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C DeAngelis

Publications and source records attributed to C DeAngelis.

At least 19 recordsLinked to original sources
PubMed2004

[Registration of clinical trials: a statement from the International Committee of Medical Journal Editors].

Altruistic motives and trust are central to scientific investigations involving people. These prompt volunteers to participate in clinical trials. However, publication bias and other causes of the failure to report trial results may lead to an overly positive view of medical interventions in the published evidence available. Registration of randomised controlled trials right from the start is therefore warranted. The International Committee of Medical Journal Editors has issued a statement to the effect that the 11 journals represented in the Committee will not consider publication of the results of trials that have not been registered in a publicly accessible register such as www.clinicaltrials.gov. Patients who voluntarily participate in clinical trials need to know that their contribution to better human healthcare is available for decision making in clinical practice.

Clinical Trials as Topic↗
PubMed2003

Radiation induced mucositis: co-ordinating a research agenda.

AIMS: A one-day workshop was hosted by the Symptom Control Committee of the National Cancer Institute of Canada, Clinical Trials Group (NCIC-CTG), in conjunction with the October 2002 annual meeting of the Canadian Association of Radiation Oncologists in Toronto, Ontario. The primary intention of the workshop was to direct the future research agenda of the Symptom Control Committee. Large group presentations were held initially to review the contemporary research issues of four selected areas of interest: fatigue, brain metastasis, bone metastasis and radiation-induced mucositis. Panel members were then charged with the identification of specific research proposals that could be considered for further development. Research questions were to be clinically relevant and currently appropriate. Any additional information needed before the launch of any potential trial was also requested. In this paper, we will review and summarise the outcomes from the radiation-induced mucositis sessions. MATERIALS AND METHODS: Thirty-four participants participated in the large group sessions and contributed to one of four panel discussions on selected supportive care issues relevant to radiation oncologists. RESULTS: Three potential and non-overlapping research questions were identified; two involving mucositis management in patients receiving radical radiation for head and neck cancer, and a third for patients with advanced lung cancer undergoing combined radiation and chemotherapy and at risk for the development of symptomatic oesophagitis. CONCLUSION: The workshop successfully identified three potential research questions. The large group and the smaller panel discussions successfully established consensus on important aspects of future study designs. The current 'standard of care', appropriate experimental treatments, primary outcomes of interest and study population parameters were each important issues that were discussed. The importance of developing meaningful biological assays was reviewed, as was the need to ensure the appropriate storage of biological samples from patients for future study.

Head and Neck Neoplasms↗
PubMed2002

Hysteroscopic findings in postmenopausal abnormal uterine bleeding: a comparison between HRT users and non-users.

OBJECTIVES: The aim of our study was to investigate hysteroscopic findings in a sample of 410 menopausal women (hormonal replacement therapy, HRT users n = 219 and HRT non-users n = 191) and to evaluate the relationship between the presence of intrauterine disease, the use of HRT and the presence of AUB. METHODS: Two hundred and nineteen women on HRT underwent standard office hysteroscopy by means of the Hamou hysteroscope (in 94 cases for abnormal uterine bleeding (AUB) and in 125 cases for periodic endometrium monitoring). One hundred and ninety-one women who had never received HRT were submitted to office hysteroscopy (154 for AUB and 37 for other reasons). RESULTS: Intrauterine diseases are more frequent in patients who do not use HRT (P = 0.02). Endometrial polyps is a frequent disease present in 30% of the sample (23.7% of HRT users and 30.8% of HRT non-users). Myomas were present in 8.7% of all patients examined (6.8% of HRT users and 11% of HRT non-users). Irregular bleeding in menopause is often associated with endouterine abnormalities: in symptomatic patients the frequency of endouterine diseases was 41% while in asymptomatic patients was 28% (P = 0.003). In patients taking HRT (n = 219) endouterine disease is demonstrated in 37% with AUB and in 26% without AUB (P = 0.07). CONCLUSION: Benign intrauterine diseases (endometrial polyps and submucous myomas) are more frequent in postmenopausal women who do not use HRT. In patients taking HRT irregular bleeding is associated with intrauterine diseases; however, the absence of AUB does not exclude the presence of endometrial polyps or myomas.

Female↗
PubMed2000

Final report of the FOPE II Pediatric Workforce Workgroup.

From the inception of the Future of Pediatric Education II (FOPE II) Project, it was acknowledged that any discussion of pediatric education would need to encompass a review of the pediatric workforce. This report looks at the current trends in pediatric workforce and draws some conclusions regarding future growth and composition. In addition to looking at demographic trends, ranging from geography to gender, the report explores influences including managed care, telemedicine, and others. Models for determining workforce needs are described and scenarios and projections are discussed. Pediatrics 2000;106(suppl):1245-1255; pediatric workforce.

Adult↗
PubMed1997

The influence of medroxyprogesterone on the duration of breast-feeding in mothers in an urban community.

OBJECTIVE: To assess the effect of medroxyprogesterone acetate on lactation when it is given immediately post partum. DESIGN: Prospective cohort study with follow-up through 16 weeks post partum. SETTING: Urban teaching hospital in Baltimore, Md. PARTICIPANTS: Consecutive sample (N = 95) of mothers who were delivered of healthy, term newborns, had home telephones, received either medroxyprogesterone or nonhormonal contraception at discharge, and were currently breast-feeding their newborns. MAIN OUTCOME MEASURES: Lactation (duration and frequency) and timing of first introduction of formula were measured by weekly telephone interviews. RESULTS: Maternal characteristics included the mean +/- SD maternal age (24 +/- 5 years), race (90% African American), history of pregnancy (63% multiparous), marital status or relationship (50% married or living with partner), and medical assistance (81% of the recipients received aid). Women who were receiving medroxyprogesterone (n = 43) were older (P < .05) and were more likely to be married (P < .05) compared with those who were receiving nonhormonal contraception (n = 52). No other factors that were likely to influence lactation were significantly different. Groups did not differ in the baseline-planned duration of lactation. Follow-up data were obtained on 90 women (96%). The groups were comparable in the duration of lactation (medroxyprogesterone: 98%, 74%, 55%, 47%, and 42% were breast-feeding at least once per day at 1, 4, 8, 12, and 16 weeks, respectively [median, 10.14 weeks], vs nonhormonal contraception: 86%, 70%, 47%, 36%, and 30%, respectively [median, 6.57 weeks] [P = .19]). The percentage of subjects who were exclusively breast-feeding at these times and the timing of formula introduction also did not differ by group. CONCLUSION: Medroxyprogesterone, when given to mothers in an urban community immediately after delivery, has no detrimental effect on the duration of lactation, frequency of lactation, and timing of introduction of formula within the first 16 weeks post partum.

Adult↗
PubMed1996

Oral prednisone as a risk factor for infections in children with asthma.

OBJECTIVE: To determine whether the frequency of acute infections in children with asthma is associated with the number of doses of prednisone received for asthma attacks. DESIGN: A cohort study. SETTING: Primary care clinic and emergency department of an inner-city teaching hospital from March 31, 1992, to May 31, 1993. PATIENTS: Convenience sample of clinic enrollees aged 2 to 14 years who had made two or more outpatient visits for acute asthma in the preceding year. Eighty-six children were enrolled. Seventy-eight (91%) completed the study. MAIN OUTCOME MEASURES: The independent variable was cumulative prednisone dose received during the study period. Outcome variables were episodes of acute infections. RESULTS: The mean (+/-SD) number of doses of prednisone (2 mg/kg to a maximum of 60 mg) received was 9.5 +/- 11.8 doses (range, 0 to 57 doses). Ninety-four episodes of acute infection occurred in 50 children. No difference was observed in the mean number of doses of prednisone received by those with the infection compared with those without the infection. No correlation was observed between the number of doses of prednisone received and the number of episodes of each infection. CONCLUSIONS: The administration of prednisone as short courses for acute asthma is not associated with an increase in the number of episodes of common acute infections.

Acute Disease↗
PubMed1995

Ataxia.

Explore the source record for details and available documents.

Adolescent↗
PubMed1995

Independent parental administration of prednisone in acute asthma: a double-blind, placebo-controlled, crossover study.

OBJECTIVE: To determine the effectiveness of a single dose of prednisone administered by a parent to a child early in an asthma attack. DESIGN: A randomized, double-blind, placebo-controlled, crossover study with children enrolled for 12 months (6 months prednisone, 6 months placebo). SETTING: A primary-care clinic and emergency department of an inner-city teaching hospital from March 1992 through May 1993. CHILDREN: Children 2 to 14 years of age enrolled in this clinic who had made two or more outpatient (emergency department or primary-care clinic) visits for acute asthma in the preceding year. SELECTION: There were 204 eligible children, of whom 86 were contacted and enrolled; of these, 78 (91%) completed the study. INTERVENTION: Capsules containing prednisone (2 mg/kg up to 60 mg) or placebo. Parents were instructed to give their child one capsule for an asthma attack that had not improved after a dose of the child's regular acute asthma medicine. MEASUREMENTS: Parents were interviewed every 3 months. Computerized patient records and chart reviews were used to verify parent reports. Outcome measures were the numbers of outpatient visits and hospitalizations for treatment of acute asthma. RESULTS: Neither the total number of attacks nor the number for which medicine was used differed significantly by arm of study. There was a larger number of attacks resulting in outpatient visits when children were in the group that received prednisone (1.1 +/- 0.59 versus 0.59 +/- 0.86). This trend was less pronounced but persisted when limited to attacks for which the medicine was given (0.58 +/- 0.99 versus 0.35 +/- 0.55). Neither the number of attacks resulting in admission nor the number of hospital days differed significantly by arm of study. CONCLUSIONS: A single dose of prednisone available for use at home early in an asthma attack was associated with an increase in outpatient visits made for acute asthma. When prednisone was given for an attack, there was no reduction in outpatient visits. This intervention can not be recommended for children with asthma. These results should be confirmed in other pediatric populations.

Acute Disease↗
PubMed1994

The impact of anti-drug advertising. Perceptions of middle and high school students.

OBJECTIVES: To examine the perceived impact of anti-drug advertising on the knowledge, beliefs, attitudes, and behavior pertaining to youth drug use and to evaluate the influence of demographic characteristics, media exposure, and substance use on the likelihood of perceiving a deterrent effect of anti-drug advertisements. DESIGN: Anonymous, self-administered survey. SETTING: Urban and suburban public schools. PARTICIPANTS: Eight hundred thirty-seven students in middle and high school (52% suburban, 50% male, 48% white) were studied in group convenience samples. OUTCOME MEASURES: Self-report of the impact of anti-drug advertising on knowledge, beliefs, attitudes, and behavior pertaining to drug use. RESULTS: Overall, 83% (95% confidence interval [CI], 80% to 86%) of the student sample was exposed to anti-drug advertising. A majority of these students reported a positive impact of anti-drug advertisements: 92% (95% CI, 89% to 95%) perceived an increase in their knowledge of drugs; 60% (95% CI, 56% to 64%) felt they gained stronger beliefs about the dangers of drugs; 52% (95% CI, 48% to 56%) felt they developed more negative attitudes toward drug users; and 75% (95% CI, 72% to 78%) reported that they had decreased, stopped, or been convinced never to initiate drug use. Multivariate analysis revealed that the non-drug-using, urban, and younger students were most likely to perceive a deterrent impact on behavior. CONCLUSION: Anti-drug advertising was perceived to have a deterrent effect on self-reported substance use among this population of adolescents.

Adolescent↗
PubMed1994

Urinary cotinine as a measure of passive smoke exposure in asthmatic children.

This study sought to determine (1) the association between passive smoke exposure and acute symptoms in asthmatic children and (2) the association between parental report and objective measures of passive smoke exposure. Asthmatic children ages 3 to 11 were eligible for the study, which involved measurement of smoke exposure by questionnaire and by urine sample at a time of an acute asthma attack and then later when the child was symptom-free. High levels of passive smoke exposure were detected at both times in most children. Parental report of passive smoke exposure correlated with urinary measure of exposure.

Acute Disease↗
PubMed1993

Phase I pharmacokinetic study of cyclosporin A combined with doxorubicin.

We performed a phase I trial of cyclosporin A (CsA) in combination with doxorubicin (dox) to determine the maximally tolerated dose (MTD) of the combination in man, to define the quantitative and qualitative toxicities of the combination, and to determine the pharmacokinetics of the two drugs when used together. CsA was administered as a continuous infusion for 6 days, and dox was administered as a single 10-min infusion 24 h after the initiation of CsA. The starting CsA infusion rate was 5 micrograms/kg/min, and the dox starting dose was 30 mg/m2. Courses were administered every 4 weeks with first CsA and then dox being escalated in consecutive cohorts of patients until the MTD was determined. Twenty-three patients and 40 courses were evaluable for toxicity. Pharmacokinetic analysis was performed in 23 patients on the first course for whole blood CsA and plasma dox and doxorubicinol. The MTD of CsA was 6 micrograms/kg/min, and for dox it was 45 mg/m2. Dose-limiting toxicity was neutropenia. Serum creatinine and creatinine clearance did not change over the infusion period. Bilirubin increased from a median of 10 mumol/liter at the initiation of the infusion to a median of 40.4 mumol/liter at the end of the infusion but returned to normal before the next cycle of therapy. Nausea and vomiting were common and marked, whereas thrombocytopenia was mild. Two patients, one with small cell lung cancer and one with breast cancer, had stable disease while receiving treatment for 5 and 6 months, respectively. Mean whole blood steady state concentrations of CsA were 2210 ng/ml during the infusion with total body clearance of 0.177 liter/h/kg. The area under the concentration x time curve (AUC) increased linearly with dose of dox, and total body clearance was independent of dose. The mean total body clearance was 2.46 liters/h/m2, and terminal half-life was 49.6 h. The AUC for dox was greater and clearance was less than has been previously reported at the doses administered in this study. The ratio of AUC for doxorubicinol to AUC for dox was less than expected, suggesting that the metabolism and/or excretion of dox was decreased when administered with CsA. We conclude that dox can be combined with infusioned CsA but at a lower dose than when given alone. This may be due to altered metabolism and/or excretion of dox or increased bone marrow stem cell sensitivity to dox.

Adult↗
PubMed1993

Radioimmunodetection of colorectal cancer metastases with 131I-labeled monoclonal antibody B72.3: a pilot study to determine efficacy of detection and pharmacokinetics.

We performed radioimmunoscintigraphy (RIS) and/or pharmacokinetic (PCK) studies in 12 patients with primary or metastatic colorectal carcinoma, utilizing an intravenous administration of 1-4 mCi (1 mg) of 131I-B72.3 monoclonal antibody. Metastatic lesions were correctly identified in 4/8 patients by RIS. Two patients with small lesions (> 2 cm diameter) had a false-negative RIS scan. Two patients had a true-negative RIS scan. Optimal images were obtained at 1 week postinjection. PCK studies showed that the plasma clearance of 131I-B72.3 was biexponential with an alpha-phase half-life ranging from 0.5 to 7.1 hr and a beta-phase half-life ranging from 47.5 to 85.3 hr. Systemic and renal clearance data indicated that 131I-B72.3 was cleared very slowly and almost entirely by deiodination. This pilot study was conducted to gain an understanding of the pharmacokinetics of this radiolabeled antibody. On the basis of these data, we are now studying second-generation antibodies as part of our long-range objectives to incorporate them in early detection and treatment protocols.

Adult↗
PubMed1992

Spironolactone pharmacokinetics and pharmacodynamics in patients with cirrhotic ascites.

The intent of this study was to identify pharmacokinetic and pharmacodynamic characteristics for spironolactone (SP) and its metabolites (canrenone, 6 beta-hydroxy-7 alpha-thiomethylspirolactone, 7 alpha-thiomethylspirolactone) in cirrhotics under steady state conditions. Nine cirrhotics with ascites participated in the study. Serial blood samples were drawn and urine was collected over a 26-hour period. Using a reverse-phase high performance liquid chromatography (HPLC) method, all samples were analyzed for SP, canrenone, 6 beta-hydroxy-7 alpha-thiomethylspirolactone, and 7 alpha-thiomethylspirolactone concentrations. Parent compound and metabolite urinary excretion rates as well as maximal concentrations and time at which these are observed were calculated. The apparent median terminal elimination rate constants (associated half-lives) were 0.0767 h-1 (9.04 hours) for SP, 0.0055 h-1 (126 hours) for 6 beta-hydroxy-7 alpha-thiomethylspirolactone, 0.029 h-1 (23.9 hours) for 7 alpha-thiomethylspirolactone and 0.012 h-1 (57.8 hours) for canrenone. SP metabolism is impaired in cirrhosis; terminal half-lives of SP and metabolites appear to be increased when compared with values reported in the literature for normals. When assuming a linear model, clearance-effect relationship estimates are best correlated with 7 alpha-thiomethylspirolactone and canrenone. Further research is required to identify specific pharmacokinetic and pharmacodynamic parameters for SP and its metabolites in this patient population.

Adult↗