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PubMed1992

Effect of verapamil on human intestinal transit.

Although constipation is a well-known side effect of calcium channel blockers such as verapamil, this side effect has not been evaluated in a quantitative manner. In a double-blind, randomized, crossover trial, the effect of verapamil (240 mg/day) was compared to placebo in 15 normal male volunteers. Subjects recorded their bowel movements and any side effects. Scintigraphy was used to quantitate gastric emptying, small intestinal transit, and colonic transit. In the study period of four days, verapamil did not change the frequency, consistency, or passage of bowel movements. A significantly increased number of side effects was noted during verapamil treatment--notably abdominal pain and dry mouth. The slope of gastric emptying was not significantly different for verapamil (0.012 +/- 0.02) than for placebo (0.013 +/- 0.001). Distal ileum filling was also not different for verapamil (0.41 +/- 0.13%/min) than placebo (0.33 +/- 0.05%/min). Progression of the colonic geometric center was significantly delayed at 48 hr by verapamil (5.2 +/- 0.4 vs 6.2 +/- 0.23; P less than 0.01). This study suggests that the constipating effect of verapamil is due to a delay of colonic transit and not due to an effect on upper gastrointestinal transit.

Adult↗
PubMed1989

Efficacy of gamma-hydroxybutyrate versus placebo in treating narcolepsy-cataplexy: double-blind subjective measures.

The efficacy of gamma-hydroxybutyrate (GHB) versus placebo for treating narcolepsy was evaluated in 20 patients with narcolepsy, 10 men and 10 women, using a double-blind counterbalanced crossover design. Each patient completed a daily sleep-wake log and questionnaire during a 14-day baseline, a 29-day placebo period, a 29-day GHB period (50 mg GHB/kg/night given 25 mg/kg h.s. and 25 mg/kg 3 hr later), and a 6-day washout period after each treatment. Cataplexy frequency was significantly lower during GHB treatment than during placebo treatment (p = 0.022). Compared to baseline values, the number of cataplexy attacks per day declined by 52% and 69% during GHB treatment weeks 1 and 4, respectively. The number of subjective arousals from sleep was less with GHB than with placebo (p = 0.035), and the number of sleep attacks was not significantly different during GHB versus placebo treatment. GHB did not have a significant effect on subjective estimates of sleep onset latency, total sleep time, Stanford Sleepiness Scale ratings at morning wake-up, methylphenidate usage, or the number of naps per day. The results indicate that GHB is efficacious for reducing the frequency of cataplexy attacks and subjective nocturnal arousals in patients with narcolepsy within the first 4 weeks of treatment.

Adolescent↗
PubMed2003

Cationic cellulose hydrogels: kinetics of the cross-linking process and characterization as pH-/ion-sensitive drug delivery systems.

The cross-linking process of two cationic hydroxyethylcelluloses of different hydroxyethyl and ammonium group contents, polyquaternium-4 (PQ-4) and polyquaternium-10 (PQ-10), with ethylenglycol diglycidylether (EGDE) was characterized and optimized through rheometric analysis of the forming network. The influence of NaOH concentration, temperature, and EGDE concentration on the cross-linking rate were studied. The evolution of the elastic (G') and viscous (G") moduli, recorded in time-sweep experiments carried out at a fixed angular frequency, showed that the cross-linker requires a minimum of 0.05 M NaOH and 30 degrees C to be active. The increase in G' and G" followed first order kinetics, the slopes of G' being higher than those corresponding to G". The gel time, i.e. the time at which the crossover of G' and G" occurs, decreases exponentially when temperature increases from 30 to 60 degrees C. Apparent activation energies, estimated from the gel times, ranged between 70 and 90 kJ/mol. The cross-linking rate was greater in PQ-4 than in PQ-10 owing to the initial lower viscosity and higher content in hydroxyethyl groups of the former. However, IR spectra of the final hydrogels suggest the formation of a similar number of cross-linking junctions in both polymer systems. The optimum conditions for hydrogel preparation were 60 degrees C in 0.10 M NaOH medium, and no depolymerization was observed. Such hydrogels were transparent, presented a smooth, continuous surface, and were superabsorbent in water. After drying in an oven, the degree of swelling was lower than that of freshly prepared hydrogels; the behavior of water uptake being Fickian. The hydrogels presented a significant loading capacity of diclofenac sodium, with which they interact through ionic and hydrophobic bonding. The affinity is kept at an acidic pH, preventing drug release. In contrast, at pH 8 the interactions are broken and the release process is sustained for more than 4 h. The results also indicate that the ionic strength as well as the initial pH of the medium, when the release was evaluated switching the pH from acidic to basic, are two critical factors which have to be considered to extract conclusions about the behavior of the hydrogels as site-specific delivery systems under in vivo conditions.

Cations↗
PubMed2002

Effects of prone and supine positions on sleep state and stress responses in mechanically ventilated preterm infants during the first postnatal week.

BACKGROUND/RATIONALE: Preterm infants in mechanical ventilation are vulnerable and may manifest physiological instability and a disorganized behavioural state when responding to external stimuli. Adequate positioning strategies may play an important role in protecting infants from environmental stressor and assisting quality of sleep. However, no study has examined effects of prone and supine positions on behavioural state and stress signs including startle, tremor, and twitch responses for ventilated preterm infants during the critical first week postbirth. AIM OF THE STUDY: The purpose of this study was to compare effects of prone and supine positions on behavioural state and stress responses in mechanically ventilated preterm infants. DESIGN/METHODS: The infants were aged 25-36 weeks of gestation, < or = 7 days of age, and without sedation or congenital abnormalities. Using a crossover design, 28 infants were randomly assigned to supine/prone or prone/supine position sequence. Infants were placed in each position for 2 hours. A stabilization period of 10 minutes before observation of each position was allowed. During the protocol, care procedures were kept minimal and ventilator settings remained unchanged. Behavioural state and frequencies of stress signs including startle, tremor, and twitch were systemically recorded and analysed with repeated measures analysis of variance. FINDINGS: Infants when prone compared with supine had (a) less crying, less active sleep, and more quiet sleep states, and (b) fewer stress responses of startle, tremor, and twitch. CONCLUSION: Results indicate that prone positioning improves the quality of sleep and decreases stress for ventilated preterm infants during the first week postbirth. These may conserve energy and assist infants' extrauterine adaptation.

Cross-Over Studies↗
PubMed1997

Analysis of recombination sites within the maize waxy locus.

Genetic fine structure analysis of the maize wx locus has determined that the ratio of genetic to physical distance within wx was one to two orders of magnitude higher than the average for the maize genome. Similar results have been found at other maize loci. In this study, we examined several mechanisms that could account for this pattern. First, crossovers in two other maize genes resolve preferentially at specific sites. By mapping exchanges between wx-B1 and wx-I relative to a polymorphic SstI site, we found no evidence for such a hotspot at wx. Second, deletion of promoter sequences from wx alleles had little effect on recombination frequencies, in contrast to results in yeast where promoter sequences are important for initiating recombination in some genes. Third, high levels of insertion polymorphism may suppress intergenic recombination. However, the presence of a 2-kb Ds element 470 bp upstream of the wx transcription start site did not further suppress recombination between Ds insertions in nearby wx sequences. Thus, none of these mechanisms is sufficient to explain the difference between intergenic and intragenic recombination rates at wx.

Crossing Over, Genetic↗
PubMed1993

Haplotype analysis to determine the position of a mutation among closely linked DNA markers.

Positional cloning involves first finding linkage between an inherited phenotype (such as a disease) and a DNA marker, followed by the use of a variety of physical and genetic mapping techniques to move from linkage to mutation. If there is a founder effect within a population, crossovers are often rare between the mutation causing the phenotype and closely situated markers and increasing disequilibrium may be observed as the site of the mutation is approached. Standard coefficients of disequilibrium may, however, be insensitive to the relative position of close markers and the mutation, because they depend upon allele frequencies in the normal population compared to those of the founder chromosome. Using cystic fibrosis in European populations as a model system, alternative methods for determining the position of a mutation are discussed. These include haplotype parsimony and three-way interval likelihood analysis. Both methods predict the location of the major CF mutation accurately from a real set of more than 600 European CF chromosomes.

Alleles↗
PubMed2006

Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-nations trial.

AIMS: The goal of the study was to determine whether continuous subcutaneous insulin infusion (CSII) differs from a multiple daily injection (MDI) regimen based on neutral protamine hagedorn (NPH) as basal insulin with respect to glycaemic control and quality of life in people with Type 1 diabetes. METHODS: The 5-Nations trial was a randomized, controlled, crossover trial conducted in 11 European centres. Two hundred and seventy-two patients were treated with CSII or MDI during a 2-month run-in period followed by a 6-month treatment period, respectively. The quality of glycaemic control was assessed by HbA(1c), blood glucose values, and the frequency of hypoglycaemic events. For the evaluation of the quality of life, three different self-report questionnaires have been assessed. RESULTS: CSII treatment resulted in lower HbA(1c) (7.45 vs. 7.67%, P < 0.001), mean blood glucose level (8.6 vs. 9.4 mmol/l, P < 0.001) and less fluctuation in blood glucose levels than MDI (+/- 3.9 vs. +/- 4.3 mmol/l, P < 0.001). There was a marked reduction in the frequency of hypoglycaemic events using CSII compared with MDI, with an incidence ratio of 1.12 [95% confidence interval (CI): 1.08-1.17] and 2.61 (95% CI: 1.59-4.29) for mild and severe hypoglycaemia, respectively. The overall score of the diabetes quality of life questionnaire was higher for CSII (P < 0.001), and an improvement in pump users' perception of mental health was detected when using the SF-12 questionnaire (P < 0.05). CONCLUSION: CSII usage offers significant benefits over NPH-based MDI for individuals with Type 1 diabetes, with improvement in all significant metabolic parameters as well as in patients' quality of life. Additional studies are needed to compare CSII with glargine- and detemir-based MDI.

Adult↗
PubMed1991

Overview of the clinical efficacy of lamotrigine.

Testing the efficacy of lamotrigine (LTG) in epileptic patients has been approached in several ways. The first pilot study examined the effect of a single dose of LTG in patients with frequent interictal spikes, and a reduction in spike frequency was observed. Subsequently, single doses reduced photosensitivity in appropriate patients. Single-blind administration of LTG for 1 week in addition to the patients' regular antiepileptic drugs (AEDs), in patients with refractory seizures, reduced seizures despite the short duration of therapy. This regimen was continued using a placebo-controlled crossover study with 1-week duration of treatment. Efficacy in partial and tonic-clonic seizures was subsequently confirmed in four double-blind crossover studies; a meta-analysis of these four studies showed a 30% reduction in partial seizures despite the intractable nature of the seizures in the patients included. Current studies aim at evaluating the drug as monotherapy and in different seizure types.

Anticonvulsants↗
PubMed1993

Quinine sulfate for leg cramps: does it work?

OBJECTIVE: To study the efficacy of quinine in the prevention of nocturnal leg muscle cramps. DESIGN: Double-blind, randomized, crossover trial with four periods of observation, each lasting 2 weeks. SETTING: General internal medicine outpatient clinic. PARTICIPANTS: Ambulatory outpatients who experienced an estimated two or more typical nocturnal leg cramps per week. INTERVENTION: 200 mg of quinine taken at bedtime. MAIN OUTCOME MEASURES: Self-reported ratings of leg cramp frequency, duration, and intensity. RESULTS: Sixteen patients completed the trial. During the 2 weeks patients used quinine, there was no statistically significant reduction in mean leg cramp number (quinine 3.5 vs placebo 4.2, P = 0.48), mean leg cramp duration (quinine 152 seconds vs placebo 163 seconds, P = 0.89), or patient ratings of severity using a 1 (low) to 10 (high) scale (quinine = 4.2 vs placebo = 4.0, P = 0.83). CONCLUSION: No significant reduction in nocturnal leg cramp frequency, intensity, or duration could be found using nightly quinine in this study. Since quinine is not without the potential for side effects and drug interactions, clinicians need to carefully consider the likelihood of modest benefit associated with quinine against the potential for side effects and drug-drug interactions.

Adult↗
PubMed1999

Electrostatic deflections and electromechanical resonances of carbon nanotubes

Static and dynamic mechanical deflections were electrically induced in cantilevered, multiwalled carbon nanotubes in a transmission electron microscope. The nanotubes were resonantly excited at the fundamental frequency and higher harmonics as revealed by their deflected contours, which correspond closely to those determined for cantilevered elastic beams. The elastic bending modulus as a function of diameter was found to decrease sharply (from about 1 to 0.1 terapascals) with increasing diameter (from 8 to 40 nanometers), which indicates a crossover from a uniform elastic mode to an elastic mode that involves wavelike distortions in the nanotube. The quality factors of the resonances are on the order of 500. The methods developed here have been applied to a nanobalance for nanoscopic particles and also to a Kelvin probe based on nanotubes.

Journal Article↗
PubMed1997

Pentoxifylline does not alter the response to inhaled grain dust.

Pentoxifylline (PTX) has been shown to reduce sepsis-induced neutrophil sequestration in the lung and inhibit endotoxin-mediated release of tumor necrosis factor-alpha (TNF-alpha). Previously, we have shown that endotoxin appears to be the principal agent in grain dust causing airway inflammation and airflow obstruction following grain dust inhalation. To determine whether PTX affects the physiologic and inflammatory events following acute grain dust inhalation, 10 healthy, nonsmoking subjects with normal airway reactivity were treated with PTX or placebo (PL) followed by corn dust extract (CDE) inhalation (0.08 mL/kg), using a single-blinded, crossover design. Subjects received PTX (1,200 mg/d) or PL for 4 days prior to CDE inhalation and 400 mg PTX or PL on the exposure day. Both respiratory symptoms and declines in FEV1 and FVC occurred following CDE exposure in both groups, but there were no significant differences in the frequency of symptoms or percent declines from baseline in the FEV1 and FVC at any of the time points measured in the study. Elevations in peripheral blood leukocyte and neutrophil concentrations and BAL total cell, neutrophil, TNF-alpha, and interleukin-8 concentrations were measured 4 h following exposure to CDE in both the PTX- and PL-treated subjects, but no significant differences were found between treatment groups. These results suggest that pretreatment with PTX prior to inhalation of CDE, in the doses used in this study, does not alter the acute physiologic or inflammatory events following exposure to inhaled CDE.

Administration, Inhalation↗
PubMed1997

Zopiclone versus diazepam effects on EEG power maps in healthy volunteers.

EEG effects of zopiclone (7.5 mg), a cyclopyrrolone derivative with hypnotic action, were compared with effects of diazepam (10 mg). Multichannel EEG recordings, double-blind crossover trials with placebo, and oral single doses were used in healthy volunteers. Vigilance-controlled EEG before and after zopiclone (and placebo), and before and after diazepam (and placebo) were analyzed into FFT power spectra. Effects were assessed as placebo-referred pre-post-medication power differences in four frequency bands. Overall statistics showed significant (P < 0.007) global differences between medication effects in the delta frequency band (0.5-3.5 Hz). After zopiclone, fronto-central delta increased bilaterally, whereas after diazepam delta decreased over centro-parietal to right temporo-occipital regions. These spatially different brain electric effects show that different neuronal populations must have become active in response to zopiclone and diazepam.

Adult↗
PubMed1995

Construction of lysine-producing strains by gene disruption and replacement in Brevibacterium divaricatum.

Gene disruption and replacement techniques were applied to block the biosynthesis of threonine and methionine and thus to construct genetically stable lysine producers in a glutamate-producing bacteria, Brevibacterium divaricatum. The homoserine dehydrogenase gene (hom), homoserine kinase gene (thrB) and hom-thrB operon were amplified as 1.8, 1.25 and 2.8 kb fragments from B. divaricatum by polymerase chain reaction (PCR) and cloned in an E. coli-coryneform bacteria shuttle vector, pSUMN18. These genes were disrupted by inserting a kanamycin resistant gene (kan) from pUC4-KISS into the structural genes. Integrative plasmids were constructed and transformed into B. divaricatum. Integrative transformants could be obtained only when the integrative plasmids were constructed from the plasmids which had escaped from the restriction barrier of the hosts. The resulting integrative transformants showed kanamycin resistance and contained no plasmids. About 1-10% of the transformants were auxotrophs. By checking the nutritional requirement, it was found that all of these transformants required threonine and/or homoserine as expected. Southern blot analysis confirmed the integrations, and both single and double crossover homologous recombination mechanisms were proposed to explain the integration and replacement. These auxotrophic integrative transformants which were derived from double crossover events accumulated 1-3% lysine in culture broth only when the added threonine was limited. Integrative transformants which were site-specifically inactivated in hom or hom-thrB genes produced more lysine than did those only inactivated at the thrB gene. These transformants were extremely stable, and the reversion frequency was below 10(-9) per generation. It is suggested that this technique will be useful in the construction of stable auxotrophic mutants.

Actinomycetales↗
PubMed1996

[Prevalence of drinkers at risk and associated factors among men attending primary care clinics].

OBJECTIVES: To quantify the prevalence of risk drinkers among men seeking health care, establish consumption patterns and relate them to socio-demographic features and health habits. DESIGN: Crossover study. First phase of an experimental study. SETTING: Four primary care teams in Area 10, Madrid. PATIENTS: Males between 18 and 65 who attended for on-demand medical care. A systematic sample was selected (n = 562). MEASUREMENTS: A questionnaire collecting socio-demographic characteristics, health habits and alcohol consumption (frequency, consumption pattern, intake of Weekly Units of alcohol (WU) and alcohol-related problems). 94.2% replied. 38% were habitual drinkers (drink four or more days a week), while 18.9% were week-end drinkers. Prevalence of drinkers consuming over 21 WU was 24.8%; and over 35 WU, 16.2%. Whether the cut-off point was fixed at 21 or 35 WU. The alcohol taken was related to educational level, physical exercise, smoking and taking other drugs. On average, single people, smokers, other drug-consumers, ex-drinkers and habitual drinkers were those who displayed most problems connected with alcohol consumption. CONCLUSIONS: There is a similar profile of health habits for the groups consuming over 21 WU and 35 WU, which should make preventive care pay attention to both groups of drinkers.

Adolescent↗
PubMed2005

Functional incidental training: a randomized, controlled, crossover trial in Veterans Affairs nursing homes.

OBJECTIVES: To test the effects of a rehabilitative intervention directed at continence, mobility, endurance, and strength (Functional Incidental Training (FIT)) in older patients in Department of Veterans Affairs (VA) nursing homes. DESIGN: Randomized, controlled, crossover trial. SETTING: Four VA nursing homes. PARTICIPANTS: All 528 patients in the nursing homes were screened; 178 were eligible, and 107 were randomized to an immediate intervention group (Group 1; n=52) and a delayed intervention group (Group 2; n=55). INTERVENTION: Trained research staff provided the FIT intervention, which included prompted voiding combined with individualized, functionally oriented endurance and strength-training exercises offered four times per day, 5 days per week, for 8 weeks. Group 1 received the intervention while Group 2 served as a control group; then Group 2 received the intervention while Group 1 crossed over to no intervention. A total of 64 subjects completed the intervention phase of the trial. MEASUREMENTS: Timed measures of walking or wheeling a wheelchair (mobility), sit-to-stand exercises, independence in locomotion and toileting as assessed using the Functional Independence Measure (FIM), one-repetition maximum weight for several measures of upper and lower body strength, frequency of urine and stool incontinence, and appropriate toileting ratios. RESULTS: There was a significant effect of the FIT intervention on virtually all measures of endurance, strength, and urinary incontinence but not on the FIM for locomotion or toileting. The effects of FIT were observed when Group 1 received the intervention and was compared with the control group and when Group 2 crossed over to the intervention. Group 1 deteriorated in all measures during the 8-week crossover period. Within-person comparisons also demonstrated significant effects on all measures in the 64 participants who completed the intervention; 43 (67%) of these participants were "responders" based on maintenance or improvement in at least one measure of endurance, strength, and urinary incontinence. No adverse events related to FIT occurred during the study period. CONCLUSION: FIT improves endurance, strength, and urinary incontinence in older patients residing in VA nursing homes. Translating these positive benefits achieved under research conditions into practice will be challenging because of the implications of the intervention for staff workload and thereby the costs of care.

Activities of Daily Living↗
PubMed1985

Double-blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria.

Fifty patients with chronic idiopathic urticaria were studied to compare responses to treatment with doxepin (10 mg three times a day) and with diphenhydramine (25 mg three times a day). All patients had an evaluation that failed to disclose a cause for their disease. Therapeutic response was assessed according to the suppression of symptoms and symptom diary scores of daily itching and frequency, number, size, and duration of hives. Total clearing of the pruritus and urticarial lesions occurred in 43% of the patients while receiving doxepin and in only 5% while receiving diphenhydramine (p less than 0.001). Partial or total control of the pruritus and hives was noted in 74% of the patients receiving doxepin and in only 10% of those receiving diphenhydramine (p less than 0.001). Doxepin induced markedly less sedation (22%) than diphenhydramine (46%) (p less than 0.05). Dermatopathologic categories included (1) urticaria simplex, (2) lymphocytic urticaria, and (3) leukocytoclastic urticaria. Patients with urticaria simplex had a more favorable response to doxepin than the two other groups.

Adolescent↗
PubMed1999

Meta-analysis of trials comparing beta-blockers, calcium antagonists, and nitrates for stable angina.

CONTEXT: Which drug is most effective as a first-line treatment for stable angina is not known. OBJECTIVE: To compare the relative efficacy and tolerability of treatment with beta-blockers, calcium antagonists, and long-acting nitrates for patients who have stable angina. DATA SOURCES: We identified English-language studies published between 1966 and 1997 by searching the MEDLINE and EMBASE databases and reviewing the bibliographies of identified articles to locate additional relevant studies. STUDY SELECTION: Randomized or crossover studies comparing antianginal drugs from 2 or 3 different classes (beta-blockers, calcium antagonists, and long-acting nitrates) lasting at least 1 week were reviewed. Studies were selected if they reported at least 1 of the following outcomes: cardiac death, myocardial infarction, study withdrawal due to adverse events, angina frequency, nitroglycerin use, or exercise duration. Ninety (63%) of 143 identified studies met the inclusion criteria. DATA EXTRACTION: Two independent reviewers extracted data from selected articles, settling any differences by consensus. Outcome data were extracted a third time by 1 of the investigators. We combined results using odds ratios (ORs) for discrete data and mean differences for continuous data. Studies of calcium antagonists were grouped by duration and type of drug (nifedipine vs nonnifedipine). DATA SYNTHESIS: Rates of cardiac death and myocardial infarction were not significantly different for treatment with beta-blockers vs calcium antagonists (OR, 0.97; 95% confidence interval [CI], 0.67-1.38; P = .79). There were 0.31 (95% CI, 0.00-0.62; P = .05) fewer episodes of angina per week with beta-blockers than with calcium antagonists. beta-Blockers were discontinued because of adverse events less often than were calcium antagonists (OR, 0.72; 95% CI, 0.60-0.86; P<.001). The differences between beta-blockers and calcium antagonists were most striking for nifedipine (OR for adverse events with beta-blockers vs nifedipine, 0.60; 95% CI, 0.47-0.77). Too few trials compared nitrates with calcium antagonists or beta-blockers to draw firm conclusions about relative efficacy. CONCLUSIONS: beta-Blockers provide similar clinical outcomes and are associated with fewer adverse events than calcium antagonists in randomized trials of patients who have stable angina.

Adrenergic beta-Antagonists↗
PubMed1977

Pericentric inversion of chromosome 14 and the risk of partial duplication of 14q (14q31 leads to 14qter).

Cytogenetic analysis after conventional staining and Q-banding demonstrated a pericentric inversion of chromosome 14 in the mother of a child with a mental retardation/multiple congenital abnormality syndrome and an abnormal chromosome 14. The proposita's partial duplication for the distal segment of 14q is apprently the result of crossing over within the inverted segment during meiosis. An attempt is made at assessing the risk that a carrier of the described pericentric inversion faces of having an abnormal child. The estimate of the risk depends on two factors: 1) the probability of a crossover occurring within the inverted segment during meiosis, and 2) the probability of a child with either of the two possible unbalanced recombinant chromosomes being born alive. An explanation is offered as to why some pericentric inversions confer a signifcant risk while others are so benign and occur with such a high frequency that they can be considered normal chromosomal variants, rather than chromosome aberrations.

Abnormalities, Multiple↗