France-based CARMAT, the developer of the most advanced total artificial heart in the world aimed at offering therapeutic alternatives for end-stage biventricular heart failure patients, has recently released additional interim data from the PIVOTAL study in San Francisco, California, at the American Society for Artificial Internal Organs (ASAIO) Annual Conference 2019.

In the completed dose escalation portion of the study (Part 1), which was primarily designed to determine safety and pharmacodynamic activity of BMN 250, three patients received escalating doses (30mg, 100mg, 300mg) of BMN 250 over 9 to12 months. Cerebrospinal fluid (CSF) heparan sulfate (HS) levels, which were markedly elevated at baseline, were reduced to the non-affected or normal range in all three patients, whether assessed as total or disease-specific HS. Sanfilippo B patients are missing one of four enzymes for HS degradation.. In those same patients, abdominal MRI scans showed significantly enlarged liver size at baseline followed by rapid decreases in liver size into the normal range for age with BMN 250 treatment, suggesting that ICV-administered BMN 250 reaches the peripheral circulation and may have activity in somatic organs. In contrast, most Sanfilippo B patients enrolled in BioMarins concurrently-running observational study (250-901) had increased liver size at baseline and ...

AMO Pharma has been conducting a Phase 2a clinical trial of Tideglusib (also known as AMO-02) for adolescents and adults with congenital myotonic dystrophy. Tideglusib is an antagonist for GSK3β, a cell signaling molecule thought to play a role in the pathogenesis of myotonic dystrophy. The AMO clinical trial is a single-blind study of 400 mg and 1000 mg doses of Tideglusib; single-blind means that those conducting the trial know the dose that each patient received and there was no placebo control included in the study. The study is being conducted at Newcastle University.. AMO recently reported interim data from the first cohort of 8 patients who received the 1000 mg dose of Tideglusib. Small, Phase 2a studies such as this are informative as to whether the candidate therapeutic is safe and well-tolerated. AMO reported that no trial subjects withdrew from the study as a result of adverse events or other issues.. Phase 2a studies also are used as a pilot to determine proof of the scientific ...

FAIRWAY, Kan., March 17, 2020 /PRNewswire/ -- Artio Medical, a medical device company developing innovative products for peripheral vascular and neurovascular diseases, announced today the recent presentation of interim nonclinical study results at the ABC-WIN Seminar in Val dIsere, France. Presented by Dr. Blaise Baxter, a neurovascular and peripheral interventional radiologist, the interim data demonstrated that use of the Endura(TM) Embolization System in bifurcation aneurysms can result in greater aneurysm occlusion and lower coil prolapse into parent arteries when compared to commercially available coil-only treatments. The Endura Embolization Device covers the aneurysm neck and provides a platform to embolize the remainder of the aneurysm sac, said Dr. Baxter, an investor and consultant to the Company. I am pleased to be the first to present the Endura technology to my peers. It is exciting to have this promising option on the horizon, and I believe it has the potential to ...

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced interim data from a Phase I study of their novel orally administered Brutons tyrosine kinase (Btk) inhibitor PCI-32765 in patients

DuoCort Pharma AB has announced that targeted enrolment is now complete in the pivotal phase II-III clinical trial evaluating 5mg and 20mg DuoCort dual-release hydrocortisone tablets for the treatment of adrenal insufficiency - the inability of the body to produce sufficient amounts of the essential hormone cortisol.. With a target of 56 patients, the five sites participating in the trial have now enrolled 59 patients.. Given the small patient numbers in this rare disease, inclusion of identified patients is continuing and will close at the end of the year.. The trial protocol was reviewed by EMEA in a protocol assistance procedure under the orphan drug programme and accepted as a pivotal study.. DuoCort was designated as an orphan drug in the EU in May 2006.. Interim data from the study are expected to be available later next year.. The pivotal phase II-III trial is a controlled study assessing the pharmacokinetics, safety and tolerability of once-daily DuoCort in comparison to conventional ...

Atrium Medical Corporation (Atrium) has released the interim results from the COBEST clinical study. This study is to evaluate the use of bare metal stents vs. balloon expandable covered stents for the treatment of aorto-iliac occlusive disease. Prof. Patrice Mwipatayi of Royal Perth Hospital, Australia, presented interim data on the Covered versus Balloon Expandable Stent Trial known as COBEST at the 2009 VIVA (Vascular InterVentional Advances) meeting in Las Vegas. COBEST is a randomized, multi-center, prospective trial comparing Atriums proprietary balloon expandable covered stent technology (Advanta V12 covered stent) to bare metal stents (BMS) commonly prescribed for iliac occlusive vessel disease.. This important clinical study randomized 167 limbs (123 patients) from 12 hospital centers across Australia. Patients were included if they had occlusive disease and lesions categorized as TASC B, C, or D vessel lesions in their iliac blood vessels. In the study, 83 limbs were randomized to the ...

Bluebird lays claim to another lentiviral-based gene therapy that might not be too far away from regulatory approval. Lenti-D is being evaluated in a phase 2/3 clinical study for treatment of rare genetic disease cerebral adrenoleukodystrophy (CALD). Interim data from that study presented earlier this year was encouraging.. The biotech has one other clinical trial in progress with its partner, Celgene. The phase 1 study of chimeric antigen receptor (CAR T) drug candidate bb2121 is focused on treatment of relapsed/refractory multiple myeloma. Bluebird also has several pre-clinical studies under way.. Inovio has a diverse pipeline lineup, although most of the candidates are only in early stage clinical trials. The company is collaborating with AstraZenecas MedImmune subsidiary on testing of INO-3112, a combination of VGX-3100 and a DNA-based immune activator, in treating cervical cancer as well as head and neck cancer.Inovios pipeline also includes three other phase 1 clinical trials for cancer ...

This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men.. Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ ...

This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men.. Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ ...

CAMBRIDGE, Mass. - bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, today announced that interim data from the ongoing Phase 2/3 Starbeam Study (ALD-102) for the treatment of cerebral adrenoleukodystrophy (CALD) will be presented in an oral presentation during the Clinical Trials plenary session on April 20, 2016 at the American Academy of Neurology (AAN) 2016 Annual Meeting. The meeting is being held April 15 - 21, 2016 in Vancouver, BC, Canada.. The childhood form of cerebral adrenoleukodystrophy is a devastating neurodegenerative genetic disease that affects boys and is generally fatal if left untreated. Allogeneic hematopoietic stem cell transplant (allo-HSCT) is currently the only available effective therapy, but is potentially associated with serious safety risks, including graft rejection, graft-versus-host disease and transplant-related ...

3.37 Defence confirmed to the ANAO that there is currently no central management of compliance with tolerances through variance analysis. Defence explained that the data structure of their fuels management software does not allow for this process to be undertaken easily or conducted within reasonable timeframes.. 3.38 In a November 2017 minute to the service chiefs the Commander Joint Logistics sought assistance to reinforce with local unit commands, base support managers and with Defence and contracted Operating Agents: the importance of accurate and responsive reporting of all fuel incidents and near misses; effective risk assessments during non-routine activities; and maintaining accurate fuel inventory records and dipping of tanks in accordance with extant policy.. 3.39 In addition, Defence advised the ANAO that it is currently working to produce a global report on variances using an interim data warehouse and reporting tool that captures data on a daily basis. The aim is to have this report ...

The Elephant is The Evidence-Epidural Steroids: Edited & Updated 1/7/2013. Epidural steroids are commonly used to treat sciatica (pinched spinal nerve) or low back pain. As of January 7, 2013 at least 40 deaths have been linked to fungal meningitis thought to be caused by contaminated epidural steroids, and 664 cases in 19 states have been identified with a clinical picture consistent with fungal infection [CDC]. Interim data show that all infected patients received injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center, located in Framingham, MA. On October 3, 2012, the compounding center ceased all production and initiated recall of all methylprednisolone acetate and other drug products prepared for intrathecal administration.. Thousands of patients receive epidural steroids without significant side effects or problems every week. In this case, patients received steroids that were mixed by a compounding pharmacy and contamination of ...

Online Training: Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonization (ICH) for the design, conduct, performance, monitoring, auditing, recording, analyzes and reporting of clinical trials that involve the participation of human ...

Abstract. A Good Clinical Practices (GCPs) course, based on the combination of theoretical modules with a practical training in real-life conditions, was held in 2010 in Burkina Faso. It was attended by 15 trainees from nine African, Asian, and Latin American countries. There were some discrepancies between the average good results at the end of the theoretical phase and the GCP application during the first days of the practical phase, underlying the difficulties of translating theoretical knowledge into good practices. Most of the findings were not unexpected and reflected the challenges commonly faced by clinical investigators in resource-poor contexts (i.e., the high workload at peripheral health facilities, the need to conciliate routine clinical activities with clinical research, and the risk of creating a double standard among patients attending the same health facility [free care for recruited patients versus user fees for non-recruited patients with the same medical condition]). Even if limited

Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice.

OBJECTIVES: To address issues about data monitoring committees (DMCs) for randomised controlled trials (RCTs). DATA SOURCES: Electronic databases. Handsearching of selected books. Personal contacts with experts in the field. REVIEW METHODS: Systematic literature reviews of DMCs and small group processes in decision-making; sample surveys of: reports of RCTs, recently completed and ongoing RCTs and policies of major organisations involved in RCTs; case studies of four DMCs; and interviews with experienced DMC members. All focused on 23 prestated questions. RESULTS: Although still a minority, RCTs increasingly have DMCs. There is wide agreement that nearly all trials need some form of data monitoring. Central to the role of the DMC is monitoring accumulating evidence related to benefit and toxicity; variation in emphasis has been reflected in the plethora of names. DMCs for trials performed for regulatory purposes should be aware of any special requirements and regulatory consequences. Advantages were

RaptormanReports The Joint Analysis Report (JAR) prepared by the Department of Homeland Security (DHS) and the Federal Bureau of Investigation (FBI) released on December 29, 2016 is being held up by mainstream as some sort of proof that The elections were hacked. What ever that means. Almost no one believes this fairy tale but it is still propagated for…

AT&T Digital Life only available in select areas in limited markets. AT&T Certified Like New Equipment provided: used equipment is fully inspected and tested. Equipment fee and monthly service charges apply. Add a Package: An addition of an Automation package is an upgrade that requires a new 2-year Automation package agreement with early termination fee. Early Termination Fee: After 14 days from installation of service/upgrade customer keeps equipment and early termination fee of up to $640 applies for all alarm monitoring packages (Smart Security; Smart Security & Automation; and Premium Security & Automation). An additional $50 early termination fee applies for incremental automation packages and customer keeps equipment. If cancelling prior to installation or within 14 days of installation, all Equipment must be returned subject to restocking fee. Restocking Fee: Up to $99 restocking fee may apply to returned equipment. Service Restrictions: Residential customers in residential buildings ...

Background In 2010, after regulatory review of rosiglitazone licensing, the US Food and Drug Administration (FDA) requested a reevaluation of cardiovascular end points in the RECORD trial.. Methods Automated screening of the original clinical trial database and manual case report form review were performed to identify all potential cardiovascular and noncardiovascular deaths, and nonfatal myocardial infarction (MI) and stroke events. Search techniques were used to find participants lost to follow-up, and sites were queried for additional source documents. Suspected events underwent blinded adjudication using both original RECORD end point definitions and new FDA end point definitions, before analysis by the Duke Clinical Research Institute.. Results The reevaluation effort included an additional 328 person-years of follow-up. Automated screening identified 396 suspected deaths, 2,052 suspected MIs, and 468 suspected strokes. Manual review of documents by Duke Clinical Research Institute clinical ...

The global COVID19 Pandemic has impacted not only drug development and clinical trial conduct worldwide, but the entire healthcare paradigm. Within months of the initial spread of COVID19, clinical trials sites globally were shut down, patient access to sites as well as staff access to sites was severely limited, and as a result so was data creation, data collection and source document verification. Telehealth visits, as well as remote patient monitoring went from a rarity to a standard of care - in some cases Telehealth use increased up to 5000% beyond pre-COVID19 levels. Clinical Data Management methodologies had to rapidly evolve to ensure data and trial integrity using both existing and novel technologies to solve for Remote Patient Monitoring, Remote Data Capture and Remote Data Monitoring. CDM technologies such as IoMT and EHR integration, the use of AI and ML all will be essential to a Post COVID19 trial paradigm. To solve the COVID19 global pandemic will require hundreds of thousands of ...

It is important to follow your Institutional Review Board (IRB) approved protocol as written. Providers are trained from the very beginning to use their judgment and make decisions that are best for their patient. In research, providers must follow the protocol. The only time it is acceptable to deviate from the protocol is when there is a risk to your study patients safety. Many investigators have both clinical roles and responsibilities in addition to research roles and responsibilities; often it can be challenging to wear both hats simultaneously. Be aware of this when making decisions and ask for help or a gut check when you need it. Creating thorough source documents at the beginning of the study will keep the study team on track with protocol compliance.. ...

I was very fortunate to present at EMA last week on results of a Phase 3 study where risk-based monitoring was performed in a clinical trial that also used direct data entry (DDE) at the time of the clinic visit. As a result of DDE, there was minimal source document verification (SDV), and when we did SDV, around only 1% or forms, not variables, were changed. We are sharing a redacted CDMoP from that study. For peer-reviewed publications, please visit our website at www.targethealth.com. A very

Use the Tags Pane to fix any issues that cannot be fixed with the TouchUp Reading Order tool. The Tags Pane displays all tags in a nested tree, so users are able to see the structure of their document. Although the Tags Pane may appear daunting, be aware that if you convert an accessible source document, such as a Microsoft Word document, into a PDF, many of your tags should already be in the proper order.. ...

OurDocuments.gov. Featuring 100 milestone documents of American history from the National Archives. Includes images of original primary source documents, lesson plans, teacher and student competitions, and educational resources.

Opposing Viewpoints in Context is the starting place for those seeking contextual information and opinions on hundreds of todays hottest social issues. It features continuously updated viewpoint articles, topic overviews, full-text magazines, academic journals, news articles, primary source documents, statistics, images, videos, audio files and links to vetted websites organized into a user-friendly portal experience. The place to go for persuasive speech or debate assignments ...

The use of predefined system test attributes in the SMIL BasicContentControl module provides a selection mechanism based on attributes that are fixed within the modules definition. The CustomTestAttribute module extends this facility with the definition of author-defined custom test attributes. Custom test attributes allow presentation authors to define their own test attributes for use in a specific document. Custom test attributes may be shared among application documents using the uid attribute.. As with system test attributes, custom test attributes may be used within timing structure and media object elements; if they evaluate to true, the containing element is activated and if they evaluate to false, the containing element is ignored. In this version of SMIL, an ignored element will be treated as if it were not part of the source document. As a result, any element referencing the ID of the ignored node will, in effect, reference an invalid ID. Languages that integrate this module must ...

The project team aimed to produce transcripts which reproduced the text of the original source document as much as possible, retaining the original spellings, layout and punctuation. The letters u, v, i and j have been shown as they appear, rather than edited to conform to modern usage. The letters thorn (þ) and yogh (з) are retained, in both upper and lower case forms. However, the initial letter of each verse line has been transcribed in upper-case, whether or not this is shown on the document. Line breaks have been maintained.. No punctuation has been added unless it is shown on the page, and scribal errors have not been corrected. Words missed out and then inserted by the scribe over a caret mark are transcribed where they were intended to appear. Words lost because of damage to the document have been inserted in square brackets, if it has proved possible to reconstruct them from published editions or the sense of the text.. Abbreviations have been extended, and are shown in the ...

Describes how local development & social economy have become more important than before in the new environment. Taken separately, these two elements do not constitute a new model of development in the new conjuncture, however, they represent unavoidable elements for rethinking the future, & for economic democratization. Preliminary remarks about different components of the new environment & the factors that contributed to its production are offered. A distinction is made between the old & new local development, from the point of view of territory & social connections, showing how it offers interesting opportunities for rethinking relations between the economy & the social. Social conomys place in the new environment is determined by demonstrating that the entire economy is social, & that it is linked to the models of development. Clarifications about what must be understood by the notion of the new social economy are presented. 24 References. Adapted from the source document ...

Global Status Report on Alcohol 2004 of the WHO (World Health Organization), a leading scientific report produced in 2004 by a large international panel of scientists.. The Levels 1 & 2 were written by Susan Barlow in collaboration with the GreenFacts editorial team.. On the WHO website, the source document can be:. ...

On Tue, May 17, 2011 at 4:09 AM, Markus Ernst ,derernst at gmx.ch, wrote: , While discussing about contenteditable elements, the WYSIWYG aspect was , mentioned. For real WYSIWYG in a text editor of a CMS, Blog, Forum or , whatever, it would be necessary for the contents of the contenteditable , element to: , - Disable the styles of the surrounding page , - Enable the styles of the target page Commonly these are the same, or close to it. Just serve the same stylesheet and apply the same classes or whatever to the contenteditable region as to the final ,div,/,article,/etc. In the cases where the styles are really different, it should be fine to require authors to use an iframe. , Rationale: , - In todays iframe-based online rich text editors, it is common to apply , the styles of the target page of the edited text to the source document of , the iframe. This is not possible in a ,div contenteditable,. , - For many use cases, such as forum and blog entries, or non-fullpage , oriented web content ...

ACC303: Accounting Information Systems is offered online by Saint Leo University. Principles involved in establishing an accounting information system. Included are source documents, internal controls, and the interfaces needed for managerial control of the business. The integration of managerial accounting information needs with the design and implementation of systems is studied.

Automation Scripts. Return the full name of the first node in the node set, including the prefix for its namespace declared in the source document. If no argument is passed, the function returns the full name of the context node.

Build your coding skills with this practical workbook! Matching the chapters in the bestselling Bucks Step-by-Step Medical Coding, this workbook offers coding review and practice with more than 1,200 theory, practical, and reporting exercises. Included are 100 original source documents to familiarize you with reports similar to those you will encounter on the job. Its a complete review of all the code sets covered in the text, including ICD-10-CM, CPT, HCPCS, and inpatient coding!

Note that I dismantled my Linkstation so I could connect the hard drive to my [Linux] PC - this made it easier to deal with replacing filesystems etc. - in particular I didnt need to bother creating custom initrd files (tricky); re-reading the source documents mentioned above (esp. re. Lenny) it is possible to achieve a Squeeze installation without dismantling the device, but I wouldnt count on it: This guide is relatively complex and even if you try to avoid it, theres a fair chance youll need to dismantle the Linkstation to access the drive like this anyway - perhaps to complete a step described here, perhaps to recover from a step that went wrong. Dismantling the device does of course void your warranty and could break your device, lose your data etc. If dismantling the device worries you, I recommend not following this guide. I strongly suggest that you should be comfortable with Linux and working at its command-line before attempting to use this guide - including being able to create or ...

scrambling, however, the first scramble still used the location prefixes (number-two letters-three numbers). The crossword clue possible answer is available in 5 letters.This answers first letter of which starts with R and can be found at the end of N. This is a list of words that end with scrambling. Several methods are disclosed, including using an IP suffix for prefix generation and for decryption, maintaining a pool of pseudo prefixes at the router, using public key encryption and symmetric key encryption, Physical Constants Units of Measure Physical Quantities SI Prefixes Ring Index General Formulae Exact Formulae Source Documents Terms by IUPAC Div. The scrambling sequence generator is initialized with c init = n ID X × 2 14 + n ssf PSSCH × 2 9 + 510 at the start of every PSSCH subframe. According to Google, this is the definition of permutation: Be the first to answer! Use our word search solver, it will build your vocabulary and you will improve your skills naturally. Scrambling ...

Trullion is the first AI-powered Lease Accounting Software that uses modern technology to extract data from source documents and connect it to the audit trail all the way down to the entries. Trullion empowers Accounting leaders to stay confident in their financial data, and lets AI-powered automation deal with lease accounting ...

Designed specifically for high school libraries,MAS Completeis a full-text database providing hundreds of popular high school magazines and reference books. Covering subjects such art, history, sports and music, it also includes thousands of biographies and primary source documents, plus over a million photos, maps and flags ...

Form 1098-C, Contributions of Motor Vehicles, Boats, and Airplanes is a source document that is filed with the IRS by a charitable...

Endpoint adjudication committee assessments help ensure that trial data is accurate and free of bias as possible. Understand how the eAdjudication® platform supports the endpoint adjudication committee through user-friendly cloud-based services, comprehensive features, and capabilities.

This summary provides a selection of the most interesting ASA adjudications in April and highlights the key issues considered in those adjudications…

Social status, social norms, and health-related factors appear to be significant influences on womens consistency of reporting.

Travel Technology has proven its mettle to the DMC operators. Travel Technology has helped DMCs make the presence of their products felt and get more traffic. It has given wings to not only Travelers but agents also.

Chi-Med Announces that Surufatinib Phase III SANET-ep Study Has Met its Primary Endpoint at Interim Analysis in Advanced Non-Pancreatic Neuroendocrine Tumors in China and Will Stop ...

Rhoda Arzoomanian, RN, MSM, joined Yale on April 1, 2014 as associate director of YCCI and Yale Cancer Center. A nationally recognized expert in cancer clinical research, clinical trials databases, and the management of an NCI-designated cancer center, Arzoomanian has over 25 years of clinical research experience. At Yale, her role encompasses clinical research across the medical campus, including Yale Cancer Center. She oversees clinical research regulatory units, developing results-oriented strategies for these areas, as well as testing and verifying compliance and good clinical practices ...

The second edition provides updated examples of how and why the basics of epidemiology are essential to anyone who is required to understand and apply the principles of disease causation and prevention. The book has a particular emphasis on modifiable environmental factors and encourages the application of epidemiology to the prevention of disease and the promotion of health, including environmental and occupational health. It shows how good clinical practice is informed by clinical epidemiology; and its lively, concise style is designed to stimulate a continuing interest in the subject. This edition includes comprehensive chapters on the nature and uses of epidemiology; the epidemiological approach to defining and measuring the occurrence of health-related states in populations; the strengths and limitations of epidemiological study designs, causation, the contribution of epidemiology to the prevention of disease, the promotion of health and the development of health policy, and the role of ...

Alexandra Coghlan-Forbes, Head of Adjudication at The DPS, looks at a case of a landlord claiming a re-protection deposit from a renter leaving a joint tenancy.

Click [2] to Access Audio Press Release -- https://prnewswire2-a.akamaihd.net/p/1893751/sp/189375100/serveFlavor/en... [2]. RARITAN, NJ, July 17, 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today six-month data from the ongoing Phase 1/2 trial (NCT03252847 [3]) of its investigational gene therapy for the treatment of inherited retinal disease X-linked retinitis pigmentosa (XLRP). The interim data showed that low and intermediate doses of the investigational adeno-associated virus retinitis pigmentosa GTPase regulator (AAV-RPGR) were generally well-tolerated and indicated significant improvement in vision. Initial data on the novel AAV-RPGR asset, jointly developed with MeiraGTx Holdings plc, will be available today as a late-breaker, pre-recorded oral presentation at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting.. In patients with XLRP, the photoreceptors in the eye that are responsible for converting light into signals that are sent ...

This press release contains forward-looking statements about ORIC as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding ORICs development plans; the ability of ORIC-101 to overcome resistance in cancer models; plans underlying ORIC-101 clinical trials and development; plans to report interim data from the two ongoing clinical trials of ORIC-101; and the potential advantages of ORICs product candidates. Words such as believes, anticipates, plans, expects, intends, will, goal, potential and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORICs current expectations and involve assumptions that may never materialize or may prove to be incorrect. ...

BARCELONA, Spain, Apr 19, 2012 (BUSINESS WIRE) --Gilead Sciences, Inc. (Nasdaq:GILD) today announced interim data from a Phase 2 trial (ATOMIC) examining a 12-week course of treatment with the once-daily nucleotide GS-7977 plus pegylated interferon (Peg-IFN) and ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. The study found that 90 percent of patients (n=47/52, missing data equals failure analysis) achieved a 12-week sustained virologic response (SVR12), defined as maintaining undetectable viral load (HCV RNA ,25 IU/mL) 12 weeks after the completion of therapy. These findings will be presented today during an oral session at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain. These data suggest that this GS-7977-based regimen could offer most patients with genotype 1 a simple, short, three-month course of treatment with very high cure rates, said Kris ...

bluebird bio (BLUE) announced new interim data from the ongoing HGB-206 Phase 1 multicenter clinical study of LentiGlobin investigational gene therapy in patients with severe sickle cell disease will be presented in an oral presentation on Saturday, June 16 at the 23rd Congress of the European Hematology Association by Julie Kanter, M.D., Medical University of South Carolina, Charleston, South Carolina.. The consistent production of increased amounts of anti-sickling HbAT87Q in the Group C patients reflects the substantial positive impact of the changes introduced with the amended HGB-206 study protocol and refined manufacturing process.. All four Group C patients with greater than or equal to three months follow-up are making over 30 percent anti-sickling HbAT87Q.. The first patient treated, now with six months of follow-up, is producing over 60 percent anti-sickling HbAT87Q with a normal total hemoglobin level of 14.2 g/dL, said David Davidson, M.D., chief medical officer, bluebird ...

Looking for online definition of interim analysis in the Medical Dictionary? interim analysis explanation free. What is interim analysis? Meaning of interim analysis medical term. What does interim analysis mean?

The sponsor is responsible for agreeing with the investigator(s) on the allocation of protocol-related responsibilities, including data processing, breaking of the trial code, handling of statistics, preparation of trial reports, and preparation and submission of documentation to the ethics committee, the drug regulatory authority, and any other required review bodies. This agreement should be confirmed in writing (protocol, contract, or alternative document) prior to the trial. The sponsor may transfer any or all clinical trial-related activities to a scientific body (commercial, academic, or other), or to a contract research organization (CRO). Any such transfer should be documented in writing ...

Evening all, Im an RM SNCO, have served 11 years and have no outstanding RoS to complete. I submitted my application for early termination on JPA...

European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.

The term reproducible research refers to the idea that the ultimate product of academic research is the paper along with the laboratory notebooks [10] and full computational environment used to produce the results in the paper such as the code, data, etc. that can be used to reproduce the results and create new work based on the research.[11][12][13][14][15] Typical examples of reproducible research comprise compendia of data, code and text files, often organised around an R Markdown source document[16] or a Jupyter notebook.[17]. Psychology has seen a renewal of internal concerns about irreproducible results. Researchers showed in a 2006 study that, of 141 authors of a publication from the American Psychology Association (APA) empirical articles, 103 (73%) did not respond with their data over a 6-month period.[18] In a follow up study published in 2015, it was found that 246 out of 394 contacted authors of papers in APA journals did not share their data upon request (62%).[19] In a 2012 paper, ...

A computer method for preparing a summary string from a source document of encoded text. The method comprises comparing a training set of encoded text documents with manually generated summary strings

If you or your kids are fans of Hamilton: the Musical, you might know about the educational program related to the show known as EduHam. When students attend the show they also go through this program where they learn about primary source documents and how Lin-Manuel Miranda used them as he was writing Hamilton, then they research, write and perform their own content based on a historical event or figure.. Since Broadway is shut down with everything else, the program has been moved online through August 2020.. Students can sign up and receive a video greeting from Miranda, access to primary source material related to 45 people, 14 events and 24 key documents on which to base their projects, videos of performances others have done, interviews with cast members and Ron Chernow, who wrote the book that inspired Miranda to write Hamilton and more.. To be honest I kind of want to do this myself.. [Photo: Hamilton the Musical.]. There are lots of music learning resources available online too. Check ...

November 5, 2020 The proposed entombment at Rolphton, Ontario Source document: Draft Environmental Impact Statement for the Nuclear Power Demonstration Closure Project Here is a quote from the document: (emphases in red text added) Normal Evolution ScenarioIn this scenario, the facility is assumed to be closed as planned, with no unforeseen events. Parts of the…

In this free lesson plan, students will use primary source documents to create an original argument to help better understand the Lincoln assassination. They will evaluate the motives of John Wilkes Booth and other conspirators, and why the assassination mattered.

Sixth graders read a high-interest nonfiction article, strengthen comprehension skills by responding to follow-up questions, study a primary source document, and demonstrate critical-thinking skills through document-based questions.

Novoclinica, Inc. is a clinical research organization driven by vision For Better Medicine™. We provide solutions for phase I-IV clinical trials in Russia by improving enrollment into clinical trials and maintaining high level of patient retention. The company operates in compliance with current FDA and ICH guidance on good clinical practice and the conduct of clinical trials (GCP).

Novoclinica, Inc. is a clinical research organization driven by vision For Better Medicine™. We provide solutions for phase I-IV clinical trials in Russia by improving enrollment into clinical trials and maintaining high level of patient retention. The company operates in compliance with current FDA and ICH guidance on good clinical practice and the conduct of clinical trials (GCP).

|p|Gain a solid foundation in clinical research by reviewing the drug development process, the principles of good clinical practice, clinical trial phases and design, the principal players in clinical research and regulatory oversight of medical devices.|/p|

Evive leverages key Contract Research Organizations (CROs) for the management of our global and China clinical trials. We partner with established CROs such as Covance and Everest Clinical Research to ensure patient safety, data integrity, and that Good Clinical Practices are in place and enforced. Working with CROs allows Evive Biotech to leverage internal Medical Affairs and Clinical Operations at scale in our global trials ...

OrbusNeich today announced that an interim analysis of 12-month follow-up data from the global e-HEALING registry show good safety and efficacy in the real-world use of the companys

Seeking to encourage high standards of medical care by promoting good clinical practice and influencing policy, Clinical Medicine is aimed at practicing physicians with general medical commitments in the UK and overseas, and has relevance to all those managing or working within the healthcare sector.

In recent years, the interest in communication issues in cancer care has steadily increased, in particular regarding the information needs of oncology patients, the communication of bad news and the impact of such news on patients, and the development of guidelines on how clinicians can deliver bad news in a sensitive way.1 ,2 Research evidence suggests that patients have varying preferences for the amount and type of information they desire.3 Good clinical practice entails oncologists recognising these variations in patient preferences, and physicians and patients working together to accomplish these preferences. In order to accommodate these varying preferences, the physicians need to elicit patient preferences and to adapt their information giving processes to meet these needs. If the expression of such needs is not facilitated or encouraged, these needs tend to remain hidden; consequently, the patients may perceive that they received too much or too little information. The literature ...

CEDR operate a commercial adjudication service for businesses and the public sector for disputes that require a binding written decision from a qualified neutral.

The Arizona General Stream Adjudication Bulletin is published in January, May, and September. Special reports may be posted to inform readers of significant rulings or breaking news ...

East Player Movement , West Player Movement , Free Agent Tracker , Trade Tracker. All of the transactions listed on this page have been officially announced by the NBA. * = Player Option; ** = Team Option; *** = Early Termination Option ...

An imaginative mixture of education, networking, and play, the Fifth Annual Global Events Partners Retreat in June brought together 250 in-house and third-party planners and representatives from GEP member destination management companies. GEP is a worldwide partnership network of DMCs that allows its members to share referrals and a whole lot more. Chris White, CEO of GEP and its sister site selection

These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will, would, could, should, possible, continue and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by our management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks. The following represent some, but not ...

First Report of MAB Use in Restenosis and Fourth Clinical Indication to Demonstrate Therapeutic Benefit of IL-1a True Human Monoclonal Antibody (MABp1) XBiotech

The need to deliver data at the time of service is critical to enabling a retail healthcare experience for members, minimizing revenue leakage for payers, and increasing collaboration and satisfaction between payers and providers.. NASCO product teams recently collaborated to assess a full end-to-end real-time claims processing integration with a provider portal.. The proposed solution would enable providers to submit claims in real-time and if they successfully finalize, the provider can collect the patients portion of the payment for qualifying products.. Funding is currently being sought. Estimated development time is six to nine months (model office), and nine to 12 months (production). To learn more, contact Tom Russell.. ...

Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim analysis of data from the th