Efficacy of hydrogen peroxide wipes for decontamination of AZD1222 adenovirus COVID-19 vaccine strain on pharmaceutical industry materials.

This study aimed to evaluate the performance of accelerated hydrogen peroxide® wipes (HPW) for decontamination of the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine in a pharmaceutical industry. Two matrices were tested on stainless-steel (SS) and low-density-polyethylene (LDP) surfaces: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were spiked, dried and the initial inoculum, possible residue effect (RE) and titre reduction after disinfection with HPW were determined. No RE was observed. The disinfection procedure with HPW resulted in complete decontamination the of AZD1222 adenovirus strain in FCV (≥7·46 and ≥7·49 log10 infectious unit [IFU] ml-1 for SS and LDP carriers respectively) and API (≥8·79 and ≥8·78 log10 IFU ml-1 for SS and LDP carriers respectively). In conclusion, virucidal activity of HPW was satisfactory against the AZD1222 adenovirus strain and can be a good option for disinfection processes of SS and LPD surfaces in pharmaceutical industry facilities during recombinant COVID-19 vaccine production. This procedure is simple and can be also applied on safety unit cabins and sampling bags made of LDP as well.

Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry.

This study aimed to evaluate the performance of hydrogen peroxide vapour (HPV) to inactivate the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine for application in cleaning validation in pharmaceutical industries production areas. Two matrixes were tested: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to HPV in an isolator. One biological indicator with population >106 Geobacillus stearothermophilus spores was used to validate the HPV decontamination cycle as standard. HPV exposure resulted in complete virus inactivation in FVC (≥5·03 log10 ) and API (≥6·40 log10 ), showing HPV efficacy for reducing chimpanzee adenovirus AZD1222 vaccine strain. However, the optimum concentration and contact time will vary depending on the type of application. Future decontamination studies scaling up the process to the recombinant COVID-19 vaccine manufacturing areas are necessary to evaluate if the HPV will have the same or better virucidal effectivity in each specific production area. In conclusion, HPV showed efficacy for reducing AZD1222 chimpanzee adenovirus strain and can be a good choice for pharmaceutical industries facilities disinfection during recombinant COVID-19 vaccine production.

Acute fasciolosis in an alpaca: a case report.

BACKGROUND: The popularity of new world camelids, particularly alpacas, is growing rapidly in Ireland, presenting a clinical challenge to veterinary practitioners who may not have worked with these species previously. To the authors' knowledge, the clinical course of a case of acute fasciolosis in an alpaca has not previously been reported, and fasciolosis has not been reported at all in alpacas in Ireland, making this case report a valuable addition to the current literature. CASE PRESENTATION: A three-year-old male castrated huacaya alpaca was admitted to UCD Veterinary Hospital with a two-day history of colic and tenesmus. He had been treated with albendazole, dexamethasone and potentiated amoxycillin by the referring veterinary practitioner with no response. On initial clinical exam, sensitivity to abdominal palpation was the only abnormality. However, the alpaca proceeded to show abnormal lying positions, tenesmus and reduced faecal output over the next 24 h. A general blood panel demonstrated moderate anaemia, marked hyperglobulinaemia and moderately increased hepatocellular and hepatobiliary enzyme activity. Abdominal radiography revealed enlargement of the first forestomach compartment without evidence of gastrointestinal obstruction or peritonitis. An abdominal ultrasound exam revealed an elongated, heterogenous mass in the caudoventral abdomen that appeared to be contiguous with the liver. FNA of this mass revealed that it was in fact a liver lobe with biliary stasis and inflammation. Faecal sedimentation demonstrated Fasciola hepatica eggs. In spite of treatment with triclabendazole and supportive treatment including blood transfusion, the alpaca's condition continued to deteriorate and he was euthanised. On post-mortem exam, acute fasciolosis was diagnosed. CONCLUSIONS: The clinical presentation and course of a case of acute fasciolosis in an individual alpaca is described, including the results of a range of diagnostic tests that were carried out. The final diagnosis is supported by a description of post-mortem findings. This information will serve as a resource for veterinary practitioners involved in the diagnosis and treatment of similar cases.

Mosquito-fungus interactions and antifungal immunity.

The mosquito immune system has evolved in the presence of continuous encounters with fungi that range from food to foes. Herein, we review the field of mosquito-fungal interactions, providing an overview of current knowledge and topics of interest. Mosquitoes encounter fungi in their aquatic and terrestrial habitats. Mosquito larvae are exposed to fungi on plant detritus, within the water column, and at the water surface. Adult mosquitoes are exposed to fungi during indoor and outdoor resting, blood and sugar feeding, mating, and oviposition. Fungi enter the mosquito body through different routes, including ingestion and through active or passive breaches in the cuticle. Oral uptake of fungi can be beneficial to mosquitoes, as yeasts hold nutritional value and support larval development. However, ingestion of or surface contact with fungal entomopathogens leads to colonization of the mosquito with often lethal consequences to the host. The mosquito immune system recognizes fungi and mounts cellular and humoral immune responses in the hemocoel, and possibly epithelial immune responses in the gut. These responses are regulated transcriptionally through multiple signal transduction pathways. Proteolytic protease cascades provide additional regulation of antifungal immunity. Together, these immune responses provide an efficient barrier to fungal infections, which need to be overcome by entomopathogens. Therefore, fungi constitute an excellent tool to examine the molecular underpinnings of mosquito immunity and to identify novel antifungal peptides. In addition, recent advances in mycobiome analyses can now be used to examine the contribution of fungi to various mosquito traits, including vector competence.

Nausea, vomiting, and retching: complex problems in palliative care.

Patients with advanced cancer commonly experience nausea, vomiting, and/or retching (NVR) as a result of the malignant process and its treatment. Recently, increasing attention is being focused on end-of-life care, which includes relief or reduction of symptoms such as NVR. Pre-chemotherapy preparation and patient education in the palliative care setting are essential to preventing acute and delayed distress from NVR, as well as anticipatory symptoms. Careful assessment of chemotherapy-related symptoms should distinguish between the three phenomena rather than taking a global approach. Strategies for preventing anticipatory nausea, for instance, may differ significantly from those designed to reduce frequency of vomiting. Management of anticancer treatment-related NVR should incorporate both pharmacologic and nonpharmacologic approaches, whenever appropriate, with the overall goal of improving and/or maintaining the patient's quality of life.

Development of emission factors for polyamide processing.

Emission factors for selected volatile organic compounds (VOCs) and particulate material were developed during processing of commercial grades of polyamide 6, polyamide 66, and polyamide 66/6 resins. A small commercial-type extruder was used, and melt temperatures ranged from 475 to 550 degrees F. An emission factor was calculated for each substance measured and is reported as pounds released to the atmosphere per million pounds of polymer resin processed. Scaled to production volumes, these emission factors can be used by processors to estimate emission quantities from similar polyamide extrusion operations.

Fatigue and quality of life outcomes of exercise during cancer treatment.

PURPOSE: Despite the recognition of fatigue as a common and distressing symptom during cancer treatment, there are few evidence-based interventions available to manage such fatigue. The purpose of this multi-institutional pilot study was to explore the effects of a home-based moderate walking exercise intervention on fatigue, physical functioning, emotional distress, and quality of life (QOL) during breast cancer treatment. DESCRIPTION OF STUDY: Fifty-two women were recruited from five university hospital outpatient departments for this pilot study with an experimental design. Subjects were randomly assigned to the walking program or to usual care during adjuvant chemotherapy or radiation therapy for breast cancer. Symptoms, physical functioning, and QOL were measured at baseline, midtreatment, and at the end of treatment. RESULTS: Women who exercised at least 90 minutes per week on 3 or more days reported significantly less fatigue and emotional distress as well as higher functional ability and QOL than women who were less active during treatment. CLINICAL IMPLICATIONS: A home-based walking exercise program is a potentially effective, low-cost, and safe intervention to manage fatigue and to improve QOL during adjuvant chemotherapy or radiation therapy for breast cancer. This health-promoting self-care activity needs further testing in large randomized clinical trials.

An instrument to measure symptom experience. Symptom occurrence and symptom distress.

This article describes the development of an instrument that measures symptom experience (symptom occurrence and symptom distress). The Adapted Symptom Distress Scale-2 (ASDS-2), adapted from the McCorkle and Young Distress Scale, is a 31-item, 5-point, self-report paper-and-pencil instrument that measures patients' perception of the occurrence and distress of 14 symptoms: nausea, vomiting, pain, eating, sleep, fatigue, bowel elimination, breathing, coughing, concentration, lacrimation, changes in body temperature, appearance, and restlessness. Use of the instrument yields a total score for symptom experience, scores for symptom occurrence, scores for symptom distress, and subscale scores for six symptom categories: gastrointestinal, fatigue/restlessness, concentration, pain/discomfort, respiratory, and appearance. Reliability and validity were determined with well adults (n = 97), medical-surgical patients (n = 82), and oncology patients (n = 175). Findings revealed a Cronbach's alpha of 0.91 for symptom experience, 0.90 for symptom occurrence, and 0.76 for symptom distress. Cronbach's alpha for the subscales ranged from 0.38 for appearance symptoms to 0.83 for gastrointestinal symptoms. Inclusion of symptoms reported by patients with cancer strengthened content validity. A contrasted groups approach was used to demonstrate construct validity.

Daily times four vinorelbine plus cisplatin in advanced non-small-cell lung cancer: a phase II trial of a novel schedule.

PURPOSE: To evaluate the efficacy of a novel multiday schedule of vinorelbine and displatin in patients with advanced NSCLC. PATIENTS AND METHODS: Thirty patients were enrolled, including 27 patients with stage IV disease, and 11 patients with performance status of 2. They received a maximum of four chemotherapy cycles with cisplatin 20 mg/m2/day and vinorelbine 15 mg/m2/day intravenously (i.v.) for four consecutive days, every three weeks, with prophylactic filgrastim. RESULTS: Sixteen patients responded (53%, 95% confidence interval (95% CI): 34%-72%), including two complete and fourteen partial confirmed responses. Median survival for all patients was 8.1 months, with actuarial one-year and two-year survival rates of 40% and 15%. Despite prophylactic filgrastim, the delivered vinorelbine dose intensity of 16.8 mg/m2/week caused febrile neutropenia in 48% of patients (16% of cycles), resulting in one treatment-related death. Common nonhematologic toxicities included delayed emesis, asthenia, and constipation. CONCLUSIONS: This multiday vinorelbine-cisplatin schedule is highly active against advanced NSCLC but results in frequent neutropenic complications. The myelotoxicity and antitumor efficacy of vinorelbine in NSCLC patients may be schedule-dependent.

The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting.

PURPOSE/OBJECTIVES: To determine the reliability of the Index of Nausea, Vomiting, and Retching (INVR), a new format of the Rhodes Index of Nausea and Vomiting Form 2 (INV-2). DESIGN AND SETTING: A parallel form study was conducted at a large, Midwestern teaching hospital and a cancer center. SAMPLE: Convenience sample of 159 subjects: 40 obstetrical, 60 oncological, 59 medical/surgical. METHODS: Two instruments, the INVR and the INV-2, were administered approximately 30-60 minutes apart. One-half of the subjects completed the INVR first, and the other half completed the INV-2 first. MAIN OUTCOME MEASURES: Equivalency measures of reliability correlation coefficients for both instruments. FINDINGS: A high rate of agreement was found in the responses between the two forms. In cases of clear disagreement, the responses to the INVR were more frequently consistent than the responses to the original form. CONCLUSIONS: INVR has tested reliability and is more user friendly for the patient and the healthcare provider. IMPLICATIONS FOR NURSING PRACTICE: Nurses have a focal role in managing symptoms. Managing nausea, vomiting, and retching requires excellent assessment skills of the patient's personal symptom experience and knowledge of pharmacology. Efficient, cost-saving assessments require accurate self-report instruments that permit patients to quantify their symptom experiences. The INVR can provide a scientific base from which to prescribe and teach patients and may improve their quality of life. Reliable and valid self-reporting instruments are essential for managing these adverse symptoms.

Phase I study of docetaxel dose escalation in combination with fixed weekly gemcitabine in patients with advanced malignancies.

PURPOSE: To determine the maximum-tolerated dose of monthly docetaxel combined with fixed-dose weekly gemcitabine and describe the dose-limiting toxicities (DLTs) of the combination. PATIENTS AND METHODS: Patients with refractory solid tumors were treated with gemcitabine days 1, 8, and 15 every 4 weeks at a fixed dose of 800 mg/m2. Two docetaxel administration schedules were studied, with the drug administered either day 1 or day 15 at doses of 45, 60, 75, and 100 mg/m2 per cycle. RESULTS: Forty patients received 132 cycles of chemotherapy. On the day-1 schedule, the maximum-tolerated docetaxel dose was the highest planned dose of 100 mg/m2 with two DLT episodes among 12 patients treated with 34 cycles at this dose level. On the day-15 schedule, delivery of the planned docetaxel doses was not feasible because of thrombocytopenia and hepatic dysfunction. Hematologic toxicities included grade 4 neutropenia in 16 patients, with three episodes of febrile neutropenia; grades 3 to 4 thrombocytopenia in nine patients; and anemia that required RBC transfusions in 10 patients. For patients treated at the highest docetaxel dose level, myelosuppression was not dose limiting and only one of 34 cycles was complicated by febrile neutropenia. The most common nonhematologic toxicities were asthenia, flu-like symptoms, and fluid retention. Antineoplastic activity was noteworthy, with partial responses in nine of 21 patients with pretreated non-small-cell lung cancer (NSCLC; 43%; 95% confidence interval, 22 to 66), in four of seven patients with breast cancer, and in one patient with esophageal adenocarcinoma. CONCLUSION: Gemcitabine 800 mg/m2 days 1,8, and 15 can be safely combined with docetaxel 100 mg/m2 day 1 of a 28-day cycle. The observed antitumor activity warrants phase II evaluation.

Hospice patients' and nurses' perceptions of self-care deficits based on symptom experience.

Although the relief and/or control of physically, emotionally, and spiritually distressing symptoms are the hallmarks of hospice care, accurate assessment of the individual's unique and often rapidly changing symptom experience is lacking. The purpose of this descriptive, correlational study was to assess and quantify hospice patients' perceptions of their symptom experiences and those of the hospice nurse assessing them. A convenience sample of 53 hospice patients (32 males, 21 females), with a mean age of 69 years, from a large midwestern home-based hospice completed the Adapted Symptom Distress Scale Form 2 (ASDS-2) at admission, and at 2 and 4 weeks after admission. The Hospice Admission Intake was completed at admission. Individual hospice nurses completed the ASDS-2 within 24 hours of their hands-on assessment, in addition to the demographic characteristics profile. Findings indicated an improvement in symptom experience, distress, and occurrence scores from admission to week 2, and in the symptom experience and distress scores from admission to week 4. Hospice nurses tended to give higher symptom experience scores than the patients gave to themselves. These findings demonstrate the importance of obtaining information about symptom experience from the patient as well as the nurse.

Establishing mechanisms to conduct multi-institutional research--fatigue in patients with cancer: an exercise intervention.

PURPOSES/OBJECTIVES: To describe the process of establishing a multi-institutional interdisciplinary team of oncology researchers and conducting a pilot study of an exercise intervention for fatigue. DATA SOURCES: Project meeting minutes and records, research team members' logs, subjects' research records, the research study proposal, and team members' individual and collective shared experiences. DATA SYNTHESIS: Site investigators established research teams at five academic medical centers. Fifty subjects were enrolled in the study and tested during their cancer treatment. Study methods, including instrumentation, were evaluated carefully and revised. CONCLUSIONS: The multi-institutional network of researchers is an effective and efficient model for testing an intervention to manage fatigue during cancer treatment. IMPLICATIONS FOR NURSING PRACTICE: Exercise is a feasible and potentially beneficial intervention to combat distressing cancer treatment-related fatigue. A pilot study is essential to determine the best methods for conducting a clinical trial and to develop the teams of researchers necessary for such a project.

Development of a preparatory sensory information videotape for women receiving chemotherapy for breast cancer.

This study describes the development and testing of a preparatory sensory information (PSI) videotape for women receiving chemotherapy for breast cancer. In telephone interviews, 40 women described the sensations they experienced before, during, and after receiving chemotherapy. Sensations described by the women were linked with procedural and temporal elements identified by certified advanced practice oncology nurses to develop a script for the PSI videotape. Women currently receiving chemotherapy or who had completed chemotherapy within the last 6 months were asked to share their experiences on videotape. After editing, a 20-minute PSI videotape was produced. Pilot testing with a group of 20 women demonstrated that the intervention helped to prepare them for the sensory experiences associated with chemotherapy and was helpful in developing anticipatory coping and self-care behaviors.

Criteria for assessment of nausea, vomiting, and retching.

PURPOSE/OBJECTIVES: To promote accurate patient assessment, effective patient teaching, and useful research design and outcomes by defining the concepts of nausea, vomiting, and retching; to review the usefulness of self-care guides in assessing the patient's symptom experience. DATA SOURCES: Journal articles, the author's clinical experiences. DATA SYNTHESIS: The concepts of nausea, vomiting, and retching may be difficult for patients to describe and for nurses to assess. Measurement and assessment methods that accurately reflect the patient's experience are critical. CONCLUSION: Management of the individual symptoms of nausea, vomiting, and retching requires expert ongoing assessment of the patient's symptom experience that extends beyond the clinic or hospital visit. Information about symptom occurrence and distress and about self-care strategies used can play a crucial role in the identification, prevention, and management of symptom experience, with the good of improving the patient's quality of life. IMPLICATIONS FOR NURSING PRACTICE: Effective management of the patient's symptom experience depends on the oncology nurse's ability to differentiate occurrence and distress of the individual symptoms and to implement current knowledge not only of chemotherapy, antiemetic drugs, and nonpharmacologic interventions but of unerring ongoing assessments that lead to cost-effective, clinically useful patient outcomes. Basic scientific knowledge for research, practice, and education necessitates reliable, valid measurement tools that differentiate the components and dimensions of the individual symptoms.

Expanded polytetrafluoroethylene patch angioplasty in carotid endarterectomy.

PURPOSE: This study retrospectively reviewed the experience with expanded polytetrafluoroethylene (ePTFE) patches for carotid endarterectomy in 924 consecutive procedures (753 patients) during a 17-year period. METHODS: The records of all patients who underwent ePTFE patch angioplasty for carotid artery stenosis performed by one surgeon were reviewed. The criterion for surgery was stenosis of 80% or greater. Follow-up by use of noninvasive methods was done by 6 months after operation the first year and annually thereafter. Recurrent stenosis was confirmed with angiography. Life-table analysis was used to estimate the risk of restenosis. RESULTS: Early morbidity and mortality included six deaths (0.6%), seven nonfatal strokes (0.9%), and 19 hemorrhages. Two postoperative infections occurred. There were no important aneurysmal dilations and no late hemorrhages. With a mean follow-up of 41.4 months (range 0 to 197), recurrent stenosis necessitating reoperation developed in 28 patients (3.7%). There were two late strokes. Life-table analysis indicated a 89% probability of freedom from stenosis at 120 months. CONCLUSIONS: In cases in which the decision to perform patch angioplasty is made at surgery, an ePTFE patch is an excellent alternative to autogenous saphenous vein, with a low rate of recurrences requiring operation and acceptable rates of perioperative and postoperative morbidity and mortality.

Symptom experience.

OBJECTIVE: To provide an overview of symptom experience, symptom occurrence, and symptom distress. DATA SOURCES: Published articles relating to the symptom experience, symptom occurrence, and symptom distress of patients with cancer. CONCLUSIONS: Symptom experience must include both the occurrence and distress associated with the symptom. To adequately assess symptom experience, obtaining information from patient about the occurrence and distress of the symptom experience is essential. IMPLICATIONS FOR NURSING PRACTICE: Nurses and other health care professionals can perform an essential role in the identification and management of symptom experience, thereby improving patient quality of life.

Nausea, vomiting, and retching: the management of the symptom experience.

OBJECTIVES: To examine the physiology of nausea, vomiting, and retching (NVR); the impact of NVR on the patient: current measures to control NVR; and selfcare interventions. DATA SOURCES: Research studies, abstracts, and review articles relating to NVR associated with cancer treatment as well as pharmacological and nonpharmacological interventions. CONCLUSIONS: Management of the individual symptoms of NVR require expert, ongoing assessment of the patient's symptom experience that extends beyond the clinic or hospital visit. Although a number of pharmacological antiemetic agents are currently available and additional antiemetic drugs are in phase II or II trials, nonpharmacological interventions are essential to achieve effective management. IMPLICATIONS FOR NURSING PRACTICE: Continual assessment of the individual's symptom experience is imperative. Effective management of the symptom experience depends on the oncology nurses's ability to implement current knowledge of antiemetic, and other drugs; non-pharmacological interventions; and cost-effective and clinically useful patient outcomes.