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Biomedical subjects

Shou-En Lu

Publications and source records attributed to Shou-En Lu.

At least 19 recordsLinked to original sources
PubMed2026

Enhancing Self Care Among Oral Cancer Survivors Using a Digital Approach: The Empowered Survivor Trial.

BACKGROUND: Oral and oropharyngeal cancer survivors experience debilitating physical and psychosocial challenges. Little knowledge exists on the efficacy of interventions to enhance self-efficacy in managing these challenges, increase survivorship preparedness, and improve health-related quality of life (HRQoL). METHODS: Individuals (n&#xa0;=&#xa0;643) diagnosed with oral or oropharyngeal cancer diagnosed within past 3&#xa0;years were randomized to a digital intervention, Empowered Survivor (ES) or a Generic Online Intervention (GO). Primary (self-efficacy, preparedness, HRQoL) and secondary outcomes (self-care activities) were measured at Baseline, 2-months, and 6-months. RESULTS: Participants assigned to ES reported greater self-efficacy and increased self-care activities of oral self-exams, swallowing, and mobility exercises than those assigned to GO (self-efficacy: 2&#xa0;months, p&#xa0;=&#xa0;0.003, 6-months, p&#xa0;<&#xa0;0.001; self-care activities). CONCLUSIONS: The ES enhanced self-efficacy and increased self-care activities. Further examinations of survivorship preparedness and HRQoL in oral and oropharyngeal cancer are warranted. TRIAL REGISTRATION: Registered on clinicaltrials. gov as NCT04713449.

Humans↗
PubMed2006

Effects of 12-O-tetradecanoylphorbol-13-acetate (TPA) in combination with paclitaxel (Taxol) on prostate Cancer LNCaP cells cultured in vitro or grown as xenograft tumors in immunodeficient mice.

PURPOSE: To investigate the effects of 12-O-tetradecanoylphorbol-13-acetate (TPA) in combination with paclitaxel (Taxol) on prostate cancer cells cultured in vitro or grown as tumors in immunodeficient mice. EXPERIMENTAL DESIGN: Human prostate cancer LNCaP cells in culture were treated with TPA alone or in combination with paclitaxel. NCr immunodeficient mice with well-established LNCaP tumors received i.p. injections with vehicle or with TPA, paclitaxel, or TPA in combination with paclitaxel. The animals either received daily treatment for 5 consecutive days followed by a 2-day intermission, which was repeated for a total of 28 days (experiment 1), or continuous daily treatment for 28 days (experiment 2). RESULTS: Treatment of LNCaP cells with a combination of TPA and paclitaxel synergistically inhibited the growth and induced apoptosis in cultured LNCaP cells, and this treatment also induced a marked increase in phosphorylated c-Jun-NH2-kinase (JNK). In animal experiments, tumor growth occurred in all mice treated with vehicle. When treated with TPA alone, the percentage of animals with some tumor regression was 33% in experiment 1 and 100% in experiment 2. Treatment of animals with paclitaxel alone caused some tumor regression in 17% and 57% of the animals in experiments 1 and 2, respectively. All animals treated with TPA + paclitaxel in both experiments had some tumor regression. CONCLUSIONS: TPA and paclitaxel in combination had a stronger inhibitory effect on the growth of LNCaP cells in culture or as xenograft tumors in immunodeficient mice than either agent alone. Clinical trials with TPA alone or in combination with paclitaxel in patients with prostate cancer may be warranted.

Animals↗
PubMed2006

Utility of serological markers in predicting the early occurrence of complications and surgery in pediatric Crohn's disease patients.

BACKGROUND AND OBJECTIVES: Many Crohn's disease (CD) patients develop complications (fistulae and abscesses), and require surgery, often repeatedly and at variable instances. Identifying serological markers that determine their early or repeated manifestation can enable implementing more aggressive preventive strategies. Our objective was to study the ability of serological markers for predicting development of early (first) and recurrent complications or requirement for surgery. METHODS: Serum anti-Saccharomyces cervisiae (ASCA) (IgA & IgG) and perinuclear antineutrophil cytoplasmic antibodies (pANCA) were assayed close to diagnosis in a pediatric cohort of CD patients identified between 1996 and 1998. At diagnosis and follow-up, information was acquired on demographic and clinical features of disease. Relation between ASCA and clinical events was studied using adjusted Cox-proportional hazards modeling. The relative rates of recurrent clinical events according to the marker measures were compared. RESULTS: The mean age (SD) at diagnosis was 11.2 (3.4) yr. Among 139 patients, 35 (25.9%) and 31 (22.3%) acquired one or more CD related surgery or complication, respectively. Time to occurrence of the first complication was lower among patients ASCA+ (IgA or IgG) (hazards ratio (HR) = 2.33; 95% confidence interval (CI) = 0.99-5.50) and among those with higher ASCA-IgA titers (HR = 1.20; 95% CI = 1.08-1.34). The rates of recurrent complications were higher among those positive or with higher ASCA titers. ASCA did not predict time to undergoing surgery independent of complications, and was unrelated to the occurrence of recurrent surgeries. CONCLUSIONS: Our study shows that serum ASCA measured close to diagnosis can determine the occurrence of early complications in pediatric CD. Preventive treatment targeted toward these susceptible patients could potentially modify the disease course.

Adolescent↗
PubMed2006

Case-cohort designs and analysis for clustered failure time data.

Case-cohort design is an efficient and economical design to study risk factors for infrequent disease in a large cohort. It involves the collection of covariate data from all failures ascertained throughout the entire cohort, and from the members of a random subcohort selected at the onset of follow-up. In the literature, the case-cohort design has been extensively studied, but was exclusively considered for univariate failure time data. In this article, we propose case-cohort designs adapted to multivariate failure time data. An estimation procedure with the independence working model approach is used to estimate the regression parameters in the marginal proportional hazards model, where the correlation structure between individuals within a cluster is left unspecified. Statistical properties of the proposed estimators are developed. The performance of the proposed estimators and comparisons of statistical efficiencies are investigated with simulation studies. A data example from the Translating Research into Action for Diabetes (TRIAD) study is used to illustrate the proposed methodology.

Biometry↗
PubMed2006

Heart rate variability biofeedback: effects of age on heart rate variability, baroreflex gain, and asthma.

OBJECTIVES: To present additional analysis of data from a previously published study showing that biofeedback training to increase heart rate variability (HRV) can be an effective component in asthma treatment. HRV and intervention-related changes in HRV are negatively correlated with age. Here we assess the effects of age on biofeedback effects for asthma. DESIGN: Ten sessions of HRV biofeedback were administered to 45 adults with asthma. Medication was prescribed by blinded physicians according to National Heart, Lung, and Blood Institute criteria. Medication needs were reassessed biweekly. RESULTS: Decreases in need for controller medication were independent of age. There were larger acute decreases in forced oscillation frequency dependence in the older group but larger increases in HRV variables in the younger group. Differences between age groups were smaller among subjects trained in pursed-lips abdominal breathing as well as biofeedback, than among those receiving only biofeedback. CONCLUSIONS: Age-related attenuation of biofeedback effects on cardiovascular variability does not diminish the usefulness of the method for treating asthma among older patients. Additional training in pursed-lips abdominal breathing obliterates the effects of age on HRV changes during biofeedback.

Adolescent↗
PubMed2005

Prodrug of proline analogue reduces hypoxic pulmonary hypertension in rats.

A polymeric prodrug of the proline analogue cis-4-hydroxy-l-proline (CHOP), poly(ethylene glycol)-lysine-CHOP or CHOP-PEG, prevents hypoxic pulmonary hypertension in rats by inhibiting collagen accumulation. A more potent prodrug was synthesized by increasing the loading of CHOP on the carrier from 14 to 100%. Pulmonary antihypertensive efficacy and pharmacokinetics are described in the rat hypoxia model. The antihypertensive effect of CHOP-PEG in rats exposed to 10% O2 for 7d showed approximately 2 x 10(2)-fold greater potency than monomeric CHOP. Routes of administration were compared to determine the lowest dose of CHOP-PEG that reduced right ventricular pressure approximately 50% vs. untreated hypoxic controls at 7d. Total doses required were: continuous s.c. via an osmotic minipump, 0.8 mg; single s.c., 10mg; single i.v., 40 mg; and single intratracheal 90 mg. Efficacy for at least 7d postdosing in pre-established pulmonary hypertension was shown. Using an ELISA-based assay, biphasic i.v. and stable s.c. pharmacokinetic profiles were observed 72 h after single injections and 7d after continuous s.c. infusion. Thus, this CHOP-PEG formulation prevents and reverses chronic hypoxic pulmonary hypertension in rats, is most effective when given by continuous s.c. infusion, and has favorable pharmacokinetic properties. Potent inhibitors of fibrosis appear to be promising agents in treating pulmonary hypertension and possibly other fibrosing diseases.

Animals↗
PubMed2005

Follow-up of 89 asymptomatic patients with adrenoleukodystrophy treated with Lorenzo's oil.

OBJECTIVES: To identify asymptomatic boys with X-linked adrenoleukodystrophy who have a normal magnetic resonance image (MRI), and to assess the effect of 4:1 glyceryl trioleate-glyceryl trierucate (Lorenzo's oil) on disease progression. METHOD: Eighty-nine boys (mean +/- SD baseline age, 4.7 +/- 4.1 years; range, 0.2-15 years) were identified by a plasma very long-chain fatty acids assay used to screen at-risk boys. All were treated with Lorenzo's oil and moderate fat restriction. Plasma fatty acids and clinical status were followed for 6.9 +/- 2.7 years. Changes in plasma hexacosanoic acid levels were assessed by measuring the length-adjusted area under the curve, and a proportional hazards model was used to evaluate association with the development of abnormal MRI results and neurological abnormalities. RESULTS: Of the 89 boys, 24% developed MRI abnormalities and 11% developed both neurological and MRI abnormalities. Abnormalities occurred only in the 64 patients who were aged 7 years or younger at the time therapy was started. There was significant association between the development of MRI abnormalities and a plasma hexacosanoic acid increase. (For a 0.1-microg/mL increase in the length-adjusted area under the curve for the hexacosanoic acid level, the hazard ratio for incident MRI abnormalities in the whole group was 1.36; P = .01; 95% confidence interval, 1.07-1.72.) Results for patients aged 7 years or younger were similar (P = .04). CONCLUSIONS: In this single-arm study, hexacosanoic acid reduction by Lorenzo's oil was associated with reduced risk of developing MRI abnormalities. We recommend Lorenzo's oil therapy in asymptomatic boys with X-linked adrenoleukodystophy who have normal brain MRI results.

Adrenoleukodystrophy↗
PubMed2005

Marginal analysis for clustered failure time data.

Clustered failure time data are commonly encountered in biomedical research where the study subjects from the same cluster (e.g., family) share the common genetic and/or environmental factors such that the failure times within the same cluster are correlated. Two approaches that are commonly used to account for the intra-cluster association are frailty models and marginal models. In this paper, we study the marginal proportional hazards model, where the structure of dependence between individuals within a cluster is unspecified. An estimation procedure is developed based on a pseudo-likelihood approach, and a risk set sampling method is proposed for the formulation of the pseudo-likelihood. The asymptotic properties of the proposed estimators are studied, and the related issues regarding the statistical efficiencies are discussed. The performances of the proposed estimator are demonstrated by the simulation studies. A data example from a child vitamin A supplementation trial in Nepal (Nepal Nutrition Intervention Project-Sarlahi, or NNIPS) is used to illustrate this methodology.

Cluster Analysis↗
PubMed2004

Evaluation of cleaning methods applied in home environments after renovation and remodeling activities.

We conducted a cleaning trial in 40 northern New Jersey homes where home renovation and remodeling (R&R) activities were undertaken. Two cleaning protocols were used in the study: a specific method recommended by the US Department of Housing and Urban Development (HUD), in the 1995 "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," using a high-efficiency particulate air (HEPA)-filtered vacuum cleaner and a tri-sodium phosphate solution (TSP); and an alternative method using a household vacuum cleaner and a household detergent. Eligible homes were built before the 1970s with potential lead-based paint and had recent R&R activities without thorough cleaning. The two cleaning protocols were randomly assigned to the participants' homes and followed the HUD-recommended three-step procedure: vacuuming, wet washing, and repeat vacuuming. Wipe sampling was conducted on floor surfaces or windowsills before and after cleaning to evaluate the efficacy. All floor and windowsill data indicated that both methods (TSP/HEPA and non-TSP/non-HEPA) were effective in reducing lead loading on the surfaces (P < 0.001). When cleaning was applied to surfaces with initial lead loading above the clearance standards, the reductions were even greater, above 95% for either cleaning method. The mixed-effect model analysis showed no significant difference between the two methods. Baseline lead loading was found to be associated with lead loading reduction significantly on floors (P < 0.001) and marginally on windowsills (P = 0.077). Such relations were different between the two cleaning methods significantly on floors (P < 0.001) and marginally on windowsills (P = 0.066), with the TSP/HEPA method being favored for higher baseline levels and the non-TSP/non-HEPA method for lower baseline levels. For the 10 homes with lead abatement, almost all post-cleaning lead loadings were below the standards using either cleaning method. Based on our results, we recommend that contractors or homeowners can use a household vacuum cleaner and a household detergent to clean lead-contaminated environments after R&R activities when HUD-recommended equipment is not available.

Air Pollution, Indoor↗
PubMed2004

Utility of serum antibodies in determining clinical course in pediatric Crohn's disease.

BACKGROUND AND AIMS: The utility of serial measurements of anti-Saccharomyces cerevisiae (ASCA) and perinuclear antineutrophil cytoplasmic (p-ANCA) antibodies in Crohn's disease (CD) evolution is unknown. We aimed to study the pattern of antibody change and the prognosis of selected outcomes by baseline (at time of diagnosis) and serial antibody measurements in pediatric CD patients. METHODS: Serum ASCA and p-ANCA antibodies were measured at baseline (n = 154) and repeated during follow-up (n = 61) using standard techniques in a cohort of patients identified at Hôpital Sainte-Justine between 1996 and 1998. Clinical information was abstracted from medical charts. Antibody patterns were examined using mixed modeling techniques. The prognostic ability of antibodies for selected outcomes was evaluated using logistic regression. RESULTS: Fifteen (24.5%), 18 (29.5%), and 11 (18%) patients with serial antibody measurements changed their ASCA-IgA, ASCA-IgG, and p-ANCA status (positivity), respectively. No distinct patterns in the evolution of antibody titers were noted. Baseline ASCA-IgA positivity significantly predicted relapses during disease course (IgA: odds ratio [OR], 2.9; 95% confidence interval [CI], 1.33-6.35). Serial antibody measurements did not predict the occurrence of clinical outcomes. CONCLUSIONS: Baseline serum antibodies were predictive of a more relapsing disease course in pediatric CD. However, the limited variability in the antibodies over time and the inability of serial measurements to predict clinical outcomes may limit their use in the establishment of intervention strategies.

Antibodies, Antineutrophil Cytoplasmic↗
PubMed2004

Sudden infant death syndrome among twin births: United States, 1995-1998.

OBJECTIVES: To compare the incidence and risk factors for sudden infant death syndrome (SIDS) in twin and singleton births and to estimate the concordance of SIDS in twins. STUDY DESIGN: A cohort analysis using the National Center for Health Statistics Linked Birth and Infant Death files (1995-1998). RESULTS: Twins had higher SIDS rate (1.3/1000 live births) compared to singletons (0.7/1000 live births), relative risk: 1.9, 95% confidence interval: 1.68, 2.01. Male and small- for-gestational age infants as well as infants of black, unmarried, and smoking mothers were at increased risk for SIDS in both twins and singletons. Placental abnormalities also were associated with SIDS in singletons and twins, although this association failed to achieve statistical significance in twins. There is a higher rate of SIDS in the second twin after a first twin SIDS. CONCLUSIONS: Twins are at higher risk of SIDS than are singletons. Overall, the epidemiology of SIDS in twins is quite similar to that seen in singletons.

Cohort Studies↗
PubMed2004

Analyzing excessive no changes in clinical trials with clustered data.

This article considers clinical trials in which the efficacy measure is taken from several sites within each patient, such as the alveolar bone height of the tooth sites, or bone mineral densities of the lumbar spine sites. Since usually only a small portion of these sites will exhibit changes, the conventional method using per patient average gives a diluted result due to excessive no changes in the data. Different methods have been proposed for this type of data in the case where the observations are mutually independent. This includes the popular "two-part model" (Lachenbruch, 2001, Statistics in Medicine 20, 1215-1234; 2002, Statistical Methods in Medical Research 11, 297-302), which is related to the "composite approach" for discrete and continuous data in Shih and Quan (1997, Statistics in Medicine16, 1225-1239; 2001, Statistica Sinica 11, 53-62). In this article, we model the data with excessive zeros (no changes) in clustered data using a mixture of distributions, and taking into account possible measurement errors. This mixture model includes the two-part model as a special case when one component of the mixture degenerates.

Algorithms↗
PubMed2004

Biofeedback treatment for asthma.

STUDY OBJECTIVES: We evaluated the effectiveness of heart rate variability (HRV) biofeedback as a complementary treatment for asthma. PATIENTS: Ninety-four adult outpatient paid volunteers with asthma. SETTING: The psychophysiology laboratory at The University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, and the private outpatient offices of participating asthma physicians. INTERVENTIONS: The interventions were as follows: (1) a full protocol (ie, HRV biofeedback and abdominal breathing through pursed lips and prolonged exhalation); (2) HRV biofeedback alone; (3) placebo EEG biofeedback; and (4) a waiting list control. DESIGN: Subjects were first prestabilized using controller medication and then were randomly assigned to experimental groups. Medication was titrated biweekly by blinded asthma specialists according to a protocol based on National Heart, Lung, and Blood Institute guidelines, according to symptoms, spirometry, and home peak flows. MEASUREMENTS: Subjects recorded daily asthma symptoms and twice-daily peak expiratory flows. Spirometry was performed before and after each weekly treatment session under the HRV and placebo biofeedback conditions, and at triweekly assessment sessions under the waiting list condition. Oscillation resistance was measured approximately triweekly. RESULTS: Compared with the two control groups, subjects in both of the two HRV biofeedback groups were prescribed less medication, with minimal differences between the two active treatments. Improvements averaged one full level of asthma severity. Measures from forced oscillation pneumography similarly showed improvement in pulmonary function. A placebo effect influenced an improvement in asthma symptoms, but not in pulmonary function. Groups did not differ in the occurrence of severe asthma flares. CONCLUSIONS: The results suggest that HRV biofeedback may prove to be a useful adjunct to asthma treatment and may help to reduce dependence on steroid medications. Further evaluation of this method is warranted.

Adult↗
PubMed2003

Detection of mutations in the mitogen-activated protein kinase pathway in human melanoma.

PURPOSE: Recent studies suggest that activating point mutations in B-RAF may commonly occur in melanoma. We devised a method to detect point mutations in heterogeneous tissues containing both wild-type and mutant B-RAF and N-RAS genes by using site-directed mutagenesis to introduce new restrictions sites in the cDNA sequence when the specific point mutations are present. We used this technique to determine the incidence of mitogen-activated protein kinase (MAPK) mutations in human melanoma. EXPERIMENTAL DESIGN: We screened 85 melanoma samples for the most common B-RAF and N-RAS mutations found in melanoma using a site-directed mutagenesis-based detection technique. Western blotting was used to evaluate downstream up-regulation of the mitogen-activated protein kinase pathway in these tissues. RESULTS: Thirty-three samples (7 of 25 primaries, 15 of 25 regional metastases, 5 of 25 nodal metastases, and 6 of 10 distant metastases) harbored the V599E B-RAF mutation (39%), 12 contained a Q61R N-RAS mutation and 5 a Q61K N-RAS mutation. Western blotting with antiphosphorylated extracellular signal-regulated kinase 1/2 antibodies demonstrated up-regulation of the MAPK pathway in samples containing activating B-RAF or N-RAS mutations compared with wild-type samples. This method of detection was sensitive and specific with no false positives. CONCLUSIONS: Activating mutations of the MAPK pathway were present in approximately 60% of samples tested and caused activation of this cellular pathway that appears to be important in the pathogenesis of melanoma.

Base Sequence↗
PubMed2003

Estimates, power and sample size calculations for two-sample ordinal outcomes under before-after study designs.

Sample size calculations are given for comparing two groups of subjects, typically referring to active and non-active intervention groups, on an ordinal outcome in experiments where the subjects are measured before and after intervention. These calculations apply to log-odds models with random intercepts, treatment, time and treatment-by-time interaction terms, the latter being the term of interest. The assumed forms of the odds ratios are flexible, allowing for proportional odds, adjacent categories, or other conditional models for ordinal responses. Simulations studies show that, for given sample sizes, the nominal and actual powers of the proposed test are similar.

Clinical Trials as Topic↗
PubMed2003

Patterns of recurrence in patients with melanoma and histologically negative but RT-PCR-positive sentinel lymph nodes.

BACKGROUND: We studied the patterns of recurrence of patients with only reverse transcriptase-polymerase chain reaction (RT-PCR) evidence of regional nodal spread to see whether or not proposed treatment interventions are likely to be effective. STUDY DESIGN: One hundred seventy-five patients who underwent selective lymphadenectomy for clinical stage I and II melanomas were included in this analysis. We preserved a portion of each sentinel lymph node (SLN) in liquid nitrogen in the operating room and performed RT-PCR on the specimens to detect the melanoma/melanocyte-specific marker tyrosinase. We then compared the pattern of recurrence (regional dermal metastases, regional nodal recurrence, or distant metastatic spread) of the patients with histologically positive SLNs to that of patients who had histologically negative SLNs. RESULTS: The mean followup time of the 175 patients was 33.83 months (SD = 15.94, median = 34.17, maximum = 62.95, minimum = 6.21). Thirty-four patients had at least one histologically positive SLN, and 17 of these patients had a recurrence (50%). Of the 141 patients that had histologically negative SLNs, 73 had SLNs that were also negative for tyrosinase by RT-PCR, and none of these patients had a recurrence. Of the 68 patients that had histologically negative but RT-PCR-positive SLNs, 14 had a recurrence (20.6%). CONCLUSIONS: Because the pattern of recurrence of patients with only RT-PCR evidence of melanoma in SLNs was identical to that in patients who had histologically evident melanoma in the SLN and underwent subsequent completion lymphadenectomy, we conclude that completion lymphadenectomy might be ineffective in decreasing the recurrence rate of patients with only RT-PCR evidence of melanoma in SLNs.

Biomarkers, Tumor↗
PubMed2002

Cohort case-control design and analysis for clustered failure-time data.

Cohort case-control design is an efficient and economical design to study risk factors for disease incidence or mortality in a large cohort. In the last few decades, a variety of cohort case-control designs have been developed and theoretically justified. These designs have been exclusively applied to the analysis of univariate failure-time data. In this work, a cohort case-control design adapted to multivariate failure-time data is developed. A risk set sampling method is proposed to sample controls from nonfailures in a large cohort for each case matched by failure time. This method leads to a pseudolikelihood approach for the estimation of regression parameters in the marginal proportional hazards model (Cox, 1972, Journal of the Royal Statistical Society, Series B 34, 187-220), where the correlation structure between individuals within a cluster is left unspecified. The performance of the proposed estimator is demonstrated by simulation studies. A bootstrap method is proposed for inferential purposes. This methodology is illustrated by a data example from a child vitamin A supplementation trial in Nepal (Nepal Nutrition Intervention Project-Sarlahi, or NNIPS).

Case-Control Studies↗