OUH STUDIES

Studies currently being run within Oxford University Hospitals NHS Foundation Trust.

Showing 131 - 140 of 699 studies

Infection

A phase IIa double blind, randomised placebo-controlled trial of Tocilizumab to investigate the effect on health-related quality of life in adults with Long COVID and persistent inflammation (PHOSP-I)

The hypothesis is that subcutaneous Tocilizumab administered for 12 weeks will improve generic health-related quality of life compared to placebo by reducing systemic inflammation and improving symptoms in adults with Long Covid. Primary outcome - to investigate the effect of 12 weeks of subcutaneous (s/c) Tocilizumab compared to placebo on health-related quality of life Secondary outcomes - to investigate the effect of 12 weeks of s/c Tocilizumab compared to placebo on: 1) Symptoms 2) Mental Health 3) Physical Performance 4) Daily physical activity 5) Cognitive impairment 6) Multi-Organ function 7) Systemic inflammation To investigate the ...

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Neurological

An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis. (LTS17043)

This is a Phase 3 extension, global, multicenter, OL study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS16004 study or 1 of the 4 Phase 3 tolebrutinib pivotal studies (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]). The LTS17043 study includes participants with RMS, PPMS, or NRSPMS who have completed the Phase 2b LTS16004 study or 1 ...

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Generic health relevance

How might Physician Associates help (or not) address the workforce crisis in the NHS

Our overall research question is: How might Physician Associates help (or not) address the workforce crisis in the NHS and more particularly are they part of the solution in NHS hospitals? This will be a multiple methods study including five activities. • Activity a: Secondary NHS workforce database analysis where we analyse secondary data analysis from publicly available database,Electronic Staff Records (ESR) and NHS trust and health board HR database Our main objectives for activity A are to (1) explore available administrative ...

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Skin

A phase IV, multi-arm muti-stage, assessor blind randomised control trial comparing the effectiveness, tolerability and cost effectiveness of systemic treatments for adults with moderate-severe atopic eczema (BEACON)

BEACON is a UK based,multicentre,1 year,assessor-blind,parallel group,superiority,randomised controlled trial. The primary aim of the trial is to determine the effectiveness of methotrexate and dupilumab compared with ciclosporin. The primary endpoint is change in objective disease severity at 6 months,presented as mean absolute change from baseline,using the Eczema Area Severity Index (EASI,blinded assessment). Patients will be randomised 1:1:1 to methotrexate,dupilumab or ciclosporin for 6 months (optional dose increase at 3 months for those on methotrexate or ciclosporin as per clinical practice). ...

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Metabolic and Endocrine Reproductive health and childbirth

PROTECT PRegnancy Outcomes using continuous glucose monitoring TEChnology in pregnant women with early-onset Type 2 diabetes: A multicentre randomised controlled trial of the clinical and cost-effectiveness of using continuous glucose monitoring (CGM) in pregnant women with early-onset type 2 diabetes (PROTECT)

Previous studies have shown that Continuous Glucose Monitoring (CGM) improves maternal glucose, reduces neonatal admissions and is clinically and cost-effective in type 1 diabetes (T1D) pregnancy, and as a result CGM is now standard care in T1D pregnancy. However, there are no well-designed adequately powered trials to compare CGM and standard care monitoring of blood glucose in type 2 diabetes (T2D) pregnancy. The purpose of this study is to examine whether using CGM improves glucose levels in pregnant women with ...

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Respiratory

A seamless, phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations (XTMAB-16-201)

This is a seamless, Phase 1b/2 Multiple Ascending Dose (MAD)/Proof of Concept (POC) Study (hereafter referred to as Phase 2 Program) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary involvement. The study is comprised of two parts: Part A is an open label multiple dose-escalating study, and Part B is a randomized double-blind placebo-controlled POC study. The primary objective of Part A is to evaluate the safety and tolerability of MAD of XTMAB-16, and to determine the recommended ...

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Eye

A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX 314 Gene Therapy in Participants with nAMD (ASCENT)

This phase 3, partially masked, randomized, multicenter study will include 2 periods: an Active Run-in Period (ie, Screening) and an Assessment Period. Participants who receive ABBV-RGX-314 will be strongly encouraged to enroll into a long-term follow-up (LTFU) study (RGX-314-5101) after completion of or early discontinuation from this current study and will sign a separate informed consent for the LTFU study at that time. The Active Run-in Period, which will last up to 6 weeks, will begin when the participant signs ...

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Cancer and neoplasms

Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Patients with Metastatic Leiomyosarcoma

Leiomyosarcoma (LMS) is a type of rare cancer that grows in the smooth muscle tissue. The prognosis for patients with metastatic LMS (cancer that has spread to other parts of the body) is poor, and there are few effective treatments available. In previous clinical studies, LMS patients were treated with lurbinectedin in combination with doxorubicin. Lurbinectedin is an experimental medication that has been shown to kill cancer cells and modify the environment around the tumour to block growth. Doxorubicin is an ...

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Cancer and neoplasms

Exploring the microbiome in patients with advanced biliary tract cancer in a first-line study of durvalumab (MEDI4736) in combination with cisplatin/gemcitabine (ABC-12)

In this study,a new drug will be used,durvalumab,to try and block this signal to increase the immune response,in combination with standard of care cisplatin/gemcitabine chemotherapy. Durvalumab is an antibody (a protein produced by the body’s defense system) and it is hoped that by blocking this signal,the immune cells will once again be able to prevent or slow down cancer growth. This drug combination has been shown in a large clinical trial to increase survival in patients with BTC where surgery ...

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Cancer and neoplasms

Phase 1b/II Trial of Checkpoint Inhibitor (Pembrolizumab an Anti PD-1 Antibody) Plus Standard IMRT in HPV Induced Stage III Squamous Cell Carcinoma of Anus (CORINTH)

This trial is for patients with advanced anal cancer. The aim of the trial is to see whether a new drug called pembrolizumab can be added safely to chemo-radiotherapy (CRT). We will explore how safe the combination is and how well tolerated it is for patients. Anal cancer responds well to CRT and this would be the treatment usually chosen for clinical care. The chemotherapy given will be the standard of care (Mitomycin and either 5FU or capecitabine) and radiotherapy ...

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