OUH STUDIES

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

Showing 151 - 160 of 716 studies

Cancer and neoplasms

Volatile Organic Compounds as Breath BIomarkers in Squamous Oesophageal Neoplasms (ViSON) (VISON)

Oesophageal squamous cell cancer (OSCC) is a cancer that grows in the food pipe and affects up to 2,000 people in the UK every year. Most patients are diagnosed when the cancer has spread to other body parts (advanced stage). As a result, the five-year survival is less than 20%. In comparison, when diagnosed early, nearly three out of four patients survive more than five years, indicating that early diagnosis improves survival. There are numerous challenges in detecting OSCC early. ...

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Infection

A dose finding human experimental infection study with SARS-CoV-2 Omicron BA.5 subvariant in healthy volunteers immunologically experienced against SARS-CoV-2 (COV-CHIM02)

The purpose of this study is to evaluate the safety and human clinical response to SARS-CoV-2 challenge with the omicron variant virus, in previously SARS-CoV-2 vaccinated people. We aim to establish the optimal challenge dose that causes re-infection and identify the lowest level of infectious dose necessary to produce viral replication in the upper respiratory tract of research volunteers while minimising risk of disease progression. Investigators aim to achieve an infection model which results in no symptoms, or symptoms no ...

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Neurological

A Phase 3 randomized, double-blind, efficacy and safety study comparing frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis (FREVIVA)

This is a parallel, Phase 3 study with 2-arms for treatment that are blinded/masked for participants, the Investigator, any Investigator site staff, and the Sponsor. The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy in delaying the disability progression and the safety of up to 48 months administration of frexalimab intravenous (IV) every 4 weeks (q4w) compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time ...

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Cancer and neoplasms

Phase I, open-label, dose finding, safety, tolerability and exploratory study of THEO-260 in patients with high grade serous or endometrioid ovarian cancer (OCTOPOD)

This is a multi-centre, open label, FIH, multi-part trial to assess safety, tolerability, and preliminary efficacy of THEO-260 in patients with high grade serous or endometrioid ovarian cancer. The trial consists of 4 parts: Part A, Part B, Part C (optional) and Part D (optional). Part A (Dose Escalation/Finding Part): The trial part will use a model-assisted methodology for dose finding, Bayesian Optimal Interval (BOIN). Four (4) escalating dose levels are planned. In Part A, RP2D will be identified. Up to 18 ...

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Blood

Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention (GRACE)

Hospital-acquired thrombosis (HAT) is defined as any VTE within 90 days of hospital admission, encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE). HAT represents a significant cause of preventable death, with over 12,000 people dying each year from hospital-associated VTE in the UK. Previous studies report that the risk of untreated high-risk surgical patients developing HAT is as high as 40-60% in orthopaedic patients and 15-40% in general surgery patients. For these patients at highest risk of VTE, key ...

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Cancer and neoplasms

A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second-or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY-Gastric 01)

This Phase III, multi-center, open-label, sponsor-blinded, randomized study is designed to evaluate the efficacy and safety of AZD0901 compared to Investigator’s choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2, and the clinical performance of the investigational IVD. As part of this combined approach, t he efficacy analyses from this study will also provide the basis to evaluate the clinical performance of Ventana CLDN18.2 (SP455) IHC assay (prototype assay and/or validated assay ...

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Renal and Urogenital

A multicenter international randomized double-blind placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in patients with chronic kidney disease treated with empagliflozin (EASi-KIDNEY)

BI 690517 is an aldosterone synthase inhibitor and participants will be randomised 1:1 (using a minimisation algorithm) to active of placebo BI 690517 in addition to study supplied empagliflozin 10mg daily.

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Oral and Gastrointestinal

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Crohn’s Disease (MK7240-008)

This protocol includes 2 independent, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2) to assess the efficacy and safety of MK 7240 in participants of any sex/gender aged 16 to 75 (inclusive) with moderately to severely active CD. While this “master” protocol includes common operational elements for both Study 1 and Study 2, randomization, data collection, statistical analyses, and data reporting will be conducted for each study independently. Each study has its own objectives and ...

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Cancer and neoplasms

DS6000-109 - A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (Dose Optimization and Phase 3 Study of R-DXd versus Investigator’s Choice of Chemotherapy in Platinum resistant Ovarian Cancer)

This is a global, multicenter, randomized, open-label, Phase 2/3 study in subjects with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. In this operationally seamless design, data from Phase 2 will not be utilized for the primary analysis in Phase 3 to strictly control the type I error in Phase 3. Phase 2 Study Design The Phase 2 part of this study is designed ...

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Inflammatory and immune system

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN)

Behçet's disease (BD) is an inflammatory condition that causes damages of the blood vessels affecting many parts of the body. The disease is characterized by intermittent symptoms of varying severity across almost all organ systems and oral ulcers, considered the most common sign at the onset of BD and are observed in nearly every patient The treatment of BD is generally based on experience, and the drug of choice is based on specific clinical signs and symptoms in each patient. The ...

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