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Thromboembolic Disease in Pregnancy

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3761. Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch

. Effective post-operative analgesia is an important component with regards to patient satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of thromboembolic disease in patients undergoing total knee or total hip replacement when compared with general anesthesia. Post-operatively, regional anesthesia has been shown to reduce pain scores and/or morphine consumption as well as opioid (...) colonization rates. Condition or disease Intervention/treatment Phase Catheter Infections Spinal Catheter (Epidural) (Subdural); Complications, Infection or Inflammation Device: Chlorhexidine impregnated patch (Biopatch) Phase 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention Official Title: Prospective

2011 Clinical Trials

3762. Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

disorders Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism Active sepsis Undefined coma status In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min Pregnancy or lactation Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer (...) has on immune function. Condition or disease Intervention/treatment Phase Cancer Hepatic Injury Drug: Omegaven Phase 2 Detailed Description: This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3

2011 Clinical Trials

3763. A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors

of a CNS disease No history of allergic reactions to compounds of similar chemical or biologic composition Not HIV positive No women who are pregnant or nursing A negative serum pregnancy test if female Patients, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study No history of significant renal, endocrinologic, metabolic, immunologic or hepatic disease No evidence of psychiatric illness/social situations Other illness (...) with gemcitabine. The clinical benefit, progression-free survival and overall survival of study participants will also be assessed. Condition or disease Intervention/treatment Phase Locally Advanced Malignant Neoplasm Malignant Solid Tumour Biological: ALT-836 in combination with gemcitabine Phase 1 Detailed Description: Tissue Factor (TF) is over-expressed in most cancer types. Results from many recent studies have suggested a key role for TF in the development of cancer-associated thrombosis, tumor growth

2011 Clinical Trials

3764. Tranexamic Acid in Hip Fracture Patients

Center Information provided by (Responsible Party): Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center Study Details Study Description Go to Brief Summary: This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture. Condition or disease Intervention/treatment Phase Closed Fracture of Hip Drug: Tranexamic acid Not Applicable Detailed Description: transfusion of allogeneic RBC's is not free of adverse events and has been (...) group Outcome Measures Go to Primary Outcome Measures : Total amount of blood loss per patient from admission to day 5 post-op [ Time Frame: 5 DAYS ] Secondary Outcome Measures : Number of packed cell transfusion per patient. [ Time Frame: 5 DAYS ] Initial functional outcome and feeling of well-being. [ Time Frame: 5 days ] thromboembolic events [ Time Frame: 5 days ] post-operative bacterial infection [ Time Frame: 5 days ] 30 day mortality rate [ Time Frame: 30 days ] Eligibility Criteria Go

2011 Clinical Trials

3765. Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects

or abutting large blood vessels Any history of thromboembolic events Ongoing therapy with oral or parenteral anticoagulants Major surgery within 4 weeks of Day 1 of treatment Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease) any history of significant vascular disease Congestive heart failure History of any condition requiring anti-platelet therapy Serious non healing wound Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis Unable or unwilling (...) untreated stage IV non-squamous non-small cell lung cancer (NSCLC). Condition or disease Intervention/treatment Phase Non Small Cell Lung Cancer (NSCLC) Drug: Bavituximab Phase 1 Detailed Description: Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated. Study Design Go to Layout

2011 Clinical Trials

3766. NG-Nitro-L-Arginine in Treating Patients With Advanced Solid Tumors

aortic aneurism, previous aortic dissection, or connective tissue disease resulting in thoracic aortic dilation, such as Marfan syndrome) No current hypertension, defined as BP consistently greater than 140/90 mm Hg or the requirement for anti-hypertensive drug treatment No history of thromboembolic disease or platelet/clotting disorders No history of cerebrovascular disease (e.g., transient ischemic attack or stroke) No clinically significant history of renal or hepatic impairment No diabetes (...) Research UK Study Details Study Description Go to Brief Summary: RATIONALE: NG-nitro-L-arginine may stop the growth of tumor cells by disrupting blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of NG-nitro-L-arginine in treating patients with advanced solid tumors. Condition or disease Intervention/treatment Phase Unspecified Adult Solid Tumor, Protocol Specific Drug: NG-nitro-L-arginine Other: laboratory biomarker analysis Other: pharmacological study

2011 Clinical Trials

3767. BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer

. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug. History of clinical symptoms of brain metastases. Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months. Known inherited or acquired bleeding disorder. Significant cardiovascular diseases. Serious infections in particular if requiring systemic antibiotic (...) (antimicrobial, antifungal) or antiviral therapy. Other malignancy diagnosed within the past 5 years. Known serious illness or concomitant non-oncological disease. Patients unable to comply with the protocol. Patients with preserved reproductive capacity who are sexually active and unwilling to use a medically acceptable method of contraception. Pregnancy or breast feeding. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may

2011 Clinical Trials

3768. Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia

Transfusion in the last 30 days prior to baseline visit Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit Increased risk of thromboembolic disease Radiotherapy in pelvis or spine in the last 60 days Myelodysplasic syndrome History of congestive heart failure Pregnant or lactating Patient with known allergy to human albumin or related products Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your (...) Sidus SA Study Details Study Description Go to Brief Summary: The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy. Condition or disease Intervention/treatment Phase Antineoplastic Chemotherapy Induced Anemia Biological: Epoetin alfa Phase 4 Detailed Description: Patients with non curable solid tumors

2011 Clinical Trials

3769. Ruxolitinib and Lenalidomide for Patients With Myelofibrosis

the informed consent form. Suspected Pregnancy, Pregnant or lactating females. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. Known positive for HIV or infectious hepatitis, type A, B or C. Known prior clinically relevant hypersensitivity to prednisone. Participants with prior history of thromboembolic disease (i.e. deep venous thrombosis (...) interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Condition or disease Intervention/treatment Phase Myeloproliferative Diseases Drug: Ruxolitinib Drug: Lenalidomide Drug: Prednisone Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 34 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment

2011 Clinical Trials

3770. A Study of LY2216684 in Healthy Females

: This study involves a single dose of 18 milligrams (mg) LY2216684 taken as 1 or 2 tablets by mouth. The study will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive Ortho Cyclen®. This study will run approximately 93 days. Condition or disease Intervention/treatment Phase Depressive Disorder, Major Drug: LY2216684 Drug: Ortho Cyclen Drug: Placebo Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 20 (...) of enrollment to this study or topical controlled delivery contraceptives (patch) for 3 months prior to enrollment into this study The history or presence of any contraindications to the combined oral contraceptive tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected) Participants determined

2011 Clinical Trials

3771. Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants. Tissue ischemia in the area to be treated. Suffering from concurrent conditions such as liver or kidney disorders, Hypertension or abnormally high blood pressure. High cholesterol and/or diabetes. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.). Epilepsy. Tuberculosis. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis (...) . Study Details Study Description Go to Brief Summary: Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. The study is only to observe the patients before, during and after their usual treatment. Condition or disease Intervention/treatment Patients Treated With VaserShape MC1 Device: VASERShape MC1 Study Design Go

2011 Clinical Trials

3772. Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

noncontiguous stage II mantle cell lymphoma stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma Additional relevant MeSH terms: Layout table for MeSH terms Lymphoma Lymphoma, Mantle-Cell Neurotoxicity Syndromes Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Nervous System Diseases Poisoning Chemically-Induced Disorders Rituximab Lenalidomide Bortezomib (...) mL/min Women (sexually mature female) must not be pregnant or breast-feeding Negative pregnancy test Women of childbearing potential and sexually active males use an accepted and effective method of contraception Men must agree to use a latex condom during sexual contact with a female of child-bearing potential, even if they have had a successful vasectomy All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure No evidence of prior

2011 Clinical Trials

3773. Liposome-encapsulated Irinotecan Hydrochloride PEP02 or Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil as Second-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

an in-range INR. Serum creatinine less than 150 micromol per L Calculated creatinine clearance greater than 30 mL per min Total bilirubin less than 1.5 times upper limit of normal Proteinuria less than 2 plus (dipstick urinalysis) or less than 1 g per 24 hours. Negative serum pregnancy test Not pregnant or nursing Fertile patients must use effective contraception No severe arterial thromboembolic events within the past 6 months, including myocardial infarction and stroke No baseline diarrhea greater than (...) cancer. Condition or disease Intervention/treatment Phase Colorectal Cancer Drug: FOLFIRI 1-Bevacizumab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: liposome-encapsulated irinotecan hydrochloride PEP02 Drug: Bevacizumab Phase 2 Detailed Description: OBJECTIVES: Primary To evaluate the objective response rates (complete response and partial response) in patients with metastatic colorectal cancer treated with liposome-encapsulated irinotecan hydrochloride PEP02

2011 Clinical Trials

3774. Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit. Condition or disease Intervention/treatment Phase Uterine Fibroids Procedure: MR Guided Focused Ultrasound Procedure: Placebo MR Guided Focused Ultrasound Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 20 participants Allocation: Randomized Intervention (...) Volunteers: No Criteria Inclusion Criteria: Age>18 years Premenopausal Symptomatic fibroids Fibroids accessible for focused ultrasound treatment Exclusion criteria: Desires future fertility Current pregnancy Hematocrit <30% Emergency room visit in last 3 months for fibroid symptoms History of venous thromboembolism Fibroids that are: >10cm, non-enhancing with contrast Adenomyosis Contraindications to undergoing MRI Unexplained menstrual irregularity Contacts and Locations Go to Information from

2011 Clinical Trials

3775. North American Study of Epistaxis in HHT

International Information provided by (Responsible Party): James Gossage, Augusta University Study Details Study Description Go to Brief Summary: The purpose of the NOSE Study is to carefully examine the efficacy and safety of 3 nasal sprays (bevacizumab, estriol, and tranexamic acid), compared to placebo, for the treatment of HHT related nosebleeds. Condition or disease Intervention/treatment Phase Telangiectasia, Hereditary Hemorrhagic Epistaxis Drug: Sterile saline Drug: Bevacizumab Drug: Estriol Drug (...) Telangiectasia, Hereditary Hemorrhagic Vascular Diseases Cardiovascular Diseases Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Hemorrhage Pathologic Processes Signs and Symptoms, Respiratory Signs and Symptoms Hemostatic Disorders Hemorrhagic Disorders Hematologic Diseases Vascular Malformations Cardiovascular Abnormalities Congenital Abnormalities Bevacizumab Endothelial Growth Factors Tranexamic Acid Estrogens Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis

2011 Clinical Trials

3776. Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)

in previously untreated and elderly patients (> 60 years) with CLL: a non-comparative phase aimed at defining the MTD of lenalidomide given in combination with chlorambucil and the efficacy and safety of the lenalidomide and chlorambucil combination. Condition or disease Intervention/treatment Phase Chronic Lymphocytic Leukemia Drug: Lenalidomide; Chlorambucil Phase 1 Phase 2 Detailed Description: All patients will receive six monthly courses of the chlorambucil (C) and lenalidomide (L) schedule consisting (...) discontinuation. Male patients must: Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a female of childbearing potential. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. If pregnancy or a positive

2011 Clinical Trials

3777. Safety Study of the Angelâ„¢ Catheter in Subjects With Risk of Pulmonary Embolism

or major bleeding . Condition or disease Intervention/treatment Phase Pulmonary Embolism Deep Vein Thrombosis Venous Thromboembolism Device: Angel Catheter Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 8 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention Official Title: A Single Treatment, Open Label, Multicenter, Safety Study of the Angel™ Catheter (...) of PE that require but are contraindicated for anticoagulation prophylaxis and will benefit from a temporary filter and a central venous access catheter Patients who had recently undergone or are about to undergo a surgical procedure that requires temporary interruption of anticoagulation for Venous Thromboembolism (VTE) and will benefit from a temporary vena cava filter and central Exclusion Criteria: Patient is less than 18 years Patient is pregnant or has a positive serum human chorionic

2011 Clinical Trials

3778. Fresolimumab and Radiotherapy in Metastatic Breast Cancer

, Los Angeles Information provided by (Responsible Party): Weill Medical College of Cornell University Study Details Study Description Go to Brief Summary: The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression. Condition or disease Intervention/treatment Phase Metastatic Breast Cancer Drug: Fresolimumab Radiation: Radiation Therapy Phase 2 Study Design Go to Layout table for study information Study Type (...) corticosteroids are allowed (if therapy is <5 days and is limited to systemic steroids as antiemetics); Cyclosporine A, tacrolimus, or sirolimus. Investigational agents within 4 weeks prior to study enrollment (≥6 weeks if treatment was long-acting agent such as monoclonal antibody). Significant or uncontrolled medical illness, e.g. congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary

2011 Clinical Trials

3779. Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid

pressure, and body weight at each study visit. Condition or disease Intervention/treatment Phase Smoking Cessation Drug: X-22 Smoking Cessation Product Drug: Active Control Cigarettes Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 216 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment (...) , or other significant pulmonary diseases. Controlled hypertensive subjects and mild asthmatics whose disease is controlled only with an as-needed inhaled beta agonist are acceptable. Subjects with a history of cancer within the past 60 months other than basal cell carcinoma. Subjects with a history of thromboembolic disease or taking warfin or any other anticoagulant, or anti-platelet drug such as clopidogrel (Plavix®) or pentoxifylline (Trental®). Low dose aspirin therapy is acceptable. Subjects

2011 Clinical Trials

3780. HAART Model 300 Annuloplasty Ring

: This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame Condition or disease Intervention/treatment Phase Aortic Regurgitation Device: HAART 300 Annuloplasty Device Not Applicable Detailed Description: Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely (...) heart block Structural device failure Endocarditis Periprosthetic leak or dehiscence Thromboembolism Bleeding Event Native Valve Deterioration Valve Thrombosis Hemolysis Reoperation and explant at 2 years Event-free Survival [ Time Frame: 6 months postprocedure ] Event-free survival is defined as survival free from device-related death New York Heart Association (NYHA) Functional Capacity Classification [ Time Frame: 6 months postprocedure ] Four classes describing the effect of cardiac disease

2011 Clinical Trials

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