A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa.

开始日期2021-10-01

申办/合作机构

Holdsworth House Medical Practice

[+1]

NCT04161014

/ Recruiting临床2期

The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial

Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.
Subjects will be treated with Nintedanib 150mg twice daily for 3 years.

开始日期2020-10-09

申办/合作机构

Holdsworth House Medical Practice

[+1]

NCT04354818

/ Unknown statusN/AIIT

Coronavirus Outcomes Registries in Immunocompromised Individuals Australia (CORIA): a Multisite Registry and Optional Biorepository in People With COVID-19 and Selected Conditions Affecting Immune Function

CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.

开始日期2020-05-11

申办/合作机构

Kirby Institute

[+12]

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项与 Holdsworth House Medical Practice 相关的文献（医药）

2024-11-27·Open Forum Infectious Diseases

Control and Elimination of Hepatitis C Virus Among People With HIV in Australia: Extended Follow-up of the CEASE Cohort (2014–2023)

Article

作者: Shaw, David ; Filep, Ecaterina ; Dore, Gregory J ; Bloch, Mark ; Read, Phillip ; Baker, David ; Hosseini-Hooshyar, Samira ; Finlayson, Robert ; Post, Jeffrey J ; Matthews, Gail V ; Doyle, Joseph ; Carson, Joanne M ; Hellard, Margaret ; Martinello, Marianne

AbstractBackgroundApproximately 10% of people with HIV in Australia had active hepatitis C virus (HCV) infection prior to availability of government-subsidized direct-acting antiviral (DAA) therapy in 2016. This analysis evaluated progress toward HCV elimination among people with HIV in Australia between 2014 and 2023.MethodsThe CEASE cohort study enrolled adults with HIV with past or current HCV infection (anti-HCV antibody positive) from 14 primary and tertiary clinics. Biobehavioral, clinical, and virologic data were collected at enrollment (2014–2016), follow-up 1 (2017–2018), and follow-up 2 (2021–2023). HCV treatment uptake, outcome, and HCV RNA prevalence (current infection) were evaluated. Death and HCV reinfection incidence and risk were assessed.ResultsOf 402 participants, 341 (85%) had current HCV infection (RNA positive) at enrollment. Among the sample, 83% were gay and bisexual men, 13% had cirrhosis, and 80% had a history of injecting drug use (42%, past 6 months). DAA treatment was scaled up rapidly, with cumulative treatment uptake increasing from 12% in 2014 to 2015 to 92% in 2022 to 2023. HCV RNA prevalence declined from 85% (95% CI, 81%–88%) at enrollment (2014–2016) to 8% (95% CI, 6%–12%) at follow-up 1 (2017–2018) and 0.5% (95% CI, 0%–3%) at follow-up 2 (2020–2023). Sixteen reinfections occurred (incidence, 1.41 per 100 person-years; 95% CI, .81–2.29) as well as 30 deaths (incidence, 1.64 per 100 person-years; 95% CI, 1.11–2.34). HCV reinfection incidence declined over time while mortality remained stable.ConclusionsUniversal access and rapid DAA uptake were associated with a dramatic reduction in HCV prevalence and reinfection incidence among people with HIV to levels consistent with microelimination.Registration: NCT02102451 (ClinicalTrials.gov).

2024-10-30·Open Forum Infectious Diseases

4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults

Article

作者: Langley, Joanne ; Wauters, Dominique ; Carter, Robert ; Dionne, Marc ; Finn, Daniel ; Staben, Jonathan ; Rok, Walter ; Langley, Joanne M ; Schear, Martin ; Tipton, Mary ; Cetin, Benhur ; Jeanfreau, Robert ; Nolan, Terry ; Ackerman, Ronald ; Ukkonen, Benita ; Toneatto, Daniela ; Pelayo, Enrique ; Spaziererova, Martina ; Surber, Joseph ; Morelle, Danielle ; Richmond, Peter C ; Osowa, Alexander ; Patel, Minesh ; de Looze, Ferdinandus ; Bloch, Mark ; Cetin, Benhur S ; Willemsen, Arnold ; Tapiero, Bruce ; Vale, Noah ; Farjo, Rand ; Rouhbakhsh, Rambod ; Bhusal, Chiranjiwi ; Zemanek, Josef ; Dzongowski, Peter ; Gupta, Anil ; Adamovska, Renata ; Silas, Peter ; Ulukol, Betul ; Gottfredson, Ryan ; Rämet, Mika ; Sadarangani, Manish ; Beran, Jiří ; Kiiroja, Kaia ; Laajalahti, Outi ; Lattanzi, Maria ; Paavola, Pauliina ; Pavlasek, Miroslav ; Bernard, David ; Simon, William ; Chakerian, Maia ; Raulier, Stefanie ; Freeman, George ; Athan, Eugene ; Vachon, Marie-Louise ; Jones, Jake ; Scott, John ; Dinleyici, Ener Cagri ; Grubb, Paul ; Dražan, Daniel ; Ince, Tolga ; Mehta, Hemalini ; Dalebout, Marije ; Seppä, Ilkka ; Byars, William ; Meisalu, Sandra ; Tiong, Florence ; Dinleyici, Ener C ; Sanchez, Yamirka ; Trapani, Mauro ; Kokko, Satu ; Ayesu, Kwabena ; Kellner, James ; Koski, Susanna ; Lechevin, Isabelle ; Richmond, Peter

AbstractBackgroundMeningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0–2, 0–6, or 0–2–6 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains.MethodsIn a phase 3 trial, 3651 healthy 10- to 25-year-old participants were randomized 5:5:9:1 to receive 4CMenB (0–6 schedule), 4CMenB (0–2–6 schedule), investigational MenABCWY vaccine, or control MenACWY-CRM vaccine. The primary objectives were to evaluate safety and demonstrate breadth of immune response by enc-hSBA assay against the MenB strain panel using test-based (percentage of samples without bactericidal activity against strains after 4CMenB vs control vaccination) and responder-based (percentage of participants whose postvaccination sera kill ≥70% strains) approaches. Success was demonstrated with 2-sided 97.5% confidence interval (CI) lower limit >65%. Immunogenicity was assessed by traditional hSBA assay against four indicator strains.ResultsBreadth of immune response (test-based) was 78.7% (97.5% CI, 77.2–80.1), 81.8% (80.4–83.1), 83.2% (81.9–84.4) for the 0–2, 0–6, and 0–2–6 schedules, respectively, and (responder-based) 84.8% (81.8–87.5), 89.8% (87.2–92.0), and 93.4% (91.2–95.2), respectively. No clinically relevant differences in immunogenicity were observed across schedules. 4CMenB was well tolerated.ConclusionsThe 2-dose (0–2, 0–6) 4CMenB schedules met predefined criteria for success for both breadth of immune response endpoints against a diverse MenB strain panel, had comparable immunogenicity, and safety in line with the established 4CMenB safety profile. The 3-dose schedule provided no additional immunological benefit, supporting use of the 4CMenB 0–2 schedule.

2024-10-01·International Journal of Transgender Health

“Ever since I knew I was trans I knew I wanted hormone therapy”: a qualitative exploration into the journey of Australian trans individuals accessing feminizing gender-affirming hormone therapy

Article

作者: Warzywoda, Sarah ; Dean, Judith A. ; Wood, Penny ; Franks, Nia ; Bisshop, Fiona ; Fowler, James A.

BackgroundFor many trans folks, gender-affirming hormone therapy (GAHT) is a desired affirming procedure that has been linked with positive health outcomes, however literature has had little focus on the journeys of trans people as they access GAHT.AimTo understand trans people's journey of accessing GAHT to delineate supports necessary to better engage trans individuals into gender-affirming care.MethodThis study conducted semi-structured interviews with a sample of 15 Australian trans adults who participated in a larger study investigating the effects of a cyproterone acetate titration protocol.FindingsA four-factor thematic structure was created from the data. Theme one describes early cognizance of being trans and the pivotal moments in their trans realization. The second theme explores the rapid engagement with community to begin accessing information and affirming healthcare, including GAHT. The third theme explores barriers to engaging in GAHT and theme four reflects on advice participants have for other trans people who are considering GAHT.ConclusionFindings from this study emphasize the importance of providing support to young trans people to help reconcile their gender identity and assist them to engage into care as early as possible. It also highlights the key role that community plays in providing links to affirming information and providers of GAHT - but also emphasizes the importance of considering how to engage with community who may be missed. The experience of accessing GAHT is personal and contextual, but signaling of affirming safe spaces and access to salient information may be key strategies to better support trans people choosing to access GAHT.

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