_id
stringlengths 11
11
| title
stringlengths 7
300
| text
stringlengths 14
35.2k
|
|---|---|---|
NCT00278902 | A Study of ARRY-334543 in Patients With Advanced Cancer | Advanced Cancer This is a Phase 1 study during which patients with advanced solid tumors will receiveinvestigational study drug ARRY-334543.This study has 2 parts. In the first part, patients will receive increasing doses of studydrug (2 dosing schedules will be evaluated) in order to achieve the highest dose possiblethat will not cause unacceptable side effects. Approximately 70 patients from the US andCanada will be enrolled in Part 1 (Completed).In the second part of the study, patients will receive the best dose(s) and schedule(s) ofstudy drug determined from the first part of the study and will be followed to see what sideeffects the study drug causes and what effectiveness it has, if any, in treating the cancer.Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed). Key Inclusion Criteria (Part 2):- Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer,pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma,ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer orother relevant cancers if approved in advance by the Sponsor.- Measurable disease (at least 1 target lesion) according to modified RECIST.- Failed at least one previous therapeutic regimen and either no longer a candidate forstandard therapy, has no standard therapy available, or chooses not to pursuestandard therapy.- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.- Must consent to allow the Sponsor access to an archival histological specimen or tohave a pre-dose tumor biopsy.- Additional criteria exist.Key Exclusion Criteria (Part 2):- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases andis on steroids, the steroid dose must be stable for at least 30 days).- Use of an investigational medication or device within 30 days prior to first dose ofstudy drug.- Major surgery within 30 days prior to first dose of study drug.- Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (notincluding palliative radiotherapy at focal sites).- Pregnancy or lactation.- Known positive serology for the human immunodeficiency virus (HIV), hepatitis Band/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they maybe enrolled even if they are positive for hepatitis B and/or hepatitis C.- Additional criteria exist. |
NCT00278304 | Radiation Therapy in Treating Patients With Cervical Cancer | Cervical Cancer RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiationuses radioactive material placed directly into or near a tumor to kill tumor cells. Givingradiation therapy in different ways may kill more tumor cells.PURPOSE: This phase II trial is studying how well giving external-beam radiation togetherwith internal radiation works in treating patients with cervical cancer. DISEASE CHARACTERISTICS:- Histologically confirmed carcinoma of the cervix of 1 of the following cellularsubtypes:- Squamous cell- Adenocarcinoma- Adenosquamous cell- Stages IB-IVA disease- Stage IVB disease allowed provided the impact on the quality of life istremendous (e.g., "frozen pelvis" or massive pelvic disease and fistulaformation, severe pain, or bleeding)- Measurable and/or evaluable disease on MRIPATIENT CHARACTERISTICS:- ECOG performance status 0-2- No physical or physiological capacity that would preclude study treatment- No cognitively impaired patients who cannot provide informed consent- Not pregnant or nursing- Negative pregnancy test- No contraindication to MRI, including any of the following:- Weight > 136 kg- Allergy to MR contrast agent- Pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronicdevices- No significant unrelated systemic illness- No serious infections- No significant cardiac, pulmonary, hepatic, or other organ dysfunction that wouldpreclude study treatment- Must be medically fit to receive anesthesiaPRIOR CONCURRENT THERAPY:- No prior definitive brachytherapy procedures- Ring implants or intravaginal cones for the relief of excessive bleeding allowed- No prior definitive surgical oncologic procedures (e.g., radical hysterectomy)- Concurrent chemotherapy, immunotherapy, or hormonal therapy allowed |
NCT00278265 | Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia | T-Cell Large Granular Lymphocytic Leukemia RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, work indifferent ways to stop the growth of cancer cells, either by killing the cells or bystopping them from dividing.PURPOSE: This phase II trial is studying how well methotrexate works as first-line therapyand fludarabine works as second-line therapy in treating patients with T-cell large granularlymphocytic leukemia. DISEASE CHARACTERISTICS:- Confirmed diagnosis of T-cell large granular lymphocytic (T-LGL) leukemia- Must have concurrent anemia or neutropeniaPATIENT CHARACTERISTICS:- Life expectancy 2 years- Not pregnant- Fertile patients must use effective contraception- No other malignancy- No active infectionPRIOR CONCURRENT THERAPY:- No prior immunosuppressive treatment- No previous treatment with methotrexate or fludarabine |
NCT00278850 | "Vestibulitis Educational Seminar Trial" Study | Vulvar Vestibulitis The purpose of this study is to investigate the efficacy of an educational seminar seriesfor women with vulvar vestibulitis syndrome (VVS). Inclusion Criteria:- Women who meet the diagnostic criteria for VVS by the Vancouver Hospital VulvarDisease Clinic- Women who have been referred to VVS Educational Seminars at Vancouver Hospital- Proficient in EnglishExclusion Criteria:- Any women referred to the VVS Educational Seminars will be eligible forparticipation. |
NCT00278460 | Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer | Lung Cancer RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in differentways to stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxelworks in treating patients with recurrent stage III or stage IV non-small cell lung cancer. DISEASE CHARACTERISTICS:- Histologically confirmed stage IIIB or IV non-small cell lung cancer, including anyof the following types:- Squamous cell carcinoma- Adenocarcinoma, including bronchoalveolar cell adenocarcinoma- Large cell anaplastic carcinoma, including giant and clear cell carcinomas- Histologic or cytologic documentation of recurrence is required- Measurable or evaluable disease, defined as any mass reproducibly measurable in 2perpendicular diameters by physical examination or imaging- The following lesions are not considered measurable or evaluable:- Bone disease only- Pleural or pericardial effusions- Previously irradiated lesions, unless subsequent progression is documented- CNS metastases allowed provided the patient undergoes at least 2 weeks ofradiotherapy prior to study entryPATIENT CHARACTERISTICS:- Not pregnant or nursing- Fertile patients must use effective contraception- Negative pregnancy test- CALGB performance status 1- Life expectancy 3 months- Granulocyte count > 1,500/mm^3- Platelet count 100,000/mm^3- Creatinine 2 times normal- Bilirubin normal- SGOT and/or SGPT 2.5 times upper limit of normal (ULN) AND alkaline phosphatase1.5 times ULN OR- Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal- Ejection fraction normal by ECHO or MUGA- No history of congestive heart failure- No psychiatric illness that would preclude study compliance- No serious medical or psychiatric illness that would preclude giving informed consentor limit survival to < 3 months- No active uncontrolled bacterial, fungal, or viral infection- No other malignancy within the past 5 years except curatively treated carcinoma insitu of the cervix or breast, basal cell or squamous carcinoma of the skin, or othersurgically resected non-recurrent primary tumor not treated with adjuvantradiotherapy or chemotherapy- No pre-existing peripheral neuropathy grade 2PRIOR CONCURRENT THERAPY:- At least 2 weeks since prior major surgery and recovered from acute effects- At least 2 weeks since prior palliative radiotherapy and recovered from acute toxiceffects- Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associatedwith clinical morbidity allowed- No prior chemotherapy- No concurrent cranial or thoracic radiation therapy- No concurrent cytotoxic or hormonal therapy- Concurrent palliative radiotherapy allowed for relief of localized pain andobstruction |
NCT00278070 | Metronomic Oral Vinorelbine in Patients With Metastatic Tumors | Breast Cancer Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of threedifferent doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomicschedule three times a week: on Monday, Wednesday and Friday. Inclusion Criteria:- Signed informed consent- Ages 16 - 75 years- Genders: both- Performance status 0-2 according to the World Health Organization (WHO) scale- Life expectancy of at least 16 weeks- Adequate bone marrow, hepatic and renal functions- Absence of brain metastasis- Metastatic/locally advanced refractory prostate, breast or non-small cell lung cancerpreviously treated with no more than two chemotherapeutic regimens- White blood cells >= 3500/mm^3- Absolute neutrophil count >= 1500/mm^3- Platelets >= 100,000/mm^3- Total serum bilirubin less than 1.5 mg/dl- Serum transaminases less than 2.0 x upper normal limit (UNL) unless attributed toliver metastases- Serum creatinine within normal rangeExclusion Criteria:- Major active infection- More than two prior chemotherapy regimens for metastatic disease- Any of the following within the 12 months prior to starting the study treatment:- myocardial infarction,- severe/unstable angina,- coronary/peripheral artery bypass graft,- congestive heart failure,- cerebrovascular accident or transient ischemic attack, or pulmonary embolism,- cardiac dysrhythmias of grade >/= 2,- atrial fibrillation of any grade, or- heart rate corrected interval (QTc) > 450 msec for males or > 470 msec forfemales.- Hypertension that cannot be controlled with medications (> 150/100 mmHg despiteoptimal medical therapy)- Ongoing anti-coagulation therapy- Pregnancy or breastfeeding- Other severe acute or chronic medical or psychiatric condition, or laboratoryabnormality that would impart, in the judgment of the investigator, excess riskassociated with study participation or study drug administration; or which, in thejudgment of the investigator, would make the patient inappropriate for entry into thetrial. |
NCT00278538 | Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus This study is designed to examine whether treating patients with lupus with high dosecyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immunesystem), followed by return of their previously collected stem cells will result inimprovement in the disease. Stem cells are undeveloped cells that have the capacity to growinto mature blood cells, which normally circulate in the blood stream. The purpose of theintense chemotherapy is to destroy the cells in the immune system which may be causing thisdisease. The purpose of the stem cell infusion is to produce a normal immune system thatwill no longer attack body. The study purpose is to examine whether this treatment willresult in improvement in the lupus disease. Inclusion Criteria:- Ages 15 to 60 years old- Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteriafor SLE (see Appendix 16.2)- Meet one of following five: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 renal category A.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 fail corticosteroids (either oral prednisone > 0.5mg/kg/day for more than 6 months or pulse methylprednisolone for at least onecycle of three days), and at least one of the following: azathioprine at 2mg/kg/day for at least 3 months, mycophenolate mofetil 2 grams daily for morethan 3 months, cyclophosphamide intravenously or orally for at least 3 months,or cyclosporine at least 3 mg/kg/day for at least 3 months, danazol for at least3 months, or splenectomy.4. For mucocutaneous disease, participants must meet BILAG mucocutaneous categoryA, be unable to be weaned from prednisone to less than 0.5 mg/kg/day for morethan 6 months and obvious cushingoid habitus, and have received at least one ofthe following: azathioprine at 2 mg/kg/day for at least 3 months, methotrexateat 15mg/week for at least 3 months, cyclophosphamide intravenously or orally forat least 3 months, or cyclosporine at least 3 mg/kg/day for at least 3 months.5. For arthritis/myositis, participants must meet BILAG musculoskeletal category A,be unable to be weaned from prednisone to less than 0.5 mg/kg/day for more than6 months and obvious cushingoid habitus, and have received at least one of thefollowing: azathioprine at 2 mg/kg/day for at least 3 months, methotrexate at15mg/ week for at least 3 months, cyclophosphamide intravenously or orally forat least 3 months, or cyclosporine at least 3 mg/kg/day for at least 3 months.- Able to give informed consent.- If indication for HSCT is nephritis, a renal biopsy must demonstrate the potential ofa reversible (non-fibrotic) component indicating that if successful the participantwould not be likely to be permanently dialysis-dependent after transplant.- Since the BILAG is only one of multiple indices for SLE, patients may also becandidates if despite prior immune suppression therapy as described above, patientsare still on active immune suppression (more than 10mg a day of prednisone).- Patients with SLE whose major manifestation is Antiphospholipid syndrome (APS) may becandidates without prior immune suppression therapy if they have had a visceral organthrombotic or embolic event despite anticoagulation.- Patients with SLE whose major manifestation is Antiphospholipid syndrome (APS) may becandidates without prior immune suppression therapy if they have had a visceral organthrombotic or embolic event despite anticoagulation.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 to active lupus.- Resting LVEF < 40% unless attributed to active lupus.- Known hypersensitivity to E Coli derived proteins.- Transaminases greater than 2 times normal unless attributed to active lupus.- Positive tuberculosis skin test- Any active infection- Any co-morbid illness that in the opinion of the investigator would jeopardize theability of the subject to tolerate the study.- Failure to collect at least 2.0 x 106 CD34+ cells/kg- ANA-negative |
NCT00278707 | GTA-Glyceryltriacetate for Canavan Disease | Infantile Canavan Disease The purpose of this study is to determine whether oral supplementation of glyceryltriacetate improves the clinical prognosis of Canavan Disease. Inclusion Criteria:- Age below 15 months- Biochemically diagnosed with Canavan DiseaseExclusion Criteria: |
NCT00278473 | Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults | Attention Deficit Disorder With Hyperactivity This study will determine the effectiveness of group cognitive-behavioral therapy ascompared to a problem-solving social support group in treating problems of time management,organization, and planning in adults with attention deficit hyperactivity disorder (ADHD). Inclusion Criteria:- Suspected of having or have been diagnosed with ADHD- May potentially benefit from the ADHD group treatmentExclusion Criteria:- Any overt cognitive disability (e.g., Alzheimer's disease, mental retardation)- Deemed not to potentially benefit from the proposed ADHD group treatment |
NCT00278499 | Prevalence of HIV and Other Sexually Transmitted Infections Among Female Sex Workers and Miners in Honghe Prefecture, Yunnan Province, China | HIV Infections The purpose of this study is to collect data on the HIV strains currently circulating amongfemale sex workers (FSWs) and their clients. In addition, this study will identify potentialparticipants for future studies. Inclusion Criteria for FSWs Completing Cross-sectional Survey:- Self-reported to have sold sex for money within the 3 months prior to study entry- Works at one of the study sitesInclusion Criteria for FSW Cohort Study:- Participated in the baseline cross-sectional survey in Kaiyuan City, HonghePrefecture, Yunnan Province, China- Willing to provide updated contact information (and a cell phone number, ifavailable)- Willing to be contacted by study staff once a month for 12 consecutive monthsInclusion Criteria for FSW Client (Miner) Study:- Male- Works at one of the selected mine sitesInclusion Criteria for All Participants:- Parent or guardian willing to provide informed consent, if applicable |
NCT00278512 | Hematopoietic Stem Cell Support in Vasculitis | Vasculitis The systemic vasculitis is a wide-ranging group of diseases that are characterized by thepresence of blood vessel inflammation (1). Despite this common feature, each type ofvasculitis has a unique variety of clinical manifestations that influences its degree ofdisease severity and ultimately its management. Immunosuppressive therapy forms thefoundation of treatment for almost all forms of systemic vasculitis.The systemic necrotizing vasculitis (SNV) are a subset of vasculitis with significantmorbidity and mortality (2). The SNV are Wegener's granulomatosis, allergic angiitis andgranulomatosis (AAG) (also known as Churg-Strauss syndrome), polyarteritis nodosum (PAN),microscopic polyangiitis (MPA), and overlap syndrome. In spite of modern therapeutic immunesuppressive agents, there remains a not inconsequential morbidity and mortality associatedwith SNV. The current standard therapy for SNV is chronic oral cyclophosphamide (1-3mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kginfused over 4 days is the most common worldwide transplant regimen for systemic lupuserythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We,therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG)for patients with SNV. Inclusion Criteria:- 1. Age 16 to 60 years old at the time of pretransplant evaluation.- 2. An established diagnosis of systemic necrotizing vasculitis (Wegener'sgranulomatosus, polyarteritis nodosum (PAN), allergic angiitis granulomatosus (AAG,also known as Churg Strauss syndrome), microscopic polyangiitis (MPA), or overlapsyndrome)Temporal arteritis, or mixed cryoglobulinemia or primary central nervoussystem vasculitis AND failure of corticosteroids and any of the following at least 6months of oral or IV cytoxan, rituximab, or cellcept. (Failure defined as: a)patients with a high disease activity and involvement of internal organs as measuredby increased FFS > 2 and/or BVAS > 20, or b) patients who develop recurrent flareswith subsequent progressive organ damage.)ORNeurovascular Behcets with recurrent oral and/or genital lesions confirmed by culture tobe herpes negative, MRI findings consistent with CNS vasculitis, recurrent neurologicalsymptoms, and clinical confirmation by a Neurologist (e.g., Dr. Rama Gourimeni) ANDfailure of at least 3 months of oral or IV cytoxan.ORPulmonary or neurovascular Sjogrens with positive SSA/SSB confirmed by a rheumatologistand neurologist (if CNS involved) or pulmonologist (if lungs involved) and eitherrecurrent neurologic attacks or progressive pulmonary compromise (dyspnea on exertion,decreased DLCO or CT findings of active disease) despite at least 6 months of intravenousmonthly pulse cyclophosphamide.- 3. Patient eligibility must be confirmed by two Rheumatologists. For patients withneurovascular Behcets, eligibility need only be confirmed by a neurologist.- 4. A minimum CD34+ cell dose of 2.0 x 10e6/kg post-selection.Exclusion Criteria:- 1. Significant end organ damage such as:1. LVEF <40% or deterioration of LVEF during exercise test on MUGA orechocardiogram unless due to active disease.2. Untreated life-threatening arrhythmia.3. Active ischemic heart disease or heart failure.4. DLCO < 40% of predicted value unless due to active disease.5. Serum creatinine > 2.5 mg/dl, unless due to active disease.6. Liver cirrhosis, transaminases >3x of normal limits, or bilirubin >2.0 unlessdue to Gilberts disease.- 2. HIV positive.- 3. Uncontrolled diabetes mellitus, or any other illness that in the opinion of theinvestigators would jeopardize the ability of the patient to tolerate aggressivetreatment.- 4. 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.- 5. 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.- 6. Psychiatric illness or mental deficiency making compliance with treatment orinformed consent impossible.- 7. Inability to give informed consent.- 8. Active infection, excluding asymptomatic bacteruria or vaginal candidiasis.- 9. Active hepatitis B (HBSAg positive) or active hepatitis C (PCR positive bloodlymphocytes). |
NCT00278005 | Infection in DiGeorge Following CHD Surgery | DiGeorge Syndrome We propose a retrospective review of patients with DiGeorge syndrome having undergonecardiac surgery to evaluate the incidence of blood stream and/or surgical site infection.The hypothesis is that we will find an increased number of infections for this sub-group. Wewill compare the incidence of infection to children of similar age and diagnosis to evaluatefor variances in the incidence of infection. Inclusion Criteria:- Children's Healthcare of Atlanta patients, Egleston DiGeorge Syndrome Cardiac Surgery200 medical charts between Jan 1, 1998 and April 31, 2005 with cardiac surgery andDiGeorge Syndrome 200 medical charts between Jan 1, 1998 and April 31,2005 withcardiac surgery and no DiGeorge SyndromeExclusion Criteria:- Those who do not meet inclusion criteria |
NCT00278993 | Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy | Prostate Cancer This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patientswith hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastaticdisease and who have had prior anti-androgen therapy. The study will further explore theefficacy of E7389 by enrollment of patients into two strata: those who have had no priorsystemic chemotherapy for their disease (except for mitoxantrone and estramustine), andthose who failed no more than one previous chemotherapeutic regimen with tubulin-bindingagents such as docetaxel. Inclusion criteria:1. Males with histologically proven adenocarcinoma of the prostate that has progressed(ie. a minimum of 3 consecutive rises in Prostate Specific Antigen (PSA) (with thelast value 4 ng/mL) taken at least 1 week apart prior to study entry) despitecastration or maintenance of castrate-level testosterone (defined as serumtestosterone .50 ng/dL or 1.7 nmol/L), or progressed during non-hormonalchemotherapy.Note: Patients previously treated with an antiandrogen must have disease progressiondocumented after antiandrogen withdrawal. Those who have not undergone orchiectomymust continue medical castration with a gonadotropin-releasing hormone analog. Atleast 4 weeks must have elapsed between the withdrawal of antiandrogens (6 weeks inthe case of nilutamide or bicalutamide and four weeks in the case of flutamide orother secondary hormonal therapy) and enrollment, so as to avoid the possibility ofconfounding results of the response due to antiandrogen withdrawal.2. Patients must fulfill one of the following two criteria to be stratified:- No prior chemotherapy (except mitoxantrone or estramustine) for advanced and/ormetastatic disease as defined in inclusion criteria #1.- Failure of no more than one previous chemotherapeutic regimen with tubulinbinding agents such as docetaxel.3. Resolution of all chemotherapy or radiation-related toxicities to less than grade 2severity, except neuropathy and alopecia4. Age 18 years.5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.6. Life expectancy of 3 months.7. Adequate renal function as evidenced by serum creatinine 1.5 times upper limits ofnormal (ULN) or calculated creatinine clearance 40 mL/minute (min) per theCockcroft and Gault formula.8. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) 1.5 x10^9/L, hemoglobin 9.0 g/dL (or 5.5 mmol/L), and platelet count 100 x 10^9/L.Adequate liver function as evidenced by bilirubin 1.5 x ULN, alanine transaminase(ALT), and aspartate transaminase (AST) 3 x ULN (in the case of liver metastases5 x ULN).9. Patients willing and able to complete the VAS (Visual Analog Scale).10. Patients willing and able to comply with the study protocol for the duration of thestudy.11. Written informed consent prior to any study-specific screening procedures with theunderstanding that the patient may withdraw consent at any time without prejudice.Exclusion criteria:1. Patients who have received chemotherapy, radiation, or experimental therapy within 4weeks of start of E7389 treatment2. Radiation therapy encompassing 30% of marrow or treatment with radioactive strontium3. Patients who require therapeutic anti-coagulant therapy with warfarin or relatedcompounds; (mini dose warfarin or related compounds are permitted).4. Severe / uncontrolled intercurrent illness/infection.5. Significant cardiovascular impairment (history of congestive heart failure > NYHAgrade II, unstable angina or myocardial infarction within the past six months, orserious cardiac arrhythmia)6. Patients with organ allografts.7. Patients with known immunosuppression such as positive HIV status.8. Patients who have had a prior malignancy, other than nonmelanoma skin cancer, unlessthe prior malignancy was diagnosed and definitively treated 5 years previously withno subsequent evidence of recurrence.9. Patients with pre-existing neuropathy > Grade 210. Patients with brain or subdural metastases are not eligible, except if they havecompleted local therapy and have discontinued the use of corticosteroids for thisindication for at least two weeks before starting treatment with E7389.11. Patients with meningeal carcinomatosis.12. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemicalderivative.13. Patients who participated in a prior E7389 clinical trial.14. Patients with other significant disease or disorders that, in the Investigator'sopinion, would exclude the patient from the study. |
NCT00278213 | Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia | Prolymphocytic Leukemia RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, andmitoxantrone, work in different ways to stop the growth of cancer cells, either by killingthe cells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, canblock cancer growth in different ways. Some block the ability of cancer cells to grow andspread. Others can find cancer cells and help kill them or carry cancer-killing substancesto them. Combination chemotherapy followed by alemtuzumab may be effective in treatingchronic lymphocytic leukemia and prolymphocytic leukemia.PURPOSE: This phase II trial is studying how well giving combination chemotherapy followedby alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia orprolymphocytic leukemia. DISEASE CHARACTERISTICS:- Diagnosis of T-cell chronic lymphocytic leukemia (T-CLL) or T-cell prolymphocyticleukemia (T-PLL)- Previously untreated disease OR patient may have received up to 2 therapiesPATIENT CHARACTERISTICS:- ECOG performance status 0-2- Life expectancy > 6 months- No severe organ dysfunction- No other concurrent or previous neoplasm- No autoimmune hemolytic anemia or thrombocytopeniaPRIOR CONCURRENT THERAPY:- See Disease Characteristics- No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab |
NCT00278824 | Fentanyl Transdermal Patch With CHADD for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain | Pain A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted DrugDelivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for thetreatment of breakthrough pain in adult patients with moderate to severe non-malignantchronic pain. The open-label study arm will last up to 12 days. The double-blind arm willlast up to 15 days. Eligible patients who complete the open-label arm will be allowed toenroll in the double-blind study arm. Inclusion Criteria:- Patient is 18 through 70 years of age.- Patient has moderate to severe non-malignant chronic pain.- Patient is opioid-tolerant, requires treatment with chronic opioids and is currentlytaking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain.Patient must have been taking this dose for at least 2 weeks.- Patient must be experiencing 1 to 4 episodes of target breakthrough pain(breakthrough pain that is related to the patient's chronic pain condition) a daywhile taking a dose of 50 mcg/hr transdermal fentanyl.Exclusion Criteria:- Patient has active cancer.- Patient has a history of substance abuse or has a substance abuse disorder.- Patient is pregnant or breastfeeding. |
NCT00278603 | Stem Cell Injection for Peripheral Vascular Disease | Peripheral Vascular Disease Severe peripheral vascular disease of the legs causes narrowing of the blood vessels in thelegs, which keeps the blood from flowing adequately through these vessels. This study isdesigned to examine whether treating patients with their own previously collected blood stemcells will improve blood flow in the most severely affected leg. Blood stem cells areundeveloped cells that have the capacity to grow into mature blood cells, which normallycirculate in the blood stream. Inclusion Criteria:- Atherosclerotic ischemic peripheral vascular disease with rest pain defined as painthat occurs at night or at rest that involves the foot and is a sign of end stagevascular disease and / or ischemic lower extremity ulcers due to infra-inguinaldisease and/or peak walking time of 1 to 6 minutes on two exercise tests separated by2 weeks on graded treadmill.- Either a or b1. Ankle brachial index (ABI) < 1.0.2. Doppler waveforms at posterior tibial artery and dorsalis pedis artery aremonophasic with toe pressure < 30 mmHg.- A non-surgical candidate for revascularization e.g. prior vascular reconstruction,inability to locate a suitable vein for grafting, diffuse multi- segment disease, orextensive infra-popliteal disease not amenable to a vascular graft.- Age > 18 years old.Exclusion Criteria:- Popliteal vascular entrapment syndrome- Lower Extremity infection or infected ulcer- Hypercoagulable state- HIV positive- HBsAg positive- Uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medicaltherapy- Unstable angina- Thrombocytopenia < 100,000/ul- Anemia that cannot be transfused to a hemoglobin greater than 10 g/dl- Leukemia or myelodysplasia- Allergy to E coli or its products- Patients with metal in their bodies cannot undergo MRIs (MRA). Therefore, patientswith, cochlear implants, or aneurysm clips are not eligible. Coronary artery stentsare not a contraindication. Patients with pacemakers are still candidates providedthey have normal creatinine (< 1.1 mg/dl) and can receive contrast dye (no allergy)for angiogram instead of MRA.- Patients who are pregnant- Poorly controlled diabetes (HbA1c > 6.5)- Current malignancy, except squamous cell or basal cell skin cancers thought to beeasily controlled.- AST, ALT, or bilirubin more than twice the upper limit of normal.- WBC < 2.5 / ul.- Any patient who is actively bleeding, including blood on urine dipstick or fecaloccult blood.- No patient may be re-treated until at least 5 patients have completed 6 months offollow-up with no notable safety findings and evidence of therapeutic efficacy(improved ABI or healing ulcer) occurred at stem cell doses higher than the patientreceived in this dose escalation study or response occurred in the treated leg andthe untreated leg meets eligibility criteria. Re-treated patients must meeteligibility criteria.- Patients who smoke unless stop smoking at least two weeks before enrollment and agreenot to smoke thereafter. |
NCT00278616 | Hematopoietic Stem Cell Transplantation in Patients With Antiphospholipid Syndrome | ANTIPHOSPHOLIPID SYNDROME Antiphospholipid syndrome is disease believed to be due to immune cells, cells whichnormally protect the body, but are now producing the protein which leads to abnormalclotting in the body. This study is designed to examine whether treating patients with highdose cyclophosphamide together with CAMPATH (drugs which reduce the function of the immunesystem), followed by return of the previously collected stem cells will result inimprovement in the disease. Stem cells are undeveloped cells that have the capacity to growinto mature blood cells, which normally circulate in the blood stream. The purpose of theintense chemotherapy is to destroy the cells in the immune system which may be causing thedisease. The purpose of the stem cell infusion is to produce a normal immune system thatwill no longer attack the body. The study purpose is to examine whether this treatment willresult in improvement in the disease. The drugs used in this study treatment are drugs forcommonly used for immune suppression. Inclusion Criteria:1. Age > 18 years< 55 years at the time of pretransplant evaluation2. A or 6.12.B:A) An established diagnosis of a definite primary APS by Sapporo criteria as follows:1. Positive LA and/or ACLA IgG or IgM on two separate measurements, AND2. Arterial, venous or small vessel thrombosis (confirmed by imaging or doppler studiesor histopathology, with the exception of superficial venous thrombosis) OR pregnancymorbidity (defined as three or more embryonic losses, OR one or more premature birthdue to preeclampsia or growth retardation, OR one or more fetal death)B) APLA-positive Sneddon syndrome defined as an association of ischemic cerebrovascularevents and a widespread livedo reticularis3. Patients failed treatment with anticoagulation including warfarin, heparin/LMWH in thepresence of positive LA and/or ACLA IgG, or IgM. Failure is defined as any of abovedescribed thromboembolic events (6.12.A-2 or 6.12.B) except for pregnancy morbidity whilereceiving therapeutic anticoagulation. Therapeutic anticoagulation is defined as at least5000 U of regular heparin SQ BID, OR unfractionated IV heparin adjusted for therapeuticPTT, OR at least 40 mg of lovenox SQ QD (or equivalent LMWH), OR coumadin adjusted for INRof at least 2.0, documented within 1 month of a refractory event or within 3 months ifpatient was known to be previously stable PLUS in the opinion of the investigator theindividual has been receiving adequate anticoagulation.Exclusion Criteria:1. Poor performance (PS) status (ECOG >2) at the time of entry, unless decline of PS isdue to the disease itself and considered to be reversible.2. Significant end organ damage such as (not caused by APS):- LVEF<40% or deterioration of LVEF during exercise test on MUGA orechocardiogram.- Untreated life-threatening arrhythmia.- Active ischemic heart disease or heart failure.- DLCO<40% or FEV1/FEV < 50%.- Serum creatinine >2.5 or creatinine clearance <30ml/min.- Liver cirrhosis, transaminases >3x of normal limits or bilirubin >2.0unless due to Gilbert disease.3. HIV positive.4.Uncontrolled diabetes mellitus, or any other illness that in the opinionof the investigators would jeopardize the ability of the patient totolerate aggressive treatment.5. Prior history of malignancy except localized basal cell or squamous skincancer. Other malignancies for which the patient is judged to be cured bylocal surgical therapy, such as (but not limited to) head and neck cancer,or stage I or II breast cancer will be considered on an individual basis.6. Positive pregnancy test, inability or unable to pursue effective meansof birth control, failure to willingly accept or comprehend irreversiblesterility as a side effect of therapy.7. Psychiatric illness or mental deficiency making compliance withtreatment or informed consent impossible.8. Inability to give informed consent.9. Major hematological abnormalities such as platelet count less than100,000/ul, ANC less than 1000/ul unless due to APS.10. Failure to collect at least 2.0 x 106 CD34+ / kg cells.*11. Patients who are already in a clinical trial for APS treatment |
NCT00278629 | Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy | Chronic Inflammatory Demyelinating Polyneuropathy Chronic inflammatory demyelinating polyneuropathy is disease believed to be due to immunecells, cells which normally protect the body, but are now attacking the nerves in the body.As a result, the affected nerves fail to respond, or respond only weakly, to stimuli causingnumbing, tingling, pain, and progressive muscle weakness.The likelihood of progression ofthe disease is high. This study is designed to examine whether treating patients with highdose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (aprotein that kills the immune cells that are thought to be causing disease), followed byreturn of the previously collected blood stem cells will stop the progression of CIDP. Stemcells are undeveloped cells that have the capacity to grow into mature blood cells, whichnormally circulate in the blood stream. The purpose of the high dose cyclophosphamide andATG is to destroy the cells in the immune system. The purpose of the stem cell infusion isto evaluate whether this treatment will produce a normal immune system that will no longerattack the body. Inclusion criteria:- Definite CIDP according to the EFNS / PNS criteriaAND- Clinically typical or atypical CIDPAND- Failure to tolerate or respond to, or an incomplete response to, or relapse after atleast 3 months of conventional treatment consisting of corticosteroids (equivalentdosage of prednisone 1.0/mg/day to 0.75mg/kg/day to start with adequate taperingtrials of no less than 0.5mg/kg/day), and/or either IVIG or plasmapheresis or cytoxanor rituxan- Failure to respond to therapy is defined by:1. Persistent muscle weakness Grade 3/5 or worse (MRC) in at least one muscle orgrade 4/5 in at least two muscle groups OR2. Persistent dysphagia documented by either aspiration or insufficient clearing onvideofluoroscopic examination.OR3. Persistent incapacitating sensory loss (e.g. gait ataxia, falls > 1/month)AND4. If patients are on IVIG or plasmapheresis, neurologic condition is documented todeteriorate (for example, new or increase finger tip paresthesias or increasedleg heaviness) upon stopping IVIG (or plasmapheresis)@- Monoclonal gammopathy of undetermined significance (MUGS) (in which the pathogenesisof are thought to be the same as CIDP) will be allowed provided bone marrow aspirateand biopsy rules out multiple myeloma.- Other immune mediated or suspected immune mediated neuropathies such as multifocalmotor neuropathy or anti-MAG neuropathy may be treated but will be analyzed andreported separately.Exclusion Criteria:- Any evidence of hereditary cause for neuropathy that is known or likely hereditarydemyelination neuropathy because of family history, foot deformity, mutilation ofhands or feet, retinitis pigmentosa, ichthyosis, or liability to pressure palsies.- Diphtheria, drug, or toxin exposure likely to be cause of neuropathy- Conditions in which the pathogenesis of the neuropathy may be different from CIDPsuch as: Lyme disease (Borrelia burgdorferi infection), POEMS syndrome,Osteosclerotic myeloma, malignancies such as Waldenstrom macroglobulinemia, andCastleman's)- Multiple myeloma- HIV positive- Insulin dependent Diabetes mellitus- Chronic active hepatitis- Age > 65 years old or < 18 years old- Significant end organ damage such as (not caused by CIDP):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 or myocardial infarction withinthe last 6 months4. DLCO <40% or FEV1/FEV < 50%5. Serum creatinine >2.0.6. Liver cirrhosis, transaminases > 2 x of normal limits or bilirubin >2.0 unlessdue to Gilbert disease.- Prior history of malignancy except localized basal cell or squamous skin cancer orother localized cancer considered cured only by surgery- Positive pregnancy test, inability or unwillingness to pursue effective means ofbirth control, or failure to willingly accept or comprehend irreversible sterility asa side effect 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 less than 100,000/ul or ANCless than 1000/ul.- Failure to collect at least 2.0 x 106 CD34+ cells by apheresis and, if necessary,bone marrow harvest is a contraindication to treatment, i.e., receiving theconditioning regimen. |
NCT00278239 | Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors | Brain and Central Nervous System Tumors RATIONALE: Questionnaires that measure quality of life may improve the ability to plantreatment for patients with primitive neuroectodermal tumors.PURPOSE: This phase III trial is studying quality of life in patients who have undergoneprevious treatment for primitive neuroectodermal tumors. DISEASE CHARACTERISTICS:- Surviving primitive neuroectodermal tumor (PNET) patients previously enrolled inInternational Pediatric Oncology Society (SIOP) 2 or 3 phase III treatment trials- Surviving PNET patients eligible for and treated according to PNET 3 protocol but notrandomized- No metastatic disease at time of allocation to treatment- No current progressive diseasePATIENT CHARACTERISTICS:- No patient deemed unsuitable for this study by treating clinicianPRIOR CONCURRENT THERAPY:- Not specified |
NCT00278577 | Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease | CROHN'S DISEASE This disease is believed to be caused by immune cells (called lymphocytes) attacking tissue.Risk of death is highest in people with active acute disease. In addition, progressiveCrohn's Disease leads to further loss of bowel function, which may eventually result in theneed for artificial nutritional support (parenteral nutrition).This study involves high dose chemotherapy followed by return (infusion) of blood stemcells. Stem cells are undeveloped cells that have the capacity to grow into mature bloodcells, which normally circulate in the blood stream. The high dose chemotherapy consists ofcyclophosphamide and anti lymphocyte antibody (a protein that depletes cells that causedamage to the body). The purpose of the intense chemotherapy is to destroy the immune systemcompletely. The purpose of the stem cell infusion is to restore the body's blood production,which will be severely impaired by the high dose chemotherapy and anti lymphocyte antibody. Inclusion Criteria:1. Less than physiologic age 60 at time of pretransplant evaluation2. An established clinical diagnosis of severe CD that has failed therapy withprednisone, azathioprine, 5 ASA products and metronidazole, and has failed ananti-TNF alpha inhibitor. Failure is defined as a CDAI (appendix A) 250-400 or aCraig Severity Score that is > 17 (appendix D)3. Pre-study peripheral blood counts must include a platelet count greater than100,000/ul and an absolute neutrophil count greater than 1500/ul.4. Stem cell harvest greater than 1.4 x 106 CD34 cells/kg after CD34+ selection (tocontinue to transplant)5. Ability to give informed consentExclusion Criteria1. HIV positive2. History of coronary artery disease, or congestive heart failure3. Uncontrolled diabetes mellitus, or any other illness that in the opinion of theinvestigators would jeopardize the ability of the patient to tolerate aggressivechemotherapy4. 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 basis5. Positive pregnancy test, lactation, inability or unwillingness to pursue effectivemeans of birth control, failure to accept or comprehend irreversible sterility as aside effect of therapy6. Psychiatric illness or mental deficiency making compliance with treatment or informedconsent impossible7. FEV I/FVC < 50% of predicted, DLCO < 50% of predicted8. Resting LVEF < 40%9. Bilirubin > 2.0 mg/dl, transferase (AST) > 2x upper limit of normal, unless theabnormalities are secondary to Crohn's disease10. Serum creatinine > 2.0 mg/dl11. Platelet count less than 100,000/ul, ANC less than 1500/ul12. Patients presenting with intestinal perforation or toxic megacolon, or a suppurativeproblem that will require urgent surgery. In addition, the patient may not have anyactive infection. The presence of intestinal stomas does not exclude the patient fromstudy. |
NCT00278759 | Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics | Respiratory Infection Acute respiratory tract infections are among the most common problems of childhood,particularly among infants and children younger than 3 years, and account for mostantibiotic prescriptions to children. Most of these infections are self-limited and do notrequire medical intervention; however, the symptoms overlap significantly with those ofsevere viral or bacterial infections. At the hospital Emergency Department (ED), medicalassessment, prescription of antibiotics (unnecessarily if the infection is viral), and aseries of investigations (e.g., blood work, X-rays) often take place before a decision onpatient management and possible hospital admission can be made. Such procedures lead tointense use of human health resources (nursing, laboratory and radiology staff) and hospitalfacilities.The literature suggests that a prompt single viral diagnosis improves decision-making. Toour knowledge, no-one has performed a controlled trial to examine the impact of a rapid,multi-viral detection test like VIRAP, or the impact of the timing of such a test, onmanagement of children with flu-like illnesses in the ED.Our objective is to determine if use of our new viral detection program, VIRAP, for rapidtesting for viral respiratory infections right after triage will improve patient managementand resource use in the ED. We will test the hypothesis that availability of VIRAP at triageto support rapid diagnosis of viral infection in children at BCCH will (i) reduce thewaiting time in the ED; (ii) improve decision making regarding diagnostic investigations andspecimen collection; and (iii) decrease antibiotic prescriptions.Study completed and manuscript accepted for publication in the Journal of Pediatrics. Patients age 3-36 months admitted to the BCCH ED with fever(38.5 0C measured inED or documented by the accompanying parent) and at least one of: cough, runny nose, nasalcongestion and sore throat will be eligible for enrolment. Excluded from the study will bepatients who are immuno-compromised, who have underlying chronic severe respiratoryconditions (cystic fibrosis, bronchopulmonary dysplasia) or chronic heart conditions(uncorrected cyanotic heart lesions, prosthetic valves), who have had prior assessment inour ED department for the current illness. Only one child per family can be enrolled.End points: The duration of stay in ED (from assessment to discharge, including time waitingfor investigations and review of results by the physician) is the primary endpoint.Secondary endpoints include whether any investigations following the assessment (blood test,radiographs or urine tests) were ordered and whether study patients were prescribedantibiotics.ELIGIBILITY:Gender: AllAge: 3 Months to 36 MonthsCriteria:Inclusion Criteria:- Admitted to the BCCH ED with fever (38.5 0C) and one or more of the following:- cough,- runny nose,- sore throat, or- congested nose.Exclusion Criteria:Excluded from the study will be patients who are:- immuno-compromised,- have chronic severe respiratory conditions (cystic fibrosis, bronchopulmonarydysplasia),- chronic heart conditions or- who is in severe distress requiring immediate care or resuscitation, or- have had prior assessment in our ED department for the current illness.Only one child per family can be enrolled. |
NCT00278837 | Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors | Breast Cancer Women with breast cancer often suffer significant distress and disability from theirdisease. A practice of meditation-based stress reduction and cognitive-affective-behaviorallearning may help women with breast cancer decrease their suffering and improve theirquality of life. Inclusion Criteria:All women with stage I-III breast cancer who have received treatment within the precedingyear will be eligible for inclusion in the study.Exclusion Criteria:1. Patients who refuse to participate will be excluded2. Patients with metastatic (stage IV) cancer are excluded. |
NCT00278200 | Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder | Lymphoproliferative Disorder RATIONALE: Vaccines made from a person's white blood cells may help the body build aneffective immune response.PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treatingpatients who are being considered for solid organ transplant who are at risk forpost-transplant lymphoproliferative disorder. DISEASE CHARACTERISTICS:- Being considered for a solid organ transplant- At high risk for post-transplant lymphoproliferative disorderPATIENT CHARACTERISTICS:- Body weight 25 kg- Karnofsky performance status 50-100% OR- Lansky performance status 50-100%- Not pregnant- Negative pregnancy test- Fertile patients must use contraception during and for 2 months after completion ofstudy treatment- Hemoglobin 8 g/dL (erythropoietin allowed)- No history of autoimmune disease, including any of the following:- Systemic lupus erythematosus- Sarcoidosis- Rheumatoid arthritis- Glomerulonephritis- Vasculitis- No primary immunodeficiency- No HIV positivityPRIOR CONCURRENT THERAPY:- No corticosteroids for 1 month before and for 1 month after the first studyvaccination, except for the following:- Physiologic steroid dosing ( 20 mg/day of prednisone or steroid equivalent) foradrenal insufficiency- Inhaled steroids |
NCT00278980 | Effect of C-Peptide on Diabetic Peripheral Neuropathy | Diabetes Mellitus, Type 1 The aim of the study is to investigate the effect of C-peptide administration on nervefunction in patients with type 1 diabetes and peripheral sensory neuropathy. Inclusion Criteria:- Subjects who have a duration of type 1 diabetes of more than 5 yrs- Subjects who are C-peptide deficient- Subjects who have diabetic distal symmetric neuropathy, according to the criteriadefined at the San Antonio Conference on Diabetic Neuropathy 1988- Subjects who have measurable action potential in the sural nerves- Subjects who have reduced nerve conduction velocity in the sural nervesExclusion Criteria:- Subjects who have neuropathy or signs of nerve dysfunction which may be a consequenceof factors other than type 1 diabetes- Subjects who have concomitant medication that may interfere with the peripheral nervefunction or measurement thereof- Subjects who are transplanted (islet cell, kidney or pancreas) |
NCT00278941 | Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder | Major Depressive Disorder The purpose of this study is to determine safety & efficacy of SEROQUEL SR in the treatmentof major depressive disorder compared to placebo & to evaluate quality of sleep, overallquality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SRand Seroquel XR refer to the same formulation. The SR designation was changed to XR afterconsultation with FDA. Inclusion Criteria:- Documented clinical diagnosis according to the DSM-IV (Diagnostic and StatisticalManual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x MajorDepressive Disorder,- Single Episode, or 296.3x Major Depressive Disorder,Exclusion Criteria:- Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,- Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on thepatients current psychiatric status.- Patients whose current episode of depression>12 months or <4 weeks from enrollment |
NCT00278772 | Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomania or Mild Mania | Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania The purpose of this research study is to evaluate the safety, tolerability, and efficacy ofdivalproex extended release compared to placebo (sugar pill without medication) in thetreatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproexextended release is approved by the United States Food and Drug Administration (FDA) for thetreatment of epilepsy and for prevention of migraine headaches. Inclusion Criteria:1. Subjects must be 18 years of age or older.2. Subjects must have bipolar I, II, or NOS disorder as defined by DSM-IV-TR. (BipolarNOS will include hypomania defined as in DSM-IV-TR, as well as "brief"hypomania-hypomania occurring for a duration of > 1 day but < 4 days - andantidepressant associated hypomania and mania).3. Subjects must have moderate-to-severe hypomania or mild mania within the past 2weeks, defined as having a YMRS >10 and < 21 at the baseline assessment.4. Subjects' overall bipolar symptoms must be clinically significant but not greaterthan severe (defined as a CGI-BP >2 and < 5).5. Subjects must be outpatients.6. Subjects must be on no psychotropics for 1 week (2 weeks for fluoxetine and 4 weeksfor depot antipsychotics) except for prn lorazepam (.5-2mg/day) or zaleplon (5-10mgqhs).7. Subjects or their legally authorized representative must sign the Informed ConsentDocument after the nature of the trial has been fully explained.8. If female, subjects must be: postmenopausal, surgically incapable of childbearing, orpracticing medically acceptable effective method(s) of contraception (e.g., hormonalmethods, intrauterine device) for at least one month prior to study entry andthroughout the study.Exclusion Criteria:1. Subjects who do not have bipolar disorder by above DSM-IV-TR criteria.2. Subjects whose bipolar symptoms are more than severely ill (CGI-BP > 5, YMRS > 21, orIDS > 39).3. Subjects who are receiving treatment with an antimanic or mood stabilizing medication(lithium, valproate, or an antipsychotic), and in the investigators' judgment,require ongoing treatment with that medication.4. Subjects who require hospitalization.5. Subjects with clinically significant suicidal ideation, homicidal ideation, orpsychotic features.6. Subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, orother cognitive disorders or a lifetime psychotic disorder (e.g., schizophrenia orschizoaffective disorder).7. Subjects with DSM-IV Axis I substance dependence within the past 3 months (except fornicotine dependence).8. Subjects with serious general medical illnesses including hepatic, renal,respiratory, cardiovascular, endocrine, neurologic, or hematologic disease asdetermined by the clinical judgment of the clinical investigator. Subjects with hypo-or hyperthyroidism unless stabilized on thyroid replacement > 3 months.9. Subjects who are allergic to or who have demonstrated hypersensitivity to anyvalproate or divalproex preparation.10. Women who are pregnant or nursing.11. Subjects who have received an experimental drug or used an experimental device within30 days. |
NCT00278564 | Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases | MYOPATHY Myositis is a disease, believed to be due to immune cells, cells which normally protect thebody, but are now attacking the muscles and other organ systems within body. As a result,the affected muscles and organs fail to work properly causing weakness, difficultyswallowing, skin rash, respiratory problems, heart problems, joint stiffness, soft tissuecalcification and vasculitis (blood circulation problems). The likelihood of progression ofthis disease is high. This study is designed to examine whether treating patients with highdose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (aprotein that kills the immune cells that are thought to be causing this disease), followedby return of previously collected blood stem cells will stop the progression of myositis. Inclusion Criteria:1. Age 16 years and 65 years at the time of pretransplant evaluation.2. An established diagnosis of polymyositis, dermatomyositis, juvenilepolymyositis/dermatomyositis, myositis associated with other collagen diseases.Diagnosis requires electrophysiological studies and histopathologic features. MRIevidence of muscle inflammation or histological evidence of active myositis ismandatory at entry. If patient had dermatomyositis/polymyositis associated withmalignancy, the patient has to be free of malignancy for 5 years and considered to becured.3. Patients who failed conventional treatment of at least 3 months duration includinghigh-dose corticosteroids (equivalent dosage of prednisone >1.0 mg/kg/day to start),and must also have failed two or more of the followings: cyclophosphamide,azathioprine, 6-MP, methotrexate, tacrolimus, cyclosporin A, mycophenolate mofetil,TNF inhibitor (e.g. etanercept), IVIG or any other immunosuppressive drugs or immunemodulating drugs.4. Failure is defined by (one or more of the following) (not caused by unrelatedconditions):- Persistent muscle weakness (grade 4/5 or worse by MRC) with elevation of musclederived enzymes (CPK, aldolase)- Worsening pulmonary function especially %VC or DLCo > 15% over 12 monthsindicating active alveolitis.- Abnormal EKG or echocardiographic evidence of cardiomyopathy.- Presence of progressive joint contracture, progressive calcinosis, vasculitis,or skin ulcers in juvenile dermatomyositis/polymyositis.Exclusion Criteria:1. Poor performance (PS) status (ECOG >2) at the time of entry, unless decline of PS isdue to the disease itself.2. Significant end organ damage such as (not caused by IIM):- LVEF <40% or deterioration of LVEF during exercise test on MUGA orechocardiogram.- Untreated life-threatening arrhythmia.- Active ischemic heart disease or heart failure.- DLCo <40% or FEV1/FEV < 50%.- Serum creatinine >2.5 or creatinine clearance <30ml/min.- Liver cirrhosis, transaminases >3x of normal limits or bilirubin >2.0 unless dueto Gilbert 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, failure to willingly accept or comprehend irreversible sterility as a sideeffect 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, ANCless than 1000/ul. |
NCT00278148 | Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer | Lung Cancer RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymesneeded for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, workin different ways to stop the growth of tumor cells, either by killing the cells or bystopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgerymay make the tumor smaller and reduce the amount of normal tissue that needs to be removed.Giving these treatments after surgery may kill any tumor cells that remain after surgery.PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effectsof erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and tosee how well they work in treating patients who are undergoing surgery for stage IIInon-small cell lung cancer. DISEASE CHARACTERISTICS:- Histologically or cytologically confirmed non-small cell lung cancer- Surgically determined stage IIIA or IIIB disease- Histology from an involved mediastinal or supraclavicular lymph nodes alone willbe allowed if a separate distal primary lesion is clearly evident on radiographs- Histological or cytological proof of mediastinal nodal involvement bymediastinoscopy, Chamberlain procedure, thoracoscopy, thoracotomy, orCT-guided biopsy is required except for cases of paralysis of left truevocal cord with separate left lung primary distinct from enlarged nodes > 1cm in the anterior-posterior window seen on the CT scan- Patients with N3 or T4 status must be evaluated and deemed potentially resectableafter induction chemotherapy and radiation therapy- Measurable and evaluable disease- No malignant pleural effusion except for effusion visible only on CT scan and deemedtoo small to tap- No pericardial effusion- No small or mixed small cell/non-small cell lung cancer- No massive lesions requiring radiation to the entire lung- No metastatic cancer to the lungsPATIENT CHARACTERISTICS:- ECOG performance status 0-1- WBC 3,000/mm^3- Platelet count > 100,000/mm^3- Serum creatinine 2.0 mg/dL- Alkaline phosphatase, AST, and ALT < 2 times upper limit of normal- Albumin > 3.0 g/dL- Serum bilirubin < 1.5 mg/dL- Adequate pulmonary function- No clinical evidence of another uncontrolled malignancy- No requirement for urgent therapy for severe local symptoms such as post-obstructivepneumoniaPRIOR CONCURRENT THERAPY:- No prior chemotherapy, radiation therapy, or immunotherapy for lung cancer- No prior surgery to treat the cancer |
NCT00278174 | Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer | Kidney Cancer RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growthof kidney cancer.PURPOSE: This phase II trial is studying how well interferon alfa works in treating patientswith metastatic kidney cancer. DISEASE CHARACTERISTICS:- Histologically or cytologically confirmed predominantly renal clear cell carcinoma- Clinical evidence of OR biopsy-proven metastatic disease to a site or sitesdistant from the primary tumor- Must have measurable disease, defined as 1 unidimensionally measurable lesionmeasured as 20 mm with conventional techniques OR as 10 mm with spiral CT scan- Good- or intermediate-risk category as defined by having 2 of the followingfactors:- Time from initial diagnosis to treatment < 1 year- Karnofsky performance status < 80%- Hemoglobin < lower limit of normal- Corrected calcium > 10.0 mg/dL- Lactate dehydrogenase (LDH) > 1.5 times upper limit of normal (ULN)- No major clinical ascites or pleural effusion- No CNS metastases by neurologic exam and CT scan or MRIPATIENT CHARACTERISTICS:- ECOG performance status 0-1- Life expectancy 3 months- WBC 3,000/mm^3- Platelet count 100,000/mm^3- Hemoglobin 9.5 g/dL- Creatinine 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)- Calcium normal- Total bilirubin 1.5 mg/dL- AST 3.0 times normal- Alkaline phosphatase 2.5 times normal (10 times ULN in presence of bone metastases)- Not pregnant or nursing- Negative pregnancy test- Fertile patients must use effective contraception prior to and for the duration ofstudy treatment- No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris,or other severe cardiovascular disease (i.e., New York Heart Association class III orIV)- No known positivity for HIV or hepatitis B surface antigen- No history of seizure disorders- No local and/or systemic infections requiring antibiotics within 28 days prior tostudy entry- No other malignancy except basal cell or squamous cell carcinoma of the skin,carcinoma in situ of the uterine cervix, or any malignancy treated with curativeintent and in complete remission for > 3 yearsPRIOR CONCURRENT THERAPY:- No prior organ allografts- No prior interferon- No prior cytokine-based therapy for metastatic disease- Prior radiotherapy is allowed for the control of pain from skeletal lesions providedtreatment was completed > 28 days prior to study entry and patient has recovered- No major surgery requiring general anesthesia within 28 days prior to study entry- No more than 2 prior therapies for metastatic disease- No concurrent palliative radiotherapy- No concurrent chemotherapy- No concurrent hormonal therapy except for hormones administered fornondisease-related conditions (e.g., insulin for diabetes)- No concurrent steroid use except ongoing replacement therapy with physiologic dosesof corticosteroids- No concurrent dexamethasone or other steroidal anti-emetics oranti-inflammatories- No other concurrent anticancer therapy- No concurrent aspirin or barbiturates- No other concurrent investigational agents |
NCT00278161 | Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma | Leukemia RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in differentways. Some block the ability of cancer cells to grow and spread. Others find cancer cellsand help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy,such as cyclophosphamide, work in different ways to stop the growth of cancer cells, eitherby killing the cells or by stopping them from dividing. Colony-stimulating factors, such aspegfilgrastim, may increase the number of immune cells found in bone marrow or peripheralblood and may help the immune system recover from the side effects of chemotherapy. Givingrituximab and cyclophosphamide together with pegfilgrastim may be effective in treatingleukemia or non-Hodgkin's lymphoma.PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamidetogether with pegfilgrastim works in treating patients with B-cell leukemia, low-gradenon-Hodgkin's lymphoma, or mantle cell lymphoma. DISEASE CHARACTERISTICS:- One of the following B-cell leukemias or lymphomas, as defined by World HealthOrganization criteria:- Chronic lymphocytic leukemia/small lymphocytic lymphoma- B-cell prolymphocytic leukemia- Lymphoplasmacytic leukemia- Marginal zone lymphoma (splenic, extranodal, or nodal)- Follicular lymphoma (grade 1 or 2)- Mantle cell lymphoma- No more than minimal (approximately 10%) morphologically identifiable cancer cells onbone marrow biopsy- When cancer cells are morphologically difficult to distinguish from normalcells, flow cytometry must show no more than 10% identifiable cancer cells- Must have received 12 months of prior cytotoxic therapy, achieving at least apartial response NOTE: A new classification scheme for adult non-Hodgkin's lymphomahas been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma willreplace the former terminology of "low", "intermediate", or "high" grade lymphoma.However, this protocol uses the former terminology.PATIENT CHARACTERISTICS:- ECOG performance status 0-1- WBC 3,000/mm^3- Hemoglobin 10.0 g/dL- Platelet count 75,000/mm^3- Serum creatinine 2.0 mg/dL- Total bilirubin 2 mg/dL unless secondary to tumor- AST or ALT < 2 times upper limit of normal- Normal ( 45%) left ventricular cardiac ejection fraction (determined byechocardiogram or MUGA scan)- DLCO > 50% predicted- Not pregnant or nursing- Negative pregnancy test- Fertile patients must use effective contraception- No known sensitivity to E. coli-derived products (e.g. filgrastim [G-CSF], insulin,asparaginase, growth hormone, or recombinant interferon alfa-2b) or any treatmentstudy drugs- No active infections requiring oral or intravenous antibiotics- No other second malignancy other than basal cell or squamous cell carcinoma of theskin or in situ carcinoma of the cervix unless the malignancy was localized andtreated or resected with > 90% probability of curePRIOR CONCURRENT THERAPY:- See Disease Characteristics- Prior anti-CD20 therapy allowed provided patient achieved a partial or completeresponse- No concurrent steroids during rituximab administration |
NCT00278954 | Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases. | Primary Immunodeficiency The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Foodand Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterialinfection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID).The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and todetermine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intactImmunoglobulin G (IgG) in subjects with PID. Inclusion Criteria:- 1. The subject is 3 years of age or older, of either sex, belonging to any ethnicgroup, and above a minimum weight of 27.5 kg. This weight is based on the amount ofblood required for testing. If subject is participating in the PK segment, theminimum weight required is 37 kg.2. The subject has a primary immunodeficiency disease, which has as a significantcomponent of hypogammaglobulinemia and/or antibody deficiency (e.g. (exempli gratia /for example), common variable immunodeficiency, X-linked and autosomal forms ofagammaglobulinemia, hyper-immunoglobulin M (hyper-IgM) syndrome, Wiskott-AldrichSyndrome). Isolated deficiency of a single IgG subclass, or of specific antibodieswithout hypogammaglobulinemia per se, does not qualify for inclusion.3. The subject has been receiving licensed or investigational (Phase III or IIIb)immunoglobulin intravenous (IGIV) replacement therapy at a dose that has not changedby + 50% of the mean dose for at least 3 months before study entry and is between 300and 800 mg/kg/infusion. The infusion interval must be between 21 and 28 daysinclusive. The subject must have maintained a trough level at least 300 mg/dL(milligram per decilitre) above baseline serum IgG levels (defined as beforeinitiation of any gamma globulin treatment for that subject). The trough level mustbe 600 mg/dL.4. Trough levels of IgG and dose of IGIV, treatment intervals, and the trade name ofthe IGIV treatments used for the last 2 consecutive routine (licensed orinvestigational product) must be documented for each subject before the firstinfusion in this study can be administered.5. If a subject is a female of child-bearing potential, she must have a negativeresult on an Human Chorionic Gonadotrophin (HCG)-based pregnancy test.6. If a subject is a female who is or becomes sexually active, she must practicecontraception by using a method of proven reliability for the duration of the study.7. The subject is willing to comply with all aspects of the protocol, including bloodsampling, for the duration of the study.8. The subject has signed an informed consent form (if at least 18 years old) or thesubject's parent or legal guardian has signed the informed consent form. Ifappropriate, the subject has signed a child assent form (See Section 12.3).Exclusion Criteria:- Subjects will be excluded if any of the following exclusion criteria are met:1. The subject has a history of any severe anaphylactic reaction to blood or anyblood-derived product.2. The subject is known to be intolerant to any component of GAMMAPLEX, such assorbitol (i.e.(id est / that is) , intolerance to fructose).3. The subject has selective immunoglobulin A (IgA) deficiency, history of reactionto products containing IgA, or has a history of antibodies to IgA.4. Subjects who have completed the study and subjects who have withdrawn cannotparticipate in the study for a second time.5. The subject is currently receiving, or has received, any investigational agent,other than an immune serum globulin (ISG) preparation that is being evaluated ina Phase III or IIIb study, within the prior 3 months.6. The subject has been exposed to blood or any blood product or derivative withinthe last 6 months, other than a commercially available IGIV or other forms ofcommercially available and licensed ISG or an ISG product that is in Phase IIIor IIIb studies.7. The subject is pregnant or is nursing.8. The subject is positive for any of the following at screening:- Serological test for Human immunodeficiency virus (HIV) 1&2, Hepatitis Cvirus (HCV), or Hepatitis B surface antigen (HBsAg)- Nucleic Acid test (NAT) for HCV- NAT for HIV9. The subject, at screening, has levels greater than 2.5 times the upper limit ofnormal as defined at the central laboratory of any of the following:- Alanine transaminase (ALT)- Aspartate transaminase (AST)10. The subject has a severe renal impairment (defined as serum creatinine greaterthan 2 times the upper limit of normal or Blood urea nitrogen (BUN) greater than2.5 times the upper limit of normal for the range of the laboratory doing theanalysis); the subject is on dialysis; the subject has a history of acute renalfailure.11. The subject is known to abuse alcohol, opiates, psychotropic agents, or otherchemicals or drugs, or has done so within the past 12 months.12. The subject has a history of deep vein thrombosis (DVT), or thromboticcomplications of IGIV therapy.13. The subject suffers from any acute or chronic medical condition (e.g., renaldisease or predisposing conditions for renal disease, coronary artery disease,or protein losing state) that, in the opinion of the investigator, may interferewith the conduct of the study.14. The subject has an acquired medical condition, such as chronic lymphocyticleukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (Absoluteneutrophil count (ANC) < 1000 x 109/L).15. The subject is receiving the following medication:- Immunosuppressive drugs- The subject is receiving the following medication: Steroids (long-termdaily, >0.15 mg /kg/day of prednisone or prednisolone of equivalent dose ofother corticosteroids) The requirement for burst or intermittent courseswould not exclude the subject.- Immunomodulatory drugs16. The subject has non-controlled arterial hypertension (systolic blood pressure >160 mmHg (millimeters of mercury) and/or diastolic blood pressure > 100 mmHg).17. The subject has anemia (hemoglobin < 10 g/dL) at screening. |
NCT00278798 | TRAIL-CC: Trachelectomy, Radical Hysterectomy, and Intimate Life After Cervical Cancer Study | Cervical Cancer The objective of this study is to compare radical hysterectomy with trachelectomy onoutcomes related to intimacy, sexual health, and mood immediately before, 1 month after, and6 months after surgery. Inclusion Criteria:1. Women who have a diagnosis of cervical cancer2. Women who are scheduled for either a radical hysterectomy or radical trachelectomy atthe British Columbia Cancer Agency - Vancouver Cancer Centre3. Proficient in EnglishExclusion Criteria:No woman who meets the inclusion criteria will be excluded from participating. |
NCT00247559 | Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet) | Lateral Canthal Lines Despite the wealth of information in the literature regarding the cosmetic applications ofbotulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmeticapplications, the number of randomised, controlled clinical trials is small. Much of thepublished information is based on open-label studies or anecdotal data. Of the robust trialdata that is available, the vast majority relates to the treatment of glabellar lines, andthere is little data available regarding the use of BoNT-A in lateral canthal lines. Thisstudy aims to determine the optimum dose for the use of BoNT-A in this area. Inclusion Criteria:- Male or female patients, 18 to 65 years of age.- In the opinion of the Investigator moderate to severe lateral canthal lines (crowsfeet) during maximum smile on both sides of the face.- In the opinion of the Investigator mild to severe lateral canthal lines (crows feet)at rest on both sides of the face.Exclusion Criteria:- Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty orbrow lift, or any prior cosmetic procedures or scars that may interfere with theevaluation of the study results.- Previous insertion of any non-absorbable material in the periorbital region or facialtreatment with augmentation material within 12 months prior to screening.- Any prior treatment with botulinum toxin (of any serotype).- Previous treatment with lasers for skin resurfacing or treatment with deep chemicalpeels within 12 months prior to screening.- Inability to substantially lessen the lateral canthal lines by physically spreadingthem apart.- Facial conditions that could affect safety or efficacy results such as: activeinfection or other skin problem in the periorbital area (e.g. acute acne lesions orulcers); history of facial nerve palsy; marked facial asymmetry; ptosis; excessivedermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc. |
NCT00247377 | Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity | Morbid Obesity PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as "morbidobesity", is defined as being 100 pounds in excess of ideal body weight. Nonsurgicaltreatments for morbid obesity include exercise, dietary restriction, behavior modification,and pharmacological intervention. However, it is estimated that most patients undergoingnonsurgical treatments for weight reduction will regain their weight within 2 to 4 yearsafter treatment. According to the NIH consensus conference in 1991, surgery remains the onlyeffective sustained weight loss treatment for morbid obesity. The Roux-en-Y gastric bypass(GBP) is currently considered the gold standard bariatric surgical operation. Mean weightloss following GBP is approximately 65% of the excess body weight during the first 12 to 18months postoperatively. Long-term weight loss is in the range of 55-70% of excess bodyweight loss.Recently, the laparoscopic approach to GBP was reported. Wittgrove and colleagues reportedtheir results of 75 patients who underwent laparoscopic GBP and demonstrated significantshort-term advantages with comparable weight loss and reversal of comorbidities compared tothe open approach. However, GBP might it be done laparoscopic or open approach canpotentially be associated with significant morbidity and mortality such as anastomotic leak,pulmonary embolism, bowel obstruction, and postoperative stricture.The FDA recently approved the laparoscopic adjustable banding system (LAP-BAND) for use inthe United States in June 2001. The LAP-BAND system is a device designed to induce weightloss in severely obese patients. It is surgically placed around the proximal stomach tocreate a small proximal stomach pouch and restricted opening, or stoma, through whichpassage of food will be slowed. An inflatable portion along the inner aspect of the band isconnected to an access port, placed intramuscularly. This enabled stoma adjustments to bemade without the need for further surgery. The advantages of the LAP-BAND system included nocutting or opening of the stomach wall, ability to adjust the stoma and a technically easieroperation to perform than laparoscopic GBP. We wanted to evaluate if the LAP-BAND procedureis as effective as the laparoscopic GBP procedure for treatment of morbid obesity. Eligibility:Inclusion Criteria:1. Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities2. Good health status with acceptable operative risk (good cardiopulmonary function)3. Willingness to follow protocol requirements: Signing informed consent, follow-up, andcompleting protocol diagnostic testsExclusion Criteria:1. Prior upper abdominal surgery except cholecystectomy2. Large abdominal ventral hernia3. Patients with hiatal hernia4. Inadequate prior medical management5. Lack of patient's motivation and contribution to long-term success6. Unacceptable operative risk7. Minors and pregnant women are excluded as these patients do not qualify for thebariatric procedures. Minors are not psychologically fit to undergo such surgery andpregnant women are excluded because of safety for the fetus. |
NCT00247000 | A Strategy of Home Telehealth for Management of Congestive Heart Failure(STARTEL) | Heart Failure To demonstrate the safety, feasibility, quality of life, primary caregiver satisfaction, andcost effectiveness of integrated Home Telehealth care versus standard care in a heartfailure clinic. Patient Population Inclusion Criteria: Patients are eligible for participating in STARTELif they satisfy all of the following inclusion criteria.1. Male or female subjects 18 years of age with a diagnosis of Heart Failure2. Subject must reside in either the Province of Nova Scotia or New Brunswick3. Subject has been hospitalized for heart failure during the past two years or has aknown history of heart failure for a minimum of two years.4. Subject must have a dedicated working telephone line in their primary place ofresidence.5. Subject must have a grounded electrical power supply in their primary place ofresidence.6. Primary care physician provides their agreement to participate in STARTELExclusion Criteria: Patients are not eligible for participating in STARTEL if they meetany of the following exclusion criteria.1. Inability to understand the English or French language or understand the study andprovide informed consent.2. Absence of a suitable area to conduct the home telehealth visit in the patient'splace of residence.3. Physical impairment, which would prohibit the successful completion of a hometelehealth visit, including attachment of the peripheral equipment (BP cuff, abilityto stand on a scale, etc).4. In cases 1 & 3 only: a live in caregiver whose presence may overcome theselimitations may allow the patient to be included in the study, however, only thepatient's next of kin or duly appointed guardian (with documentation and with patientassent) may provide informed consent to participate).5. Subject has a planned cardiac procedure such as open-heart surgery or percutaneouscoronary intervention (PCI) within the next 6 months.6. Subject has had cardiac surgery, percutaneous coronary intervention or a diagnosis ofacute myocardial infarction within 1 month before randomization).7. Condition where existing routine follow up occurs more than once weekly (i.e.hemodialysis, cancer treatment including: chemotherapy/radiation treatment). .8. Patient is institutionalized (includes chronic care facility) |
NCT00247572 | Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories | Attention Deficit Disorder With Hyperactivity This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is tolearn if NRP104, when injected into a vein, produces a high and any other effects likeamphetamine and other stimulant drugs that are abused. This information will give someindication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 withhistories of substance abuse that include stimulant drugs, may join. Amphetamines are drugsthat are used most often to treat attention deficit hyperactivity disorder (ADHD) inchildren, to treat narcolepsy (excessive sleepiness) and for weight loss. Inclusion Criteria:- Male or female subject is 18 to 55 years of age, inclusive.- Except for women who are post menopausal or surgically sterile, all female subjectsmust have a negative urine pregnancy test at screening and at admission to theresearch unit. They must abstain from sexual activity, or use acceptablecontraceptives throughout the study, and for 30 days after the last dose of studydrug. Acceptable contraceptives include double barrier method (such as condom withspermicidal gel or diaphragm with spermicidal gel), IUDs and hormonal contraceptiveswhich must be pharmacologically effective prior to study drug exposure.- Meet DSM-IV criteria for the diagnosis of substance abuse.- Have a history of IV drug use.- Subject must be in good health and have venous access sufficient for (1) IV drugadministration and (2) blood collection, as determined by medical history, physicalexam, and clinical labs.- Agree to be admitted to the inpatient research unit for a minimum of 8 days, and beable to complete all protocol-specified assessments.- Able to understand that they can withdraw from the study at any time.- Minimum reading level of Grade Six as determined by the REALM test, at theinvestigator's discretion.- Subject must voluntarily consent to participate in this study.Exclusion Criteria:- History of clinically significant gastrointestinal, renal, hepatic, endocrine,oncologic, hematologic, neurologic, psychologic, immunologic or pulmonary disorders;or cardiovascular disease, tuberculosis, epilepsy, diabetes, psychosis, glaucoma, orany condition which in the opinion of the Investigator would jeopardize the safety ofthe subject or impact study results or prevent the subject from completing the study.- Presence or history of any medically diagnosed, clinically significant Axis Ipsychiatric disorders other than substance abuse (including bipolar disorder, anypsychotic disorder, and Tourette's disorder or family history of Tourette's).- Serious suicidal risk determined by the investigator.- Presence of a severe learning difficulty or mental retardation, or any condition thatwould interfere with participation or completion of the study.- History of allergic or adverse response or hypersensitivity to d-amphetamine orNRP104.- Participation in a previous clinical trial within 30 days prior to study initiation.- Blood loss, donation of one pint or more, or plasma donation within 60 days prior tostudy initiation.- Clinically significant abnormalities at screening or admission on results of ECG orlab tests, including lab deviations requiring acute medical intervention or furthermedical attention.- Treated with a monoamine oxidase inhibitor, currently or within 13 days of initiationof the study medication.- Require any of the following medications: clonidine or other alpha-2 adrenergicreceptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors(SSRIs) theophylline, coumarin anticoagulants, or anticonvulsants; or have taken anSSRI in the 35 days before initiation of the study medication.- Currently physically dependent on benzodiazepines as determined by clinicalevaluation and/or urine drug screen at screening.- Currently physically dependent on opiates as determined by naloxone challenge.- Currently physically dependent on alcohol as determined by clinical evaluation or hasa positive Breathalyzer test at screening or admission and confirmed by a secondreading.- Preexisting severe gastrointestinal narrowing.- Use of any prescription medications (except birth control methods) within 14 days ofadmission, or will require any prescription medications, or any over-the-counter(OTC) medications (other than acetaminophen), or herbal supplements or vitaminsduring the study.- Positive urine pregnancy test at screening or admission.- Female subject is pregnant or lactating.- Another member of the subject's household currently participating in the study. |
NCT00247611 | Improving Treatment Adherence in HIV-Infected Individuals | HIV Antiretroviral Therapy (ART) Adherence This study will develop and evaluate the efficacy of an individualized, interactive,computer software program delivered in conjunction with clinical care in increasing andsupporting antiretroviral therapy adherence in HIV-infected individuals. Inclusion Criteria:- HIV-infected- English-speaking- Currently receiving treatment at one of the participating sites- Currently receiving antiretroviral therapyExclusion Criteria:- Marked cognitive impairment |
NCT00247013 | Automated Tele Counseling for Screening Mammography | Breast Cancer The purpose and aim of this study is to test the use of a computer-based, automatedtelecommunications system and its effectiveness in increasing the rates of regular screeningmammography among women ages 50-74. The system will not only help in scheduling appointmentsbut will help women in overcoming any barriers that may deter them from having the procedureat all. The programs are designed to be user friendly and easy to implement in clinicalpractice. Inclusion Criteria:- Ages 50-74- A recent (within the last 6 months) negative screening mammogramExclusion Criteria:- Lack a permanent address or planning to move from the Boston area during the studyperiod- No home telephone or no touch tone service- Cannot use a telephone unassisted- Cannot understand conversational English over the telephone- Major medical illness that would preclude participation- History of breast cancer- Mammography or other breast diagnostic procedures (except CBE) or therapeuticprocedures since the last screening mammogram- Another member of household enrolled in the study (to eliminate possible studycontamination) |
NCT00247832 | Readiness for Discharge Following Lobectomy | Pain This study aims to examine the relationship between the patient's perception of readinessfor discharge after lobectomy and mobilization rates, frequency of visitation by family andfriends, anxiety levels and pain levels. We will test the hypotheses that a) those patientswho walk farther early after surgery and who have more visitors and decreased anxiety andpain levels will have a greater self-perceived readiness for discharge and b) that patientswho receive daily ambulation goals and personal motivation will have higher step rates, andtherefore have a greater self-perceived readiness for discharge, than those that do not. Wewill monitor patients, during the post-operative recovery period using pedometers to countsteps taken, visitor log sheets, and questionnaires on the patients' anxiety, pain andperceived readiness for discharge. Furthermore, we will examine how the patient'sself-perceived readiness for discharge is affected by study interventions which includeambulation goals and daily personal motivation. Inclusion Criteria:- Undergoing elective lobectomy,- speak, write and read English,- ambulate prior to surgeryExclusion Criteria: |
NCT00247403 | Safety Study of 2DG With Stereotactic Radiosurgery | Intracranial Neoplasms Ionizing radiation produces cancer cell death by creating high levels of reactive oxygenspecies (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cellsare preferentially affected by ROS. The investigators, therefore, propose that interferingwith the detoxification of ROS will make radiation more toxic to cancer cells. Severalcellular mechanisms exist to detoxify ROS, and glucose metabolism plays an important role inmany of these mechanisms. The investigators propose that interfering with glucose metabolismwill sensitize cancer cells to radiation.The investigators' central hypothesis is that 2DG will sensitize cancer cells to ionizingradiation by inhibiting the use of glucose to detoxify reactive oxygen species produced byradiation. As an initial step to evaluate this hypothesis, the investigators have designedthis phase I study. Inclusion Criteria:- Ability to understand and the willingness to sign a written informed consentdocument.- Brain metastases from histologically confirmed extracranial cancer or previouslyconfirmed intracranial carcinoma. Carcinoma must be staged using the American JointCommittee on Cancer (AJCC) staging criteria version 6.- Morphologically well-defined tumor mass on computed tomography (CT)/magneticresonance imaging [MRI] (largest diameter less than 40 mm) after resection.- Intracranial mass or masses 4 cm in greatest diameter. Patients with multiplemasses will be eligible if their radiosurgery treatment time is expected to last lessthan one hour (typically a maximum of 6 lesions).- Standard institutional radiotherapeutic treatment is stereotactic radiosurgerydelivered using bite-plate localization.- Greater than or equal to 21 years of age. Pediatric subjects represent a minority ofpatients who otherwise meet the eligibility criteria. Inclusion of children in adifferent study would be considered if therapy is found to be effective in adults andnot as part of this trial because the safety of 2DG in children has not beeninvestigated.- Karnofsky greater than or equal to 70% at time of screening- Life expectancy of greater than 3 months- Subjects must have normal organ and marrow function as defined below:- serum glucose < 200 mg/dl- hemoglobin A1C (HbA1c) < 8.5 %- Contraceptive use in men and women of childbearing potential prior to, and for theduration of, this study. The teratogenic effects of ionizing radiation are welldocumented, and 2DG has the potential for teratogenic or abortifacient effects.- Nursing of infants must be suspended during the study. There is an unknown butpotential risk for adverse events in infants nursing from patients treated with 2DG,therefore breastfeeding must be discontinued for the duration of the study.- Ability to ingest 50 ml of fluid either by mouth or feeding tube.- Inclusion of women and minorities: Both men and women of all races and ethnic groupsare eligible for this trial.Exclusion Criteria:- Subjects with diabetes mellitus, elevated HbA1c or elevated blood glucose.- Subjects requiring a headring ('halo') immobilization for standard stereotacticlocalization. Patients with metastases adjacent to optic chiasm, optic nerve or otherradiosensitive tissue necessitating the accuracy of a headring will be excluded.- Subjects must not be receiving any other investigational agents.- Subjects with a history of myocardial infarction in the past year and/or dependent onbeta-adrenergic blocking agents.- Subjects with an uncontrolled seizure disorder.- Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements.- Because there is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the nursing mother with 2DG, breastfeeding must bediscontinued while the nursing mother is treated.- Pregnant women are excluded from this study. The teratogenic effects of ionizingradiation are well documented, and 2DG has the potential for teratogenic orabortifacient effects. Women of childbearing potential must have a negative pregnancytest result immediately prior to the study and should they become pregnant or suspectthat they are pregnant during the study, they must inform their treating physiciansimmediately.- Inclusion of prisoners and other vulnerable populations: Prisoners and othervulnerable populations, such as children, will not be enrolled. |
NCT00247364 | A Double Blind Crossover Trial of Levetiracetam (Keppra) and Placebo in the Treatment of Restless Legs Syndrome (RLS) | Restless Legs Syndrome To define the effective dose and tolerability of levetiracetam in individuals with RestlessLegs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe andeffective in treating the symptoms of RLS. Inclusion Criteria:- Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria1. An urge to move the legs, usually accompanied or caused by uncomfortable andunpleasant sensations in the legs.2. The urge to move or unpleasant sensations begin or worsen during periods of restor inactivity such as sitting or lying down.3. The urge to move or unpleasant sensations are partially or totally relieved bymovement, such as walking or stretching, at least as long as the activitycontinues4. The urge to move or unpleasant sensations are worse in the evening or night thanduring the day or only occur in the evening or night.IRLS Rating Scale score greater than 15 at Baseline visit PLM-Index of 5 or greater duringthe first night of polysomnography Written informed consent obtained prior to any studyprocedures being performed.Exclusion Criteria:1. Women of childbearing potential, who have a positive urine pregnancy test or arelactating as the screening visit, or do not practice a clinically accepted method ofcontraception.2. Individuals who are taking medication for Restless Legs Syndrome without a properwashout period3. Individuals who are taking hypnotics, sedatives, antipsychotics, or neuroleptics4. History of current diagnosis of other clinically relevant diseases that may confoundassessments of RLS symptoms (e.g., Parkinsons disease, dementia, ALS, etc.)5. Subjects with serum ferritin below 10g/L6. Subjects with an untreated sleep disorder that may confound assessments (e.g.,narcolepsy, sleep apnea syndrome or other breathing-related sleep disorders, or REMsleep behaviour disorder)7. Subjects with an apnea/hypopnea index of 15 or greater at the initial polysomnographyvisit8. Subjects employed in shift work (e.g., employment hours disruptive to the normalcircadian sleep-wake cycle such as nighttime or variable rotating shifts)9. Subjects who have clinically significant or unstable medical conditions which in theopinion of the investigator would render the subject unsuitable for the study (e.g.severe cardiovascular disease, major depression, psychosis, hepatic or renal failure,etc.)10. subjects with a positive urine drug test for illicit use of amphetamines,barbiturates, benzodiazepines, opiates, synthetic narcotics, and miscellaneous drugscommonly known as recreational drugs (e.g., cannabinoids including THC, heroine,cocaine)11. Participation in any clinical drug or device trial in the 30 days prior to thescreening visit. |
NCT00247416 | Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer | Stage IV Non-small Cell Lung Cancer The purpose of this study is to find better treatment for lung cancer and to find out whateffects the combined treatment of carboplatin and gemcitabine when given with or withoutdexamethasone have on cancer.This study will determine if dexamethasone, when given before standard chemotherapy willincrease the cancer fighting effects and reduce the side effects of chemotherapy. Inclusion Criteria:- Untreated, stage IIIB with pleural effusion- Untreated, Stage IV, non-small cell lung cancer- Recurrent after surgery if no previous radiation therapy or chemotherapy wereadministered as part of their primary treatment, except for palliative radiotherapy- 18 years of age or older- ECOG PS 0, 1 or 2- At Least one target lesion according to the RECIST Criteria- Adequate organ and marrow functionExclusion Criteria:- Previous cancer history unless they have had curative treatment completed at least 5years prior to entry.- No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except forradiation therapy to the brain to control metastasis, bone to control pain, or lungto relieve bronchial obstruction.- No radiation therapy for any previous cancer to more than 25% of bone marrow.- Uncontrolled, intercurrent illness- Non-study corticosteroids- Pregnant women- Peripheral neuropathy greater than grade 1- Uncontrolled seizures, central nervous system disorders- Major surgery within 4 weeks of the start of study treatment- Lack of complete recovery from major surgery.- Glaucoma- Lack of physical integrity of upper gastrointestinal tract, inability to swallowtablets- Severe acquired or hereditary immunodeficiency- Patients with brain metastases must receive definitive treatment (radiation, surgeryor both) and be clinically and radiologically stable for 4 weeks & offcorticosteroids for at least 2 weeks prior to randomization. |
NCT00247819 | The Genetic Basis for Vulnerability to Substance Abuse | Substance Abuse This investigation seeks to better define the genetic basis for vulnerability to substanceabuse. Inclusion Criteria:- Substance abusers- Allow for blood drawExclusion Criteria:- Cognitively impaired |
NCT00247429 | Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients | Depressive Syndrome In this study we will assess as a primary objective the effect of venlafaxine retardtreatment on primary care attended elderly patients with depressive syndrome. We will alsostudy secondarily its effects on anxiety, somatic and painful symptoms of depression. Inclusion Criteria:- Patients older than 60 years- Depressive syndrome with associated anxiety symptoms, according to a symptomsintensity HAM-D1714Exclusion Criteria:- Participation in other studies in the last 3 months before the start of the study- Known hypersensibility to venlafaxine- Clinically significant abnormalities according to the venlafaxine labeling |
NCT00247039 | Garlic in Patients With Febrile Neutropenia | Chemotherapy To determine the clinical effects of garlic in preventing and treatment of patients withchemotherapy related febrile neutropenia.These patients have a very high incidence ofinfections which are not routinely covered by the standard empiric therapy. Adding a non-toxic and possibly effective therapy may reduce the risk for infections, synergize theempiric antibiotic treatment and may lessen the need for broader spectrum and more severeside effects. Inclusion Criteria:FN patients expected to have at least 5 days or more of neutropenia will be eligible fortreatment with garlic compounds AST/ALT 3 times the upper limit of institutionallaboratory normal.Total bilirubin 2 times the upper limit of institutional laboratory normal.BUN and creatinine should be 3 times the upper limit of institutional laboratory normal.Newly diagnosed as well as previously treated patients will be eligible.Exclusion Criteria:History of clinically significant liver or kidney disease.Patients on anti-coagulation therapy with Coumadin will be excluded because of thepotential garlic interference with metabolism.Patients receiving concomitant chemotherapeutic treatment |
NCT00247260 | Safety of 32P BioSilicon in Patients With Hepatocellular Carcinoma | Liver Cancer Brachytherapy is a recent technique used in the treatment of tumours and involves the use ofradioactive sources brought into close contact with the target tissues. One of the principalbenefits of brachytherapy is that high radiation doses can be localised within the tumourwith the consequence of minimal side effects. 32P is a radionuclide ideal for brachytherapyas it has high energy beta emitting properties, typically a maximum tissue range of about 8mm and a half life of 14.3 days. 32P BioSiliconTM is an active implantable medical deviceencapsulating 32P within the internal microcrystalline structure of highly pure inertsilicon and acts as a sealed source for the provision of 32 phosphorous.Tumours targeted with 32P BioSiliconTM are hypothesized to show a reduction in volume with alow incidence of side effects associated with the treatment. Prolongation of survival andimproved quality of life would be favourable outcomes of the investigational product. Inclusion Criteria:1. Written informed consent.2. Male or female patients equal to or greater than 18 years old.3. Patients with diagnosis of hepatocellular carcinoma (HCC) meeting one of the criteriabelow:1. Histology OR2. Radiological evidence'*' of HCC demonstrated by dynamic contrast enhancedcomputed tomography (CT) or dynamic contrast enhanced magnetic resonance imaging(MRI) >/ 1cm AND serum AFP of at least 400 mcg/L OR3. Radiological evidence'*' of HCC demonstrated by dynamic contrast CT or dynamiccontrast enhanced MRI >/ 1cm AND serology positive for hepatitis B or Cinfection.'*' Criteria for radiological evidence of HCC are: central enhancement on hepaticarterial phase AND wash out on portal venous or delayed phase.4. Hepatic tumour mass not amenable to surgical resection or patient refuses surgery.5. ECOG performance status 0 - 2.6. Okuda stage I - II7. Total volume of any single treatable tumour not more than 65 cc (not more thanapproximately 5 cm in longest dimension).8. Total treatable volume of not more than 125 cc (Group 1), 111 cc (Group 2), 139 cc(Group 3) - as defined by maximum radioactivity level (MBq) for the respectivegroups.9. Adequate haematological, renal and hepatic functions as defined by the followinglaboratory values obtained within 14 days prior to Visit 2- Absolute granulocyte count (AGC) >/1500 cells/mm3- Serum creatinine < 2 times upper limit of normal (ULN)- Serum bilirubin < 3 times ULN- ALT (SGPT) < 5 times ULN and/or AST (SGOT) < 5 times ULN within 24 hours priorto implantation (Supportive care and correction permitted) Platelet count >/60,000/mm3 (60 x 10^9/L)- Prothrombin time < 3 seconds prolonged10. Women of childbearing potential must have a negative urine pregnancy test withinthree days of Visit 2.11. Contraception must be used (both male and female) for six months after implantationand during the duration of the whole study.12. Patients must be accessible for treatment and follow up.Exclusion Criteria:1. Clinical encephalopathy2. Patients younger than 18 years old.3. No life threatening tumours in other sites (e.g. brain)4. Less than four weeks after local therapy with radiofrequency ablation (RFA), orethanol, and less than six weeks after local therapy with transarterialchemoembolization therapy (TACE), or since prior chemotherapy or biologic therapy(e.g. immunotherapy, systemic vaccine therapy).5. Prior radiotherapy to liver, pancreas or gastrointestinal tract.6. Total volume for each tumour is greater than 65 cc (greater than approximately 5 cmin longest dimension).7. Amenable to surgery.8. Pregnant or lactating females.9. Other diagnosed malignancy within the last five years, which may impact on studyoutcome.10. Life expectancy of less than 12 weeks.11. Patients with a significant history of cardiac disease, that is, uncontrolled highblood pressure, unstable angina, congestive heart failure, myocardial infarctionwithin the past three months and cardiac ventricular arrhythmias requiringmedication.12. Patients with serious active infection or other serious underlying medical conditionsthat would impair the ability of the patient to receive protocol treatment atimplantation visits.13. Patients with any condition (e.g. psychological) that does not permit compliance withthe protocol.14. Patients who are known to be HIV positive. Testing is not required in the absence ofclinical signs and symptoms suggestive of HIV infection. |
NCT00247923 | Endometrial Polyps: Pathophysiology and Clinical Consequences | Endometrial Polyp The aim of these studies is to study the natural history, the symptoms of, as well as theeffect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is tostudy new diagnostic techniques to differentiate between malignant and benign endometrialpolyps. Inclusion Criteria:- Study 1:- Endometrial polyp (EP) group: Presence of endometrial polyp verified by vaginalultrasound examination.- Cancer group: Presence of endometrial cancer verified by histologicalexamination.- Study 2:- Pre- or perimenopausal women.- Presence of endometrial polyp verified by vaginal ultrasound.- Study 3:- EP group: Presence of endometrial polyp verified by vaginal ultrasound.- Control group: Normal endometrium by vaginal ultrasound examination.Exclusion Criteria:- Study 1: Earlier severe allergic reactions.- Study 2:- Postmenopausal patient.- Pregnancy.- Additional condition requiring treatment detected during examination. Malignancyor atypical hyperplasia detected by histological examination.- Study 3:- Previous hysterectomy.- Pregnancy.- Additional condition requiring treatment detected during examination. Malignancyor atypical hyperplasia detected by histological examination. |
NCT00247117 | Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD) | Liver Diseases The purpose of this study is to examine the effect of metformin on biochemical andhistological findings in NAFLD patients with insulin resistance syndrome. Inclusion Criteria:- ALT > 2 times normal range.- Liver histology revealing non-alcoholic steatohepatitis [NASH] (type 2-4), withoutcirrhosis.- Clinical characteristics of the metabolic syndrome as defined by the NationalCholesterol Education Program (NCEP), but no overt diabetes.- Negative work-up for other causes of liver diseases including alcohol intake < 40g/week.Exclusion Criteria:- Diabetes mellitus.- Alcohol intake > 40 g per week. |
NCT00247936 | Combined Thoracoscopic and Laparoscopic Esophagectomy vs. Hand-assisted Transhiatal Esophagectomy: A Prospective Trial. | Adenocarcinoma Esophagectomy for benign or malignant disease of the esophagus can be performed using atranshiatal technique or Ivor Lewis technique (combined laparotomy with thoracotomy). Theseprocedures can be associated with significant morbidity and mortality [1]. Advances inminimally invasive technology and surgical techniques have allowed us to explore thepossibility of performing esophagectomy using minimally invasive surgical techniques.Minimally invasive esophagectomy represents a new alternative to conventional openesophagectomy. It is a technically demanding operation requiring advanced laparoscopicsurgical skills, appropriate instrumentation, and thorough knowledge of open esophagectomy.Multiple authors have reported the use of video-assisted thoracoscopy or laparoscopy tofacilitate esophagectomy [2-6]. Most of these reports have utilized a standard laparotomy incombination with thoracoscopy to perform esophageal mobilization or laparoscopy with amini-laparotomy to perform esophagectomy. DePaula was the first to report a large series of48 patients undergoing laparoscopic transhiatal esophagectomy for benign (n=24) andmalignant disease (n=24) [7]. In 2 patients, conversion to open surgery was required and 2others required thoracoscopic assistance. Postoperative complications were low in the benigngroup but higher in the carcinoma group. The 30-day mortality rate was 16% in patients withcarcinoma undergoing laparoscopic transhiatal esophagectomy. DePaula concluded that thepatients who benefit most from this procedure are those with benign disease. Swanstromrecently reported nine cases of laparoscopic total esophagectomy [8]. There were noconversions to laparotomy. One patient required a right thoracoscopy with intrathoracicanastomosis due to poor viability of the gastric tube. The mean operative time was 6.5 hourswith a mean hospital stay of 6.4 days. However, the advantages of minimally invasiveesophagectomy have not been observed. The aim of this prospective trial is to evaluate thephysiologic outcome, clinical outcome, and quality of life after combined thoracoscopic andlaparoscopic esophagectomy vs. transhiatal esophagectomy. Inclusion Criteria:1. Patients with biopsy proven esophageal malignancies2. Patients with recalcitrant severe esophageal stricture3. Karnofsky score >604. No previous treatment for any other cancer over the past 2 years (except for skincancer)Exclusion Criteria:1. Malignant tracheoesophageal fistula or presence of tracheal involvement2. Unacceptable operative risk3. Tumor size greater than 12 centimeters.4. Tumor involvement of the aorta or trachea.5. Renal or liver insufficiency (Creatinine > 2.0, transaminase > fourfold)6. WBCs <2,000, platelets <80,0007. Presence of metastatic disease8. Patients with previous esophageal resection9. Minors and pregnant women are excluded. The chance of esophageal cancer presenting inanyone under 18 years of age is essentially null. Pregnant women are excluded becauseof safety for the fetus.- All physician, hospital, surgery, and laboratory costs will be billed to thesubject and/or their insurance carrier as customary for they are consideredstandard of care procedures. All research-related procedures such as pulmonaryfunction tests and study questionnaires conducted in this study will be paid forby the primary investigator. |
NCT00247507 | The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients | Anemia The aim of this study is to explore and identify the effects of acetylcysteine, a commonmucolytic with anti-oxidant property, on alleviating the damage caused by increasedoxidative stress in hemodialysis patients. Inclusion Criteria:- On HD thrice a week at our HD unit for more than three months- Informed consent- The dose of EPO and iron supplement is stationary in the previous one month- No taking acetylcysteine in previous one month- No using vitamin E-bonded dialysis membraneExclusion Criteria:- Severe liver disease (AST or ALT >40 IU/L), proven malignancy, and severecardiovascular disease (proved by cardiac catheter or echography examination)- Active infection or hospitalization in previous one month- Clinically significant bleeding episode in previous one month- Taking vitamin C, vitamin E or other known antioxidants. |
NCT00247897 | Comparing Skin Disinfectants Before Labour Epidural Analgesia | Skin Bacteria The purpose of this study is to compare the current standard skin disinfectant solution forlabour epidurals used at BC Women's Hospital to another common skin disinfectant and to theskin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior toplacing special intravenous lines. There is very little information available to guidedoctors in deciding which is the best skin disinfectant for epidural analgesia. The studyhypothesis is that the disinfectant solution recommended by the PHAC will be the mosteffective. Inclusion Criteria:Request labour epidural analgesia. Able to understand English. No antibiotics taken inprevious 24 hours. Membranes ruptured less than 24 hours. No current local or systemicinfection. No contraindication to labour epidural analgesiaExclusion Criteria: |
NCT00247299 | Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform | Telangiectases The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used foreliminating, among other application, benign vascular lesions and unwanted leg veins. Lightenergy heats the deeper structures of the skin. IPL devices provide a broad wavelengthspectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focusedby a reflector and then transmitted through various filters that cut off the lowerwavelength range of the emitted light; therefore, only those wavelengths longer than theseof the filters are transmitted.objectives:1. evaluate and optimize the clinical performance of the Luminis ONE platform for each ofthe aforementioned clinical applications.2. Reconfirm the parameter settings for each of the aforementioned clinical applications.3. Confirm the user friendly design of the device, in aspects of software (user interface)and various technical operational features. Inclusion Criteria:- Healthy Subjects, presenting with at least one of the clinical indications mentionedabove- Willing and being able to comply with all visit and evaluation requirements- Willing and being able to provide signed Informed ConsentExclusion Criteria:- A history of keloid scar formation or poor wound healing- Wounded or tanned in area to be treated- Pregnant or intending to become pregnant during the evaluation period- Subjects with a bleeding disorder or who take anticoagulation medications- Significant concurrent illnesses, such as diabetes, epilepsy, lupus or congestiveheart failure- Significant concurrent skin conditions affecting area to be treated- Having a history of skin cancer or any other cancer in the area to be treated- History of immunosuppressive disease |
NCT00247702 | The Association of Warfarin Dosage and Plasma Enantiomer Concentration With the Gene Polymorphisms of CYP and VKOR | Deep Venous Thromboembolism Oral warfarin anticogulation for the prevention and treatment of patients with venousthromboembolism is one of the most used therapies in clinical practice. Patients requiredifferent dosage to achieve the target therapeutic anticoagulation. Optimal dosage andbleeding complication are two most clinical concerns. Besides of multiple individual factors(e.g. age, dietary intake, vitamin supplement, drug compliance etc.), some genetic factorsmay determine the drug requirement and safety.The cytochrome P450 CYP2C9 is a liver enzyme required for the oxidative metabolism ofwarfarin. The vitamin K epoxide redutase (VKOR) is a liver enzyme associated with the reuseof the oxidative hydroquinone form of vitamin K. The VKOR enzyme is the target of warfarin.Recent studies revealed both genes may determine the pharmacodynamic of warfarinanticogualation. To date, there are more than thirteen identified polymorphism at CYP2C9gene. Majority of those variant polymorphisms may decrease the warfarin requirement. TheVKOR complex subunit 1 (VKORC1) is a newly identified gene. Some polymorphisms also werereported.As we know, the Chinese patients need a lower dosage of warfarin in comparison with theCaucasian patients. We are interested in finding the genetic causes of Taiwneses Chinesepatients. In our study we will first identify the polymorphism patterns of these two genesin normal population. Then, we will try to find the association between these polymorphismand patient warfarin requirement. Our pharmacogenetics study will be valuable for preventionof bleeding complication of warfarin treatment in Chinese population. Inclusion Criteria:- Use warfarin therapy for at least two months before study- Stable INR value during recent three monthsExclusion Criteria:- higher age(>80 y/o)- liver and renal dysfunction- alcohol abuse- BMI<18kg/m2- coadministered medicine that can affect pharmacokinetics or pharmacodynamics ofwarfarin |
NCT00247676 | An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer | Liver Neoplasms The study will consist of two parts. In Part 1 the study will start enrolling 38 patientsand then further 25 patients up to a total of 63 eligible patients. If the study gives goodresults it can be expanded to a total of 160 patients. SU011248 will be administered orallydaily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] withprovision for dose reduction based on tolerability. All patients will receive repeatedcycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or otherwithdrawal criteria are met. After discontinuation of treatment, patients will be followedup in order to collect information on further antineoplastic therapy and survival Inclusion Criteria:- Histologically confirmed diagnosis of hepatocellular carcinoma- Patients must present with disease not amenable to curative surgery (i.e. eitherhepatectomy, or liver transplant).- Evidence of measurable disease by radiographic technique- Adequate organ function.Exclusion Criteria:- Prior treatment with any systemic treatment for liver cancer- Presence of clinically relevant ascites- Severe hemorrhage <4 weeks of starting study treatment.- Diagnosis of second malignancy within last 3 years- History of or known brain metastases, spinal cord compression, or carcinomatousmeningitis- Known human immunodeficiency virus (HIV)- Serious acute or chronic illness- Current treatment on another clinical trial- Pregnant or breastfeeding |
NCT00247104 | The Use of Cranberries in Women With Preterm Premature Rupture of Membranes | Fetal Membranes, Premature Rupture Cranberries have been proved to reduce the rate of urinary tract infections in a populationof women with recurrent urinary tract infections in previous studies. The purpose of thestudy is to examine the efficacy of cranberries in pregnant women with preterm prematurerupture of membranes in a)prolonging the latent period (=the time period between the timethe water broke and delivery of the fetus) and b)reduction of infectious morbidity of boththe mother and infant. Inclusion Criteria:- Proven premature rupture of membranes- less than 35 weeks of gestation with good obstetrical dating- no suspicion of amnionitis- signed informed consentExclusion Criteria:- Known sensitivity / allergy to cranberries- Women treated with warfarin- Drug intolerance |
NCT00247689 | Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics | Substance Abuse Background:- Research has shown that several human genes have been associated with vulnerability tosubstance abuse and dependence. However, little is known about how people with thesegenetic tendencies react to drugs in controlled settings.- Methylphenidate, also known as Ritalin, is commonly prescribed for a number ofconditions, including attention deficit disorder. Because methylphenidate is widelyused in studies of brain chemistry and behavior and has relatively low risks associatedwith it use, researchers are interested in seeing how it affects the thinking processesof people with apparent genetic vulnerability to drug abuse.Objectives:- To evaluate whether individuals with apparent genetic vulnerability to drug abuse reactdifferently to methylphenidate than people who do not have this vulnerability.Eligibility:- Individuals at least 18 years of age or older who have participated in the NIDA protocolAllelic Linkage in Substance Abuse.Design:- Participants will be asked to avoid using a number of over-the-counter medications,including antihistamines, cough medicines, and nasal decongestants, for 24 hours beforethe study day. Participants will also be asked to avoid consuming caffeinatedbeverages, nicotine or tobacco products, or alcohol on the morning of the day of thestudy, and will provide a urine sample at the start of the study to be tested forchemicals that may interfere with the study.- Because of the nature of the study drug, participants will not be allowed to drive tothe clinical center on the day of the study. (Return transportation will be arranged.)- At the start of the study, participants will take two tablets (each 1 hour apart), andwill not be told whether the tablets are the study drug or a placebo.- Participants will give regular answers to questions about mood and thinking processeson a computer for approximately 5 hours. Blood samples will be taken during this partof the study. - INCLUSION CRITERIA:Self-reported White/Caucasian or Black/African American individual who have participatedin the protocol #148 (90-DA-N448) in order to obtain the molecular genetic variablesneeded in the current study. We will contact only those individuals (substance abusers,non-substance abusing controls, and family members if the proband does not qualify) whohave participated in study #148 (90-DA-N448) at times when their consent included writtenagreement to be contacted at a later date and are enrolled at the NIDA Intramural ResearchProgram.EXCLUSION CRITERIA:1. Do NOT have a history of1. Seizures,2. Head injury resulting in unconsciousness and/or requiring hospitalization3. Cardiovascular abnormalities (i.e. murmur)4. Uncontrolled or untreated hypertension-Diastolic >95 mmHg and/or Systolic > 145 mmHg5. Clinically significant anxiety, depression, and/or panic disorder6. Coronary artery disease.History of known coronary artery disease,- History of a prior myocardial infarction or stroke.- An 12 lead EKG will be done during screening (no more than three monthsprior to enrollment), reviewed by an M.D, and may be sent to an outsidecardiologist for manual reading.- EKG abnormalities which will EXCLUDE a subject will include the following:QTc interval > 450 ms or changes suggesting acute ischemia, second or thirddegree heart block, left bundle branch block, atrial fibrillation, signs ofleft ventricular hypertrophy or other clinically important arrhythmias.7. Dependence on methylphenidate or a psychostimulant8. History of an adverse reaction to cocaine, methylphenidate, amphetamine, otherpsychostimulant, herb and/or over the counter medication9. Urine sample positive for a psychostimulant on the day of the study. (Anobserved urine specimen will be tested on the day of the study)10. Clinically significant abnormal renal and/or liver function- Renal (lab cut off ): BUN > 35mg/dl; Cr > 2.0 mg/dl- Liver (lab cut off): AST > 200 U/L; ALT >200 U/L; Alk P > 200 U/L; GGT> 400U/L11. Diagnosed with a movement disorder12. Diagnosed with glaucoma13. Currently taking any of the following: monoamine oxidase inhibitors (within 2weeks of protocol participation), insulin, and/or a psychostimulant14. A major medical diagnosis (i.e. .stroke, rheumatoid arthritis on therapy,diabetes)2. Competent to give informed consent. Competency of research participation at the NIDAwill be determined by a Shipley Institute of Living Scales estimated IQ score of 80or greater and an SCL-90-R Global Severity Index T-score of 70 or less. Cognitiveimpairment will be defined using the Shipley Institute of Living Scale or WRAT(equivalent to WAIS-R IQ < 79). With individuals having SCL-90-R scores greater than70 referred for evaluation to a Counselor or Physician before admission to the studycan be complete. The counselor or physician using his/her clinical judgment will make1 of 2 determinations: a) The applicant may continue with the screening process; b)The applicant is disqualified from participation in the study and an appropriatereferral is made if indicated.3. To evaluate the understanding of the study, its risk and benefits, and how towithdrawal from the study at anytime will be determined by a Consent Quiz score of 80percent or greater (answering 8 of 10 questions correctly) in NIDA participants |
NCT00247845 | Evaluation of Atazanavir Substitution Intervention (EASI) Study | HIV Infections With the advent of highly active antiretroviral therapy (HAART), it was hypothesized thatits consistent use could lead to a cure for HIV infection in as little as three years[Perelson, 1997]. Subsequent research has shown this model to be incorrect [Finzi, 1999]. Inaddition, long term use of HAART has now been associated with significant metabolicabnormalities, which could lead to unintended morbidity, possibly worse than what one couldexpect from the progression of untreated HIV-associated immune disease over the same periodof time [Carr, 2000]. Accordingly, current recommendations for antiretroviral therapy havebecome more conservative. It is now suggested that a person with a CD4 count > 350 cells/mmmay safely delay initiation of HAART [Yeni, 2002].However, for those who still requireHAART, the risks of short-term and long-term toxicities remain, even if full virologicsuppression is achieved. In this setting, a number of switching strategies have beenevaluated (Negredo et al, 2002 & Martinez et al, 2003), mostly involving single drugsubstitutions of a protease inhibitor (PI) for a non-nucleoside agent (NNRTI) or abacavir(ABC). In general terms, these hae shown that virologic suppression is usually maintained,with improvement in drug-related side effects, including metabolic toxicities. A number ofpatients who are currently taking effective HAART are experiencing side effects to one ormore of the agents in their regimen that is not severe enough to mandate an immediate changein their regimen, but that is having a measurable effect on their qualify of life. Overtime, these effects may have an impact on adherence to therapy and its long-term efficacy.Given the recent availability of ATV (+/-RTV), its once daily administration, low pill countand favourable side effect profile, it is being used in clinical practice as part of singledrug substitution strategies in patients exhibiting a maximal response to HAART. There is aclear need to examine this practice in a systematic manner to document its occurrence,efficacy and safety.We hypothesize that, in patients with maximal virologic suppression on a double classregimen (including two NRTIs and an NNRTI or a PI, boosted with RTV or not), and in whom adecision has been made to implement a single drug substitution of the NNRTI or PI for ATV(+/-), this will lead to an improvement in objectively measured quality of life without anynegative impact on the virologic efficacy of the regimen. Inclusion Criteria:18 years of age or older; a confirmed diagnosis of HIV infection; 2 consecutive HIV RNAlevels <50 copies/mL with the most recent being within the past 3 months; have been on thesame HAART regimen for the past 3 months; have side effects to their currentantiretroviral medications that warrant a consideration of a change in therapy. There mustbe a clinical suspicion by the investigator that these side effects are attributable toeither the PI or the NNRTI component of the regimen; Have agreement between the treatingphysician and the patient that a single drug substitution to ATV +/- RTV will be proposed,independent of participation in the study; be able to provide written informed consent andcomplete the quality of life instruments and, in the opinion of the investigator, complyin every other way with the requirements of the study protocol.Exclusion Criteria:Exclusion criteria: Have received investigational drug within 30 days prior to thebaseline visit of the study; if female, be pregnant or breast-feeding; have an acuteillness, including an acute opportunistic infection; have grade 3-4 laboratoryabnormalities on any of the following parameters: CBC, ALT, AST, GGT, LDH, bilirubin,amylase, and alkaline phosphatase. |
NCT00247312 | Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial | Prostatic Neoplasm The purpose of this study is to determine the most appropriate radiation implant dose forpalladium-103 monotherapy. Radiation dose is related to potential cure. From previouslypublished studies, it appears that the prescribed radiation dose can be reduced by 14-20%without any difference in potential cure (in this study, the dose is being decreased 10%).Although most patients tolerate brachytherapy well, complications to appear to be related toradiation exposure to normal structures (i.e. urethra, rectum and proximal penis). Byreducing the prescribed dose, it is conceivable that fewer patients will experience sideeffects and complications. Inclusion Criteria:- Low risk patients: Gleason score less than or equal to 6, PSA less than or equal to10 ng/mL and clinical stage T1b-T2b (2002 AJCC.- An enzymatic prostatic acid phosphatase must be obtained prior to implantation.- No pelvic external beam radiation therapy for either prostate cancer or othermalignancies.- Androgen deprivation therapy less than 4 month duration for size reduction isallowable.- No surgical staging for prostate cancer.- A minimum of 5 year life expectancy.- No other invasive cancer diagnosis other than non-melanoma skin cancer within thelast 5 years.Exclusion Criteria:- Exclusion criteria will be limited to patients who do not meet the above eligibilitycriteria. |
NCT00247663 | Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer | Postmenopausal Women With Advanced Breast Cancer - To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozolemonotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancerwhich participated in double blind study. Inclusion Criteria:- Patients which participated in double blind studyExclusion Criteria:- Patients with intolerable toxicity.- Patients which confirmed progressive disease during double blind study.- Patients which have received concurrent anti-cancer therapy during double blindstudy. |
NCT00247273 | A Study of Monthly Risedronate for Osteoporosis | Postmenopausal Osteoporosis The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimenas compared to the standard daily dosing regimen of risedronate 5 mg daily. Inclusion Criteria:- Female: 50 years of age or older- >5 years since last menses natural or surgical- have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD)below the young adult mean, or have 1-spine BMD more than 2.0 SD below the youngadult female mean value and also have at least one prevalent vertebral body fractureExclusion Criteria:- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia- BMI (body mass index) >32 kg/m^2- use of medications within 3 months of starting study drug that impact bone metabolismsuch as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates andparathyroid hormone- hypocalcemia or hypercalcemia of any cause- markedly abnormal clinical laboratory measurements that are assessed as clinicallysignificant by the investigator |
NCT00247715 | Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study) | Dyspepsia The purpose of this study was to determine which treatment strategy, the step-up or thestep-down treatment strategy, is the most cost-effective treatment for patients with newonset dyspepsia in primary care. Inclusion Criteria:- Presence of a new episode of dyspepsia, defined as episodic or persistent symptomsincluding abdominal pain or discomfort and which are, in the opinion of the generalpractitioner, referable to the upper gastrointestinal tract.- Over 18 years of age- Informed consent (written) given.Exclusion Criteria:- Use of prescribed acid suppressive medication during 3 months before consult- Investigated by upper gastrointestinal endoscopy one year before inclusion- Malignancy- Contraindication to the study medication- Pregnancy- Alarming symptoms like weight loss, bleeding, and disturbed food passage- Patients with insufficient comprehension of the Dutch language |
NCT00247338 | The Impact of Low Calorie and Low Nitrogen Parenteral Nutrition Support on the Clinical Outcome of Postoperative Patients | Gastrointestinal Neoplasms The study is designed to investigate the influence of parenteral nutrition (PN) with lownitrogen and calorie supply on the clinical outcome of patients after an operation comparedto that of traditional PNs. Inclusion Criteria:- Patients undergone resection of stomach, intestine, or rectum, having the indicationof nutrition- Nutrition risk screening scores around 3- The age of the patients must be between 18 to 80- The patients sign the confirmed consent letter- Weight falls in the range of either 45-56 kg or 60-75 kgExclusion Criteria:- Pregnant or breast feeding- Contraindication of fluid infusion, acute pulmonary edema, brain edema and functionalinsufficiency of the heart- Hypersensitive to the ingredient of the trial product nutrient- Chemotherapy within 7 days before the beginning of this trial- Unstable angina pectoris- Diabetes mellitus- Disorder of lipid metabolism: triglycerides, cholesterol increased by 1.5 times abovethe reference value- Abnormal renal function: serum creatinine or BUN 1.5 times above normal referencevalue- Abnormal liver function: ALT or serum total bilirubin 1.5 times above normalreference value- Having severe drug allergy history and/or asthma- On operation day, blood loss above 800 ml- Contraindication to parenteral nutrition- Receiving regular parenteral nutrition within 7 days before the trial |
NCT00247884 | Pender Assisted Therapy (PATh) - Prospective Study of the Treatment of HCV | Hepatitis C Virus Infection The treatment of HCV-infected IDUs presents multiple challenges, such as adherence totherapy, relapse of substance use, re-infection, and co-morbid psychiatric disease. Someguidelines recommended that IDUs not be offered HCV treatment until they had stopped allsuch use for > 6 months, raising some questions about fairness and discrimination. Littlepublished data exist on HCV therapy in active IDUs. However, extensive evidence exists that,when specific programs are developed, IDUs can be successfully engaged in care. In IDUs,strategies shown to improve adherence include directly-observed therapy (DOT), cashincentives, and comprehensive case management. Weekly interferon dosing now provides a meansof improving HCV treatment adherence, and makes a DOT approach more practical. Within anobservational, prospective clinical cohort, we will be able to identify a group of IDUsinfected with HCV genotype 2 or 3 who would most benefit from treatment for their infection.We will design a systematic approach to the determination of their appropriateness fortreatment, refine the approach to their treatment within a directly observed therapy (DOT)setting, and evaluate the success of the approach (defined as the achievement of SustainedVirologic Response (SVR)). Taken together, this project will help define a systematicapproach to HCV infection in the inner city. The hypothesis is that the development of asystematic approach for the diagnosis of HCV and the establishment of a directly observedtherapy (DOT) program for the treatment of HCV infection in IDUs will constitute aneffective means of controlling the epidemic of this infection within this population. Inclusion Criteria:Age greater than 18 years; Serum HCV-RNA positive; HCV genotype 2 or 3; HBsAg negative;serum ALT greater than 1.5x upper limit normal greater than 3 months; Agreement from eachparticipant of childbearing age to practice contraception; Ability to provide informedconsent; judged to be appropriate for immediate treatment by case conference.Exclusion Criteria:Any cause for chronic liver disease other than HCV (including alcohol use greater than 350g/wk); Pregnant or breastfeeding women; Active HBV infection; Hemolytic anemia;Decompensated cirrhosis or portal hypertension; Active suicidal ideation, psychosis, maniaor hypomania; Serum creatinine greater than 180 g/mL; Hemoglobin less than 120 g/L in menor 110 g/L in women; Platelets < 90 x 109/L; Neutrophils less than 1.5 x 109/L; Activeautoimmune disease; NYHA disease > grade 2; Psoriasis requiring systemic therapy; Activemalignancy apart from non melanoma skin cancer; Use of systemic immunosuppressant agents;Weight greater than 105 kg ; Prior treatment of HCV with interferon or ribavirin; HIVpositive with CD4 count less than 250 cells/mm3 or receiving didanosine (due tointeraction with ribavirin); Life expectancy less than 2 years; judged to be inappropriatefor immediate treatment by case conference |
NCT00247728 | PI-88 in Hepatocellular Carcinoma After Hepatectomy | Carcinoma, Hepatocellular The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumorrecurrence in patients with hepatocellular carcinoma following hepatectomy. Inclusion Criteria:- Patients have voluntarily given written informed consent- Age 18 years but 75 years- Males or females- Histological diagnosis of hepatocellular carcinoma- Curative hepatectomy within the past 4-6 weeks- ECOG performance status of 0 to 2- Cardiac functional capacity to class II (New York Heart Association)- Patients with adequate renal, hepatic, and haematopoietic function as defined by:- Serum creatinine 2.0 mg/dL- Total bilirubin < 2.5 mg/dL- Neutrophil count > 1.5 x 10^9/L- ALT < 5 x upper limit of normal (ULN)- White blood cell (WBC) count 3 x 10^9/L- Platelet count 80 x 10^9/L- Prothrombin time international normalized ratio (PT-INR) 1.3 (or PT-INR 1.4but PT within normal range)- Activated partial thromboplastin time (APTT) < ULNExclusion Criteria:- Patients with history of allergy and/or hypersensitivity toanticoagulants/thrombolytic agents, especially heparin.- Patients with history of immune mediated thrombocytopenia, thromboticthrombocytopenic purpura, or other platelet disease- Patients with previous positive result in a heparin-induced thrombocytopenia (HIT)antibody test.- Patients with any tumour metastasis.- Patients with uncontrolled infection or serious infection within the past 4 weeks.- Patients with myocardial infarction, stroke, or congestive heart failure within thepast 3 months.- Patients with history of inflammatory bowel disease, any other abnormal bleedingtendency, or patients at risk of bleeding due to open wounds or planned surgery.- Patients with acute or chronic gastrointestinal bleeding within the past 1 year.- Patients with a history of drug abuse or psychiatric disorder.- Patients with known HIV infection or AIDS-related illness.- Patients who received other investigational or anti-neoplastic medication within thepast 4 weeks.- Use of aspirin, aspirin-containing medications, non-steroidal anti-inflammatory drugs(except for COX-2 inhibitors), heparin, low molecular weight heparin, warfarin,anti-platelet drugs, or any other anticoagulant medications 2 weeks prior to orduring the study period.- Women who are pregnant or breast-feeding.- Women of child-bearing potential who are not using an adequate method ofcontraception. |
NCT00247533 | Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia | Stroke There are many reports about the association of coronary artery disease (CAD) and cerebralartery stenosis (CAS), which had been proved to induce stroke and cognition decline afterthe revascularization including coronary bypass surgery (CABG) or percutaneous coronaryintervention. Perfusion defect on nuclear brain scan is also noted to correlate with theseneurological complications. On the other hand, the perioperative arrhythmia and followingcerebral embolism was also attributed to be one factor inducing such neurological hazards.In the patients with coexistent CAD and CAS (1st group), and also the patients scheduled forCABG or percutaneous coronary intervention (PCI) (2nd group), we, the researchers at FarEastern Memorial Hospital, attempted to integrate all the parameters mention above,including angiography of coronary and cerebral system, quantitative analysis of nuclearbrain scan, biochemical profile, and signals of a new ambulatory device which could recordthe electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, in order todefine the correlation between them. A chorological relation between EEG signals and ECGsignals is our first target to be worked out. Thereafter, we hope to establish a regressionmodel of all involved parameters according to the relation. Such a model, we believe, isessential not only to explain the post-CABG neurological complications, but to prevent them.Furthermore, for the undetermined ischemic stroke patients who had no obvious culprit arteryor embolism source, the paroxysmal arrhythmia had long been regarded as the cause. Whether aparoxysmal atrial fibrillation, which had not been disclosed by routine ECG, could inducemost of such a stroke is still not known. With this new ambulatory device which could recordthe electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, we want toanswer the question. Inclusion Criteria:- Coronary artery stenosis 50% and either carotid or brain artery stenosis 50%Exclusion Criteria:- Creatinine > 2.0 mg/dL- Co-morbidity- ER- A letter of authorization is not given |
NCT00247650 | Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy | Breast Cancer This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acidare given before surgery to newly diagnosed post-menopausal women with early breast cancer Inclusion Criteria- Postmenopausal women- Newly diagnosed with non metastatic breast cancer- Candidate for mastectomy or breast-conserving surgeryExclusion Criteria- Patients with invasive tumors- Patients receiving anti-cancer treatment- Patients who have undergone surgeryOther protocol-defined exclusion criteria may apply. |
NCT00247247 | Comtess Versus Cabaseril as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off. | Parkinson's Disease Multi-centre, randomised, parallel-group study, rater-blinded. Total duration of the studyper subject is 12 weeks plus a one- to two-week screening period. There are 6 pre-plannedvisits per subject: screening visit followed by 5 visits. Approximately 300 patientsaltogether in up to 25 active German study centres and up to 3 active Lithuanian studycentres will be randomised. Inclusion Criteria:- patients suffering from idiopathic Parkinson's Disease (PD) with wearing-offphenomenon- OFF-time per day >= 60 min after the first ON-period in the morning- 3-5 daily dosages of standard levodopa/DDC inhibitor- stable antiparkinsonian treatment 3 weeks prior to the randomisationExclusion Criteria:- symptomatic parkinsonism- concomitant treatment with non-selective MAO inhibitors or a selective MAO-Ainhibitor while treated with a MAO-B inhibitor already- concomitant treatment with one of the following catechol-structured drugs: rimiterol,isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine or apomorphine- concomitant treatment with alpha-methyldopa, reserpine, typical or atypicalneuroleptics, neuroleptic antiemetics (such as metoclopramide) or other drugs withantidopaminergic action- treatment with COMT-inhibitors 4 weeks prior to the randomisation- treatment with dopamine agonists 4 weeks prior to the randomisation- known hypersensitivity to ergot derivatives and entacapone- dementia (MMSE <= 24)- depression (Beck Scale >= 17) |
NCT00247910 | Behavioural Treatment of Hypertension | Hypertension The objective of the study is to determine whether psychological therapy (self-help orindividualized intense stress management) is different than a single drug treatment in termsof their effectiveness for lowering blood pressure. Inclusion Criteria:- must be at least 19 years of age- subjects can be male or female- subjects must have an average resting blood pressure of >140 systolic pressure an/ or>90 diastolic pressure off anti-hypertensive medicationExclusion Criteria:- must not be on more than 2 blood pressure lowering drugs- must not have known or suspected of having secondary hypertension on initialexamination- must not be pregnant or anticipating pregnancy during study period- must not have history of allergy, hypersensitivity or intolerance to diuretics- must not have medical condition that may result in an unacceptable risk ofcomplications due to uncontrolled hypertension during time period of study- must not have average resting BP readings that exceed 190 systolic, or 115 diastolic,or have two consecutive readings of 180 systolic or 110 diastolic |
NCT00247858 | Analysis of Methicillin Resistant Staphylococcus Aureus (MRSA) Obtained Through the Emergency Department in a Tertiary Care Hospital in Vancouver Canada From 2001-2005 | Infection With MRSA Bacteria To analyze microbiological data from MRSA samples obtained through the emergency departmentfrom 2001-2005. There is a strong clinical suspicion that we are now seeing an outbreak of anew strain of MRSA and we plan to better characterize the Vancouver population and completea chart review to assess specific associated factors. Inclusion Criteria:- Patient had a microbiological sample submitted from the emergency department of thestudy hospital from 2001- 2005 which grew MRSA. |
NCT00247455 | Fibre and Appetite Regulation Trial (FART) | Obesity High intake of cereal fibre has been shown to be associated with reduced weight gain andimproved insulin sensitivity. We hypothesize these effects are due to the short chain fattyacids derived from the bacterial fermentation (breakdown) of fibre in the colon (largeintestine). Insulin resistant subjects will be randomized to receive 2 servings of alow-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal)per day for one year. The effects of the diets on body weight, appetite, abdominal fat,blood short chain fatty acids, glucose, insulin, lipids and hormones will be measured Inclusion Criteria:- Non-diabetic male or non-pregnant females- aged 18-60- BMI<36- fasting insulin >40pmol/L (70%ile)Exclusion Criteria:- intention to lose >5kg in weight- presence of diabetes (fasting glucose >6.9mmol/L)- use of diuretics, beta-blockers or weight reducing drugs- use of antibiotics in last 3 months and use of antibiotics more than once annuallyfor the last 2 years- significant gastrointestinal, liver or kidney disease- use of lipid-lowering drug- major medical or surgical event in last 6 mo.- fibre intake >30g/d- inability to eat low or high fibre breakfast cereals- unwilling or unable to give consent or comply with protocol |
NCT00247468 | Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients | Respiratory Failure The study objective is to improve morbidity and mortality of high-risk critically illchildren. Our hypothesis is that a strict ICU glucose control protocol will decreasemorbidity and mortality associated with hyperglycemia in a population of high-riskcritically ill pediatric patients. Inclusion Criteria:- Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or- Invasive mechanical ventilation- Age between 1 mo and 21 yrsExclusion Criteria:- Type I diabetes mellitus- Have an illness that requires insulin daily- Recipients of solid organ transplants- Participation in an experimental trial that might affect outcome- Post-operative patients with planned extubation upon recovery- Patients on a dopamine infusion of less than 3 mcg/kg/minute |
NCT00247871 | Microbiological Characterization and Nasal Carriage Rates of Methicillin Resistant Staphylococcus Aureus (MRSA) in Vancouver Downtown Eastside | Nasal Colonization With MRSA Bacteria We plan to compare data from 300 nasal swab in Vancouver's Downtown Eastside taken in 2001to data obtained in 2005. The nasal carriage rate of MRSA and the specific characteristic ofeach MRSA found will be analyzed. A limited amount of associated information will beobtained Inclusion Criteria:Patient had a microbiological sample submitted from the emergency department of the studyhospital from 2001- 2005 which grew MRSA.Exclusion Criteria: |
NCT00247130 | Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer | Peptic Ulcers The present study will compare the hemostasis-maintaining effects of intravenous omeprazoleand ranitidine in patients with upper gastrointestinal hemorrhage that have undergoneendoscopic hemostasis, to establish which anti-secretory medication prior to the start oforal alimentation is effective in preventing re-hemorrhage after hemostasis. Inclusion Criteria:- Patients with identified gastric or duodenal ulcer- Patients with hemorrhagic exposed vessel at the ulcer lesion, oozing or projectilehemorrhage (predominantly arterial) from the ulcer, and where endoscopic hemostasishas been performed.- Over 20 years of age of either sex.- The subject or his or her proxy consenter has provided written informed consent.Exclusion Criteria:- Serious hepatopathy, nephropathy, or heart disease.- Complicating malignant tumor.- Hemorrhage from malignant tumor.- The patient is on, or in need of, treatment with a drug considered to interact withthe test drug.- History of allergy to the test drug.- History of anaphylactic shock.- Pregnant, possibly pregnant, or lactating.- patient who is unable to fully understand the explanation about the study.- patient who is judged by the investigator to be otherwise inappropriate forinclusion. |
NCT00247078 | The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism | Arachnidism The purpose of this study is to compare the safety and effectiveness of an investigationalantivenom and the current standard of care (pain management with opioid analgesics) fortreating patients with a widow spider bite. The working hypotheses are as follows:1. the investigational antivenom is more promptly effective at alleviating the painassociated with a widow spider bite than routine management with opioid pain medication2. the investigational antivenom is as safe a treatment as opioid pain medication intreating patients with a widow spider bite. Inclusion Criteria:- patient presents for treatment within 72 hours from time of symptoms onset- clinical diagnosis of widow spider envenomation- patient has moderate to severe pain intensityExclusion Criteria:- history of significant cardiac, respiratory, hepatic, or renal disease- distracting injury or chronic pain syndrome that would obscure pain intensityassessment- history of asthma or known sensitivity to fentanyl, morphine, diazepam, or equineserum- pregnant or lactating |
NCT00247520 | Safety and Efficacy Study of rEV131 in Allergic Rhinitis | Hay Fever The purpose of this study is to see whether rEV131 when given as a nasal spray in a singledose to each nostril is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) caused by an allergen challenge. All patients enrolled will be known to be allergicto ragweed pollen and will be given ragweed pollen extract in both nostrils 30 minutes aftereither rEV131 or innactive vehicle (placebo). The signs and symptoms (sneezing, itching,stuffiness and runny nose) will each be given a score from 0 to 3 by the patient and thesewill be added together and the combined scores from patients treated with rEV131 will becompared with those who received placebo. Inclusion Criteria:- a) Have a known past history of allergic rhinitis including allergy to ragweedpollen.b) Able and willing to give informed consent. c) Able and willing to follow all studyrelated instructions. d) Able and willing to make all required visits. e) Agedbetween 18 and 80 years. f) Willing to avoid prohibited medications (see below). g)Has met at least one of the endpoints to allergen challenge at Visit 11. Total symptom score of at least 6 OR2. 30% reduction in nasal volume in at least one side of the nose as measured byacoustic rhinometry AND total symptom score of at least 4.h) Has met endpoint to allergen challenge at Visit 2: Total symptom score of atleast 4 from a possible total of 12.Exclusion Criteria:- a) Patients with known exaggerated immuogenicity responses including severe asthma orpeanut allergy.b) Patients with known allergy to ticks or severe reaction to arthropod venom (e.g.bee or wasp venom).c) Patients with known chronic sinusitis, deviated nasal septum or nasal polyposis.d) Patients having a total Baseline symptom score of >4 at Visit 1 (ie before thefirst nasal washout).e) Patients known or found to be allergic to pollens prevalent in the trial sitelocality during the period of the study (e.g. mountain cedar).f) Patients who have taken systemic or topical corticosteroids, long actingantihistamines or immunosuppressives within 4 weeks of selection (V1) or who takethem within the course of the trial. Loratidine may not be taken within 10 days ofentry. Short acting antihistamines may not be taken within 72 hours of entry exceptas comfort medication following nasal allergen challenge (oral antihistamines only).Patients excluded from the study for non-compliance with regard to prohibitedmedications but who have received one or more doses of the test medications will beincluded in the safety analysis. |
NCT00247052 | Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion | Pericardial Effusion The aim of the sudy is to evaluate, through clinical, biological and transthoracicechocardiography follow up, the evolution of post operative (cardiac surgery) pericardialeffusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory (NSAID)drug (diclofenac)for this indication. Inclusion Criteria:- -Every patient hospitalized in a post operative cardiac rehabilitation center lessthan 30 days after cardiac surgery and presenting at the first TTE (Trans Thoraciccardiac Echography) a PE of severity > or equal to 2 (that is to say loculatedeffusion >10 millimeters or circumferential effusion > 1 mm ) will be includedExclusion Criteria:- Cardiac transplantation- Age <18 and > 80- Pregnancy- Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency,cardiac failure) |
NCT00247091 | Impact of HIV on Measles and Measles Immunisation | HIV Infection We conducted a longitudinal study to assess the immunogenicity of standard-titer measlesvaccine in HIV-infected and uninfected Zambian children. The study hypothesis was thatHIV-infected children would have higher rates of primary and secondary measles vaccinefailure compared to uninfected children, contributing to decreased levels of populationimmunity to measles and facilitating measles virus transmission in regions of high HIVprevalence. Inclusion Criteria:- children aged 2 to 8 months presenting for well-child care- reside within 10 miles of the study clinic- parents or caretakers provide signed informed consentExclusion Criteria:-children with severe illness |
NCT00247442 | Australian Screening Mammography Decision Aid Trial (ASMDAT) | Breast Neoplasms The purpose of the study is to develop and evaluate a decision aid to assist women aged 70years and over to make an informed choice about whether to continue screening mammography. Inclusion Criteria:- Women who are due their FIRST screening mammogram over the age of 70, and who havepreviously participated in screening mammography at BreastScreen NSW.Exclusion Criteria:- Inability to complete a telephone interview in English.- Personal history of breast cancer (invasive and pre-invasive). |
NCT00247481 | ZD1839 (Iressa) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer | Breast Cancer This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial ofZD1839 and placebo in combination with chemotherapy in patients with metastatic breastcancer. Inclusion Criteria:- Histologically or cytologically confirmed breast cancer at a metastatic stage.- Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to theResponse Evaluation Criteria in Solid Tumours (RECIST) criteria- World Health Organisation (WHO) performance status (PS) of 0 to 2- Life expectancy of greater than 12 weeks- Normal cardiac function (left ventricular ejection fraction [LVEF] by isotopicexamination greater than or equal to 55%)Exclusion Criteria:- Symptomatic lepto-meningeal metastasis- Concomitant infectious disease- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancertherapy- Incomplete healing from previous oncologic or other surgery- Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than100 x 109/L- Serum creatinine greater than 1.5 times the ULRR or clearance < 60 ml/min- ALT or AST greater than 2.5 times the ULRR- ALP > 5 times the ULRR- ALP > 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR |
NCT00247494 | Effects of Mycophenolate Mofetil (MMF) on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients | HIV Infection This study is a substudy of the MAN2 -study (Mycophenol mofetil in Antiretroviral Navepatients 2, see elsewhere in the ClinicalTrials.gov database). In the MAN2 study, HIV-1infected patients who are not treated with antiretroviral treatment will be randomized totreatment with Mycophenol mofetil (MMF)500 mg BID or a control group without treatment (openlabel). Both patients randomized to treatment with MMF and patients randomized to thecontrol group will be asked to participate also in this substudy.In this substudy we want to show whether monotherapy with Mycophenol mofetil (MMF) inpatients infected with HIV-1 can reduce acceleration of atherogenesis by attenuating variousinflammatory pathways normally involved in progression of atherosclerosis. Inclusion Criteria:- Any patient included in the MAN2-study van enter this substudy (see protocol MAN2study)Exclusion Criteria:- Any condition, illness or use of medication which according to the investigator isnot compatible with the conduct of the substudy or which could interfere with theevaluations required by the study. |
NCT00247325 | RECOVER:Comparison of Renal Toxicity Between Visipaque(Iodixanol)and Hexabrix(Ioxaglate)in Renal Insufficiency Undergoing Coronary Angiography | Kidney Failure In the treatment of coronary heart disease which is the major cause of heart attack, directmechanical treatment with catheters such as the coronary angiography,coronary balloonintervention and stenting intervention are the mainstay of therapy in recent years. In thatprocedures, we should use the contrast media, and it may cause kidney toxicity especially inthe patients with underlying kidney disease and decreased kidney function. We intended tofind out which contrast agent has less kidney toxicity in the catheter based treatment ofcoronary arterial diseases in patients with underlying decreased kidney function Inclusion Criteria:- creatinine clearance rates 60 mL/min using the Cockcroft-Gault formula- Patients who undergo coronary catheterization- Age of 19 or over 19.Exclusion Criteria:- pregnancy- lactation- having received contrast media within 7 days of study entry- emergent coronary angiography- acute renal failure- end-stage renal disease requiring dialysis- history of hypersensitivity reaction to contrast media- cardiogenic shock- pulmonary edema- multiple myeloma- mechanical ventilation- parenteral use of diuretics- use of N-acetylcysteine- use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of theprocedure. |
NCT00247286 | Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial. | Urinary Incontinence, Stress The purpose of this study is to determine the objective (urodynamic) cure rates and effecton patient quality of life after six months of treatment for two different nonsurgicalmanagement options for genuine stress urinary incontinence in females: weighted vaginalcones and formal supervised pelvic floor physiotherapy with biofeedback.Hypothesis: Assuming a minimum of six months of treatment, weighted vaginal cones are aseffective as a formal supervised program of pelvic floor physiotherapy with biofeedback forthe treatment of uncomplicated genuine stress urinary incontinence in females. Inclusion Criteria:- Females, between the ages of 18-65 years, will be entered into this study. Additionalinclusion criteria are a history of urinary stress incontinence and multichannelcystometry confirming the presence of genuine stress incontinence (GSI).Exclusion Criteria:- urodynamic identification detrusor instability- active (untreated or resistant) urinary tract infection- any other disease that is felt by the investigators to potentially interfere withparticipation (e.g. arthritis limiting dexterity and thus interfering with theinsertion and removal of vaginal cones)- previous treatment with pelvic floor physiotherapy with biofeedback or functionalelectric stimulation for urinary incontinence- previous use of weighted vaginal cones- previous anti-incontinence surgery- significant pelvic organ prolapse or those with abnormal vaginal anatomy (the PelvicOrgan Prolapse Quantification (POP-Q) system of scoring for prolapse will be used,Grade > III)- use of concomitant treatments during the trial or the start of new medications thatmay alter continence mechanism- inability to understand instructions in French or English or provide informed consent(e.g., psychiatric disease).- pregnancy (which may alter pelvic anatomy may over the course of the study and thusmake evaluation of treatment methods impossible) |
NCT00247949 | Accuracy of Non-invasive Continuous CO2-Monitoring | Blood Gas Monitoring, Transcutaneous Arterial carbon dioxide partial pressure (PaCO2) is an essential indicator of ventilationand respiratory function. It is routinely tested invasively by arterial blood gas analysis(ABGA) but recently developed miniaturized carbon dioxide tension sensors promisenon-invasive and continuous transcutaneous PCO2 (PtcCO2) monitoring. We, the researchers atUniversity Hospital, Basel, Switzerland, determined the accuracy of two PtcCO2 monitors(TOSCA 500 with Sensor 92, Linde Medical Sensors AG, Basel; and Sentec Digital Monitor withV-Sign Sensor, Sentec AG, Therwil) for measurement of single values and trends in PaCO2 incritically ill patients, using ABGA as a reference. Inclusion Criteria:- Patients older than 18 years with clinical indication of repeated arterial blood gasanalysesExclusion Criteria:- No informed consent |
NCT00247975 | Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy | Heart Failure Breast cancer is very common and afflicts 1 in 9 North American women. The treatment ofbreast cancer often requires the use of chemotherapy including "anthracyclines".Anthracyclines can damage the heart resulting in heart failure and even death. Cliniciansand researchers are continually seeking methods that will reduce the toxic effects ofanthracycline treatment.L-carnitine is a substance that is produced naturally in the body and is required for normalheart function. Animal studies have suggested that L-carnitine protects the heart from theeffects of anthracyclines, however this has not been verified in humans.This study will assess the potential role of L-carnitine in the prevention of anthracyclineinduced heart damage. The investigators will enroll 144 patients into this study. Patientswill be randomly assigned to L-carnitine therapy or to standard care (no L-carnitinetherapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitineprior to and after their anthracycline therapy. Patients will undergo regular follow up andtesting to assess heart function. The investigators believe that patients treated withL-carnitine will benefit and have fewer complications associated with anthracyclinetreatment. Inclusion Criteria:- Female patients must have histologically or cytologically indicated breast cancer(stages I, II, III) eligible for adjuvant anthracycline chemotherapy [FEC100 orAC-Taxol(paclitaxel) every 21 days.- HER2 negative or HER2 positive breast cancer by immunohistochemistry (IHC3+) and/orfluorescent in-situ hybridization.- Eastern cooperative oncology group (ECOG) performance status = 0, 1, 2- Age 18 years old.- Ability to understand and the willingness to sign a written informed consentdocument.- The effects of L-carnitine on the developing human fetus at the recommendedtherapeutic dose are unknown. For this reason, women of child-bearing potential mustagree to use adequate contraception prior to study entry and for the duration ofstudy participation. Should a woman become pregnant or suspect she is pregnant whileparticipating in this study, she should inform her treating physician immediately.Exclusion Criteria:- Patients with evidence of metastatic breast cancer.- Resting LV ejection fraction < 50%.- Patients having received previous anthracycline therapy or contraindication toanthracycline.- Patients having a contraindication to L-carnitine therapy- Dexrazoxane therapy at the time of enrollment.- Patients with abnormal baseline bloodwork:- hemoglobin 100 mg/L- platelets 100 x 10^9/L- white blood cells 4 x 10^9/L- creatinine, AST, ALT, bilirubin > 1.5 x the upper normal limits- Participation in another randomized clinical trial.- Patients having significant cardiac disease (previous myocardial infarction,congestive heart failure, or hemodynamically significant valvular heart disease) thatwould limit compliance with study requirements.- Patients taking medication that may affect LV function (b-blockers, amiodarone,ACE-inhibitors, calcium channel blockers, or digoxin).- Patients with symptoms of heart failure.- Patients unable to participate in a study requiring long term follow up.- Pregnant or lactating women. |
NCT00247182 | Stepped Care for Mandated College Students | Alcohol Use This project provides stepped care to college students mandated for alcohol-relatedoffenses. Students are first provided with a minimal intervention, a 15-minute discussion oftheir alcohol use. Students who continue to drink in a risky manner are provided with a moreintensive, hour-long brief motivational interview. By providing more intensive treatment tothe students who exhibit risky drinking, we hope to maximize the efficiency of campusalcohol programs. Inclusion Criteria:- Male and female students 18 years of age or older.- Participants will have signed a witnessed informed consent.- Participants will have been referred for an alcohol-related offenseExclusion Criteria:- Participants who meet current DSM-IV criteria for substance use disorder- Participants who are currently in treatment for substance use. |
NCT00247169 | Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II | Cervical Intraepithelial Neoplasia The investigators want to test whether treatment with a natural progesterone intravaginallyincreases the cure rate of cervical intraepithelial neoplasia grade I and II. Inclusion Criteria:1. Histological evidence of CIN I and II2. Transformation zone and lesion margins fully visible3. Compliant subject4. Safe contraception5. Negative pregnancy testExclusion Criteria:Lesion related1. CIN III, (micro)-Invasive Cancer2. Endocervical lesion, upper margin of lesion not visible on colposcopy3. Non-compliance of patient4. PAP VDrug related1. Age > 602. Hypersensitivity to progesterone or any component of the formulation3. Thrombophlebitis4. Undiagnosed vaginal bleeding5. Carcinoma of the breast6. Cerebral apoplexy7. Severe liver dysfunction8. Pregnancy9. Depression10. Diabetes11. Epilepsy12. Migraine13. Renal dysfunction14. Asthma15. HIV infection16. Hepatitis B or C17. Concurrent use of anticoagulants18. Uncontrolled hypertension (> 160/90 mmHg)19. Breast cancer in personal history20. Concurrent hormonal therapy including OCClinical laboratory related1. Hemoglobin < 11 g/dl2. Leukocytes < 4,0 x 109/L3. Platelet count < 100 x 109/L4. Serum bilirubin > 2 x above upper cut-off value5. Serum GOT > 2 x above upper cut-off value6. Serum GPT > 2 x above upper cut-off value7. Serum alkaline phosphatase > 2 x above upper cut-off value8. Serum creatinine > 2 x above cut-off value |
NCT00247221 | Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event | Alcohol Abuse The purpose of this study is to compare the effectiveness of a brief family intervention inreducing alcohol use and alcohol-related problems among families of underage drinkers (13-17years old) who are treated in a hospital emergency department for an alcohol-related event. Inclusion Criteria:- Child aged 13-17 years- Receiving treatment at the approved medical Emergency Department- Child living in a home with at least one parent or legal guardianExclusion Criteria:- Children who are suicidal, in police custody, not alert/oriented, non-Englishspeaking, in severe pain, or who have sustained severe trauma- Children with a history of prior substance abuse treatment |
NCT00247962 | Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis | Ankylosing Spondylitis The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in thetreatment of Ankylosing Spondylitis. Inclusion Criteria:- Clinical diagnosis of ankylosing spondylitis- Active ankylosing spondylitisExclusion Criteria:- Complete ankylosis of spine- Previous treatment with etanercept |
NCT00247143 | High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease | HIV The purpose of this study is to evaluate the safety, tolerability and efficacy of higherdoses of lopinavir/ritonavir, in combination with other anti-HIV medications whenadministered as either the capsule or liquid formulations, among patients who have not hadfull viral suppression despite treatment with 3 classes of HIV medications, and at least 2prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics ofthe active agents, lopinavir and ritonavir will be measured following administration of boththe liquid and capsule formulations and compared. Inclusion Criteria:1. Signed informed consent prior to trial participation.2. HIV-1 infected males or females at least 18 years of age.3. Weight > 60 kg and < 100 kg4. Acceptable laboratory screening values as defined in the exclusion criteria.5. Three class ARV experienced, including current PI regimen for at least 12 weeks, atleast one other PI based regimen for at least 12 weeks, treatment with at least oneNNRTI and with at least 2 nucleoside agents.6. Screening Virologic Phenotype demonstrating lopinavir phenotypic fold resistancebetween 10 and 80 (if patients have had Virologic Phenotype within 8 weeks of studyscreening this may be used as the qualifying lopinavir phenotypic fold resistance).7. HIV-1 viral load 1000 copies/mL at screening.8. Acceptable screening laboratory values that indicate adequate baseline organfunction. Laboratory values are considered to be acceptable if the following apply:- Total Cholesterol DAIDS Grade 3- Total Triglycerides DAIDS Grade 3- ALT and AST DAIDS Grade 3).- Any Grade GGT is acceptable.- Any Grade CK is acceptable as long as there is no concurrent myopathy.- All other laboratory test values DAIDS Grade 2.9. Willingness to discontinue treatment with NNRTIs throughout 48 weeks of studyparticipation (prior or current treatment with enfuvirtide is permitted).10. Acceptable medical history, as assessed by the investigator, with an unremarkablechest X-ray and ECG within 1 year of study participation.11. Willingness to abstain from ingesting substances during the study which may alterplasma study drug levels by interaction with the cytochrome P450 system (these arelisted in the informed consent under the risks of lopinavir/ritonavir).12. A prior AIDS-defining event is acceptable as long as it has resolved or the patienthas been on stable therapy for at least 12 weeks.Exclusion Criteria:1. ARV medication nave.2. Patients on recent drug holiday, defined as off ARV medications for at least 7consecutive days within the last 28 days3. Female patients of child-bearing potential who:- have a positive serum pregnancy test at screening or during the study,- are breast feeding,- are planning to become pregnant,- are not willing to a use barrier method of contraception, or- require ethinyl estradiol administration.4. Prior high-dose LPV/RTV therapy (higher than recommended doses in package insert).5. Active diarrhea not controlled with antidiarrheal medications (not to exceed 3 bowelmovements/day), malabsorption, or GI intolerance to lopinavir/ritonavir6. Use of investigational medications within 30 days before study entry or during thetrial.7. Are receiving medications that are contraindicated with, or result in significantdrug-drug interactions, with LPV and/or RTV (including, but not limited to triazolam,astemizole, ergot medications, cisapride, midazolam, bepridils, or rifampin).8. Use of immunomodulatory drugs within 30 days before study entry or during the trial(e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).9. Active malignancy requiring chemotherapy or radiation.10. Inability to adhere to the requirements of the protocol, including active substanceabuse as assessed by the investigator.11. In the opinion of the investigator, likely survival of less than 6 months because ofunderlying disease. |
NCT00247195 | Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder | Depression This study will develop and evaluate the effectiveness of a culturally based program thataims to facilitate entry, retention, and successful treatment in specialized mental healthservices for Hispanics with major depressive disorder. Inclusion Criteria:PHASE 1 FOCUS GROUP 1:- Self-identifies as Hispanic- Screened positive for MDD during the previous study (WH-PCDP), but was unable toparticipate in that study due to ongoing depression treatment at the time- Spanish-speakingPHASE 1 FOCUS GROUP 2:- Self-identifies as Hispanic- Family member of a patient with MDD who participated in the previous study (WH-PCDP)- Spanish-speakingPHASES 1-3:Pre-Engagement Phase- Self-identifies as Hispanic- Spanish-speaking- Positive screen for MDD on the Patient Health Questionnaire (PHQ) and a preliminarydiagnosis of MDD from the primary care physician during a standard medical interviewTreatment Phase- Meets DSM-IV criteria for MDD- Score of at least 16 on the Hamilton Depression Scale (HAM-D17) at the time of studyentry- Willing to abstain from any other type of specialized mental health services for theduration of the treatment (participants in general health care or participating infolk/spiritual healing practices are expected to continue these during the study)- Ability to tolerate a drug-free period (2 weeks for most medications; 4 weeks forfluoxetine) if on an ineffective psychotropic medication; if current medication iseffective, participants will not be asked to discontinue it (zolpidem for insomnia isalso a permitted medication)- Agrees to use an effective form of contraception for the duration of the studyExclusion CriteriaPHASE 1 FOCUS GROUP 1:- Comorbid medical or psychiatric conditions that may prevent focus group participation(e.g., substance use disorders, psychosis, unstable medical conditions)- Active suicidal or homicidal ideation that may pose a danger to oneself or othersPHASE 1 FOCUS GROUP 2:- Comorbid medical or psychiatric conditions that may prevent focus group participation(e.g., substance use disorders, psychosis, unstable medical conditions)PHASES 1-3:Pre-Engagement Phase- Declines referral by a primary care physician to specialized mental health services- Comorbid medical or psychiatric conditions that may prevent safe study participation(e.g., substance use disorders, psychosis, unstable medical conditions)- Active suicidal or homicidal ideation that may pose a danger to oneself or othersTreatment Phase- History of schizophrenia, bipolar disorder, schizoaffective disorder, depression withpsychotic symptoms, or organic brain syndromes- Clinically unstable medical disease, including glaucoma- Blood pressure higher than 150/90- Pregnant or breastfeeding- Current or past history of seizure disorder (except febrile seizure in childhood)- Meets DSM-IV criteria for alcohol or substance abuse or dependence (except nicotine)within the 6 months prior to screening- Use of monoamine oxidase inhibitors (MAOIs) or fluoxetine within 4 weeks prior toscreening, or use of other selective serotonin reuptake inhibitors (SSRIs),antidepressants, neuroleptics, mood stabilizers, buspirone, benzodiazepines, or otherpsychotropic drugs, except zolpidem for insomnia within 2 weeks prior to screening- Currently receiving formal psychotherapy from a mental health provider, whether ornot the focus of the therapy is MDD |
NCT00247624 | Improving Sleep and Psychological Functioning in People With Depression and Insomnia | Sleep Initiation and Maintenance Disorders This study will evaluate the safety and effectiveness of treatment with both a sleeping pilland antidepressant medication in improving sleep and psychological functioning in peoplewith depression and insomnia. Inclusion Criteria:- Score of greater than 10 on the PRIME-MD-PHQ telephone screen- Diagnosis of major depressive episode based on the Structured Clinical Interview forDSM-IV (SCID)- Score of greater than 20 on the Hamilton Rating Scale for Depression- Meets research diagnostic criteria for insomnia disorder at least 4 nights per week- Reported mean sleep latency greater than 30 minutes and mean sleep efficiency lessthan 85%- Suitable for outpatient treatmentExclusion Criteria:- Use of any psychotropic medications within 2 weeks of initial screening- Bipolar disorder, schizophrenia, psychotic depression, or any other psychoticdisorder- Uncontrolled asthma or chronic obstructive pulmonary disease- Chronic pain that may be a significant sleep-disturbing factor- Uncontrolled thyroid disease- Poorly controlled diabetes mellitus- Poorly compensated congestive heart failure- Currently taking lipophilic beta blockers, opioids, glucocorticoids, theophylline, orother medications known to interfere with sleep- History of intolerance or treatment resistance to either fluoxetine or eszopiclone- Inability to abstain from taking any psychotropics other than the study medicationsduring the course of the protocol, including sedating antihistamines- Use of any herbal or naturopathic treatments for sleep or mood (i.e., St. John'swort, melatonin, kava kava, valerian root, etc.)- Currently undergoing behavioral, cognitive-behavioral, or interpersonal therapy- Pregnant or breastfeeding- Agrees to use an effective form of contraception for the duration of the study- Uncontrolled symptoms of menopause, including hot flashes- Uncontrolled hypertension (systolic blood pressure consistently greater than 140 mmHg, diastolic blood pressure consistently greater than 90 mm Hg)- Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome- Reports habitual bedtime earlier than 9 PM or later than 1 AM more than 2 times perweek- Reports habitual rising time later than 9 AM more than 2 times per week- Body mass index greater than 30- Consumes more than 3 alcoholic beverages per day- Consumes more than 4 caffeinated beverages per day- Habitual smoking between 11 PM and 7 AM- Use of illicit drugs- Score greater than 24 on the Mini Mental State Examination- Determined to be incompetent- Determined to be at imminent risk for suicide- More than 5 lifetime SCID diagnoses of major depressive episodes- More than 3 failed antidepressant trials during the current episode of depression, asdetermined by the Antidepressant Treatment History Form- A course of electroconvulsive therapy during the present depressive episode |
NCT00247156 | An Autism Study Using Nambudripad's Food Allergy Elimination Treatments | Autism 1. We hypothesize that children in the experimental group will show a significantimprovement over the control group as all food allergens groups and some other relevantallergenic substances are desensitized in a systematic way using the NAET methodologywithin the specified period of study. Inclusion Criteria:Volunteers will be selected based on the well-defined inclusion criteria such as allcontrol and sample children showed typical autistic symptoms before NAET treatment: madeno eye contact, unable to talk and communicate. All subjects (both control and sample)should be within the age limit of 3 to10 years and should have established anddemonstrated autism spectrum disorder by a conventional physician. -Exclusion Criteria:Any child that has a history of various complications of illness other than autismspectrum disorder would be disqualified. Previously treated with NAET treatments for thiscondition will be disqualified to enroll in the study. Any patient who has any of thefollowing incidents will also be disqualified.1. Previous surgeries, congenital deformities of heart, lung, liver, brain, kidney, etc.2. Any type of cancer3. Aids4. Any physically debilitating disorders and diagnosed mental retardation, Down'ssyndrome, etc.5. Children with the history of severe allergies or anaphylactic reactions will berejected. |
NCT00247793 | Immunonutrition in Cardiac Surgery | Thoracic Surgery Effect of two preoperative oral immune-enhancing nutritional supplements in patients at highrisk of infection after cardiac surgery: a randomized placebo-controlled study.Introduction: In our first study we showed that the use of a preoperative oralimmune-enhancing nutritional supplement (OIENS) resulted in an improved patientshost-defence with a reduction in postoperative infectious morbidity in high-risk cardiacsurgery patients. The use of the OIENS resulted also in less postoperative organdysfunction. Experimental studies have shown that additional glycine results in lessischemia-reperfusion damage and that glycine has anti-inflammatory properties.Objective: The use of an OIENS in the preoperative period in patients at high risk ofinfection after elective cardiac surgery with the use of cardiopulmonary bypass (CPB)results in a reduction in infections as in our first study. The addition of 9.6 gram glycineper sachet OIENS results in a further reduction in postoperative dysfunction.Design: A prospective randomized placebo controlled study with two oral immune enhancingnutritional formulas and an isocaloric control formula. Patients: Seventy-four consecutivepatients undergoing cardiac surgery with the use of an CPB who met one or more of thefollowing inclusion criteria: Age 70 years or older, mitral valve replacement or cardiacejection fraction less then 40%. Exclusion criteria were age < 18 years, proven malignancy,use of corticosteroids, severe renal and liver failure. Definition of a protocol violationwas the intake of less then 5 L or more then 10 L of the nutritional supplement in thepreoperative period.Intervention: Patients were split up in three groups by concealed randomisation. One groupreceived the arginine, omega3-PUFAs and nucleotides enriched formula (OIENS). Another groupreceived the OIENS further enriched with glycine (OIENS+glyc). The control group received anisocaloric nutritional supplement without the enrichments. Inclusion Criteria:Patients undergoing cardiac surgery with the use of cardiopulmonary bypass, who met one ofthe following criteria- age >= 70 years- poor left ventricular function (ejection fraction < 0.4)- mitral valve replacementExclusion Criteria:- Age =< 21 years- Pregnancy- Insulin dependent diabetes mellitus- Hepatic Cirrhosis- Known malignancy- Use of chemotherapy, NSAIDs (except ASA), or corticosteroids- Schizophrenia- Severe renal failure (creatinine clearance < 25 mL/h) before study entrance- Patients with an organ transplantation in the past |
NCT00247988 | Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers | Platinum Sensitive Relapsed Ovarian Cancer Weekly carboplatin and taxotere will be tolerable and effective as second line treatment ofplatinum-sensitive ( >6 month treatment free interval) relapsed ovarian cancerPrimary efficacy parameter will be response rate (CR and PR) according to RECIST criteria.Secondary endpoints will be duration of response, progression free survival and overallsurvival. Toxicity will also be evaluated. Inclusion Criteria:1. Subjects must demonstrate their willingness to participate in the study (reliable andcompliant for repeated treatments) and comply with its procedures by signing awritten informed consent.2. Subjects must be 18 years of age or older.3. Subjects must have received a platinum regimen, with or without paclitaxel orcyclophosphamide, and have maintained a disease-free status for at least 6 monthsfollowing the completion of first line therapy.4. Documented measurable or evaluable ovarian, tubal or primary peritoneal cancer byappropriate radiologic imaging (x-ray, or CT scan). Radiation therapy is allowed aslong as not at the site of measurable disease. Recurrent disease based on elevatedCA-125 alone is allowed, provided it meets the CA-125 progression definition.5. Subjects must have adequate hepatic, renal and marrow function (AST/ALT< 3UNL,creatinine<2UNL, ANC>2, HGB>90)6. Histologic diagnosis of ovarian, tubal or primary peritoneal cancer.7. Performance status: ECOG Score greater than or equal to 2.8. Subjects must have life expectancy of at least 6 months.9. Women of childbearing potential must have a negative pregnancy test at time ofenrollment and must be using an acceptable method of birth- control during the study.Exclusion Criteria:1. Female subjects who are pregnant, breast-feeding, or unwilling to use adequatecontraception.2. Any other active primary tumor under treatment, except basal cell carcinoma of theskin, or carcinoma in situ of the cervix;3. Two or more prior chemotherapy regimens for ovarian cancer4. Serious infection within one month of commencement of treatment.5. Patients with known brain metastasis. However baseline CT of the head is not a must.6. Patients with severe gastro-intestinal symptoms- e.g.- partial obstruction, bleedingor diarrhea.7. Patients with Grade 2 or higher neuropathy [NCI Common toxicity criteria]. |
NCT00247585 | Hangover, Congeners, Sleep and Occupational Performance | Sleep The objective is to investigate residual effects of heavy drinking, with or without hangoversymptoms. The primary aim is to test several hypotheses about residual effects of heavydrinking. Hypotheses about how heavy drinking affects next-day performance include directphysiological effects of alcohol, alcohol withdrawal effects, and non-ethanol effects, suchas congeners, or family history of alcohol problems. The investigators will test thefollowing hypotheses:1. relative to placebo, heavy drinking will degrade next-day performance, and thisrelationship will be mediated in full or in part by quality of sleep;2. a high congener alcoholic beverage will affect performance to a greater degree than alow congener beverage and this relationship will be mediated by severity of hangoversymptoms. Inclusion Criteria:- Ages 21-30- Currently enrolled or have completed college/university- Have had 5 or more drinks (4 if female) in the last 30 days- Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST)- No self-reported history of counseling or treatment for substance abuse- Not taking any medication contraindicated for alcohol use or that disrupts sleep- Doesn't have a health condition contraindicated for alcohol use- Has not been diagnosed with a primary sleep disorder- Has not been diagnosed with a mental health disorder- Not currently working night shifts at a job- Not routinely taking medications that affect sleep- No evidence of extreme morningness or eveningness as assessed by questionnaire- Not a regular smokerExclusion Criteria:- Less than age 21 and greater than age 30- Not currently enrolled or has not completed college/university- Hasnt had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker)- Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST)- Self-reported history of counseling or treatment for substance abuse- Taking any medication contraindicated for alcohol use or that disrupts sleep- Has a health condition contraindicated for alcohol use- Has been diagnosed with a primary sleep disorder- Has been diagnosed with a mental health disorder- Currently working night shifts at a job- Routinely taking medications that affect sleep- Evidence of extreme morningness or eveningness as assessed by questionnaire- Is a regular smoker- Not a regular drinker- Is pregnant or nursing |
NCT00247208 | The SOS (Stenting Of Saphenous Vein Grafts) Trial | Coronary Artery Bypass The main purpose of this study is to determine whether implantation of a paclitaxel-elutingstent (Taxus) in saphenous vein graft lesions will reduce the incidence of in-stentrestenosis after 12 months when compared to a similar bare metal stent. Inclusion Criteria:- at least one 50-99% de-novo or restenotic lesion in a saphenous vein graft that isbetween 2.5 and 4.0 mm in diameter, requiring percutaneous coronary interventionaccording to the opinion of the attending cardiologist- willing to return for repeat coronary angiography after 12 months- able to give informed consentExclusion Criteria:- previous or planned use of intravascular brachytherapy in the target vessel- a left ventricular ejection fraction of less than 25 percent- hemorrhagic diatheses- contraindications or allergy to aspirin, thienopyridines, paclitaxel, or stainlesssteel- a history of anaphylaxis in response to iodinated contrast medium- use of paclitaxel within 12 months before study entry or current use of colchicine- a serum creatinine level of more than 2.0 mg per deciliter (177 mol per liter)- a leukocyte count of less than 3500 per cubic millimeter, or a platelet count of lessthan 100,000 per cubic millimeter- a recent positive pregnancy test, breast-feeding, or the possibility of a futurepregnancy- coexisting conditions that limit life expectancy to less than 24 months or that couldaffect a patient's compliance with the protocol |
NCT00247234 | Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders | Personality Disorder, Borderline This study intends to compare the effectiveness of schema therapy with standard psychiatricoutpatient care for patients with borderline or avoidant personality disorder. Inclusion Criteria:- Avoidant or Borderline personality disordersExclusion Criteria:- Do not speak Scandinavian languages- Antisocial personality disorder- Narcissistic personality disorder- Affective bipolar disorder I- Schizophrenia- Mental impairment/organic brain disorder- Substance dependence- Planned pregnancy- Serious somatic illness- Anorexia Nervosa |
NCT00247546 | Prevention of Falls and Injurious Falls Among Elderly People | Falls The aim of this study is to describe and analyse the effects of multifactorial trial on theincidence of falls and injurious falls and on different risk factors of falling among thehome-dwelling aged. Inclusion Criteria:- 65 years of age or older- home-dweller- having fallen at least once during the previous 12 months- at least moderate cognitive abilities (MMSE over 17)- able to walk 10 metres independentlyExclusion Criteria:- MMSE under 17 |
NCT00247026 | The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes | Myelodysplastic Syndrome To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopeniasof patients with myelodysplastic syndromes. we propose to explore the efficacy of thenatural compounds curcumin and CoQ10 in MDS because these two agents possess many of theeffects that are desirable in MDS. Inclusion Criteria:- MDS patients with RA, RARS or RAEB will be eligible for treatment with CoQ10 as longas their IPSS score 1.5.Exclusion Criteria:- Pregnant women and nursing women will be excluded.- History of clinically significant liver or kidney disease.- ECOG>2- IPSS score >1.5- Poorly controlled diabetes mellitus, hypertension, or other serious medical orpsychiatric illness that could potentially interfere with the completion of treatmentaccording to the protocol. |
NCT00247754 | VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children) | Anxiety Objective:1. To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program inreducing anxiety disorder symptoms in at-risk public school children.2. To determine whether parent education and involvement improves outcome in anxiouschildren treated with CBT.3. To determine the ability of school personnel in a) recognizing classroom behaviors asanxiety disordered after targeting training of observable child behaviors e.g.,avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and4. To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.Hypothesis:1. A CBT oriented intervention as delivered by school personnel will be superior to anattention control procedure in reducing anxiety symptoms in at-risk children.2. Children who have parental involvement will post stronger and more enduring treatmentgains. Inclusion Criteria:Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms.1. Anxiety disorder symptoms (identified by a score of 56 or higher on the MASC; andteacher report, and /or parent recommendation) as the primary presenting problem. Anenrolled child must have at least 2 of these criterions.2. Fluency in English.3. Parent willingness to sign consent form and to complete required assessments.4. Student willingness to participate (child assent) in 10-week affective educationprogram and completion of required assessments.Exclusion Criteria: |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.