scholarly journals Successful nutritional control of scratching and clinical signs associated with adverse food reaction: A randomized controlled COSCAD '18 adherent clinical trial in dogs in the United Kingdom

2021 ◽  
Author(s):  
James L. Weemhoff ◽  
Jennifer M. MacLeay ◽  
John Brejda ◽  
Heidi Schiefelbein ◽  
Susan M. Wernimont ◽  
...  
Keyword(s):  
Clinical Trial ◽  
United Kingdom ◽  
Clinical Signs ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Adverse Food Reaction

scholarly journals RIC in COVID-19—a Clinical Trial to Investigate Whether Remote Ischemic Conditioning (RIC) Can Prevent Deterioration to Critical Care in Patients with COVID-19

2021 ◽  
Author(s):  
Sean M. Davidson ◽  
Kishal Lukhna ◽  
Diana A. Gorog ◽  
Alan D. Salama ◽  
Alejandro Rosell Castillo ◽  
...  
Keyword(s):  
South Africa ◽  
Clinical Trial ◽  
United Kingdom ◽  
Inflammatory Cytokines ◽  
In Vitro Cytotoxicity ◽  
Cytokine Storm ◽  
Remote Ischemic Conditioning ◽  
Ischemic Conditioning ◽  
The United Kingdom

Abstract Purpose Coronavirus disease 19 (COVID-19) has, to date, been diagnosed in over 130 million persons worldwide and is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Several variants of concern have emerged including those in the United Kingdom, South Africa, and Brazil. SARS-CoV-2 can cause a dysregulated inflammatory response known as a cytokine storm, which can progress rapidly to acute respiratory distress syndrome (ARDS), multi-organ failure, and death. Suppressing these cytokine elevations may be key to improving outcomes. Remote ischemic conditioning (RIC) is a simple, non-invasive procedure whereby a blood pressure cuff is inflated and deflated on the upper arm for several cycles. “RIC in COVID-19” is a pilot, multi-center, randomized clinical trial, designed to ascertain whether RIC suppresses inflammatory cytokine production. Methods A minimum of 55 adult patients with diagnosed COVID-19, but not of critical status, will be enrolled from centers in the United Kingdom, Brazil, and South Africa. RIC will be administered daily for up to 15 days. The primary outcome is the level of inflammatory cytokines that are involved in the cytokine storm that can occur following SARS-CoV-2 infection. The secondary endpoint is the time between admission and until intensive care admission or death. The in vitro cytotoxicity of patient blood will also be assessed using primary human cardiac endothelial cells. Conclusions The results of this pilot study will provide initial evidence on the ability of RIC to suppress the production of inflammatory cytokines in the setting of COVID-19. Trial Registration NCT04699227, registered January 7th, 2021.

scholarly journals Randomized Clinical Trial To Evaluate the Immunogenicity of Quadrivalent Meningococcal Conjugate and Polysaccharide Vaccines in Adults in the United Kingdom

2014 ◽  
Vol 21 (8) ◽  
pp. 1164-1168 ◽  
Author(s):  
Maheshi N. Ramasamy ◽  
Elizabeth A. Clutterbuck ◽  
Kathryn Haworth ◽  
Jaclyn Bowman ◽  
Omar Omar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
United Kingdom ◽  
Children And Adolescents ◽  
Randomized Clinical Trial ◽  
Antibody Responses ◽  
Conjugate Vaccines ◽  
Protective Antibody ◽  
Meningococcal Vaccines ◽  
The United Kingdom ◽  
Geographic Regions

ABSTRACTMeningococcal conjugate vaccines are today successfully deployed in universal programs for children and adolescents in different geographic regions to control meningitis and septicemia. However, in adults, the advantages of these conjugates over the older polysaccharide vaccines are less clear. In this randomized clinical trial, we demonstrated that both conjugate and polysaccharide quadrivalent meningococcal vaccines elicit protective antibody responses in adults aged 18 to 70. (This study has been registered atwww.clinicaltrials.govunder registration no. NCT00901940.)

scholarly journals Effectiveness of COVID-19 vaccine BNT162b2 at age 12-15 years with one dose

2021 ◽  
Author(s):  
Oren Miron ◽  
Rachel Wilf-Miron ◽  
Nadav Davidovitch
Keyword(s):  
Clinical Trial ◽  
United Kingdom ◽  
The United Kingdom

The clinical trial of BNT162b2 at age 12-15 years reported 100% effectiveness in preventing COVID-19 after 7 days from dose-2, which is administrated at day 21. We reanalyzed the data and found 100% effectiveness also after 14-20 days from dose-1 administration. This could relate to studies showing increased dose-1 effectiveness at younger ages. Our findings support the possibility of vaccinating younger ages with the United Kingdom regimen, which delays dose-2 to day 84 to allow more dose-1 vaccinations.

scholarly journals A European Approach to Irritable Bowel Syndrome Management

1999 ◽  
Vol 13 (suppl a) ◽  
pp. 85A-88A ◽  
Author(s):  
Michel Delvaux ◽  
Jacques Frexinos
Keyword(s):  
United States ◽  
Irritable Bowel Syndrome ◽  
United Kingdom ◽  
The United States ◽  
Multiple Factors ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Number Of Patients ◽  
Irritable Bowel ◽  
Yearly Cost

Irritable bowel syndrome (IBS) is characterized by a number of clinical features and probably comprises a cluster of different conditions. The most frequent symptom reported by IBS patients is abdominal pain, although for a number of patients, bowel disturbances are the most prominent symptoms. Diarrhetic patients are seen in referral centres in continental Europe less frequently than in the United Kingdom or the United States. On the contrary, patients with constipation-prone IBS may comprise up to 80% of the IBS population referred to these centres. The pathophysiology of IBS is based on multiple factors. Most of the therapeutics proposed for the management of patients with IBS have been developed on the assumption that motility disorders of the gut are the most reliable pathological findings among these patients. Consequently, antispasmodics and motility regulatory agents have been widely used, alone or in association with intestinal adsorbents (clay-derived preparations), and laxatives or antidiarrhetic agents. Most of these drugs were developed several decades ago, and studies showing their efficacy have not reached the level of quality that is now required of randomized controlled trials. Therefore, following a complete and detailed review published in 1989, these drugs have not been used extensively in the United Kingdom or the United States. Large inquiries have also shown that the duration of prescription is quite different among countries. In European countries, maintenance therapy is frequently prescribed for several weeks to attempt to decrease the number of acute episodes. In contrast, psychotropic drugs are less popular among European gastroenterologists than among American gastroenterologists. However, multidisciplinary approaches to the treatment of these patients are frequent, and such drugs are often prescribed by home physicians. The results of large surveys estimated the yearly cost of such treatments to be around US$850. Patients with constipation and elderly patients with chronic disease receive more expensive treatments.

scholarly journals Ibrutinib at First Relapse for Mantle Cell Lymphoma: A United Kingdom Real World Analysis of Outcomes in 169 Patients

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3993-3993 ◽  
Author(s):  
Rory McCulloch ◽  
Simon Rule ◽  
Toby A. Eyre ◽  
Harshita Goradia ◽  
Simon Bolam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
United Kingdom ◽  
Drug Toxicity ◽  
Research Funding ◽  
Advisory Committees ◽  
Durable Response ◽  
Educational Support ◽  
The United Kingdom ◽  
First Relapse ◽  
Frontline Therapy

Background: Ibrutinib has transformed the clinical approach to relapsed mantle cell lymphoma (MCL) with those receiving ibrutinib at first relapse obtaining the greatest benefit encouraging use earlier in the treatment algorithm (Rule et al, 2019). However, the general applicability of clinical trial findings is not established and concerns regarding ibrutinib tolerability persist, especially in non-trial populations enriched for frailer patients with multiple co-morbidities. In the United Kingdom, ibrutinib is funded as standard of care at first relapse. This study has analysed the clinical effectiveness and tolerability of this approach in a non-clinical trial real world population. Method: 23 centres across the United Kingdom contributed data from consecutive patients treated with ibrutinib for MCL at first relapse. Patients received standard dose 560 mg OD, unless documented, and commenced treatment between August 2014 and April 2019. Response to therapy was defined as per Lugano classification (Cheson et al, 2014), although CR assessment by bone marrow biopsy was not always undertaken. Data was collected on baseline characteristics, including response to prior therapy, and MIPI at time of relapse. The study primary outcome was PFS. Predictors of progression were determined using univariate Cox regression. Results: 169 patients were included in the study. Median age at start of ibrutinib was 72 years (range 33 to 97) and 122 (72.2%) were male. At diagnosis 13.5% had blastoid histology; 59.3% Ki67 ≥30%; 32.0% received cytarabine based induction and 27.8% HSCT consolidation; 11.2% received low intensity frontline therapy (i.e. not fit for R-CHOP) due to frailty. Median PFS following frontline therapy was 21.4 months (95% CI 14.6 to 28.3) and 52.1% progressed within 2 years. At start of ibrutinib 52.2% were MIPI high risk; 23.9% were ECOG 2 or higher and 2.4% had CNS involvement. Overall response rate (ORR) to ibrutinib was 71.6% with 30.4% achieving CR/CRu. Estimated median PFS from start of ibrutinib was 16.5 months (95% CI 11.5 to 21.5) and estimated OS 23.9 months (95% CI 13.0 to 34.8), with median follow up 26 months. Median PFS for patients with early relapse to frontline therapy (progression of disease <2 years) was significantly shorter than those with more durable response (PFS 10.6 months vs. 20.6 months, HR 2.1, p=<0.001). Age ≥75 yrs and ECOG >1 were also negative predictors of PFS (see table 1 for univariate analysis). 10 patients (5.9%) received attenuated dose from start of therapy due to frailty and 20 patients (11.8%) underwent dose reductions while on therapy due to drug toxicity. Of 109 patients to discontinue ibrutinib 72 (66.1%) were due to progressive disease, 15 for consolidation alloHSCT (13.8%), 13 due to medical co-morbidities and unrelated death (11.9%), and 9 due to drug toxicity (8.3%), including 1 bleed. Only 5.3% of all patients stopped therapy due to drug toxicity. Patients ≥80 yrs were more likely to stop therapy early for reasons other than progressive disease or alloHSCT (OR 2.92, p=0.02), but frailer patients who received low intensity frontline therapy also showed a trend for more durable response with second-line ibrutinib (PFS 10.0 months versus 4.0 months, p=0.36) justifying use in this patient group. Conclusion: This study population is enriched for several recognised adverse prognostic markers, including older age and poor performance status, which is likely to explain differences in PFS relative to clinical trial data. Despite these features response rates were similar, and it is notable that 46.7% of evaluable pts achieved longer PFS with ibrutinib than preceding front-line therapy. It is reassuring that the proportion of patients stopping ibrutinib due to toxicity was similar to trial data and bleeding events that required alterations to therapy were rare (3 cases, 1.8%). Although ibrutinib represents a significant breakthrough with clear benefit to most patients the results also highlight that outcome for many remains poor. 40% of patients progressed within 1 year of starting ibrutinib and median OS post ibrutinib was only 3.6 months. 35.2% of patients died within 1 month of documented relapse suggesting many, predominantly older patients, were not fit for further therapy. Of the 53 pts surviving beyond 1 month median OS was 7.5 months and 21.9% lived beyond 1 year. Improved treatment strategies in the post-ibrutinib setting remains a priority. Disclosures Rule: Pharmacyclics: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Sunesis: Consultancy, Honoraria; TG Therapeutics: Consultancy, Honoraria; Napp: Consultancy; Roche: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Astra-Zeneca: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Kite: Consultancy. Eyre:Gilead: Consultancy, Honoraria, Other: commercial research support; Abbvie: Honoraria; Janssen: Honoraria; Roche: Honoraria. Furtado:Abbvie: Honoraria. Shah:ABBVIE: Consultancy. Campbell:Novartis: Consultancy, Other: Educational support; Takeda: Consultancy, Other: Educational support; Bristol Myers-Squibb: Other: Educational support; Roche: Other: Educational support; Celgene: Other: Educational support. McCarthy:Janssen: Honoraria, Other: Educational grant to attend meetings . Lambert:Takeda Pharmaceuticals: Other: Funding to attend a scientific conference in 2018. McKay:Epizyme: Consultancy, Honoraria. Osborne:Roche: Consultancy, Honoraria, Other: Travel, Speakers Bureau; Gilead: Consultancy; MSD: Consultancy; Takeda: Consultancy, Honoraria, Other: Travel, Speakers Bureau; Novartis: Other: Travel; Pfizer: Honoraria, Speakers Bureau; Servier: Consultancy. Bishton:Takeda: Other: Travel support, Research Funding; AbbVie: Research Funding; Celltrion: Membership on an entity's Board of Directors or advisory committees, Other: travel support; Janssen: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; Roche: Other: Travel support, Research Funding. Crosbie:Janssen: Honoraria.

scholarly journals Is it worthwhile to conduct a randomized controlled trial of glaucoma screening in the United Kingdom?

2013 ◽  
Vol 19 (1) ◽  
pp. 42-51 ◽  
Author(s):  
Jennifer Burr ◽  
Rodolfo Hernández ◽  
Craig Ramsay ◽  
Maria Prior ◽  
Susan Campbell ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
United Kingdom ◽  
Controlled Trial ◽  
Glaucoma Screening ◽  
Randomized Controlled ◽  
The United Kingdom
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