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PubMed2002

Using the CABLES model to assess and minimize risk in research: control group hazards.

CABLES is both an acronym and metaphor for conceptualizing research participation risk by considering 6 distinct domains in which risks of harm to research participants may exist: cognitive, affective, biological, legal, economic, and social/cultural. These domains are described and illustrated, along with suggestions for minimizing or eliminating the potential hazards to human participants in biomedical and behavioral science research. Adoption of a thoughtful ethical analysis addressing all 6 CABLES strands in designing research provides a strong protective step toward safeguarding and promoting the well-being of study participants.

Behavioral Research↗
PubMed2004

An evaluation of maternal illnesses in the origin of neural-tube defects.

OBJECTIVE: The objective of the study was to estimate risk of acute and chronic maternal diseases during pregnancy in the origin of neural-tube defects. MATERIALS AND METHODS: Mothers with neural-tube defect fetuses/newborns (the NTD group), controls without any congenital defects (the normal control group) and controls with other defects (the other CA control group) were compared in the population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996. Of 1,202 cases with neural tube defects, 559 (49.8%) and 229 (19.1%) had mothers with one or more acute and chronic diseases, respectively. Of 38,151 mothers in the normal control group 14,004 (36.7%) and 8,328 (21.8%) had mothers with one or more acute or chronic diseases, respectively. Of 22,475 mothers in the other CA control group, 8,999 (40.0%) and 3,793 (16.9%) were affected with one or more acute or chronic maternal diseases, respectively. The prevalence of these diseases was evaluated in the 2nd months of gestation, however, if diseases occurred in the 1st month and continued in the 2nd month were also included. RESULTS: There was a potential recall bias between the NTD group and the normal control group, but not between the NTD group and the other CA control group. CONCLUSIONS: We suggest that maternal fever is a possible cause of neural-tube defects. Thus, these fevers should be treated with antipyretics during pregnancy. Among chronic maternal diseases, the possible association of migraine-headache, on the one hand and neural tube defects (particularly anencephaly) on the other hand cannot be excluded.

Acute Disease↗
PubMed1986

Control groups in routine evaluations of outcomes of alcoholism treatment.

The use of no treatment or waiting list controls for the time span of both treatment and follow-up of one year or longer involves ethical and methodological problems such as sample attrition; however, shorter follow-ups would lead to overestimates of long-term outcomes. Other comparison groups such as nonspecific treatment controls do not provide an estimate of what would happen to the clients without treatment and what their recovery chances would be in other treatment centers. Therefore, as an alternative to traditional design for outcome rate evaluations, the present paper suggests comparisons to pooled data from follow-ups of treated alcoholics. Until methodologically more acceptable pooled data is available, the data on untreated alcoholics pooled and re-analyzed by Emrick and the data on treated alcoholics presented by Gillies, Laverty, Smart, and Aharan could provide a temporary interpretational background. The most serious drawback of the two criterion samples is insufficient description of basic characteristics of the clients (e.g., in respect to age, education, sex, occupation, and to personality measures). More detailed descriptions in most future evaluation studies would make it possible to create better described criterion samples by pooling the data. This would also allow further analyses of the relationship of client characteristics to outcomes and, thus, would allow for special credit to outcomes with difficult clientele.

Alcoholism↗
PubMed2005

Quantitative gait analysis in Parkinson's disease: comparison with a healthy control group.

OBJECTIVE: To compare gait parameters in Parkinson's disease (PD) during the on-phase of medication cycle with those of healthy elderly control subjects. DESIGN: A group-comparison study. SETTING: Gait analysis laboratory of a university hospital. PARTICIPANTS: Fifteen patients with PD and 9 healthy elderly controls. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Spatiotemporal, kinematic, and kinetic gait parameters. RESULTS: The PD spatiotemporal results showed a significant reduction in step length and walking velocity compared with controls. In the kinematics, the major feature of the PD group was a markedly reduced ankle plantarflexion excursion (at 50%-60% of the gait cycle). Most important, the kinetics showed reduced ankle push-off power and hip pull-off power. Unlike the control subjects, the patients with PD did not show any correlation between ankle generation (push-off) power and stride length ( r =.19) or with gait speed ( r =.29). Correction for walking velocity did not result in significant changes in the kinetics between the groups. CONCLUSIONS: Reduced ankle (push-off) power generation and reduced hip flexion (pull-off) power persisted in PD gait despite being tested in the on-phase of the medication cycle. Lack of a correlation between ankle and hip power generation and walking velocity suggests that peripheral and central factors contribute to lack of forward progression. Patients with PD may benefit from intervention strategies that correct the kinematic and the kinetic gait components.

Aged↗
PubMed2005

The Calgary Depression Rating Scale for schizophrenia in a healthy control group: psychometric properties and reference values.

BACKGROUND: Assessment of depression in schizophrenia is of great importance as depressive signs and symptoms and suicidality are highly prevalent in patients with schizophrenic disorders. The Calgary Depression Rating Scale (CDSS) is the standard assessment instrument for that purpose due to its proven reliability and validity. However, so far no reference values derived from an adequate healthy sample have been published. METHODS: The present study analyzed CDSS item scores and summary scores in 154 healthy subjects (49% female, mean age 32.8+/-11.7 years) selected from studies as controls for schizophrenic patients. RESULTS: The total CDSS score was 2.6+/-2.7 (range 0-12), about 1/3 of healthy subjects had scores=0. Gender differences were observed with respect to "early awakening" and "suicidal ideation" with higher scores in females. Total CDSS scores (r=-0.17, P=0.03) and single items were slightly negatively correlated with age. The psychometric properties of the CDSS scale were satisfying (corrected item-score correlations r(tc)=0.33-0.61, internal consistency Cronbach's alpha=0.76, one-dimensional factor structure). CDSS total scores showed a skewed distribution fitting the upper part of a normal distribution. Based on the empirical distribution of CDSS values, reference values were listed for the total group of healthy subjects, and for females and males separately. CONCLUSIONS: The results corroborate the favourable psychometric properties of the CDSS found previously in clinical samples in a healthy control group. The reference values reported here can assist the clinical use and interpretation of CDSS values and emphasize the usefulness of the CDSS for a thorough assessment of depression and suicidality in schizophrenia.

Adult↗
PubMed2006

Vibrotactile sense in patients with different upper limb disorders compared with a control group.

BACKGROUND: Upper limb disorders (ULDs) are common, and so are the difficulties with regard to their specific diagnoses. According to diagnostic consensus criteria, specific diagnoses include neuropathy and muscular- and connective-tissue disorders (MCDs). There is a need for valid objective diagnostic tools to reveal underlying mechanisms for specific diagnoses. OBJECTIVE: To investigate the possible differences in vibration perception threshold (VPT) and tolerance to suprathreshold stimulation (STS) between controls and specific diagnostic ULD patient groups with uni- and bilateral neuropathy and/or MCD. METHODS: In 161 ULD patients and 40 controls, the VPT of the median, ulnar, and radial nerves innervating the hand was examined by vibrometry using the "method of limits". The tolerance to STS of the anterior forearm was tested in 128 of the patients and all controls. RESULTS: The ULD patients in all diagnostic groups had significantly higher VPT (P<0.05) in all the nerves in limbs, with and without diagnoses compared with controls. Only patient groups defined with neuropathy demonstrated significantly higher VPT in the limb with diagnoses compared with the contralateral limb without diagnoses. The highest VPTs were found in the patient group with unilateral neuropathy and MCD, and for the radial nerve, VPT was significantly higher than that for patients with unilateral MCD alone. These findings were confirmed by almost similar findings in STS responses. CONCLUSIONS: The ULD patients generally demonstrated increased VPT compared with controls, indicating a neurogenous component independent of specific ULD diagnosis. Contralateral significant findings in limbs without diagnoses compared with controls indicate central neurogenous affection and/or the possibility of certain exposures elevating VPT before a positive status of a limb diagnosis is attained. Significantly higher VPT values in limbs with neuropathy diagnoses compared with limbs without and not in MCD alone, may indicate peripheral sensibilization or nerve affection only in the group with a specific diagnosis of neuropathy. These findings underline the importance of specific diagnoses among ULD patients.

Adolescent↗
PubMed2005

[Effect of ileocecum interposition graft as pylorus replacement on glycometabolism].

OBJECTIVE: To evaluate the application of ileocecum interposition (ii) graft as pylorus replacement in alimentary reconstruction. METHODS: Twenty- one minipigs were randomly divided into three groups: sham operation group (control group), B - i group and ii group. The levels of blood glucose were measured by quick blood glucose testing of paper at 0, 30, 60, 90, and 120 minutes of oral glucose after 60 and 120 post- operative days to compare gastric emptying of liquid feeds. RESULTS: Two months after operation,the peak of blood glucose was (7.8+/- 1.0)mmol/ L, (7.1+/- 0.8)mmol/ L, (4.1+/- 0.4)mmol/ L in B - i, ii group and control group respectively, there were significant differences between the two operation groups and control group (P< 0.01). Four months after operation, the peak of blood glucose was (6.9+/- 1.0) mmol/ L, (5.2+/- 0.8)mmol/ L, (4.2+/- 0.5)mmol/ L, respectively, there was no significant difference between ii group and control group (P > 0.05),but there were significant differences between both of the above two groups and B - i group (P< 0.01). CONCLUSION: The ileocecum interposition graft can offer specific advantages over current reconstruction procedures.

Animals↗
PubMed2006

[Inhibitory effect of bcl-2 antisense oligodeoxynucleotides on growth of human lung carcinoma xenograft in nude mice].

BACKGROUND & OBJECTIVE: Antisense oligodeoxynucleotides (ASODN) targeting bcl-2 have in vitro and in vivo antitumor activities. We have identified a novel antisense sequence in the coding region of bcl-2 mRNA that could enhance chemosensitivity and radiosensitivity of leukemia cells and lung carcinoma cells. This study was designed to investigate inhibitory effects of bcl-2 ASODN on development and growth ability of human lung carcinoma NCI-H460 cells xenograft in nude mice. METHODS: bcl-2 ASODN was added to NCI-H460 cells. Inhibitory rate of cell growth was assayed by MTT assay. bcl-2 ASODN-treated NCI-H460 cells were implanted subcutaneously into nude mice to observe tumor growth and calculate tumor inhibitory rate. Seven days after subcutaneous implantation of untreated NCI-H460 cells, the tumor-bearing mice were randomized into 3 groups: control group, ASODN group, and nonsense oligodeoxynucleotides (NSODN) group. bcl-2 ASODN, bcl-2 NSODN, and saline were separately injected into the tumor bodies of mice in relevant groups for 3 week. The tumor weight and volume were measured, and the morphology of tumor cells was observed under microscope. RESULTS: bcl-2 ASODN reduced the growth of NCI-H460 cells in a time-dependent manner. Inhibitory rate of NCI-H460 cells was significantly higher in bcl-2 ASODN group than in bcl-2 NSODN group (P<0.05). The tumorigenic ability of NCI-H460 cells was reduced by bcl-2 ASODN, with the maximum tumor growth inhibitory rate of 87.5% (P<0.01). The tumor formation time was prolonged to 12.6 days. Tumor growth was significantly inhibited in bcl-2 ASODN group as compared with that in NSODN group and control group(P<0.01). The tumor weight was significantly lighter in bcl-2 ASODN group than in bcl-2 NSODN group and control group (P<0.01). The growth inhibitory rate was 71.0% in bcl-2 ASODN group. Serious necrosis foci and inflammatory cell infiltration were observed in tumor tissues of bcl-2 ASODN group, while cancer cells were diffused in tumor tissues of bcl-2 NSODN group and control group. CONCLUSION: bcl-2 ASODN can suppress tumorigenic ability of NCI-H460 cells and inhibit tumor growth in nude mice.

Animals↗
PubMed2006

[Specific inhibition of HER-2 expression in ovarian carcinoma cells by siRNA targeting HER-2].

OBJECTIVE: To investigate the effects of RNA interference (RNAi) targeting HER-2 gene on the biological traits of human ovarian carcinoma. METHODS: siRNA specific to HER-2 gene was synthesized according to the sequence in the GenBank. Human ovarian carcinoma cells of the line SKOV-3 were cultured and divided into 3 groups: control group; non-specific group, transfected with non-specific siRNA; and specific group, transfected with specific HER-2 siRNA. On the 5th day after transfection cisplatin was added into the culture fluid. The expression of HER-2 mRNA and the expression of protein both before and after transfection were detected by RT-PCR and Western blotting. The cell apoptosis was assessed by flow cytometry. The chemosensitivity of transfected cells to cisplatin was determined by MTT method. RESULTS: Since the 3rd day after transfection the expression of HER-2 mRNA of the HER-2 siRNA group was suppressed till 10 days later. On the 7th day after transfection the expression rate of HER-2 protein of the HER-2 siRNA group was (25.5 +/- 0.8)%, significantly lower than those of the nonspecific siRNA group and control group, (95.7 +/- 0.8)% and (96.6 +/- 1.2)% respectively (both P < 0.001). On the 9th day after transfection no expression of HER-2 protein was found in the HER-2 siRNA group. The apoptosis rate of SKOV-3 cells increased time-dependently after transfection in the HER-2 siRNA group and reached the peak, (53.2 +/- 1.0)% on the 6th day, significantly higher than those of the non-specific siRNA group and control group, (4.1 +/- 0.3)% and (4.1 +/- 0.3)% respectively (both P < 0.001). After exposure to cisplatin for 24 hours, the survival rate of the HER-2 siRNA group was (58.4 +/- 0.8)%, significantly higher than those of the nonspecific siRNA group and control group, (68.0 +/- 0.6)% and (67.0 +/- 0.3)% respectively (both P < 0.001). CONCLUSION: siRNA targeting HER-2 synthesized in vitro and transfected into human ovarian carcinoma cells effectively suppresses the HER-2 expression, induces cell apoptosis, and increases the sensitivity to cisplatin of the cells. The successful application of HER-2 siRNA extends the list of available therapeutic modalities in the treatment of human ovarian cancer.

Antineoplastic Agents↗
PubMed1996

Thiol group control of sodium-lithium countertransport kinetics in uraemia: evidence of a membrane abnormality affected by haemodialysis.

Uraemia affects erythrocyte metabolism and membrane function but no consistent effect on Na/Li countertransport (CT) has been reported. We report only small differences in Na/Li CT at 150 mmol/l Na over haemodialysis, but major differences in other properties of Na/Li CT. The Km for external sodium and Vmax both increased during haemodialysis but the Vmax/Km ratio, which was greater than normal, was not affected. The thiol reagent, N-ethylmaleimide (NEM), which causes a decrease in Km and Vmax in normal subjects, had no effect on Km in the predialysis erythrocytes. After haemodialysis, the sensitivity of Na/Li CT to NEM was improved. The changes in Na/Li CT kinetics were not related to changes in membrane lipid fluidity or plasma lipids. These observations suggest that uraemia affects a thiol group that controls Na/Li CT kinetics and that haemodialysis temporarily improves this aspect of membrane function.

Aged↗
PubMed1985

Neoplasms observed in untreated and corn oil gavage control groups of F344/N rats and (C57BL/6N X C3H/HeN)F1 (B6C3F1) mice.

Control data on F344/N rats and (C57BL/6N X C3H/HeN)F1 (B6C3F1) mammary tumor virus-free mice from the National Toxicology Program (NTP) were examined to determine if animals receiving corn oil by gavage showed tumor incidences that differed from those of untreated control animals. Analyses of these data were adjusted for interlaboratory variability, time-related trends, and supplier effects. Two biologically significant effects were found: Male F344/N control rats receiving corn oil by gavage showed a higher (P less than .05) incidence of pancreatic acinar cell adenoma and a lower (P less than .001) incidence of leukemia (primarily mononuclear cell leukemia) than did the corresponding untreated controls. The increased incidences of pancreatic acinar cell adenoma seen in male rats administered corn oil by gavage were associated with elevated body weights observed in these animals relative to untreated controls. Female F344 rats and male and female B6C3F1 mice showed little or no evidence of a difference in tumor incidence between corn oil gavage-treated and untreated controls. A review of nearly 300 carcinogenesis studies done by the National Cancer Institute (NCI) and the NTP revealed that there were no corn oil gavage studies in which increased incidences of pancreatic acinar cell tumors or leukemia in male F344/N rats were the sole evidence of the carcinogenicity of a test chemical. Thus use of corn oil appears to have little impact on the interpretation of NCI-NTP carcinogenicity studies.

Animals↗
PubMed1993

Weight gain among juvenile rhesus macaques: a comparison of enriched and control groups.

Environmental enrichment techniques for captive primates are aimed at improving their psychological well-being. While behavioral variables are used to measure changes in psychological well-being, physiologic measures (e.g., heart rate, cortisol response) are sometimes gathered in addition to the behavioral evidence. Some of these physiologic indices measure acute changes in the animals' well-being, limiting their usefulness. Body weight, however, is a measure of physical well-being that may have meaning as a long-term indicator of psychological well-being. We therefore collected body weight data from two groups of rhesus macaques (Macaca mulatta group 1: n = 34, group 2: n = 30) every 8 weeks beginning at the age of 1 year, as they passed through various housing conditions as part of a program to develop a specific pathogen-free breeding colony. One-half of the subjects in each group received a variety of environmental enhancements during all housing conditions; the other half received no enrichment and served as controls. At the beginning of the study (age 1 year), control and enriched subjects did not differ in body weight. Among group-1 subjects, enriched animals weighed significantly more than controls after 4 months of enrichment, and the weight difference was maintained 24 months later. Enriched animals in group 2 never differed in weight from their controls. The order in which different types of enrichment were presented and the extra-cage environment of the two groups differed, which may account for this discrepancy.(ABSTRACT TRUNCATED AT 250 WORDS)

Animal Husbandry↗
PubMed1977

Serum levels and urinary concentrations of kanamicin, bekanamicin and amikacin (BB-K8) in diabetic children and a control group.

Serum levels of kanamicin, bekanamicin, and amikacin were studied, after a single intramuscular dose of each antibiotic, in three groups of diabetic children, with their respective normal controls, paired by age, weight and sex. Lower serum levels were observed with kanamicin and bekanamicin in diabetic children compared to their controls. The difference in low serum levels was less noticeable with amikacin.

Adolescent↗
PubMed2005

Evaluation of a cognitive-behavioral, group, randomized controlled intervention trial to prevent sexually transmitted infections and unintended pregnancies in young women.

BACKGROUND: Few cognitive-behavioral interventions have focused on preventing sexually transmitted infections (STIs) and unintended pregnancies (UPs) in young, sexually active women in a single study. Military recruit training provides a well-defined, national, nonclinic sample in which to evaluate such an intervention. METHODS: All female Marine recruits (N=2,288) in training were approached. Of these, 2,157 (94.3%) voluntarily agreed and were randomly assigned, by platoons, to participate in cognitive-behavioral interventions to prevent STIs or UPs or to prevent physical training injuries and cancer. Participants completed self-administered questionnaires and were screened for pregnancy, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis at baseline and, on average, 1 and 14 months postintervention. RESULTS: A higher proportion of the control group had a postintervention STI or UP [odds ratio (OR)=1.41, 95% confidence interval (CI)=1.01-1.98]. Among participants who had no history of STIs or pregnancy, but who engaged in risky sexual behaviors just before recruit training, the control group was more likely to acquire a postintervention STI (OR=3.24, CI=1.74-6.03). Among participants who were not sexually experienced at baseline, the control group was more likely to have casual (OR=2.05, 95% CI=1.04-4.08) and multiple (OR=1.87, 95% CI=1.01-3.47) sexual partners postintervention. CONCLUSIONS: This randomized controlled trial indicates that cognitive-behavioral interventions are effective for reducing behavioral risk and preventing STIs and UPs in young, sexually active women who are not seeking health care.

Adult↗
PubMed2006

Effect of PA-MSHA vaccine on plasma phospholipids metabolic profiling and the ratio of Th2/Th1 cells within immune organ of mouse IgA nephropathy.

Phospholipids as a class of important constituents in the biomembranes have been paid increasing attention in many fields. IgA nephropathy is now generally known to be the most common form of primary glomerulonephritis in the world. However, phospholipids metabolism in IgA nephropathy was not clear. Until recently, there was no effective treatment available for patients with IgA nephropathy. In this paper, effect of PA-MSHA vaccine on plasma phospholipid metabolic profile of mouse IgA nephropathy was investigated using high performance liquid chromatography/mass spectrometry (HPLC/MS) and principal components analysis (PCA). Female Balb/c mice were divided into four groups: model group, control group, PA-MSHA treatment group and medicine control group (dipyridamole+common threewingnut root). The experimental IgA nephropathy model was established by the immunity combination method of oral BSA and injection of SEB. It was found that combination of LC/MS technology with PCA can be successfully applied to phospholipids profile analysis, clearly classify the model group and normal group, and PA-MSHA treatment group is closer to the normal control group than medicine control group. The result showed that Th(2)/Th(1) (=CD(4)(+)CD(30)(+)/CD(4)(+)CD(30)(-)) of the model group is 20.70+/-3.57, which is significantly higher than that of the control group (1.34+/-0.14) (P<0.001). The Th(2)/Th(1) ratio of the PA-MSHA treatment group and the medicine control group are lower than that of the model group (P<0.01). It is suggested that mouse IgA nephropathy has the phospholipids metabolic abnormality, PA-MSHA vaccine cannot only regulate the abnormal phospholipids metabolism mouse with the IgA nephropathy, but also correct the over unbalance of Th(2)/Th(1) proportion.

Animals↗