海外の治験の状況「1」での検索結果
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Authorised
- We’re planning a large multicentre controlled randomized trial to demonstrate that volatile anesthetics vs TIVA can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass) and 30 days after surgery (co-primary endpoint) in patients undergoing coronary artery bypass grafting
- PATIENTS UNDERGOING CORONARY ARTERY BYOASS GRAFT SURGERY;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Belgium, Italy
- 2014-01-27
Authorised
- A Phase 1/3 Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma
- Advanced Follicular Lymphoma MedDRA version: 20.0 Level: PT Classification code 10016910 Term: Follicle centre lymphoma, follicular grade I, II, III stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016909 Term: Follicle centre lymphoma, follicular grade I, II, III stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- Belarus, Brazil, Bulgaria, Chile, Georgia, Greece, India, Italy, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Turkey, Ukraine
- 2014-01-22
Authorised
- A Phase II Study of Dose Density Regimen with Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days with Filgrastim Support followed by Weekly Paclitaxel in Women with Primary Breast Cancer. - ND
- Patients with primary breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006187
- Italy
- 2010-07-26
Authorised
- Evaluation of post-operative pain relief for local anaesthetic (LA) 0.5% Bupivacaine is administered to a patient prior to the closure of surgical wound for a distal forearm fracture using: Method 1. Injection of LA subcutaneously around the wound site, prior to wound closure, while the patient is under a general anaesthetic. or Method 2. Percolation of LA directly into wound cavity, prior to wound closure, while the patient is under a general anaesthetic. No needle used
- Fracture of distal radius or ulna;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Ireland
- 2015-03-05
Authorised
- NOR-SASS is a multi-centre PROBE (prospective randomised, open-label, blinded endpoint) trial, designed to establish the superiority of contrast-enhanced sonothrombolysis given within 4½ hours after stroke onset in consecutively admitted patients with acute ischaemic stroke, as compared with 1) standard iv thrombolysis with tenecteplase (TNK) or alteplase (tPA), and 2) no specific treatment in patients not eligible for thrombolytic treatment.
- All patients found eligible for thrombolysis may enter the thrombolysis-arm (NOR-SASS I), all patients with contraindications to thrombolysis within the 4 ½ hour time window may enter the no-thrombolysis-arm (NOR-SASS II). MedDRA version: 14.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Norway
- 2012-04-02
Authorised
- R-CHOP-14 or R-CHOP-21 & consolidation PET–oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)
- Patient with diffuse large B cell lymphoma (DLBCL) with low risk profile according to age-adjusted IPI (0 with bulky or 1) MedDRA version: 17.1 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Italy
- 2012-03-07
Authorised
- First therapy of patients suffering from advanced follicular lymphoma who are not in the state of health for the standard immunochemotherapy. It is a forward-looking comparison of two therapy schemes wherein the patients are assigned to the particular test group (arm) according to a special mathematical based principle. In arm 1 only GA 101 and in arm 2 GA 101 and Bendamustin is administered. After the initial therapy only GA 101 is given in both arms.
- Comparison of the effectiveness of GA 101 versus GA 101 plus Bendamustin, followed by GA 101 in medically non-fit patients as first line therapy of advanced stage follicular lymphoma MedDRA version: 20.0 Level: PT Classification code 10016908 Term: Follicle centre lymphoma, follicular grade I, II, III stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016910 Term: Follicle centre lymphoma, follicular grade I, II, III stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016909 Term: Follicle centre lymphoma, follicular grade I, II, III stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- Germany
- 2016-07-07
Authorised
- A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib vs. Placebo with Cabozantinib in Patients with Advanced or Metastatic Renal Cell Carcinoma. Randomized means allocation to CB-839 or a placebo isde termined by chance. 1 out of every 2 patients will get CB-839. Double-blinded means that neither the participant nor investigator knows what group the patient is assigned to. Every patient on study will get cabozantinib.
- Advanced or metastatic clear-cell renal cell carcinoma;Therapeutic area: Diseases [C] - Cancer [C04]
- Australia, France, Germany, Italy, New Zealand, Spain, United Kingdom, United States
- 2018-05-21
Authorised
- An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects =1 and =30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10066109 Term: Precursor B-lymphoblastic leukemia acute System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10066110 Term: T-cell lymphoblastic leukemia acute System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
- Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
- 2018-02-14
Authorised
- An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate - A PK study on Optivate in patients with von Willebrands Disease
- von Willebrands Disease
- United Kingdom
- 2008-02-22
Authorised
- Estudio doble ciego, aleatorizado, controlado con placebo de dosis escaladas de deferoxamina intravenosa en pacientes con ictus isquémico agudo tratado con activador tisular del plasminógeno. Double-blind, randomized, placebo controlled, dose-finding phase II clinical trial of intravenous deferoxamine in patients with acute ischemic stroke treated with tissue plasminogen activator. - tandem-1
- La deferoxamina es un neuroprotector en modelos animales de isquemia/reperfusión cerebral. Si la deferoxamina es segura y bien tolerada en pacientes con ictus agudo puede significar una nueva estrategia terapéutica en la isquemia/reperfusión cerebral. Deferoxamine is neuroprotective in ischemia/reperfusion animal models. If deferoxamine demonstrate to be secure and well tolerated in acute stroke patients, it may be a new therapy after ischemia and reperfusion. MedDRA version: 9.1 Level: LLT Classification code 10027580 Term: Middle cerebral artery stroke
- Spain
- 2008-01-28
Authorised
- Multicenter randomized, double blind, 3 parallel arms, controlled trial of the clinical efficacy of topical 'Diclofenac 1%, gel' (diclofenac diethylamine 1.16%) for the treatment of osteoarthritis of the knee: equivalence of Generic product versus the Reference product and superiority versus placebo. - NA
- Patient présentant une ostéorthrose douloureuse d'au moins un des genoux. MedDRA version: 12.0 Level: LLT Classification code 10031165 Term: Osteoarthritis knee
- France
- 2009-08-17
Authorised
- Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure
- heart failure associated with impaired glucose tolerance or type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10019279 Term: Heart failure
- Netherlands, United Kingdom
- 2009-07-20
Authorised
- CeCil: A randomized, non-comparative phase II clinical trial of the effect of radiation therapy plus Temozolomide combined with Cilengitide or Cetuximab on the 1-year overall survival of patients with newly diagnosed MGMT-promoter unmethylated glioblastoma. - CeCil
- Subjects with newly diagnosed glioblastoma, who have met all eligibility criteria for the CENTRIC study (EMD 121974-011 study, EudraCT 2007-004344-78) with the exception of NOT having a tumor with a methylated MGMT-promoter will be invited for participation in the present CeCil trial. Documentation of the MGMT promoter methylation status will be obtained from the test result from the screening phase of the Phase III CENTRIC study (EMD 121974-011). MedDRA version: 12.0 Level: LLT Classification code 10018336 Term: Glioblastoma
- Belgium
- 2009-07-13
Authorised
- Evaluation of the effects of pegylated-proline-Interferon-alpha-2b (AOP2014) added to the best available therapy based on phlebotomies in low-risk patients with Polycythemia Vera (PV), who are younger than 60 and who have never experienced thrombosis.
- Polycythemia Vera MedDRA version: 20.0 Level: LLT Classification code 10036061 Term: Polycythemia vera System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Italy
- 2017-05-19
Authorised
- An extension to a phase II study to determine the efficacy and the safety of STI571 in patients with chronic myeloid leukemia who are refractory to or intolerant of interferon-alpha
- treatment of patients with CML who are refractory to or intolerant of interferon alpha. br>MedDRA version: 14.1 Level: LLT Classification code 10052065 Term: Chronic phase chronic myeloid leukaemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
- Italy
- 2005-06-22
Authorised
- Treatment Strategies in Patients with Type 2 Diabetes Mellitus Not Achieving Glycemic Control while on Therapy with Premixed Insulin Analogues and Metformin: A Comparison of Insulin Lispro MM Intensive Mixture Therapy with Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70 - S019
- Type 2 Diabetes Mellitus MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
- Hungary
- 2006-07-27
Authorised
- RAPSODY - RANDOMIZED, PROSPECTIVE TRIAL OF TWO SCHEDULES OF SORAFENIB 800 mg DAILY AND INTERFERON ALPHA IN METASTATIC RENAL CELL CARCINOMA MRCC A GOIRC PHASE II STUDY - RAPSODY
- Patients with histologically- or cytologically-confirmed, metastatic, clear cell renal cell cancer RCC MedDRA version: 6.1 Level: PT Classification code 10050513
- Italy
- 2006-02-17
Authorised
- Long term impact of renin angiotensin system RAS inhibition on cardiorenal outcomes. A randomized controlled trial of cardio-renal effects of RAS inhibition in patients with cardio-renal risk. A comparative trial of Angiotensin Converting Enzyme ACE inhibitors, angiotensin receptor blockers or combined therapy with both agents in patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic. - LIRICO Long term Impact of Renin angiotensin system RAS Inhibition on Cardiorenal Outcomes
- Patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic. MedDRA version: 9.1 Level: LLT Classification code 10027525 Term: Microalbuminuria
- Italy
- 2007-04-06
Authorised
- Evaluation of additional intraocular pressure reduction with once daily, evening administration of travoprost 0.004%, once daily, evening administration of travoprost 0.004%/timolol 0.5% fixed combination and once daily, evening administration of travoprost 0.004%/timolol 0.5% fixed combination plus twice daily brinzolamide 1% in open angle glaucoma
- Open-angle glaucoma
- Hungary
- 2007-03-21