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34701. Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer

Version 4) summarized by system organ class and/or preferred term, severity and relation to study treatment. Phase lb: Progression free survival (PFS) [ Time Frame: At first treatment intake, every 8 weeks (C3D1, C5D1, C7D1, etc.) until disease progression or death for any cause [estimated time frame: 18 months]. ] PFS is defined as the time from start of treatment to objective tumor progression or death from any cause. Radiological assessments will be performed every 8 weeks. Phase lb: Overall (...) malignancy or malignancy in the last 5 years prior to start of study treatment Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF > 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) Inadequately controlled hypertension Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption

2011 Clinical Trials

34702. The Myocet/Lapatinib Study. ICORG 10-03, V5

during, or after, treatment with trastuzumab and taxanes as measured by MTD (Phase I) Secondary Outcome Measures : Overall survival [ Time Frame: From registration to death ] overall survival time (OS - time from registration to death from any cause) as assessed by standard RECIST criteria Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding (...) to swallow and retain oral medication. Formalin-fixed paraffin-embedded tissue from archived tumour tissue samples available (from the primary or metastatic tissue. Patients meeting any of the following exclusion criteria are not eligible for enrolment into this study: Exclusion Criteria: Pregnant or lactating women Prior anthracycline chemotherapy with a lifetime dose exceeding 360 mg/m2 doxorubicin or 550 mg/m2 epirubicin Documented history of poorly controlled hypertension), arrhythmia, clinically

2011 Clinical Trials

34703. Chikungunya Virus Vaccine Trial in Healthy Adults

the past two years or that is expected to require the use of oral or intravenous corticosteroids Diabetes mellitus (type I or II), with the exception of gestational diabetes Idiopathic urticaria within the past year Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws Malignancy that is active, or treated malignancy for which (...) ): National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) Study Details Study Description Go to Brief Summary: Background: - Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. CHIKV outbreaks are most common

2011 Clinical Trials

34704. Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

should not be enrolled. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied. Study participants cannot receive another investigational drug while participating in the study. Known allergy to any component of the study drug. Blood pressure > 180/110 (systolic above 180 or diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment (...) Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months

2011 Clinical Trials

34705. A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain

on the natural history of the condition. Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed to treat chronic back pain. NSAIDs are only moderately effective in relieving pain. NSAIDs are the leading cause of drug-induced gastrointestinal bleeds, the most common cause of drug-induced morbidity and mortality particularly at high dose. They can also exacerbate hypertension, edema and produce nephrotoxicity. The effects are also dose dependent. Recent data indicates NSAIDs are a risk factor (...) for myocardial infarction, particularly at high doses. Recent data also indicates NSAIDs disrupt collagen repair in injured tissue. Muscle relaxants and narcotic analgesics show limited efficacy and often produce sedation, constipation or inappropriate usage. Physical therapy and local modalities often are not satisfying, costly, and require considerable investment of patient time. Neurotransmitter depletion has been demonstrated to contribute to chronic pain states. Increased nutrient requirements

2011 Clinical Trials

34706. A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

<=6 months prior to beginning treatment. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to Day 1 of study treatment. New York Heart Association Grade II or greater congestive heart failure. Serious cardiac arrhythmia requiring medication. Patients with chronic, rate (...) ; IV Other Name: Eloxatin Outcome Measures Go to Primary Outcome Measures : Progression-free Survival [ Time Frame: 24 months ] Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. Secondary Outcome Measures : Objective Response Rate [ Time Frame: every 8 weeks, assessed up to approximately 24 months ] Defined as the percentage of evaluable patients showing a complete

2011 Clinical Trials

34707. FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation

Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest. [ Time Frame: 33 months ] Secondary Outcome Measures : All-cause Death [ Time Frame: 33 months ] Arrhythmia-related Death [ Time Frame: 33 months ] Total Procedure Duration [ Time Frame: Through the initial ablation procedure ] Total Time of Fluoroscopy [ Time Frame: Fluoroscopy meter time through the initial (...) . Exclusion criteria related to a cardiac condition Patients with prosthetic valves. Any previous LA ablation or surgery. Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment. Unstable angina pectoris. Myocardial infarction within three months prior to enrollment. Symptomatic carotid stenosis. Chronic obstructive pulmonary disease with detected pulmonary hypertension. Any condition contraindicating chronic anticoagulation. Stroke or transient ischemic

2011 Clinical Trials

34708. Developing Memory Reconsolidation Blockers as Novel Post-traumatic Stress Disorder (PTSD) Treatments

that contraindicates the administration of mifepristone, e.g., history of adrenal failure; concurrent corticosteroid therapy; hemorrhagic disorders; cardiovascular, hypertensive, hepatic, respiratory or renal disease; insulin dependent diabetes mellitus; severe anemia; heavy smoking; porphyria; allergy to mifepristone; concurrent anticoagulant therapy; or medical condition that contraindicates the administration of DCS e.g., hypersensitivity to cycloserine, epilepsy, severe renal insufficiency. Pregnant (...) Developing Memory Reconsolidation Blockers as Novel Post-traumatic Stress Disorder (PTSD) Treatments Developing Memory Reconsolidation Blockers as Novel Posttraumatic Stress Disorder (PTSD) Treatments - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please

2011 Clinical Trials

34709. A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome

by the physician (e.g. body weight, blood pressure, Low Density Lipoprotein (LDL)). [ Time Frame: up to 12 months ] after collecting all Case Record Form Description of newly occurred cardiac symptoms (e.g. troponin, LVH), as determined by routine examinations by the cardiologists, which cause a declining state of health. [ Time Frame: up to 12 months ] after collecting all Case Record Form Frequency of changes in ambulant treatment according to the acceptance of the program. [ Time Frame: up to 12 months (...) patients Criteria Inclusion Criteria: Patients hospitalized because of ACS (ST segment elevation myocardial infarction (STEMI)), non-ST elevation myocardial infarction (NSTEMI) Unstable Angina (UA)) and planned to be discharged alive soon. Exclusion Criteria: Myocardial infarction (UA, STEMI and NSTEMI) precipitated by or as a complication of surgery, trauma, or Gastrointestinal Bleeding or post- percutaneous coronary intervention (PCI). Myocardial infarction (UA, STEMI and NSTEMI) occurring

2011 Clinical Trials

34710. EG-VEGF : Potential Marker of Pre-eclampsia and / or Intrauterine Growth Restriction

, 2015 Last Verified: February 2015 Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France: EG-VEGF Endocrine Gland-derived Vascular Endothelial Growth Factor Pre-eclampsia intra-uterine growth retardation prognosis Additional relevant MeSH terms: Layout table for MeSH terms Eclampsia Pre-Eclampsia Fetal Growth Retardation Hypertension, Pregnancy-Induced Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Endothelial Growth Factors Growth (...) and will allow checking whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be proposed as prognostic marker for preeclampsia. Condition or disease Intervention/treatment Phase Pre-eclampsia Intra-uterine Growth Retardation Other: blood sample and doppler Ultrasound of uterine arteries Not Applicable Detailed Description: Successful human placentation depends on adequate transformation of the uteroplacental vasculature by extravillous trophoblast (EVT) following proliferation, migration

2011 Clinical Trials

34711. The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women

. In addition, need for additional dilation, additional pain medicine such as paracervical block, inability to place the IUD, and complications will be tracked. To determine if nitroglycerin ointment applied vaginally 30-45 minutes prior to IUD insertion is safe and well tolerated. Side effects related to treatment with nitroglycerin ointment or placebo will be compared. Blood pressure will be measured at multiple time points. Study Design Go to Layout table for study information Study Type : Interventional (...) ) or loop electrosurgical excision procedure (LEEP); contraindication to LNG-IUS (including pregnancy, fibroids that distort the uterine cavity, exam consistent with PID, allergy to any component of the LNG-IUS, etc); concurrent use of any form of nitrate therapy or medications that interact with nitroglycerin (such as phosphodiesterase V inhibitors); known allergy to nitroglycerine or common topical ointment ingredients; known renal or hepatic impairment; history of hypertensive or hypotensive disorder

2011 Clinical Trials

34712. Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

. Known allergy to fosaprepitant or any of its active components. Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months. Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free (...) provided by (Responsible Party): M.D. Anderson Cancer Center Study Details Study Description Go to Brief Summary: The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied. Fosaprepitant is designed to block

2011 Clinical Trials

34713. Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men

. Behavioral: Health Promotion Control The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans (...) , brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet). Other Name: HIV/STD Risk Reduction Intervention Active Comparator: Health Promotion Control Health Promotion Intervention was designed to increase physical activity, healthful diet, and other behaviors to reduce risk of noncommunicable diseases, including diabetes, hypertension, and cancers

2011 Clinical Trials

34714. Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild or moderate concomitant asthma is allowed. Patients will preferably be monosensitized to Phleum pratense. Polysensitized patients to other seasonal allergens will be accepted if sensitizations are caused by Pollens whose seasons do not overlap with Phleum pratense. Polysensitized patients to perennial allergens will also be accepted if not clinically relevant during the study period. Women of childbearing (...) . Patients with a previous history of anaphylaxis Patients with unstable angina Patients with uncontrolled hypertension Patients with clinically significant arrythmias Patients with neoplasia Patients with clinically relevant malformations of the upper respiratory tract. Other chronic or immunological disease that could interfere with the assessment of the investigation product or that could generate any additional risk for the patient Patients who have participated in another clinical trial within 3

2011 Clinical Trials

34715. Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

if other sensitizations are caused by seasonal allergens whose pollination do not overlap with the study period. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0 Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active Exclusion Criteria: Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion. Patients sensitised to other perennial (...) , renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study. Patients with a previous history of anaphylaxis Patients with chronic urticaria Patients with unstable angina Patients with uncontrolled hypertension Patients with clinically significant arrythmias Patients with neoplasia Patients with clinically relevant malformations of the upper respiratory tract. Other chronic or immunological disease that could interfere

2011 Clinical Trials

34716. Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML)

are qualifying for and consenting into a therapy with hypomethylating agents Patients who are eligible for and consenting into a standard chemotherapy Known central nervous system manifestation of AML Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic infiltration Known chronically active hepatitis C infection or acute hepatitis Chronically impaired renal function (creatinin clearance < 30 ml/min) Uncontrolled hypertension with a resting pressure systolic > 160 mmHg or diastolic

2011 Clinical Trials

34717. Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study

quality stereoscopic fundus photography. Intraocular pressure (IOP) of 21 mmHg or less (local anti-hypertensive medication of any duration permitted). The treating ophthalmologist should be comfortable that focal laser (direct and grid as needed) can be deferred for at least 18 weeks in the study eye, even though focal laser is indicated. Type I, or Type II diabetic subjects, of both genders, and aged 18 years. Women must be using effective contraception, be post-menopausal for at least 12 months (...) or is likely to be needed within the next 6 months. Eyes that have active PDR with high risk characteristics (HRC) as defined by the DRS: Mild neovascularization of the disc (NVD) of at least 1/3 disc area as shown in standard photograph 10A of the DRS. Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS. Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema

2011 Clinical Trials

34718. A Phase II Neo-adjuvant Study Assessing TCH (Docetaxel, Carboplatin and Trastuzumab) and TCHL (Docetaxel, Carboplatin, Trastuzumab and Lapatinib) in HER-2 Positive Breast Cancer Patients.

of self-limiting cardiac dieases (e.g. pericarditis, temporary secondary arrythmias) more than 1 year must have past prior to enrolment on the study Inflammatory bowel disease or other bowel condition causing chronic diarrhoea, requiring active therapy. Active, uncontrolled infection requiring parenteral antimicrobials or any condition requiring maintenance therapeutic (i.e. non-replacement) doses of corticosteroids. The presence of any other medical or psychiatric disorder that, in the opinion (...) these agents 14 days prior to enrolment. Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to enrolment. Pre-existing motor or sensory neurotoxicity of a severity ≥ Grade 2 by NCI-CTCAE version 4.0. Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg.) Any history of myocardial infarction, angina pectoris or congestive heart failure. Patients on current therapy for arrythmias are excluded. For other patients with a history

2011 Clinical Trials

34719. Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer

as determined by the treating physician, at time of registration. Known history of immune deficiency and be receiving combination anti-retroviral therapy Known or clinically manifest brain metastases, as progressive neurologic dysfunction may develop, that would confound the evaluation of neurologic and other adverse events. Presence of gastrointestinal disorders or abnormalities that would influence the absorption of the study drug. Presence of uncontrolled hypertension, arrhythmia, congestive heart (...) a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. Patients will be treated at either dose Level +2 or the MTD dose level of BIBF 1120 as defined by the Phase I cohort. Each cycle will be 28 days. Patients will continue treatment with the combination therapy for a total of up to 12 cycles. ECOG Performance Status 0-1 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count ≥ 1500 cells/mm3 White cell blood count ≥ 3000 cells/mm3 Hemoglobin

2011 Clinical Trials

34720. Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects

prior to the administration of the study medication) Physically and mentally healthy volunteers Exclusion Criteria: Clinically significant electrocardiographic abnormality in the opinion of the Investigator History of cardiovascular abnormalities/conditions including syncope in the 3 months preceding enrollment or any history of significant previous cardiac arrhythmia; Potassium levels outside of the normal ranges (3.5 to 5.2 mEq/L) Clinically significant deviations from normal blood pressure (BP (...) Completion Date : September 2013 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: EVP-6124 A single low dose of 8-mg EVP-6124 and A single high dose of 80-mg EVP-6124 Drug: Placebo Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2. Placebo Comparator: Placebo Cranberry juice (180 mL) Drug: EVP-6124 A single oral low dose of EVP-6124 in cranberry juice (180 mL) administered on Day 1

2011 Clinical Trials

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