Development of an Adaptable Qualification Test Set for Personnel Involved in Visual Inspection Procedures of Parenteral Drug Products Manufactured Under Good Manufacturing Practice Conditions in Hospital Pharmacy Compounding Facilities.

Parenteral drug products manufactured under GMP conditions should be visually inspected for defects and particulate contamination by trained and qualified personnel. Although personnel qualification is required, no practical protocols or formal guidelines are available for the development of qualification test sets (QTSs) used for qualification procedures. The current practice is to either procure a standardized QTS from a commercial supplier or amass sufficient manufacturing rejects during visual inspection procedures to compile in-house QTSs.

Arthrocentesis versus conservative treatments for temporomandibular joint disorders: A systematic review with meta-analyses and trial sequential analyses.

This systematic review aimed to evaluate the efficacy of arthrocentesis compared to conservative treatments for symptomatic temporomandibular joint disorders. A systematic search for randomized, prospective and retrospective controlled trials was undertaken in five electronic databases. Various patient outcomes and economic evaluations were analysed for short-term (<6 months), intermediate-term (6 months to 5 years) and long-term (≥5 years) follow-up periods.

Outcomes of implants placed in sites of previously failed implants: a systematic review and meta-analysis.

The survival rate of implants placed at sites of previous failures including the best treatment strategies remain unclear. This systematic review was performed to assess implant survival and peri-implant health for such cases, including subgroup analyses of immediate versus delayed implant placement and augmentation. Four electronic databases were searched.

Analysis of 8.5 mm Long Dental Implants Provided with Splinted or Solitary Implant Restorations: A 15-Year Prospective Study.

The long-term effects of implant properties, such as implant length, platform switch, and crown splinting, on peri-implant health require more investigation. Therefore, the aim was to assess the long-term peri-implant health and patient satisfaction in a patient cohort, obtained from two prospective randomized controlled trials, who received 8.5 mm long dental implants, with either splinted or solitary suprastructures and with or without a platform switch, over a period of 15 years.

Prognostic value of single photon emission computed tomography myocardial perfusion imaging for the prediction of MACE in pre- kidney transplant recipients: A systematic review and meta-analysis.

Background: Kidney transplantation provides substantial benefits in extending survival and improving quality of life for patients with end-stage renal disease. The incidence of major adverse cardiac events (MACE) increases with a decline of kidney function in patients with chronic kidney disease. After kidney transplantation, the incidence of MACE remains high.

Immediate single-tooth implant placement in bony defect sites: A 10-year randomized controlled trial.

Background: It is unclear whether an intact buccal bony plate is a prerequisite for immediate implant placement in postextraction sockets. The aim of this 10-year randomized controlled trial was to compare peri-implant soft and hard tissue parameters, esthetic ratings of, and patient-reported satisfaction with immediate implant placement in postextraction sockets with buccal bony defects ≥5 mm in the esthetic zone versus delayed implant placement after alveolar ridge preservation.

Methods: Patients presenting a failing tooth in the esthetic region and a buccal bony defect ≥5 mm after an extraction were randomly assigned to immediate (Immediate Group, n = 20) or delayed (Delayed Group, n = 20) implant placement.

Optimization of the Production Process of Clinical-Grade Human Salivary Gland Organoid-Derived Cell Therapy for the Treatment of Radiation-Induced Xerostomia in Head and Neck Cancer.

Head and neck cancer is a common cancer worldwide. Radiotherapy has an essential role in the treatment of head and neck cancers. After irradiation, early effects of reduced saliva flow and hampered water secretion are seen, along with cell loss and a decline in amylase production.

Single crown restorations supported by 6-mm implants in the resorbed posterior mandible: A 10-year prospective case series.

Purpose: To assess marginal bone level changes, implant and restoration survival, condition of the peri-implant mucosa, and the patient's satisfaction with the single restoration supported by a 6-mm long implant in the posterior mandible after 10 years in function.

Materials And Methods: Twenty-one consecutive patients missing premolars or molars in the posterior mandible, with a bone volume consisting of a width of at least 6 mm and an estimated height of 8 mm between the top of the ridge and alveolar nerve, were included. Each patient received one or more 6-mm implants.

Similar long-term outcomes for venous, bovine pericardial, and polyester patches for primary carotid endarterectomy.

Background: Currently, the type of patch used for carotid endarterectomy closure depends on the preference of the operating surgeon. Various materials are available, including autologous venous patches, bovine pericardial patches (BPP), and synthetic patches. The purpose of this study was to compare the long-term outcomes.

Arthroscopy versus arthrocentesis and versus conservative treatments for temporomandibular joint disorders: a systematic review with meta-analysis and trial sequential analysis.

The aim of this systematic review was to assess the efficacy of arthroscopy compared to arthrocentesis and to conservative treatments for temporomandibular joint disorders. Thirteen controlled studies on various patient outcomes were included after a systematic search in seven electronic databases. Meta-analyses were conducted separately for arthroscopic surgery (AS) and arthroscopic lysis and lavage (ALL), and short-term (<6 months), intermediate-term (6 months to 5 years), and long-term (≥5 years) follow-up periods were considered.

Single immediate implant placement in the maxillary aesthetic zone with and without connective tissue grafting: Results of a 5-year randomized controlled trial.

Aim: To assess the 5-year effects of grafting connective tissue while undertaking single immediate implant placement and provisionalization at the mid-buccal mucosa level (MBML). Secondary outcomes were buccal bone wall thickness (BBT), marginal bone level (MBL) and patient satisfaction.

Materials And Methods: Sixty patients with a single failing tooth in the maxillary anterior region were provided with an immediately placed and provisionalized implant.

Single crowns in the posterior maxilla supported by either 11-mm long implants with sinus floor augmentation or by 6-mm long implants: A 10-year randomized controlled trial.

Objectives: To compare the clinical performance of single crowns in the posterior maxilla supported by either 11-mm long implants combined with maxillary sinus floor augmentation (MSFA) surgery or by 6-mm long implants during a 10-year follow-up period.

Materials And Methods: Subjects were randomly allocated to receive one 11-mm long implant in combination MFSA or to receive one 6-mm long implant without any grafting. Twenty-one implants in 20 patients were placed in the 6-mm group and 20 implants in 18 patients were placed in the 11-mm group.

Validation of an LC-MS/MS assay for rapid and simultaneous quantification of 21 kinase inhibitors in human plasma and serum for therapeutic drug monitoring.

Kinase inhibitors have revolutionized cancer treatment in the past 25 years and currently form the cornerstone of many treatments. Due to the increasing evidence for therapeutic drug monitoring (TDM) of kinase inhibitors, the need is growing for new assays to rapidly evaluate kinase inhibitor plasma concentrations. In this study, we developed an LC-MS/MS assay for the rapid and simultaneous quantification of 21 kinase inhibitors.

Dental implant treatment for two adjacent missing teeth in the esthetic region: A systematic review and 10-year results of a prospective comparative pilot study.

Objectives: The aim of the systematic review was to compare studies on implant-supported two-unit cantilever crowns with two adjacent implant-supported crowns in the anterior region. The second aim was to assess in a 10-year prospective comparative pilot study, hard and soft peri-implant tissue changes in patients with a missing central and adjacent lateral upper incisor, treated with either an implant-supported two-unit cantilever crown or two single implant-supported crowns.

Materials And Methods: Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched (last search March 1, 2023).

Success rate of sialendoscopy. A systematic review and meta-analysis.

Objective: To perform a systematic review and meta-analysis on the efficacy and safety of sialendoscopy in the treatment of obstructive diseases of the major salivary glands.

Materials And Methods: We searched four databases for literature. The primary outcome assessed was the success rate.

Long-term outcome of patients with transposition of the great arteries and a systemic right ventricle: A systematic review and meta-analysis.

Background: Patients with a transposition of the great arteries (TGA) and a systemic right ventricle are at risk of heart failure (HF) development, arrhythmia and early mortality. Prognostic evaluations in clinical studies are hampered by small sample sizes and single-centred approaches. We aimed to investigate yearly rate of outcome and factors affecting it.

Long-term treatment outcomes with zygomatic implants: a systematic review and meta-analysis.

Purpose: The purpose of this study was to perform a systematic review with meta-analysis on the long-term survival rates of zygomatic implants (ZI). ZI success, prostheses survival and success, sinus pathology and patient reported outcomes were also investigated.

Methods: Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines were followed.

Outcomes of Omniflow® II prosthesis used for revascularization in the femoral tract both in infected and non-infected setting.

Background: Evidence regarding the outcomes of Omniflow II prosthesis in peripheral arterial revascularization at different anatomical sites and for different indications is scarce. Therefore, the aim of this study was to evaluate the outcomes of the Omniflow II used at various positions within the femoral tract both in infected and non-infected setting.

Methods: Patients who underwent reconstructive lower leg vascular surgery with implantation of an Omniflow II from 2014 until 2021 at five medical centers were retrospectively included (N.

Use of Omniflow® II Biosynthetic Graft for the Treatment of Vascular Graft and Endograft Infections.

Background: Vascular graft/endograft infection is a rare but life-threatening complication of cardiovascular surgery and remains a surgical challenge. Several different graft materials are available for the treatment of vascular graft/endograft infection, each having its own advantages and disadvantages. Biosynthetic vascular grafts have shown low reinfection rates and could be a potential second best after autologous veins in the treatment of vascular graft/endograft infection.

Capsules with Ileocolonic-Targeted Release of Vitamin B, B, and C (ColoVit) Intended for Optimization of Gut Health: Development and Validation of the Production Process.

The ileocolonic-targeted delivery of vitamins can establish beneficial alterations in gut microbial composition. Here, we describe the development of capsules containing riboflavin, nicotinic acid, and ascorbic acid covered with a pH-sensitive coating (ColoVit) to establish site-specific release in the ileocolon. Ingredient properties (particle size distribution, morphology) relevant for formulation and product quality were determined.

Patch angioplasty during carotid endarterectomy using different materials has similar clinical outcomes.

Objective: Patch angioplasty during carotid endarterectomy (CEA) is commonly used to treat carotid artery stenosis. However, the choice of which patch to use remains a matter of debate. Autologous venous material has disadvantages such as wound-related problems at the harvest site and a prolonged intervention time.

The Development and Implementation of Airflow Visualization Studies ("Smoke" Studies) as a Training Tool in Aseptic Hospital Compounding Facilities.

In the compounding facilities of hospital pharmacies, extemporaneous preparations for parenteral administration are produced using aseptic handling. The designated environment for this practice is a clean area, such as a laminar airflow (LAF) cabinet placed in a classified cleanroom complying with good manufacturing practices (GMP) and International Organization for Standardization (ISO) 14644-1 guidelines. The European GMP Annex 1 (Revision 2020) and United States Pharmacopeia (USP) <797> monograph state that airflow visualization studies (“smoke” studies) should be performed to substantiate the cleanroom and LAF cabinet performance and their qualification status.

Arthrocentesis versus non-surgical intervention as initial treatment for temporomandibular joint arthralgia: a randomized controlled trial with long-term follow-up.

Arthrocentesis for arthralgia of the temporomandibular joint (TMJ) is often only indicated when conservative, non-surgical interventions have failed. However, performing arthrocentesis as initial therapy may facilitate earlier and better recuperation of the joint. The aim of this study was to assess the efficacy of this therapy with a long-term follow-up.