GCP

BACKGROUND: Good clinical practice (GCP) is put in place to protect human participants in clinical trials as well as to ensure the quality of research. Non-adherence to these guidelines can produce research that may not meet the standards set by the scientific community. Therefore, it must be ensured that researchers are well-versed in the GCP. But not much is known about the knowledge and practices of the GCP in the medical colleges of North India. AIM: To assess the knowledge and practices of researchers about GCP and analyze these with respect to the demographics of participants...

MOTIVATION: The NanoString™ nCounter® technology platform is a widely used targeted quantification platform for the analysis of gene expression of up to ∼ 800 genes. Whereas the software tools by the manufacturer can perform the analysis in an interactive and GUI driven approach, there is no portable and user-friendly workflow available that can be used to perform reproducible analysis of multiple samples simultaneously in a scalable fashion on different computing infrastructures...

A large body of research demonstrates positive impacts of the Coping Power Program as a preventive intervention for youth behavioral outcomes, but potential collateral effects for caregivers is less known. The current study examined whether the youth-focused Coping Power Program can have a secondary impact on caregiver self-reported symptoms of depression and in turn result in longer-term impacts on child disruptive behavior problems including aggression, conduct problems and hyperactivity. Data from 360 youth/caregiver pairs across 8 waves of data (grades 4 through 10) were analyzed...

Adaptive optics using direct wavefront sensing (direct AO) is widely used in two-photon microscopy to correct sample-induced aberrations and restore diffraction-limited performance at high speeds. In general, the direct AO method employs a Sharked-Hartman wavefront sensor (SHWS) to directly measure the aberrations through a spot array. However, the signal-to-noise ratio (SNR) of spots in SHWS varies significantly within deep tissues, presenting challenges for accurately locating spot centroids over a large SNR range, particularly under extremely low SNR conditions...

In this study we aimed to analyze the feasibility of the gasless renal biopsy technique in canine cadavers. The cadavers were randomly divided into two groups: laparoscopic GCG, in which gasless laparoscopy was performed and GCP, laparoscopy with pneumoperitoneum was performed. The procedures were randomly performed on the right and left kidneys. The total surgical time, procedural steps, and intraoperative complications were recorded. The degree of difficulty of the surgical approaches was evaluated by the surgeon, assistant, and external evaluators...

Human glutamate carboxypeptidase 2 (GCP2) from the M28B metalloprotease group is an important target for therapy in neurological disorders and an established tumor marker. However, its physiological functions remain unclear. To better understand general roles, we used the model organism Caenorhabditis elegans to genetically manipulate its three existing orthologous genes and evaluate the impact on worm physiology. The results of gene knockout studies showed that C. elegans GCP2 orthologs affect the pharyngeal physiology, reproduction, and structural integrity of the organism...

Spline functions have received widespread attention in the fields of image sampling and reconstruction. To enhance the computational performance of splines in reconstruction and avoid solving large linear equations, we propose a family of generalized cardinal polishing splines (GCP-splines) and provide a linear equation to obtain the expressions of GCP-splines. First, compared with general splines, we propose a cardinal spline function with high-precision. Then, we propose a class of GCP-splines and give a general theory of GCP-splines...

BACKGROUND: Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve...

This case report describes a laparoscopic approach using fluorescence imaging guidance to treat gangrenous cholecystitis with perforation (GCP). A male patient in his early 60s presented with 3 days of right upper abdominal pain. Computed tomography and ultrasonography findings were consistent with a stone incarcerated in the gallbladder neck, GCP, and localized peritonitis. Percutaneous gallbladder drainage was initially performed, followed by laparoscopic cholecystectomy 7 days later, using combined intravenous and intracholecystic fluorescent cholangiography...

As the burden of cancers impacting low and middle-income countries (LMICs) is projected to increase, formation of strategic partnerships between institutions in high-income countries and LMIC institutions may serve to accelerate cancer research, clinical care, and training. As the United States (US) National Cancer Institute (NCI) and its Center for Global Health continue to encourage cancer centers to join its global mission, academic cancer centers in the US have increased their global activities. In 2015, the Helen Diller Family Comprehensive Cancer Center (HDFCCC) at the University of California, San Francisco (UCSF) responded to the call for international partnership in addressing the global cancer burden through the establishment of the Global Cancer Program (GCP) as a priority initiative...

BACKGROUND: Prurigo nodularis (PN) is a chronic disease characterized by intense pruritus and nodular lesions associated with reduced quality of life. Until recently, no US Food and Drug Administration (FDA)-approved therapies have been available for the management of PN. Treatment regimens have been highly variable and clinical management guidelines are lacking overall; formal treatment guidelines do not exist within the US. In 2022, dupilumab became the first FDA-approved medication for PN...

Currently, there are no clinically approved drugs that directly thwart mutant KRAS G12D, a major driver of human cancer. Here, we report on the discovery of a small molecule, KRB-456, that binds KRAS G12D and inhibits the growth of pancreatic cancer patient-derived tumors. Protein NMR studies revealed that KRB-456 binds the GDP-bound and GCP-bound conformation of KRAS G12D by forming interactions with a dynamic allosteric binding pocket within the switch-I/II region. Isothermal titration calorimetry demonstrated that KRB-456 binds potently to KRAS G12D with 1...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's (ICH) renovation of Good Clinical Practice (GCP) represents a philosophical shift in the conduct of clinical research away from a one-size-fits-all application to promoting a proactive, risk-based approach. The aim of this paper is to enhance the understanding of specific topics detailed in ICH E8 based on direct feedback from TransCelerate member companies who identified Quality by Design (QbD), Critical to Quality (CtQ), Fit for Purpose, and Stakeholder Engagement, as most changed and open to interpretation...

Despite the intensive research in room-temperature phosphorescent (RTP) polymers, the synthesis of RTP polymers with well-defined macromolecular structures and multiple functions remains a challenge. Herein, reversible deactivation radical polymerization was demonstrated to offer a gradient copolymer (GCP) architecture with controlled heterogeneities, which combines hard segment and flexible segment. The GCPs would self-assemble into a multiphase nanostructure, featuring tunable stretchability, excellent RTP performance, and intrinsic healability without compromising light emission under stretching...

BACKGROUND: Grade C (previously aggressive) periodontitis (GCP) in adolescents is prevalent in certain parts of Africa where it is associated with JP2 genotype, a highly virulent strain of Aggregatibacter actinomycetemcomitans . The aim of this study was to characterize the subgingival bacteriome in Moroccan subjects with GCP positive to A. actinomycetemcomitans JP2 genotype. METHODS: Subgingival plaque samples were collected from shallow and deep pockets of 8 subjects with GCP (17...

AIM: Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population, so many recommendations have been approved to ensure optimal management. Clinical research was notably impacted by COVID too. This review aims to analyze the challenges occurred during a pandemic for the management of enrolled patients (enrollment, use of telemedicine visits, study procedures) and for the clinical trials system (from feasibility to selection visit, site initiation visit, monitorings, use of e-signature, deviations and discontinuations)...

INTRODUCTION: Tofacitinib, a selective inhibitor of JAK1 and/or JAK3, is considered to alleviate the pulmonary condition of primary Sjögren's syndrome (pSS)-associated interstitial lung disease (ILD) through its anti-inflammatory and antifibrotic effects. METHODS AND ANALYSIS: This is a single-center, prospective, randomized, open-label trial. The trial will compare a 52-week course of oral tofacitinib with traditional therapy cyclophosphamide (CYC) combined with azathioprine (AZA) in the treatment of pSS-ILD...

Conducting a vaccine trial in a low- and middle-income country (LMIC) can present unique challenges and lessons learned. This Ebola vaccine trial, enrolling 699 healthcare providers and frontliners and jointly set up by the University of Antwerp (Sponsor) and the University of Kinshasa (Principal Investigator (PI)), was conducted in Boende, a remote city in the Democratic Republic of the Congo (DRC), between December 2019 and October 2022 (ClinicalTrials.gov: NCT04186000). While being bound by strict ICH-GCP and international funder regulations, this trial, exemplary for being a public-private partnership, required collaboration between several international stakeholders (e...

Cell competition is a process that compares the relative fitness of progenitor cells, resulting in winners, which contribute further to development, and losers, which are excluded, and is likely a universal quality control process that contributes to the fitness of an individual. Cell competition also has pathological consequences, and can create super-competitor cells responsible for tumor progression. We are studying cell competition during germline regeneration in the colonial ascidian, Botryllus schlosseri...

BACKGROUND: Clinicians around the world perform clinical research in addition to their high workload. To meet the demands of high quality Investigator Initiated Trials (IITs), Clinical Trial Units (CTUs) (as part of Academic Research Institutions) are implemented worldwide. CTUs increasingly hold a key position in facilitating the international mutual acceptance of clinical research data by promoting clinical research practices and infrastructure according to international standards. AIM: In this project, we aimed to identify services that established and internationally operating CTUs - members of the International Clinical Trial Center Network (ICN) - consider most important to ensure the smooth processing of a clinical trial while meeting international standards...