: Methylprednisone, prednisone (PRED), prednisolone (PNL) Conventional synthetic DMARD (...) to AEs • Serious c AEs • Specific d AEs 4. Benefits and harms of drug therapies in subgroups of patients Subgroups of patients defined by: • Age • Sex • Race or ethnicity • Disease activity • Prior treatment • Concomitant therapies • Coexisting conditions Timing of Review Beginning Search Date: January 2011 End Search Date: October 5, 2017 ES-3 Overview of Important Studies Underway Six trials either ongoing or completed, but findings not yet published. • One trial of ETN plus MTX versus a treat

2018 Effective Health Care Program (AHRQ)

142. Dolutegravir rilpivirine (Juluca) - For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA copies <50 copies/mL) on a stable antiretroviral regimen

Dolutegravir rilpivirine (Juluca) - For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA copies <50 copies/mL) on a stable antiretroviral regimen Published 10 September 2018 1 dolutegravir 50mg / rilpivirine 25mg film-coated tablets (Juluca ® ) SMC2091 ViiV Healthcare Ltd. 10 August 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug (...) and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following a full submission dolutegravir / rilpivirine film-coated tablet (Juluca ® ) is accepted for use within NHSScotland. Indication under review: The treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA 50 copies/mL in the 6-month period before screening and no more than one instance of viral load >50 copies/mL but <200 copies/mL

2018 Scottish Medicines Consortium

143. BHIVA/BASHH guidelines on the use of HIV pre-exposure prophylaxis (PrEP)

(PEPSE) 65 6.4.2 HIV testing 65 6.4.3 Acute HIV infection 65 6.4.4 Assessment of renal function 65 6.4.5 STI screen 66 6.4.6. Assessment of viral hepatitis status 66 6.4.7 References 68 6.5 Other considerations 70 6.5.1 Women who are pregnant or trying to conceive 70 6.5.2 Bone health 70 6.5.3 References 70 6.6 Prescribing PrEP 71 6.6.1 What to use 71 6.6.2 Lead-in period 71 6.6.3 Frequency of dosing to attain benefit 71 6.6.4 On-demand dosing 71 6.6.5 Indications for post-exposure prophylaxis (...) following suboptimal adherence to PrEP 72 6.6.5 References 73 BHIVA/BASHH guidelines on the use of PrEP 4 7 Clinical follow-up and monitoring on treatment 75 7.1 Overview 75 7.2 Continued prescribing 75 7.3 Assessing adherence and adverse events 75 7.4 Management of short-term side effects 75 7.5 Monitoring on PrEP 77 7.5.1 HIV testing 77 7.5.2 Management of HIV seroconversion 77 7.5.3 STI screening 78 7.5.4 Viral hepatitis 78 7.5.5 Renal monitoring 78 7.5.6 Pregnancy testing 79 7.5.7 Bone monitoring 79

2018 British Association for Sexual Health and HIV

144. I heard a snap! Clay Shoveler’s Fracture

rotation, flexion, and extension. He also has exquisite, sharp tenderness on palpation over the C6 vertebrae. Initial Impression and Investigations While on history you had suspected a cervical sprain or strain, due to his midline tenderness over C6 and age you decide to obtain a x-ray of his cervical spine. Uh-oh, what happened to Reginald? Image courtesy of: Dr Chris O’Donnell ( Clay Shoveler’s Fracture (...) these fractures when the heavy clay that they tossed over their shoulder was stuck to their long-handled shovel causing a sudden flexion force on the neck and back muscles 2 . Exam and Investigations Patients with this injury present with sharp pain between the shoulder blades that is worsened with palpation. They may also have pain with neck movement and unilateral upper back pain 3 . The Clay Shoveler fracture can usually be seen on plain film lateral radiograph. CT can be performed if clinical suspicion

2018 CandiEM

145. Bruising

of Health and Care Excellence (NICE) guideline Suspected cancer: recognition and referral [ ]. The recommendation to check a blood film is based on expert opinion in review articles that this can confirm whether there is true thrombocytopenia; and platelet and leukocyte morphology and characteristics can suggest haematological malignancies and hyperproliferative conditions [ ; ]. Pancytopenia indicates bone marrow disease [ ]. The recommendation to consider checking clotting is based on expert opinion (...) film is helpful to confirm whether there is true thrombocytopenia; and platelet and leukocyte morphology and characteristics can suggest haematological malignancies or hyperproliferative conditions [ ]. Pancytopenia indicates bone marrow disease [ ]. Blood results can be normal in the presence of mild coagulation or platelet disorders This recommendation is based on expert opinion in review articles [ ; ]. What else might it be? Skin conditions which might be mistaken for bruising include: Linear

2017 Prodigy

146. Cenegermin (Oxervate) - neurotrophic keratitis

% relative standard deviation SAP Statistical Analysis Plan SC subcutaneous SD Standard Deviation SDS-PAGE Sodium dodecyl sulfate polyacrylamide gel electrophoresis SE-HPLC Size exclusion HPLC Ser Serine SH-SY5Y Human neuroblastoma cell line SIRC Statens Seruminstitut Rabbit Cornea SLPM Standard litre per minute S/N ratio Signal to noise ratio ssDNA single stranded DNA SOC System Organ Class TAMC Total aerobic microbial count TF-1 Human bone marrow erythroblast suspension cell line TFA Trifluoracetic (...) . A classification based on disease severity was proposed by Mackie (1995), who distinguished three stages (1 to 3 in order of increasing severity): Assessment report EMA/351805/2017 Page 12/104 ? Stage 1 is characterized by punctate keratopathy and/or corneal epithelial hyperplasia and irregularity, which may be associated with superficial neovascularization and stromal scarring. In addition dry eye signs may be observed, including vital dye staining of the inferior palpebral conjunctiva and decreased tear film

2017 European Medicines Agency - EPARs

147. Maviret (glecaprevir / pibrentasvir) - chronic (long-term) hepatitis C

is presented as film coated tablets, containing 100 mg of glecaprevir and 40 mg of pibrentasvir as the active substances. Other ingredients of the core tablets are copovidone (Type K 28), vitamin E (tocopherol) polyethylene glycol succinate, colloidal anhydrous silica, croscarmellose sodium, sodium stearyl fumarate, propylene glycol monocaprylate (Type II). The film coating is composed of hypromellose 2910 (E464), lactose monohydrate, titanium dioxide, macrogol 3350 and iron oxide red (E172). The product (...) Description of the product and Pharmaceutical development The finished product is an immediate release film coated tablet containing 100 mg of glecaprevir and 40 mg of pibrentasvir. The film-coated tablets are pink, oblong, biconvex, with “NXT” debossed on one side, the other side being plain intended for oral administration. The list of excipients is included in section 6.1 of the SmPC. The aim of the pharmaceutical development work was to develop a stable formulation containing 100 mg of glecaprevir

2017 European Medicines Agency - EPARs

148. Ribociclib (Kisqali) - breast cancer

-dimension five-level questionnaire ER estrogen receptor EU European Union FAS Full Analysis Set FCT film-coated tablet FDA Food and Drug Administration GC Gas chromatography HER2 human epidermal growth factor receptor 2 HPLC High performance liquid chromatography HR hazard ratio or hormone receptor ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICP-MS Inductively coupled plasma mass spectrometry Assessment report EMA/CHMP/506968 (...) cancer is based on clinical examination in combination with imaging, and confirmed by pathological assessment. Clinical examination includes bimanual palpation of the breasts and locoregional lymph nodes and assessment for distant metastases (bones, liver and lungs; a neurological examination is only required when symptoms are present) 4 . Metastatic breast cancer is an incurable disease with a median overall survival of 2~3 years and a 5-year survival of only~25%. Median overall survival in patients

2017 European Medicines Agency - EPARs

149. Darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza) - HIV Infections

the curve from 0h up to the time of the last measurable concentration after dosing AUCinf area under the curve from time 0h to infinity BMD bone mineral density BMI body mass index CatA cathepsin A CCDS Company Core Data Sheet CHMP Committee for Medicinal Products for Human Use CI confidence interval CKD-EPI Chronic Kidney Disease Epidemiology Collaboration CL/F clearance Cmax maximum observed analyte concentration COBI cobicistat CPT Child-Pugh-Turcotte CR child resistant CSR clinical study report %CV (...) . The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 28 January 2016. The applicant applied for the following indication: Symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg) (see sections 4.2, 4.4 and 5.1). The legal basis for this application refers to: Article 10(b) of Directive 2001/83/EC – relating to applications for new fixed

2017 European Medicines Agency - EPARs

150. Anamorelin (Adlumiz) - Anorexia, Cachexia, Non-Small-Cell Lung Carcinoma

has been developed as an immediate release film-coated tablet containing 100 mg anamorelin HCl intended for administration as a single oral daily dose at least one hour prior to the first meal of the day. The initially proposed indication for Adlumiz was for the treatment of anorexia, cachexia or unintended weight loss in adult patients with non-small cell lung cancer (NSCLC). During the evaluation of this application by the CHMP, the applicant proposed to amend the indication to “treatment (...) treated dose groups. Locomotor Activity in Rats (Study No. IR-21990, GLP) Anamorelin HCl was administered orally by gavage to 3 groups of 5 male rats at 10, 25 or 50 mg/kg. No changes were noted for anamorelin HCl-treated rats at any dose. Body Temperature in Rats (Study No. F07PD003, GLP) The influence of anamorelin HCl on the body temperature was assessed in male SD rats aged 6 weeks, administered orally with a single doses ranging from 10 to 100 mg/kg. The only significant finding was of body

2017 European Medicines Agency - EPARs

151. Investigation and management of a raised serum ferritin Full Text available with Trip Pro

or treatment (e.g. blood transfusion or iron infusion) that lead to a genuine increase in RES iron stores. Upper limit of the normal range for serum ferritin Most UK laboratories simply report 300–400 μg/l as the upper limit of normal for SF in adult males and 150–200 μg/l as the upper limit of normal for adult females (Association for Clinical Biochemistry, ; Worwood et al , ). There is however considerable variation in SF values in response to age, ethnic origin and sex. Mean SF values in neonates (...) are high (around 200 μg/l) and remain so for about 2 months. From 2 to 12 years mean values approximate 30 μg/l for both boys and girls (Worwood, ). Within this age group values >100 μg/l are only seen in the context of inflammatory disease, malignant disease or juvenile hereditary haemochromatosis. Mean SF values at 18 years are significantly higher in males (60–80 μg/l) than in females (25–30 μg/l) (White et al , ; Wiedemann & Jonetz‐Mentzel, ; Custer et al , ; Milman et al , ). Thereafter, in males

2018 British Committee for Standards in Haematology

152. Shoulder Pain - Atraumatic

. Fluoroscopy, CT, or ultrasound (US) can be used to guide needle placement for arthrography. Nuclear Medicine In the setting of atraumatic shoulder pain, nuclear medicine studies are rarely used. Sometimes a PET scan is used in conjunction with CT and MRI in the workup of soft-tissue tumors, bone tumors, and metastases. Otherwise, in the setting of atraumatic shoulder pain, bone scintigraphy, gallium, and indium scans have been largely replaced by MRI and CT. CT CT plays an important role in the evaluation (...) surface defects, even though the therapeutic impact of these subtle irregularities may be limited [21,22]. CT arthrography is helpful in the preoperative planning of total shoulder arthroplasty. Evaluation of potentially irreparable rotator cuff disease is critical in determining arthroplasty type (conventional versus reverse). CT provides important osseous detail in the evaluation of glenoid morphology, version, and extent and location of glenoid bone loss. This information is critical

2018 American College of Radiology

153. Good practice paper on the diagnosis and investigation of patients with mantle cell lymphoma Full Text available with Trip Pro

or if clinical stage 1A disease is present and radiotherapy with curative intent is planned. Where endoscopy is performed, biopsies of any suspicious lesions, and also macroscopically normal areas, should be taken for histological examination. Pregnancy testing in women of childbearing age prior to chemotherapy. Staging The modified Ann Arbor staging system (Lister et al , ) is used. As most patients with MCL have blood and bone marrow involvement at presentation, clinical stage in isolation is not of great (...) blood tests including full blood count and film, and biochemical tests including lactate dehydrogenase should be performed Virological testing for hepatitis B, hepatitis C and human immunodeficiency virus is recommended prior to immunochemotherapy Patients should undergo staging bone marrow aspirate and trephine biopsy unless there is peripheral blood involvement; trephine may be avoided if flow cytometry is carried out on aspirate sample Patients should undergo clinical staging with computed

2018 British Committee for Standards in Haematology

154. Investigation and management of Transient Leukaemia of Down Syndrome Full Text available with Trip Pro

and/or of quantitative assessment of the size of any residual GATA1‐ mutant clone in TL‐DS or silent TL‐DS has yet been demonstrated. (Grade 2B). All children with previous TL‐DS or silent TL‐DS should be monitored for progression to ML‐DS with 3 monthly clinical review and FBC and film until the age of 2 years. If the FBC and film are normal and there are no clinical features of ML‐DS, monitoring should continue 6 monthly until the age of 4 years. Abnormal blood counts should prompt early bone marrow aspirate (...) marrow examination is not generally useful in TL‐DS: blast cells are believed to originate in the liver and marrow blasts are variable and less prevalent than in peripheral blood. Bone marrow involvement does not correlate with disease severity (Massey et al , ; Klusmann et al , ; Gamis et al , ). Figure 1 Typical appearances of TL‐DS in peripheral blood of a neonate with Down syndrome. Photomicrograph from a blood film of a neonate with transient leukaemia of Down syndrome showing blast cells

2018 British Committee for Standards in Haematology

156. Shoulder Conditions Diagnosis and Treatment Guideline

tendonitis is still unknown. It does, however, affect up to 10-20% of the population between the ages of 30-50 [56-58] . Diagnosis and Treatment The diagnosis of calcific tendonitis is typically made with conventional plain films alone. Calcific tendonitis is not always symptomatic. When calcific tendonitis is symptomatic, non- operative treatment of the condition is typically successful [56, 59] . If symptoms continue after 12 weeks of conservative management then debridement of the calcified tendon (...) motion Tenderness over the AC joint AND Documented pain relief with an anesthetic injection MRI (radiologist interpretation) reveals: ? Moderate to severe degenerative joint disease of AC joint, or ? Distal clavicle edema, or ? Osteolysis of distal clavicle OR Bone scan is positive OR Radiologist’s interpretation of x-ray reveals moderate to severe ac joint arthritis Conservative care* for at least 6 weeks (if done in isolation) Surgery is not indicated before 6 weeks. Washington State Department

2018 Washington State Department of Labor and Industries

157. CRACKCast Episode 183 – The Immunocompromised Patient

! KEEP coming back to it. 1) What are the three primary defense systems of the body? Hold on to your drawers… this is going to be a wild ride… The body’s defense mechanisms = Surface barriers , such as skin, enzymes, and mucus, First line of defense against microorganisms, consist of intact skin, gastrointestinal and respiratory mucosa, cilia, bio film, gastric acid, antibacterial substances in pancreatic and biliary secretions, antimicrobial peptides and proteins on skin and mucous membranes (...) , maximum daily dose 1500 mg/day). Imipenem-cilastatin (for adults: 500 mg IV every six hours; for children: 25 mg/kg IV every six hours up to a maximum of 1 g per dose for infants older than one month of age and children) or meropenem (for adults: 1 g IV every eight hours; for children ≥3 months of age: 20 mg/kg IV every eight hours up to a maximum of 1 g per dose). We reserve the carbapenems for patients who are allergic to the other options or who are infected or colonized with an organism

2018 CandiEM

158. Clinical Appropriateness Guidelines: Radiation Oncology Brachytherapy, intensity modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT) and stereotactic radiosurgery (SRS) treatment guidelines

10 Bone Metastases 12 Breast Cancer 19 Central Nervous System Cancers 29 Colorectal and Anal Cancers 38 Gastrointestinal Cancers, Non-Colorectal 42 Genitourinary Cancers 49 Gynecologic Cancers 54 Head and Neck Cancers 60 Lung Cancers: Small Cell and Non-Small Cell 64 Lymphoma: Hodgkin and non-Hodgkin 71 Other Tumor Types: Sarcoma, Thymoma and Thymic Carcinoma, Pediatric Tumors, Other Malignancies 76 Prostate Cancer 82Description and Application of the Guidelines | Copyright © 2018. AIM Specialty (...) and SRS. When highly tailored dose distributions such as IMRT and stereotactic radiotherapy are not being utilized, sub-centimeter precision is not generally needed and accurate patient setup is achieved with other techniques. These include patient immobilization with custom treatment devices like body molds or thermoplastic masks, placement of tattoos aligned to a 3-dimentional laser array in the treatment room and offline review of port verification films. Small daily setup uncertainties exist

2018 AIM Specialty Health

159. Induced Pluripotent Stem Cells for Cardiovascular Disease Modeling and Precision Medicine: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

rates and exposure to ultraviolet radiation. This could be particularly relevant when deriving iPSCs from older donors, because mutations and other abnormalities appear to occur with increasingly higher frequency with increased age. The second choice to make is the method by which to deliver the Yamanaka factors into the cell type. Initial efforts to generate iPSCs entailed the use of an integrating virus (eg, retrovirus or lentivirus) to introduce the factors as DNA transgenes. This led to concerns (...) for a frameshift mutation in PKP2 . Although the iPSC-CMs from these patients exhibited subtle molecular defects in standard differentiation conditions, they did not fully manifest ARVC-related phenotypes until they were exposed to conditions that resulted in metabolic aging, namely, treatment with a cocktail of 5 adipogenic factors, whereupon they displayed increased lipogenesis and apoptosis, as well as abnormal calcium handling. In another study, iPSC-CMs from 2 patients heterozygous for different PKP2

2018 American Heart Association

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