Abstract：
AIMS OF THE STUDY:Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. METHODS USED TO CONDUCT THE STUDY:Published literature was reviewed to identify preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID-19 vaccines were reviewed to determine if risks were properly disclosed. RESULTS OF THE STUDY:COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials. CONCLUSIONS DRAWN FROM THE STUDY AND CLINICAL IMPLICATIONS:The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.
journal_name
Int J Clin Practjournal_title
International journal of clinical practiceauthors
Cardozo T,Veazey Rdoi
10.1111/ijcp.13795subject
Has Abstractpub_date
2020-10-28 00:00:00pages
e13795eissn
1368-5031issn
1742-1241pub_type
杂志文章abstract：BACKGROUND:Plasminogen Activator Inhibitor 1 (PAI-1) is a prothrombotic adipokine involved in the coagulation cascade and fibrinolysis that associated with proinflammatory adipokines may increase the risk related to obesity. Anthropometric measures are commonly used in clinical practice and, currently, neck circumferen...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/ijcp.12041
更新日期：2013-03-01 00:00:00
abstract：:There has been much debate over the past 50 years concerning the association between colorectal carcinoma and inflammatory bowel disease. Until recently, it was widely accepted there was a higher risk in those with widespread ulcerative colitis. However, evidence now suggests an almost equal incidence in those with Cr...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：
更新日期：1999-06-01 00:00:00
abstract：:This prospective study describes and evaluates the efficacy of an integrated care pathway for the management of the critically ischaemic diabetic foot patients by a multidisciplinary team. A weekly joint diabetes/vascular/podiatry ward round and outpatient clinic was established where patients were assessed within 7 d...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/j.1368-5031.2006.00953.x
更新日期：2006-06-01 00:00:00
abstract：:This randomised, double-blind, placebo-controlled, parallel-group study compared the efficacy and tolerability of lumiracoxib (a novel COX-2 selective inhibitor) with rofecoxib, celecoxib and placebo in patients with moderate-to-severe post-operative dental pain. Following third molar extraction, patients received sin...
journal_title：International journal of clinical practice
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1111/j.1368-5031.2004.00155.x
更新日期：2004-03-01 00:00:00
abstract：BACKGROUND:The decision on whether or not to treat a first seizure is dependent on several medical and non-medical factors. AIMS:In this review, we have summarised the important aspects that determine the advantages and disadvantages of treating a first seizure. We have looked at evidence from randomised controlled tr...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：10.1111/j.1742-1241.2008.01896.x
更新日期：2008-12-01 00:00:00
abstract：BACKGROUND:Substantial residual cardiovascular risk persists despite effective LDL lowering treatment in populations at elevated risk for adverse cardiovascular outcomes. Low HDL cholesterol is an independent cardiovascular risk factor and occurs in about one-third of patients treated for dyslipidaemia in Europe. Moreo...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：10.1111/j.1742-1241.2007.01514.x
更新日期：2007-11-01 00:00:00
abstract：:Tobacco dependence remains the major preventable cause of early mortality and morbidity in the developed world. The primary reinforcer of the dependence is the nicotine present in tobacco smoke and, for many smokers, successful treatment depends upon breaking this dependence. Until recently, the only specific pharmaco...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：
更新日期：2001-01-01 00:00:00
abstract：:The difficulties in establishing a diagnosis of acute disseminated encephalomyelitis (ADEM) are illustrated in this case report, which attempts to raise awareness of the condition among general physicians, since they are the practitioners most likely to see such acute neurological presentations. Clinical and investiga...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：
更新日期：2003-04-01 00:00:00
abstract：:In the vast majority of cases, Clostridium difficile-associated diarrhoea and pseudomembranous colitis develop following the use of antibiotics. We report a case in which C. difficile-associated diarrhoea was diagnosed in the absence of previously reported predisposing factors. It transpired that the patient had a col...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：
更新日期：1998-03-01 00:00:00
abstract：:Fever of unknown origin (FUO) is a clinical dilemma in western countries and in China. To investigate the causes and prognosis of FUO, 208 patients with FUO admitted to a large university hospital in China were investigated. The final diagnoses established in 158 cases (75.96%) were: infectious disease in 66 cases (31...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：
更新日期：2003-09-01 00:00:00
abstract：INTRODUCTION:Niacin is underutilised because of flushing. Lack of a quantitative tool to assess niacin-induced flushing has precluded the objective evaluation of flushing associated with extended-release (ER) niacin formulations. We developed the Flushing Symptom Questionnaire((c)) (FSQ), a quantitative tool to assess ...
journal_title：International journal of clinical practice
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1111/j.1742-1241.2008.01739.x
更新日期：2008-06-01 00:00:00
abstract：:Influences on bladder health begin during infancy and continue throughout the lifespan. Bladder anatomy and physiology change as individuals age, and the risk and propensity for bladder conditions, including lower urinary tract symptoms, throughout life are related to factors specific to age, sex, and life events. Bla...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/ijcp.12127
更新日期：2013-05-01 00:00:00
abstract：AIMS:The association between inhaled corticosteroid (ICS) use and pulmonary tuberculosis (TB) development is uncertain. We conducted a population-based case-control study to investigate whether ICS use increases the risk of developing TB. METHODS:Tuberculosis patients aged 18 years and older were identified using the ...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/ijcp.12459
更新日期：2014-10-01 00:00:00
abstract：:Erectile Dysfunction (ED) is common in men with diabetes. Diabetic men are three times as likely to develop ED as non-diabetic men. The cause is multifactorial, but most commonly reflects endothelial dysfunction and autonomic neuropathy. Diabetes and vascular disease often coexist and ED may be a marker for silent occ...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：10.1111/j.1368-5031.2004.00180.x
更新日期：2004-04-01 00:00:00
abstract：OBJECTIVE:Cutaneous leishmaniasis (CL) is a skin disease characterised by prolonged nodulo-ulcerative lesions of the skin that heals with atrophic scar. Clinical features of CL vary depending on the type of parasite and host immune resistance. The aim of this study was to investigate the clinical features of atypical a...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/ijcp.13730
更新日期：2020-10-26 00:00:00
abstract：BACKGROUND:Anticoagulant therapy in patients with atrial fibrillation (AF) increases the risk of minor bleeding, which is mostly accepted by patients. We aimed to assess whether continuation of anticoagulation despite minor bleeding is associated with a higher level of knowledge on AF and anticoagulation. METHODS AND ...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/ijcp.13483
更新日期：2020-06-01 00:00:00
abstract：BACKGROUND:Systemic lupus erythematosus (SLE) is a heterogenous disease with complex pathogenesis. AIM:In this review, we summarise recent progress in the understanding of SLE pathogenesis and discuss implications for the treatment of SLE patients using standard and experimental medications. CONCLUSIONS:The discovery...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：10.1111/j.1742-1241.2007.01528.x
更新日期：2007-12-01 00:00:00
abstract：BACKGROUND:DPP-4 inhibitors (DPP4-I) have been shown to provide non-inferior glycaemic control compared with sulfonylureas (SU), but result in a reduction of body weight and a significantly lower risk of hypoglycaemia in patients with type 2 diabetes. We aimed to validate these results in a large real-world sample of p...
journal_title：International journal of clinical practice
pub_type： 杂志文章,多中心研究
doi：10.1111/ijcp.12179
更新日期：2013-10-01 00:00:00
abstract：:Asthma treatment is suboptimal in many patients, with impacts on morbidity and mortality, healthcare resource utilisation and patients' quality of life. The reasons for this include the inherent variability of asthma and the unpredictability of exacerbations, which can range from mild to fatal. In addition, asthma can...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：10.1111/j.1368-5031.2004.00182.x
更新日期：2004-06-01 00:00:00
abstract：:Both hepatitis B and hepatitis C are spread parenterally. Chronic hepatitis C is fast becoming the leading indication for liver transplantation. Most infected patients go on to develop chronic hepatitis, with approximately 20% developing liver cirrhosis or hepatocellular carcinoma after 20 years. Standard treatment no...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：
更新日期：2000-09-01 00:00:00
abstract：:A press through package (PTP) is commonly used as a package for drugs and also being seen increasingly in cases of foreign body in the digestive tract. We presented three cases of inadvertent PTP ingestion with a variety of clinical presentations. Although commonly considered to be small and soft to cause bowel damage...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/j.1742-1241.2006.00766.x
更新日期：2006-02-01 00:00:00
abstract：BACKGROUND:Patient-controlled sedation (PCS) with propofol has been used successfully in various conditions, but controversies exist about its use in sedation of elderly patients for cataract surgery. This study evaluates the efficacy of anaesthetic nurse-controlled sedation (ACS) compared with PCS using the same devic...
journal_title：International journal of clinical practice
pub_type： 杂志文章,随机对照试验
doi：10.1111/j.1742-1241.2007.01544.x
更新日期：2008-05-01 00:00:00
abstract：:We report a case of Pott's puffy tumour in a 12-year-old. Owing to the late development of the frontal sinuses, frontal sinus infection in children is rare. When present it can lead to osteomyelitis associated with forehead swelling. Early diagnosis and active treatment prevent progression to life-threatening intracra...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：
更新日期：2000-05-01 00:00:00
abstract：BACKGROUND:Temporomandibular disorders (TMD) are the most common orofacial impairment, but the relevance of certain clinical features in TMD is not clear. OBJECTIVE:The main objective of this study was to analyse if temporomandibular disorders (TMD) are associated with sociodemographic (eg age, height, weight, body ma...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/ijcp.13961
更新日期：2021-01-02 00:00:00
abstract：:A randomised, double-blind, parallel, placebo-controlled, 12-week study was carried out to evaluate the efficacy and safety of 20-mg tadalafil taken 'as needed' in a population of men with erectile dysfunction (ED) from Egypt and Turkey. One hundred and thirty-two patients were randomised in this study. Tadalafil was ...
journal_title：International journal of clinical practice
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1111/j.1742-1241.2006.00993.x
更新日期：2006-07-01 00:00:00
abstract：:The potential effect of orlistat on cardiovascular co-morbidities may have been previously underestimated. This study assesses the efficacy of orlistat therapy for weight loss and cardiovascular risk factor reduction in obese patients with cardiovascular risk. This was a 54-week, double-blind, randomised, placebo-cont...
journal_title：International journal of clinical practice
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：
更新日期：2002-09-01 00:00:00
abstract：:Tissue inflammation has been linked to cancer in several disease models. We tested the association between chronic inflammation and prostate cancer (PCa), as well as high-grade prostatic intraepithelial neoplasia (HGPIN), in prostatic needle biopsy specimens. Tissues from 4526 men, who underwent systematic ultrasound-...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：10.1111/j.1742-1241.2006.00905.x
更新日期：2007-03-01 00:00:00
abstract：AIMS:To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI). METHODS:Patients with T2DM with moderate RI (estimated glomerular filtration rate [eGFR] ≥30 to <60 mL/min/1.73 m2 ) (N=114), severe RI (eGFR <30 mL/min/1.73 m2 ) (N=55) or end-sta...
journal_title：International journal of clinical practice
pub_type： 杂志文章,随机对照试验
doi：10.1111/ijcp.12955
更新日期：2017-06-01 00:00:00
abstract：:Monomeric prolactin (PRL) of molecular weight 23 kDa constitutes up to 95% of adult serum PRL. Macroprolactin is a large antigen-antibody complex of molecular weight greater than 100 kDa and constitutes less than 1% of circulating PRL. Thus, in most cases, hyperprolactinaemia is usually a result of high levels of mono...
journal_title：International journal of clinical practice
pub_type： 杂志文章,评审
doi：10.1111/j.1368-5031.2006.00732.x
更新日期：2006-04-01 00:00:00
abstract：:Motor restlessness, characterised by an irresistible urge to move about, can be a manifestation of many underlying disorders. Unfortunately, it is often poorly recognised and underdiagnosed in clinical practice, possibly because patients do not seek medical attention, or their complaints were thought to be secondary t...
journal_title：International journal of clinical practice
pub_type： 杂志文章
doi：
更新日期：2001-06-01 00:00:00
