Search PubMed⌕ Search

Biomedical subjects

T Davidson

Publications and source records attributed to T Davidson.

At least 37 records · Page 2Linked to original sources

Evaluation and extraction of the Accufix atrial J lead.

The Accufix (Telectronics Pacing Systems, Englewood, Colo.) atrial active fixation pacemaker lead has a preformed J stiff retention wire that can fracture and erode through the atrium. We screened 85 patients with digital fluoroscopy and detected 18 (21%) lead fractures. Fourteen (16%) leads were successfully extracted by percutaneous techniques. The mean time for extraction and placement of a new atrial lead was 109 +/- 53 min, and a lead > 1 year old but not in the presence of a fracture was associated with a significantly longer extraction time. There were two extraction complications. One patient had a fever following the extraction, and one patient had a focal sensory deficit 1 week after the extraction probably caused by a paradoxical embolus. Standard percutaneous extraction tools can be used for successful and safe removal of a fractured Accufix lead.

Aged↗

Breast surgery after neoadjuvant treatment. Is it necessary?

The optimum management of women with advanced loco-regional breast cancer (T3-4, N1-2) is controversial. Neoadjuvant therapy in the form of chemotherapy and or radiotherapy is popular and results in an encouraging local response in over 70% of patients. However, should subsequent surgery (either mastectomy or breast conservation treatment) be undertaken in women who respond? We present a prospective evaluation of 15 patients with T3-4, N1-2 tumours (including 1 bilateral cancer) who underwent mastectomy after achieving a complete clinical response to neoadjuvant treatment. All patients had 6 cycles of chemotherapy and 10 also received 50 Gy radiotherapy. In addition to clinical examination, the response to neoadjuvant treatment was assessed by mammography (in all cases) and by magnetic resonance imaging (MR) (in eight patients). Careful histopathological assessment of the breast was undertaken to determine the extent of residual disease. In all patients histological malignancy was recognized within the breast. The size varied from 0.6 to 6.5 cm in maximum diameter with three grade I, eight grade II and five grade III tumours. Axillary lymph nodes were positive in seven patients. In conclusion, surgery is indicated for control of residual disease in locally advanced breast cancer regardless of the response to neoadjuvant treatment. Our preliminary observations suggest a potential role for breast MR in defining the extent of residual disease which may aid in the planning of surgery.

Adult↗

Pharmacokinetics and pharmacodynamics of CTLA4lg (BMS-188667), a novel immunosuppressive agent, in monkeys following multiple doses.

The dose proportionality and multiple dose pharmacokinetics of CTLA4Ig, an immunosuppressive drug under development, were investigated in 12 cynomolgus monkeys in a parallel study. The activity of CTLA4Ig in suppressing the immunoresponses to sheep red blood cell (SRBC) was also assessed. Two monkeys per gender were randomly assigned to one of the three dose levels, 1.0, 2.9, and 8.7 mg/kg of CTLA4Ig. The monkeys in each dose level received the assigned intravenous dose of CTLA4Ig by a bolus injection into a saphenous vein on days 1, 4, 8, 11, 15, and 18. Immediately after the administration of CTLA4Ig on day 1, each monkey was challenged with SRBC. Serial blood samples were collected up to 720 h following administration of CTLA4Ig on day 18 (last dose). In addition, predose blood samples were obtained on days 1, 4, 8, 11, 15, and 18. Serum samples were analyzed for the concentrations of CTLA4Ig using a validated ELISA method. The data obtained were subjected to noncompartmental pharmacokinetic analyses. The serum concentrations of CTLA4Ig attained steady state by day 11 regardless of the dose levels. The mean AUC0-720 values of CTLA4Ig increased in a dose proportional manner. The mean values of Cmax increased in a ratio of 1:3:3:8:5 while the dose administered increased in a ratio of 1:3:9. Predose serum concentrations (Cmin) of CTLA4Ig increased in a dose proportional manner. The mean T1/2 values were not significantly different among the dose groups, suggesting that the elimination characteristics of CTLA4Ig were not altered as the dose increased. Dose-related immunosuppressive activity of CTLA4Ig (78-98% inhibition) was observed in monkeys immunized intravenously with SRBC. In conclusion, CTLA4Ig exhibits linear kinetics and demonstrates significant immunosuppressive activity over a dose range of 1.0-8.7 mg/kg in monkeys.

Abatacept↗

Confidentiality and managed care: ethical and legal concerns.

As managed care companies take over the allocation of funds, the monitoring of treatment, and the measurement of outcomes, social workers encounter an ethical and legal dilemma with the demise of confidentiality in the professional-client relationship. Given that the profession has long heralded the protection of client confidentiality, it is timely that social workers re-examine traditional ethical and legal responsibilities to clients and challenge managed care personnel to protect clients' right to confidentiality. This article highlights problems concerning confidentiality that often arise for social workers working with managed care systems. It focuses also on ethical and legal standards related to confidentiality and social work responsibilities regarding informed consent.

Confidentiality↗

Testosterone replacement therapy improves mood in hypogonadal men--a clinical research center study.

The effect of testosterone (T) replacement on changes in mood was studied for 60 days in 51 hypogonadal men. All patients were withdrawn from their prior T replacement for at least 6 weeks before enrollment. Of these patients, 18 received T enanthate 200 mg im every 20 days, 16 received sublingual T cyclodextrin (SLT) at a dose of 2.5 mg three times daily, and 17 received SLT at a dose of 5.0 mg three times daily. The total treatment period was 60 days. The patients were asked to respond to a questionnaire on 7 consecutive days before the start of treatment and on 7 consecutive days before their visits to the clinic on days 21, 41, and 60 of treatment. The following mood parameters were assessed using a 7-point Likert rating scale: angry, alert, irritable, full of pep (energy), sad/blue, tired, friendly, nervous, and well/good. When compared with the baseline period, T replacement led to significant decreases in anger (P = 0.0045), irritability (P = 0.0009), sadness (P = 0.0033), tiredness (P = 0.0035), and nervousness (P = 0.0291), and significant improvement in energy level (P = 0.0020), friendliness (P = 0.0072), and sense of well-being (P = 0.024) in all subjects as a group. Analyses of the area under the curve (AUC) of baseline serum T levels before T replacement showed significant positive correlations between serum T (AUC) and friendliness (r = 0.29, P < 0.05) and sense of well-being (r = 0.27, P < 0.05), and significant negative correlations with nervousness (r = -0.27, P < 0.05), irritability (r = -0.29, P < 0.05) and tiredness (r = -0.28, P < 0.05). Similar correlations were found between serum dihydrotestosterone (DHT) and some of the mood parameters. After T replacement in the hypogonadal men, these correlations between AUC of serum T levels and the positive and negative mood scores disappeared. These results were corroborated in a subsequent study in which 30 hypogonadal men were supplemented with SLT 5 mg three times daily for 6 months. The patients were less nervous (P = 0.0025) and more alert (P = 0.0004), friendly (P = 0.042), and energetic (P = 0.0001) during the 6-month treatment period compared with baseline. We conclude that T replacement therapy in hypogonadal men improved their positive mood parameters, such as energy, well/good feelings, and friendliness and decreased negative mood parameters including anger, nervousness, and irritability, and direct correlations between serum T and DHT with mood scores were only observed in the baseline period when serum androgen levels were below the normal range. The latter observation suggests that once a minimally adequate serum T/DHT level was achieved by T replacement therapy, further increases in serum T/DHT levels did not further contribute to the improvement in mood variables.

Administration, Sublingual↗

Sublingual testosterone replacement improves muscle mass and strength, decreases bone resorption, and increases bone formation markers in hypogonadal men--a clinical research center study.

To study the effects of androgen replacement therapy on muscle mass and strength and bone turnover markers in hypogonadal men, we administered sublingual testosterone (T) cyclodextrin (SLT; 5 mg, three times daily) to 67 hypogonadal men (baseline serum T, < 8.4 nmol/L) recruited from 4 centers in the U.S.: Torrance (n = 34), Durham (n = 12), New York (n = 9), and Salem (n = 12). Subjects who had received prior T therapy were withdrawn from injections for at least 6 weeks and from oral therapy for 4 weeks. Body composition, muscle strength, and serum and urinary bone turnover markers were measured before and after 6 months of SLT. We have shown previously that this regimen for 60 days will maintain adequate serum T levels and restore sexual function. Total body (P = 0.0104) and lean body mass (P = 0.007) increased with SLT treatment in the 34 subjects in whom body composition was assessed. There was no significant change in total body fat or percent fat. The increase in lean body mass was mainly in the legs; the right leg lean mass increased from 8.9 +/- 0.3 kg at 0 months to 9.2 +/- 0.3 kg at 6 months (P = 0.0008). This increase in leg lean mass was associated with increased leg muscle strength, assessed by leg press (0 months, 139.0 +/- 4.0 kg; 6 months, 147.7 +/- 4.2 kg; P = 0.0038). SLT replacement in hypogonadal men led to small, but significant, decreases in serum Ca (P = 0.0029) and the urinary calcium/creatinine ratio (P = 0.0066), which were associated with increases in serum PTH (P = 0.0001). At baseline, the urinary type I collagen-cross linked N-telopeptides/creatinine ratio [75.6 +/- 7.9 nmol bone collagen equivalents (BCE/mmol] was twice the normal adult male mean (41.0 +/- 3.6 nmol BCE/mmol) and was significantly decreased in response to SLT treatment at 6 months (68.2 +/- 7.7 nmol BCE/mmol; P = 0.0304) without significant changes in urinary creatinine. Serum skeletal alkaline phosphatase did not change. In addition, SLT replacement caused significant increases in serum osteocalcin (P = 0.0001) and type I procollagen (P = 0.0012). Bone mineral density did not change during the 6 months of SLT treatment. We conclude that SLT replacement therapy resulted in increases in lean muscle mass and muscle strength. Like estrogen replacement in hypogonadal postmenopausal females, androgen replacement therapy led to decreased bone resorption and urinary calcium excretion. Moreover, androgen replacement therapy may have the additional benefit of increasing bone formation. A longer term study for several years duration would be necessary to demonstrate whether these changes in bone turnover marker levels will result in increased bone mineral density decreased fracture risks, and reduced frailty in hypogonadal men.

Administration, Sublingual↗

Myocardial perfusion scintigraphy in patients undergoing major non-vascular abdominal surgery.

The prognostic value of myocardial perfusion scintigraphy is beginning to be recognised in patients undergoing cardiovascular surgery. The aim of this prospective study was to assess the predictive value of scintigraphy in elderly patients undergoing major non-vascular abdominal surgery. Adenosine stress thallium-201 (201Tl) single-photon emission tomography (SPET) was employed for imaging using a standard protocol. Patients over the age of 60 years (n = 55) with an intermediate to high likelihood of coronary artery disease were evaluated prospectively. The clinical outcome variables analysed were cardiac mortality and major cardiac morbidity occurring within 30 days of surgery. Cardiac events were cardiac death (n = 5), angina pectoris (n = 5), nonfatal mycardial infarction (n = 1), acute left ventricular failure (n = 2) and arrhythmias requiring treatment (n = 4). All cardiac events occurred in the first 10 postoperative days except one cardiac death which happened on the 29th postoperative day. Patients with an abnormal 201Tl SPET scan had a higher risk of postoperative death (4 vs 1) or any postoperative cardiac event (13 patients vs 4 patients; P < 0.0001) when compared with those with a normal scan. The sensitivity, specificity and positive predictive value of 201Tl imaging for perioperative ischaemia and adverse outcomes were 76%, 82% and 65%, respectively. The occurrence of an intraoperative event (P < 0.02) and the length of surgery (P < 0.01) were also predictors of a postoperative cardiac event. Clinical risk variables and an abnormal electrocardiogram in isolation were poor predictors. In conclusion, preoperative myocardial perfusion scintigraphy is a valuable technique for identifying elderly patients with a high risk for cardiac events when undergoing major non-vascular abdominal surgery.

Abdomen↗

Pharmacokinetics, bioefficacy, and safety of sublingual testosterone cyclodextrin in hypogonadal men: comparison to testosterone enanthate--a clinical research center study.

We studied and compared the pharmacokinetics and bioefficacy of two doses of sublingual testosterone cyclodextrin (SLT; 2.5 and 5.0 mg, administered three times per day) with testosterone enanthate (TE; 200 mg) given once every 20 days by im injections over a 60-day study period in 63 hypogonadal men. After SLT administration, serum testosterone (T) levels peaked at 20 min and then fell, reaching baseline levels by 360 min. The calculated half-lives were 60.3 +/- 7.5 and 68.8 +/- 5.0 min after a single dose of 2.5 and 5.0 mg SLT, respectively. The mean area under curve (AUC) of serum T was computed over 20-day periods for the 3 treatment groups. The mean net AUC of serum T after TE administration was about 4- and 2-fold higher than that in the 2.5 and 5 mg groups over the last 20 days. Serum estradiol and dihydrotestosterone followed the same pattern as serum T. Serum estradiol to T ratios decreased after T replacement in all 3 groups, whereas serum dihydrotestosterone to T ratios were not significantly changed by T treatment. Suppression of serum LH and FSH levels was more marked in the patients treated with TE than in those given SLT. Similarly, serum sex hormone-binding globulin levels showed significant decreases with androgen replacement only in the TE and SLT 5.0 mg range groups. There were no significant adverse effects based on comprehensive physical examinations, urea, electrolytes, and renal or liver function tests. Hematocrit levels increased in the TE-treated group, but remained slightly lower than baseline levels in the SLT groups. Serum high density lipoprotein cholesterol showed a small, but significant, decrease with time of treatment in all groups. Despite the differences in the AUC of serum T levels achieved by different androgen replacement therapies, all patients showed significant improvements in sexual motivation and performance, with no significant difference between the treatment groups. We conclude that SLT may be a useful addition to the currently available injectable and transdermal delivery systems for treatment of hypogonadal men. Because of the ease of administration, rapid reversibility of effects, and lower AUC of serum T levels achieved compared to those of TE injections, SLT may be especially suitable for treatment of boys with delayed puberty and older men with androgen deficiency.

Administration, Sublingual↗

Antitachycardia pacing: an overview.

Ventricular tachycardia is the most common life-threatening tachyarrhythmia seen in patients with structural heart disease. In the past 10 years, many thousands of lives have been saved by the addition of the implantable cardioverter-defibrillator to the armamentarium of treatment options. Yet, despite the success of these devices in the prevention of sudden cardiac death, many patients felt that the psychological cost was too high. Loss or restriction of some of the most basic activities such as driving and working and not knowing when they would receive the life-saving but painful shock took a toll on patients' perceptions of the quality of their lives. When antitachycardia pacing was demonstrated to provide about half of these patients a life-saving, yet comfortable, means of controlling episodes of ventricular tachycardia, physicians and patients were eager to try it. None of the many ways to provide antitachycardia pacing has proved overwhelmingly more effective than the others. This paper describes and illustrates each type of antitachycardia pacing and demonstrates their programmed parameters. Several clinical case illustrations are included.

Adult↗

A survey of actinic keratoses among paraquat production workers and a nonexposed friend reference group.

Follow-up on two reports of an excess of keratoses among paraquat production workers was conducted to evaluate the contribution of occupational exposures to the prevalence of keratoses among workers in a paraquat production plant in Texas. A cross-sectional study design was used to compare the prevalence of keratoses among current workers to an age, race, and sex frequency-matched group of their friends who had never worked at the plant. The analysis is based on 112 workers and 232 friends. Exposure, outcome, and covariables used in the analyses were obtained from an interview questionnaire, dermatology exam, and company records. Overall, the prevalence proportion of the presence of any actinic keratoses among workers and friends was similar (0.30 and 0.28, respectively). Among high cumulative exposed workers, the prevalence of any actinic keratoses was 0.40 compared to 0.20 among low-exposed workers and 0.28 among friends. These results were further explored using a multiple logistic regression approach to adjust for known risk and possibly confounding variables. Statistically significant high risks of actinic keratoses were demonstrated for freckling before age 16 years, older age, suntanning behaviors, occupational exposure to polycyclic aromatic hydrocarbons (PAH), and Fitzpatrick skin type. There was no significant contribution of overall exposure status (worker vs. friend). Similar to the crude analysis, the odds of actinic keratoses of high-exposed workers compared to friends was 1.9 (confidence interval [CI] = 0.9-4.2) whereas the comparable odds ratio for low-exposed workers vs. friends was 0.6 (CI = 0.2-1.7). These data do not demonstrate an excess of actinic keratoses overall nor any consistent increase in the odds of keratoses with an increase in plant exposure level.

Adult↗

Swallowing assessment in primary brain tumor patients with dysphagia.

Dysphagia is a common problem in patients with neurologic disease and is often associated with significant morbidity and mortality. To evaluate primary brain tumor patients who complained of dysphagia, we adapted grading scales for severity of complaint and level of alertness (scale of 1 to 4) and bedside swallowing assessment and videofluoroscopic examination (scales of 1 to 5). Over 13 months, we prospectively screened 117 patients for dysphagia. Seventeen of these (14.5%) complained of dysphagia (mean age, 50.2 years; range, 20 to 75); an additional six control patients were studied from a group with no dysphagic complaints. Scoring for severity of complaint (mean, 2.3) and level of alertness (mean, 2.2) was mild-moderate in the majority of patients. Eleven of 17 patients scored > or = grade 3 (mean 3.2, moderate impairment, requiring supervision) on bedside testing, and six of seven scored > or = grade 3 (mean 3.8, moderate-moderately severe abnormality, trace or frequent aspiration) during videofluoroscopic evaluation. Bedside testing scores of the study group differed significantly (p < 0.001) from those of the control group. Level of alertness correlated strongly with bedside (r = 0.794) and videofluoroscopic (r = 0.780) scoring. Primary brain tumor patients with dysphagia are likely to have impairment of swallowing out of proportion to their complaints and therefore are at risk for aspiration and nutritional compromise. We recommend that these patients undergo formal swallowing assessment followed by rehabilitation or implementation of alternative feeding methods.

Adult↗

Putative determinants of the cellular response to hyperthermia.

Recently, it has been demonstrated that two different thermal resistant states found in Chinese hamster cells, one transient, associated with thermotolerance, and the other permanent, associated with the increased expression of the cognate member of the hsp 70 family, are characterized by faster recovery from heat-induced perturbations in several cellular processes (Laszlo 1992b). These processes include total cellular protein and RNA synthesis, the localization of hsp70, the organization of vimentin, and the protein composition of the nucleus. In the present study, the recovery from heat-induced perturbations in cellular physiology was extended further to two more types of Chinese hamster cells: permanently heat resistant cells in which thermoresistance is associated with the overexpression of hsp27 and heat-sensitive cell lines. When the heat-resistant hsp27 transfected cell lines were compared with the control wild-type cell line, the recovery of protein synthesis from heat-induced inhibition was similar in the normal and hsp27 transfected cells, while the recovery from heat-induced inhibition of total RNA synthesis and the recovery from heat-induced increased association of hsp70 with nuclei were both more rapid in the hsp27 transfected cell lines. In the permanently heat-sensitive cell lines, the kinetics of recovery from heat-induced inhibition of protein synthesis did not correlate with the heat sensitive state. However, delays in the recovery from heat-induced alterations in total cellular RNA synthesis and from heat-induced excess nuclear association of hsp70 were associated with the heat-sensitive state. Overall, these results suggest that the kinetics of recovery from heat-induced alterations in total cellular RNA synthesis and the localization of hsp 70 are putative candidates for being determinants of the cellular response to hyperthermia, and thus have the potential to form the basis of predictive assays for use in conjunction with clinical hyperthermia.

Adaptation, Physiological↗

Preoperative drinking does not affect gastric contents.

We have compared the effect of allowing free clear fluids until the time of oral premedication with conventional preoperative fasting. In a prospective, randomized trial, the residual volume and pH of gastric contents after induction of anaesthesia were measured in 100 elective surgical patients allocated randomly to a group in whom the intake of free clear fluids up to the time of premedication was measured (mean 388 ml in 6 h before surgery) or a control group who were fasted for 6 h. Preoperative drinking did not affect either mean (SD) residual gastric volume (22 (21) ml in the study group vs 19 (16) ml in the control group) or pH (study group 2.64 (1.57) vs control group 2.26 (1.45)). The study group experienced less preoperative thirst. Problems with aspiration or regurgitation were not encountered. We believe that allowing elective surgical patients to drink clear fluids until 2 h before anaesthesia may enhance patient comfort without compromising safety.

Adult↗

Interference from a hand held radiofrequency remote control causing discharge of an implantable defibrillator.

A 46-year-old man with a history of sustained monomorphic ventricular tachycardia underwent an implantation of a third generation multiprogrammable implantable cardioverter defibrillator. One year post implant, while manipulating a remote control to a radiofrequency modulated toy car, the patient experienced a defibrillator discharge not preceded by an arrhythmia prodrome. Subsequent interrogation of the defibrillator revealed that a 34-joule shock had been delivered and had been preceded by RR intervals ranging from 141-406 msec, consistent with sensing lead noise. The remote control utilizes a 12-volt battery and has a carrier frequency of 75.95 MHz and a modulating frequency of 50 Hz. Evaluation of the remote control and defibrillator interaction revealed that the remote control was able to trigger tachyarrhythmia sensing and reproduce the clinical episode. Interference was present only when the remote control was within 8 cm of the pulse generator and at specific angles relative to the device and only when the antenna length was > 45 cm. Interference was eliminated when a ground wire was attached to the antenna and when an aluminium shield was placed between the pulse generator and the remote control. This case report suggests that patients with third generation multiprogrammable defibrillators should be cautioned against close contact with potential sources of electromagnetic interference, such as remote control units.

Artifacts↗