Endoscopy Sample Clauses

Endoscopy. One, or more, imaging techniques associated with endoscopic apparatus, including, without limitation, such apparatus producing pseudo-color images of body tissues (“Endoscopy”).
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Endoscopy. Hours of on-call will be 4:00pm Friday through 7:00am Monday Holiday on-call will be 4:00pm the day before the holiday until 7:00am the day after the holiday. On call during the week will be on a voluntary basis. In the event that there are volunteers, the general provisions for on-call listed above shall apply.
Sample 1
Endoscopy. The Department of Gastroenterology and Endoscopy provides inpatient and outpatient treatment and diagnosis for patients with diseases or disorders of the gastro-intestinal system within NHSG, providing services also for NHS Orkney and Shetland. There are three distinct sub-specialisms within the department, though the specific service affected by this proposal is endoscopy:  Luminal Gastroenterology  Hepatology  Endoscopy Endoscopy services are predominantly provided at ARI though these are also undertaken in Xx Xxxx’x Hospital and at the Aberdeen Health Village (by a 3rd party) and via the Community Hospital Scoping Service – available in Aboyne, Banff, Peterhead, and Stonehaven, undertaken by trained GPs. A ‘hub and spoke’ type model is in place with XXX accepting more complex clinical work and other centres focusing more on disease exclusion. Endoscopic inpatient and day case diagnostic and therapeutic interventions are delivered by Gastroenterologists, General Surgeons, Nurse Endoscopists and GPs with special interest. The Endoscopy service is provided at four sites within ARI. The main endoscopic interventions are grouped under the following:  Diagnostic  Bowel Screening  Emergency  Interventional/therapeutic procedures The Endoscopy unit at ARI has three endoscopy rooms. Each room can support two lists per day and each list has a total of 10 or 12 ‘slots’. Each procedure is allocated a number of required slots:  Colonoscopy three slots  Upper GI one slot  Flexible Sigmoidoscopy one slot  Endoscopy/colonoscopy four slots Demand for colonoscopy has been increasing in the last 3 years as indicated in table S2 below, which shows net additions of patients to waiting lists. There has been a 60% increase in demand for repeat colonoscopy procedures over the 3 year period 2013/14 to 216/17. As is shown in tables S3 and S4, demand for repeat Sigmoidoscopy and Upper GI and has increased by 50% and 25% during the same period. Maintaining activity has been challenging for Colonoscopy which has also experienced increased demand, although activity has also been higher since 2015/16 as an artefact of the 3rd party contract to provide additional Endoscopy activity at the Aberdeen Health Village (AHV) and linked to Waiting List Initiatives. Table S2: Colonoscopy Demand Colonoscopy Demand FY1112 FY1213 FY1314 FY1415 FY1516 FY1617 ARI Booked New Day Case 4296 4011 3759 3787 4552 4655 Repeat Day Case 1012 1095 1007 1230 1618 1609 New Inpatient 297 209 213 182 ...
Sample 1
Endoscopy. Endoscopic examination was performed at Gastroenterology and Gastrointestinal Endoscopy Unit of Siena University Hospital. In all cases chromoendoscopy with indigo xxxxxxx solution (0.5-1.0 %) was used to obtain a precise analysis and classification of the lesions. The elevation or depression of superficial lesions was evaluated with a millimeter scale for the columnar epithelium according to guidelines of Japanese Gastric Cancer Association (11). All endoscopic images, at least 4 per case, were stored electronically for later evaluation using Image Bank Software (United Medical Software- Italy). Endoscopic images were reviewed and the diagnoses confirmed in photographs by the same endoscopists who had made the original diagnoses, according to Paris classification (Table 1). These photographs, without any diagnostic indications, were then sent to Japanese endoscopists working at the National Cancer Center in Tokyo, who subtyped them and sent their diagnoses back to the endoscopists in Siena. A complete intra- and interobserver agreement was reached among Italian endoscopists and among Japanese endoscopists.
Sample 1
Endoscopy. ■ Response and remission as assessed by change in SES-CD score as continuous variable ■ Preferred over CDEIS ■ Central read (e.g., Robarts or BioClinica) ■ Proportion of patients with a 25% or 50% change from baseline in SES-CD ○ PoM endpoints ■ Circulating myeloid cells by flow cytometry [Possibly the fastest endpoint to change in the study] ■ Mucosal Histology (biopsies at baseline and end of study): reduction in inflammatory myeloid cells (DC1, Macrophages) ■ Mucosal mRNA signature: reduction in disease signature, compared to anti-TNF and other benchmarks available [This is the most sensitive endpoint. We will use Jxxxxxx’x tissue mRNA data as benchmark and should see a change if the drug works] ○ PROs ■ Novel Crohn’s endpoint based on SF and AP ○ Biomarkers of inflammation ■ Change in serum CRP: analysis of the subgroup with elevated CRP at baseline ■ Stool calprotectin: reduction in FCP (stool also stored for potential future microbiome analysis), thresholds in fecal calprotectin such as those with FC < 250 or FC <500. - OPERATIONAL CONSIDERATIONS (BASED ON RECENT EXPERIENCE) ○ Countries ■ Target 70% Eastern Europe (Ukraine, Hungry, Poland, Russia) and 30% US/Canada (possible: select EU countries such as Germany, Spain) ○ Enrollment estimates for 70-90 patients ■ Eastern Europe, approximately 0.2-0.3 patients/site/month ■ US/Canada approximately 0.1-0.2 patients/site/month ○ Scree-Failure rate ■ Assuming 50% ○ Number of active sites: ■ 40-50 sites ■ US/Canada: ~20 sites ■ Ukraine: ~10 sites ■ Poland: ~5 sites ■ Hungary: ~5 sites ■ Russia:~5 sites ○ Examples of CROs to be evaluated ■ PSI, Easthorn, Arensia for Eastern Europe ■ Robarts vs Bioclinica for endoscopy ○ Consider also at-home/in-pharmacy visits and remote data collection with the goal of improving ‘enrolability’ and reduce costs.
Sample 1

Related to Endoscopy

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than the term of any Patent issuing therefrom. All other records shall be maintained by each Party during the relevant Research Term and for [**] thereafter. All such records of a Party shall be considered such Party’s Confidential Information.

  • Field The term “

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Technology Discoveries, innovations, Know-How and inventions, whether patentable or not, including computer software, recognized under U.S. law as intellectual creations to which rights of ownership accrue, including, but not limited to, patents, trade secrets, maskworks and copyrights developed under this Agreement.

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