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Clinical Trials - Science topic

Clinical Trials, Bioequivalence and Bioavailability Studies, Clinical Studies
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We examine the implications of lowering barriers to access to scientific publications for science and innovation in developing countries. Specifically, we investigate whether and how free or low-cost online access to scientific publications through the UN-led Access to Research for Health (Hinari) Programme leads to more scientific publications and...
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Oncolytic viruses represent a distinct class of viruses that selectively infect and destroy tumor cells while sparing normal cells. Despite their potential, oncolytic viruses encounter several challenges as standalone therapies. Consequently, the combination of oncolytic viruses with other therapeutic modalities has emerged as a prominent research...
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Generalized Anxiety Disorder (GAD) is a prevalent and debilitating condition, characterized by excessive and persistent worry that impairs daily functioning.1 Despite various treatment options, many show limited efficacy, prompting interest in novel interventions through clinical trials.2 A review of GAD clinical trials provides insights into resea...
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Financial toxicity is ubiquitous in cancer patients, including in patients enrolled in early phase clinical trials. The prevalence of financial toxicity has implications for policymakers.
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In 2024, global healthcare private equity surged to an estimated $115 billion, marking the second-highest total deal value ever recorded. This growth was driven by an uptick in large-scale deals, with five transactions exceeding $5 billion, up from just two in 2023 and one in 2022. North America remained the dominant market, accounting for 65% of...
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This case report presents positive outcomes from deep brain stimulation (DBS) targeting the bed nucleus of the stria terminalis (BNST) in two patients with treatment‐resistant depression and generalized anxiety disorder. DBS effects in the medial forebrain bundle (MFB) area were unclear. Further research into DBS's efficacy when comorbid anxiety is...
Preprint
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Bayesian design of experiments and sample size calculations usually rely on complex Monte Carlo simulations in practice. Obtaining bounds on Bayesian notions of the false-positive rate and power therefore often lack closed-form or approximate numerical solutions. In this paper, we focus on the sample size calculation in the binomial setting via Bay...
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Effect of Ayurvedic therapy in the relief of gastro-intestinal diseases is very much significant. Considering the above fact, a clinical trial of two common Ayurvedic preparations has been taken up in the treatment of common gastro-intestinal disease-Amlapitta (non-ulcer dyspepsia). The diagnosis, selection criteria and assessment of effect has bee...
Chapter
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A critical piece of information for a survival trial is when it is expected to end. This is essential not only for trial planning and execution, but also for funding. The power of a trial is driven by the number of events, rather than patients. Implementing clinical trials presents problems not typically encountered in other experiments, such as wi...
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Esta revisión describe los cambios fisiológicos que ocurren en los sistemas respiratorio y cardiovascular como parte del proceso de envejecimiento y evalúa el fitness cardiorrespiratorio (FCR), destacando el VO2peak como un posible biomarcador de fragilidad en personas mayores (PM). La evidencia disponible indica una relación inversa entre el VO2pe...
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Background/Objectives: Osteoarthritis (OA) is a highly prevalent, degenerative joint disease capable of causing severe pain and impaired mobility. Current treatments mitigate symptoms but do not cure the disease. The development of a disease-modifying osteoarthritis drug (DMOAD) could improve patient outcomes by slowing, halting, or reversing joint...
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Adverse Drug Reactions (ADRs) stand out as a pressing challenge in public health and a critical aspect of drug discovery. The dilemma arises from the inherent impossibility of conducting a comprehensive evaluation of a drug before its market release, constrained by the limitations in scale and duration of clinical trials. Therefore, the post-market...
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The relationship between heart failure (HF) and immune activation has garnered significant interest. Studies highlight the critical role of inflammation in HF, affecting cardiac structure and function. Despite promising anti‐inflammatory therapies, clinical trials have faced challenges, indicating an incomplete understanding of immune mechanisms in...
Preprint
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Many data problems contain some reference or normal conditions, upon which to compare newly collected data. This scenario occurs in data collected as part of clinical trials to detect adverse events, or for measuring climate change against historical norms. The data is typically multivariate, and often the normal ranges are specified by a multivari...
Article
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While observational studies and small pilot trials suggest that vitamin D, omega-3 and exercise may slow biological aging, larger clinical trials testing these treatments individually or in combination are lacking. Here, we report the results of a post hoc analysis among 777 participants of the DO-HEALTH trial on the effect of vitamin D (2,000 IU p...
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Atezolizumab, a biotherapeutic monoclonal antibody directed against PD-L1, has been shown to be efficacious in multiple oncology indications. In clinical trials, a subset of patients developed anti-atezolizumab antibodies, necessitating the development of a neutralizing antibody (NAb) assay. A bead-based sample pretreatment method was developed to...
Article
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Objective An important criterion for selecting clinical trials to be compared in systematic reviews and meta-analyses is that they measure the same outcomes. However, this represents a challenge as there is a wide variety of outcomes, and it is difficult to standardize them for comparing clinical trials containing them. To address this challenge, w...
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Objective Organ damage in patients with systemic sclerosis (SSc) in individual organs such as the lungs may be prevented by receiving immunosuppressive drugs (ISs). A new measure of global organ damage, the Scleroderma Clinical Trials Consortium Damage Index (SCTC‐DI), has allowed us to investigate whether receiving ISs may reduce global organ dama...
Article
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Objective The aim of this research was to determine how common gout flares are after ceasing anti‐inflammatory prophylaxis. Methods A rapid literature review and meta‐analysis were undertaken. PubMed was searched from inception to February 2024. Eligibility criteria included any clinical trial of people with gout with at least one arm starting or...
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Background Emergency department admissions significantly burden hospital staff and countries’ health system. Studies are encouraged for effective and correct utilization of emergency departments. Rational management of obesity-related medical problems and postoperative complications may reduce emergency department visits. This study aimed to determ...
Preprint
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Handling highly dependent data is crucial in clinical trials, particularly in fields related to ophthalmology. Incorrectly specifying the dependency structure can lead to biased inferences. Traditionally, models rely on three fixed dependence structures, which lack flexibility and interpretation. In this article, we propose a framework using a more...
Article
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Lecanemab the humanized IgG1 mAB, is administered intravenously, and binds to Aβ species. It is the only drug among all the currently available treatments that shows a 37% decline of the abnormal Aβ protein plaques and slowes the loss of the brain function. This drug works in patients in the starting stages of Alzheimer's and dementia. On January 6...
Article
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Background: Anorexia is a serious condition, especially in older adults, often leading to malnutrition, weight loss, and other severe health problems. Habb-e-Hilteet is a commonly prescribed Unani pharmacopoeial formulation for anorexia. However, no scientific data are available regarding its safety and efficacy. This study assessed the appetite-in...
Article
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Long COVID, potentially emerging post COVID-19 infection, involves extreme health challenges. Based on current literature in the field, we propose a novel approach to Long COVID treatment based on epipharyngeal abrasive therapy targeting ostia of the oral and nasal mucosa, having been identified for the first time. The presented case report documen...
Preprint
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Psoriasis is a chronic skin condition that requires long-term treatment and monitoring. Although, the Psoriasis Area and Severity Index (PASI) is utilized as a standard measurement to assess psoriasis severity in clinical trials, it has many drawbacks such as (1) patient burden for in-person clinic visits for assessment of psoriasis, (2) time requi...
Article
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Large-scale manufacturing procedures have been developed in response to the growing demand for monoclonal antibodies (mAbs) utilized in therapeutic and diagnostic applications. Continuous optimization of the underlying systems has improved product. Numerous enhancements and changes to monoclonal antibodies have been devion. In response to mAb limit...
Article
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In case of venous route abnormality during a leadless pacemaker (LP) implantation, it can be challenging if we still performed via the predesigned femoral vein. We report a patient with normal preoperative laboratory and image results, but azygos continuation of the inferior vena cava (IVC) was suspected during the procedure. Then, we decided to ch...
Article
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Las variables subrogadas requieren de una adecuada validación para acreditar su utilidad. No obstante, las autoridades sanitarias admiten variables con un nivel de exigencia progresivamente menor. Las aprobaciones aceleradas precisan de estudios confirmatorios que, con frecuencia, no se completan. La carga viral del VIH o la hipertensión arterial s...
Preprint
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Intercurrent events, common in clinical trials and observational studies, affect the existence or interpretation of final outcomes. Principal stratification addresses these challenges by defining local average treatment effects within latent subpopulations, but often relies on restrictive assumptions such as monotonicity and counterfactual intermed...
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Carrying out clinical trials is essential for pushing forward the cause of medical science in that such is a stance from which it is possible to provide the proofs necessary for sanctioning new treatment methods including making sure they are safe and generally efficient. Clinical research help researcher to discover new medications to treat, preve...
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Background Physical literacy (PL) is pivotal for improving sedentary behaviors, enhancing intrinsic motivation for physical activity, and supporting the growth and development of adolescents. This study aims to measure the current situation and internal pathway of PL among Chinese elementary school students. Methods This study was conducted from J...
Article
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Monoclonal antibodies (mAbs) have completely changed the face of oncology over the last 50 years, and they have contributed to a major breakthrough in terms of cancer therapy. Esophageal and gastric cancers, the eighth and fifth most commonly diagnosed types of cancer worldwide, respectively, have lately, been managed more effectively, with the int...
Article
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The concept of synthetic lethality has emerged as a powerful tool in the targeted treatment of DNA repair-deficient tumors, offering a precision-based approach to cancer therapy. This research explores the intricate molecular mechanisms underlying synthetic lethality, emphasizing its application in the treatment of tumors with deficiencies in DNA r...
Preprint
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Background Acquired cystic kidney disease (ACKD) occurs in patients with end-stage kidney disease (ESKD), leading to renal cyst formation. Although typically asymptomatic, large cysts can cause unusual complications like gastrointestinal obstruction. Case presentation An 18-year-old female with stage V chronic kidney disease developed abdominal dis...
Article
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Current cancer treatments are known for their low selectivity, and life-threatening toxicity. To solve these issue, various innovative approaches were applied. One of them is the inhibition of DNA repair mechanisms, which have been developed as a new hotspot for its selective inhibition and low toxicity. Notably, PARP inhibition has shown potential...
Cover Page
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Certificate Course on GOOD CLINICAL PRACTICE MODULES Institutional Review Boards Informed Consent Confidentiality & Privacy Participant Safety & Adverse Events Quality Assurance The Research Protocol Documentation & Record-Keeping Research Misconduct Roles & Responsibilities Recruitment & Retention Investigational New Drugs Course Comple...
Article
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Minimal residual disease (MRD) evaluation is a recognized endpoint in clinical trials. Both next-generation flow and sequencing could be used as complementary techniques to detect myeloma cells after therapy to measure the depth of response and novel drug efficacy. Anti-CD38 monoclonal antibodies combined with proteasome inhibitors and immunomodula...
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Brain-computer interface (BCI) has been used to treat neurological diseases. Traditional BCI technologies are usually invasive and may damage neural tissue during implantation. However, endovascular electrodes (EE) are a promising solution to the above problem. They represent a minimally invasive neural technique that can reduce the risks associate...
Article
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Purpose of Review Medium and, rarely, large vessel vasculitis may affect the skin, and dermatologists can be instrumental in making a timely diagnosis. The purpose of this review is to present a general overview of medium and large vessel vasculitis presenting in the skin, with a focus on the latest research. Recent Findings Newly published studie...
Article
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Objective To assess the development of extramusculoskeletal manifestations (EMMs) among patients with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with upadacitinib 15 mg. Methods Data (cutoff: August 15, 2022) from five clinical trials in PsA (2), radiographic axSpA (r‐axSpA; previously ankylosing spondylitis) (2), and non...
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Colorectal cancer (CRC) is the second leading cause of cancer-related deaths globally. The risk of disease increases with age, as most CRC patients are over 50 years old. Due to the progressive aging of societies in high-income countries, the problem of CRC will increase. This makes the development of new early detection methods and the implementat...
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Clinical trials for cancer treatments often rely on surrogate endpoints to predict overall survival. In this commentary, we describe seven arguments deployed to support the use of surrogate endpoints, which we counter with research evidence and discussion of why overall survival is the endpoint that best serves the interest of patients.
Article
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Facial thread lifting with absorbable threads such as poly(L-lactide-co-ε-caprolactone) (P(LA/CL)) has been explored in an animal model. This experimental study utilized P(LA/CL)-HA-micro threads enhanced with hyaluronic acid microencapsulation via NAMICA technology in five four-month-old female pigs. The effects were compared to those of P(LA/CL)-...
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Purpose Meaningful change thresholds are important to help interpret patient-reported outcome scores. To date, meaningful within-patient change (MWPC) thresholds have only been proposed for NSCLC-SAQ total score. This study proposed clinically MWPC thresholds, and group-level minimal important change/difference (MIC/MID) thresholds for both improve...
Article
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Exon skipping, mediated through antisense oligonucleotides (ASOs), is a promising approach to exclude pathogenic variants from the DYSF gene and treat dysferlinopathies. Understanding the applicability of various exon skipping strategies in the total patient population, an analysis not previously performed, can help guide researchers in prioritizin...
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Recent studies have suggested that improved glycemic control in patients with diabetes may cause acute Charcot foot. To conduct a narrative review of studies investigating whether improved glycemic control in patients with diabetes causes acute Charcot foot. Publications found by searching PubMed, EMBASE, and Cochrane Library as well as reference l...
Preprint
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In the design of clinical trials, it is essential to assess the design operating characteristics (i.e., the probabilities of making correct decisions). Common practice for the evaluation of operating characteristics in Bayesian clinical trials relies on estimating the sampling distribution of posterior summaries via Monte Carlo simulation. It is co...
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The prevalence of autism spectrum disorder (OSB) has been increasing worldwide for many reasons. This situation triggers an intense concern in public health in terms of both families and authorities. Studies are aimed at increasing the quality of life of individuals with ASD. Many studies show that various exercises provide physical and mental deve...
Article
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Amyotrophic lateral sclerosis (ALS) and Huntington’s disease (HD) are diverse in clinical presentation and are caused by complex and multiple factors, including genetic mutations and environmental factors. Numerous therapeutic approaches have been developed based on the genetic causes and potential mechanisms of ALS and HD. Currently, available tre...
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Huntington's disease (HD) is a progressive neurodegenerative disorder for which, until now, only symptomatic treatment has been available. Lately, there have been multiple ongoing clinical trials targeting therapeutic agents for preventing disease onset or slowing disease progression in HD. These studies are in constant need of reliable biomarkers...
Presentation
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La presentación describe el estudio SPROUT, un ensayo clínico fase III sobre la eficacia y seguridad de apremilast en pacientes pediátricos (6-17 años) con psoriasis en placas moderada a grave. Los resultados muestran mejoras significativas y sostenidas en indicadores como sPGA y PASI 75 desde la semana 16 hasta la 52, con un perfil de seguridad co...
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The effectiveness and safety of combining anlotinib with gemcitabine and cisplatin in the first‐line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) have not been definitively established. This research seeks to investigate the potential benefits and risks of utilizing this combination therapy in the first‐line management of R/...
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Patients receiving methadone maintenance treatment (MMT) elicited poor response and rapid anti-HBs loss after standard hepatitis B vaccination. An optimal hepatitis B vaccination was urgent. A randomized, parallel-controlled trial was conducted in patients receiving MMT from 2019 to 2020, and patients were randomized to receive 3 or 4 doses of 20 o...