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NCT00240838 | An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness. | Pain The purpose of this study is to compare the effectiveness and safety of acetaminophenextended release caplets and ibuprofen in relieving the muscle soreness that occurs after amarathon. Inclusion Criteria:- Patients must complete the marathon- be able to swallow the study medication- comply with study requirements regarding the use of any other pain medicationsbefore, during or after the marathon- rate their muscle soreness on the evening after the marathon as at least a 4, on azero-to-ten point scale- if female, must not be pregnant or breastfeeding, and must be using an acceptableform of contraceptionExclusion Criteria:- Previous diagnosis of osteoarthritis requiring pain medication therapy- currently have a major medical illness- have a history of cardiovascular disease, heat injury (heat exhaustion or heatstroke) or collapse during a running or endurance event- known hypersensitivity to acetaminophen or ibuprofen |
NCT00240435 | 12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD | Pulmonary Disease, Chronic Obstructive The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily toplacebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondaryobjective was to compare the safety of tiotropium inhalation solution delivered by theRespimat to placebo and ipratropium bromide MDI. Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60%predicted [ECCS criteria] and FEV1/FVC </= 70%) |
NCT00240409 | Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease | Parkinson Disease The objective of this study was to investigate the efficacy and safety of PramipexoleTablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly)in a single blind, comparative method using Bromocriptine tablets as comparators (phase IIIcomparative trial) Inclusion Criteria:- Patients aged 30-80 years- Patients with idiopathic Parkinson's disease corresponding to stages II-IV accordingto the classification of Hoehn and Yahr during an "on" period, and/or patients inwhom the individual optimized dosage of levodopa (and decarboxylase inhibitor) causesmotor fluctuations characterized as end-of-dose phenomena or "wearing-off" effectsfor at least 30 days prior to initial administration of study medication and whosedaily total "off" time is at least 2 hours and no more than 6 hours during wakingtime.- Patients able to keep an accurate patient diary of the times of "on"- and"off"-periods during waking hours. Family members, guardians or nursing personnel mayassist the patient.- Informed Consent (consent in writing)Exclusion Criteria:- Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders ,encephalitis, or degenerative disease.- Dementia that could impair compliance with medication, impair maintenance of accuratepatient diaries, and/or preclude the signing of informed consent.- History of psychosis except that which was elicited by treatment with levodopa ordopamine agonists unless the patient remains psychotic and in the opinion of theinvestigator would be unable to participate in the study.- History of active epilepsy within the last two years prior to Visit 2.- Patients with second or third degree AV block or sick sinus syndrome.- Patients with resting heart rate below 50 beats per minute.- Patients with congestive heart failure classified as functional Class III or IV bythe New York Heart Association.- Patients with myocardial infarction within six months of randomization.- Patients with other clinical significant heart conditions which would negativelyimpact on the patient completing the study.- Clinically significant kidney disease which may prevent the patient from completingthe study and/or an elevation in either blood creatinine or urea nitrogen >1.5 timesthe laboratory normal.- Clinically significant liver disease which may prevent the patient from completingthe study and/or an elevation in either total bilirubin, SGPT, or SGOT of >1.5 timesthe laboratory normal.- Retinopathia pigmentosa- Presence of active neoplastic disease- Patients with surgery within 180 days of Visit 2 which in the opinion of theinvestigator would negatively impact on the patient's participation in the clinicalstudy or a history of stereotaxic brain surgery.- At screening supine systolic blood pressure less than 100mmHg or evidence of a 20mmHg decline in systolic blood pressure at one minute after standing compared withthe previous supine systolic blood pressure obtained after 5 minutes of quiet rest inthe supine position if the decline in blood pressure upon standing is associated withsymptoms. Blood pressure at study entry (supine and standing) is expressed as theaverage of the second and third measured values.- Patients who have received any of the following drugs during the 30 days prior toadministered of study medication unless a longer period of time is specificallynoted: neuroleptics (60 days), a-methyl-dopa, metoclopramide (60 days), flunarizine,cinnarizine, parenteral ergot preparation, bromocriptine, pergolide, A monoamineoxidase (MAO) inhibitors excluding l-deprenyl, methylphenidate hydrochloride,amphetamine derivatives, beta blockers (e.g. propranolol) only if used as anadjunctive treatment for PD, or reserpine.- Females of childbearing potential not using oral contraceptives or a medicallyrecognized mechanical means of contraception.- Electroconvulsive therapy within 90 days of Visit 2.- Patients who are participating in other drug studies or who receive otherinvestigational drugs within 30 days prior to Visit 2, nor the patients previouslyrandomized into this study. |
NCT00240916 | Ontogeny of Measles Immunity in Infants | Measles This is an immunogenicity study evaluating the development of the immune response of healthyinfants following primary vaccination with Attenuvax at 6 or 9 months of age compared withresponses in 12 month-old infants receiving MMR-II. Responses of infants receiving an earlytwo dose measles vaccine regimen with the first dose given at 6 or 9 months followed by asecond dose administered at 12 months will also be compared to infants given a single doseat 12 months of age (Table 2). The current approved regimen for measles vaccination is afirst vaccination at 12-15 months and a subsequent vaccination at school entry.A secondary endpoint of this study will be to assess the safety of measles vaccineadministered as Attenuvax at 6 or 9 months of age and in an early two dose measles vaccineregimen with Attenuvax administered at 6 or 9 months followed by MMR-II at 12 months of age. Inclusion Criteria:Subjects must meet all of the following criteria in order to beenrolled:1. Healthy infants 6, 9, or 12 months (+ 3 weeks) of age2. Free of obvious health problems as established by medical history and clinicalexamination before entering into the study3. Parent/legal guardian willing and capable of signing written informed consent4. Parent/legal guardian expected to be available for entire study5. Parent/legal guardian can be reached by telephoneExclusion Criteria:All subjects meeting any of the following exclusion criteria atbaseline will be excluded from study participation:1. Former premature infants (<36 weeks)2. Birth weight < 2500grams3. Significant underlying chronic illness4. Immunodeficiency disease or immunosuppressive therapy in the participant5. Any other condition which in the clinical judgment of the investigator mightinterfere with vaccine evaluation6. Allergy to any components of the vaccine, including anaphylaxis or anyphalaxoidreaction to neomycin or eggs7. Administration of an investigational drug8. Blood products within 3 months of initial enrollment9. Current febrile respiratory illness or other active febrile infection10. Family history of congenital/hereditary immunodeficiency, unless immune competence ofsubject has been determined.11. Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasmsaffecting the bone marrow or lymphatic systems. |
NCT00240123 | Effect of Benadryl Sedation During ERCP or EUS | Gallbladder Disease The purpose of the study is to determine if adding Benadryl improves sedation for patientsscheduled to undergo ERCP or EUS procedures. Inclusion Criteria:- Patients between 18 and 65 years of age who present for outpatient ERCP or EUS atStrong Memorial Hospital Endoscopy Center will be includedExclusion Criteria:- Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent |
NCT00240877 | Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024) | Influenza To assess the safety of a vaccine in healthy adults prior to the release of the trivalentvaccine (FluMist). Inclusion Criteria:- 18-64 years of age (not yet reached their 65th birthday);- In good health;- Available by telephone;- Ability to understand and comply with the requirements of the protocol; and- Signed informed consent.Exclusion Criteria:- Any condition, other than age, for which the inactivated influenza vaccine isindicated, including: chronic disorders of the pulmonary or cardiovascular systems,including asthma; chronic metabolic diseases (including diabetes mellitus) renaldysfunction, or hemoglobinopathies which required regular medical follow-up orhospitalization during the proceeding year;- Acute febrile (>100.0F oral) illness or clinically significant respiratory illnesswithin the 14 days prior to enrollment;- Hypersensitivity to egg or egg protein;- Signs or symptoms of any immunosuppressive or immune deficiency disease, includingHIV infection, or ongoing immunosuppressive therapy; or an immunosuppressedindividual living in the same household;- Participation in another investigational trial within one month prior to enrollmentor expected enrollment in another investigational trial during this study; and- Any condition that in the opinion of the investigator, might interfere with thevaccine evaluation. |
NCT00240136 | Long-term Observation of Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis The purpose of this research is to observe the effects of RA over a long period in order tolearn which of the early characteristics of patients' early RA predict future joint damageand disability. We also investigate whether certain treatments can prevent or slow thedevelopment of joint damage and disability. Additionally, the costs and effects of RA on thepatient are studied in order to improve the methods used to measure these effects. Clinical,demographic, radiographic, and laboratory measures are taken by the rheumatologist in theoffice. In addition, patient questionnaires are mailed & completed by the patient andreturned to the coordinating center at UCLA. All information obtained by these means will bestudied in their effects on early, severe RA. Inclusion Criteria:- >=6 swollen joints & >=9 tender joints- symmetrical rheumatoid arthritis (RA)- <= 2 years worth of symptoms- rheumatoid factor seropositivityExclusion Criteria:- <18 years old- Inability to see rheumatologist, complete questionnaires (lack of compliance)- >2 years worth of symptoms |
NCT00240903 | Revaccination With Subunit Influenza A/Vietnam/1203/2004 (H5N1) Vaccine | Influenza The purpose of this study is to determine whether having received an H5 vaccine in the pastprimes the immune system to respond rapidly to another dose of H5 vaccine. One hundredseventeen participants in a previous vaccine study (involving the A/Hong/Kong/97 virus)during the fall of 1998 at the University of Rochester will be eligible to enroll in thisstudy. Participation in this study will up to 64 days and will involve donation of smallsamples of blood 7, 28, and 56 days after vaccination. Inclusion Criteria:1. Participant in the previous study of the rec H5 HA 1997 vaccine.2. Male or non-pregnant female (as indicated by a negative urine pregnancy testimmediately prior to vaccine administration) between the ages of 18 and 65 years.3. Females of childbearing potential who are at risk of becoming pregnant must agree topractice adequate contraception (i.e., barrier method, abstinence, Depo-Provera,Norplant, oral contraceptives, contraceptive patches or other licensed, effectivemethods) for the entire study period.4. In good health, as determined by medical history and a targeted physical examination,if necessary.5. Able to understand and comply with planned study procedures.6. Able to provide informed consent and be available for all study visits.Exclusion Criteria:1. Has participated in DMID 04-063 Study.2. Has a known allergy to eggs, other components of the vaccine or latex.3. Has a positive urine pregnancy test at screening or prior to vaccination (if female),is lactating, or has the intention to become pregnant within 3 months of enrollmentin this study.4. Is undergoing immunosuppression as a result of an underlying illness or treatment.5. Has an active neoplastic disease or a history of any hematologic malignancy.6. Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day ofbeclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxicdrugs.7. Has a history of receiving immunoglobulin or other blood products within the 3 monthsprior to enrollment in this study.8. Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or4 weeks (for live vaccines) prior to enrollment in this study.9. Has an acute or chronic medical condition that, in the opinion of the investigator,would render vaccination unsafe or would interfere with the evaluation of responses(this includes, but is not limited to: known chronic liver disease, significant renaldisease, unstable or progressive neurological disorders, diabetes mellitus, andtransplant recipients).10. Has a history of severe reactions following immunization with contemporary influenzavirus vaccines.11. Has an acute illness, including an oral temperature greater than 100.0 degrees Fwithin one week of vaccination.12. Received an experimental vaccine or medication within 1 month prior to enrollment inthis study, or expects to receive an experimental vaccine, medication, or bloodproduct during the 6 to 7-month study period.13. Has a history of alcohol abuse or drug abuse (including chronic pain medication) inthe last 5 years.14. Has any condition that would, in the opinion of the site principal investigator,place the volunteer at an unacceptable risk of injury or render the subject unable tomeet the requirements of the protocol. |
NCT00240526 | LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers | Hepatitis B To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years afteradministration of the first dose of the study vaccine. The Protocol Posting has been updatedin order to comply with the FDA Amendment Act, Sep 2007.No additional subjects will be recruited during this long-term follow-up study and novaccine will be administered. Inclusion Criteria:- Subjects who had received at least one dose of the study vaccine in the primary study- Written informed consent obtained from each subject before each blood sampling visitExclusion Criteria: |
NCT00240097 | Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC) | Non-Small Cell Lung Cancer The primary objective of Part I of the study is to determine tumor response rate ofsequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-nave patients with extensive small cell lung cancer. Theprimary objective of Part II of the study is to determine the objective tumor response rateof irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed tofirst line chemotherapy or chemoradiotherapy. Inclusion Criteria:1. Histologic or cytologic diagnosis of SCLC.2. Measurable or assessable tumor parameters.3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.4. Age between 18 and 79 years (in the State of Alabama > 18).5. Adequate bone marrow, liver and renal function, defined as:- Absolute neutrophil count (ANC) 1500/L- Platelet count 100,000/L- SGOT/SGPT 2.5 x upper limit of normal or 5 x upper limit of normal whenliver metastases are present.- Total bilirubin value 1.5 x upper limit of normal.- Serum creatinine value 1.5 x upper limit of normal.6. Fully recovered from any previous surgery (at least 4 weeks since major surgery)7. Must have recovered from prior radiation therapy (at least 3 weeks)8. All participants must agree to practice approved methods of birth control (ifapplicable). A negative pregnancy test must be documented during the screening periodfor women of childbearing potential.9. Must provide written informed consent and authorization to use and disclose healthinformation (HIPAA).For Part I10. Extensive-stage SCLC as defined as disease not confined to one hemithorax, includingipsilateral pleural effusion or pericardial effusion.11. No prior chemotherapy.For Part II12. Patients with either refractory disease, or who have relapsed 1st line therapy. Noprior chemotherapy with Oxaliplatin or irinotecan.13. Demonstrated tumor progression at the time of study entry.Exclusion Criteria:1. Concurrent cancer chemotherapy, biologic therapy or radiotherapy.2. Administration of any investigational drug within 28 days prior to administration ofthe current therapy.3. Symptomatic brain metastases; those patients should be treated first with eitherwhole brain radiation therapy or radiosurgery.4. Concurrent serious infection.5. Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor,which is likely to compromise patient safety and affect the outcome of the study.6. History of other malignancy (except non-melanoma skin cancer or carcinoma in situ ofthe cervix), unless in complete remission and off all therapy for a minimum of 2years.7. Neuropathy at baseline Grade 2.8. Any evidence or history of hypersensitivity or other contraindications for the drugsused in this trial.9. History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normalfrequency) in the past 2 weeks.10. History of a positive serology for human immunodeficiency virus (HIV).11. Psychiatric disorder that prevents patients from providing informed consent orfollowing protocol instructions.12. Pregnant or lactating women. |
NCT00240929 | A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis) | -Unhealthy Children With a History of Prematurity A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one ofthe following treatment sequence A or B. Inclusion Criteria:- The child must have been born at greater than or equal to 35 weeks gestation and begreater than or equal to 6 months of age at the time of randomization (child must berandomized on or before their 6-month birthday)- The child's parent or legal guardian must provide written informed consent; and- The child must be able to complete the follow-up visits on Study Days 30 and 60within the protocol specified windows (2 days)- Parent/legal guardian of patient has available telephone access.Exclusion Criteria:- Be hospitalized;- Birth hospitalization > 6 weeks duration;- Be receiving mechanical ventilation at the time of study entry (including CPAP);- Bronchopulmonary dysplasia (BPD), defined as history of prematurity and associatedchronic lung disease with oxygen requirement for >28 days;- Congenital heart disease (CHD). (Children with medically or surgically corrected[closed] patent ductus arteriosus and no other CHD may be enrolled.)- Known renal impairment, hepatic dysfunction, chronic seizure disorder, orimmunodeficiency;- Any of the following laboratory findings in blood obtained within 7 days prior tostudy entry:- BUN or creatinine >1.5 the upper limit of normal for age- AST (SGOT) or ALT (SGPT) >1.5 the upper limit of normal for age- hemoglobin <9.0 gm/dL- white blood cell count <4,000 cells/mm3- platelet count <110,000 cells/mm3- Acute illness or progressive clinical disorder;- History of recent difficult venous access;- Active infection, including acute RSV infection;- Previous reaction to IGIV, blood products, or other foreign proteins;- Received within the past 120 days or currently receiving IGIV, other immunoglobulinproducts, or any investigational agents;- Have ever received palivizumab;- Currently participating in any investigational study; or- Previously participated in any investigational study of RSV vaccines or monoclonalantibodies. |
NCT00240487 | Nitric Oxide Administration for Acute Respiratory Distress Syndrome | Acute Respiratory Distress Syndrome This research project is an open-label, randomized study for the use of Nitric Oxide inpediatric patients with acute respiratory distress syndrome (ARDS). The study examineswhether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure ofoxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goalof the study is to evaluate whether the order of NO therapy will have any effect onresponse, and evaluate the characteristics of patients who respond to NO compared to thosewho do not. Inclusion Criteria:- Patient is intubated and mechanically ventilated in the Pediatric Intensive Care Unitwith a PaO2/FiO2 ratio less than or equal to 100, FiO2 greater than or equal to 0.60,PEEP greater than or equal to 10, and a Murray score greater than or equal to 2.5.Exclusion Criteria:- Neonates (1 week to 28 days) and/or patients on extracorporeal membrane oxygenation |
NCT00240253 | A Study Evaluating the Efficacy and Safety of Adding Symlin to Lantus (Insulin Glargine) in Subjects With Type 2 Diabetes | Type 2 Diabetes Mellitus The purpose of this study is to evaluate the efficacy and safety of adding Symlin to anestablished regimen of insulin glargine in subjects with type 2 diabetes who are notachieving glycemic targets. Inclusion Criteria:- Has HbA1c >7.0% and <=10.5%- Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2- Has received insulin glargine for 3 months prior to study start and has been on astable dose for 1 month prior to study start- If taking oral antidiabetic agents, has been on a stable dose for at least 2 monthsExclusion Criteria:- Has been previously treated with Symlin/pramlintide (or has participated in aSymlin/pramlintide clinical study)- Has received any investigational drug within 1 month of screening |
NCT00240045 | The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction | Type 2 Hepatorenal Syndrome We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome aremediated in part by diminished circulatory volume and that treatment with midodrine,octreotide and albumin can improve renal and patient outcomes by restoring effectivecirculating volume and systemic perfusion.Our primary objective is to assess change in creatinine clearance using inulin. We willenroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion andexclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR,albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before,during, and after initiation of drug and compared. Inclusion Criteria:- Cirrhosis (biopsy or compatible clinical (ascites, varices), laboratory (low albumin,elevated bilirubin, elevated INR) and radiologic data (nodular appearing liver onultrasound)).Type 2 hepatorenal syndrome and/or refractory ascitesExclusion Criteria:- Secondary causes of renal dysfunction (proteinuria >500 mg/day, active urinarysediment, abnormal renal ultrasound, nephrotoxic medications) Bacterial infection(positive blood, urine or ascites cultures) within the past 2 weeks Gastrointestinalhemorrhage or encephalopathy within the past 2 weeks Age <18 Transvenous intrahepaticportosystemic stent shunt (TIPS) Hepatocellular carcinoma beyond the Milan criteria |
NCT00240643 | Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke | Fibrillation, Atrial This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323in a relevant population. The data from this study will be used along with other data to aidin choosing the most appropriate dose for the later phase study. Inclusion Criteria:- Patients with non valvular atrial fibrillation and any of the following:- </= 60 years old with no heart disease.- 60 years old with heart disease but no risk factors.- >/=60 years old and </=75 years old with no risk factors and no heart disease.- Must be able to take aspirin.Exclusion Criteria:- Previous heart attack or stroke.- History of high blood pressure, diabetes or a prior blood clot.- Liver or kidney disease.- Need for anti-thrombotic or anti-platelet drugs.- Need for cardiovascular medicines. |
NCT00240864 | An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain | Pain The purpose of this study is to determine the onset of pain relief from a single dose ofacetaminophen and ibuprofen in subjects experiencing postoperative dental pain following thesurgical extraction of at least three molars. Inclusion Criteria:- Indicates moderate to severe pain following the extraction of at least three molars(including at least one partial or complete bony mandibular third molar impaction)- weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28- not taking any medications for anxiety, depression or schizophrenia- if female, not pregnant or breastfeedingExclusion Criteria:- Used ibuprofen or acetaminophen within 12 hours preceding surgery or any other painrelievers or anti-inflammatory drugs within 24 hours preceding surgery- have any gastrointestinal disease that would interfere with the absorption andexcretion of study medications- unable to swallow the study medication whole- have any significant medical condition- have a history of adverse reactions to acetaminophen, ibuprofen or any anestheticagent used in the extraction |
NCT00240695 | A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive Impairment | Cognition Disorder The purpose of this follow-up study is to assess the long-term safety and tolerability ofgalantamine in individuals with mild cognitive impairment who participated in a previousstudy with galantamine Inclusion Criteria:- Completed 24 months of double-blind treatment in 1 of 2 previous studies withgalantamine without progressing to dementia (CDR< 1)- Able to safely receive open-label galantamine in the opinion of the investigator andtreatment is in the individual's best interest- Regular (at least 3 days a week) visits from a person able to accompany patient toscheduled visits- Enrolled within 7-30 days after the previous galantamine study Exclusion Criteria:- Individuals who converted to dementia (CDR > = 1) during 1 of the previousgalantamine studies- Prematurely discontinued 1 of the previous galantamine studies or completed 1 of theprevious studies more than 30 days prior to this study- Current clinically significant cardiovascular disease (including heart surgery,unstable angina, congestive heart failure, fibrillation, valve disease oruncontrolled high blood pressure) |
NCT00240656 | Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial Hypertension | Hypertension, Pulmonary The purpose of this study is to determine whether a larger dose of the aldosteroneantagonist spironolactone combined with an ACE inhibitor (captopril) and a beta-blocker(carvedilol) is effective in reverse pulmonary artery remodeling in patients with pulmonaryarterial hypertension (PAH)secondary to congenital heart disease Inclusion Criteria:- A mean pulmonary artery pressure higher than 25 mm Hg or, when estimated byechocardiography, pulmonary artery pressure more than half the systemic arterypressure- Congenital systemic-to-pulmonary shunts |
NCT00240734 | Treatment of Anemia in Diabetic Subjects With CKD | Anemia The purpose of this study is to compare the proportion of subjects receiving either Epoetinalfa (PROCRIT) or placebo who are able to achieve a hemoglobin response, defined by atleast a 1 gram/deciliter increase from baseline by Week 17. Inclusion Criteria:- Subjects with a clinical diagnosis of diabetes mellitus- History of documented proteinuria or microalbuminuria- A glomerular filtration rate between 15 and 90 mL/minute/1.73m2- Subjects with hemoglobin greater than or equal to 9.0 /dL and less than or equal to11.0 g/dL.Exclusion Criteria:- A current diagnosis of poorly controlled high blood pressure (hypertension) (systolicblood pressure > 150 mm Hg or diastolic blood pressure > 100 mm Hg) after adequateanti hypertensive therapy- Subjects with severe neuropathy or peripheral vascular disease with gait instability- Subjects scheduled to receive dialysis during the course of the study- Subjects with a transferrin saturation < 20% or ferritin level < 50 ng/dL- Subjects with active malignancy, defined as a malignancy requiring current therapy(surgery, chemotherapy, or radiotherapy) or a history of treatment for malignancy inthe last 5 years. |
NCT00240708 | A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With Schizophrenia | Schizophrenia The purpose of this study is to evaluate the effectiveness and safety of risperidone,formulated as a long-acting injectable drug, compared with risperidone tablets in thetreatment of patients with schizophrenia. Inclusion Criteria:- Diagnosis of schizophrenia by the criteria of Diagnostic and Statistical Manual ofMental Diseases, 4th Edition (DSM-IV )- treatment with an antipsychotic drug (up to 6 milligrams/day of risperidone orequivalent dose) for 28 days before study initiation with no change in the dosage- Total Positive and Negative Syndrome Scale (PANSS) score >=60 and <120 at start ofstudy.Exclusion Criteria:- Diagnosis of mental disease other than schizophrenia- treated with a sustained-release injection of other antipsychotic medications within60 days before the initiation of the study- history of cerebrovascular accident, convulsive disorder such as epilepsy, diabetesmellitus, liver disease, kidney disease, cardiovascular disorder, malignancy orphysical exhaustion due to dehydration or malnutrition- have risk factors of diabetes mellitus, such as hyperglycemia. |
NCT00240318 | A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID) | Coronary Arteriosclerosis The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce theatherosclerosis (fatty deposits) in your arteries Inclusion Criteria:- Clinical indication for coronary catheterization. Target Coronary Artery: The targetvessel must have .50% reduction in lumen diameter by angiographic visual estimationthroughout a segment of at least 40 mm in length (the target segment) and the vesselmust be large enough to accommodate the IVUS catheter. A lesion of up to 60% ispermitted distal to the target segment. Side branches of the target (imaged) vesselmay be narrowed up to 70% by visual estimation, provided the target segment containsno lesion greater than 50%.Exclusion Criteria:Use of lipid-lowering medication for more than 3 months within the previous 12 months.Longer periods of treatment are not permitted because of the potential effects of suchtherapy on coronary atherosclerosis. Subjects receiving treatment with a lipid-loweringmedication within the past 4 weeks require a 4-week wash-out period following which abaseline lipid profile will be taken at visit 2.Clinically significant heart disease which, in the opinion of the Principal Investigator(or designee), is likely to require coronary bypass surgery, cardiac transplantation,surgical repair and/or replacement during the course of the study. |
NCT00240331 | AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD) | Renal Failure The purpose of this study is to see if rosuvastatin helps to reduce the number of heartattacks, strokes and cardiovascular deaths in patients undergoing haemodialysis. Inclusion Criteria:- Male or female subjects with end-stage renal failure aged 50-80 years, who havereceived regular haemodialysis treatment for at least 3 monthsExclusion Criteria:- Subjects will have no underlying condition that is expected to limit survival to lessthan 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects shouldnot have received a statin therapy within the past 6 months |
NCT00240682 | Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR | Skin Diseases The purpose of this study is to determine whether cetuximab is effective in the treatment oflocally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR. Inclusion Criteria:- Histological SCC of the skin expressing (IHC) moderately or highly the EGFR (++ and+++, on a semi-quantitative scale).- Locally advanced or metastatic SCC of the skin not suitable for local surgery withdocumented progression.- Presence of at least one measurable target lesion by RECIST criteria.- At least one lesion accessible to biopsies.- ECOG Performance status < 2.- Life expectancy > 3 months.- Age > 18 years.- Normal hematological (Neutrophils > 1.5x109 cells/l, platelets > 100x109 cells/l),hepatic (bilirubin < 1.5 times the upper limit of the normal range (ULN); alkalinephosphatase and transaminases < 5 x UNL in case of hepatic metastases or < 2.5 x UNLin absence of hepatic metastases) and renal (serum creatinine < 150 micromol/L)functions.- Written informed consent.- In case of second tumor,excepted carcinoma of the cervix and adequately treated basalor squamous cell skin carcinoma, the possibility for including a patient may bediscussed with the principal investigator.Exclusion Criteria:- Prior chemotherapy- Prior radiotherapy < 1 month.- Prior therapy with agent targeting EGFR- Unstable systemic diseases or active uncontrolled infections.- Patients (male and female) not using effective contraception if of reproductivepotential.- Females pregnant or lactating. Women of child bearing potential must have a negativeserum or urine pregnancy test prior to start each cycle of treatment. |
NCT00240669 | RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery | Maxillo-Facial Surgery Primary objective : To evaluate the quality of fractures setting and osteotomy of the facialmassif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.Secondary objective :- To evaluate the resorbable device ergonomy versus Titanium.- To evaluate the clinical tolerance of resorbable device versus Titanium.Hypothesis :Osteosynthesis with resorbable device demonstrates a non inferiority success probabilityregarding the success observed in osteosynthesis with Titanium, with a less importantprobability of re-operation.Study duration : 14 months for each patient.Study treatment :- Group I : Resorbable device PLLA/PGA.- Group II : Titanium device.Study visits :- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day45(Traumatology)/Day 90 (orthognatic) Month 6,12 and 14.Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic ororthognatic criteria. Inclusion Criteria:- 18<Age<50.- One or more fractures of facial massif requiring a surgical setting withosteosynthesis plates.- One or more osteotomy of facial massif requiring a surgical setting withosteosynthesis plates.- Orally and written informed patient. Patient willing to participate the study.- Signed informed consent.Exclusion Criteria:- Any previous surgery at the same operative site.- Patient suffering from chronic affection which could interfere with boneconsolidation.- Corticotherapy, immunosuppressive or anticonvulsant treatment or long termantibiotherapy.- Nursing or pregnant female.- Patient with a high risk of non compliance to sudy visits.- Unconscious patient. |
NCT00240084 | Nesiritide and Vo2 Max in Heart Failure Patients | Heart Failure This research study, funded by Scios, Inc., and conducted by the Cardiology Division of theDepartment of Medicine at the University of Rochester School of Medicine and Dentistryinvestigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improvingexercise capacity in patients with heart failure (HF). Previous studies have shownbeneficial hemodynamic and neurohumoral effects of nesiritide infusion in the therapy ofdecompensated heart failure. Other studies have demonstrated increases in endogenous BNPlevels (normalized for exercise workload) in HF patients during and after exercise. However,trials involving the measurement of exercise capacity in this population following BNPadministration are lacking. This is an experimental prospective, non-blinded, pilot studywith a sample size of 20 patients, all serving as their own controls. This study involvesoff-label use of the drug nesiritide (indicated for IV treatment of NYHA Class II and IIIpatients, and this study is enrolling Class II and III patients) and has received FDAapproval, and an IND. Subjects are recruited from the population of referrals to the StrongMemorial Hospital Heart Failure and Transplantation clinical service, who meet all theinclusion criteria and none of the exclusion criteria may participate in the study. Enrolledstudy subjects perform an exercise VO2 max test, receive a 24 hour infusion of nesiritideand perform a second exercise VO2 max test. Inclusion Criteria:- Aged 18-65 with NYHA Class II or III heart failure- Referred to Strong Memorial Hospital for consideration of heart transplant- Male or female and infertile or using effective contraception with negative pregnancytest- Capable of IV access- Able to perform a maximal bicycle test and tolerate mouthpiece and nose clip- Fully understands and has signed Informed Consent Form before study begins- Endogenous BNP level of at least 100 pg/mL- Current smokers smoking < 3 cigarettes / day. Smoking is not permitted within thehospital, ergo subjects would not be permitted to smoke during study participation.Exclusion Criteria:- NYHA Class i or IV heart failure- Creatinine clearance < 30 ml/min, as determined within 2 weeks of the start of thestudy- EF > 40%- Evidence of primary lung disease- Hypersensitivity to nesiritide or any of its' components- Current smokers as defined by > 3 cigarettes / day- Stroke within 3 months, myocardial infarction within 2 months, or any evidence ofactive myocardial ischemia- Unwillingness ir inability to remain in the hospital overnight- Clinical condition or laboratory abnormality which may increase risks associated withparticipation or interfere with result interpretation- Any condition which would preclude heart transplantation. |
NCT00240721 | A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder | Bipolar Disorders The primary purpose of this study is to evaluate the effectiveness and safety of topiramatecompared with placebo in the treatment of acute manic or mixed episodes in patients withBipolar I Disorder. Inclusion Criteria:- Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual ofMental Diseases, 4th edition (DSM-IV), and currently experiencing a manic or mixedepisode by DSM-IV and Structured Clinical Interview criteria- experienced at least one previous manic or mixed episode- Young Mania Rating Scale (YMSR) score >=20- physically healthy- females must be postmenopausal, surgically sterile, or using adequate contraceptivemeasures, and have a negative pregnancy test.Exclusion Criteria:- Diagnosis of alcohol or substance dependence (with the exception of nicotine orcaffeine dependence) by DSM-IV criteria- DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder- experienced a manic episode while taking an antidepressant or psychostimulant drug- no significant and untreated or unstable medical illness of the liver, kidney, heart,lungs, or endocrine system- no hypersensitivity to topiramate or have previously participated in a topiramatestudy. |
NCT00240292 | Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines | Heart Failure, Congestive The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of40mg/day) compared to placebo on cardiac remodelling, estimated by change in leftventricular ejection fraction on radionuclide ventriculography, at 26 weeks postrandomisation from baseline. Inclusion Criteria:- Signed informed consent, males or females aged 18 or older, LVEF 40% assessed byRNVG or contrast ventriculogram or 35% assessed by TTE within the previous 6months, LVEF < 45% as assessed by RNVG during Visit 1, NYHA Class II, III or IVsymptoms primarily related to heart failure, ischaemic and non-ischaemic patients andon stable heart failure therapy as defined by physician's best practice.Exclusion Criteria:- Key exclusion criteria include acute myocarditis within the last 12 months, diabetesmellitus not controlled by diet, oral therapy or insulin therapy, homozygous familialhypercholesterolaemia, receiving biventricular pacing or expected to receivebiventricular pacing in the next 6 months, subjects who normally would be consideredfor statin therapy in the next 6 months, sever hypertension, history of definitemyocardial infarction, cerebrovascular accident, percutaneous transluminal coronaryangioplasty or coronary bypass graft within 3 months prior to enrolment in the study,body mass index < 15, plus others. |
NCT00240279 | The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study | Hypercholesterolemia To investigate the effect of rosuvastatin compared to placebo on the aortic stiffness inhemodialysis patients as measured by pulse wave velocity (at 3, 6 and 12 months) Inclusion Criteria:- Signed informed consent, between 50 and 80 years of age, end stage renal failurepatients receiving hemodialysisExclusion Criteria:- Received statins within past 6 months, a clear indication for use of lipid alteringdrug, contra indication for lipid altering drug, history of statin induced myopathyitems in very |
NCT00240513 | Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin | Acne Vulgaris The use of oral antibiotics alone to treat inflammatory acne provides little to no long termtherapeutic benefit.Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction withminocycline, thereby increasing the therapeutic effect of the oral antibiotic. Inclusion Criteria:- Provision of written consent- Either sex- Any age- Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on theface.Exclusion Criteria:- Known hypersensitivity to tetracyclines- Use of any oral antibiotics in the previous 3 months- Pregnancy, breast-feeding or lactating- Inability or unwillingness to comply with the requirements of the protocol, or agreeto the use of their data as determined by the investigator.- Concomitant medical condition which, in the investigator's opinion, may confound thestudy results or interfere with study assessments or outcomes.- Patients with severe acne on the chest, back or trunk. |
NCT00240539 | Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg) | Hepatitis B This study is performed to evaluate the persistence of anti-hepatitis B surface antigen(HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose ofthe study vaccine, Engerix-B. No new subjects will be recruited in this long-term follow-upstudy.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep2007. Inclusion Criteria:- Subjects who had participated in the primary study.- Written informed consent obtained from the subject. |
NCT00240500 | Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers | Hepatitis B The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen(anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose ofthe study vaccine. The Protocol Posting has been updated in order to comply with the FDAAmendment Act, Sep 2007. Inclusion Criteria:- Subjects who had received at least one dose of the study vaccine in the primary study(103860/064)- Written informed consent obtained from each subject before each blood sampling visit |
NCT00240266 | Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT) | Metabolic Syndrome The purpose of this study is to investigate the effect of treatment with rosuvastatin on thecapacity of plasma to promote cholesterol efflux, which is the first and likely ratelimiting step in reverse cholesterol transport. Inclusion Criteria:- Signed informed consent- males aged 45-65- insulin resistance- central obesity- LDL-C <6 mmol/L- plasma triglycerides >=1.7 and 5.5 mmol/L- HDL-C 1.2 mmol/L.Exclusion Criteria:- total cholesterol >7mmol/L- pre-existing cardiovascular disease, diabetes, proteinuria or renal failure |
NCT00240058 | Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity | Blood Pressure This is a research project to test two study techniques among healthy adults. The procedureslook at how blood flow is controlled by substances in blood vessels. Inclusion Criteria:Healthy men and women:- Age 18 to 55 years- Who have Blood Pressure less than or equal to 120/80.Exclusion Criteria:Individuals with:- Diabetes, lung disease- Stomach disease, liver disease- Blood vessel disease- Kidney disease- High blood pressure- Heart disease- Hereditary blood disorders- Hematocrit (amount of red blood cells) less than 30%,- Who smoke- Women who are pregnant or lactating |
NCT00240110 | Valproate Efficacy in Cocaine-Bipolar Comorbidity | Bipolar Disorder This proposal will test the efficacy of a promising pharmacological approach for thetreatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized,double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium(Valproate) plus treatment as usual compared to placebo plus treatment as usual indecreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocainedependence and bipolar disorder. Treatment as usual includes the use of lithium carbonatefor mood stabilization plus supportive psychosocial treatment. Inclusion Criteria:- Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorderExclusion Criteria:- Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolarmajor depression, primary anxiety disorder, mental retardation, and signs of impairedcognitive functioning.- Current DSM-IV criteria for dependence on substances other than cocaine, alcohol,cannabis, nicotine, or caffeine- Neurological conditions including epilepsy, history of brain injury, encephalitis, orany organic brain syndrome or documented focally abnormal EEG- Medical conditions including severe cardiac, liver, kidney, or liver disease.- Pregnancy- Inability or unwillingness to use contraceptive methods- Any medical condition or other reason that in the opinion of the investigator wouldprevent the subject from completing the protocol. |
NCT00240851 | An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race | Pain The purpose of this study is to compare the effectiveness of acetaminophen extended releasecaplets to placebo in treating the muscle aching and pain (soreness) that occurs after amarathon. Inclusion Criteria:- Patients must be able to comply with the study schedule- be able to swallow the study medication- complete the marathon- not take any analgesics after completing the marathon and before their eligibility toparticipate in the study has been determined- rate their muscle soreness at least a 4, on a 0 - 10 point scaleExclusion Criteria:- Previous diagnosis of osteoarthritis- currently have or have had a medical condition that may be relevant in one'seligibility to participate in the study- known hypersensitivity to acetaminophen- unable to understand or follow the instructions for the study- taken any investigational medication within 30 days of the marathon |
NCT00240474 | A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study) | Hypertension The primary objective of this study was test non-inferiority of telmisartan 80 mg +hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg inreducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosinginterval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients withpredominantly systolic hypertension. Inclusion criteria:- aged at least 60 years old- mean SBP greater than 140 mmHg and mean DBP less than or equal to 95 mmHg- 24-hour mean ambulatory SBP greater than 125 mmHg- hypertensive patients not on current antihypertensive therapy or able to stop theircurrent treatment for a period of up to eighteen weeks- willing and able to provide written informed consentExclusion criteria:- women of child-bearing potential who are NOT practicing acceptable means of birthcontrol- known or suspected secondary hypertension- mean SBP equal to or greater than 200 mmHg- hepatic and/or renal dysfunction as defined by the following laboratory parameters:- bilateral renal artery stenosis, renal artery stenosis in a solitary kidney,patients post-renal transplant or with only one functioning kidney- clinically relevant hypokalemia or hyperkalemia- uncorrected volume or sodium depletion- primary aldosteronism- hereditary fructose intolerance- biliary obstructive disorders- patients who have previously experienced symptoms characteristic of angioedema duringtreatment with ACE inhibitors or angiotensin-II receptor antagonists- history of drug or alcohol dependency within the previous six months- chronic administration of any medication known to affect blood pressure, other thanthe trial medication- concurrent participation in another clinical trial or any investigational therapywithin thirty days prior to signing the consent form.- symptomatic congestive heart failure (New York Heart Academy (NYHA) functional classCHF II-IV)- unstable angina pectoris, myocardial infarction, percutaneous transluminal coronaryangioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than threemonths prior to informed consent- stroke less than six months prior to informed consent- sustained ventricular tachycardia, atrial fibrillation, atrial flutter or otherclinically relevant arrhythmias as determined by the investigator- hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of theaortic or mitral valve- insulin-dependent diabetes mellitus whose diabetes has not been stable and controlledfor the previous three months- night-shift workers who routinely sleep during the daytime and whose working hoursinclude midnight to 4:00 AM- known allergic hypersensitivity to any component of the formulations underinvestigation- concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliancewith study medication (defined as less than 80% or more than 120%) during the run-inperiod- current treatment with any antihypertensive agent- any other clinical condition which, in the opinion of the investigator, would notallow safe completion of the protocol and safe administration of telmisartan,amlodipine or hydrochlorothiazide |
NCT00240448 | A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients | Hypertension The primary objective of this study is to compare the effectiveness of telmisartan 80mg/hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg/hydrochlorothiazide 25 mg[Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension. Inclusion criteria1. Ability to provide written informed consent.2. Age 18 years or older.3. Ability to stop current antihypertensive therapy without unacceptable risk to thepatient (investigator's discretion).4. Seated cuff DBP of 95 mmHg at Visit 2 (baseline).Exclusion criteria1. Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:- Are not surgically sterile and/or- Are nursing or pregnant- Are of child-bearing potential and are NOT practicing acceptable means of birthcontrol, do NOT plan to continue using this method throughout the study and doNOT agree to submit to periodic pregnancy testing during participation instudies of > 3-months duration. Acceptable methods of birth control includeoral, implantable, transdermal, or injectable contraceptives, and Intra-UterineDevice (IUD).2. Known or suspected secondary hypertension.3. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visitprior to randomization.4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:- SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or- Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney,post-renal transplant or with only one kidney.6. Clinically relevant hypokalemia or hyperkalemia.7. Uncorrected volume depletion.8. Uncorrected sodium depletion.9. Primary aldosteronism.10. Hereditary fructose intolerance.11. Biliary obstructive disorders, cholestasis or moderate to severe hepaticinsufficiency.12. Patients who have previously experienced symptoms characteristic of angioedema duringtreatment with ACE inhibitors or angiotensin II receptor antagonists.13. History of drug or alcohol dependency within six months prior to start of run-inperiod.14. Chronic administration of any medications known to affect blood pressure, etc.15. Any investigational drug therapy within one month of start of run-in period.16. known hypersensitivity to any component of the formulation study drugs (telmisartan,valsartan, HCT).17. Contra-indication to a placebo run-in period (e.g. stroke within the past six months,MI, cardia surgery, PTCA or angina within the past three months prior to the start ofrun-in period.18. Any other clinical condition which, in the opinion of the principal investigator,would not allow safe completion of the protocol and safe administration oftelmisartan, valsartan, or HCT.19. Night shift workers.20. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutteror other clinically relevant cardiac arrhythmias as determined by the investigator.21. NYHA functional class CHF III-IV.22. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevantstenosis of aortic or mitral valve.23. Patients whose diabetes has been unstable and uncontrolled for at least the past 3months as defined by a HbA1c >/= 10%.24. Concomitant use of lithium or cholestyramine or colestipol resins (potential druginteractions with HCT).25. History of non-compliance with prescribed medication or protocol procedures. |
NCT00240461 | Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors | Respiratory Tract Infection Seniors are a population vulnerable to respiratory infections. It is hypothesized thatregular use of COLD-fX following an influenza vaccination would potentially augment immuneresponse in the elderly. Use of COLD-fX may also provide additional protection againrespiratory infection and reduce the incidence and severity of respiratory infections inotherwise healthy seniors. Inclusion Criteria:- Age 65 years of age and older- current season influenza immunization- available for follow-up visits- willing and able to sign written informed consentExclusion Criteria:- HIV infection- malignancy (under active observation or treatment)- unstable cardiovascular diseases- renal abnormalities (serum creatine >200umol/l)- pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment inthe last 3 months with oral steroids - prednisone >10mg/day, other chronicrespiratory illness)- acute or active chronic liver disease- neurologic or psychiatric disease (progressive or currently under treatment- active tuberculosis- multiple sclerosis- bleeding disorders- planned surgery over the course of the trial- on immunosuppressive therapy- taking oral steroids at dose = to prednisone 10 mg/day or more- taking phenelzine, pentobarbital, haloperidol, warfarin, heparin- use of natural health products(except the study product and vitamins and mineralswith a dose <600 mg/day of vitamin E and containing no vitamin K) including echinaceaor ginseng-containing products (tea, capsules, extracts, tablets)- current alcohol/drug abuse- major surgery in the past 6 months- allergies to ginseng |
NCT00240071 | Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Previously Hormone Responsive Metastatic Breast Ca. | Metastatic Breast Cancer The purpose of this study is to determine if acquired hormone therapy resistance can bereversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluatetoxicity of the combination of hormone treatment plus Avastin (Bevacizumab). Inclusion Criteria:- Patients must have cytologically or histologically proven breast cancer which isestrogen receptor or progesterone receptor positive and is locally advanced and /ormetastatic.- Give written informed consent prior to study specific screening procedures, with theunderstanding that the patient has the right to withdraw from the study at any time,without prejudice (Appendix E).- Be female and greater than or equal to 19 years of age (age limit required by theState of Alabama). Women of childbearing potential must have a negative pregnancytest and must be willing to consent to using effective contraception while ontreatment and for a reasonable period thereafter. Should a woman become pregnant orsuspect she is pregnant while participating in this study, she should inform hertreating physician immediately.- Be ambulatory (outpatient) and have an ECOG PS <2 (Appendix B).- Previous treatment: Patients must have responded to first or second line hormonaltherapy (Partial and complete response greater than 6 months using RECIST criteria.Patients with stable disease for more than 6 months will be eligible) and becameresistant to the hormonal agent. They must remain on the current hormone therapy towhich they initially responded but now are resistant.- Clear documentation of acquired hormonal resistance.- Evaluable disease will be considered eligible, but measurable disease according toRECIST criteria will be preferable (Appendix C). The target lesion(s) must not havebeen previously irradiated (newly arising lesions in previously irradiated areas areacceptable).- Patients must have adequate organ and marrow function as defined as follows: absoluteneutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelets > 75,000/mm3, totalbilirubin < 2 mg/dl, serum creatinine < 2 mg/dl, transaminases (AST, ALT) may be upto 2.5 x institutional upper limit of normal for patients with no liver metastasesand up to 5 x institutional upper normal limit for patients with documented livermetastases. In addition < 1 gr of protein in 24 hr urine collection and urineprotein/creatinine ratio < 1.0- Prior chemotherapy does not exclude patients from study as long as the currenttherapy was hormonal therapy alone.- Patients with de novo hormone therapy resistance will not be eligible.- No life threatening parenchymal disease or rapidly progressing disease warrantingcytotoxic chemotherapy.- No history of brain metastases.- No history of thrombosis during the previous year, including transient ischemicattack.- Hypertension must be controlled (< 150/100 mmHg).- Ejection Fraction > 50%.Exclusion Criteria:- Patients who are "de novo" resistant to hormone therapy.- Current, recent (within 4 weeks of the first infusion of this study), or plannedparticipation in an experimental drug study other than this Genentech-sponsoredbevacizumab cancer study.- Blood pressure of >150/100 mmHg- Unstable angina- New York Heart Association (NYHA) Grade II or greater congestive heart failure- History of myocardial infarction within 6 months- History of stroke within 6 months- Clinically significant peripheral vascular disease- History of a bleeding disorder- Presence of central nervous system or brain metastases- Major surgical procedure, open biopsy, or significant traumatic injury within 28 daysprior to Day 0, anticipation of need for major surgical procedure during the courseof the study- Minor surgical procedures, fine needle aspirations or core biopsies within 7 daysprior to Day 0- Pregnant (positive pregnancy test) or lactating- Urine protein: creatinine ratio greater than or equal to 1.0 at screening. Patientsdemonstrating > 1 gr of protein in 24 hr urine collection within 4 weeks prior tostudy entry will not participate in the trial.- History of abdominal fistula, gastrointestinal perforation, or intra-abdominalabscess within 6 months prior to Day 0- Serious, non-healing wound, ulcer, or bone fracture- Unwilling or unable to comply with the protocol for the duration of the study.- Psychiatric illness/social situations that would limit compliance with studyrequirements.- Previously radiated area(s) must not be the only site of disease.- History of another malignancy within the last five years except cured basal cellcarcinoma of skin and carcinoma in-situ of uterine cervix. |
NCT00240305 | A Study to Investigate the Effect of Rosuvastatin (CRESTOR) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome | Metabolic Syndrome The purpose of this study is to investigate the dose-related effect of treatment withrosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) andapolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-densitylipoprotein cholesterol (HDL-C) concentration. Inclusion Criteria:- Signed informed consent- male aged 30 to 70 years of age- LDL-C <6 mmol/L- HDL-C 1.2 mmol/L- at least 2 of the following:- insulin resistance (fasting glucose >6 mmol/L or insulin >10 mU/L or HOMA score >2.5)- central obesity (waist circumference >=94 cm).- plasma triglycerides >=1.7 and <4.5 mmol/L.- blood pressure >=130/ >=85 mm Hg or on drug treatment for hypertensionExclusion Criteria:- LDL cholesterol >=6 mmol/L- pre-existing or history of cardiovascular disease, diabetes, renal dysfunction,anaemia, history of significant dyspepsia or gastrointestinal disease- apolipoprotein genotype E2/E2 |
NCT00240565 | Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma | Lymphoma, Non-Hodgkin This study will further characterize the activity of Tositumomab and Iodine I131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who haveprogressed following treatment with rituximab. Inclusion criteria:- Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3or marginal zone B-cell non-Hodgkin's lymphoma.- Must have received at least two prior courses of systemic treatment including atleast one treatment of rituximab (lymphoma must not have progressed during their mostrecent systemic chemotherapy treatment).- Must have evidence that their lymphoma expresses CD20 antigen and have adequate renaland hepatic function.Exclusion criteria:- Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatmentwithin 4 weeks prior to study entry.- Have active obstructive hydronephrosis.- Had prior autologous hematopoietic stem cell transplant or any allogenic stem celltransplant.- Have active infection requiring IV antibiotics.- Have brain or leptomeningeal metastasis.- Had previous allergic reaction to iodine, previously received radioimmunotherapy orare currently receiving approved or experimental anti-cancer drugs.- Patients who are pregnant or breast feeding, have known HIV infection, or are Humananti-murine antibody (HAMA) positive.- Other criteria will be evaluated at the screening visit. |
NCT00240773 | A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee | Osteoarthritis, Hip The purpose of this study is to compare the long-term safety and effectiveness ofacetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment ofosteoarthritis of the hip or knee. Inclusion Criteria:- Osteoarthritis of the hip or knee for a minimum of six months duration requiringtreatment with either an analgesic or anti-inflammatory agent on a regular basis(greater than or equal to three days/week) for at least three months- History of osteoarthritis of the hip or knee characterized by pain of mild ormoderate intensity- Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren andLawrence radiographic entry criteria- Physical ability must be either American College of Rheumatology (ACR) FunctionalClass I or II- Following the washout period, reports mild to moderately severe pain over theprevious 24 hours and demonstrates a minimum increase of 20% in the WOMACOsteoarthritis Index pain subscale score, relative to the screening score.Exclusion Criteria:- History of surgery, including arthroscopy, or major trauma to the study joint in theprevious 12 months- Radiographic evidence of severe osteoarthritis of the study joint based on theKellgren and Lawrence radiographic criteria of grade 4 osteoarthritis- Signs of active study joint inflammation including redness, warmth, and/or, ifqualifying with osteoarthritis of the knee, a large, bulging effusion of the studyknee joint with the loss of normal contour of the joint at the screening visit or atthe baseline examination after the washout period- Morning stiffness of >30 minutes duration- Significantly incapacitated or disabled and would be categorized as ACR FunctionalClass III (able to perform only few or none of the duties of usual occupation orself-care) or IV (largely or wholly incapacitated), or unable to walk withoutassistive devices |
NCT00240968 | H5 Booster After a Two Dose Schedule | Influenza The purpose of this study is to determine whether a third dose of vaccines containingA/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in thisstudy will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. Inthis study, each subject will be asked to receive a third dose of the H5 vaccine at the samelevel administered in protocol 04-063. Subjects will be asked to record oral temperature andany experienced side effects for 7 days following the vaccine. Study procedures will includeup to 3 blood sample collections. Participants will be involved in study related proceduresfor up to 6 months. Inclusion Criteria:- Previous recipient of inactivated Influenza A/H5N1 vaccine in study DMID 04-063.- Male or nonpregnant female (as indicated by a negative urine pregnancy testimmediately prior to vaccine administration) between the ages of 18 and 65 years,inclusive.- Women of childbearing potential who are at risk of becoming pregnant must agree topractice adequate contraception (i.e., barrier method, abstinence, and licensedhormonal methods) for the entire study period.- Is in good health, as determined by vital signs (heart rate, blood pressure, oraltemperature), medical history and a targeted physical examination based on medicalhistory.- Able to understand and comply with planned study procedures.- Provides informed consent prior to any study procedures and is available for allstudy visits.In order to be eligible to participate in the blood specimen collection substudy, subjectsmust also meet the following additional inclusion criteria:- Previously achieved a 4-fold or greater increase from baseline in GMT following thesecond immunization with A/H5N1 approximately 28 days after dose 2 of study DMID04-063 (approximately Day 56).- Agrees to the storage of clinical specimens for an indefinite period of time at acentral laboratory for use in future research.Exclusion Criteria:- Received placebo in DMID Study 04-063.- Known allergy to eggs or other components of the vaccine or latex.- Has a positive urine pregnancy test prior to vaccination (if female of childbearingpotential) or women who are breastfeeding.- Is undergoing immunosuppression as a result of an underlying illness or treatment.- Has or had a neoplastic disease diagnosed or treated within the last 5 years or anylifetime history of hematologic malignancy. Those participants with any history ofbenign basal cell carcinoma of the skin may participate.- Is using oral or parenteral steroids, high-dose inhaled steroids (>800 micrograms/dayof beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxicdrugs.- Has a history of receiving immunoglobulin or other blood product within the 3 monthsprior to enrollment in this study.- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or4 weeks (for live vaccines) prior to enrollment in this study.- Has an acute or chronic medical condition that, in the opinion of the investigator,would render vaccination unsafe or would interfere with the evaluation of responses(this includes, but is not limited to: known chronic liver disease, significant renaldisease, unstable or progressive neurological disorders, diabetes mellitus, andtransplant recipients).- Has a history of severe reactions following immunization with contemporary influenzavirus vaccines.- Has an acute illness, including an isolated oral temperature greater than 100.4degrees F, within 1 week of vaccination.- Received an experimental agent (vaccine, drug, biologic, device, blood product, ormedication) within 1 month prior to enrollment in this study other than DMID 04-063,or expects to receive an experimental agent during the 7-month study period.- Has a history of alcohol abuse or drug abuse (including chronic pain medication) inthe last 5 years.- Has any condition that would, in the opinion of the site investigator, place thesubject at an unacceptable risk of injury or render the subject unable to meet therequirements of the protocol. |
NCT00240149 | Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit | Hyperglycemia Recent studies of adult intensive care unit (ICU) patients have shown significantlydecreased morbidity and mortality when blood sugar concentrations are closely controlled.The safety and efficacy of this type of blood sugar management has not been studied in thepediatric ICU population. Based on the current pediatric literature data as well as ourextensive retrospective study, blood sugar concentrations have a potentially profound roleto play among PICU patients. In preparation for a multi-center randomized control trial, wepropose a prospective feasibility study to evaluate the safety and effectiveness of using aninsulin delivery algorithm to manage blood sugar in the PICU. Our hypothesis for thisfeasibility trial is that uniformly monitoring and controlling blood glucose with aDiscrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, andconsistent means of delivering insulin to manage glucose in the pediatric intensive careunit. Inclusion Criteria::Patients between 1-18 years of age admitted to the PICU at LPCH will be asked toparticipate in a randomized feasibility trial during their hospitalization. This initialage restriction will be adjusted as experience is gained.Patient displays evidence of hyperglycemia (>150mg/dl) Exclusion Criteria:Initially,patients younger than 5 years of age will be excluded. These patients appear to have ahigher sensitivity to insulin as well as a proposed higher risk of hypoglycemia. Sincethis is a feasibility trial using insulin to control glucose, we feel that it would beprudent to establish success in an older patient population before extending the study toinclude younger children and infants. In addition, our PICU study revealed no significantincreased risk of hyperglycemia based on age. This age restriction will be adjusted afterthe mid-study data analysis.Patients who are known to be pregnant will be excluded.Patients who have known platelet dysfunction will be excluded.Patients without intact, uninfected skin at the future site of sensor insertion.Study patients re-admitted to the PICU after hospital discharge will not be eligible forrepeat participation |
NCT00240175 | Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population | Diabetes Foot orthotics or shoe inserts are currently utilized as a common conservative treatmentoption for a wide variety of foot disorders. This treatment is used for both the relativelyhealthy active population and the more sedentary population with diabetes or peripheralvascular disease (dysvascular). However, there is limited objective scientific datadocumenting the actual benefits or effectiveness of either customized or over-the-counterfoot orthoses. It is the aim of this study to determine the effects of three popular footorthotics on plantar pressures in diabetic populations. If foot orthoses can be utilized asa preventive treatment option to reduce the risk for foot ulceration by redistributingplantar pressures, then orthoses would be a cost effective solution to a high cost (mentaland fiscal) medical impairment. Inclusion Criteria:- normal gait pattern- Category 1 diabetic rating by the UTHSCSA Podiatry scale - Category 1 diabetics havedocumentable peripheral neuropathy but no history of foot ulceration.- males or females between the ages of 18 and 66Exclusion Criteria:- neuromuscular deficits- no foot abnormalities (hammer toes, pes cavus) that requires specialized footwear.The participant must be tolerant of the study shoes to be supplied. To address thismatter a four week accommodation period to the study shoe will be required forinclusion to the study.- No pregnant females due to subsequent alterations in gait patterns |
NCT00240955 | Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients | Renal Transplantation The objective of this study is to assess the long-term safety and tolerability of EC-MPS onthe patients who completed the core study and wish to continue treatment on EC-MPS. Inclusion Criteria/ Exclusion Criteria- All patients who completed the core study and who are still receiving the EC-MPS andwish continue treatment with EC-MPS and from whom written informed consent has beenobtainedOther protocol-defined exclusion criteria may apply. |
NCT00240799 | An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee. | Osteoarthritis The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day)compared to placebo for safety and effectiveness in the relief of signs and symptoms ofosteoarthritis of the hip or knee over 12 weeks Inclusion Criteria:- Symptoms of osteoarthritis of the hip or knee for a minimum of six months- History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs,acetaminophen or another analgesic agent on a regular basis (>= three days/week) forat least three months before the screening visit- History of positive benefit with acetaminophen use for osteoarthritis pain- History (ie, at any time in the past since diagnosis) of osteoarthritis pain of thehip or knee when not taking osteoarthritis analgesic medication- Subjects must report a history of a pain level of moderate, moderately severe, orsevere, a WOMAC pain score >= 65 at baseline, and a 20% or greater increase in theirpain score relative to their score at screeningExclusion Criteria:- History of surgery, including arthroscopy, or major trauma to the study joint in theprevious six months before the screening visit- Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrenceradiographic criteria- Signs of clinically important active inflammation of the study knee joint includingredness, warmth, and/or a large, bulging effusion with the loss of normal contour atthe screening and/or baseline visits- Secondary osteoarthritis of the study joint including, but not limited to, septicarthritis, inflammatory joint disease, gout, Paget's disease of bone, articularfracture, major dysplasias or congenital abnormality, ochronosis, acromegaly,hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis- History of acute inflammatory arthritis or pseudogout of the study joint. |
NCT00240214 | Study Evaluating Rapamune in Patients After Kidney Transplantation | Renal Transplantation The purpose of this study is to obtain data on the effectiveness and safety of Rapamuneunder everyday conditions Inclusion Criteria:- Patients having received a renal allograft from a cadaveric or living donor with lowor moderate risk of developing acute rejection episodes.Exclusion Criteria:- Contraindications according to Summary of the Product Characteristics (SmPC). |
NCT00240994 | Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients | Kidney Failure, Chronic The purpose of this study is to evaluate the safety of alemtuzumab after kidneytransplantation as part of a multitherapy regimen to prevent kidney graft loss and death andto avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplantrecipients 1 to 20 years of age. Inclusion Criteria:- Between the ages of 1 to 20 (prior to 21st birthday)- End Stage Renal Disease- Necessity of kidney transplant- First kidney transplant received from a living donor- A living kidney donor identified- No known contraindications to therapy with alemtuzumab- Negative pregnancy test before study entry- Willing to use approved methods of contraception for the duration of the study, 6weeks after discontinuation of MMF, and 12 weeks after discontinuation of sirolimus- Informed consent from participant, parent, or guardian- Current vaccinations, including varicella-zoster (VZV) vaccine, before studyenrollmentExclusion Criteria:- Recipient of a deceased donor kidney transplant- Multiorgan transplant- History of prior organ transplantation- Participant sensitized to greater than 0% Panel Reactive Antibody (PRA) within 4weeks before study enrollment. (If participant receives a blood transfusion statuspost PRA test, then the PRA must be repeated within 1 week of transplantation)- Participants with human leukocyte antigen (HLA) identical living related donors- History of primary focal segmented glomerulosclerosis- History of other disorders requiring continuous maintenance steroids or calcineurininhibitors- Active systemic infection at time of transplant- History of malignancy- Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), orhepatitis C virus (HCV)- Contraindication to receive tacrolimus, sirolimus, MMF, or monoclonal antibodytherapy- Use of investigational drugs within 4 weeks before study enrollment- Recipient of any licensed or investigational live attenuated vaccine(s) within 2months before study enrollment- Family history of high cholesterol |
NCT00240604 | Prevention of Corticosteroid-induced Glucose Intolerance | Glucose Intolerance Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aimof the study is to examine the hypothesis that co treatment with rosiglitazone can preventglucose intolerance in patients treated with corticosteroids. Inclusion Criteria:- corticosteroid treatmentExclusion Criteria:- congestive heart failure pedal edema |
NCT00240162 | PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma | Multiple Myeloma The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing atleast a 50% reduction in paraprotein in patients with multiple myeloma whose paraproteinlevels are < 5 g/dL following high dose chemotherapy (HDCT) and autologous stem celltransplantation (ASCT). Inclusion Criteria:- Patients eligible for this trial are those diagnosed with multiple myeloma bystandard criteria and treated with HDCT and ASCT on protocols at WashingtonUniversity School of Medicine. Following HDCT and ASCT patients must have:1. M-component (IgG or IgA) with persistent measurable paraprotein, or >=2 gmonoclonal protein in 24 hr urine specimen or patients with an abnormal serumkappa/lambda ratio and a level of kappa or lambda light chain > 10 mg/dl.2. >=90 days and <= 120 days post transplant3. Laboratory values less than or equal to 2 weeks prior to initiation oftreatment:- Absolute neutrophil count (ANC) greater than or equal 1.5 x 10^9/L- Platelets (PLT) greater than or equal to 100 x 10^9/L- Hemoglobin (Hgb) greater than or equal to 9 g/dL- Serum creatinine less than or equal to 1.5 upper limit of normal (ULN)- Serum bilirubin less than or equal to 1.5 ULN- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase(ALT/SGPT) less than or equal to 3.0 x ULN- Negative for proteinuria based on dip stick reading OR, if documentation of+1 result for protein on dip stick reading, then total urinary albumin500 mg and measured creatinine clearance (CrCl) greater than or equal to 50mL/min from a 24-hour urine collection4. A negative pregnancy test 48 hours prior to study treatment and must not belactating if they are females of childbearing age.5. Ability to understand and the willingness to sign a written informed consentdocument in accordance with the guidelines of the Washington University HumanStudies Committee.6. Age greater than or equal to 18 years old.7. ECOG performance status less than or equal to 2.Exclusion Criteria:1. Receiving any other investigational agents.2. Receiving concurrent steroids with a dose equivalent of prednisone of >= 150mg/month.3. Female patients who are pregnant or breast feeding, or adults of reproductivepotential not employing an effective method of birth control. Barrier contraceptivesmust be used throughout the trial in both sexes. Oral, implantable, or injectablecontraceptives may be affected by cytochrome P450 interactions, and are therefore notconsidered effective for this study.4. Biopsy proven amyloidosis.5. Patients with a history of another primary malignancy within less than or equal to 5years, with the exception of inactive basal or squamous cell carcinoma of the skin.6. Prior chemotherapy less than or equal to 3 weeks prior to registration and/orrandomization. Patients must have recovered from all therapy-related toxicities.7. Prior biologic or immunotherapy less than or equal to 2 weeks prior to registrationand/or randomization. Patients must have recovered from all therapy-relatedtoxicities.8. Prior full field radiotherapy less than or equal to 4 weeks or limited fieldradiotherapy less than or equal to 2 weeks prior to randomization. Patients must haverecovered from all therapy-related toxicities.9. Pleural effusion or ascites that cause respiratory compromise (greater than or equalto CTC grade 2 dyspnea).10. Major surgery (i.e. laparotomy) less than or equal to 4 weeks prior to randomization.Minor surgery less than or equal to 2 weeks prior to randomization. Insertion of avascular access device is not considered major or minor surgery in this regard.Patients must have recovered from all surgery-related toxicities.11. Patients who have received investigational drugs less than or equal to 4 weeks priorto registration and/or randomization.12. Prior therapy with anti-vascular endothelial growth factor (VEGF) agents.13. Any of the following concurrent severe and/or uncontrolled medical conditions whichcould compromise participation in the study:- Uncontrolled high blood pressure, history of labile hypertension, or history ofpoor compliance with an antihypertensive regimen- Unstable angina pectoris- Symptomatic congestive heart failure- Myocardial infarction less than or equal to 6 months prior to registrationand/or randomization- Serious uncontrolled cardiac arrhythmia- QTc interval > 450 milliseconds in males or > 470 milliseconds in femalesUncontrolled diabetes- Active or uncontrolled infection- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of thelung14. Acute or chronic liver disease (e.g. hepatitis, cirrhosis).15. Impairment of gastrointestinal (GI) function or GI disease that may significantlyalter the absorption of PTK787/ZK 222584 (i.e., ulcerative disease, uncontrollednausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inabilityto swallow the tablets).16. Patients with confirmed diagnosis of human immunodeficiency virus (HIV) infection areexcluded at the investigator's discretion if he/she feels that: a potential druginteraction between PTK787/ZK 222584 and any of the patient's anti-HIV medicationscould influence the efficacy of the anti-HIV medication, or it may place the patientat risk due to the pharmacologic activity of PTK787/ZK 222584.17. Patients who are taking therapeutic warfarin sodium (Coumadin) or similar oralanticoagulants that are metabolized by the cytochrome P450 system. Heparin isallowed.18. Patients unwilling to or unable to comply with the protocol. |
NCT00240188 | A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh | Hernia, Ventral The purpose of this research is to compare open ventral incisional hernia repair to thelaparoscopic repair with respect to complications, recurrence, pain, return to normalactivities of daily living, and return to work. Inclusion Criteria:Patients will be eligible for enrollment into the study if they meet the followingcriteria: -Are 18 years of age or older -Have a diagnosis of ventral primary incisionalhernia 9-225 cm2 in size. -Give informed consent for randomization - Have a negativepregnancy test. (Women)Exclusion Criteria:Patients will be excluded for the following reasons: -Hernia cannot be detected onphysical examination - Primary ventral or umbilical hernia - Small hernia defined as lessthan 9 cm2 - Giant hernia defined as greater than 225 cm2 in size - ASA class 4 or 5, orcontraindications to general anesthesia - Severe co morbid conditions likely to limitsurvival to less than 3 years - History of malignancy within the past 5 years except fornon-melanoma skin cancer - Cirrhosis with or without ascites - Presence of bowelobstruction( partial or intermittent), strangulation, peritonitis, or perforation. -Presence of local or systemic infection - Participation in another clinical trial -Emergency operation - Prisoner |
NCT00240942 | Letrozole in the Treatment of Severe and Recurrent Endometriosis | Severe and Recurrent Endometriosis Endometriosis is a condition in which abnormal growth of tissue histologically resemblingthe lining of the uterus (endometrium) is present outside of the uterus. This study willinvestigate the effect of a daily dose of letrozole compared to GnRH is safe and in additioneffective in reducing measurable endometriosis lesions and in reducing pain in patients withactive endometriosis which were pretreated with GnRH analogs for 2 months. Inclusion Criteria- Premenopausal women > 18 years of age.- Laparoscopic and Histologically confirmed diagnosis of moderate or severeendometriosis according rASRM-Score III and IV- BMI less than 40 kg/m.- Patient is sexually abstinent or using mechanical (condoms, diaphragms) orsterilization methods of contraception and is willing to continue using themthroughout the study.- Patient is willing and able to comply with study requirements.- Written informed consent.Exclusion Criteria- Endometriosis stage I-II acc. according to rASRM- Women with other causes of chronic pelvic pain including infectious,gastrointestinal, musculoskeletal, neurologic or psychiatric.- Significant abnormalities in the physical or laboratory examination including renaland liver function more than twice the normal range.- Patient desires pregnancy for the duration of the study, is pregnant or breastfeeding.- GnRH therapy during the last 6 months- Use of hormonal contraception, selective estrogen receptor modulators, progestins,estrogens, steroids, or ovulation induction in the 4 weeks prior to inclusion intothe study.- Untreated abnormal pap smear or other gynecologic condition.- History of venous thrombosis events including deep vein thrombosis, pulmonaryembolism, or retinal vein thrombosis.- History of stroke, complicated migraine, or documented transient ischemic attack.- Known hypersensitivity to any ingredient of the study medication.- Treatment with other aromatase inhibitors- Other investigational drugs within the past 30 days and the concomitant use ofinvestigational drugs.- History of non-compliance to medical regimens, and patients who are consideredpotentially unreliable.Additional protocol-defined inclusion / exclusion criteria may apply |
NCT00240981 | TOM: Testosterone in Older Men With Sarcopenia | Sarcopenia The purpose of this study is to determine whether testosterone replacement in older men withlow testosterone levels will increase muscle strength, improve physical performance andoverall sense of well being, and reduce fatigue. Inclusion Criteria:- Community dwelling, ages 65 and older- Self-reported difficulty in climbing 10 steps without resting, or difficulty inwalking 2 or 3 blocks outside on level ground- A score of 4 to 9 on the Short Physical Performance Battery (mild to moderatephysical impairment)- Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL- Without dementia (Mini-Mental State Examination [MMSE] score > 24)Exclusion Criteria:- Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA),androstenedione or recombinant growth hormone (rGH) in the past year- Alcohol or drug abuse- Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day)- Prostate cancer, breast cancer or other cancers with life expectancy < 5 years- Limiting neuromuscular, joint or bone disease, or history of stroke with residualneurological problems- Any neurological condition that would impact cognitive functioning including:- epilepsy- multiple sclerosis- HIV- Parkinson's disease- stroke- other focal lesion- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis Ipsychiatric disorder in past year or use of psychotropic medications in 6 months- Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21- Unstable angina, New York (NY) class III or IV congestive heart failure or myocardialinfarction within 3 months of entry- Abnormal laboratory values (at discretion of principal investigator)- Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg- Body mass index > 40 kg/m2- Untreated severe obstructive sleep apnea |
NCT00240370 | A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics | Type 2 Diabetes The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemiccontrol on metformin alone, have a similar, or not inferior, glycemic response when treatedwith the combination of muraglitazar and metformin compared to pioglitazone and metformin. Inclusion Criteria:- Type 2 diabetics- HbA1c 7.0% and 10.0%,currently receiving a stable dose of metformin 1500 to 2550mg/day for at least 6 weeks prior to screening were enrolled in this study.- Fasting C-peptide 1.0 ng/mL- BMI41 kg/m2 mean fasting serum trig. 600 g/dLExclusion Criteria:- symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study- history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy,inability to take muraglitazar, pioglitazone, or metformin according to investigatorbrochure or labeling- History of MI (myocardial infarction), coronary angioplasty or bypass graft(s),valvular disease or repair, unstable angina pectoris, transient ischemic attack(TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months,congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, historyof, or renal disease, peripheral vascular disease (PVD), pulmonary disease,gastrointestinal disease, active liver disease or endocrine disease. |
NCT00240760 | Memantine and Down's Syndrome | Down's Syndrome This is a study to assess whether memantine is effective and safe in preventing age relatedcognitive deterioration and dementia in people with Down's syndrome (DS) age 40 and over.The study will last for a year and it will include 180 people with Down's syndrome with andwithout dementia. Participants will be assessed on memory skills, attention and problemsolving abilities. Quality of life and abilities for everyday living skills will also beregularly checked.Primary AimsClinical:- To determine the clinical efficacy of memantine versus placebo in preventing cognitivedecline in people with DS.- To compare the safety and tolerability of memantine versus placebo in people withDowns syndrome (DS).Biochemical and pathological:- To examine the ability of memantine to alter markers of disease progression in DSpatients.Secondary AimsClinical:- To determine whether memantine has, as compared with placebo, a significant positiveimpact on:- level of independent functioning as measured by the carer-rated adaptivebehavioural scale, (ABS) in adults with DS;- quality of life in adults with DS.Biochemical and pathological:- To investigate putative markers of memantines mechanism of action in peripheralsamples from living patients with DS. Inclusion Criteria:Inclusion criteria will be:1. Participants with learning disabilities due to Downs syndrome (DS) confirmed bykaryotype. A clinical diagnosis (provided by the participants general practitioneror hospital specialist) will be accepted if karyotype is not known and participantdoes not agree to have it tested2. Ages 40 years and over or any age if a diagnosis of dementia is established3. In participants with dementia, the diagnosis will be consistent with the 10th versionof the International Classification of Diseases (ICD-10) (World Health Organization[WHO], 1992) diagnostic criteria4. Level of speech and comprehension of verbal commands are sufficient to understand andto answer simple requests5. Resident in care facility or community living with a carer who is willing to acceptresponsibility for supervising the treatment and will provide input to efficacyparameters in accordance with protocol requirements6. Not receiving treatment with memantine currently or in past 4 weeks and responsibleclinician not considering treatment with memantine7. Participant willing to take part in study; and carer, with capacity, willing toassent to study and agrees that participant can take part if participant is alsowilling.Exclusion Criteria:Exclusion criteria will be:1. Participants known to have sensitivity to memantine2. Severe, unstable or uncontrolled medical or psychiatric conditions apparent fromhistory, physical examination or investigations3. A current diagnosis of primary neurodegenerative disorder other than dementia such asHuntingtons disease, etc.4. Uncontrolled epilepsy5. Presence of challenging behaviour likely to preclude the participation during testing6. Presence of severe motor or sensory impairment (severe deafness or blindness) thatrenders the participant as untestable with the battery of tests used in the study7. Current evidence of delirium8. Severe renal impairment9. Low probability of treatment compliance10. Previous evidence of lack of efficacy or tolerability to memantine11. Taking any of the following substances:- an investigational drug during the 4 weeks prior to randomization- a drug known to cause major organ system toxicity during the 4 weeks prior torandomization- started any new psychotropic during the 4 weeks prior to randomization;participants who had been on a stable dose of psychotropic during the 4 weeksprior to randomization are still eligible.- memantine during the 6 weeks prior to randomization- other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, anddextromethorphan- barbiturates and primidone- baclofen and dantrolen- dextromethorphan- antimuscarinics |
NCT00240006 | A Study Comparing Shared Solutions Plus MS Center Support Versus Shared Solutions Alone | Multiple Sclerosis To compare the effectiveness of a 90-day Copaxone adherence enhancement program for asample of MS patients who are at high risk of nonadherence and receive support from SharedSolutions and their MS Center versus those who receive support only from Shared Solutions. Inclusion Criteria:1. Males or females, 18 years of age or older.2. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).3. Beginning or restarting therapy with Glatiramer Acetate (Copaxone).4. Willing and able to complete all procedures and evaluations related to the study.5. Willing to provide informed consent.Exclusion Criteria:1. Taking any other immunomodulatory or immunosuppressant therapy in conjunction withCopaxone.2. Has a significant medical illness other than MS that may interfere with theassessment of endpoints or the subject's participation in the trial for the fullduration of the study.3. Any situation that the investigator or nurse (if not the investigator) feel mayinterfere with participation in the study.4. Pregnant or trying to become pregnant, or breast feeding during the study.5. Previously participated in this study or another clinical research study in the past30 days. |
NCT00240825 | An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain. | Pain The purpose of this study is to determine the onset of pain relief from a single dose ofacetaminophen and ibuprofen in subjects experiencing postoperative dental pain following thesurgical extraction of at least three molars. Inclusion Criteria:- Indicates moderate to severe pain following the extraction of at least three molars(including at least one partial or complete bony mandibular third molar impaction)- weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28- Not taking any medications for anxiety, depression or schizophrenia- if female, not pregnant or breastfeedingExclusion Criteria:- Used ibuprofen or acetaminophen Used ibuprofen or acetaminophen within 12 hourspreceding surgery or any other pain relievers or anti-inflammatory drugs within 24hours preceding surgery- have any gastrointestinal disease that would interfere with the absorption andexcretion of study medications- unable to swallow the study medication whole- have any significant medical condition- have a history of adverse reactions to acetaminophen, ibuprofen or any anestheticagent used in the extraction |
NCT00240617 | Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks | Migraine Disorders The purpose of this study is to determine the consistency of response for Treximet (formerlyknown as Trexima) when treating four acute migraine attacks at the mild pain phase andwithin 1 hour of onset of head pain. Inclusion Criteria:- At least a 6 month history of physician diagnosed migraine and typically experiences2-6 migraine attacks per month.- Typically experiences moderate to severe migraine pain preceded by a mild pain phase.- Differentiate between mild migraine pain and other headache types.- Women of childbearing potential must be on adequate contraception.Exclusion Criteria:- Pregnant and/or nursing mother.- History of cardiovascular disease.- Uncontrolled hypertension.- Basilar or Hemiplegic migraine.- History of stroke or transient ischemic attacks (TIA).- History of epilepsy or treated with anti-epileptics within past 5 years.- Impaired hepatic or renal function.- History of gastrointestinal bleeding or ulceration.- Allergy or hypersensitivity to Aspirin or any other NSAID.- Allergy or hypersensitivity to triptans.- Participated in an investigational drug trial in the previous 4 weeks. |
NCT00278018 | Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors | Cancer of Skin Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized,this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapyrepresents an approach to treatment based on the immune response to cancer antigens.The long-term objective of this study is to develop a therapeutic approach for the treatmentof cancer in general, and melanoma in particular, based on immunotherapy, using acombination of local tumor irradiation followed by injection of immature dendritic cells(iDC).The treatment will be followed by the injection of interferon alpha, which we expectwill induce activation of the iDC.This trial is based on the hypothesis that local radiation, which causes destruction of thetumor, in combination with injection of the patient's own iDC and the activation of thesecells with interferon alpha, will induce an effective immune response against the tumor. Inorder to test the suggested approach, we propose a 20-patients clinical trial that willevaluate the objective clinical and immunological response to the proposed treatment inpatients with malignant melanoma and other solid tumors. Inclusion Criteria:1. Any patient above age 18, with measurable metastatic melanoma or other solid tumor,with at least one tumor deposit that is easily accessible to peri-tumoral DCinjection. The preferred location is subcutaneous or intradermal. Patients withadditional metastatic sites will not be excluded. Patients should have an expectedsurvival of greater than three months.Patient must have received accepted standard treatment of his or her cancer:- for melanoma - DTIC -containing protocol ,unless unwilling. Previous treatmentwith IL-2 is not an excluding factor.- for breast cancer - adriamycin and cyclophosphamide, taxanes, andvinorelbine-containing protocols- for lung, renal and GIT cancers- one previous chemotherapy line2. Serum creatinine of 2.0 mg/dl or less.3. Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome whomust have a total bilirubin less than 3.0 mg/dl.4. WBC 3000/mm3 or greater.5. Platelet count 90,000 mm3 or greater.6. Serum AST/ALT less then two times normal.7. ECOG performance status of 0, 1 or 2.8. Patients of both genders must be willing to practice effective birth control duringthis trial.9. Patient agreed to participate in the study and has signed a written informed consent.Exclusion Criteria:Patients will be excluded:1. who are undergoing or have undergone in the past 3 weeks any other form of therapyexcept from surgery for their cancer.2. have active systemic infections, coagulation disorders, autoimmune disease or othermajor medical illnesses of the cardiovascular or respiratory systems or any knownimmunodeficiency disease.3. who require steroid therapy.4. who are pregnant (because of possible side effects on the fetus).5. who are known to be positive for hepatitis B and C or HIV antibody (because ofpossible immune effects of these conditions).6. who have any form of primary or secondary immunodeficiency. (The experimentaltreatment being evaluated in this protocol depends on an intact immune system.Patients who have decreased immune competence may be less responsive to theexperimental treatment and more susceptible to its toxicities.)7. who are allergic to eggs.i. who have an active major medical illnesses such as cardiac ischemia |
NCT00278226 | Motivational Program for Smokers Enrolled in a Methadone Maintenance Program | Unspecified Adult Solid Tumor, Protocol Specific RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer fromforming.PURPOSE: This clinical trial is studying how well a motivational program works in helpingsmokers enrolled in a methadone maintenance program quit smoking. DISEASE CHARACTERISTICS:- Must be currently enrolled in a methadone maintenance program- Smokes at least 10 cigarettes a dayPATIENT CHARACTERISTICS:- Not pregnant- No concurrent medical condition that precludes the use of nicotine patchesPRIOR CONCURRENT THERAPY:- No concurrent use of other nicotine replacement therapy |
NCT00278434 | Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 | Cervical Cancer RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing,or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flowto cervical intraepithelial neoplasia cells. The use of zoledronate may keep cancer fromforming.PURPOSE: This randomized is studying how well zoledronate works in treating patients withcervical intraepithelial neoplasia 2/3 or 3. DISEASE CHARACTERISTICS:- Biopsy confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3- Planning loop excision or cone biopsy- Diagnosis within 2 months prior to study entry- Standard histological grading according to Richart- Visible lesion by colposcopy- No unsatisfactory colposcopy or lesions extending into the endocervical canalthat cannot be visualized entirely by colposcopy- No suspicion of invasive cervical cancer by cytology, histology or colposcopy- No cytologic evidence of glandular atypia or dysplasiaPATIENT CHARACTERISTICS:- Creatinine normal- Screening laboratory values within normal range (e.g., complete blood count, liverfunction tests, renal panel, and electrolytes)- Not pregnant or nursing- Negative pregnancy test- Fertile patients must use effective contraception- Able to read and speak English or Spanish- No known hypersensitivity to bisphosphonates- Not immunocompromised- No known HIV positivity- No aspirin-sensitive asthma due to association of bisphosphonates withbronchoconstriction- No unexplained abnormal vaginal bleedingPRIOR CONCURRENT THERAPY:- No concurrent loop diuretics, aminoglycosides, other nephrotoxic drugs,immunosuppressive drugs, or other investigational agents |
NCT00278408 | Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma | Lymphoma RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in differentways. Some find cancer cells and kill them or carry cancer-killing substances to them.Others interfere with the ability of cancer cells to grow and spread. Drugs used inchemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, andprednisone, work in different ways to stop the growth of cancer cells, either by killing thecells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to killcancer cells. Giving rituximab and combination chemotherapy together with radiation therapymay kill more cancer cells. It is not yet known which schedule of rituximab and combinationchemotherapy is more effective when given with or without radiation therapy in treatingnon-Hodgkin's lymphoma.PURPOSE: This randomized phase III trial is studying two different schedules of rituximaband combination chemotherapy with or without radiation therapy to compare how well they workin treating patients with aggressive B-cell non-Hodgkin's lymphoma. DISEASE CHARACTERISTICS:- Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including thefollowing subtypes:- Grade 3 follicular lymphoma- Diffuse B-cell lymphoma, including diffuse large cell lymphoma with thefollowing variants:- Centroblastic- Immunoblastic- Plasmablastic- Anaplastic large cell- T-cell-rich B-cell lymphoma- Primary effusion lymphoma- Intravascular B-cell lymphoma- Primary mediastinal B-cell lymphoma- Burkitt's or Burkitt-like lymphoma- Mantle cell lymphoma (blastoid)- Aggressive marginal zone lymphoma (monocytoid)- Previously untreated disease- CD20-positive disease- International prognostic index (IPI) score 0 or 1 (age-adjusted)- Only patients with bulky disease, as defined by largest single or conglomeratetumor 7.5 cm in diameter, are allowed to have an IPI score of 0- No mucosa-associated lymphoid tissue (MALT) lymphoma- No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)PATIENT CHARACTERISTICS:- ECOG performance status 0-2- Platelet count 100,000/mm- WBC 2,500/mm- No known hypersensitivity to the study medications- No known HIV-positivity- No active hepatitis infection- Not pregnant or lactating- Negative pregnancy test- No other malignancy within the past 5 years except carcinoma in situ or basal cellskin cancer- No impaired left ventricular function- No severe cardiac arrhythmias- No other impaired organ function- No other serious disorderPRIOR CONCURRENT THERAPY:- No prior chemotherapy or radiotherapy- No prior immunosuppressive treatment with cytostatics- No concurrent participation in other treatment studies |
NCT00278187 | Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer | Lung Cancer RATIONALE: Monoclonal antibodies, such as volociximab, can block tumor growth in differentways. Some block the ability of tumor cells to grow and spread. Others find tumor cells andhelp kill them or carry tumor-killing substances to them. Volociximab may also stop thegrowth of non-small cell lung cancer by blocking blood flow to the tumor. Erlotinib may stopthe growth of tumor cells by blocking some of the enzymes needed for cell growth. Givingvolociximab together with erlotinib may kill more tumor cells.PURPOSE: This phase II trial is studying how well giving volociximab together with erlotinibworks in treating patients with stage III or stage IV non-small cell lung cancer. DISEASE CHARACTERISTICS:- Histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic(stage IV) non-small cell lung cancer (NSCLC)- Failed 1 prior chemotherapy regimen OR refused first-line therapy- Measurable disease- No active and untreated CNS tumor or metastasis- Previously treated CNS tumor(s) allowed if CT scan or MRI shows clear-cutresponse or resolution of the original lesion(s)PATIENT CHARACTERISTICS:- ECOG performance status 0-1- Hemoglobin 9.0 g/dL- WBC 2,500/mm^3- Absolute neutrophil count 1,000/mm^3 (growth factor independent)- Platelet count 100,000/mm^3- Total bilirubin 1.5 mg/dL- AST and ALT 3 times upper limit of normal (ULN) (5 times ULN if patient has livermetastases)- Alkaline phosphatase 5 times ULN- Serum creatinine 2.0 mg/dL- PT/PTT normal- Not pregnant or nursing- Negative pregnancy test- Fertile patients must use effective (double barrier or abstinence) contraception- No uncontrolled seizure disorder or active neurological disease- No thromboembolic events (i.e., stroke or deep vein thrombosis) within the past year- No clinically significant medical condition that would complicate compliance withstudy treatment or be exacerbated by bleeding, including but not limited to:- Known bleeding disorders, such as coagulation defects and thrombasthenias- Active gastric or duodenal ulcer- History of gastrointestinal (GI) bleeding requiring transfusion within the pastyear- History of tumor bleeding- History of significant hemoptysis requiring intervention (i.e., transfusion,laser therapy, surgical treatment, or radiation) within the past year- No known active infections requiring IV antibiotics, antivirals, or antifungals(e.g., HIV, hepatitis B, or hepatitis C infection)- No unstable cardiac disease, including any of the following:- Poorly controlled angina- Congestive heart failure- Arrhythmias- Myocardial infarction within the past year- Acute ischemia by ECG- Untreated significant conduction abnormality- Bifascicular block (defined as left anterior hemiblock in the presence ofright bundle branch block)- Second- or third-degree atrioventricular block- No asthma or oxygen-dependent chronic pulmonary disease- No cerebrovascular event (e.g., stroke or transient ischemic attack) within the pastyear- No peripheral vascular disease requiring surgery within the past year- No clinically significant or unstable medical condition, including, but not limitedto, any of the following:- Diabetes mellitus requiring insulin- Uncontrolled hypertension- Uncontrolled or symptomatic orthostatic hypertension- No serious psychiatric illness, active alcoholism, or drug addiction that maypreclude study treatment- No condition that, in the investigator's opinion, would make the patient unsuitablefor study treatmentPRIOR CONCURRENT THERAPY:- See Disease Characteristics- Prior immunotherapy, including monoclonal antibodies, or vaccine therapy allowed- No systemic biologic, immunotherapy, or radiation therapy within the past 4 weeks- Local radiotherapy to a single site of bone metastasis within the past 2 weeksallowed provided patient has recovered from any side effects- No prior volociximab, epidermal growth factor receptor (EGFR) tyrosine kinaseinhibitors, or inhibitors of 51 integrin (antibodies or small molecules)- No known hypersensitivity to murine proteins or chimeric antibodies or othercomponents of study drugs- No other investigational drug within the past 4 weeks or 5 half-lives (whichever islonger)- No monoclonal antibody therapy within the past 4 weeks or 5 half-lives (whichever islonger)- No major surgery (e.g., thoracotomy) within 4 weeks prior to study entry- No minor surgery (e.g., central venous line placement) within 1 week prior to studyentry- No sargramostim (GM-CSF) or filgrastim (G-CSF) within the past 7 days- No prior bone marrow or stem cell transplantation- No concurrent chronic medications that would interfere with study drug assessmentincluding, but not limited to:- High-dose glucocorticoids (prednisone 20 mg/day or equivalent)- Chronic nonsteroidal anti-inflammatory drugs (NSAIDs)- Infrequent or as occasion requires use of NSAIDs allowed- No concurrent high-dose aspirin (> 81 mg/day), high-dose warfarin, or heparin- Aspirin 81 mg/day, low-dose warfarin (1 mg/day), or low-dose heparin forIV-catheter patency allowed- No concurrent chemotherapy, therapeutic radiation, or anticancer hormonal therapy- No other concurrent immunotherapy- No other concurrent potentially antiangiogenic therapy (e.g., cyclo-oxygenase-2inhibitors, thalidomide, or tretinoin) |
NCT00278811 | Emergency Linkage to Outpatient Psychiatric Services | Emergency Services, Psychiatric The purpose of this study is to compare two different kinds of follow-up care and theireffects on psychiatric service use and psychological well-being. This randomized, controlledtrial of subjects discharged from the psychiatric emergency services to outpatient carereceive traditional hospital-based outpatient clinic referrals (treatment as usual) orappointments for community-based follow-up by a mobile crisis team. Inclusion Criteria:- English and Spanish-speaking adult patients (18-and above) presenting to thepsychiatric emergency service who rate a "1" or higher on the Spectrum of SuicidalBehavior of Pfeffer screening scale, and who have outpatient followup organized byComprehensive Psychiatric Emergency Program staff through hospital outpatientpsychiatric services are eligible for inclusion.Exclusion Criteria:- Subjects less than 18 years old, those rated as not suicidal in the emergencydepartment, subjects with mental retardation/developmental delay, and subjects whohave community psychiatric treatment that they elect to continue in lieu of hospitaloutpatient psychiatric services referral are ineligible. |
NCT00278421 | Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma | Lymphoma RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in differentways. Some find cancer cells and kill them or carry cancer-killing substances to them.Others interfere with the ability of cancer cells to grow and spread. Drugs used inchemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work indifferent ways to stop the growth of cancer cells, either by killing the cells or bystopping them from dividing. Giving rituximab together with combination chemotherapy maykill more cancer cells. It is not yet known which schedule of rituximab and combinationchemotherapy is more effective in treating non-Hodgkin's lymphoma.PURPOSE: This randomized phase III trial is studying two different schedules of rituximaband combination chemotherapy to compare how well they work in treating patients withaggressive B-cell non-Hodgkin's lymphoma. DISEASE CHARACTERISTICS:- Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including thefollowing subtypes:- Grade 3 follicular lymphoma- Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of thefollowing variants:- Centroblastic- Immunoblastic- Plasmablastic- Anaplastic large cell- T-cell-rich B-cell lymphoma- Primary effusion lymphoma- Intravascular B-cell lymphoma- Primary mediastinal B-cell lymphoma- Burkitt's or Burkitt-like lymphoma- Mantle cell lymphoma (blastoid)- Aggressive marginal zone lymphoma (monocytoid)- Previously untreated disease- CD20-positive disease- International Prognostic Index (IPI) score 0- No bulky disease- Largest single or conglomerate tumor < 7.5 cm in diameter- No mucosa-associated lymphoid tissue (MALT) lymphoma- No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)PATIENT CHARACTERISTICS:- ECOG performance status 0-1- Platelet count 100,000/mm^3- WBC 2,500/mm^3- Lactate dehydrogenase normal- Not pregnant or lactating- Fertile patients must use effective contraception during and for 1 year after studyparticipation- Negative pregnancy test- No known hypersensitivity to the study medications- No known HIV-positivity- No active hepatitis infection- No impaired left ventricular function- No severe cardiac arrhythmias- No other impaired organ function- No other serious disorder- No other malignancy within the past 5 years except carcinoma in situ or basal cellskin cancerPRIOR CONCURRENT THERAPY:- No prior chemotherapy or radiotherapy- No prior immunosuppressive treatment with cytostatics- No planned radiotherapy to extranodal involvement- No concurrent participation in other treatment studies |
NCT00278031 | Quality of Life in Children Cured of Retinoblastoma | Retinoblastoma The aim of the study is to assess the quality of life of children who have been cured ofretinoblastoma - a malignant eye tumor. The study is questionnaire-based, and usesstandardized quality of life assessment tools. Inclusion Criteria:- Past treatment for retinoblastoma |
NCT00278967 | An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects | Colonoscopy To compare the safety and efficacy of 2 different bowel cleansing preparations prior tocolonoscopy in adult subjects. Inclusion Criteria:- Male or female outpatients who are undergoing colonoscopy for the following routinelyaccepted indications:Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic diseasesurveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipationetiology Polypectomy Laser therapy Routine Screening- At least 18 years of age- Otherwise in good health, as determined by physical exam and medical history- If female, and of child-bearing potential, is using an acceptable form of birthcontrol (hormonal birth control, IUD, double-barrier method, depot contraceptive,sterilized, abstinent, or vasectomized spouse)- Negative urine pregnancy test at screening, if applicable- In the Investigators judgment, subject is mentally competent to provide informedconsent to participate in the studyExclusion Criteria:- Subjects with known or suspected ileus, gastrointestinal obstruction, gastricretention, bowel perforation, toxic colitis, or toxic megacolon- Subjects with impaired consciousness that predisposes them to pulmonary aspiration- Subjects who are undergoing colonoscopy for foreign body removal and decompression- Subjects with pre-existing electrolyte disturbances, such as dehydration, or thosesecondary to the use of diuretics- Subjects who are taking drugs that may affect electrolyte levels- Subjects taking laxatives or prokinetic agents that refuse to discontinue thesetreatments for the duration of the study- Subjects with known clinically significant electrolyte abnormalities such ashypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia- Subjects who are pregnant or lactating, or intending to become pregnant during thestudy- Subjects of childbearing potential who refuse a pregnancy test- Subjects who are allergic to any preparation components- Subjects who, in the opinion of the Investigator, should not be included in the studyfor any reason, including inability to follow study procedures- Subjects who have participated in an investigational clinical, surgical, drug, ordevice study within the past 30 days |
NCT00278369 | Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer | Kidney Cancer RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carrytumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate thewhite blood cells to kill kidney cancer cells. Giving denileukin diftitox together withinterleukin-2 may kill more tumor cells.PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitoxand interleukin-2 in treating patients with metastatic kidney cancer. DISEASE CHARACTERISTICS:- Documented histologically confirmed metastatic renal cell carcinoma- Clear cell histology- Disease must be measurable as defined by lesions that can be accurately measured inat least one dimension with longest diameter > 20 mm using conventional techniques or> 10 mm with spiral CT scan- Must have at least one measurable lesion- If the measurable disease is restricted to a solitary lesion, its neoplasticnature should be confirmed by cytology/histology- Clinical lesions will only be considered measurable when they are superficial(e.g., skin nodules and palpable lymph nodes)- The following are considered nonmeasurable lesions:- Bone lesions- Leptomeningeal disease- Ascites- Pleural/pericardial effusion- Inflammatory breast disease- Lymphangitis cutis/pulmonis- Cystic lesions- Abdominal masses not confirmed and followed by imaging techniques- No CNS metastasesPATIENT CHARACTERISTICS:- ECOG performance status < 2- Life expectancy of at least 4 months- Serum creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min- Total bilirubin normal- Platelets > 100,000/mm- WBC > 3,500/mm- No evidence of congestive heart failure- No symptoms of coronary artery disease- No serious cardiac arrhythmias- A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatmentif any cardiac symptoms are present (patients with documented ischemia on thepretreatment cardiac stress test will be excluded from the study)- Adequate pulmonary reserve- Pulmonary function tests (PFTs) must be performed within 42 days of IL-2treatment- FEV_1 > 2.0 liters of > 75% predicted for height and age- Patients unable to perform PFTs will be excluded- Women who are pregnant or lactating are not eligible- Women of childbearing potential and sexually active males must commit to the use ofeffective contraception while on study- Negative pregnancy test- No known HIV-positive patients- No evidence of active infection requiring antibiotic therapy- Must not have a contraindication to treatment with pressor agents- Must not have any significant medical disease that, in the opinion of theinvestigator, may interfere with completion of the study- No history of another malignancy within the past 5 years other than basal cell skincancerPRIOR CONCURRENT THERAPY:- Recovered from all toxic effects of prior therapy- Must not currently receive chronic medication for asthma- No prior interleukin-2 (IL-2) therapy- No prior organ allografts- No systemic corticosteroids in the 4 weeks prior to treatment- No concurrent systemic steroids- No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the firstdose of study treatment- No concurrent radiotherapy, chemotherapy, or other immunotherapy- No previous investigational agent within 4 weeks prior to the start of studytreatment |
NCT00278382 | Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma | Anaplastic Large Cell Lymphoma Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and byblocking some of the enzymes needed for cell growth. This phase II trial is studying howwell sorafenib works in treating patients with chemosensitive recurrent aggressivenon-Hodgkin's lymphoma Inclusion Criteria:- Histologically or cytologically confirmed aggressive* non-Hodgkin's lymphoma byexcisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 ofthe following types:- Mantle cell lymphoma- Primary mediastinal large B-cell lymphoma- Diffuse large B-cell lymphoma- Anaplastic large cell lymphoma (T-cell or null-cell type)- Recurrent disease- Patients must have received 1 induction regimen containing anthracyclines (e.g.,CHOP [with or without rituximab] or R-EPOCH)- Chemosensitive disease at the time of relapse- Patients who responded with a complete or partial remission that lasted at least8 weeks after their last chemotherapy regimen are considered chemosensitive- Measurable disease, defined as a lymph node or a nodal mass of > 1 cm in its longesttransverse diameter on CT scan- Ineligible for, refused, or relapsed after stem cell transplant (for patients withnon-mantle cell lymphoma)- No known brain metastases, including meningeal involvement- ECOG performance status (PS) 0-2- Karnofsky PS 60-100%- Life expectancy > 3 months- WBC 3,000/mm^3- Absolute neutrophil count 1,500/mm^3- Platelet count 100,000/mm^3- Bilirubin normal- AST and ALT 2.5 times upper limit of normal- Creatinine normal OR creatinine clearance 60 mL/min- Fertile patients must use effective contraception- Not pregnant or nursing- Negative pregnancy test- No uncontrolled illness- No history of allergic reactions attributed to compounds of similar chemical orbiologic composition to sorafenib- No known positive HIV serology- No inflammatory bowel disease- No swallowing dysfunction that would prevent ingestion of pills- No hemorrhagic diathesis- No ongoing or active infection- No symptomatic congestive heart failure- No unstable angina pectoris- No cardiac arrhythmia- No uncontrolled hypertension- No psychiatric or social situation that would limit compliance with studyrequirements- No poorly controlled medical condition that would seriously complicate compliancewith this study- Patients with inflammatory or exfoliative skin disease are excluded (regardless ofthe extent of the involvement) unless the skin condition is lymphoma related- See Disease Characteristics- Previous treatment-related toxic effects should be resolved to grade 1 or better- No chemotherapy or radiation therapy within the past 4 weeks- 6 weeks for nitrosoureas or mitomycin C- No prior antibody therapy for at least 3 months- Prior radiation for localized disease or total body irradiation as part of aconditioning regimen prior to stem cell transplant allowed- Prior radio-immunotherapy allowed- No concurrent therapeutic anticoagulation- Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterialaccess devices are acceptable provided that the requirements for PT, INR, andPTT are met- No concurrent use of another investigational agent- No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital,rifampin, or Hypericum perforatum (St. John's wort)- No other concurrent anticancer therapy |
NCT00278590 | Allogeneic Stem Cell Transplantation in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus This trial is designed to evaluate the safety of treating systemic lupus erythematosusparticipants with cyclophosphamide and CAMPATH-1H followed by allogeneic stem celltransplant. There will be no randomization in this study. All subjects who are determined tobe eligible for the study treatment will receive cyclophosphamide and CAMPATH-1H followed byallogeneic stem cell transplant. The purpose of the intense chemotherapy is to destroy thecells in the immune system which may be causing this disease. The purpose of the stem cellinfusion is to produce a normal immune system that will no longer attack body. The studypurpose is to examine whether this treatment will result in improvement in the lupusdisease. Recipient Inclusion Criteria:- Ages 18 to 50 years old.- Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteriafor SLE (see Appendix 1).- Able to give informed consent.- HLA matched sibling donor available.- Meet one of following three:1. For lupus nephritis, participants must fail pulse cyclophosphamide (500 to 1000mg/m2 monthly for a minimum of 6 months). Failure is defined as meeting criteriato be considered as BILAG (Appendix 4) renal category A. If indication for HSCTis nephritis, a renal biopsy must be obtained and document either class III orIV glomerulonephritis.2. For visceral organ involvement other than nephritis, participants must be BILAGcardiovascular/respiratory category A, vasculitis category A, or neurologiccategory A and must fail at least 3 months of oral or IV cyclophosphamide and becorticosteroid dependent. Steroid dependence being defined as at least 3 monthsof steroid therapy and inability to wean corticosteroid to less than 20 mg/dayof prednisone or equivalent.3. For cytopenias that are immune mediated, participants must be BILAG hematologiccategory A. Participants must have an inability to maintain platelets > 15,000,an inability to prevent active bleeding without transfusion, an inability tomaintain hemoglobin > 7.0, or an inability to prevent cardiovascular diseasewithout transfusion. In addition, participants must fail corticosteroids (eitheroral prednisone > 0.5 mg/kg/day for more than 6 months or pulsemethylprednisolone for at least one cycle of three days), be refractory to IVIG,and at least one of the following: azathioprine at 2 mg/kg/day for at least 3months, mycophenolate mofetil 2 grams daily for more than 3 months,cyclophosphamide intravenously or orally for at least 3 months, or cyclosporineat least 3 mg/kg/day for at least 3 months, danazol for at least 3 months, orsplenectomy.Recipient Exclusion Criteria:- HIV positive.- Ongoing malignancy except localized basal cell or squamous skin cancer. Othermalignancies for which the participant is judged to be cured by local surgicaltherapy, such as head and neck cancer, or stage I or II breast cancer will beconsidered on an individual basis by the investigators doing the final screening forparticipant qualification.- Positive pregnancy test, inability or unwillingness to pursue effective means ofbirth control, failure to willingly accept or comprehend irreversible sterility as aside effect of therapy.- Psychiatric illness or mental deficiency making compliance with treatment or informedconsent impossible.- DLCO < 45% of predicted unless attributed solely to active lupus.- Resting LVEF < 40% unless due to active lupus.- Known hypersensitivity to E. Coli derived proteins.- Transaminases greater than 2 times normal unless due to active lupus.- Any illness that in the opinion of the investigator would jeopardize the ability ofthe patient to tolerate this treatment.Donor Inclusion Criteria- Donor must be a HLA identical sibling or HLA matched cord blood donor.- If donor is HLA matched sibling, donor must be > 18 years of age and less than50years old.- If multiple HLA matched donors are available, preference will be given to samesex,same CMV status, and nulliparous donor, or in the case of cord blood higher nucleatedcell count.- If donor is HLA matched cord blood, cord blood stem cells will be obtained from theNew York Blood Center Cord Blood Registry (Tel 212-570-3230) which is aninternationally recognized registry or, if a match is not available, from Stemcyte(626-821-9860) which is a commercial registry that specializes in minority donors orfrom National Marrow Donor Program (NMDP). One unit of HLA matched cord blood unitwill be infused on day zero.Donor Exclusion Criteria- Physiologic age > 50 years old or <18 years old.- HIV positive.- Active ischemic heart disease or heart failure.- Acute or chronic active hepatitis.- Uncontrolled diabetes mellitus or any other illness that in the opinion of theinvestigators would jeopardize the ability of the donor to tolerate stem cellcollection.- Prior history of malignancy except localized basal cell or squamous skin cancer.Other malignancies for which the patient is judged to be cured by local surgicaltherapy, such as (but not limited to) head and neck cancer, or stage I or II breastcancer will be considered on an individual basis.- Positive pregnancy test.- Positive ANA or anti-ds DNA.- Psychiatric illness or mental deficiency making compliance with treatment or informedconsent impossible.- Major hematological abnormalities such as platelet count less than 150,000/ul, ANCless than 1000/ul.- If donor is sibling must collect a minimum of 2. 106CD34+ cells/kg to proceed toTransplant.- If donor is cord blood unit(s) then a minimum number of nucleated cells availablemust be more than 2 x 107 /kg. To achieve this number of nucleated cells, two unitsof HLA matched cord blood may be utilized. (Wagner JE Blood. 2005 Feb1;105(3):1343-7) |
NCT00278551 | Stem Cell Support in Patients With Rheumatoid Arthritis | RHEUMATOID ARTHRITIS Rheumatoid arthritis (RA) is a chronic illness, immunologically mediated, probably inducedby the exposure to an antigen or antigens, to which immunologic tolerance is lost. Thedisease has a variable course, from a mild, intermittently symptomatic illness requiringonly symptomatic therapy to a fulminant illness requiring dangerous immunosuppressivetherapy, surgery or both. The molecular defect causing RA has not been characterized, butmay involve aberrant T cell, B cell, and macrophage function. Although RA often responds toimmunosuppressive medication including corticosteroids, methotrexate, azathioprine andcyclophosphamide, or to non-steroidal anti-inflammatory drugs, no therapy has been curative.In patients with severe RA, who have been unresponsive to corticosteroids, and who have morethan 20 active joints or vasculitis, we propose, as a phase I-II study, complete immuneablation and subsequent reconstitution with autologous in vitro T lymphocyte depleted PBSCsharvested from the patient prior to immune ablation. The combination of high dosecyclophosphamide and anti-thymocyte globulin conditioning will be followed by rescue withautologous lymphocyte depleted PBSCs. Subsequent disease activity will be followed by: (1)RA disease activity index, (2) type and amount of therapy for RA, and (3) flow cytometry ofperipheral blood lymphocyte subsets, (4) joint count, (5) patients' assessment of pain, (6)arthritis impact measurement scales (AIMS) questionnaire, (7) acute phase reactants. Thisstudy will dose standard therapy, i.e. immune suppression, to the point of complete immuneablation and subsequent recapitulation of lymphocyte ontogeny by PBSC rescue. We anticipatethat this study will also form the basis to clarify further the role of the immune system inRA. Inclusion Criteria:1. Physiologic age < 60 years old or >18 years old.2. An established clinical diagnosis of rheumatoid arthritis by American College ofRheumatology criteria, and a positive rheumatoid factor will be required.3. Patients must have failed two disease-modifying agents, such as methotrexate,plaquenil, gold, azathioprine, asulfidine or D-penicillamine.4. Patients must have six (6) swollen joints from active RA and either thirty (30) orgreater involved joints (swelling, tenderness, deformity, pain on motion, ordecreased motion), or have answered less than 75 percent of Health AssessmentQuestionnaire (HAQ) questions "without any difficulty."5. A harvest of PBSC greater than 1.4 x 106 CD34+ cells /kg after CD34+ selection willbe necessary for the patient to proceed to transplant.6. Ability to give informed consent7. Patients with Juvenile Rheumatoid Arthritis (JRA) will be candidates if disease onsetis polyarthritic or systemic and they have at least 6 swollen joints and have failedcorticosteroids and two disease-modifying drugsExclusion Criteria:1. HIV positive2. History of coronary artery disease, or congestive heart failure.3. Uncontrolled diabetes mellitus, or any other illness that in the opinion of theinvestigators would jeopardize the ability of the patient to tolerate aggressivechemoradiotherapy4. Prior history of malignancy except localized basal cell or squamous skin cancer.Other malignancies for which the patient is judged to be cured by local surgicaltherapy, such as head and neck cancer, or stage I breast cancer will be considered onan individual basis.5. Positive pregnancy test, inability or unwillingness to pursue effective means ofbirth control, failure to willingly accept or comprehend irreversible sterility as aside effect of therapy.6. Psychiatric illness or mental deficiency making compliance with treatment or informedconsent impossible7. FEV1/FVC < 75% of predicted, DLCO < 50% of predicted.8. Resting LVEF < 45 %9. Bilirubin > 2.0 mg/dl, transferase (AST) > 2x upper limit of normal10. Serum creatinine > 2.0 mg/dl11. Platelet count less than 100,000/ul, ANC less than 1000/ul12. History of allergy to eggs or murine proteins13. Known hypersensitivity to E. coli derived proteins |
NCT00278343 | Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer | Recurrent Fallopian Tube Cancer This phase II trial is studying how well cediranib maleate works in treating patients withpersistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, orfallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blockingblood flow to the tumor and by blocking some of the enzymes needed for cell growth. Inclusion Criteria:- Patients must have histologically or cytologically confirmed epithelial ovariancancer, fallopian tube cancer, or primary peritoneal cancer that has recurred or isrefractory to initial therapy; patients must have received platinum-basedchemotherapy before entry into this protocol- Patients must have measurable disease, defined as at least one lesion that can beaccurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT)scan OR patients must have evidence of progression based on an elevated CA-125(defined as a value of > 2 x upper limit of normal [ULN] documented on two separatedeterminations made > 2 weeks apart) if the physical exam is normal and CT scan ofthe chest/abdomen/pelvis, has a disease volume < 1 cm in maximum diameter- Patients may have received no more than one prior chemotherapy regimen (i.e. initialfirst-line chemotherapy only)- Life expectancy of greater than 12 weeks- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)- Leukocytes >= 3,000/mcL- Absolute neutrophil count >= 1,500/mcL- Platelets >= 100,000/mcL- Hemoglobin >= 8 g/dL- Total bilirubin within normal institutional limits- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])=< 2.5 institutional upper limit of normal- Creatinine within normal institutional limits OR creatinine clearance >= 60mL/min/1.73 m^2 for patients with creatinine levels above institutional normal- Women of child-bearing potential must have a negative pregnancy test prior to studyentry; women of child-bearing potential and men must agree to use adequatecontraception (hormonal or barrier method of birth control; abstinence) prior tostudy entry and for the duration of study participation; should a woman becomepregnant or suspect she is pregnant while participating in this study, she shouldinform her treating physician immediately- Ability to understand and the willingness to sign a written informed consent documentExclusion Criteria:- Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6weeks for nitrosoureas or mitomycin C) prior to entering the study or those who havenot recovered from adverse events due to agents administered more than 4 weeksearlier- Patients with borderline tumors or tumors of low malignant potential- Patients with current bowel obstruction- Patients may not be receiving any other investigational agents nor have participatedin an investigational trial within the past 30 days- Patients with known brain metastases should be excluded from this clinical trial- History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to AZD2171 (cediranib maleate)- Mean corrected QT (QTc) > 470 msec (with Bazett's correction) in screeningelectrocardiogram or history of familial long QT syndrome- Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 weekapart- Uncontrolled intercurrent illness including, but not limited to hypertension, ongoingor active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limitcompliance with study requirements- Pregnant women are excluded from this study, breastfeeding should be discontinued ifthe mother is treated with AZD2171- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviraltherapy are ineligible- Any significant abnormality noted in the electrocardiogram (ECG) within 14 days oftreatment- A New York Heart Association classification of III or IV (NOTE: patients classifiedas class II controlled with treatment may continue with increase monitoring)- Conditions requiring concurrent use of drugs or biologics with proarrythmicpotential; these drugs are prohibited during studies with AZD2171 |
NCT00278395 | Vorinostat in Treating Patients With Kidney Cancer | Recurrent Renal Cell Carcinoma This phase II trial is studying how well vorinostat works in treating patients with advancedkidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways tostop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Vorinostat may also stop the growth of tumor cells by blocking blood flow to thetumor. Inclusion Criteria:- Histologically or cytologically confirmed diagnosis of advanced renal cell carcinomathat is either metastatic or inoperable- Measurable disease, defined as 1 unidimensionally measurable lesion 20 mm byconventional techniques OR 10 mm by spiral CT scan- Disease is recurrent or refractory to interleukin-2 (IL-2) or interferon-basedtherapy OR new diagnosis in previously untreated patients who are not appropriatecandidates to receive IL-2 based treatment- Patients who have failed up to 4 lines of prior immunotherapy or biological therapyallowed- No known brain metastases or leptomeningeal disease- Stable brain metastases or curatively resected brain metastases without neurologicdysfunction for 6 months allowed- ECOG performance status 0-2 OR Karnofsky 70-100%- Life expectancy 12 weeks- Absolute neutrophil count 1,500/mm^3- Platelet count 100,000/mm^3- Hemoglobin 9.0 g/dL- Serum creatinine 1.5 times upper limit of normal (ULN) OR creatinine clearance > 50mL/min- Total bilirubin within normal limits- AST/ALT 2.5 times ULN ( 5 times ULN if liver metastasis is present)- No history of active malignancy (other than renal cell carcinoma) within the past 3years other than nonmelanomatous skin cancer, in situ breast cancer, or in situcervical cancer- No history of allergic reactions to compounds of similar chemical or biologicalcomposition to vorinostat (SAHA)- No uncontrolled concurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, or cardiacarrhythmia- No psychiatric illness or social situation that would preclude study compliance- No clinically significant hypercalcemia- No significant traumatic injury within the past 21 days- Not pregnant or nursing- Negative pregnancy test- Fertile patients must use effective contraception- No gastrointestinal disease resulting in an inability to take oral medication- No requirement for IV alimentation- No active peptic ulcer disease- Recovered from prior therapy- Prior nephrectomy or resection of metastatic lesions allowed provided full surgicalrecovery has occurred- No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin)- No radiotherapy within the past 4 weeks- No valproic acid for at least 2 weeks prior to study enrollment- No prior surgical procedures affecting absorption- No major surgery within the past 21 days- No concurrent antiretroviral therapy for HIV-positive patients- No other concurrent investigational agents- No other concurrent anticancer therapy |
NCT00278746 | Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting | Diarrhea Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. Therewas a significant reduction in duration of the treated episodes and in their severity asmeasured by diarrheal stool output or frequency. Zinc is a potentially importantimmunomodulator or nutraceutical which may have great impact as therapeutic agent inconditions like diarrhea and pneumonia. The issue is whether and how zinc should beintroduced in primary health care programs for treatment of acute diarrhea. A practical,sustainable intervention for introduction of zinc as treatment of acute diarrhoea innational programs is therefore required. This study aimed to address this issue. Inclusion Criteria:- Children aged 1 month to 5 years with diarrheaExclusion Criteria:- Illness requiring referral to hospital |
NCT00278785 | Brief Intervention for Alcohol Use Among Injured Patients | Alcohol Drinking The underlying hypothesis that providing brief interventions to individuals who engage inpotentially harmful patterns of alcohol use will alter their drinking behavior and thereforeavoid negative consequences. Specifically, this study aims to determine if briefinterventions will:1. Reduce the number of re-admissions and deaths due to injuries associated with alcoholconsumption2. Reduce the number of driving under the influence (DUI) arrests3. Reduce harmful drinking behavior Inclusion Criteria:- >=18 yrs old- English or Spanish Speaking- Mentally and physically able to provide consent and participate in the intervention- Admission to the trauma ward or ICUExclusion Criteria:- <18 yrs old- Non-English or Non-Spanish Speaking- Severe Psychiatric illness- incarcerated |
NCT00278655 | Hematopoietic Stem Cell Therapy for Patients With Multiple Sclerosis | Multiple Sclerosis Multiple sclerosis is disease believed to be due to immune cells, cells which normallyprotect the body, but are now attacking the tissue in the brain and possibly the spinalcord. The likelihood of progression of this disease is high. This study is designed toexamine whether treating patients with high dose cyclophosphamide and CAMPATH-1H (drugswhich reduce the function of the immune system) followed by return of previously collectedblood stem cells will stop the progression of your multiple sclerosis. Stem cells areundeveloped cells that have the capacity to grow into mature blood cells, which normallycirculate in the blood stream. The purpose of the cyclophosphamide and CAMPATH-1H is todestroy the cells in your immune system which are thought to be causing your disease. Thepurpose of the stem cell infusion is to restore the body's blood production, which will beseverely impaired by the high dose chemotherapy and to produce a normal immune system thatwill no longer attack the body. Inclusion Criteria:1. Age between 18-50, inclusive.2. Diagnosis of Multiple Sclerosis (MS) using Poser criteria (Appendix A).3. An Expanded Disability Status Scale (EDSS) of 2.0 - 5.5 (Appendix B).4. Inflammatory disease despite primary disease modifying therapy with at least 3 monthsof interferon. Failure is defined as two or more clinical relapses with documentedneurologic changes within the year prior to the study. (NOTE: Relapses must haverequired treatment with corticosteroids. Sensory only relapses are excluded.) Failuremay also be defined as one relapse within the year prior to study if there isevidence on MRI of active inflammation (i.e., gadolinium enhancement).Exclusion Criteria:1. Any illness that in the opinion of the investigators would jeopardize the ability ofthe patient to tolerate aggressive chemotherapy.2. Prior history of malignancy except localized basal cell, squamous skin cancer orcarcinoma in situ of the cervix. Other malignancies for which the patient is judgedto be cured, such as head and neck cancer, or breast cancer will be considered on anindividual basis.3. Positive pregnancy test.4. Inability or unwillingness to pursue effective means of birth control. Effectivebirth control is defined as 1) refraining from all acts of vaginal intercourse(ABSTINENCE); 2) consistent use of birth control pills; 3) injectable birth controlmethods (Depo-provera, Norplant); 4) tubal sterilization or male partner who hasundergone vasectomy; 5) placement of an intrauterine device (IUD); or 6) use, withevery act of intercourse, of diaphragm with contraceptive jelly and/or condoms withcontraceptive foam.5. Failure to willingly accept or comprehend irreversible sterility as a side effect oftherapy.6. Forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) < 60% ofpredicted after bronchodilator therapy (if necessary).7. Diffusing capacity of the lung for carbon monoxide (DLCO) < 50% of predicted.8. Resting left ventricular ejection fraction (LVEF) < 50 %.9. Bilirubin > 2.0 mg/dl.10. Serum creatinine > 2.0 mg/dl.11. Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to ironcompounds/medications.12. Presence of metallic objects implanted in the body that would preclude the ability ofthe patient to safely have MRI exams.13. Diagnosis of primary progressive multipole sclerosis (MS).14. Platelet count < 100,000/ul.15. Psychiatric illness, mental deficiency or cognitive dysfunction making compliancewith treatment or informed consent impossible.16. Active infection except asymptomatic bacteruria. |
NCT00278668 | ECT Schizophrenia Serotonin Study | Schizophrenia We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT Inclusion Criteria:Participants must meet DSM-IV criteria for schizophrenia, as assessed by the StructuredClinical Interview - Patient Version (SCID) (First et al., 1995).Ages 18 -55 Men and/or women -Exclusion Criteria:1. History of neurological disorders, active substance abuse in the previous 3 months.2. Estimated IQ less then 70.3. SSRIs treatment 4 weeks prior to the study.4. Any subject suffering from inflammatory fever disease will be excluded from thestudy. |
NCT00278330 | Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia | Blastic Phase Chronic Myelogenous Leukemia This phase I trial is studying the side effects and best dose of flavopiridol when giventogether with vorinostat in treating patients with relapsed or refractory acute leukemia orchronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may causeleukemia cells to look more like normal cells, and to grow and spread more slowly.Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes neededfor cell growth. Giving flavopiridol together with vorinostat may be an effective treatmentfor leukemia or refractory anemia. Inclusion Criteria:- Diagnosis of one of the following:- Relapsed or refractory acute leukemia (acute myeloid leukemia [AML], acutelymphoblastic leukemia [ALL], or acute leukemia unclassifiable) following atleast one prior systemic treatment- Acute leukemia in a patient 60 years or older (no requirement for priortreatment)- Acute leukemia that has evolved from a prior myelodysplastic syndrome- Chronic myelogenous leukemia (CML) in blast crisis following prior imatinibmesylate therapy- Refractory anemia with excess blasts-2 (RAEB-2)- No known CNS leukemia- ECOG performance status 0-2- WBC < 50,000L- Hydroxyurea and/or leukaphereses may be used to lower WBC- Creatinine =< 1.5 times upper limit of normal (ULN) OR creatinine clearance >= 50mL/min- Total bilirubin =< 2 times ULN- AST/ALT =< 2.5 times ULN- QTc interval =< 0.470 seconds- Not pregnant or nursing- Negative pregnancy test- Fertile patients must use effective contraception during and for 3 months after studyparticipation- No other condition that would preclude study participation- At least 3 weeks since prior treatment (expect leukaphereses)- No valproic acid therapy within the past 2 weeks- No prior autologous or allogeneic bone marrow or stem cell transplantation- No hydroxyurea use within the past 24 hours- No concurrent treatment with other anti-cancer agents or investigational agents |
NCT00278278 | Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas | Brain and Central Nervous System Tumors RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumorcells, either by killing the cells or by stopping them from dividing. Giving more than onedrug (combination chemotherapy) may kill more tumor cells. Radiation therapy useshigh-energy x-rays to kill tumor cells. It is not yet known whether giving methotrexatetogether with combination chemotherapy and radiation therapy is more effective thancombination chemotherapy and radiation therapy alone in treating gliomas.PURPOSE: This randomized phase III trial is studying giving methotrexate together withcombination chemotherapy and radiation therapy to see how well it works compared tocombination chemotherapy and radiation therapy alone in treating young patients with newlydiagnosed gliomas. DISEASE CHARACTERISTICS:- Newly diagnosed tumors of the brain or spinal cord, meeting one of the followingcriteria:- Histologically* confirmed diagnosis of 1 of the following high-grade gliomas:- Glioblastoma (WHO IV)- Anaplastic astrocytoma (WHO III)- Gliosarcoma (WHO III or IV)- Anaplastic oligo-astrocytoma NOTE: *Histological requirement may be waivedfor other types of brainstem glioma- Radiologically proven diffuse intrinsic pontine glioma- Second malignancy or disseminate metastases or multifocal tumors are allowed if thefield of irradiation is not too large- No diffuse metastases making craniospinal irradiation necessaryPATIENT CHARACTERISTICS:- No cardiorespiratory insufficiency requiring medical respiration- No low blood pressure requiring systemic catecholamines- No severe neurological damage (e.g., coma)- No tetraplegia without possibility to communicate- No other poor clinical condition- Not pregnant- Fertile patients must use effective contraception- No hypersensitivity to methotrexate, cisplatin, vincristine, lomustine, or ifosfamide- No other malignancy preceding radiotherapy that does not allow further radiationPRIOR CONCURRENT THERAPY:- No prior chemotherapy for brain tumor- The following prior therapies are allowed:- Mistletoe- H15 (extract of Boswellia serrata)- Homeopathy therapy with dilution > 4D- Alternative medicine without proven efficacy- No prior radiotherapy for brain tumor- No concurrent alcohol or tobacco consumption- No concurrent participation in another study |
NCT00278044 | Clinical Study and Gene Mutation Analysis of Adrenoleukodystrophy in Taiwanese Children | Adrenoleukodystrophy Study the clinical manifestations and gene mutation of Taiwanese ALD patients Inclusion Criteria:- X-ALD patients and familyExclusion Criteria: |
NCT00278252 | Etoposide in Treating Young Patients With Relapsed Ependymoma | Brain and Central Nervous System Tumors RATIONALE: Drugs used in chemotherapy, such as etoposide, work in different ways to stop thegrowth of tumor cells, either by killing the cells or by stopping them from dividing.PURPOSE: This phase II trial is studying how well etoposide works in treating young patientswith ependymoma. DISEASE CHARACTERISTICS:- Histologically confirmed intracranial ependymoma at first, second, or third relapse- Anaplastic (malignant) or low-grade ependymoma (cellular, papillary, clear cell,or mixed variants)- Unequivocal evidence of tumor recurrence or progression by MRI scan after failingconventional treatment (e.g., primary surgery and adjuvant radiotherapy) for initialor recurrent disease- Unresectable disease OR not amenable to complete surgical resection- Measurable enhancing or non-enhancing disease on baseline scan performed within thepast 2 weeks- Patients who have undergone prior surgery must have residual measurable diseasePATIENT CHARACTERISTICS:- Lansky performance status 30-100%- Life expectancy 8 weeks- Absolute neutrophil count > 1,000/mm^3- Platelet count > 100,000/mm^3- Serum total bilirubin normal- AST < 2 times upper limit of normal- No unrelated medical condition (e.g., renal or liver impairment) that would precludechemotherapy treatment- No active infection- No known HIV positivityPRIOR CONCURRENT THERAPY:- See Disease Characteristics- No radiotherapy within the past 6 weeks- No chemotherapy within the past 4 weeks- Prior IV etoposide allowed |
NCT00278681 | Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting | Diarrhea Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations andchild mortality as it could reach the most vulnerable children in a community and reduceseverity of not only diarrhea but also of associated infections. It might also potentiallyreduce antibiotic use.We conducted a pilot study prior to conducting a community based controlled effectivenesstrial to assess whether addition of zinc as a therapeutic modality for diarrhea deliveredthrough existing channels, reduces visits to health care providers, antibiotic and otherdrug use, and increases ORS use during diarrhea. Inclusion Criteria:- Children aged 1 month to 5 years with diarrheaExclusion Criteria:- Illness requiring hospitalization (referral) |
NCT00278642 | Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin Disorders | Pemphigus Autoimmune Bullous Skin Disorders are believed to be due to immune cells, cells thatnormally protect the body and are now causing damage to the body. This study is designed toexamine whether treating patients with high dose cyclophosphamide (a drug which reduces thefunction of the immune system) together with anti-thymocyte globulin (a protein that killsthe immune cells that are thought to be causing your disease), followed by return of thepreviously collected special blood cells (stem cells) will result in improvement of thisdisease. Stem cells are undeveloped cells that have the capacity to grow into mature bloodcells, which normally circulate in the blood stream. The purpose of the intense chemotherapyis to destroy the cells in the immune system which may be causing this skin disease. Thepurpose of the stem cell infusion is to restore the body's blood production, which will beseverely impaired by the high dose chemotherapy and anti-thymocyte globulin. Inclusion Criteria:1. Less than chronologic age 60 years at the time of pre-transplant evaluation.2. An established diagnosis of an autoimmune skin disorder that includes any of thefollowing:1. pemphigus vulgaris2. pemphigus foliaceusDiagnosis of bullous skin lesions will be based on history and physical, skin biopsy(light microscopy and indirect fluorescence), indirect immunofluorescence titer, BP180 and 230 titers, Desmolglein-3 and Desmoglein-1 antibody, and photograph.3. Patients who failed corticosteroids (equivalent dosage of prednisone 0.5 mg/kg/dayfor more than 3 months), and at least two of the following: azathioprine,mycophenolate mofetil, gold, tetracycline (or minocycline), cyclosporin,methotrexate, gold, or plasmapheresis. Failure is defined as the inability to weansteroids to less than 0.5 mg/kg/day.4. Potential candidates must have involvement of more than 10% of skin body surfacearea, involvement of one or more mucosal lesions, or recurrent infections requiringmore than two hospitalizations in which the source of the infection was due tobullous skin disease.5. All candidates must be evaluated by two dermatologists, Dr. Joan Guitart and Dr.Joaquin Brieva, who must concur that the patient has refractory disease that may, intheir clinical judgement, be associated with a 5-10% mortality if not controlled.6. A minimum of 2.0 x 106 CD34+ cells/kg after selection are necessary to proceed totransplant.Exclusion Criteria:1. Individuals less than 18 years of age.2. Significant end organ damage such as:1. LVEF <40% or deterioration of LVEF during exercise test on MUGA orechocardiogram.2. Untreated life-threatening arrhythmia.3. Active ischemic heart disease or heart failure.4. DLCO <45% or FEV1/FEV < 50%.5. Serum creatinine > 2.5 mg/dl.6. Liver cirrhosis, transaminases >3x of normal limits or bilirubin >2.0 unless dueto Gilberts disease.3. HIV positive.4. Uncontrolled diabetes mellitus, or any other illness that in the opinion of theinvestigators would jeopardize the ability of the patient to tolerate aggressivetreatment.5. Prior history of malignancy except localized basal cell or squamous skin cancer.Other malignancies for which the patient is judged to be cured by local surgicaltherapy, such as (but not limited to) head and neck cancer, or stage I or II breastcancer will be considered on an individual basis.6. Positive pregnancy test, inability or unable to pursue effective means of birthcontrol, or failure to willingly accept or comprehend irreversible sterility as aside effect of therapy.7. Psychiatric illness or mental deficiency making compliance with treatment or informedconsent impossible.8. Inability to give informed consent.9. Major hematological abnormalities such as platelet count less than 100,000/ul, or ANCless than 1000/ul.10. Presence of infected skin lesions. All skin lesions should be free of suppurativeexudate. |
NCT00278694 | Oxaliplatin and 5-FU Based Preoperative Chemoradiation | Rectal Cancer Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer. Rectal cancer |
NCT00278928 | Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic | Hypertriglyceridemia This will be a prospective, randomized trial to determine if differences exist in thetolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipidinjectable emulsions are an essential nutrient for neonatal growth and development.Traditionally, lipid injectable emulsions have been commercially available in sterile glassbottles, but in April of 2004, a new container was introduced as a sterile plastic bag. InJanuary, 2005, NICU personnel observed what appeared to be a higher than usual incidence ofhypertriglyceridemia. Upon further laboratory investigation of the lipid injectableemulsions stored in glass bottles versus those in plastic, significant differences werenoted in the population of large-diameter fat globules by globule size analysis, reflectiveof a less stable emulsion in plastic. The United States Pharmacopeia (USP) which sets thestandards for drug purity and safety in the U.S., and whose drug monographs are enforceableby the FDA, has proposed to limit this large diameter fat globule population to avolume-weighted percent fat greater than five micrometers or PFAT5 to be less than 0.05% ofthe total lipid concentration. (At the present time, the USP monograph is not officiallyrecognized, but is on track for adoption in 2006.) Our preliminary analyses of four lots of20% lipid injectable emulsion packaged in glass to have a PFAT5 of 0.0030.0008%, comparedto an approximate 55-fold increase in the large-diameter fat globule population or0.1660.016% for an equal number of products packaged in plastic. We hypothesize thisdifference may explain the recent clinical observations. We will compare the incidence ofhypertriglyceridemia in neonates between lipids packaged in glass versus those in plastic.The study will attempt to discern whether the differences in packaging influence thestability and subsequent tolerance of lipid injectable emulsions. Inclusion Criteria:- All patients who present to the neonatal intensive care unit at BIDMC who requireintravenous nutritional supportExclusion Criteria:- Any patients receiving intravenous steroids |
NCT00278096 | Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly | Disability In this study we aim to assess whether unsolicited occupational therapy compared to notherapy can decelerate the increase in disability in high-risk elderly. Inclusion Criteria:- age 85 years- living independently- MMSE score > 18 pointsExclusion Criteria: |
NCT00278733 | Campus Health Intervention Projects UBC Site | High Risk Drinking The goal of the study is to test the efficacy of brief physician advice in reducing thefrequency of high risk drinking and alcohol-related harm in a population of universitystudents seeking routine care at UBC Student Health Service. It is hypothesized thatreceiving the intervention will reduce the amount of alcohol consumed and the incidence ofalcohol-related harm among the students in the intervention group, as compared to thecontrol group. Inclusion Criteria:Full time students 18 and older; students seeking routine care at UBC Student HealthServices; students who report high risk drinking in the last 28 days; students able toread and communicate in EnglishExclusion Criteria:Students graduating or leaving campus before the first intervention is complete; studentswho are acutely ill; students who are under 18 years; female students who are pregnant;students who are suicidal; students consuming more than 200 drinks in the past 28 days |
NCT00278525 | Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma | SYSTEMIC SCLERODERMA Scleroderma is a systemic disorder categorized as an immunologically mediated disease thatcauses collagen deposition of skin and visceral organs. The molecular pathogenesis ofscleroderma has been elusive, although vasculopathy and immune mediated mechanisms arethought to be important. Once extensive cutaneous or visceral disease occurs, prognosis issignificantly shorter than the general population. Although various treatments have beentried, none of them seems to have changed the natural history of scleroderma. Standard doseimmunosuppressive treatment has been disappointing. Recently, cyclophosphamide at 1-2mg/kg/day orally or 800-1400 mg intravenous (IV) monthly for 6-9 months has proven effectivein treatment of scleroderma alveolitis (1). Recent phase I studies of immunoablation withautologous peripheral blood stem cell transplantation (PBSCT) showed some promising data,but the exact efficacy is undetermined (2,3). We now propose, as a phase II randomizedstudy, autologous unmanipulated PBSCT versus pulse cyclophosphamide in patients withsystemic scleroderma. Inclusion Criteria:- Age 60 year or < 60 year old at the time of pretransplant evaluation.- An established diagnosis of scleroderma.- Diffuse cutaneous scleroderma with involvement proximal to the elbow or knee and aRodnan score of > 14ANDScleroderma with any one of the following:- Diffusing capacity of the lung for carbon monoxide (DLCO) < 80% of predicted ordecrease in lung function [DLCO, diffusing capacity divided by the alveolar volume(DLCO/VA) or forced vital capacity (FVC) ] of 10% or more over 12 months.- Active alveolitis on bronchoalveolar lavage.- Pulmonary fibrosis or alveolitis on computed tomography (CT) scan or chest x-ray(CXR) (ground glass appearance of alveolitis).- Renal disease that is not explained by a bacterial infection or other renaldisorders. (Subjects must have two or more of the following: proteinuria - greaterthan trace on dipstick, hematuria - urine blood on dipstick or sediment, hypertensionthat requires treatment with anti-hypertensive medications or untreated but with adiastolic blood pressure (BP) > 95 mm/hg.)- Abnormal electrocardiogram (EKG) (non-specific ST-T wave abnormalities, low QRSvoltage, or ventricular hypertrophy), or pericardial effusion or pericardialenhancement on magnetic resonance imaging (MRI)- Gastrointestinal tract involvement confirmed on radiological study. Radiologicfindings of scleroderma are small bowel radiographs showing thickened folds withdilated loops, segmentation, and flocculation +/- diverticulae, orpseudodiverticulae. A hide-bound appearance due to valvulae packing i.e. dilated andcrowded circular folds, may be present. Gastrointestinal (GI) involvement may also beconfirmed by D-xylose malabsorption, patulous esophagus, or esophageal manometry.ORAs published in NEJM, 2006, 345:25 2655-2709. Limited or diffuse SSL with lung involvementdefined as active alveolitis on bronchoalveolar lavage (BAL) or ground-glass opacity onCT, a DLCO < 80% predicted or decrease in lung function (DLCO/VA,DLCO, FVC) of 10% or morein last 12 months.Exclusion Criteria:- Poor performance status Eastern Cooperative Oncology Group (ECOG 2) at the time ofentry.- Significant end organ damage such as:1. Left Ventricular Ejection Fraction (LVEF) < 40% or deterioration of LVEF duringexercise test on Multiple Gated Acquisition (MUGA) or echocardiogram.2. Untreated life-threatening arrhythmia.3. Active ischemic heart disease or heart failure.4. End-stage lung disease characterized by total lung capacity (TLC) <45% ofpredicted value.5. Pulmonary hypertension (systolic pulmonary arterial pressure > 40 mmHg or meanpulmonary arterial pressure (PAP) > 25 mmHG measurement by pulmonary arterialcatheter).6. Serum creatinine > 2.0 mg/dl.7. Liver cirrhosis, transaminases > 3x of normal limits or bilirubin > 2.0 unlessdue to Gilberts disease.8. Pericardial effusion> 200ml unless successful pericardiocentesis9. Tricuspid annular peak systolic excursion (TAPSE) 1.9 cm10. MRI of heart showing D sign (intraventricular flattering)- Human immunodeficiency virus (HIV) positive.- Uncontrolled diabetes mellitus, or any other illness that in the opinion of theinvestigators would jeopardize the ability of the patient to tolerate aggressivetreatment.- Prior history of malignancy except localized basal cell or squamous skin cancer.Other malignancies for which the patient is judged to be cured by local surgicaltherapy, such as (but not limited to) head and neck cancer, or stage I or II breastcancer will be considered on an individual basis.- Positive pregnancy test, inability or unable to pursue effective means of birthcontrol, failure to willingly accept or comprehend irreversible sterility as a sideeffect of therapy.- Psychiatric illness or mental deficiency making compliance with treatment or informedconsent impossible.- Inability to give informed consent.- Major hematological abnormalities such as platelet count < 100,000/ul or absoluteneutrophil count (ANC) < 1000/ul.- Patients with duration of disease > 5 years.- Exclude if > than 6 prior monthly IV cyclophosphamide treatments. |
NCT00278486 | Hematopoietic Stem Cell Transplantation in Autoimmune-Related Retinopathy(ARRON) | Retinal Disease ARRON is a disease believed to be due to immune cells, cells which normally protect thebody, but are now attacking the tissue in the retina and/or optic nerve. In addition, thedisease may affect the nerves in the ear or other parts of the body . The affected nervesfail to respond, or respond only weakly, to stimuli causing numbing, tingling, pain, andprogressive muscle weakness. If the nerves to the ear are affected, reduced hearing ordeafness may result. The likelihood of progression of your disease is high. This study isdesigned to examine whether treating patients with high dose cyclophosphamide and rabbit ATG(drugs which reduce the function of the immune system) followed by return of previouslycollected blood stem cells will stop the progression of ARRON syndrome. Stem cells areundeveloped cells that have the capacity to grow into mature blood cells, which normallycirculate in the blood stream. The purpose of the cyclophosphamide and rabbit ATG is todestroy the cells in the immune system which are thought to be causing this disease. Thepurpose of the stem cell infusion is to restore the body's blood production, which will beseverely impaired by the high dose chemotherapy and to produce a normal immune system thatwill no longer attack the body. Inclusion Criteria:1. Age between 18-60.2. Diagnosis of ARRON syndrome. Diagnostic criteria described below.Unexplained visual loss over weeks to months. The visual loss includes both visualacuity and field loss define as follows:- Visual acuity: 20/40 or lessOR- Visual field: perimetric mean deviation -5b- Positive antibody to retina or optic nerve.ORA response to immunosuppressive drugs or immune modulators (response is defined byimprovement of vision or decrease the rate of decline of visual loss).- Absence of malignancy {negative physical examination, gastrointestinalendoscopies, mammography and gynecologic examination (for female), and serum PSAmeasurement (for male) within a year}.- Negative MRI of brain.3. The patient has failed at least 3 months of corticosteroids (prednisone 0.5mg/kg tostart), IVIG and at least one other immunosuppressive drug such as methotrexate,Imuran, cyclosporine, etc. Failure is defined by decline of visual acuity (bystandard Snellen acuity clinical testing) or visual field (by Humphrey AutomatedMachine with the 30-2 program or using Kinetic Visual Fields on the GoldmanPerimeter)Exclusion Criteria:1. Absence of light perception lasting more than 6 months2. Any illness that in the opinion of the investigators would jeopardize the ability ofthe patient to tolerate aggressive chemotherapy.3. Prior history of malignancy except localized basal cell, squamous skin cancer orcarcinoma in situ of the cervix. Other malignancies for which the patient is judgedto be cured, such as head and neck cancer, or breast cancer will be considered on anindividual basis.4. Positive pregnancy test.5. Inability or unwillingness to pursue effective means of birth control. Effectivebirth control is defined as 1) refraining from all acts of vaginal intercourse(ABSTINENCE); 2) consistent use of birth control pills; 3) injectable birth controlmethods (Depo-provera, Norplant); 4) tubal sterilization or male partner who hasundergone vasectomy; 5) placement of an IUD (intrauterine device); or 6) use, withevery act of intercourse, of diaphragm with contraceptive jelly and/or condoms withcontraceptive foam.6. Failure to willingly accept or comprehend irreversible sterility as a side effect oftherapy.7. FEV1/FVC < 60% of predicted after bronchodilator therapy (if necessary).8. DLCO < 50% of predicted.9. Active ischemic heart disease and/or those who have had a myocardial infarctionwithin 6 months.10. Resting LVEF < 40 %.11. Bilirubin > 2.0 mg/dl12. Serum creatinine > 2.0 mg/dl.13. Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to ironcompounds/medications.14. Presence of metallic objects implanted in the body that would preclude the ability ofthe patient to safely have MRI exams.15. Diagnosis of primary progressive MS.16. Platelet count < 100,00/ul17. Psychiatric illness, mental deficiency or cognitive dysfunction making compliancewith treatment or informed consent impossible.18. Active infection except asymptomatic bacteruria. |
NCT00278109 | Radiation Therapy, Cyclophosphamide, and Doxorubicin in Treating Women With Stage I or Stage II Breast Cancer Who Have Undergone Surgery | Breast Cancer RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used inchemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop thegrowth of tumor cells, either by killing the cells or by stopping them from dividing. Givingradiation therapy together with cyclophosphamide and doxorubicin after surgery may kill anytumor cells that remain.PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when giventogether with cyclophosphamide and doxorubicin and to see how well they work in treatingwomen with stage I or stage II breast cancer who have undergone surgery. DISEASE CHARACTERISTICS:- Histologically confirmed adenocarcinoma of the breast by routine hematoxylin andeosin (H&E) staining- Primary tumor 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2,pathologic N0-N1, M0)- Patients with lymph nodes positive only by cytokeratin staining (i.e., H&Enegative) are eligible- No squamous cell carcinoma or sarcoma of the breast- Patients must have undergone a segmental mastectomy (SM) with a level I and llaxillary dissection or sentinel lymph node biopsy within the past 14 weeks- Surgical margins at the time of SM must be negative (> 3 mm) for both invasivecarcinoma and for non-invasive ductal carcinoma- No active local-regional disease- Hormone receptor status not specifiedPATIENT CHARACTERISTICS:- ECOG performance status 0-1- Sex: female- Menopausal status not specified- Not pregnant- Negative pregnancy test- Fertile patients must use effective non-hormonal contraception- No other malignancy within the past 5 years except adequately treated basal cell orsquamous cell skin cancer or carcinoma in situ of the cervix- No other serious or poorly controlled medical or psychiatric condition that could beexacerbated by, or complicate compliance with study treatmentPRIOR CONCURRENT THERAPY:- No prior radiation therapy to the breast- No prior trastuzumab (Herceptin )- No other concurrent chemotherapy- No concurrent hormonal therapy except the following:- Steroids given for adrenal failure- Hormones administered for non-disease-related conditions (e.g., insulin fordiabetes, synthroid for hypothyroidism)- Intermittent dexamethasone as an antiemetic or premedication |
NCT00278135 | Memory Improvement With Docosahexaenoic Acid Study (MIDAS) | Age-Related Cognitive Decline The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA,22:6n-3) in improving cognitive functions in subjects with age-related cognitive decline.DHA is a long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural andvisual development and cardiovascular health. Inclusion Criteria:- Males or females, aged 55 or greater.- Have a subjective memory complaint and have a Logical Memory subtest (of the WechslerMemory Scale - III [WMS-III]) raw score one standard deviation or greater below themean of a younger population.- Have the ability to understand the requirements of the study; be willing to providewritten informed consent; and agree to abide by the study restrictions and return forthe required assessments.- If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).Exclusion Criteria:- Have a screening Mini-Mental State Examination (MMSE) < 26.- Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnairein the prior 2 months to screening.- Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in theprior 2 months to screening.- Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening.- Use major anti-psychotics or major anti-depressants.- Use lipase inhibitors such as Xenical (orlistat).- History of major medical conditions including ischemic stroke, head trauma with lossof consciousness, epilepsy, psychosis, vascular dementia, depression (GeriatricDepression [15-item] > 5), myocardial infarction (within 1 year), uncontrolleddiabetes, or blindness.- History of major surgery within the past 6 months.- Current use or history of drug and/or alcohol abuse within 5 years.- Administration of any investigational product within the past 30 days.- Inability to swallow capsules. |
NCT00278083 | TNF-alpha Directed Therapy in Asthma | Asthma This trial is a randomised, single-center, placebo-controlled, double blind, parallel groupstudy in patients with asthma symptomatic on inhaled steroids.This trial will examine the efficacy and safety of 5 mg/kg doses of infliximab in patientswith inhaled corticosteroid-dependent asthma. The primary objective of this study is toobtain pharmacological evidence for a role of the pro-inflammatory cytokine TNF-alpha inpatients with asthma symptomatic on inhaled steroids and to evaluate the safety andtolerability of repeated intravenous administration of infliximab. Inclusion Criteria:1. Have a diagnosis of moderate asthma as defined by the American Thoracic Societycriteria (NIH, 1997) for > 1 year.2. Men and women, >/= 18 to </= 60 years of age and within 60-140% of desirable heightand weight range established by the 1983 Metropolitan Life Insurance Companystandards.3. Non-smoker for at least 1 year and less than a 10 pack year history of smoking.4. Screening values for haematology, biochemistry and urinalysis should be withinclinically acceptable limits for this patient group.5. Chest radiograph at screening must show no evidence of malignancy, infection, orfibrosis. The chest radiographs should also show no apical scarring, cavitarylesions, or calcified granulomas, as evidence of past tuberculosis infections.6. Serological assays for hepatitis B and C must be negative for active infection.Exclusion Criteria:1. Are pregnant, nursing, or planning a pregnancy within 12 months of enrolment.2. Diagnosis of chronic obstructive pulmonary disease, cystic fibrosis or othersignificant respiratory disorder (excluding asthma).3. Exacerbation of asthma symptoms requiring hospitalisation within the previous 12weeks.4. History of clinically significant seasonal allergies will require that the patient isstudied outside the allergy season.5. Have been previously treated with infliximab or any other therapeutic agent targetedat reducing TNF.6. Have been treated with any anti-CD-4 antibody.7. Have been treated with any investigational drug within the previous 3 months orwithin 5 half-lives, whichever is greater.8. Have previously used cyclophosphamide, nitrogen mustard, chlorambucil, or otheralkylating agents.9. Have a history of any clinically significant adverse reaction to murine or chimericproteins, including but not limited to allergic reactions.11. Have had a serious infection during the previous 2 months. 12. Have a chronic orrecurrent infectious disease 13. Have a history of opportunistic infections 14. Havecurrent signs or symptoms of severe, progressive or uncontrolled renal, hepatic,hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebraldisease.15. Have a history of lymphoproliferative disease, including lymphoma 16. Currently haveany known malignancy or have a history of malignancy within the previous 5 years.17. Have had substance abuse (drug or alcohol) problem within the previous 10 years.18. Use of restricted respiratory medication prior to screening within the following timeperiods: 1) oral or systemic steroids, 1 month; 2) immunosuppressant therapy, 3 months.19. Have a history of chronic cough, haemoptysis, weight loss, or pyrexia consideredsuggestive of possible current tuberculosis infection.20. Patients with current active tuberculosis (TB) or atypical mycobacterial infection ora previous history of these infections.21. Be considered at high risk for tuberculosis according to US Centers for DiseaseControl and Prevention (CDC) criteria, 22. A tuberculin (purified protein derivative, PPD)intradermal skin test > 10mm induration.23. Have demyelinating disease (multiple sclerosis), autoimmune conditions such assystemic lupus. |
NCT00278915 | Faslodex in McCune Albright Syndrome | Puberty, Precocious The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of astudy drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty(early puberty) in girls with McCune-Albright syndrome (MAS). Inclusion Criteria:- Females less than or equal to 10 years of age (prior to 11th birthday)- Diagnosis of McCune-Albright syndrome (MAS)- Progressive precocious puberty (PPP) associated with MASExclusion Criteria:- Received any prior treatment for PPP associated with MAS with fulvestrant- Abnormal platelet count or liver function tests- Bleeding disorders- Long term anticoagulation therapy- Known hypersensitivity to any component of the study drug |
NCT00278863 | Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial | Gastric Cancer A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years ofage and older. In addition, patient delay in seeking care for symptoms results in diagnosisat a more advanced stage than that seen in younger individuals. However, clinical trials ongastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs,which have been reported to have clinically significant response rates and survival withmild or negligible toxicities, have been widely used for the patients with AGC. However, fewstudies have been conducted in elderly patients. Inclusion Criteria:- Pathologically proven gastric or gastroesophageal junction adenocarcinoma- Metastatic or recurrent unresectable disease- Measurable lesions (according to Response Evaluation Criteria in Solid Tumors[RECIST])- Age: 65-85 years old- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2- Adequate bone marrow function: absolute neutrophile counts(ANC) 1,500/ul, plateletcount 100,000/ul, hemoglobin 9 g/dl)- Adequate renal function (serum creatinine 1.5)- Adequate liver function (serum bilirubin 2 x upper limits of normal [UNL],aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 3 x UNL)- No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior tostudy treatment is allowed with the exception of capecitabine or S-1) Writteninformed consent was signed by the patientExclusion Criteria:- Previous palliative chemotherapy- Known allergy to study drugs- CNS metastasis- Significant medical comorbidities- Active ongoing infection which antibiotic treatment is needed.- Previous ( within 5 years) history of other malignancy except cured non-malignantskin cancer and uterine cervical cancer in situ. |
NCT00278122 | Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery | Melanoma (Skin) RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stopthe growth of tumor cells, either by killing the cells or by stopping them from dividing.Biological therapies, such as GM-CSF, may stimulate the immune system in different ways andstop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective intreating melanoma.PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSFworks in treating patients with stage III or stage IV melanoma that cannot be removed bysurgery. DISEASE CHARACTERISTICS:- Histologically or cytologically confirmed unresectable stage III or IV melanoma froma cutaneous, mucosal, or unknown primary site- Unresectable stage III disease, defined as meeting 1 of the following criteria:- Regional metastasis that, in the judgement of the treating physician,cannot be surgically resected with clear margins- Regional metastasis that can be surgically resected with clear margins onlyby extensive surgery that is inadvisable or unacceptable to the treatingphysician and/or patient- Staging of cutaneous and mucosal melanoma based on the revised American JointCommittee on Cancer (AJCC) staging system- Must have measurable disease as defined by Response Evaluation Criteria in SmallTumors (RECIST) criteria- No ocular melanoma- Patients with brain metastases may be eligible if all of the following are true:- Total number of brain metastases ever is 3- Each brain metastasis has been completely removed by surgery or each unresectedbrain metastasis has been treated with stereotactic radiosurgery- Stereotactic radiosurgery, such as gamma knife, can be used up to 1 weekbefore study entry- No evident growth of any brain metastasis since treatment- No brain metastasis that is > 2 cm in diameter at study entryPATIENT CHARACTERISTICS:- ECOG performance status 0-1- Absolute neutrophil count > 1,500/mm^3- Platelet count > 100,000/mm^3- Hemoglobin > 9 g/dL- AST and ALT 2.5 times upper limit of normal (ULN)- Alkaline phosphatase 2.5 times ULN- Bilirubin normal- Creatinine 1.5 times ULN- No New York Heart Association class III or IV heart disease- Not pregnant or nursing- Negative pregnancy test- Fertile patients must use effective contraception- No previous or concurrent autoimmune disorder requiring cytotoxic orimmunosuppressive therapy- No autoimmune disorder with visceral involvement- The following conditions are allowed:- Laboratory evidence of autoimmune disease (e.g., positive ANA titer)without symptoms- Clinical evidence of vitiligo- Other forms of depigmenting illness- Mild arthritis requiring steroidal anti-inflammatory drugs- HIV negative- Hepatitis C negative- No other serious or poorly controlled medical condition that could be exacerbated byor complicate compliance with study therapyPRIOR CONCURRENT THERAPY:- No more than 1 previous chemotherapy regimen for metastatic melanoma- No previous paclitaxel- No chemotherapy, interferon, growth factors, interleukin, or radiotherapy (excludinggamma knife therapy for brain metastases) within the past 4 weeks- No surgical resection of metastatic lesions within the past 4 weeks- No other investigational medication within the past 4 weeks or during study- No nitrosoureas (e.g., carmustine or lomustine) within the past 6 weeks and duringstudy treatment- No other concurrent chemotherapy, interferon, other growth factors, interleukin,illegal drugs, radiotherapy, surgery, or steroid therapy- No concurrent oral or injectable hydrocortisone (at doses > 15 mg per day) or itsequivalent |
NCT00278889 | Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX) | Colorectal Cancer The primary purpose of this study is to compare the efficacy of AZD2171 in combination withFOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-linetreatment of patients with metastatic colorectal cancer Inclusion Criteria:- Clinical diagnosis of colon or rectal cancer,- Received prior systemic therapy for cancer,- Cancer must have progressed during or after first treatmentExclusion Criteria:- Prior treatment with a VEGF inhibitor,- Poorly controlled hypertension |
NCT00278876 | Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation | Sarcoma The presence of c-kit mutation is an independent poor prognostic factor for relapse inaddition to large size (> 5 cm) and high mitotic rate (> 5/50 high power field [HPF]) inlocalized gastrointestinal stromal tumor (GIST) patients who underwent complete surgicalresection. In addition, the localized GIST which had exon 11 c-kit mutation and features ofhigh-risk for relapse according to National Institute of Health (NIH) consensus guideline(tumor size > 10 cm or mitotic count > 10/50 HPF) also have high-risk of relapse. Untilrecently, there has been no effective therapy for advanced, unresectable GISTs. However, anew agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11mutation is the strongest prognostic factor for better response and survival. It isreasonable to try imatinib in an earlier and minimal residual status especially for patientsat higher risk of relapse and a higher probability of response to imatinib. Inclusion Criteria:- Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117)- Tumor size > 5 cm and mitotic rate > 5/50HPF(High Power Field), or tumor size > 10 cmirrespective of mitotic rate, or mitotic rate > 10/50 HPF irrespective of tumor size.- Presence of mutation in exon 11 of c-kit gene.- Surgery performed from 3 weeks to 8 weeks before administration of Imatinib mesylate.- No evidence of residual macroscopic and microscopic disease after surgery.- Absence of distant metastases- No prior radiation therapy, no prior chemotherapy, no prior therapy with Imatinibmesylate, or any other molecular targeted or biological therapy.- Age 18 yrs or older- ECOG(Eastern Cooperative Oncology Group electrocorticogram) performance status = 0-2- No New York Heart Association (NYHA) Class 3~4 cardiac problems- Absence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolleddiabetes, uncontrolled chronic renal disease, uncontrolled liver disease, includingchronic viral hepatitis judged at risk of reactivation, uncontrolled activeinfection, such as human immunodeficiency virus (HIV) infection, etc.).- No ongoing pregnancy or nursing..- No prior, or ongoing other malignancy, except adequately treated basal cell orsquamous cell skin cancer, in situ cervical cancer or adequately treated cancer witheradicative intent for which the patient has been continuously disease-free for 5years.- No use of coumarin derivatives at the time of treatment start.- Adequate liver function, as defined by a serum bilirubin < 1.5 x the institutionalupper limit of normal (IULN), aspartate aminotransferase (AST) or alanineaminotransferase (ALT) < 2.5 IULN, obtained within 7 days prior to randomization.- Adequate renal function, as defined by a serum creatinine < 1.5 x IULN, obtainedwithin 7 days prior to randomization.- Absolute neutrophil count (ANC) > 1.5 x 109/l and a platelet count > 100 x 109/lobtained within 7 days prior to randomization. Baseline hemoglobin > 9 g/dl (this maybe achieved by transfusions if needed).- Absence of any psychological, familial, sociological or geographical conditionpotentially hampering compliance with the study protocol and follow-up schedule;those conditions should be discussed with the patient before registration in thetrial. |
NCT00278447 | Addiction Health Evaluation And Disease Management (AHEAD) Study | Alcohol Dependence The objective of this study is to test whether a chronic disease management (CDM) programfor substance abusers in primary care leads to improved alcohol and drug-related outcomes(such as reduced consumption and health problems) and health care utilization patterns. Inclusion Criteria:- 18 years of age or older- Fluent in English or Spanish- Alcohol or drug dependent- Heavy drinking in the past 30 days or recent drug use- Provide 2 contacts to assist with follow-up- Have no plans to move from the local area within a year of screening- Score >21 on Mini-Mental State Examination (no serious cognitive impairment)Exclusion Criteria:- Pregnant (self-report)- Breath alcohol >100 mg/dL- Inability to provide informed consent determined by trained research associates |
NCT00278057 | STUDY OF GLUCOSE IN DIALYSIS WATER WITH REGARD TO BLOOD PRESSURE AND QUALITY OF LIFE | Hemodialysis We wanted to test the hypotheses that blood pressure level was lower, that the variabilityof blood pressure and blood glucose was reduced, and that quality of life was improved whenglucose was added to the dialysis fluid. Inclusion Criteria:- age more than 18 years, both men and women, and hemodialysis treatment for more thanthree monthsExclusion Criteria:- treatment with hemodiafiltration, change to another dialysis modality, renaltransplantation, alcohol abuse defined as more than 21 drinks a week for men and morethan 14 drinks a week for women, and unwillingness to participate. |
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