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125321. Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein

with prophylactic antibiotics is strongly recommended. Since the incidence of OPSI in our country isn't clear, most (>95%) splenectomized patients in our hospital (National Taiwan University Hospital) did not have vaccination or prophylactic antibiotics. We'll try to determine the incidence of OPSI by reviewing of our hospital charts and by structured interviews with patients. The spleen is a phagocytic filter. So asplenic patients have higher risks of getting infection and some spleen-preserving procedures (...) bacteria if splenic arterial blood flow is reduced because experimental animal studies have demonstrated that an intact splenic arterial system is necessary for optimal control of infection. Thus, although the spleen is preserved in above mentioned procedure, the function of the preserved spleen is questionable and has never been studied of. Our second object is to determine the splenic function after after spleen-preserving distal pancreatectomy with excision of splenic artery and vein by comparison

2008 Clinical Trials

125322. Impact of Preoperative Chemotherapy on Complications and Regeneration After Resection of Colorectal Liver Metastases

information Ages Eligible for Study: Child, Adult, Older Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Probability Sample Study Population Records from 184 consecutive patients undergoing liver resection due to colorectal metastases between 2003 and July 2008 were reviewed from a prospective database Criteria Inclusion Criteria: Liver resection due to colorectal liver metastases between 2003 and 2007 Exclusion Criteria: Incomplete assessment of preoperative (...) after liver resection Additional relevant MeSH terms: Layout table for MeSH terms Neoplasm Metastasis Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases

2008 Clinical Trials

125323. Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma

before adding more. Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. Identifier: NCT00775957 Recruitment Status : Terminated (Terminated by institutional review board) First Posted : October 20, 2008 Last Update Posted : September (...) Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases

2008 Clinical Trials

125324. Bioequivaelnce Study of Doxycycline Monohydrate 100mg Tablets Under Fed Conditions

or difficulty in donating blood. e) Received an investigational drug within the 4 weeks prior to study dosing. f) Currently taking any systemic prescription medication, except oral / cutaneous/ vaginal hormone contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. Any non (...) -prescription medication consumption reported will be reviewed by the investigator prior to dosing. At the discretion of the investigator these volunteers may be enrolled if the medication is not anticipated to alter study integrity. g) Regular smoking of more than 5 cigarettes per week or the daily use of nicotine-containing products beginning 3 months before the study medication administration through the final evaluation. h) If female, the subject is lactating or has a positive pregnancy test

2008 Clinical Trials

125325. Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)

of the Royal College of Physicians. Nicotine addiction in Britain. London: Royal College of Physicians of London, 2000. Hughes J, Stead L, Lancaster. Antidepressants for smoking cessation. Cochrane Database of Systematic Reviews 2000;Issue 4, 2000. Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd, 2003. Publications automatically indexed to this study by Identifier (NCT (...) Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

2008 Clinical Trials

125326. Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines for the study treatment and for the pre-entry tumor block submission for HER2 testing and B-43 (...) failure; or Documented cardiomyopathy Uncontrolled hypertension, i.e., systolic blood pressure [BP] greater than 180 mm/Hg and/or diastolic BP greater than 100 mm/Hg (patients with hypertension that is well controlled on medication are eligible) Other nonmalignant systemic disease that would preclude a patient from receiving trastuzumab or radiation therapy or would prevent prolonged follow-up Other malignancies unless the patient is considered to be disease-free for 5 or more years prior

2008 Clinical Trials

125327. Optic Discs in Children With Cerebral Palsy

of the cup/disc ratio in the 2 groups of children based on the approximate timing of the neurological insult will also be done. The results of this study may allow pediatric ophthalmologists and glaucoma specialists to spare a child with static encephalopathy and isolated optic nerve head cupping extensive, risky and expensive glaucoma work-up. This study will also provide more information on the patho-physiology of the developing visual nervous system. Study Design Go to Layout table for study (...) of static encephalopathy or equivalent terms- CNS malformation syndrome or cerebral palsy. Criteria Inclusion Criteria: Children born prematurely at age 24-36 weeks of gestation; are currently in the age group 0-17 years and enrolled in Dr Vedanarayanan's pediatric neurology clinic. Diagnosis of static encephalopathy, cerebral palsy or CNS malformations Availability of CT head or MRI brain for review. Exclusion Criteria: Parents/guardians or the child refuse consent or assent. Presence of ocular media

2008 Clinical Trials

125328. Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Any stage with an estimated risk of node involvement at least 15% (and therefore at significant risk for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.: GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest pretreatment value (...) ) to prostate only (PO) radiotherapy and neoadjuvant to adjuvant total androgen suppression (TAS): preliminary analysis of RTOG 9413. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): Plenary A-5, 3, 2001. Other Publications: Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract

2008 Clinical Trials

125329. S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

of differentiation antigen 20 (CD20) antigen-positive disease NOTE: *Needle aspiration or cytology are not considered adequate for pathology review Patient must have unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days Positive biopsy performed > 42 days but < 6 months allowed Previously untreated disease Bidimensionally measurable disease No clinical evidence of central nervous system (CNS) involvement by lymphoma PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Cardiac (...) Lymphoma, Non-Hodgkin Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Doxorubicin Liposomal doxorubicin Prednisone Vincristine Iodine-131 anti-B1 antibody Antibodies, Monoclonal Iodine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms

2008 Clinical Trials

125330. Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)

embolism. Inhaled nitric oxide (iNO) has been shown to be a pulmonary vasodilatator with minimal systemic effects and has also been shown to improve gas exchange in both animal and human acute lung injury (ALI). The combined effects of iNO gas of improving pulmonary ventilation to perfusion matching, reducing alveolar and systemic inflammation, modulate the course of acute chest syndrome, which combine the physiopathology of vaso-occlusive crisis and acute lung injury. We hypothesise inhaled (...) , prospective, randomized, controlled clinical trial Enrollment: 24 months Patients will be treated for 72 hours Patients will be followed for 15 days or until discharged home Sample size: The study will accrue a maximum of 240 patients Progress of the trial will be reviewed by an independent data and safety monitoring committee to determine if randomization should stop for safety reasons. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment

2008 Clinical Trials

125331. Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Outcome Measures Go to Primary Outcome Measures : Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC) [ Time Frame: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months) ] PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new (...) system fails to recognize red blood cells as "self" and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented. Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study [ Time Frame: From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months) ] Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took

2008 Clinical Trials

125332. CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD)

Reasons) First Posted : September 8, 2008 Results First Posted : July 16, 2014 Last Update Posted : July 23, 2015 Sponsor: CSA Medical, Inc. Information provided by (Responsible Party): CSA Medical, Inc. Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the safety, and tissue effect of the CryoSpray Ablation(TM) System (CryoSpray Ablation(TM), "CSA" or "cryospray therapy") at multiple centers to treat malignant airway disease in the lung using liquid (...) of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Cryospray Ablation Cryospray Ablation 4, 5-second spray cycles Device: CryoSpray Ablation Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment. Subjects may undergo up to one bronchoscopy with CryoSpray Ablation every seven days for a total of four (4) treatments in the first month. Other Names: CryoSpray Ablation(TM)System CSA (TM) System Cryo

2008 Clinical Trials

125333. Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")

First Posted : June 8, 2015 Last Update Posted : July 16, 2015 Sponsor: CSA Medical, Inc. Information provided by (Responsible Party): CSA Medical, Inc. Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the safety, efficacy, and side effects of the CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal pleural surface. Condition or disease Intervention/treatment Phase Cancer Pleural Neoplasms Device: CryoSpray Ablation (...) (TM) System Phase 4 Detailed Description: The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci. Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary, dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if dosimetry will need to be increased to enhance effectiveness. The PI may increase

2008 Clinical Trials

125334. Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

Update Posted : August 18, 2015 Sponsor: CSA Medical, Inc. Information provided by (Responsible Party): CSA Medical, Inc. Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) Condition or disease (...) by the National Library of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Cryospray Ablation Experimental CSA (Cryospray Ablation) Device: CryoSpray Ablation Cryospray Ablation up to 4 -5 second cycles for up to 4 treatments in the first 30 days Other Names: CryoSpray Ablation(TM)System Cryotherapy Cryosurgery Cryospray Cryo Outcome Measures Go to Primary Outcome Measures : Improvement in Luminal Patency Following Cryospray Treatment [ Time Frame: 30

2008 Clinical Trials

125335. Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)

such as your age and employment status. Your second questionnaire asks about any brain cancer symptoms that you may be experiencing, and asks you to rate how severe they may be. Your caregiver's second questionnaire asks the same questions as yours. It asks the caregiver to rate how severe he or she believes your symptoms may be. In total, the questionnaires should take about 10 minutes to complete. Symptom Review: The study staff will review the questionnaire responses right away. If you rate any symptom (...) . Anderson Cancer Center: Primary Brain Tumor Caregivers Symptom Severity Questionnaire M.D. Anderson Symptom Inventory-Brain Tumor MDASI-BT Additional relevant MeSH terms: Layout table for MeSH terms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases

2008 Clinical Trials

125336. A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)

. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form Male or female ≥ 18 years old. Life expectancy ≥ 3 months (...) to informed consent for HCC diagnosis. Resection samples are not acceptable. undergo a biopsy to confirm HCC diagnosis At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria. (Extension Phase) Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form. Male or female ≥ 18 years old. Life expectancy ≥ 3 months. ECOG Performance Status of 0-1. Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype

2008 Clinical Trials

125337. Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery

Thrombosis [DVT] (proximal or distal, symptomatic or not) and non-fatal Pulmonary Embolism [PE] as confirmed by a Central Independent Adjudication Committee [CIAC] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE. Secondary Outcome Measures : Percentage of Participants Who Experienced "Major" VTE or All-cause Death [ Time Frame: From randomization up to 10 days after surgery or the day of mandatory (...) venography, whichever came first ] "major" VTE included any proximal DVT, symptomatic distal DVT and non-fatal PE as confirmed by the CIAC. Percentage of Participants Who Experienced Clinically Relevant Bleedings [ Time Frame: From first study drug injection up to 3 days after last study drug injection ] Bleedings were centrally and blindly reviewed by the CIAC and classified as: "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative

2008 Clinical Trials

125338. Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer

be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. Asymptomatic, central nervous system metastases are permitted if patients remain (...) colitis). Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors: Medications that inhibit or induce CYP3A4 are prohibited. Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator. Renal function as measured by creatinine clearance < 30ml/min Patients are permitted to participate in other non

2008 Clinical Trials

125339. A Comparison of Two Daily Disposable Contact Lenses.

: Proportion of Eyes Successfully Fit [ Time Frame: Within 20 minutes of lens insertion ] Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit (...) . They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC). They have successfully worn contact lenses within six months of starting the study. Exclusion Criteria: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact

2008 Clinical Trials

125340. Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after (...) ) invasive fungal infection without infectious disease (ID) consult and approval Active central nervous system malignancy Patients who have received >= 2 cycles of multiagent chemotherapy within the 3 months previous to UCBT; patients who have had previous autologous transplant within 12 months of UCBT are excluded regardless of history of recent treatment DONOR: Any cord blood units with < 1.5 x 10^7 total nucleated cells per kilogram recipient weight DONOR: Any cord blood units without the full

2008 Clinical Trials

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