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125441. Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients

History of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or central nervous system mass lesion Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation (...) consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.) Refusal to provide written authorization for use and disclosure of protected health information (If the patient is incapacitated, informed consent will be sought from a legally acceptable representative.) Have received another

2008 Clinical Trials

125442. A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 4 Months to 16 Years (Child) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Institutional Review Board (IRB)-approved written informed Consent / Assent (as applicable) and HIPAA Authorization must be obtained from the subject (as able) and /or subject's parent/legally authorized representative prior to any study-related (...) of an active systemic or disseminated fungal infection prior to enrollment Subject has a history of anaphylaxis, hypersensitivity, or any serious reactions to the echinocandin class of antifungals Subject had received treatment with an echinocandin within one week prior to first dose of study drug Subject status is unstable and subject is unlikely to complete required study procedures Female subject is pregnant or nursing. Females of childbearing potential must avoid becoming pregnant while receiving study

2008 Clinical Trials

125443. A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma

of primary tumor histology. Must be ≥ 18 years old. Must have a Karnofsky performance status (KPS) ≥ 60% Measurable disease per MacDonald criteria required using contrast enhanced cranial MRI. Life expectancy ≥ 12 weeks. Must sign and date an Institutional Review Board (IRB) approved informed consent stating that he or she is aware of the neoplastic nature of the disease. Must willingly provide written consent after being informed of procedure to be followed, the experimental nature of the therapy (...) immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection. Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed. Concomitant use of ketoconazole and other agents known to inhibit Cytochrome P450 3A4 (CYP3A4). Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system. Ongoing treatment with therapeutic doses of Coumadin (low dose up to 2

2008 Clinical Trials

125444. Detection of Neutralizing Antibodies in Patients Treated With Bevacizumab or Ranibizumab

in the retina, but the treatment is becoming less effective Are receiving injections of bevacizumab or ranibizumab for bleeding or swelling in the retina and the treatment is still effective Have bleeding or swelling in the retina, but have never received either bevacizumab or ranibizumab Participants have blood samples drawn once when they start the study, once in the middle of the study, and once at the end of the study. They are asked permission for study researchers to review the results of their eye (...) will be excluded from participating in this study: Patients who are currently receiving any form of systemic immunosuppressive or immunomodulatory therapy, including corticosteroids. Immunosuppressive medication could lower the titers of neutralizing that are present in a given patient, and this could give the false impression that such a patient has little to no immune response against bevacizumab or ranibizumab. Patients who have autoimmune or rheumatologic disease. Patients with autoimmune diseases tend

2008 Clinical Trials

125445. Study of Oral Palifosfamide Tris in Solid Tumors

cc/min Total bilirubin ≤2×ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN Granulocytes in peripheral blood ≥2.0×109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000/µL Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site. Men and women of childbearing potential must use effective contraception from Screening through his/her duration of study participation. Women (...) of childbearing potential must have a negative serum pregnancy test prior to entering the study. Exclusion Criteria: New York Heart Association (NYHA) functional Class ≥III myocardial infarction (see Appendix 5) within 6 months. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc. Pregnancy and/or lactation. Uncontrolled systemic infection (documented

2008 Clinical Trials

125446. Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy

of measuring laboratory). The patient is 5 years of age and under. The patient is male. The patient's parent(s), or patient's legal guardian must have voluntarily signed an Institutional Review Board approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient's parent(s), or the patient's legal guardian. Exclusion Criteria: The patient has received treatment with another investigational therapy within 30 days prior to enrollment. The patient has (...) Metabolism, Inborn Errors Genetic Diseases, Inborn Lysosomal Storage Diseases Mucinoses Connective Tissue Diseases Metabolic Diseases Mental Retardation, X-Linked Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System

2008 Clinical Trials

125447. Avastin (Bevacizumab) and RAD001 (Everolimus) in Advanced Low or Intermediate Grade Neuroendocrine Carcinoma

interactions, and are therefore not considered effective for this study. Barrier method of contraception is required during the study. Contraception should continue for 6 months after the last dose of bevacizumab. Exclusion Criteria: Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study. Prior treatment with a mTOR inhibitor or bevacizumab. Chronic treatment with systemic steroids or another immunosuppressive agent. A known history (...) of immunocompromise, including a positive HIV test. An HIV test will not be required; however, previous medical history will be reviewed. Inadequately controlled hypertension (defined as systolic blood pressure >140 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications). Any prior history of hypertensive crisis or hypertensive encephalopathy. New York Heart Association (NYHA) Grade II or greater congestive heart failure. History of myocardial infarction or unstable angina within 6 months prior

2008 Clinical Trials

125448. Usefulness of Shirodhara for Insomnia

size and the preliminary nature of the study, a single case study or case series are classified under Observational Descriptive Studies. The investigators will seek local Institutional Review Board (IRB) approval. Ten volunteers who respond to the recruitment efforts will be enrolled into the study. Successful enrollment is based on strict inclusion and exclusion criteria. Brahmi oil (sesame oil processed with Bacopa monieri and other herbs) will be used to perform Shirodhara. Each participant (...) , 2008 Last Update Posted: September 20, 2012 Last Verified: September 2012 Keywords provided by Sivarama Vinjamury, Southern California University of Health Sciences: Insomnia Ayurveda Shirodhara Quality of Life Additional relevant MeSH terms: Layout table for MeSH terms Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders

2008 Clinical Trials

125449. Albumin Use in Burn Patients

of burn injury, basic demographic data, co-morbidities, outcomes and, for the first 72 hours post injury, if albumin was used and why, amount of resuscitation fluids and urine output, and use of vasopressors and diuretics. Each participating site will retrospectively review 20 charts of consecutive admissions with at least a 20% TBSA burn. In addition, each site will collect data prospectively on 20 more patients with 20% TBSA burns. Prospective data is requested in order to capture as close (...) Hospital Burn Center St. Paul, Minnesota, United States, 55101 United States, North Carolina North Carolina Jaycee Burn Center, University of North Carolina Hospitals Chapel Hill, North Carolina, United States, 27514 United States, Ohio Paul and Carol David Foundation Burn Institute, Akron Children's Hospital Akron, Ohio, United States, 44308 Shriners Hospitals for Children Cincinnati, Ohio, United States, 45229 United States, Oregon Oregon Burn Center, Legacy Health System Portland, Oregon, United

2008 Clinical Trials

125450. Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

program and was required to record all observed doses in an mDOT diary log. All participants and partners received health education through the study. Adherence was measured using Medication Event Monitoring System (MEMS) caps and self-report questionnaires. This study lasted 52 weeks. Per protocol, participants were to be stratified according to their screening viral load and the proposed study treatment. The study treatment each participant received was based on their treatment history. At entry (...) were reviewed at most visits. An mDOT exit questionnaire and exit interview were required at the end of the study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 529 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention Official Title: International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First

2008 Clinical Trials

125451. Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)

% of the theoretical value Renal failure defined as creatinin clearance < 30 ml/mn Hepatic failure defined as a 2-fold increase of bilirubin or transaminases except if due to the lymphoma Known hypersensitivity to murine antibodies and other proteins, the active ingredients or any of the ingredients of the products under review Patient under the protection of justice Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact (...) Allogenic stem cell transplantation Additional relevant MeSH terms: Layout table for MeSH terms Lymphoma Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Fludarabine Fludarabine phosphate Antibodies, Monoclonal Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological

2008 Clinical Trials

125452. Prospective Study of Possible Infectious Disease

Inclusion Criteria: Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, or non-follicular lymphoma: lymphoplasmacytoid lymphoma, small lymphocytic lymphoma, marginal B-cell lymphoma, or MALT lymphoma (as defined in the WHO classification2) as reviewed by a hematopathologist at Memorial Hospital. Staging fulfills criteria for no initial treatment according to GELF criteria for advanced stage disease. None of the following should be present: 1) a nodal or extranodal mass (...) with a diameter of >7 cm, 2) involvement of at least three nodal sites [each with a diameter of >3 cm], 3) systemic symptoms, 4) plenomegaly, or 5) ureteral compression. No prior treatment for lymphoma is permitted. Karnofsky performance status > 70% The patient may not have a previous history of radiation therapy. Patient or guardian must be able to sign voluntary written consent. Male or female patients 18 years of age or greater. Exclusion Criteria: Histologic diagnosis of intermediate grade or high grade

2007 Clinical Trials

125453. Family-Based HIV Prevention for Latinos

prevention intervention or a general health promotion condition. Estimate the effect size of the Latino family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes and parental monitoring/supervision over 6 months. Based on a thorough review of the literature, the following is anticipated: The revised intervention will be feasible, acceptable, and appropriate for Latino families and will be enthusiastically received. The family-based HIV prevention (...) Prevention HIV Seronegativity Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

2007 Clinical Trials

125454. Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

absorption from baseline (vitamin D insufficiency) to follow up (vitamin D repletion and whether increased absorption results in subsequent increased retention of calcium within bone over the one-year interval as measured by bone densitometry. We will also study the effect of vitamin D repletion upon whole body muscle mass, quality of life and physical function. A review of medical records and a screening visit will determine eligibility. Eligible and consenting subjects will present to the GCRC (...) Hypercalciuria Bone Diseases Musculoskeletal Diseases Metabolic Diseases Deficiency Diseases Malnutrition Nutrition Disorders Parathyroid Diseases Endocrine System Diseases Calcium Metabolism Disorders Water-Electrolyte Imbalance Urological Manifestations Signs and Symptoms Vitamins Vitamin D Ergocalciferols Calcium, Dietary Calcium Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

2007 Clinical Trials

125455. Erlotinib and Sunitinib in NSCLC

(or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. Female patients must be surgically sterile, postmenopausal or agree to use effective contraception during the period of therapy. Male patients must be surgically sterile or agree to use effective contraception during the period of therapy. Exclusion Criteria: Squamous cell histology. History of untreated brain metastases Prior treatment with >1 systemic chemotherapy-based regimens (...) ). Eligibility of patients receiving any medications or substances known to induce or inhibit CYP3A4 and /or with the potential to affect the activity or pharmacokinetics of sunitinib or erlotinib will be determined following review of their case by the Principal Investigator. NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy. Ongoing treatment with warfarin Prior treatment with high-dose chemotherapy requiring stem cell rescue. Prior irradiation to >25% of the bone marrow (whole pelvis = 25

2007 Clinical Trials

125456. Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck

). If the only site of measurable disease is a previously irradiated area, the patient must have documented progression of disease in this area. All available prior computed tomography (CT) or magnetic resonance imaging (MRI) scans should be reviewed and noted, and measurements showing progression of disease should be documented whenever possible. However, documentation of disease progression is not mandatory for enrollment. Patients must have multigated acquisition scan (MUGA) scan showing left ventricular (...) by 0.85 if the patient is female. Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. Patients must not have history of congestive heart failure of any grade according to Heart Association (NYHA) (see Appendix 2

2007 Clinical Trials

125457. A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer

), the "next generation" of radiation treatment delivery systems, results in less radiation exposure to the heart and lungs than the best current RT technique in women with node positive breast cancer. This proposal will test the potential clinical value of IMRT compared to the best standard 3D plan (partially wide tangent fields, PWTF) in the treatment of breast cancer. These two treatment techniques will be studied in a Phase II randomized trial using quantitative indicators of potential cardiac and lung (...) diagnosis: Patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (SCV), infraclavicular nodes (ICV), and internal mammary nodes (IMN). Patients must have pathologic T 1, 2, 3 or 4, N 1, 2, or 3 Stage II or III disease as defined by the AJCC Staging System, 6th edition. Patients who do not undergo axillary staging but are at risk for nodal involvement may also

2007 Clinical Trials

125458. Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults

history or diagnosis of cancer. The study was conducted in accordance with the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review board of the University Hospital of Bordeaux (France). Written informed consent was obtained for all patients and investigations were conducted according to the institutional guidelines and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but had not been registered in ClinicalTrials.gov because (...) Description: • Principal Objective : Efficacy of DHEA on exercise capacity (six-minute walk test) Secondary Objective : Efficacy of DHEA on pulmonary arterial pressures (mean, systolic and diastolic), on systemic arterial pressures, pulmonary vascular resistances Safety of DHEA treatment Observance of treatment by DHEA Study design : Double-blind, randomized, placebo-controlled Phase III study. Patients will be randomized into two parallel groups to receive either 200 mg oral DHEA or placebo over a one

2007 Clinical Trials

125459. Does Omeprazole Decrease Intestinal Calcium Absorption?

will participate in this study. The primary study outcome is the change in intestinal calcium absorption following omeprazole therapy 40 mg daily for 30 days. The secondary outcomes include the change in urine n-telopeptide. We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo three calcium absorption studies. The first 2 studies will determine the monthly variation in calcium absorption, while the 3rd study will occur after taking 40 mg (...) Gastrointestinal Diseases Digestive System Diseases Acid-Base Imbalance Calcium Calcium, Dietary Omeprazole Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

2007 Clinical Trials

125460. LABS-3 Psychosocial

by (Responsible Party): Neuropsychiatric Research Institute, Fargo, North Dakota Study Details Study Description Go to Brief Summary: Bariatric surgery is associated with long-term weight loss, as well as short-term improvements in obesity-related medical comorbidities. However, a significant proportion of patients fail to lose sufficient weight, or experience significant weight regain. Although no robust predictors of response have been identified, pilot data that will be presented and reviewed suggest (...) of psychopathology, eating pathology and quality of life in detail. The Investigators believe that the measures and tasks added at year 7 will allow the examination of theories of affect regulation, cognitive control, and reward processing in understanding postsurgical outcomes regarding pathological eating behavior and alcohol/substance use and their shared similarities as well as underlying neurobiological systems. Study Design Go to Layout table for study information Study Type : Observational Actual

2007 Clinical Trials

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