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Diarrhea Secondary to Medications


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7221. Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

cord compression Other: No active serious infection requiring IV antibiotics No concurrent uncontrolled illness No concurrent unstable or serious medical condition No chronic diarrhea or malabsorption No history of allergic reactions to compounds similar in chemical or biological composition to benzoylphenylurea No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic (...) the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays >2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting <5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. Secondary Outcome Measures : Number of Patients With Adverse Events [ Time Frame: every 4 weeks ] Area Under the Plasma

2001 Clinical Trials

7222. Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation

and over Performance status: Not specified Life expectancy: At least 2 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 for at least 1 week prior to enrollment Hepatic: Not specified Renal: Creatinine no greater than 2.5 mg/mL Other: No hypersensitivity to ganciclovir or valganciclovir No uncontrolled diarrhea or severe gastrointestinal disease that would preclude oral medication Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during (...) treated with these drugs. Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs. Secondary Compare the incidence of CMV infection or disease at baseline and at days 270 and 640 after allogeneic hematopoietic stem cell transplantation in patients treated with these drugs. Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs

2001 Clinical Trials

7223. Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

arrhythmias requiring medication Gastrointestinal: No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) No post-surgical malabsorption characterized by: Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR Requires IV hyperalimentation Pancreatic enzyme supplementation allowed provided that the above criteria are not met Ophthalmic: No ocular inflammation (...) , 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle) Outcome Measures Go to Primary Outcome Measures : Overall survival [ Time Frame: 3 years ] Secondary Outcome Measures : Progression free survival [ Time Frame: 3 years ] Quality of Life [ Time Frame: 3 years ] Canada, US and selected countries only Response rates [ Time Frame: 3 years ] Complete and partial response only. Toxicity [ Time Frame: 3 years ] EGFR levels [ Time Frame: 3 years ] Correlate

2001 Clinical Trials

7224. G-CSF to Treat Crohn's Disease

on a Crohn's Disease Activity Index score between 225 and 450 (with either a diarrhea rating or abdominal pain rating of greater than or equal to 25). If currently receiving any medications for Crohn's disease, subjects may only be on a stable regimen of one or a combination of the following drug doses and durations: antibiotic therapy for greater than or equal to 2 weeks; Corticosteroids (less than or equal to 25 mg Prednisone/d, or Prednisone equivalent) for greater than or equal to 4 weeks; 5-ASA (...) will examine the effectiveness of G-CSF in treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine. Patients may have swelling and bleeding of the intestinal lining, which can lead to infection and abdominal pain, weight loss, fever, diarrhea, bloody stools, fistula (connections between the skin and intestine), intestinal blockages, and abscesses. Although there are various treatments for Crohn's disease, many patients continue to have inflammation

2001 Clinical Trials

7225. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

for four weeks) Radiation Therapy (5 days/week for 6-7 weeks) Surgery (if required) 14 -12 weeks after radiotherapy Follow-up Drug: Taxotere Other Name: Docetaxel Procedure: Surgery Radiation: radiation therapy Outcome Measures Go to Primary Outcome Measures : MTD of Taxotere [ Time Frame: 8 Weeks ] Dose Limiting Toxicity [ Time Frame: 8 Weeks ] Secondary Outcome Measures : Overall Response Rate [ Time Frame: 4-12 weeks post chemo/radiation therapy ] Tumor Resistance Predictors [ Time Frame: Up to 1 (...) or a normal absolute neutrophil count (ANC) ≥ 1000; Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 10 gm/d1 (transfusion to bring the hemoglobin to or above this level is permitted if clinically indicated, however, transfusions should not be used solely in order to meet eligibility criteria). Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2. Other: Lack of other serious illness or medical condition Informed consent: -- Patients must give written informed consent. Follow-up: All

2000 Clinical Trials

7226. Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer

adequate oral nutrition (i.e., at least 1200 calories estimated intake per day) No significant infection or other concurrent medical condition that would preclude study No significant nausea or vomiting No malabsorption secondary to short-gut syndrome, Crohn's disease, or sprue No patients with more than 6 bowel movements per day or baseline no greater than grade 3 diarrhea for patients with colostomy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception (...) , Pennsylvania CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania, United States, 17822-2001 United States, South Dakota Rapid City Regional Hospital Rapid City, South Dakota, United States, 57709 CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota, United States, 57105-1080 Canada, Saskatchewan Allan Blair Cancer Centre Regina, Saskatchewan, Canada, S4T 7T1 Sponsors and Collaborators Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) Investigators Layout

1999 Clinical Trials

7227. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities

shown that certain anti-HIV medications can cause a number of side effects, including high blood sugar (resulting from the body's failure to use insulin), high insulin, and excess fat build-up in the abdominal area. These side effects are known to increase the risk of heart disease. Metformin and rosiglitazone are 2 drugs that have been shown to lower insulin resistance and lessen abdominal fat in patients who are not HIV-infected. This study will investigate the use of these drugs in HIV-infected (...) : and subcutaneous abdominal] fat are assessed. [AS PER AMENDMENT 02/05/02: Patients who discontinue study treatment due to pregnancy during the study will have the Week 32 evaluations (except CT and DEXA scans).] [AS PER AMENDMENT 02/05/02: A mid-thigh measurement was added to the study as a secondary endpoint to look for changes in extremity subcutaneous fat from therapy with rosiglitazone. Rosiglitazone and other peroxisome proliferator-activated receptor (PPAR) gamma activators increase subcutaneous

2001 Clinical Trials

7228. The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients

or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria Concurrent Medication: Allowed: Primary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration. Patients must have: HIV (...) -positive status. One HIV RNA count > 10,000 copies/ml within 30 days prior to entry, with a second count at least 3-fold above or below the first value. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active medical problems including chronic diarrhea and active opportunistic infections such as cryptococcosis, Pneumocystis carinii, histoplasmosis, etc.. Malignancy for which systemic therapy or radiation therapy is expected to be required during

1999 Clinical Trials

7229. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

CPDD DDP Outcome Measures Go to Primary Outcome Measures : MTD alvocidib when administered in conjunction with irinotecan hydrochloride and cisplatin [ Time Frame: Course 1 ] Defined as the dose one level below the dose at which two or more of the patients in the initial cohort experience dose limiting toxicity (DLT) during the first treatment course. DLT is defined as the occurrence of Grade 4 hematologic toxicity, Grade 3 or 4 non-hematologic toxicity including diarrhea despite antidiarrheal (...) prophylaxis, or any delay in treatment resulting in less than 2 treatments in 3 weeks. Secondary Outcome Measures : Clinical pharmacokinetics of the regimen [ Time Frame: Week 1 of courses 1 and 2 ] Therapeutic activity of alvocidib in combination with irinotecan hydrochloride in patients with advanced solid tumors [ Time Frame: After 2 courses of treatment ] Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Safety and tolerability [ Time Frame: Weekly ] Evaluated using the National

2002 Clinical Trials

7230. Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis

of these cytokines. Interferon-beta1a (AVONEX) is currently FDA-approved to treat multiple sclerosis, a disease involving inflammation of the brain and spinal cord. Patients 18 years of age and older who have had ulcerative colitis for at least 4 months may be eligible for this study. Candidates will be screened with a review of their medical records, a medical history and physical examination, electrocardiogram (EKG), blood, urine, and stool tests, and a pregnancy test for women of childbearing potential (...) or disease Intervention/treatment Phase Ulcerative Colitis Drug: AVONEX Phase 2 Detailed Description: The purpose of this pilot study is to evaluate the immunologic and clinical response to type I interferon administered to patients with ulcerative colitis. Ulcerative colitis (UC) is a chronic, relapsing inflammation of the colonic mucosa with major symptoms of diarrhea, hematochezia, abdominal pain, and an accompanying increase in colorectal carcinoma risk. Novel approaches to therapy of UC are required

2002 Clinical Trials

7231. Efficacy Study of Zenapax in Combination With CellCept, Cyclosporine and Corticosteroids in Heart Transplant

to understand the requirements of the study White blood count =<2500/mm^3, platelets =<50,000/mm^3 or hemoglobin =<6 g/dL HIV-1, the presence of positive HBsAg, or chronic active hepatitis C Active peptic ulcer disease Severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication Malignancies within the past 5 years, excluding skin carcinoma that have been adequately treated Participants who have received within the past 30 days or require concomitant (...) or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up. Secondary Outcome Measures : Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT [ Time Frame: Up to 12 months PT ] The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT

2002 Clinical Trials

7232. Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

Procedure: peripheral blood stem cell transplantation Drug: mycophenolate mofetil Drug: cyclosporine Phase 2 Detailed Description: PRIMARY OBJECTIVES: I. To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen (HLA)-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody (mAb) Campath (alemtuzumab) in patients with hematologic malignancies. SECONDARY (...) : bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement

2002 Clinical Trials

7233. Oral Magnesium Pidolate, Hemoglobin SC Disease, MG Pidolate

this preparation has less side effects such as diarrhea than other Mg preparations. The study medication will be a liquid containing 0.6 meq Mg pidolate/kg body weight per day, divided into 2 daily doses. The Mg pidolate (45 g) will be distributed as a pre-mixed powder containing Koolaid Tropical Punch powder (9 gm), and sucrose (67 gm). Other Name: Magnesium Pidolate Outcome Measures Go to Primary Outcome Measures : Evaluation of whether treatment with oral Mg pidolate decreases the number of painful crises (...) on the amount of water in the red blood cells. One of the most important minerals influencing this is called magnesium. Magnesium is present in food and also in certain medications used to treat heartburn. Magnesium has been used successfully both in animals and people to increase the amount of water in the red blood cells and is very well tolerated by most people. Investigators are using a new form of magnesium known as magnesium pidolate because this form of magnesium may help with the symptoms of disease

2002 Clinical Trials

7234. Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer

radiation treatment for prostate cancer can decrease common side effects of treatment, including diarrhea, painful bowel movements, bleeding, and gas. Patients 18 years of age or older with prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, bone scan if a recent one is not available, and possibly computed tomography (CT) and magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention (...) /AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx Secondary Outcome Measures : Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer. [ Time Frame: The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment. ] A good toxicity outcome is defined as having less than grade 2

2002 Clinical Trials

7235. OGT 918-006: A Phase I/II Randomized, Controlled Study of OGT 918 in Patients With Neuronopathic Gaucher Disease

. Patients currently undergoing therapy with other investigational agents or patients taking drugs or food supplements which may interfere with gastrointestinal absorption or motility. Patients suffering from clinically significant diarrhea (greater than 3 liquid stools per day for greater than 7 days) without definable cause within 3 months of the Screening Visit, or who have a history of significant gastrointestinal disorders. Patients with an intercurrent medical condition that would render them (...) . It also has been shown to enter the brain. It is hoped that taking OGT 918 will reduce the storage of glycolipids in cells and improve the neurological symptoms of the disease. This clinical trial seeks to evaluate OGT 918 as a treatment for neuronopathic Gaucher disease by assessing changes in eye movement velocity. A secondary goal is to assess the clinical safety and tolerability of OGT 918 therapy. Up to 30 patients from the National Institutes of Health and the Institute of Child Health (London

2002 Clinical Trials

7236. Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease. (PubMed)

. All patients underwent serial, variable-grade, constant-speed treadmill testing. Absolute claudication distance (ACD), assessed at the end of the 12-hour dosing interval (trough), was the primary end point. Secondary end points included ACD assessed 3 to 4 hours after dosing (peak) and initial claudication distances (trough and peak). Functional status measures, including the Medical Outcomes Scale (SF-36) and Walking Impairment Questionnaire, were used to assess subjective changes over the 16 (...) with the placebo group (0.68 +/- 0.02 to 0.69 +/- 0.02) (p < 0.0125). The most frequent adverse events were headache, abnormal stools (e.g. loose stools), diarrhea, and dizziness.Cilostazol significantly increased ACD at all measured time points and initial claudication distances at most time points. This agent may represent a new treatment option for patients with intermittent claudication.

1998 Journal of vascular surgery

7237. A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis. (PubMed)

frequency of taste perversion and diarrhea in the clarithromycin group. Levofloxacin had an advantage over clarithromycin based on two quality-of-life (QOL) parameters: number of times taking other drugs for targeted medical conditions and mean total cost of these drugs. No statistical significance was found in other QOL variables. These findings suggest that the efficacy and tolerability of levofloxacin 500 mg once/day are comparable with those of clarithromycin 500 mg twice/day in the treatment (...) was clinical response, based on resolution of signs and symptoms 2-5 days after therapy. A secondary efficacy measure was relapse rate 1 month after therapy. Among evaluable patients, clinical success rates (cured or improved) were 96.0% and 93.3% for levofloxacin (L) and clarithromycin (C), respectively (95% CI -9.2%, 3.7%). The confidence interval (CI) for treatment difference (C-L) included zero and its upper limit was less than 15%, indicating that levofloxacin was as effective as clarithromycin

1999 Pharmacotherapy

7238. A randomized double-blind trial of acarbose in type 2 diabetes shows improved glycemic control over 3 years (U.K. Prospective Diabetes Study 44) (PubMed)

months for 3 years. The main outcome measures were HbA1c, FPG, body weight, compliance with study medication, incidence of side effects, and frequency of major clinical events.At 3 years, a lower proportion of patients were taking acarbose compared with placebo (39 vs. 58%, P < 0.0001), the main reasons for noncompliance being flatulence (30 vs. 12%, P < 0.0001) and diarrhea (16 vs. 8%, P < 0.05). Analysis by intention to treat showed that patients allocated to acarbose, compared with placebo, had (...) , incidence of hypoglycemia, or frequency of major clinical events.Acarbose significantly improved glycemic control over 3 years in patients with established type 2 diabetes, irrespective of concomitant therapy for diabetes. Careful titration of acarbose is needed in view of the increased noncompliance rate seen secondary to the known side effects.

1999 Diabetes Care

7239. Immune Regulation in Ulcerative Colitis or Crohn s Disease

in inflammatory responses. This protocol does not involve any experimental treatments. Patients between the ages of 8 and 75 years of age with Crohn s disease or ulcerative colitis or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may include the following: medical history and physical examination, routine blood tests, examination of stool specimens, X-rays such as barium enema or upper GI series, proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel (...) biopsy. Participants will receive medical treatment according to the best generally accepted measures for treating Crohn s disease or ulcerative colitis. This may include anti-inflammatory drugs, immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be recommended for patients whose disease does not respond to medical treatment. If surgery to remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform the procedure. In addition

1999 Clinical Trials

7240. The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma

chemotherapy. Severe (> 2+) tumor-associated edema. Concurrent neoplasia other than basal cell carcinoma, or anogenital intraepithelial neoplasia. Current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications. Significant symptomatic cardiac disease. Medical contraindication. Concurrent Medication: Excluded: Other investigational, antiviral, immunomodulating, or antitumor agents. Drugs (...) . Prior history of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications. History of myocardial infarction or ventricular arrhythmias. Prior Medication: Excluded: Prior IFN-alpha. Corticosteroids, biological response modifiers, cytotoxic chemotherapy, or known neurotoxic drugs (other than ddI or ddC) within 30 days prior to study entry. Therapy with antiretroviral drugs (other than ddI) within 7 days prior

1999 Clinical Trials

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