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Fetal Foot Measurement

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141. Addyi - Flibanserin

Health Drugs (AC) on June 18, 2010. Pivotal to the indication sought were two Phase 3 clinical trials conducted in North America, where efficacy was assessed by two pre-specified co-primary endpoints – satisfying sexual events (SSEs) and sexual desire (measured daily by an electronic diary, eDiary). Notably, both trials failed to show a statistically significant improvement relative to placebo in sexual desire. However, both trials demonstrated nominally statistically significant improvement vs (...) . placebo in sexual desire measured by another instrument – the Female Sexual Function Index desire domain (FSFI-desire). The Applicant stated that the results from the secondary FSFI-desire endpoint should be adequate to support approval. Most of the AC members did not agree with the Applicant’s proposal to alter the methodology of analysis post-hoc. The AC voted 10 to 1 that the Applicant had not provided sufficient evidence of efficacy. Safety concerns raised by the AC included central nervous system

2015 FDA - Drug Approval Package

142. Strensiq - asfotase alfa

on weight, with regard to patient compliance issues. In order to provide greater clarity regarding product administration, a dosing table has been included in the SmPC. Another point for clarification was raised with regard to this, concerning feasibility of accurate dose measurement. The Applicant has subsequently provided adequate reassurance with regard to the accuracy of dose measurement using widely available syringes for both proposed dosing regimens. Stability data indicate that the active (...) supplementation. This way PLP (the primary vitamin B6 coenzymic form) measurements would not be affected by dietary intake. The evaluation was carried out as a pilot to a planned study ALP-PT-26, which confirmed the previously submitted results. It has been shown that continuous treatment of Akp2-/- mice with asfotase alfa for the full duration of the study (47 days), partially improved the reduced grip strength in the forelimbs, completely prevented the increase in both plasma PLP and liver glycogen levels

2015 European Medicines Agency - EPARs

143. Akynzeo (netupitant / palonosetron)

and this was agreed by the CHMP. Administration of netupitant to rabbits during the period of organogenesis was shown to increase the incidence of some foetal malformations: limb and paw positional anomalies, minimal/partial fusion of sternebrae, and agenesis of accessory lung lobe. The NOAEL for embryo-fetal development is 3 mg/kg/day. Taking into account the teratogen effect of netupitant in rabbit without a safety margin, a contraindication of AKYNZEO during pregnancy with a contraception measure for women (...) : IC50 = 8 µM ; Ki = 8 µM. Metabolite = M, netu = netupitant EMA/236963/2015 Page 21/153 Table 2: In vivo pharmacology studies with netupitant and its metabolites Type of study No of animals/dose GLP aspect Doses (mg/kg) Major findings Induced Foot-Tapping in Gerbils Inhibition of NK1 Agonist-Induced Foot-Tapping in Gerbils M + F, number not provided No GLP Netupitant metabolites: M1: 10, M2: 10, M3: 10 oral, ip Netupitant : ED 50 = 0.5 mg/kg p.o. and 1.5 mg/kg i.p.. M1: ED 50 = 2.4 mg/kg p.o

2015 European Medicines Agency - EPARs

144. Nerventra - laquinimod

Results SF-36 Short Form 36 Health Survey SIR Standardized incidence ratio SLE Systemic Lupus Erythematosus SmPC Summary of Product Characteristics SMQ Standardised MedDRA Queries SMR Standard Maintenance Diet SOC System Organ Class SPMS Secondary Progressive Multiple Sclerosis SWP Safety Working Party T25FW Timed -25- Foot-Walk TCDD 2,3,7,8-tetrachlorodibenzo-p-dioxin TK Toxicokinetic Tmax Time to maximum plasma concentration TSE Transmissible spongiform encephalopathy UDS Unscheduled DNA synthesis (...) of the application, the PIP P/0027/2012 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 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition related to the proposed indication. New active

2014 European Medicines Agency - EPARs

145. Moventig - naloxegol

Administration DAMGO [D-Ala2, N-MePhe4, Gly-ol]-enkephalin EC European Commission Assessment report EMA/CHMP/738815/2014 Page 6/120 ECG Electrocardiogram eDiary Electronic diary EDQM European Directorate for the Quality of Medicines & Healthcare EFD Embryo-fetal development EMA European Medicines Agency EU European Union FDA US Food and Drug Administration GC Gas chromatography GI Gastrointestinal GI-EAC Gastrointestinal event adjudication committee HPLC High performance liquid chromatography ICH (...) 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

2014 European Medicines Agency - EPARs

146. Tecfidera - dimethyl fumarate

Standard Deviation SF-36 Short Form 36 Heatlh Survey SGOT Serum glutamic oxaloacetic transaminase SGPT Serum Glutamic Pyruvate Transaminase SmPC Summary of Product Characteristics SOC System Organ Class SPMS Secondary Progressive Multiple Sclerosis Srxn 1 Thioredoxin reductase 1 t1/2 Half Life T25FW Time 25-Foot Walk TCA Tricarboxylic Acid TGA Thermogravimetric Analysis TID Three Times Daily Tmax Time to Peak Plasma Concentration TNFa Tumor Necrosis Factor-alpha Trxnd1 Sulfiredoxin 1 TSE Transmissible (...) ) on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/76/2011 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 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orphan

2014 European Medicines Agency - EPARs

147. Vokanamet - canagliflozin / metformin

concentration AUMC Area under the first moment of the concentration versus time curve from the time of dosing up to a specific time, t, to infinite time, or to the time of the last measurable concentration BA Bioavailability BG blood glucose BID twice daily BLQ below the limit of quantitation BMD bone mineral density BrdU bromo-deoxyuridine BSA body surface area Ca Calcium CANA Canagliflozin CANVAS Study DIA3008 CFU Colony Forming Units CHD coronary heart disease CHMP Committee for Medicinal Products (...) ) cells as measured by inhibition of alpha-methylglycopyranoside (AMG) uptake with an IC 50 of 3.7 nM for rSGLT2 and 4.2 nM hSGLT2, respectively. The inhibition of SGLT1 in the same cell system was more than 150-times lower, with an IC 50 of 550 nM for rSGLT1 and 663 nM for hSGLT1, respectively. Functional activity of canagliflozin on SGLT2 and SGLT1 of other species was not determined. Off target effects on other human glucose transporters such as SGLT3, SGLT4, SGLT6, facilative glucose transporters

2014 European Medicines Agency - EPARs

148. Rixubis - nonacog gamma

on the 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/0159/2012 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0159/2012 was not yet completed as some measures were deferred. Information relating to orphan market exclusivity Similarity (...) gamma and its effects on the cardiovascular and respiratory system. The highest dose tested (750 IU/kg bw) in animals with normal haemostasis was 10 times the intended maximum human prophylactic clinical dose (75 IU/kg). Assessment report EMA/702760/2014 Page 20/103 Table 2: Overview Safety Pharmacology Studies Wessler score was used to measure thrombogenicity, this is based on 7-part ordinal scale (0, 0.5, 1, 2, 3, 3.5, 4), where 0 = no thrombus formation, 4 = high thrombus formation 1 (Wessler S

2014 European Medicines Agency - EPARs

149. SNMMI Procedure Standard for Sodium 18F-Fluoride with PET/CT Bone Scans 1.1

). For a typical activity of 370 MBq (10 mCi), the effective dose is 8.9 mSv (0.89 rem). For comparison, the effective dose for 99m Tc-MDP is 0.0057 mSv/MBq (0.021 rem/mCi). For a typical activity of 925MBq(25mCi),theeffectivedoseis5.3mSv(0.53rem). Thus,theradiationdosetopatientsisapproximately70% higher using 18 F-?uoride (370 MBq · 0.024 mSv/MBq5 8.9 mSv) than using 99m Tc-MDP. A radiation dose comparison between 18 F-?uoride and 99m Tc-MDP is presented in Table 1, and fetal dose esti- mates are presented (...) of 2.0 h, dose to bladder wall would change by factor of 2/3.5. Data are from the International Commission on Radiological Protection (42,43). TABLE 2 The Pregnant or Potentially Pregnant Patient: Fetal Dose Estimates Stage of gestation Estimated mean dose Estimated dose range 18 F-?uoride* Early 0.022 mGy/MBq (0.081 rad/mCi) 4.1–8.1 mGy (0.41–0.81 rad) 3 mo 0.017 mGy/MBq (0.063 rad/mCi) 3.1–6.3 mGy (0.31–0.63 rad) 6 mo 0.0075 mGy/MBq (0.028 rad/mCi) 1.4–2.8 mGy (0.14–0.28 rad) 9 mo 0.0068 mGy/MBq

2010 Society of Nuclear Medicine and Molecular Imaging

150. Clinical Care Guidelines for Cystic Fibrosis-Related Diabetes

protocol ( ). Patients fast for at least 8 h (water is permitted) and should consume a minimum of 150 g (600 kcal) of carbohydrate per day for the preceding 3 days (generally not an issue because CF patients have high-calorie diets). The patient drinks a standard beverage containing 1.75 g/kg glucose (maximum 75 g) dissolved in water and sits or lies quietly for 2 h. Glucose levels are measured at baseline and 2 h. Unless the patient is experiencing classical symptoms of polyuria and polydipsia (...) be confirmed by laboratory plasma glucose measurement. CF patients with acute pulmonary exacerbation requiring intravenous antibiotics and/or systemic glucocorticoids should be screened for CFRD by monitoring fasting and 2-h postprandial plasma glucose levels for the first 48 h. If elevated blood glucose levels are found by SMBG, the results must be confirmed by a certified laboratory. (ADA-E; Consensus) Screening of CF patients during continuous drip enteral feedings Supplemental continuous drip feedings

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2010 Cystic Fibrosis Foundation

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

be trained in techniques for plasma and red cell exchange, photophoresis, stem cell collection and cord blood collection. Health workers may need to collect specimens from in-dwelling central lines or arterial lines. Training should include techniques that ensure that the specimen collected will be adequate, and measures that reduce the risk of contamination, clerical error, infection and injury. When taking blood, health workers should wear well-fitting, non-sterile gloves, and should also carry out

2010 World Health Organisation Guidelines

152. Is capillary refill time a useful marker of haemodynamic status in neonates?

No significant interobserver variability. No long-term follow-up of sample Raju et al, 1999 137 Normal newborn term infants, single unit (45, 2b, Prospective cohort study with poor follow-up Triplicate measurement. Mean (SD, 95th centile) Temperature. 4.23 s (1.47 s, 7.11 s) CRT: 4.64 s (1.41 s, 7.4 s) Hand Decreasing CRT with each subsequent assessment Foot Inverse relation between CRT and temperature No long-term follow-up of sample. Only peripheral CRT measured LeFlore et al, 2005 42 Healthy, term infants (...) CRT and low SVC flow. Area under ROC 0.72 (95% CI 0.64 to 0.80). ≤3 s: LR for low SVC fl ow 2.75. ≤4 s: LR for low SVC fl ow 7.25 Gold standard validated. Appropriate spectrum of patients. Gold standard applied regardless of CRT result. No mention of blinding Miletin et al, 2009 38 VLBW infants, single unit. CRT, BP, serum lactate and UO measured and compared to SVC flow (gold standard), in first 24 h (median 18 h). CRT measured at head, chest and foot. Pressure applied for 5 s 2b, Exploratory

2010 BestBETS

153. Calcium Phosphate Cement Registry (CPC Registry)

/phone calls will be collected (at 3 months (+/-14 days), 6 months (+/- 14 days), 9 months (+/-21 days), 12 months (+/- 30 days) and 24 months (+/-60 days)). Each visit/phone call includes the collection of Adverse Events, the measurement of health status (quality of life and functional scores) and the X-ray scoring (if X-ray imaging is available). No additional exams (other than the routine clinical practice) are requested. The surgeons have to follow their usual practices (e.g. X-Rays have (...) topics: available for: (AHRQ) related information: Groups and Cohorts Go to Outcome Measures Go to Primary Outcome Measures : Adverse Device Effect rate [ Time Frame: For 24 months ] Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients. Secondary Outcome Measures : Technical Success rate [ Time Frame: At surgical procedure ] Technical Success rate defined as successful delivery of the bone substitute in the target defect bone without evidence

2015 Clinical Trials

154. Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient). These anomalies in utero could (...) not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance

2015 Clinical Trials

155. Gestational Age Assessment Tool

characteristics of the face, ear and foot during newborn development. There is an element of subjectiveness which reduces the precision of such an assessment which is only reduced with significant training and experience. Simpler techniques of postnatal gestational age assessment such as anthropometric measures are time consuming and lack the accuracy required. Emerging evidence suggests that gestational age can be calculated postnatally by measuring the newborn foot length and comparing to population (...) : In the UK and worldwide many babies are born without carers knowing their gestation as the mothers will not have had good antenatal care. It is possible to estimate gestation but this requires a detailed clinical exam. The investigators wish to improve this by using software analysis to pick out features of the baby (face and foot) to try and estimate the gestation of the baby once it is born. The investigators will also look explore if the software can distinguish the normal face or a baby

2015 Clinical Trials

156. Telavancin (Vibativ)

period after introduction to the market. A risk evaluation and mitigation strategy (REMS) was also implemented due to the risk of fetal toxicity and the Applicant was required to establish a pregnancy registry to collect data on fetal outcomes in women exposed to telavancin during pregnancy. In pursuit of the indication for the treatment of NP, the Applicant conducted two Phase 3 clinical trials (0015 and 0019) of non-inferiority design. These trials compared the safety and efficacy of telavancin (...) be minimized and rapid de-escalation criteria should be included in the study protocol. In Studies 0015 and 0019, the diagnosis of renal failure was left to the discretion of the investigator, and in some cases it is unclear whether some of the patients may have had acute as well as chronic renal failure. For patients with potential risk factors, renal status should be more specifically defined by standardized measures at entry and followed more closely for at least 28 days in future clinical trials

2013 FDA - Drug Approval Package

157. Dalbavancin hydrochloride (HCl) (Dalvance)

or in combination with a bacterial pathogen. 9. Venous catheter entry site infection. 10.Infections that involved diabetic foot ulceration, a perirectal abscess or a decubitus ulcer. 11.Patient with an infected device, even if the device was removed. Examples included infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysis (...) of study drug. The secondary outcome was clinical status at EOT (Day 14-15) in the CE-EOT and ITT populations. Clinical status was also determined at short term follow-up (SFU) in the CE-SFU and ITT populations. Secondary efficacy outcome measures included evaluation of clinical status at the EOT and SFU visits. Clinical success was defined based on the following: ? The patient’s lesion size, as defined by erythema, had decreased from Baseline; ? The patient’s temperature was =37.6° C (by any

2013 FDA - Drug Approval Package

158. Patient Modesty: Volume 67

. They are open to listening and recognizing what is being said on all these blogs and bulletin boards about patient modesty. Artiger is no different. What I have noticed is that the one measurable item is time. Artiger , you, and all the "good" providers take time to build the trust and relationship with the patient. The "bad" providers take the "get over it approach." This response is very indicative of a "you are wasting my time" scenario. --Banterings At , said... And Banterings, it shouldn't take much (...) principles are violated for whatever reason, often patients are traumatized because they wrongfully assumed that they were in a caring, trusting, environment. While individuals who work in that environment may have those qualities, a hospital is nothing more than an institution with systems in place to make things easy for them. A traumatized individual is not necessarily mentally unstable. What they are, is a product of their experience and instability would need to be measured by a mental health

2014 Bioethics Discussion Blog

159. Sarcoma, Childhood Soft Tissue

in the pediatric age group. J Pediatr Surg 27 (2): 241-4; discussion 244-5, 1992. Rao BN: Nonrhabdomyosarcoma in children: prognostic factors influencing survival. Semin Surg Oncol 9 (6): 524-31, 1993 Nov-Dec. Zeytoonjian T, Mankin HJ, Gebhardt MC, et al.: Distal lower extremity sarcomas: frequency of occurrence and patient survival rate. Foot Ankle Int 25 (5): 325-30, 2004. Benesch M, von Bueren AO, Dantonello T, et al.: Primary intracranial soft tissue sarcoma in children and adolescents: a cooperative (...) Press, 2013. Dantonello TM, Int-Veen C, Leuschner I, et al.: Mesenchymal chondrosarcoma of soft tissues and bone in children, adolescents, and young adults: experiences of the CWS and COSS study groups. Cancer 112 (11): 2424-31, 2008. Steelman C, Katzenstein H, Parham D, et al.: Unusual presentation of congenital infantile fibrosarcoma in seven infants with molecular-genetic analysis. Fetal Pediatr Pathol 30 (5): 329-37, 2011. Evans HL: Low-grade fibromyxoid sarcoma: a clinicopathologic study of 33

2012 PDQ - NCI's Comprehensive Cancer Database

160. Late Effects of Treatment for Childhood Cancer

survivors demonstrate a steeper trajectory of age-dependent decline in health status than do male survivors.[ ] The even-higher prevalence of late effects among clinically ascertained cohorts is related to the subclinical and undiagnosed conditions detected by screening and surveillance measures.[ ] Figure 2. Cumulative incidence of chronic health conditions for (A) grades 3 to 5 chronic health conditions, (B) multiple grade 3 to 5 conditions in survivors, (C) multiple grade 3 to 5 conditions (...) .[ ] Access to health insurance appears to play an important role in risk-based survivor care.[ , ] Lack of access to health insurance affects the following: Cancer-related visits. In the CCSS, uninsured survivors were less likely than those privately insured to report a cancer-related visit (adjusted relative risk [RR], 0.83; 95% CI, 0.75–0.91) or a cancer center visit (adjusted RR, 0.83; 95% CI, 0.71–0.98). Uninsured survivors had lower levels of utilization in all measures of care than privately

2012 PDQ - NCI's Comprehensive Cancer Database

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