Clinical Trials - Science topic

Background: The therapeutic assessment of functioning in cardiac rehabilitation from the perspective of the International Classification of Functioning, Disability and Health (ICF) can provide a biopsychosocial approach to health care. However, it is unclear which components are reflected in the instruments used for cardiac rehabilitation in indivi...

PURPOSE: Central subfoveal thickness measurement is used in a large number of clinical trials to monitor the progression and treatment response of diabetic macular edema (DME) in patients of diabetic retinopathy (DR). Several studies have been carried out to investigate various factors affecting the central subfoveal thickness in order to minimize...

Objetivo: investigar se exercícios físicos melhoram a capacidade física de pessoas idosas durante a hospitalização. Métodos: a amostra foi composta por 67 pessoas idosas com idade mediana de 73 (60-90) anos, hospitalizadas em unidade de internação devido a condições agudas de saúde (20,9% por motivos renais/urinários, 19,4% causas metabólicas e 17,...

When intervention scientists plan a clinical trial of an intervention, they select an outcome metric that operationalizes their definition of intervention success. The outcome metric that is selected has important implications for which interventions are eventually supported for implementation at scale and, therefore, what health benefits (includin...

El acné vulgar es una enfermedad inflamatoria frecuente y crónica de la piel que afecta a la unidad pilosebácea. Sus características clínicas incluyen piel grasa, lesiones no inflamatorias (puntos blancos y negres), lesiones inflamatorias (pápulas y pústulas) y diversos grados de cicatrización. El acné se asocia con efectos adversos sobre la calida...

Purpose Autism spectrum disorder (ASD) is a neurodevelopmental condition that affects patients’ ability to communicate, engage with others, and behave in certain ways. Despite the existence of several therapy possibilities, an effective treatment for ASD has not yet been identified. Cell therapies have been becoming increasingly recognized in recen...

Overactive bladder (OAB) is a prevalent condition affecting 23% of the population in the USA. There are several options for third-line therapies (intradetrusoronabotulinumtoxinA injections, sacral (S3) nerve stimulation, and posterior tibial nerve stimulation (PTNS)), each with its own strengths and weaknesses. Implantable tibial nerve stimulators...

Background: Risky alcohol consumption (RAC) can lead to alcohol-related liver disease (ALD). Liver cirrhosis caused by ALD continues to increase as alcohol consumption continues unabated. In turn, the elderly are more sensitive to alcohol. Population ageing calls for preventive activities to improve their health. Brief interventions have proven to...

Objetivo: evaluar la efectividad de la auriculoterapia para reducir el dolor musculoesquelético crónico de la columna vertebral de los trabajadores de la salud. Método: ensayo clínico aleatorizado, triple ciego, realizado con trabajadores de la salud diagnosticados con dolor crónico en la columna vertebral. Se aplicaron ocho sesiones de auriculoter...

As the world adapts to living with SARS-CoV-2, the continuous emergence of new variants has become a primary focus of current studies. In this review, we examined a range of available COVID-19 drugs, including FDA-regulated drugs and those undergoing late-stage clinical trials. Some FDA-regulated drugs, such as Veklury (remdesivir), Olumiant (baric...

Objetivo: comprobar la tasa de evaluación correcta mediante la comparación visual directa de las medidas de dilatación cervical en modelos de cuello uterino de consistencia dura. Método: estudio aleatorizado abierto con 63 estudiantes de obstetricia a los que se les asignó usar o no la comparación visual directa con una guía de dilatación. Los estu...

Background To explore the changes of cytokines expression in aqueous humor (AH) of eyes of patients with congenital cataract (CC) who underwent delayed sequential bilateral cataract surgery (DSBCS). Methods 28 patients with CC underwent DSBCS. AH samples were collected from each eye before surgery. The contents of cytokines in AH were detected by...

Background Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR‐TKI) acquired resistance was an inevitably events in NSCLC treatment. Aims Intending to overcome the acquired resistance of EGFR‐TKI. Materials & Methods A clinical trial was, we enrolled 12 patients who were slowly progressing on first‐generation EGFR‐TKI, and added apa...

Introducción. El envejecimiento humano constituye un proceso multidimensional en los seres humanos que se caracteriza por ser heterogéneo, intrínseco e irreversible; se inicia en la concepción, se desarrolla durante el curso de vida y termina con la muerte. El objetivo de este artículo fue identificar los cambios fisiológicos de la aptitud física c...

Activating mutations in KRAS are highly relevant to various cancers, driving persistent efforts toward the development of drugs that can effectively inhibit KRAS activity. Previously, KRAS was considered ‘undruggable’; however, the recent advances in our understanding of RNA and nucleic acid chemistry and delivery formulations have sparked a paradi...

Therapeutic vaccines are a promising alternative for active immunotherapy for different types of cancers. Therapeutic cancer vaccines aim to prevent immune system responses that are not targeted at the tumors only, but also boost the anti-tumor immunity and promote regression or eradication of the malignancy without, or with minimal, adverse events...

Tirzepatide is an emerging hypoglycemic agent that has been increasing used in adults, yet its pharmacokinetic (PK) behavior and dosing regimen in pediatric population remain unclear. This study aimed to employ the physiologically based pharmacokinetic (PBPK) model to predict changes of tirzepatide exposure in pediatric population and to provide re...

Background Upadacitinib is an oral, selective Janus kinase inhibitor. Aim To assess the efficacy and safety of upadacitinib in patients with moderate‐to‐severe ulcerative colitis following 16‐week extended induction therapy, and 52‐week maintenance therapy in patients achieving clinical response after 16‐week extended induction therapy Methods Pa...

A growing number of gene therapy‐ and gene editing‐based treatments for patients with sickle cell disease (SCD) are entering clinical trials. These treatments, designed to target the underlying cause of SCD, have the potential to provide functional cures, which until now were possible only through allogeneic hematopoietic stem cell transplant. Howe...

Introducción: la enfermedad hepática esteatósica asociada a disfunción metabólica (MASLD) ha emergido como un desafío principal en salud pública, vinculándose con trastornos metabólicos y enfermedades cardiovasculares. Esta patología, que implica la acumulación de grasa en el hígado, tiene potencial de progresar a condiciones más severas, como cirr...

Background and Objective: Type 2 diabetes is a common disease that could be prevented or managed with a healthy lifestyle. This study was conducted to determine the effects of self-healing with mindfulness-integrated cognitive behavior therapy on the health-promoting lifestyle profile of patients with type 2 diabetes.

Over the last few years, several review articles described the adverse events analysis as sub-optimal in clinical trials. Indeed, the context surrounding adverse events analyses often imply an overwhelming number of events, a lack of power to find associations, but also a lack of specific training regarding those complex data. In randomized control...

Radiotherapy for cancer has been known to affect the responses of immune cells, especially those of CD8+ T cells that play a pivotal role in anti-tumor immunity. Clinical success of immune checkpoint inhibitors led to an increasing interest in the ability of radiation to modulate CD8+ T cell responses. Recent studies that carefully analyzed CD8+ T...

Lymphoma diagnoses in the U.S. are substantial, with an estimated 89,380 new cases in 2023, necessitating innovative treatment approaches. Phase 1 clinical trials play a pivotal role in this context. We developed a binary predictive model to assess trial adherence to expected average durations, analyzing 1,089 completed Phase 1 lymphoma trials from...

Due to the small sample sizes in early-phase clinical trials, the toxicity and efficacy profiles of the dose-schedule regimens determined for subsequent trials may not be well established. The recent development of novel anti-tumor treatments and combination therapies further complicates the problem. Therefore, there is an increasing recognition of...

The document «Guide to Excellence in the Conduct of Clinical Trials in Hospital Pharmacy» was drawn up by hospital pharmacists and representatives of the pharmaceutical industry. Its objective is to unite criteria, introduce improvements in communication, harmonize and digitalize processes in all phases of development of a clinical trial in hospita...

La lombalgie chronique non spécifique (LCNS), sans cause patho-anatomique déterminée, a été identifiée comme l’une des principales causes d’invalidité dans le monde. À ce jour, la majorité des essais cliniques l’évaluent à l'aide d'échelles ou de questionnaires, faisant état de l'influence de facteurs cognitifs, émotionnels et comportementaux. Une...

Despite the motivation of oncology patients to take part in clinical trials, only a minority of them are enrolled in clinical trials. Implementation of new practical procedures can become a barrier that withholds patients from participating in clinical trials. Treating physicians are crucial in augmenting trial accrual. The drivers that promote phy...

We propose a Bayesian hypothesis testing framework that allows for the assessment of evidence collected during a clinical trial about the cost-effectiveness of a healthcare technology. The model exploits a Bayesian updating rule that makes the link between the evidence collected in clinical research and the expected payoffs of adoption to the healt...

Background The past few decades have seen remarkable developments in dose-finding designs for phase I cancer clinical trials. While many of these designs rely on a binary toxicity response, there is an increasing focus on leveraging continuous toxicity responses. A continuous toxicity response pertains to a quantitative measure represented by real...

Photobiomodulation causes an immediate increase in local blood flow. This study aimed to investigate the effect of 890 nm NIR exposure on local skin blood flow in young and middle-aged healthy subjects. In this placebo-controlled clinical trial, 12 young and 12 middle-aged healthy subjects received either continuous or intermittent NIR exposure (89...

In the pursuit of optimal anti-tumor immune effects, both “passive” and “active” immunotherapies have made significant progress recently. In situ vaccines offer a promising solution by using intratumoral administration of immunomodulators or other local treatments, to scientifically combine active and passive immunotherapies. It forms a repetitive...

Background: Dental caries is one of the most prevalent diseases among children worldwide. Saliva plays a significant role in the demineralization/remineralization of the dental surface. Several salivary characteristics, such as flow rate, pH, and buffering capacity, provide relevant information regarding the development of carious lesions. Photobio...

Branch retinal Vein occlusion treatment

Responsive neurostimulation (RNS) is an effective therapy for people with drug-resistant focal epilepsy. In clinical trials, RNS therapy results in a meaningful reduction in median seizure frequency, but the response is highly variable across individuals, with many receiving minimal or no benefit. Understanding why this variability occurs will help...

Background: The CHOP-INTEND is an established outcome measure used to assess motor function in young and weak SMA patients previously validated in type I infants older than 3 months. Objective: The aim of our study was to assess the maturation of the CHOP-INTEND scores in a group of healthy infants, establishing which items of the scale can be reli...

In Clinical trials studies of Unani Medicine , Author involve with randomized controlled trials and pharmacopoeial studies at RRIUM, Aligarh. Author Defining the Statistical Analysis, sequential analysis, hierarchical models, Bayesian analysis etc. Small clinical trials frequently need to be viewed as part of a process of continuing data collection...

Lipedema is a common yet often misdiagnosed adipose tissue disorder estimated to affect up to 11% of women worldwide, potentially affecting as many as 418,000,000 women. There is no clinically agreed-upon case definition for lipedema, confounding the ability to build an evidence-base in lipedema by amassing case-control, cohort study, or clinical t...

We present a case of an adult female diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD) and Optic Nerve Hypoplasia (ONH), with a confirmed delayed Dim Light Melatonin Onset (DLMO), who reports the inability to fall asleep at their desired bedtime and obtain adequate sleep nightly, despite the ability to have a full night’s sleep when not requ...

Traditional Chinese medicine (TCM) is increasingly used to manage type 2 diabetes and its nonpharmacological interventions are showing potential for preventing type 2 diabetes. This study mainly reviews relevant research. The most mentioned non-drug treatments for preventing type 2 diabetes in TCM are healthy diet, physical activity, emotional ther...

Background VOYAGE 1, VOYAGE 2, ORION, and ECLIPSE are Phase 3, double-blind trials of guselkumab 100 mg s/c at Weeks 0, 4, 12, then Q8W in moderate to severe plaque psoriasis. VOYAGE 1 and VOYAGE 2 included placebo and active comparator groups, ORION was placebo controlled, and ECLIPSE included an active comparator control group. The objective of t...

Introducción: La enfermedad cardiovascular aterosclerótica es la principal causa de mortalidad y morbilidad a nivel mundial. Uno de los factores clave en su desarrollo es el colesterol LDL elevado. La proproteína convertasa subtilisina/kexina tipo 9 (PCSK9) es una molécula que regula los niveles de colesterol LDL. Objetivo: El propósito de esta rev...

The COVID-19 pandemic has been sweeping the world, which has adversely affected both the social and economic sectors. However, there is hope in the development of various vaccines designed to combat the virus. These vaccines come in different forms, including inactivated vaccines, mRNA vaccines and others. When it comes to vaccine safety, attenuate...

Definition of a core outcome set (COS), which represents an agreed set of outcomes for each hematological malignancy (HM) may improve the interpretation and comparability of clinical trials. HARMONY – the Healthcare Alliance for Resourceful Medicine Offensive against Neoplasms in Hematology – and the follow up project HARMONY PLUS developed COS for...

Clinical trials often involve new substances characterized or developed for a specific pathology or class of pathologies. At other times, a clinical trial is observational; in other words, a known sub-stance has a range of effects on a given cohort of subjects. The types of trials are different and complex, and often, young clinical novice and the...

Aim: We aimed to evaluate early versus delayed removal of the indwelling urethral catheter (IUC) following transurethral resection of prostate (TURP). Methods: In this clinical trial conducted between July 2016 and June 2020, 90 patients underwent TURP were randomized equally into: group A, early IUC removal (24 h), and group B, delayed IUC removal...

Objective Test sustainability of Web-based Implementation for the Science of Enhancing Resilience (WISER) intervention efficacy in reducing healthcare worker (HCW) emotional exhaustion (EE), a key component of burnout. Design: One-year follow-up of WISER RCT using two cohorts (one waitlist) of HCWs of four NICUs each, to improve HCW well-being (pri...

Background Nivolumab plus ipilimumab has demonstrated improved survival for treatment-naïve advanced clear cell renal cell carcinoma (RCC). A series of clinical trials evaluated the effect of salvage nivolumab plus ipilimumab in patients without an objective response to nivolumab. Given the size and heterogeneity of these studies, we performed a po...

Adherence to HIV pre-exposure prophylaxis (PrEP) study drug is critical for safety, tolerability, and efficacy trials, and may be affected by how adherence is communicated by the study staff to trial participants. Increasingly, clinical trials investigating PrEP are creating and implementing ‘participant-centered’ approaches that discuss potential...

Introduction This prospective study aimed to assess the effectiveness of a Y-shape connection device in reducing pain and bleeding in pediatric patients with indwelling catheters during urodynamic studies (UDS), while also obtaining effective results in the filling phase. Methods A total of 45 pediatric patients with a mean age of 13 years were in...

China has became the world’s second largest pharmaceutical market, and the number of her registered clinical trials exceeded 3000 in 2021. Although thousands of healthy volunteers are participating in a large number of clinical trials in this country, there is no report about the characteristics, recognition, attitude of Chinese healthy volunteers...

Metastatic porocarcinomas (PC) are vanishingly rare, highly aggressive skin adnexal tumors with mortality rates exceeding 70%. Their rarity has precluded the understanding of their disease pathogenesis, let alone the conduct of clinical trials to evaluate treatment strategies. There are no effective agents for unresectable PC. Here, we successfully...

The coronavirus 2019 (COVID-19) pandemic, as well as the resulting public health measures, impacted many aspects of society. The conduct of important pediatric vaccine trials was among these. Analyzing data from six ongoing non-COVID-19 pediatric vaccine trials we aimed to assess the operational impact of the COVID-19 pandemic using descriptive ana...

Gene therapy is a new class of medical treatment that alters part of a patient’s genome through the replacement, deletion, or insertion of genetic material. While still in its infancy, gene therapy has demonstrated immense potential to treat and even cure previously intractable diseases. Nevertheless, existing gene therapy prices are high, raising...

Plain English summary Patient and public involvement and engagement (PPIE) is when members of the public are directly involved in carrying out research projects. This is important because we as researchers want to make sure we are focusing on what matters most to patients, so that the research has as large an impact as possible. PPIE has typically...

Introduction Keynote-775 defined the SOC for MMRp recurrent EC. AEs with recommended dosing of lenvatinib/pembrolizumab led to dose reductions in 66.5% of patients. Real world prescription patterns vary significantly from clinical trial. We describe prescribing patterns and outcomes across a multi-institutional consortium. Methods A national multi...

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are widely used in patients with kidney disease to improve clinical outcomes. They are known to increase serum magnesium levels. There are rare case reports of these helping treat hypomagnesemia with or without urinary losses of magnesium. We present a case report to add to this data in treating ref...

Background and Aims Dapagliflozin has been widely used for the treatment of type 2 diabetes mellitus (T2DM) and heart failure (HF). However, data concerning the association between dapagliflozin and the recurrence of atrial fibrillation (AF), especially in patients following Cox Maze IV (CMIV), are rare. We aim to explore the effect of dapagliflozi...

In this study, we have introduced a novel approach to cancer treatment involving the deactivation of metalloenzymes through the utilization of radioisotopes. The concept of leveraging radioisotopes to interact with metalloenzymes represents a groundbreaking theoretical advancement. Through simulations utilizing the MIRD code and based on the consis...

Introducción. Es indispensable implementar procesos de intervención durante la primera infancia para el reconocimiento, gestión y manejo de las emociones. Esta etapa del desarrollo es la base para el aprendizaje y la adquisición de habilidades cognitivas, comportamentales y sociales. Objetivo. Evaluar la calidad de las intervenciones desde los aspe...

Radiation therapy and anti-CTLA-4 combination therapy can induce meaningful responses in some patients. Adding CD40 may provide additional benefit. Next-generation anti-CTLA-4 antibodies, such as botensilimab, are showing promise in clinical trials. Combining botensilimab with RT and/or CD40 agonist may offer additional benefits for challenging tum...

Racial and Ethnic Distribution Among AMD Clinical Trial Participants in the United States From 2002 to 2021

Presentamos 6 trabajos que están en las páginas 1,2,3,4,9 y 23 del documento - Análisis comparativo entre Colágeno polimerizado tipo I y Baricitinib como tratamientos de COVID-19 - Hallazgos espirométricos en pacientes convalecientes de neumonía severa por COVID-19 y su relación con agentes inmunomoduladores como dexametasona y colágeno polimeri...