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Clinical Study Design - Science topic

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Publications related to Clinical Study Design (754)
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Article
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Reported levels of amyloid-beta and tau in human cerebrospinal fluid (CSF) were evaluated to discover if these biochemical markers can predict the transition from Mild Cognitive Impairment (MCI) to Alzheimer’s disease (AD). A systematic review of the literature in PubMed and Web of Science (April 2021) was performed by a single researcher to identi...
Article
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Purpose The aim of the present study was to evaluate changes of best corrected visual acuity (BCVA), retinal nerve fiber layer thickness (RNFL), total macular volume (TMV), intraocular pressure (IOP) and central retinal thickness (CRT) after intravitreal injection of ranibizumab, bevacizumab and aflibercept in patients with neovascular age-related...
Article
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Delirium is a cognitive disorder with complex etiology, which brings a great burden to social health care. Articles with high citation frequency can provide important information about the current research situation in a certain field. Web of Science was used to search the 100 most-cited articles and we extracted key information, such as the author...
Article
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Purpose: Current understanding of COVID-19 disease progression suggests a major role for the “cytokine storm” as an important contributor to COVID-19 mortality. To prevent an exaggerated immune response and improve COVID-19 patient endpoints, anti-inflammatory therapeutics have been proposed as clinically useful in severe patients with COVID-19. Th...
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Background: Chronic pain that follows amputation of a limb is reported as "one of the most severe pains in the human experience," due to the magnitude of tissue injury and the multiple potential of pain generators at the local peripheral, spinal, and cortical levels. The Altius® System was developed to deliver high-frequency nerve block (HFNB) the...
Article
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Background: Preemptive analgesia is about the administration of an analgesic agent before the initiation of noxious stimulus, aiming of preventing sensitization of the neural system to successive stimulus that could intensify pain perception. Pregabalin is derivative of gabapentinoid which exhibits analgesic properties. Aims and Objectives: This c...
Article
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Cancer is the leading cause of death in dogs, yet there are no established screening paradigms for early detection. Liquid biopsy methods that interrogate cancer-derived genomic alterations in cell-free DNA in blood are being adopted for multi-cancer early detection in human medicine and are now available for veterinary use. The CANcer Detection in...
Article
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Age-related macular degeneration (AMD) is the main irreversible blindness disease worldwide. The current study aimed to investigate whether the consumption of 100% fruit juice increases the risk of age-related macular degeneration and find approaches to prevent and reduce the development of age-related macular degeneration from the aspect of dietar...
Article
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Background Achondroplasia is the most common short-limbed skeletal dysplasia resulting from gain-of-function pathogenic variants in fibroblast growth factor receptor 3 ( FGFR3) gene, a negative regulator of endochondral bone formation. Most treatment options are symptomatic, targeting medical complications. Infigratinib is an orally bioavailable, F...
Article
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Beyond their effect on blood pressure, the effect of energy drinks on heart rate in children and teenagers has not been evaluated until now. Thus, this study aimed to investigate the acute cardiovascular effects of energy drinks in healthy children and teenagers. Twenty-six children and adolescents (mean age 14.49 years) received a commercially ava...
Article
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Combination treatment, i.e., the use of two or more drugs for the same condition, is frequent in medicine if monotherapy yields an insufficient therapeutic response. We review and challenge clinical study designs and formats of reporting outcomes for the evaluation of the benefit/risk ratio of combination treatment over monotherapy. We demonstrate...
Article
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Background and Objective The outbreak of the novel coronavirus disease (COVID-19) is currently ravaging worldwide. A large number of studies were registered and conducted in rapid response to the epidemic, but how to choose the proper design for clinical trials still remains the main concern. This study aimed to determine fundamental characteristic...
Article
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Purpose: The multicenter studies reviewed were designed to evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus and corneal ectasia after laser refractive surgery. The results of these studies led to approval by the United States Food and Drug Agency for both conditions in 2016. This...
Article
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MK-2075 is a small-molecule selective inhibitor of the NaV1.7 channel investigated for the treatment of postoperative pain. A translational strategy was developed for MK-2075 to quantitatively interrelate drug exposure, target modulation, and the desired pharmacological response in preclinical animal models for the purpose of human translation. Ana...
Article
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Objective: This study aimed to compare the efficacy of different first-line strategies based on different EGFR mutation types (19 deletion and 21 Leu858Arg mutations). Methods: We conducted a systematic review and network meta-analysis (NMA) by searching and analyzing RCTs on PubMed, Embase, Cochrane Library, ASCO.org, and ESMO.org, from incepti...
Article
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Oxaliplatin-induced peripheral neuropathy (OIPN) is a common side effect in patients receiving chemotherapy for colorectal cancer (CRC) and it remains the most frequent dose-limiting toxicity, affecting especially quality of life (QoL) of patients. The best known pathogenetic mechanisms is the production of reactive oxygen species (ROS) and their n...
Article
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This review aims to identify factors causing heterogeneity in breast DWI–MRI and their impact on its value for identifying breast cancer patients with pathological complete response (pCR) on neoadjuvant systemic therapy (NST). A search was performed on PubMed until April 2020 for studies analyzing DWI for identifying breast cancer patients with pCR...
Article
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Based on the findings in recent years, we summarize the therapeutic potential of vorinostat (VOR), the first approved histone deacetylase (HDAC) inhibitor, in disorders of brain, and strategies to improve drug efficacy and reduce side effects. Scientific evidences provide a strong case for the therapeutic utility of VOR in various disorders affecti...
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Background With headache experienced by up to 75% of adults worldwide in the last year, primary headache disorders constitute a major public health problem, yet they remain under-diagnosed and under-treated. Headache prevalence and burden is changing as society evolves, with headache now occurring earlier in life. Contributing factors, mostly assoc...
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Diabetes mellitus is a major public health problem worldwide. This endocrine disease is clustered into distinct subtypes based on the route of development, with the most common forms associated with either autoimmunity (T1DM) or obesity (T2DM). A shared hallmark of both major forms of diabetes is a reduction in function (insulin secretion) or mass...
Article
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Background: Chronic nonspecific low back pain (LBP) is one of the common health issues. Hamstring tightness contributes to the development of LBP. This study aimed to investigate the acute and short-term effects of deep dry needling (DN) in patients with chronic nonspecific LBP and hamstring muscle tightness. Methods: A single-group pretest-post...
Article
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Authors: Ma Nwet, Vignesh Ramachandran, Swe Swe Latt, Win Khaing, Soe San, Htet Aung Kyaw Background: Management of lateral condyle fracture of the humerus needs accurate reduction and stabilization because of rotational displacement. Neglected lateral condyle fractures of humerus are misdiagnosed or insufficiently treated fractures, presenting la...
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Objective Through preliminary investigation of needs for clinical research training, to provide some initial evidence for design and operation of clinical research training programs in China. Methods An online questionnaire containing 23 questions about demographics, current practice of clinical research and needs for clinical research training wa...
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The statistical procedures as outlined by the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) guidelines for bioequivalence testing of highly variable drugs (HVDs) are complex. Additionally, the sample size is affected by clinical study designs or practical real-world problems, such as dropout rate or study budg...
Chapter
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The quality, reliability, dependability, and publishability of a study depend on its design. A clinical study design includes the preparation of trials, ]experiments, and observations in research involving human beings. The various types of study designs are depicted in Fig. 8.1.
Preprint
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Background: Chronic urticaria is a clinically refractory skin disease with long symptom duration and high recurrence rate. The current research demonstrates that the first-line drugs treated by medicine are the second-generation non-sedation antihistamines. Although the effect is good In the treatment process, the first-line drugs often relapse wit...
Article
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El diseño y la planificación de una investigación requiere conocer detalladamente el problema de estudio y las formas que se han abordado para investigarlo. Identificar el propósito del estudio ayudará a elegir el diseño más apropiado, determinar el o los grupos a estudiar, el conjunto suficiente de variables a evaluar y, en el caso de los pediatra...
Article
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Background Increasingly, it is argued that clinical trials struggle to recruit participants because they do not respond to key questions or study treatments that patients will be willing or able to use. This study explores how elicitation of patient-preferences can help designers of randomized controlled trials (RCTs) understand the impact of chang...
Article
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Purpose Drug protocols in intensive care units may require the concomitant administration of many drugs as patients’ venous accesses are often limited. A major challenge for clinicians is to limit the risk of simultaneously infusing incompatible drugs. Incompatibilities can lead to the formation of particles and inactivation of drugs, whose consequ...
Article
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The future clinical application of animal-to-human transplantation (xenotransplantation) is of importance to society as a whole. Favourable preclinical data relevant to cell, tissue, and solid organ xenotransplants have been obtained from many animal models utilising genetic engineering and protocols of pathogen-free husbandry. Findings have reache...
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A randomized controlled trial (RCT) is a prospective, comparative, quantitative experiment/study that is performed under controlled conditions with random allocation of interventions to comparison groups. Among all the clinical study designs, evidence generated from RCTs is considered to be at top of the evidence pyramid. There are many different R...
Article
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Background Transvenous implantable cardioverter defibrillators (TV ICD) provide life-saving therapy for millions of patients worldwide. However, they are susceptible to several potential short- and long- term complications including cardiac perforation and pneumothorax, lead dislodgement, venous obstruction, and infection. The extravascular ICD (EV...
Article
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Background Coronary artery disease (CAD) remains one of the leading causes of mortality worldwide and is associated with multiple inherited and environmental risk factors. This study is designed to identify, design, and develop a panel of genetic markers that combined with clinical and angiographic information, will facilitate the creation of a per...
Poster
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Objectives The objective is to conduct a systematic review on the safety of using enteral nutrition formulations containing dietary fiber in hospitalized critical care patients. Methods This systematic review was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Version 6.1,2020). Searches were implemented...
Article
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We are the first to present results from a pilot clinical study designed for the purpose of establishing spectral mapping patterns, as a potential novel imaging assay for identifying and discriminating between functional and nonfunctional endometrial polyps in vivo. The Spectral Artificial Vision Endoscope (SAVE) was used and validated in this stud...
Article
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Metformin is the first-line treatment for many people with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM) to maintain glycaemic control. Recent evidence suggests metformin can cross the placenta during pregnancy, thereby exposing the fetus to high concentrations of metformin and potentially restricting placental and fetal g...
Article
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A combination of olanzapine and samidorphan (OLZ/SAM) is in development for treatment of patients with schizophrenia or bipolar I disorder. Population pharmacokinetic (PopPK) models for olanzapine and samidorphan were developed using data from 11 clinical studies in healthy subjects or patients with schizophrenia. A 2-compartment disposition model...
Article
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Hesperidin in orange juice may affect chronic disease biomarkers. This narrative systematic review aimed to determine appropriate recommendations toward the dose and frequency of hesperidin consumption from 100% orange juice and conduct a gap analysis. The Preferred Reporting Items for Systematic Review and Meta-analysis was conducted to identify a...
Article
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There are currently ten COVID-19 vaccines being announced their preliminary efficacies from phase 3 clinical trial, and nine of them have been authorized for emergency use or conditional licensed, which brings some issues to present placebocontrolled efficacy trial of other COVID-19 vaccines. The approval of “first wave” COVID-19 vaccines raises co...
Article
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Background: Esophageal cancer is one of the leading causes of cancer-related death worldwide. Despite the significant progress in the overall treatment of esophageal cancer in recent years, the prognosis for patients who require surgery remains poor. Methods: The present study investigated the clinicopathological features of 503 patients who und...
Article
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Accurate and individualized prediction of response to therapies is central to precision medicine. However, due to the generally complex and multifaceted nature of clinical drug response, realizing this vision is highly challenging, requiring integrating different data types from the same individual into one prediction model. We use the anti-epilept...
Preprint
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SUMMARY Prospective, controlled clinical trials avoid the pitfalls of uncontrolled and/or retrospective clinical study designs. Hence, the identification of such trials provides an important first step when questioning the evidence-base of any dental product. Dissemination of such information to dental academia or oral health care providers with in...
Article
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Objectives Clinical validation of a bioluminescence imaging system (Cis) as measured by the level of agreement between clinician visual and tactile assessment of carious lesion presence and activity and the presence/absence of elevated luminescence on a tooth surface determined from intraoral image mapping. Materials and Methods This was a regulat...
Article
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Arianna Burton,1 Adam Castaño,1 Marianna Bruno,1 Steve Riley,2 Jennifer Schumacher,1 Marla B Sultan,3 Sandi See Tai,4 Daniel P Judge,5 Jignesh K Patel,6 Jeffery W Kelly7 1Medical Affairs, Pfizer Inc, New York, NY, USA; 2Clinical Pharmacology, Pfizer Inc, Groton, CT, USA; 3Global Product Development, Pfizer Inc, New York, NY, USA; 4Global Product De...
Article
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Objective: The objective of this article is to provide a high-profile review and discussion on the study design and statistical analysis of pivotal clinical trials conducted to demonstrate the safety and effectiveness of closed-loop investigational artificial pancreas device systems (APDSs) in premarket approval applications. Methods: The United...
Article
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The pandemic has drawn focus to the need for greater racial and ethnic diversity in Clinical trials. This is not a new issue diverse communities have long been underrepresented in clinical research but COVID-19 has put a necessary spotlight on the work to do. This Pictorial representation may guide to design clinical data.
Article
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In this study, we assessed the prognostic relevance of temporal muscle thickness (TMT), likely reflecting patient’s frailty, in patients with primary central nervous system lymphoma (PCNSL). In 128 newly diagnosed PCNSL patients TMT was analyzed on cranial magnetic resonance images. Predefined sex-specific TMT cutoff values were used to categorize...
Article
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It is challenging to compare amyloid PET images obtained with different radiotracers. Here, we introduce a new approach to improve the interchangeability of amyloid PET acquired with different radiotracers through image-level translation. Deep generative networks were developed using unpaired PET datasets, consisting of 203 [¹¹C]PIB and 850 [¹⁸F]fl...
Article
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Background Atypical antipsychotics as first-line drugs have been used in patients with schizophrenia in China and abroad. However, its safety still needs to be evaluated in a large population, especially in Chinese patients. Objective The main objective of this study is to evaluate the safety and related factors of long-term atypical antipsychotic...
Article
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With this review, we aim to increase the quality standards for clinical studies with microbiome as an output parameter. We critically address the existing body of evidence for good quality practices in oral microbiome studies based on 16S rRNA gene amplicon sequencing. First, we discuss the usefulness of microbiome profile analyses. Is a microbiome...
Article
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The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the “translational valleys of death” requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Tran...
Article
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The use of high dose ascorbate infusions in cancer patients is widespread, but without evidence of efficacy. Several mechanisms whereby ascorbate could affect tumor progression have been proposed, including: (i) the localized generation of cytotoxic quantities of H 2 O 2 ; (ii) ascorbate-dependent activation of the 2-oxoglutarate-dependent dioxygen...
Article
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Angiosarcoma (AS) is a rare disease with dismal prognosis. The treatment landscape and prognostic factors for advanced AS, including locally advanced, unresectable, and metastatic disease remain elusive. The Asian Sarcoma Consortium is an international collaborative effort to understand the sarcoma treatment landscape in Asia. We undertook a retros...
Chapter
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Wie können wir intersektionale Biopolitiken der Biomedizin beschreiben? Inwiefern spielten intersektionale Macht- und Wissensordnungen bei der "Geburt" und "Produktion" der HeLa-Zelle eine Rolle? Und welcher Bedeutung kommen Repräsentationstechniken bei dem Design klinischer Studien zu?
Article
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The predictive performance of physiologically based pharmacokinetic(s) (PBPK) models for PK in renal impairment (RI) and hepatic impairment (HI) populations was evaluated using clinical data from 29 compounds with 106 organ impairment study arms were collected from 19 member companies of the International Consortium for Innovation and Quality in Ph...
Article
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Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection among infants and young children, resulting in annual epidemics worldwide. INFORM-RSV is a multi-year clinical study designed to describe the global molecular epidemiology of RSV in children under five years of age by monitoring temporal and geographical evo...
Article
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Purpose: Fedratinib (INREBIC®), a Janus kinase 2 inhibitor, is approved in the United States to treat patients with myelofibrosis. Fedratinib is not only a substrate of cytochrome P450 (CYP) enzymes, but also exhibits complex auto-inhibition, time-dependent inhibition, or mixed inhibition/induction of CYP enzymes including CYP3A. Therefore, a mech...
Article
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Purpose of review: High lipoprotein(a) (Lp(a)) level is an independent cardiovascular risk factor with higher prevalence among patients with atherosclerotic cardiovascular disease (ASCVD). The actual problem is that most currently available lipid-lowering drugs are unable to abolish Lp(a) pathogenicity. Lipoprotein apheresis (LA) is an effective m...