Nondisclosure of HIV Status in a Clinical Trial Setting: Antiretroviral Drug Screening Can Help Distinguish Between Newly Diagnosed and Previously Diagnosed HIV Infection

Blockchain technology in a clinical trial setting is a valuable asset due to decentralization, immutability, transparency, and traceability features. For this chapter, a literature review was conducted to map the current utilization of blockchain systems in clinical trials, particularly data security managing systems and their characteristics, such as applicability, interests of use, limitations, and issues. The advantages of data security are producing a more transparent and tamper-proof clinical trial by providing accurate, validated data, therefore producing a more reliable and credible clinical trial. On the other hand, data integrity is a critical issue since data obtained from trials are not instantly made public to all participants. Work needs to be done to establish the significant implications in security data when applying blockchain technology in a real-world clinical trial setting and generalized conditions of use to establish its security.

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Ibrutinib monotherapy outside of clinical trial setting in Waldenström macroglobulinaemia: practice patterns, toxicities and outcomes

British Journal of Haematology ◽

10.1111/bjh.16168 ◽

2019 ◽

Vol 188 (3) ◽

pp. 394-403 ◽

Cited By ~ 9

Author(s):

Jithma P. Abeykoon ◽

Saurabh Zanwar ◽

Stephen M. Ansell ◽

Morie A. Gertz ◽

Shaji Kumar ◽

...

Keyword(s):

Clinical Trial ◽

Practice Patterns ◽

Clinical Trial Setting ◽

Trial Setting

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Implementing a standard-of-care clinic for stroke prevention in children with sickle cell disease in Nigeria: a feasible strategy outside a clinical trial setting

Blood Advances ◽

10.1182/bloodadvances.2017gs101266 ◽

2017 ◽

Vol 1 (Suppl) ◽

pp. 23-25

Author(s):

Najibah A. Galadanci ◽

Shehu U. Abdullahi ◽

Leah D. Vance ◽

Musa A. Tabari ◽

Shehi Abubakar ◽

...

Keyword(s):

Clinical Trial ◽

Sickle Cell Disease ◽

Sickle Cell ◽

Stroke Prevention ◽

Standard Of Care ◽

Cell Disease ◽

Care Clinic ◽

Clinical Trial Setting ◽

Trial Setting

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Clinical and laboratory characteristics of ocular syphilis and neurosyphilis among individuals with and without HIV infection

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-315699 ◽

2020 ◽

Vol 105 (1) ◽

pp. 70-74 ◽

Cited By ~ 2

Author(s):

Dony Mathew ◽

Derrick Smit

Keyword(s):

Hiv Infection ◽

Posterior Uveitis ◽

Intraocular Inflammation ◽

Hiv Positive ◽

Newly Diagnosed ◽

Hiv Status ◽

Ocular Syphilis ◽

Bilateral Involvement ◽

Frequent Form ◽

Hiv Coinfection

Background/aimsIn the era of increasing incidence of syphilis globally, ocular syphilis is re-emerging as an important cause of uveitis. The aim of this study was to determine the clinical and laboratory characteristics of ocular- and neurosyphilis among individuals with and without HIV infection.MethodsRetrospective analysis of patients diagnosed with ocular syphilis presenting to Tygerberg Hospital, South Africa, over a 5-year period ending December 2018.ResultsTwo-hundred and fifteen eyes of 146 patients were included. HIV coinfection was present in 52.1% of the patients, with 23.7% of these patients being newly diagnosed on presentation. The median age was 36.5±9.8 years. Bilateral involvement occurred in 47.3%, with 68.1% of these patients being HIV positive. The most frequent form of intraocular inflammation was posterior uveitis (40.9%), followed by panuveitis (38.1%), both of which were more predominant in HIV-positive eyes. Seventy-four per cent of all eyes had a visual acuity ≤20/50 and 40% <20/200 at presentation. A lumbar puncture was performed in 113 patients (77.4%). Sixteen patients had confirmed neurosyphilis and 27 probable neurosyphilis according to the UpToDate algorithms.ConclusionThis study included the largest number of ocular syphilis cases with the largest proportion of HIV infection to date. Forty-three of 146 patients (37.0%) had neurosyphilis. HIV status must be determined in all patients with ocular syphilis since almost ¼ of patients were newly diagnosed with HIV infection by doing so.

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FOLFIRINOX in locally advanced or metastatic pancreatic cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.313 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 313-313 ◽

Cited By ~ 4

Author(s):

Jason Edward Faris ◽

Theodore S. Hong ◽

Shaunagh McDermott ◽

Alexander R Guimaraes ◽

Dushyant Sahani ◽

...

Keyword(s):

Pancreatic Cancer ◽

Clinical Trial ◽

Advanced Disease ◽

Locally Advanced ◽

Phase Iii ◽

Metastatic Pancreatic Cancer ◽

Clinical Trial Setting ◽

Locally Advanced Disease ◽

Grade 3 ◽

Trial Setting

313 Background: The recently published Phase III trial of 5-FU, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) demonstrated improved survival compared to gemcitabine in good performance status (PS) patients with metastatic pancreatic cancer (Conroy et al, NEJM 2011). Less is known about the efficacy and tolerability with FOLFIRINOX in the non-clinical trial setting. In this retrospective analysis, we report our institutional experience with FOLFIRINOX. Methods: 29 patients with locally advanced or metastatic pancreatic cancer treated with FOLFIRINOX between July 2010 and April 2011 were used for this analysis. Clinical characteristics, and gradeable toxicities were tabulated, and formal radiographic review performed to determine best overall response rates (ORR). Results: 17 patients received FOLFIRINOX for metastatic disease and 12 patients for locally advanced disease. The median age of patients was 60 (range 39-76). 22/29 patients were men. 18/29 patients had received no prior chemotherapy. There was one patient with PS 2; all others had PS 0 or 1. 8/29 patients had biliary stents. Overall, 11 partial responses (PR) were observed (ORR 38%); 10/11 partial responses were in chemo-naïve patients, who had an ORR of 56%. In the metastatic setting, there were 6 PR, for an ORR of 35%, and 7 patients with stable disease (SD). In the locally advanced setting, there were 5 PR (ORR 42%), and 7 patients with SD. Following treatment with FOLFIRINOX, one patient with locally advanced disease has subsequently undergone R0 resection. The median number of cycles performed was 8 in both the locally advanced and metastatic settings. 12/29 patients required an ED visit or hospitalization during treatment. Grade 3/4 neutropenia was observed in 10 patients; 7/10 had not received prophylactic growth factor treatment from the start of FOLFIRINOX. 4 patients developed febrile neutropenia, 4 patients developed grade 3/4 thrombocytopenia, and 1 patient developed grade 4 anemia. Conclusions: In a non-clinical trial setting, FOLFIRINOX demonstrated activity in both the metastatic and locally-advanced settings. FOLFIRINOX appears to be associated with manageable, but significant toxicities, with over 40% of patients requiring hospitalization.

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