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Biomedical subjects

R Tucker

Publications and source records attributed to R Tucker.

At least 19 recordsLinked to original sources
PubMed2001

A randomized study of a flexible booster dosing regimen of VAQTA in adults: safety, tolerability, and immunogenicity.

BACKGROUND: VAQTA (hepatitis A vaccine inactivated, Merck & Co., Inc., West Point, PA) is licensed for use in healthy adults in a two-dose schedule at 0 and 6 months. OBJECTIVE: to determine whether the responses to a booster dose of VAQTA administered to adults 12 or 18 months after the first dose were similar to the response when the booster dose was administered 6 months after the first dose. METHODS: healthy adults were randomized to receive 50-U of VAQTA at 6 (Group I), 12 (Group II), or 18 months (Group III) following receipt of Dose 1 on Day 0. Blood samples were collected immediately prior to Doses 1 and 2 and then, 4 weeks following Dose 2. Seropositivity rates (SPRs), geometric mean titers (GMTs) in milli-international units per milliliter (mIU/ml) and booster response rates (BRRs) were compared among treatment groups. Safety data were collected on Vaccination Report Cards. RESULTS: no serious adverse experiences were reported, and the vaccine was well-tolerated by subjects in the three treatment groups. One month following the booster dose, SPRs and GMTs for Groups I, II, and III, respectively, were, 100% (102/102) and 6726.4 mIU/ml; 97.9% (93/95) and 4863.8 mIU/ml; 100% (86/86) and 6068.3 mIU/ml. The BRRs were 88.2% (Group I), 90.2% (Group II) and 94.2% (Group III). CONCLUSION: responses to the booster dose were comparable regardless of the timing (i.e. 6, 12, or 18 months following Dose 1). Flexibility in the timing of the booster dose of VAQTA in adults would allow the vaccination schedule to be the same for adults, adolescents, and children and may increase the likelihood that adults receive the booster dose.

Adult↗
PubMed2001

Impact of fluorine-18 fluorodeoxyglucose positron emission tomography on patient management: first year's experience in a clinical center.

PURPOSE: To measure the impact of whole-body fluorodeoxyglucose (FDG) positron emission tomography (PET) on patient management during its first year of use in a community hospital. MATERIALS AND METHODS: First-year FDG-PET impact was determined from 463 referring physicians' evaluations of their patients' PET imaging results using two surveys. Survey 1 was given to all physicians referring patients to PET to discover whether PET changed patient management or had decision-making value in the patient's clinical algorithm. Survey 2 was given to one surgeon and one pulmonologist after therapy to determine how PET affected the surgical, chemotherapeutic, and/or radiotherapeutic treatment for the 53 cancer patients they referred. RESULTS: The 463 responses to survey 1 described 23 different PET indications. Lung (40%), head and neck (18%), and colorectal cancers (11%) were the three leading causes of referral. PET changed patient management/therapy in 45% of all patients referred and had inferential/decision-making value in another 44%. Overall, PET had some type of positive influence in 412 (89%) of the patients. Survey 2 provided a more detailed assessment of 53 referrals from two specialists. PET positively affected surgery in 31 patients (58%), prompted the addition of chemotherapy or radiation therapy in nine patients (17%), and eliminated chemotherapy or radiation therapy in four cases (8%). Overall, PET affected patient management/therapy in 70% of the cases and had some decision-making value in another 26%, for a combined PET impact on patient management of 96%. CONCLUSION: FDG-PET can be valuable for physicians in clinical practice. Its sensitivity and specificity in metabolic imaging, when combined with complementary anatomic imaging techniques, contribute significantly to the clinical treatment of cancer patients. In addition, the high accuracy of FDG-PET makes it a cost-effective radiologic procedure in the work-up of all suspected and/or recurrent cancer patients. Further research is needed to link this demonstrated impact on patient management to cost-effectiveness.

Fluorodeoxyglucose F18↗
PubMed2000

Survival and neonatal morbidity at the limits of viability in the mid 1990s: 22 to 25 weeks.

OBJECTIVE: We determined neonatal survival and morbidity rates based on both fetal (stillborn) and neonatal deaths for infants delivered at 22 to 25 weeks' gestation. STUDY DESIGN: Two hundred seventy-eight deliveries at 22 to 25 weeks' completed gestation were analyzed by gestational age groups between January 1993 and December 1997. Logistic regression models were used to identify maternal and neonatal factors associated with survival. RESULTS: The rate of fetal death was 24%; 76% of infants were born alive and 46% survived to discharge. Survival rates including fetal death at 22, 23, 24, and 25 weeks were 1.8%, 34%, 49%, and 76%; and survival rates excluding fetal death were 4.6%, 46%, 59%, and 82%, respectively. Logistic regression analyses showed that higher gestational age (P<.0002), higher birth weight (P<.001), female sex (P<.005), and surfactant (P<.003) were associated with neonatal survival. Cesarean section was associated with decreased survival (P <.006). CONCLUSION: Hospital neonatal survival rates of infants at the limits of viability are significantly lower with the inclusion of fetal deaths. This information should be considered when providing prognostic advice to families when mothers are in labor at 22 to 25 weeks' gestation.

Female↗
PubMed2000

Sublingual enteric duplication cyst.

We describe a case of enteric duplication arising from the floor of the mouth and base of the tongue of a 7-year-old child. This mass was asymptomatic and was detected on routine dental examination. The unusual location, possible etiology, and a brief review of the literature are discussed.

Child↗
PubMed2000

Measuring injection-site pain associated with vaccine administration in adults: a randomised, double-blind, placebo-controlled clinical trial.

BACKGROUND: Pain at the injection site is one of the most commonly-reported local reactions associated with administration of a vaccine, but it has not been quantified by a validated instrument for pain measurement. We conducted a randomised, double-blind clinical trial to evaluate the measurement characteristics of two commonly-used pain questionnaires, the McGill Present Pain Intensity (PPI) and the Brief Pain Inventory (BPI) Current Pain Question, in the assessment of intramuscular injection-site pain associated with vaccine administration. The PPI measures pain on a scale of 0 (no pain) to 5 (excruciating pain) and the BPI measures pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). METHODS: Two hundred healthy adults were randomised to one of the five regimens: tetanus and diphtheria toxoids adsorbed (Td), aluminum hydroxide adjuvant (alum), physiological saline, or one of the two licensed hepatitis A vaccines, VAQTA, or HAVRIX. Pain assessment was made at eight time-points over a 2-day period after injection. RESULTS: The differences in the time-averaged pain (+/- standard deviation) on the PPI were statistically significant between Td (0.58+/-0.59) and either saline (0.14+/-0.23) (p < 0.005) or alum (0.22+/-0.35) (p < 0.01). Reported time-averaged pain were significantly lower for VAQTA than HAVRIX (p = 0.028). Similar differences were observed for the BPI. CONCLUSIONS: Both instruments have sufficient discriminative validity to distinguish between different levels of injection-site pain in adults.

Adolescent↗
PubMed1999

Concurrent administration of inactivated hepatitis A vaccine with immune globulin in healthy adults.

301 healthy adult volunteers were randomized to one of three treatment groups: inactivated hepatitis A vaccine alone; inactivated hepatitis A vaccine with immune globulin (Ig) concurrently; or Ig alone. The first two treatment groups received a second dose of hepatitis A vaccine at week 24. Anti-HAV was measured 4, 8, 12, 24 and 28 weeks after the primary immunization. When comparing subjects receiving inactivated hepatitis A vaccine alone to those receiving vaccine and Ig, the seropositivity rates were not significantly different at 4, 8, 12 and 28 weeks, but at week 24 the seropositivity rate was lower in the group receiving both vaccine and Ig compared to the group receiving vaccine alone (92.0% compared to 97.0%). At weeks 8, 12 and 24 the geometric mean titers (GMTs) were significantly lower for subjects receiving both vaccine and Ig. The GMTs were not significantly different after the second dose of vaccine. At all time points, the lower serum antibody concentrations observed in subjects receiving both inactivated hepatitis A vaccine and Ig were nevertheless substantially higher than the cutoff for assay seropositivity and much higher than after Ig alone; these differences are therefore clinically insignificant.

Adolescent↗
PubMed1999

Effects of maternal gestational diabetes on offspring adiposity at 4-7 years of age.

OBJECTIVE: The purpose of this study was to assess the long-term effects of maternal prenatal factors, including gestational diabetes mellitus (GDM), adiposity, and weight gain during pregnancy, on adiposity of offspring from 4 to 7 years of age. A second purpose was to investigate the relationships among childhood adiposity, blood pressure, and 2-h postprandial glucose level. RESEARCH DESIGN AND METHODS: Prospective observational study of four groups of children including large-for-gestational-age (LGA) offspring of mothers with gestational diabetes (OGDM); appropriate-for-gestational-age (AGA) OGDM; LGA control subjects; and AGA control subjects. Anthropometrics including skin-fold measurements, blood pressure measurements, and a 2-h postprandial glucose measurement were obtained at each visit. Repeated measures analysis of variance models were used to detect different patterns of longitudinal change among the groups. RESULTS: LGA OGDM were more likely to be heavier, have larger circumferences and skin-fold measurements, and have a higher BMI than AGA OGDM and control subjects, and these findings increased with increasing age. Blood pressures and postprandial glucose values were similar for OGDM and control subjects at 4-7 years. Multivariable analyses showed that infant BMI and maternal prepregnant BMI predicted 7-year BMI for OGDM, whereas for control subjects, maternal prepregnancy BMI and weight gain during pregnancy were positive predictors with a small negative contribution from birth BMI. CONCLUSIONS: We conclude that LGA OGDM have evidence of increasing body size and adiposity with increasing age and that maternal GDM and maternal prepregnant adiposity are significant predictors of their unique growth patterns.

Adipose Tissue↗
PubMed1998

Histologic localization of indocyanine green dye in aging primate and human ocular tissues with clinical angiographic correlation.

OBJECTIVE: This study aimed to histologically localize indocyanine green (ICG) dye in the geriatric primate and human eye and to correlate these findings with clinical ICG angiography. DESIGN: The study design was a clinicopathologic correlation. PARTICIPANTS: Six eyes of three geriatric monkeys (Maccaca mulatta) with macular drusen, 19 to 29 years of age, housed at the California Primate Research Center and an enucleated human eye from a 66-year-old patient with choroidal melanoma were examined. INTERVENTION: All six monkey eyes and the human eye underwent clinical ICG angiography. Five monkey eyes were enucleated at varying intervals after intravenous ICG dye injection for histologic examination. One monkey eye was removed without prior ICG injection as an age-matched control. The human eye was enucleated after intravenous injection of ICG dye. MAIN OUTCOME MEASURES: Infrared fluorescence microscopy of freeze-dried tissue sections was performed to detect ICG fluorescence. Histologic sections were stimulated with an 810-nm diode laser, and the fluorescence emitted was detected with a Hamamatsu infrared camera. The images were digitally recorded. The distribution of fluorescence on histologic examination was correlated with the fluorescence of the clinical ICG angiogram. RESULTS: Infrared fluorescence microscopy of monkey sections localized fluorescence within retinal and choroidal vessels early after injection of ICG dye. The ICG fluorescence was seen in the extravascular choroidal stroma within 10 minutes after injection. The stromal fluorescence persisted in sections obtained 50 minutes after injection of ICG. The retinal pigment epithelium (RPE)-Bruch's membrane complex was brightly fluorescent in the middle- and late-stage histologic sections. Drusen deposits were brightly fluorescent at all timepoints examined. Similar findings were observed in freeze-dried tissue sections of the human eye. The fluorescence detected on histologic sections correlated closely with the fluorescence of the clinical ICG angiograms for the same interval. CONCLUSIONS: The ICG dye does not remain solely within the choroidal intravascular space but extravasates into the choroidal stroma and accumulates within the RPE. Extravascular ICG binds to drusen material. These findings will enhance the interpretation of clinical ICG angiography.

Aged↗
PubMed1997

Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group.

OBJECTIVE: To compare the safety and efficacy of topical 1% penciclovir cream with vehicle control cream (placebo) for the treatment of a recurrent episode of herpes simplex labialis (cold sores) in immunocompetent patients. DESIGN: Randomized, double-blind, placebo-controlled, patient-initiated, 2-armed, parallel clinical trial. Patients were prospectively dispensed study medication, and treatment was self-initiated by the patient within 1 hour of the first sign or symptom of a recurrence. SETTING: A total of 31 ambulatory clinics in the United States in a variety of settings, including private practices, public health facilities, and universities. PATIENTS: Otherwise healthy individuals with a history of frequent episodes of herpes simplex labialis. A total of 2209 patients were enrolled and given study medication, and 1573 initiated treatment for a recurrence. INTERVENTIONS: Topical 1% penciclovir cream or vehicle control cream. Subjects applied treatment every 2 hours while awake for 4 consecutive days. MAIN OUTCOME MEASURES: Lesion healing was the primary efficacy variable. Secondary end points included time to loss of lesion pain and time to cessation of viral shedding. RESULTS: Healing of classical lesions (vesicles, ulcers, and/or crusts) was 0.7 day faster for penciclovir-treated patients compared with those who received vehicle control cream (median, 4.8 days vs 5.5 days; hazard ratio [HR], 1.33; 95% confidence interval [CI], 1.18-1.49; P<.001). Pain (median, 3.5 days vs 4.1 days; HR, 1.22; 95% CI, 1.09-1.36; P<.001) and lesion virus shedding (median, 3 days vs 3 days; HR, 1.35; 95% CI, 1.10-1.64; P=.003) also resolved more quickly for penciclovir-treated patients compared with patients who applied the vehicle control. The efficacy of penciclovir cream was apparent when therapy was initiated early (prodrome or erythema lesion stage) and when initiated late (papule or vesicle stage). The incidence of adverse events was comparable between penciclovir and placebo groups. CONCLUSIONS: Penciclovir cream is the first treatment to clearly demonstrate an impact on the course of recurrent herpes labialis in immunocompetent patients. Efficacy was seen in all clinical and laboratory measures of the disease (lesion healing, pain resolution, and cessation of viral shedding). Faster healing and pain resolution occurred both among patients who first applied penciclovir cream in the prodrome and erythema stages and among those who started treatment in the papule and vesicle lesion stages.

Acyclovir↗
PubMed1996

Group and single-subject evaluation of a programme to promote self-care in elderly nursing home residents.

Residents and staff of a nursing home in a metropolitan area were randomly assigned to three conditions to: (a) test whether staff's use of operant behavioural management strategies (Condition 1) would cause a greater increase in residents' self-care behaviour than staff's use of mutual goal setting (Condition 2) or routine nursing care (Condition 3), and (b) examine how useful group scores were, compared to individual scores, in determining change in individual residents' behaviour due to treatment. In-service training was provided to staff in Conditions 1 and 2 but not in Condition 3. Over a period of 22 weeks, nursing staff encouraged subjects to perform targeted self-care tasks independently. Data analysis indicated significantly greater change in self-care behaviours for subjects in Condition 1 than for subjects in Conditions 2 and 3. However, visual inspection of data for each case revealed that individual scores were more useful than averages and differences between groups for determining the effectiveness of the clinical interventions.

Aged↗
PubMed1995

Factors precluding patients' discharge to the community. A geropsychiatric hospital survey.

Study subjects were the 206 inpatients at a 210-bed university-affiliated, state-operated geropsychiatric hospital in July 1993. Staff psychiatrists, using the behavioral component of the Agitation Behavior Mapping Instrument (ABMI) and a nonbehavioral component added by the authors, determined reasons why their patients could not return to the community at the time of the study. Aggression, nonbehavioral problems, and inability to care for self accounted for three-quarters of the primary reasons precluding immediate community placement. Of these three reasons, aggressive behavior was both the most common and the most correctable factor keeping subjects in the hospital. Aggressive behavior occurred most commonly among psychotic patients, intermediate among demented patients and least commonly among patients with mood disorders. The authors suggest the need to better define those aggressive behaviors and to develop effective treatments that can be transported with patients as they return to the community.

Activities of Daily Living↗
PubMed1994

Bipolar versus monopolar sphincterotomy: a prospective trial.

OBJECTIVES: To determine the frequency of complications, specifically pancreatitis, associated with endoscopic sphincterotomy, comparing the standard, monopolar electrocautery current to the bipolar system. METHODS: One-hundred consecutive patients requiring ERCP and sphincterotomy, 50 patients in each group, were randomized to receive a sphincterotomy using either the bipolar system (Bitome) or the standard monopolar system. Cannulation with the selected sphincterotome was successful in 92 patients, but crossover to the other system was necessary in eight patients, five bipolar and three monopolar. The performance of sphincterotomy was conducted similarly and by the same investigator. Excessive manipulation of the papilla during difficult cannulation was avoided, and no pre-cut, needle knife, or wire-guided assisted cannulation techniques were used in either group. RESULTS: Complications were assessed during follow-up review of charts and telephone interviews. Pancreatitis did not occur in the bipolar group; however, six patients in the monopolar group developed clinical and biochemical evidence of pancreatitis (p < 0.047). CONCLUSIONS: Sphincterotomy using bipolar technology appears to reduce the frequency of pancreatitis when compared to monopolar technology in a prospective, randomized fashion. Because bipolar electrocautery current is localized to the accessory tip, radiofrequency does not encounter impedance through the patient's body mass, and tissue injury is reduced. This fact may account for the decreased incidence of pancreatitis in the bipolar group. Larger studies are called for to support this conclusion.

Cholangiopancreatography, Endoscopic Retrograde↗