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Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis Clinical research trials and Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis. Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis



Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis

For Condition: Hepatic Encephalopathy,Portal Hypertension,Cirrhosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Northwestern University
Synopsis: OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. III. Assess which elements of the neuropsychological test battery show the response to lactulose.
Details: PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks. A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting --Prior/Concurrent Therapy-- - No concurrent therapy for hepatic encephalopathy --Patient Characteristics-- - Age: Under 65 - Performance status: Not specified - Hematopoietic: Not specified - Hepatic: See Disease Characteristics - Renal: Not specified - Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel
Total Enrollment: 16

Location and Contact Information:

Overall Study Official:
AndresBlei,  Study Chair,  Northwestern University


Additional Information:
Study ID Numbers:  199/11934;  NU-523
Study Start Date: November 1994
Record last reviewed: February 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004796

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