A5061074316- Cerebral Venous Sinus Thrombosis
- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Glaucoma and retinal disorders
- Colorectal Cancer Surgical Treatments
- Liver Diseases and Immunity
- Colorectal and Anal Carcinomas
- Neurological Complications and Syndromes
- Abdominal vascular conditions and treatments
- Cerebrovascular and Carotid Artery Diseases
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Glioma Diagnosis and Treatment
- Cholinesterase and Neurodegenerative Diseases
- Retinal Diseases and Treatments
- Colorectal Cancer Screening and Detection
- Meta-analysis and systematic reviews
- Cancer Genomics and Diagnostics
- Amyotrophic Lateral Sclerosis Research
- Burn Injury Management and Outcomes
- Wound Healing and Treatments
- Chromatin Remodeling and Cancer
- Biliary and Gastrointestinal Fistulas
- Adenosine and Purinergic Signaling
- Pregnancy and preeclampsia studies
- Cystic Fibrosis Research Advances
Cancer Research UK Clinical Trials Unit
2020-2025
University of Birmingham
2020-2025
NIHR Birmingham Biomedical Research Centre
2024
University Hospitals Birmingham NHS Foundation Trust
2023
Abstract Aim Organ‐saving treatment for early‐stage rectal cancer can reduce patient‐reported side effects compared to standard total mesorectal excision (TME) and preserve quality of life. An optimal strategy achieving organ preservation longer‐term oncological outcomes are unknown; thus there is a need high trials. Method Can we S ave the rectum by watchful waiting or T rans A nal surgery following (chemo) R adiotherapy versus otal early RE ctal C ancer (STAR‐TREC) an international...
There are limited longitudinal data evaluating outcomes in idiopathic intracranial hypertension (IIH). We aimed to evaluate the long-term a real-world cohort of patients with IIH and sought establish prognostic factors.A prospective study was conducted over 9 years (2012-2021). Data included demographics disease status. All consenting were recruited. Visual visual acuity, Humphrey field optical coherence tomography (OCT) imaging measurements. Headache frequency, severity, impact noted....
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). The strong association between gut and liver inflammation has driven several pathogenic hypotheses to which intestinal microbiome proposed contribute. Pilot studies faecal microbiota transplantation (FMT) in PSC IBD are demonstrated be safe associated with increased bacterial diversity. However, longevity such changes impact on markers activity progression have not been...
Introduction Wolfram syndrome ( WFS1- Spectrum Disorder) is an ultra-rare monogenic form of progressive neurodegeneration and diabetes mellitus. In common with most rare diseases, there are no therapies to slow or stop disease progression. Sodium valproate, anticonvulsant neuroprotective properties, anticipated mediate its effect via alteration cell cycle kinetics, increases in p21 cip1 expression levels reduction apoptosis increase Wolframin protein expression. To date, have been...
This paper reports guidelines for the content of statistical analysis plans early phase clinical trials, ensuring specification minimum reporting requirements, by detailing extensions (11 new items) and modifications (25 to existing guidance after a review various stakeholders.
Abstract Background The risk of cutaneous squamous cell carcinoma (cSCC) is significantly increased in organ transplant recipients (OTRs). Clearance actinic keratoses (AKs) generally regarded as a surrogate biomarker for cSCC prevention. OTR-cSCC chemoprevention with topical AK treatments has not been investigated randomized controlled trials (RCTs), although there evidence that 5% 5-fluorouracil (5-FU) may be chemoprotective immunocompetent patients. Objectives To assess the feasibility,...
Idiopathic intracranial hypertension (IIH) most typically occurs in women of childbearing age with increased weight as a key risk factor for development or exacerbation the disease. Pregnancy is common this group patients. The longer-term effect pregnancy on IIH has not been established and was aim study.
PurposeTo characterise the phenotype of idiopathic intracranial hypertension (IIH) patients who received cerebrospinal (CSF) diversion surgery and detail trajectory recovery.DesignProspective cohort registry studyMethodsIIH with sight threatening papilloedema presenting to a single United Kingdom neuroscience centre between 2019-2021 were included. Outcomes consisted perimetric mean deviation (PMD) optical coherence tomography measures (retinal nerve fibre layer [RNFL]) macular ganglion cell...
Abstract Introduction Idiopathic intracranial hypertension (IIH) and polycystic ovary syndrome (PCOS) are hyperandrogenic metabolic disorders that affect women of reproductive age living with obesity. The previously reported prevalence comorbid PCOS in IIH patients is highly variable the longitudinal impact on visual headache outcomes unknown. Methods In this prospective cohort study were identified from IIH: Life database over a nine-year period (2012–2021). Data collected included...
Abstract Background Little is known about the presentation and prognosis of asymptomatic idiopathic intracranial hypertension (IIH). Papilloedema can be found incidentally on routine fundus examination, with many these patients actually having symptoms direct questioning. The aim was to evaluate visual headache outcomes in people IIH who present or without symptoms. Methods Prospective observational cohort study, between 2012 2021, 343 confirmed diagnosis were enrolled IIH:Life database....
Idiopathic intracranial hypertension (IIH) predominantly affects reproductive-aged females with obesity. However, the prevalence and impact of a healthy weight body mass index (BMI) at disease presentation is not known. This study aimed to evaluate visual headache outcomes stratified by presenting BMI. was longitudinal prospective cohort (IIH Life) based on tertiary neuro-ophthalmology IIH service, University Hospitals Birmingham NHS Trust, United Kingdom, recruiting consecutive patients...
Primary sclerosing cholangitis is a progressive inflammatory liver disease characterized by biliary and fibrosis. Vascular adhesion protein-1 (VAP-1) important in the process driving We evaluated safety efficacy of VAP-1 blockade with monoclonal antibody (timolumab, BTT1023) patients primary cholangitis.
Abstract Background The overwhelming majority of dose-escalation clinical trials use methods that seek a maximum tolerable dose, including rule-based like the 3+3, and model-based CRM EWOC. These assume incidences efficacy toxicity always increase as dose is increased. This assumption widely accepted with cytotoxic therapies. In recent decades, however, search for novel cancer treatments has broadened, increasingly focusing on inhibitors antibodies. rationale higher doses are associated...
3502 Background: No randomised trials have compared non-operative organ preservation (OP) therapy for early-stage rectal cancer versus standard of care (SoC) using total mesorectal excision (TME) alone. STAR-TREC evaluated the feasibility recruiting to a study comparing contrasting OP therapies, optimised treatment early tumours, SoC. Methods: was prospective, randomised, open-label, in UK, Netherlands and Denmark. Patients with biopsy proven adenocarcinoma rectum, staged ≤mrT3b N0 M0, ≤40mm...
Background Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig´s disease, is a rare neurological condition and the most common motor neurone disease. It fatal disease with specific loss of neurons in spinal cord, brain stem, cortex leading to progressive paralysis usually death within five years diagnosis. There remains no cure for ALS, management focused on combination neuroprotective medication, respiratory support, by multidisciplinary clinics. Patients methods This prospective,...
Background Primary sclerosing cholangitis is a progressive and fibrotic liver disease. Treatments remain inadequate, patients with persistent elevations in activity of alkaline phosphatase are at greatest risk disease progression. Studies patient cohorts have implicated the serum amine oxidase vascular adhesion protein 1 pathophysiology disease, including fibrogenesis. We hypothesised that blockade by monoclonal antibody would result reduction fibrosis/injury, as evaluated tests other...
Introduction Despite of recent advancement in the burns wound management, burn infection (BWI) is still one major cause mortality. Patients who survive their injury suffers from BWI related complication like delayed healing and poor scarring. has been treated by application topical antimicrobial agents or systemic antibiotics. Due to global risk developing antibiotics resistance, medical research focuses on identifying single agent which effective activity, easily available cost effective....
The R1 addendum to ICH E9 (E9-R1) provides guidance on the definition of estimands in clinical drug development. While E9-R1 has seen uptake randomized late-stage trials, its implementation early development remains sporadic potentially jeopardizing clarity, consistency, and coherency phase. In this article, we call for a more systematic use estimand thinking phase 1 dose escalation oncology trials. these adaptive primary objective is usually characterize dose-toxicity relationship ascertain...