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PubMed2006

Comparison of a new aspiration needle device and the Quick-Core biopsy needle for transjugular liver biopsy.

AIM: To evaluate sample adequacy, safety, and needle passes of a new biopsy needle device compared to the Quick-Core biopsy needle for transjugular liver biopsy in patients affected by liver disease. METHODS: Thirty consecutive liver-disease patients who had major coagulation abnormalities and/or relevant ascites underwent transjugular liver biopsy using either a new needle device (18 patients) or the Quick-Core biopsy needle (12 patients). The length of the specimens was measured before fixation. A pathologist reviewed the histological slides for sample adequacy and pathologic diagnoses. The two methods'specimen adequacy and complication rates were assessed. RESULTS: Liver biopsies were technically successful in all 30 (100%) patients, with diagnostic histological core specimens obtained in 30 of 30 (100%) patients, for an overall success rate of 100%. With the new device, 18 specimens were obtained, with an average of 1.1 passes per patient. Using the Quick-Core biopsy needle, 12 specimens were obtained, with an average of 1.8 passes per patient. Specimen length was significantly longer with the new needle device than with the Quick-Core biopsy needle (P < 0.05). The biopsy tissue was not fragmented in any of the specimens with the new aspiration needle device, but tissue was fragmented in 3 of 12 (25.0%) specimens obtained using the Quick-Core biopsy needle. Complications included cardiac arrhythmia in 3 (10.0%) patients, and transient abdominal pain in 4 (13.3%) patients. There were no cases of subcapsular hematoma, hemoperitoneum, or sepsis, and there was no death secondary to the procedure. In particular, no early or delayed major procedure-related complications were observed in any patient. CONCLUSION: Transjugular liver biopsy is a safe and effective procedure, and there was significant difference in the adequacy of the specimens obtained using the new needle device compared to the Quick-Core biopsy needle. Using the new biopsy needle device, the specimens showed no tissue fragmentation and no increment in major procedure-related complications was observed.

Adult↗
PubMed2004

Escherichia coli sampling reliability at a frequently closed Chicago Beach: monitoring and management implications.

Monitoring beaches for recreational water quality is becoming more common, but few sampling designs or policy approaches have evaluated the efficacy of monitoring programs. The authors intensively sampled water for E. coli (N=1770) at 63rd Street Beach, Chicago for 6 months in 2000 in order to (1) characterize spatial-temporal trends, (2) determine between and within transect variation, and (3) estimate sample size requirements and determine sampling reliability. E. coli counts were highly variable within and between sampling sites but spatially and diurnally autocorrelated. Variation in counts decreased with water depth and time of day. Required number of samples was high for 70% precision around the critical closure level (i.e., 6 within or 24 between transect replicates). Since spatial replication may be cost prohibitive, composite sampling is an alternative once sources of error have been well defined. The results suggest that beach monitoring programs may be requiring too few samples to fulfill management objectives desired. As the recreational water quality national database is developed, it is important that sampling strategies are empirically derived from a thorough understanding of the sources of variation and the reliability of collected data. Greater monitoring efficacy will yield better policy decisions, risk assessments, programmatic goals, and future usefulness of the information.

Chicago↗
PubMed2004

Pharmacokinetics and safety of GW433908 and ritonavir, with and without efavirenz, in healthy volunteers.

OBJECTIVE: To evaluate the safety and pharmacokinetic interaction between GW433908, ritonavir (RTV), and efavirenz (EFV). METHODS: In period 1, subjects received either a once daily (QD) regimen of GW433908 1395 mg + RTV 200 mg (Study 1) or a twice daily (bid) regimen of GW433908 700 mg + RTV 100 mg (Study 2) for 14 days. In period 2, subjects received EFV 600 mg QD with either the same GW433908 + RTV regimen as in period 1 (arm 1) or with a GW433908 + RTV regimen that included an additional 100 mg of RTV (arm 2) for 14 days. Amprenavir (APV) pharmacokinetic sampling and safety assessments were performed on the last day of each period. RESULTS: Plasma APV exposure was not significantly altered when EFV was coadministered with GW433908 700 mg twice daily (BID) + RTV 100 mg BID. Plasma APV exposure was decreased when EFV was coadministered with GW433908 1395 mg QD + RTV 200 mg QD. However, administration of EFV with GW433908 1395 mg QD + RTV 300 mg QD (i.e., adding an extra 100 mg of RTV) was able to negate this interaction. Adverse events were consistent with prior data for each of the separate agents. CONCLUSION: When EFV is coadministered with the GW433908 700 mg + RTV 100 mg BID regimen, no dosage adjustment is recommended. However, when EFV is coadministered with the GW433908 1400 mg + RTV 200 mg QD regimen, an increase to RTV 300 mg QD is needed to maintain plasma APV exposure.

Adult↗
PubMed1997

Hazardous chemical exposure: guidelines for the optometric office.

BACKGROUND: The Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) applies to all types of employers, including optometrists. The purpose of the standard is to ensure that employees are aware of chemical hazards in the workplace and know how to protect themselves. Any optometric office that uses chemicals such as acetone, alcohol, lens-tinting dyes, or disinfection chemicals must comply with HCS. METHODS: Optometrists must develop, implement, and maintain a written Hazard Communication Program for their practices. The program must describe how they plan to meet the requirements of HCS. It should include the development of a listing of all hazardous chemicals used in the office, the collection of appropriate Material Safety Data Sheets (MSDS) for each chemical, the labeling of hazardous chemical containers, and the provision of an effective employee-training program. RESULTS: The implementation of an effective Hazard Communication Program will help ensure employee safety. A sample outline for a Hazard Communication Program for an optometric office is provided. CONCLUSIONS: Optometrists with one or more employees have an obligation to ensure these employees are provided with a healthy and safe workplace. OSHA has established specific requirements relating to employees' potential exposure to chemicals. Failure to comply with OSHA regulations may result in significant fines.

Hazardous Substances↗
PubMed2001

Incidence of hepatitis C virus RNA in anti-HCV negative plasma pools in Croatia.

The risks of transmitting viral infection by blood and products derived from plasma have long been known and still remain an area of concern. Blood banks and transfusion centres are faced with the imminent introduction of nucleic acid amplification testing (NAT) of plasma pools as used by the plasma industry. In this paper, we show a part of our results of a validation study of an in-house method for routine polymerase chain reaction (PCR) screening for hepatitis C virus (HCV) RNA in plasma pools and the results of testing 2,718 anti-HCV negative plasma pools for the presence of HCV RNA. The European Committee for Proprietary Medical Products (CPMP) recommended that from 1 July 1999, only batches derived from plasma pools tested and found non-reactive for HCV RNA, using validated test methods of suitable sensitivity and specificity, should be batch released by authorities. The quality and efficiency of NAT detection of HCV RNA is among others influenced by the efficacy of RNA isolation, the primer selection and the use of control samples. Using modern molecular biology techniques (sensitive and specific in-house amplification methods for detection of HCV RNA and automated sequencing), we analysed samples of plasma pools from different Croatian transfusion centres. By detection of HCV RNA in an NIBSC working reagent (genotype 3) and a Pelispy HCV RNA run control (genotype 1) we determined a high reproducibility and sensitivity (below 100 International Units (IU)/ml) for our in-house method. By direct sequencing PCR cDNAs we proved the specificity of the test system and the possibility of determining the HCV genotype when the method was used for PCR screening of HCV RNA in single donations. Of 2,718 anti-HCV negative plasma pools we have found that 2.1$ were HCV RNA positive. Results of our investigation confirm the necessity of testing HCV RNA in plasma pools to further increase the safety of human plasma-derived drugs.

Base Sequence↗
PubMed1998

Evaluation of an HIV saliva test for the detection of HIV-1 and HIV-2 antibodies in high-risk populations in Abidjan, Côte d'Ivoire.

To evaluate saliva testing in a West African field situation where both HIV-1 and HIV-2 are present, a cross-sectional study was conducted among female sex workers (FSWs) and their stable male partners (SMPs) at a STD/HIV clinic in Abidjan, Côte d'Ivoire. Saliva samples were collected with the Omni-SAL device and tested for antibodies to HIV-1 or HIV-2 by GACELISA. The HIV seroprevalence was 71% among 468 FSWs and 61% among 31 SMPs. Salivary HIV antibodies were detected in all 227 HIV-1-seropositive, in all 6 HIV-2-seropositive and in 115 of 117 dually seroreactive participants, while no salivary HIV antibodies were detected in 148 of 149 seronegative participants. The sensitivity and specificity of the saliva test were 99.4% and 99.3% respectively, and the positive and negative predictive values were 99.7% and 98.7% respectively. In this West African field situation saliva testing has a high validity compared to serum testing. The Omni-SAL and GACELISA combination is an alternative strategy to serological testing because of its high sensitivity and specificity, the ease and safety of sample collection and its relatively low cost.

Cote d'Ivoire↗
PubMed2001

Adverse events and vaccination-the lack of power and predictability of infrequent events in pre-licensure study.

The recent setback in the development of a safe and effective rotavirus vaccine illustrates an important problem regarding prelicensure testing and its ability to identify rare vaccine-related adverse effects. It is our contention that the possibility of a rare but serious vaccine adverse effect is difficult to detect in prelicensure testing. In this paper, we review the history regarding the testing and eventual studies that led to the permanent withdrawal of that vaccine. The post-licensure discovery of a serious adverse event associated with the rotavirus vaccine is not unique among vaccines, but represents a recurrent phenomenon that in fact is mathematically predictable. Prelicensure studies examine thousands of subjects and not hundreds of thousands. A sample size of 10,000 subjects may provide excellent estimates of efficacy, but cannot provide an adequate denominator to rule out rare adverse events. It lacks the power. Just as with the rotavirus vaccine, only after hundreds of thousands of doses of vaccines are distributed, will such rare events appear often enough to permit detection. For that reason, we must depend upon the modern post-licensure surveillance programs that we already have in place.

Clinical Trials as Topic↗
PubMedDate not supplied

Women as motivators in the use of safety belts.

A sample of rural and urban women was interviewed using a questionnaire based on Fishbein's and Ajzen's Theory of Reasoned Action. Two hundred women were asked about their intentions to use safety-belts and to encourage others to use safety-belts. Both intent and nonintent women highly valued saving lives, feeling safer, and reducing the likelihood of injuries, but they differed markedly in their beliefs that using safety-belts would necessarily save life, enhance their feeling of safety, and reduce the likelihood of injuries. Intent and nonintent users differed least in their beliefs that safety-belts would reduce injuries. Women who intended to use their safety-belts felt their action would encourage others to use belts and believed that they should encourage others to use their safety-belts. These intent safety-belt users did not see a strong social support for encouraging others to use safety belts and therefore were unlikely to do so. Programs to promote safety-belt use would capture the generally supportive attitudes of women if they could assist women to develop skills and confidence to express effectively their existing predisposition for safety-belt use.

Attitude to Health↗
PubMed1993

Mode of ascertainment is critical in assessing safety of percutaneous umbilical blood sampling.

Percutaneous umbilical blood sampling (PUBS) is increasingly utilized for cytogenetic assessment of the fetus. In the present study, outcome of 109 PUBS-derived fetal blood samples were analyzed according to mode of ascertainment: ultrasound-detected anatomic anomalies or intrauterine growth retardation (IUGR). Abnormal chromosome complements were found in 6 of 47 (12.8%) fetuses with anomalies but in only 1 of 62 (1.6%) fetuses with IUGR alone. Perinatal loss in fetuses with anatomic anomalies was 64.4%, compared with only 1.6% in fetuses with IUGR alone. Mode of patient ascertainment is an important factor that must be considered in determining procedure-related risks for PUBS.

Blood Specimen Collection↗
PubMed2001

Seeing is believing: what do boys do when they find a real gun?

OBJECTIVES: To determine how boys behave when they find a handgun in a presumably safe environment and to compare parental expectations of their child's interest in real guns with this observed behavior. METHODS: A convenience sample of 8- to 12-year-old boys was recruited from families that completed a survey on firearm ownership, storage practices, and parental perceptions. Parents were asked to rate their child's interest in real guns on a scale from 1 to 5: 1-2 = low interest, 3 = moderate interest, and 4-5 = high interest. Parents of an eligible child were asked to bring to the exercise 1 of their son's playmates and/or a sibling in the same age range. After informed parental consent was obtained, each pair or trio of boys was placed in a room with a 1-way mirror and observed for up to 15 minutes. Two water pistols and an actual.380 caliber handgun were concealed in separate drawers. The handgun contained a radio transmitter that activated a light whenever the trigger was depressed with sufficient force to discharge the firearm. After the exercise, each boy was asked whether he thought that the pistol was real or a toy. Before leaving, each child was counseled about safe behavior around guns. RESULTS: Twenty-nine groups of boys (n = 64) took part in the study. The mean age of participants was 9.8 years. Twenty-one of the groups (72%) discovered the handgun (n = 48 boys); 16 groups (76%) handled it (n = 30 boys). One or more members in 10 of the groups (48%) pulled the trigger (n = 16 boys). Approximately half of the 48 boys who found the gun thought that it was a toy or were unsure whether it was real. Parental estimates of their child's interest in guns did not predict actual behavior on finding the handgun. Boys who were believed to have a low interest in real guns were as likely to handle the handgun or pull the trigger as boys who were perceived to have a moderate or high interest in guns. More than 90% of the boys who handled the gun or pulled the trigger reported that they had previously received some sort of gun safety instruction. CONCLUSION: Many 8- to 12-year-old boys will handle a handgun if they find one. Guns that are kept in homes should be stored in a manner that renders them inaccessible to children.guns, weapons, firearms, children, childhood behavior, injury prevention.

Adult↗
PubMed1998

The smoking gun: do clinicians follow guidelines on firearm safety counseling?

OBJECTIVES: To describe clinicians' behavior regarding firearm safety counseling practices, develop a model to predict current counseling behavior, and identify resources that might positively influence willingness to counsel according to medical guidelines. DESIGN: Four hundred sixty-five primary care Los Angeles County, California, pediatricians, family physicians, and pediatric nurse practitioners who serve families with children aged 5 years and younger received mailed questionnaires; 325 (70%) responded. MAIN OUTCOME MEASURE: Clinician self-reported behavior. RESULTS: Of the respondents, 80% stated that they should counsel on firearm safety; only 38% do so. Of those clinicians who currently counsel, only 20% counsel more than 10% of their patient families. Firearm safety counseling behavior is positively associated with a clinician being 49 years or younger (odds ratio [OR]=2.19, P=.02); a perception that counseling is beneficial (OR=2.62, P=.02); and household handgun ownership (OR=2.47, P=.02). Clinician households that report gun ownership counsel differently than those clinicians who report not possessing a household gun. There are no significant differences in the rates of counseling across specialties and crime area types. Forty-one percent of clinicians report that patient education handouts would increase their likelihood of counseling. CONCLUSIONS: In Los Angeles County gaps exist between clinicians' views of the benefits of counseling families with young children regarding firearm safety and their actual behavior. Guidelines and handouts are available from major medical organizations. Research should focus on how to get practitioners to use available materials, enabling them to better adhere to guidelines.

Adult↗
PubMed1996

Effect of a state law on reported bicycle helmet ownership and use.

OBJECTIVE: To evaluate the effect of a state law on reported bicycle helmet ownership and use. DESIGN: Multistage cluster random-digit-dialing telephone survey. SETTING: Georgia, June through November 1993. PARTICIPANTS: Adults who reported the behavior of bicyclists 4 through 15 years old. INTERVENTION: State law mandating helmet use after July 1, 1993, for all bicyclists aged younger than 16 years. MAIN OUTCOME MEASURES: Bicycle helmet ownership and use. RESULTS: Reported helmet ownership increased from 39% before the law took effect to 57% afterward (+ 46%, P = .06). Reported use increased from 33% before to 52% afterward (+ 58%, P < .05). About 7% of riders changed from "never-wearing" to "always-wearing" behavior. After the law took effect, in those households in which the law was known, 69% of riders owned and 64% used a helmet. By comparison, in those households in which the law was not known, only 30% owned and 25% used a helmet (P < .01). Reported ownership and use were 93% concordant, inversely related to rider age, and directly related to household income. Multivariable analysis indicated that race was an effect modifier of reported helmet ownership and use. In black riders, knowledge of the law appeared to be highly associated with both reported helmet ownership and use but was not significant in white riders. In white riders, though age and income were significantly associated with reported helmet ownership and use. CONCLUSIONS: This law appeared important in increasing reported helmet ownership and use, particularly in black riders. Since knowledge of the law was associated with increased ownership and use, additional publicity about the law might further increase helmet use. Because most riders who owned helmets used them, give-away programs targeting areas of low ownership may also increase use.

Adolescent↗
PubMed2000

Therapeutic drug monitoring of once daily gentamicin in serum and saliva of children.

UNLABELLED: Gentamicin is widely used in paediatric medicine and therapeutic monitoring is mandatory due to the narrow margin of safety. Saliva sampling may be of potential interest, especially in children in whom blood sampling is often difficult. Experience with once daily intravenous administration of aminoglycosides has grown in recent years. Gentamicin levels were measured in serum and saliva of 55 children treated with the drug (5 mg/kg per day), administered intravenously in three different regimens: thrice (n = 19), twice (n = 18), and once daily (n = 18). No correlation was found between serum gentamicin concentrations and saliva levels when the drug was administered twice or thrice daily, however, there was good correlation when the drug was administered once daily (r2 = 0.96, P < 0.0001). CONCLUSION: In children with uncomplicated infections treated with once daily gentamicin, trough concentrations of the drug can be monitored in saliva.

Child↗
PubMed2026

A multicenter phase II trial of ramucirumab plus irinotecan for early recurrence of gastric cancer during or after adjuvant chemotherapy with docetaxel plus S-1 therapy: the RAMIEL trial (OGSG1901).

BACKGROUND: There is currently no established chemotherapy regimen for early recurrence of pathological stage III gastric cancer (GC) following adjuvant chemotherapy with docetaxel plus S-1 (DS) after D2 gastrectomy. We aimed to evaluate the efficacy and safety of ramucirumab plus irinotecan in patients with GC who experienced early recurrence during or within 6&#xa0;months after DS adjuvant chemotherapy. METHODS: This prospective, open-label, multicenter phase II trial enrolled eligible patients treated at 25 centers of the Osaka Gastrointestinal Cancer Chemotherapy Study Group in Japan. Patients received ramucirumab (8&#xa0;mg/kg) and irinotecan (150 mg/m2) every 2&#xa0;weeks. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. The sample size was set at 40 based on a threshold median OS of 7&#xa0;months and an expected median OS of 11&#xa0;months, with a one-sided alpha error of 0.05 and a power of 0.80. RESULTS: Between November 2019 and July 2023, 43 patients were enrolled, and 39 were included in the analysis after excluding three ineligible patients and one who did not initiate protocol treatment. The median OS was 15.9&#xa0;months (95% CI: 8.8-42.0; p = 0.003). The median PFS was 5.5&#xa0;months (95% CI: 3.9-8.1), and the ORR was 38.5%. Grade &#x2009;&#x2265;&#x2009;3 adverse events, including neutropenia (25.6%) and hypertension (25.6%), were observed in more than 20% of patients. CONCLUSION: Ramucirumab plus irinotecan demonstrated promising efficacy and manageable toxicity in patients with early recurrence of GC following adjuvant DS therapy. TRIAL REGISTRATION: This study was prospectively registered in the Japan Registry of Clinical Trials (jRCTs05119071, October 6, 2019, https://jrct.niph.go.jp/latest-detail/jRCTs051190071 ).

Docetaxel↗
PubMed2004

Pharmacomechanical thrombectomy for treatment of symptomatic lower extremity deep venous thrombosis: safety and feasibility study.

PURPOSE: The current standard of care for deep venous thromboembolism (DVT) is anticoagulation; however, this treatment method does not rapidly relieve clot burden or clinical symptoms. We describe a rapid and effective method of thrombus removal, with simultaneous percutaneous mechanical thrombectomy (PMT) and thrombolysis. METHODS: Over 26 months 20 patients (22 men, 2 women; mean age, 52 +/- 6 years [range, 38-79 years]) with extensive lower extremity DVT were treated with PMT with the AngioJet thrombectomy device in combination with lytic agent (urokinase, tissue plasminogen activator, or reteplase) added to the infusion. Three patients underwent treatment twice, because of recurrent DVT. The primary end point was angiographic evidence of restoration of venous patency at completion of the procedure. Complications, recurrent ipsilateral DVT, and improvement in clinical symptoms were evaluated. RESULTS: Complete thrombus removal was obtained in 15 procedures (65%), and partial resolution in the remaining 8 procedures (35%). Inciting occlusive lesions responsible for acute DVT were revealed in 14 patients (61%), and angioplasty with or without stenting was performed when necessary. In the 8 procedures with partial resolution additional catheter-directed thrombolysis was carried out on average for 5.7 hours, with further thrombus reduction. Overall, immediate (<24 hours) improvement in clinical symptoms was noted in 17 patients (74%). There were no complications related to either PMT or the short duration of lytic agent infusion. At average follow-up of 10.2 +/- 0.3 months (range, 3-26 months), 3 patients had recurrent ipsilateral DVT, and underwent repeat treatment. CONCLUSIONS: Addition of lytic agent to PMT facilitates thrombus extraction, decreases overall interventional treatment time, and improves patient outcomes. In addition, definitive management of underlying anatomic lesions can be performed in the same setting. Further outcome measures are necessary to study the long-term efficacy of this treatment method on preservation of valve function, reduction of chronic venous insufficiency, and improved quality of life.

Adult↗
PubMed2000

Towards clinical testing of a single-administration tetanus vaccine based on PLA/PLGA microspheres.

The availability of single-administration vaccines would assist in the control of global mortality caused by infectious diseases where protection can be achieved only upon repeated immunisations with appropriate vaccines. Biodegradable microspheres of poly(lactide-co-glycolide) have been studied pre-clinically for this purpose and shown to be promising for several protein and sub-unit antigens. In view of preparing a microsphere-based tetanus vaccine for clinical trials, final candidate vaccine-formulations were pre-clinically optimised here. Specifically, the importance of particular materials and processing for the induction of neutralising antibodies in guinea pigs were examined. The most efficacious vaccines were small-sized (<5 microm), co-adjuvanted with admixed alum and fabricated from fast-degrading polymers. Interestingly, the immunogenicity was less influenced by the type of antigen-stabilising excipient, the number of microsphere populations mixed together, or the microencapsulation technology, i.e. spray-drying versus coacervation, used. On the basis of these, we plan to prepare clinical samples for safety and immunogenicity testing in man.

Animals↗
PubMed2001

Importance of patients' perceptions and general practitioners' recommendations in understanding missed opportunities for immunisations in Swiss adults.

Over the last decades, tremendous efforts have been made to strengthen childhood immunisation programs. However, the burden of influenza and pneumococcal infections remains disturbingly high in adults and elderly. We conducted a cross-sectional self-administered mail survey to identify characteristics associated with low use of recommended vaccines in adult patients attending routine primary care appointments in Switzerland. Tetanus vaccination was reported by 84% of respondents aged 16-34, and by only 42% of respondents aged 65 or more. For influenza and pneumococcal vaccination, of high-risk patients (age > or =65 or history of diabetes, kidney, heart, or chronic pulmonary disease), only 41% were on schedule for influenza and 6% for pneumococcal vaccination. Compared with patients from the German- and Italian-speaking areas of the country, patients from the French-speaking region were more likely to report past immunisation against influenza and pneumococcal disease or a recent physician's recommendation for immunisation against influenza, but equally likely to have ever refused influenza vaccination. For all three diseases, area of residence, physician's recommendation for immunisation, and patient's perceived usefulness of vaccination were independently and significantly associated with vaccination status. Although patient's opinion is an important determinant of vaccination coverage in adults, lack of physician's encouragement accounted for most missed vaccination opportunities in this study. The higher vaccination coverage among patients from the French-speaking area suggests that the promotion campaigns carried out in this region effectively improved influenza vaccine use. Interventions designed to increase vaccination coverage in adults must help providers incorporate immunisation in routine health care.

Adolescent↗