Impact of GAMP 5, data integrity and QbD on quality assurance in the pharmaceutical industry: How obvious is it?

In the pharmaceutical industry, it is essential to ensure the safety and efficacy of medicinal products. Therefore a robust quality assurance framework is needed. This manuscript examines the impact of GAMP 5 and data integrity (DI) on quality assurance, while also highlighting the role of quality by design (QbD) principles.

Strategy to increase vaccination coverage in diabetic patients at a public tertiary university hospital: A randomized controlled trial.

Objective: To evaluate whether there is an increase in vaccination rates of patients with diabetes mellitus who received guidance to update their vaccination schedules for influenza, hepatitis B, pneumonia, and tetanus.

Methodology: A randomized controlled trial was conducted between December 2018 and November 2020. The sample consisted of 139 patients from the endocrinology service outpatient clinic of Santa Maria University Hospital was randomized into an intervention group ( = 68) and a control group ( = 71).

The governance of E-waste recycling networks: Insights from São Paulo City.

Electronic waste is an environmental problem because its production volume exceeds its recycling capacity. Academic and managerial production affirm two reasons: (a) dominant market logic and; (b) unresolved asymmetries among actors, causing conflicts to work together. Following the qualitative methodology, we investigate the e-waste situation in São Paulo City.

Vulcano: A new robotic challenge for legged robots.

The challenge is a new and innovative robotic challenge for legged robots in a physical and simulated scenario of a volcanic eruption. In this scenario, robots must climb a volcano's escarpment and collect data from areas with high temperatures and toxic gases. This paper presents the main idea behind this challenge, with a detailed description of the simulated and physical scenario of the volcano ramp, the rules proposed for the competition, and the conception of a robot prototype, , used in the competition.

Primary Anti-Phospholipid Antibody Syndrome: Real-World Defining Features of Rethrombosis in the Course of Disease.

Objective: We aimed to identify features that allow differentiation of primary antiphospholipid syndrome (PAPS) patients that suffer recurrent thrombotic events (RTE) despite anticoagulation, from the other diagnosed PAPS patients.

Methods: This was an exploratory study of anticoagulated PAPS patients attending an Autoimmune Diseases Unit (1998-2018). From 2016, anti-phospholipid antibodies and lupus anticoagulant were determined for each patient at consecutive visits, collected together with retrospective clinical characteristics, laboratory, and therapeutic markers and compared according to the occurrence of thrombotic events during follow-up.

Red algae industrial residues as a sustainable carbon platform for the co-production of poly-3-hydroxybutyrate and gluconic acid by .

Polyhydroxyalkanoate (PHA) production using halophilic bacteria has been revisited because less severe operational conditions with respect to sterility can be applied, also alleviating production costs. was selected because it is a moderate halophile able to grow and attain high poly-3-hydroxybutyrate (P3HB) contents under 5-45 g/L NaCl concentrations, conditions that discourage microbial contamination. Industrial residues of the red alga after agar extraction were used as sugar platform to reduce costs associated with the carbon source.

Percutaneous transluminal angioplasty and stenting in acute stroke caused by basilar artery steno-occlusive disease: The experience of a single stroke centre.

Background: Percutaneous transluminal angioplasty and stenting in acute stroke due to severe basilar artery stenosis or basilar artery occlusion remain a matter of debate. The higher risk of stroke recurrence in patients with vertebrobasilar stenosis compared to anterior circulation atherosclerotic disease creates high expectations concerning endovascular approaches. This study aims to review our experience with percutaneous transluminal angioplasty and stenting in acute stroke caused by basilar artery steno-occlusive disease.

Idiopathic Chronic Eosinophilic Pneumonia.

Idiopathic chronic eosinophilic pneumonia (CEP) is a rare disease of unknown cause characterized by eosinophilic alveolar and interstitial infiltration. The authors describe the case of a 46-year-old black man, presenting with insidious onset and progressive course of dyspnea on minimum exertion, cough, fever, night sweats, and weight loss for one year and worsening in the last three months. The main findings were serum eosinophilia.

Cytotoxicity of Chelating Agents Used In Endodontics and Their Influence on MMPs of Cell Membranes.

This study evaluated the cytotoxic effect and the ability to inhibit matrix metalloproteinases (MMP-2 and MMP-9) of 0.2% chitosan (CH) and 1% acetic acid (AA) compared with 17% ethylenediaminetetraacetic acid (EDTA). Cell viability assay was performed according to ISO 10993-5 with mouse fibroblasts (L929).

Catastrophic Gastrointestinal Bleeding: Always Consider Meckel's Diverticulum.

Unlabelled: Meckel's diverticulum, a congenital malformation of the gastrointestinal tract, is asymptomatic in the majority of patients but can be associated with some complications. Gastrointestinal bleeding is one such complication and is more common in children than in adults. Despite the variety of examinations available, diagnosis can be difficult, especially in older patients, because the sensitivity of examinations decreases with patient age.

Rectal ulcer due to Kayexalate deposition - an unusual case.

Sodium polystyrene sulfonate (PSP) or Kayexalate is a cation-exchange resin, widely used in the management of hyperkalaemia due to renal disease. A rare, yet potentially dangerous, adverse event related to sodium polystyrene sulfonate use is intestinal mucosal injury, especially in the colon. The injury to the gastrointestinal mucosa can range from mild and superficial to wall necrosis and bowel perforation.

HOW SCAPHOID FRACTURES ARE TREATED IN BRAZIL.

Objective: To verify how hand surgeons manage scaphoid fractures and their complications.

Methods: Two hundred questionnaires were distributed during the 36 Brazilian Hand Surgery Congress (2016).

Results: On suspicion of fracture without radiographic confirmation, 57% of surgeons request a CT or MRI scan, while 43% opt for immobilization and consecutive radiographs.

Vasculitis of small and large vessels, a casual association?

The authors report a case of a 69-year-old man with idiopathic leukocytoclastic cutaneous vasculitis. For three years, the lesions recurred with progressive worsening and were associated with systemic manifestations of low-grade fever, weight loss and raised inflammatory markers. The patient latter presented a 6th cranial nerve involvement, raising the concern of a possible systemic vasculitis, which was latter evidenced by the development of deep vein thrombosis and angina pectoris.

Eruption of Impacted Teeth in Cleft Lip and Palate Patients following Alveolar Bone Graft.

Introduction: This study aimed to assess the eruption of impacted teeth in cleft lip and/or palate (CLP) after alveolar bone graft.

Materials And Methods: Research was carried out through a cross-sectional study at the Craniofacial Rehabilitation Center of the University General Hospital of the University of Cuiabá, Mato Grosso, Brazil. Variables related to cleft, cleft side, gender, age, laterality of cleft, impacted teeth, and orthodontic traction were analyzed.

Can different stages of leprosy treatment influence the profile of oral health? Oral status in leprosy.

Background: The aim of study was to evaluate the oral health status, salivary flow and halitosis among individuals diagnosed with leprosy as compared with healthy subjects.

Material And Methods: A sample of 160 individuals was allocated into four groups, as follows: (G1) individuals with complete leprosy treatment; (G2) individuals diagnosed with leprosy and under multi-drug therapy; (G3) individuals diagnosed with leprosy not yet under treatment; and (G4) healthy individuals. Then individuals were submitted to periodontal clinical examination (visible plaque index, bleeding index, depth of probing and clinical attachment level); DMFT index (decayed-missing-filled teeth index); evaluation of salivary flow and halitosis using a halimeter equipment (Interscan Corp, Chatsworth, CA, USA).

Forensic DNA typing from teeth using demineralized root tips.

Teeth are widely used samples in forensic human genetic identification due to their persistence and practical sampling and processing. Their processing, however, has changed very little in the last 20 years, usually including powdering or pulverization of the tooth. The objective of this study was to present demineralized root tips as DNA sources while, at the same time, not involving powdering the samples or expensive equipment for teeth processing.

Assessment of the Amount of Calcium Ions Released after the use of Different Chelating Agents and Agitation Protocols.

Background: The main goal of endodontic treatment is to achieve cleaning and shaping prior to the filling process.

Objective: This study aimed to evaluate, using atomic absorption spectrometry, the release of Calcium ions after the use of different chelating agents and protocols of agitation.

Method: Ninety human canine teeth were randomly assigned to one of nine groups (n=10), as follows: 1) 0.

Nonequilibrium random matrix theory: Transition probabilities.

In this paper we present an analytic method for calculating the transition probability between two random Gaussian matrices with given eigenvalue spectra in the context of Dyson Brownian motion. We show that in the Coulomb gas language, in large N limit, memory of the initial state is preserved in the form of a universal linear potential acting on the eigenvalues. We compute the likelihood of any given transition as a function of time, showing that as memory of the initial state is lost, transition probabilities converge to those of the static ensemble.

Root Canal Transportation and Centering Ability of Nickel-Titanium Rotary Instruments in Mandibular Premolars Assessed Using Cone-Beam Computed Tomography.

Introduction: The aim of this study was to evaluate, using cone-beam computed tomography (CBCT), transportation and centralization of different nickel-titanium (NiTi) rotary instruments.

Methods: One hundred and twenty eight mandibular premolars were selected and instrumented using the following brands of NiTi files: WaveOne, WaveOne Gold, Reciproc, ProTaper Next, ProTaper Gold, Mtwo, BioRaCe and RaCe. CBCT imaging was performed before and after root canal preparation to obtain measurements of mesial and distal dentin walls and calculations of root canal transportation and centralization.

Status of Endodontic Treatment and the Correlations to the Quality of Root Canal Filling and Coronal Restoration.

Introduction: This cross-sectional study evaluated the prevalence and quality of root canal treatment in 1,977 digital radiological files.

Materials And Methods: Data were statistically analyzed using descriptive analysis, and the chi-square test was performed with a 5% significance level.

Results: The mean age of the study population was 34.

Periodontal and Microbiological Profile of Intensive Care Unit Inpatients.

Introduction: The bidirectional relationship between the periodontal diseases and systemic diseases was attributed to the focal infection concept. The aims of this study were to assess the periodontal and microbiological profile of intensive care unit (ICU) inpatients submitted to orotracheal intubation, and classify them regarding gender, age group, ethnic, hospitalization reason and period, nosocomial infection occurrence, and death.

Materials And Methods: Inpatients were assessed, distributed into toothed and toothless groups.

Cariogenic microbiota of children under chemotherapy: A pilot study.

Aim: To analyze the cariogenic microbiota of children who are under antineoplastic therapy.

Methods: Twenty-seven patients undergoing cancer treatment in the Pediatric Unit of Mato Grosso Cancer Hospital were selected. The inclusion criteria of volunteers were being under chemotherapy in the saliva collection period, age between 2 and 18 years, collaborate with the protocol for clinical examination and saliva collection, and responsible have given their written consent.

Effect of repeated sterilization cycles on the physical properties of scaling instruments: a scanning electron microscopy study.

Background: Repeated sterilizations cycles cause undesirable alterations in the material properties of the instruments, such as corrosion, alterations in the hardness of the metal and the loss of the cutting sharpness of the instrument. This research examined the effect of repeated dry heat sterilization and autoclaves cycles on carbon steel (CS) and stainless steel (SS) curettes during the scaling and root planning.

Materials And Methods: A total of 77 Gracey curettes were used in this study.