Biomedical subjects

M Caulfield

Publications and source records attributed to M Caulfield.

39 records · Page 3Linked to original sources

PubMedDate not supplied

Management of inflammatory bowel disease: 30 years of observation.

Management of inflammatory bowel disease has become more precise and effective in the last 30 years, ensuring long, productive lives for most patients. Data such as family history, duration of disease, the onset of complications, and type of therapy are presented from 450 patients with inflammatory bowel disease treated during a 10-year period ending in 1984. The incidence of general complications over three decades is compared. Perianal disease and intestinal obstructions dominate complications of Crohn's disease. The most common nongastrointestinal complication for patients with either disease is monarticular large joint arthritis. Approximately 75% of patients with Crohn's disease will eventually undergo surgery. In the first decade of data collection, 50% of patients with ulcerative colitis had surgery; in the second decade, 26%; and in the third decade, 39%. The changing percentages correspond initially to advances in medical therapy and then to advances in surgical therapy.

Adolescent↗

PubMedDate not supplied

Associated ulcerative colitis, sclerosing cholangitis, and insulin-dependent diabetes mellitus.

We report two young men with clinical and laboratory evidence of macroscopic ulcerative colitis, sclerosing cholangitis, and insulin-dependent diabetes mellitus. The first patient presented at age 15 with vomiting, abdominal pain, weight loss, and abnormal liver function test results. Liver biopsy and endoscopic retrograde cholangiopancreatography (ERCP) demonstrated sclerosing cholangitis. Colonoscopy with biopsy revealed ulcerative colitis which responded to sulfasalazine. Diabetes occurred at age 18 and insulin therapy was begun. The second patient was 19 at presentation with diarrhea, hematochezia, and weight loss. Proctosigmoidoscopy revealed ulcerative colitis, and sulfasalazine led to clinical remission. Three months later he developed diabetes requiring insulin therapy. At age 28, he developed elevated alkaline phosphatase, and ERCP revealed sclerosing cholangitis. At age 37 he expired from adenocarcinoma that metastasized to the liver. Literature review revealed only one possible case report of this association with microscopic asymptomatic ulcerative colitis in that patient. Statistical analysis suggests that this association is real rather than a chance occurrence. An autoimmune process may be involved and a specific histocompatibility locus antigen (HLA) type may exert a regulatory influence.

Adolescent↗

PubMedDate not supplied

Sponsor/contract laboratory communication: a team approach to quality.

The true measure of any successful quality endeavor is the final product. The final product generated at contract facilities conducting nonclinical studies is the final report. This should be accurate, complete, and consistent with regard to the raw data, and in compliance itself. The final report resulting from studies conducted at contract laboratories should be reflective of the collaborative efforts of sponsor and laboratory staffs. The dual interaction of the respective Quality Assurance Units (QAUs) in ensuring that optimal study performance is maintained from initiation through final report submission is of paramount importance. Key to any productive sponsor/contract laboratory relationship is communication. The multidirectional flow of information inherent in the conduct of nonclinical studies must be managed to maximize the strengths of the principals involved, while at the same time assuring that consistent emphasis is placed on team focus. Although the role of the QAUs representing the contract facilities and the sponsor both ensure the quality of study conduct, and ultimately the final product, their respective approaches may be from different perspectives. The contract QAU's primary focus is the specific study conduct, including appropriate inspections of ongoing critical phases and audits of raw data and reports, along with compliance to site Standard Operating Procedures (SOPs), protocols and sponsor requirements. On the other hand, sponsor QAUs focus mainly on overall study conduct, assurance that contract QAUs are operating effectively, and ensuring that sponsor monitors are communicating adequately with contract facility personnel. Open communication between the respective QAUs is the most productive and useful way of ensuring that all quality criteria are met.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Protocols↗