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Biomedical subjects

B Spilker

Publications and source records attributed to B Spilker.

At least 19 recordsLinked to original sources
PubMed1991

Teaching courses in clinical trial research methods.

This article describes nine separate elements that are part of any course: 1) the teachers, 2) the students, 3) expectations and attitudes of the teachers, 4) expectations and attitudes of the students, 5) a strategy of how to achieve the expectations, 6) materials to use, 7) types of presentations, 8) organizing the individual sessions, and 9) time and place for the course and each of its sessions. The relationship of each of these elements to a course on clinical-trial research methods is discussed. Approaches to use for designing an overall curriculum for a school, company, or regulatory authority also are discussed. Sixteen separate courses are identified and briefly described. Several methods to enhance the effectiveness of individual lectures or discussions are mentioned. Potential courses, as well as those currently offered, should be periodically evaluated by all institutions that are involved in the area of clinical-trial research methods.

Clinical Trials as Topic↗
PubMed1984

Validation of the phenomenon of regression of seizure frequency in epilepsy.

A phenomenon known as regression of seizure frequency toward the median was observed in a previous clinical study performed in patients with partial seizures. Regression of seizure frequency is a situation in which patients with a frequency of seizures above the median value for the group during an initial period have a tendency to have frequency of seizures decrease during a subsequent period, and other patients with a lower frequency of seizures during the initial period increase their frequency during a subsequent period. To investigate this further, eight published sets of clinical data obtained in epileptic patients with various seizure types were identified by a literature search. Three separate analyses were conducted for each data set. All three analyses clearly demonstrated that regression to the median was present in the studies evaluated. It was concluded that this phenomenon is a real effect in epilepsy and occurs in patients with a wide variety of seizure types. The implication of this phenomenon for physicians treating epileptic patients is that there is value in establishing pattern of seizure frequency for individual patients. This information can be used in assessing those patients whose seizure frequency has increased. The implications of this phenomenon for designing and evaluating antiepileptic drug studies are also discussed.

Adult↗
PubMed1983

A double-blind crossover study of cinromide versus placebo in epileptic outpatients with partial seizures.

Cinromide was evaluated versus placebo as add-on therapy in a double-blind crossover study in epileptic outpatients with partial seizures at three sites. Four-week base lines were used before, between, and after the two 12-week treatment periods of the crossover. An operational definition was used to classify each partial seizure as Type A, B, or C. Doses of concurrent antiepileptic drugs were adjusted to maintain pretreatment therapeutic plasma levels. Doses of cinromide ranged from 1,200 to 4,800 mg/day, depending on patient response. Seven patients were withdrawn from the study because of adverse experiences (two receiving placebo and five receiving cinromide). Twenty-eight patients completed the entire 36-week study. A decrease in the average frequency of seizures/week was observed in 12 patients receiving cinromide and in 16 patients receiving placebo. The median frequencies with cinromide and placebo were 3.3 and 2.9 seizures/week, respectively (median initial base-line frequency 3.5 seizures/week for all 28 patients). Although patients were randomly assigned to receive either cinromide or placebo first, the median base-line seizure frequency was greater at the start of the first treatment period in the cinromide group (4.3 versus 2.5 seizures/week) and greater at the start of the second treatment period in the placebo group (3.8 versus 1.4). The median seizure frequency in each higher group decreased with treatment, whereas it increased in each of the lower groups. This study did not demonstrate a beneficial effect of cinromide over placebo for Type A, B, or C partial seizures. The data suggested the presence of an oscillation of seizure frequency in our population of epileptic patients having partial seizures, as well as a placebo effect. No significant carry-over effects were observed. Cinromide has previously been shown to have significant antiepileptic activity in various animal models of epilepsy. The lack of an antiepileptic response to cinromide in humans may have been due to factors other than species differences but indicates that a positive results of a drug in animal models is not the sole factor necessary to predict beneficial antiepileptic activity in humans.

Adolescent↗
PubMed1983

Practical considerations in planning and conducting clinical trials with investigational or marketed drugs.

A system is presented to increase efficiency in planning, initiating, conducting, and analyzing the results of a clinical trial. The procedures to be used are designed to assist clinical investigators of sponsored or unsponsored studies, as well as drug corporations and other sponsors of drug studies. The series of checklists and steps to follow may be easily modified for individual trials. The procedures and steps to be implemented are described in terms of the following nine categories: Interview and Selection of Investigator(s); Clinical Study Initiation: I. Internal Documents and Procedures; Clinical Study Initiation: II. Information for the Investigator to Send to the Sponsor; Clinical Study Initiation: III. Information for the Sponsor to Send to the Investigator; Prestudy Roundtable Meeting; Conducting the Clinical Study; Monitoring and Troubleshooting a Study; Clinical Study Termination; and Clinical Study Data Entry and Analysis.

Clinical Trials as Topic↗
PubMed1978

Medication records.

Explore the source record for details and available documents.

Drug Interactions↗
PubMed1976

On the question of tachyphylaxis to isoproterenol in guinea pigs.

Isoproterenol (4 mug/kg, i.m.) decreased mortality of conscious guinea pigs to histamine, when histamine was injected 8 min after a single dose. But, when guinea pigs were injected with isoproterenol or saline every 20 min for 5 hr, followed by a histamine challenge 8 (or 120) min later, there was no difference in mortality between the two groups. This failure of repeated doses of isoproterenol to protect guinea pigs (from effects of histamine) may be related to its cardiovascular effects, since control blood pressure decreased significantly more in the isoproterenol group than in the saline group. This hypothesis was supported by the observation that histamine-induced mortality was significantly increased in guinea pigs treated with a vasodilator (minoxidil), whose blood pressure decreased to the same level (54 +/- 5 mm Hg) as that observed after repeated doses of isoproterenol. Tachyphylaxis to heart rate or blood pressure responses of isoproterenol was not observed. 10 repeated additions of isoproterenol to spontaneously beating atria or tracheal strips did not show any tachyphylaxis, nor did 15-20 additions of isoproterenol to perfused lungs.

Animals↗
PubMed1975

Cardiovascular effects and blood concentrations of ajmaline and its 17-monochloroacetate ester in cats.

The antiarrhythmic drugs ajmaline and its 17-monochloroacetate ester (MCAA; Rtimos-Elle) were studied in cats. MCAA was less than half as toxic as ajmaline. Non-lethal doses of MCAA decreased blood pressure before heart rate, whereas ajmaline initially decreased heart rate. Both drugs prolonged the PR, QRS and QT intervals of the EKG. Recovery of these effects was within one hr. MCAA (10 mg/kg) and ajmaline (4.05 mg/kg) were studied separately by a one and 10 min infusion in the same cat. The dose of MCAA was ten times the usual dose in man and that of ajmaline four times the usual clinical dose. More marked effects were observed with the one min infusion. Arrhythmias were usually observed with ajmaline, but not with MCAA, even though it was rapidly converted to ajmaline. Maximal cardiovascular effects of MCAA and ajmaline were observed within 3 min of the end of infusion, which was also the time of peak blood levels. The elimination of MCAA resembled the kinetics of a multi-compartment system after a one min infusion. Peak blood levels declined by one-half in 3 min. Ajmaline blood levels declined linearly, with a half-life of 100 min, after a one min infusion. The peak blood level of MCAA after an intraduodenal dose of 25 mg/kg occurred at 20 min, whereas the peak blood level of the ajmaline formed occurred at 4 hr. In conclusion, MCAA has some different pharmacological properties and different kinetics of elimination than ajmaline.

Acetates↗
PubMed1975

Comparison of animal models for predicting bronchodilator efficacy in man.

In vitro and in vivo models of bronchodilation were compared to assess their relative usefulness for predicting clinical efficacy. Drugs studied were isoproterenol, isoetharine, salbutamol, hexoprenaline, terbutaline, ephedrine and aminophylline. In vitro preparations were guinea pig perfused lung, tracheal strip and spontaneously beating right atria. In vivo, drugs were compared by three routes in conscious guinea pigs and anesthetized dogs and relative potency estimates and separations of bronchodilator and heart rate effects of these agents were determined. The Spearman rank correlation coefficient was statistically significant when the effects of the drugs were compared for guinea pig perfused lung and tracheal responses, in vivo guinea pig and dog intravenous and oral (or intraduodenal) responses. Aerosol results did not correlate, most likely due to differences in experimental techniques. Relative potency estimates were in general agreement with human data in the literature and support the use of these tests for the study of bronchodilator agents.

Administration, Oral↗
PubMed1975

The role of bronchoconstrictors in evaluating smooth muscle relaxant activity.

Several bronchoconstrictor and smooth muscle relaxant agents were studied in a dog preparation (in vivo) and on guinea pig tracheal strips (in vitro). Isoproterenol, isoetharine and N-t-butylnorepinephrine, individually, had similar dose-response curves and ED50 values when tested as antagonists of histamine and carbamylcholine-induced bronchoconstriction in dogs. Diphenhydramine, cyproheptadine, thenyldiamine, atropine and suloxifen each exhibited more selective antagonism. A ratio of anticholinergic and antihistamine ED50s was obtained in dogs and on guinea pig tracheal strips. The rank order correlation coefficient of this ratio for each drug in the two species (rs = 0.93) was highly significant. Dose-responses to smooth muscle relaxant effects of isoproterenol were obtained with several different constrictors and experimental conditions on guinea pig tracheal strips. The choice of a constrictor and experimental conditions was found to affect EC50 values. The influence of resting tension, temperature, season, dibenamine-pretreatment and manner of performing the dose-response was evaluated. Both Ba and carbamylcholine were found to be suitable constricting agents under various conditions, whereas histamine, serotonin, potassium and rubidium had more limitations and eight other inorganic ions were not suitable.

Aerosols↗