海外の治験の状況「1」での検索結果
2039件の検索結果
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Authorised
- The effect of reduced corticosteroid therapy in patients with acute exacerbation of COPD
- 1) Whether a reduction of the dose systemic corticosteroids (SC) therapy in patients with acute exacerbation of COPD(AE-COPD) - compared with AE-COPD patients in the standard treatment- leading to non-inferiority 2)Whether there is a difference in treatment response in AE-COPD patients with eosinophilic airway inflammation compared to AE-COPD patients with non-eosinophilic airway inflammation 3) whether a lower accumulated dose SC may be associated with fewer corticosteroid adverse events MedDRA version: 20.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Denmark
- 2015-09-14
Authorised
- An Extension Study in Patients with Moderate or Severe Hemophilia A or B who have Participated in a Previous Clinical Study with ALN-AT3SC
- Hemophilia A or Hemophilia B MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Bulgaria, Russian Federation, Switzerland, United Kingdom, United States
- 2015-07-17
Authorised
- Study to compare efficacy of two strategies of rituximab administration du rituximab (rituximab sub cutaneous versus rituximab intravenous) in patients with previously untreated follicular lymphoma.
- Stage II-IV follicular lymphoma grade 1-3a not previously treated MedDRA version: 17.1 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- France
- 2015-01-07
Authorised
- Desmopressin and FVIII concentrate combination treatment in non-severe hemophilia A patients undergoing minor interventions
- Hemophilia A MedDRA version: 19.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 19.0 Level: LLT Classification code 10053753 Term: Hemophilia A without inhibitors System Organ Class: 100000004850 MedDRA version: 19.0 Level: LLT Classification code 10060612 Term: Hemophilia A System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Netherlands
- 2016-12-19
Authorised
- A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
- Patients with relapsed or refractory CD20+ follicular non-Hodgkin’s lymphoma (NHL) Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström’s macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma), according to the WHO classification system. MedDRA version: 20.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000013103 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Albania, Argentina, Austria, Brazil, Bulgaria, Canada, Colombia, Ecuador, Egypt, France, Germany, Greece, Hungary, Italy, Lithuania, Norway, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom
- 2011-07-05
Authorised
- A Study of fitusiran (ALN-AT3SC) in hemophilia A and B patients with inhibitors
- Hemophilia A or Hemophilia B MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Australia, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Portugal, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
- 2017-08-03
Authorised
- A study of fitusiran (ALN-AT3SC) in hemophilia A and B patients without inhibitors
- Hemophilia A or Hemophilia B MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Australia, Bulgaria, Canada, China, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Portugal, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
- 2017-07-10
Authorised
- A Study of fitusiran (ALN-AT3SC) in hemophilia A and B patients with inhibitors
- Hemophilia A or Hemophilia B MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Australia, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Portugal, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
- 2017-07-07
Authorised
- A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients with Inhibitors
- Haemophilia A with inhibitors Haemophilia B with inhibitors MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053752 Term: Hemophilia B with anti factor IX System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Austria, Canada, Croatia, Denmark, European Union, Greece, Israel, Japan, Malaysia, Spain, Sweden, Ukraine, United States
- 2017-06-02
Authorised
- Immune Therapy in Combination with Checkpoint Inhibitor Treatment
- Unresectable, Stage III or Stage IV metastatic melanoma who are either previously untreated (cohort A), or whose disease has progressed during PD-1 blockade (cohort B). MedDRA version: 20.0 Level: PT Classification code 10028980 Term: Neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- United Kingdom
- 2018-04-19
Authorised
- A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIA
- Beta-thalassemia major (TM) or Diamond Blackfan anemia (DBA) or myelodysplastic syndromes (MDS) (low and INT-1 risk as per the IPSS for MDS) or sideroblastic anemia and myocardial iron overload as indicated by a T2* =6 but not greater than 20 ms, with no symptoms of cardiac dysfunction, and an MRI measured LVEF =56%.
- Italy, United Kingdom
- 2007-12-13
Authorised
- A multiple ascending dose study to evaluate the safety, tolerability and effect on tumor response of the mTOR inhibitor (RAD001) in combination with the IGF-1R antagonist (R1507) in patients with advanced solid tumors
- PIb: solid malignancy that is metastatic or unresectable PII: C 1: Advanced metastatic renal cell carcinoma C 2: Advanced low- to intermediate grade metastatic or unresectable locoregional pancreatic neuroendocrine tumors + carcinoid tumors MedDRA version: 9.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma MedDRA version: 9.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor MedDRA version: 9.1 Level: LLT Classification code 10052399 Term: Neuroendocrine tumour MedDRA version: 9.1 Level: LLT Classification code 10026664 Term: Malignant pancreatic islet neoplasm
- France
- 2009-08-06
Authorised
- Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- For the treatment of patients with B-cell chronic lymphocytic leukemia who have failed at least 1 prior therapy MedDRA version: 20.0 Level: LLT Classification code 10003946 Term: B-Lymphocytic, CLL (Kiel Classification) System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Canada, France, Germany, Italy, Spain, Sweden, United Kingdom, United States
- 2009-07-31
Authorised
- A survey on the success of inhibitor elimination using individualized concentrate selection and controlled immune tolerance induction - OBSITI
- patients with haemophilia A MedDRA version: 9.1 Level: LLT Classification code 10018937 Term: Haemophilia A MedDRA version: 9.1 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) MedDRA version: 9.1 Level: LLT Classification code 10056492 Term: Haemophilia A with anti factor VIII
- France
- 2009-04-03
Authorised
- 'To assess the role of an early intensification of 2 AML induction blocks versus protocol Ib directly after induction in randomized MR & HR patients'
- acute lymphoblastic leukemia (including acute biphenotypic leukemia) in infants 1 year of age MedDRA version: 14.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Austria, Belgium, Denmark, France, Germany, Italy, Portugal, United Kingdom
- 2007-10-17
Authorised
- A trial comparing chemotherapy and bevacizumab or lapatinib with chemotherapy alone for cancer of the stomach, oesophagus or the junction of the stomach and oesophagus
- Patients with histologically verfied lower oesophageal, Siewert Type I, II or III oesophagogastric junction or gastric adenocarcinoma. Type III or gastric tumours should be stage 1b (T1N1, T2a/bN0), II,III or stage IV (T4 N1orN2 M0). Lower oesophageal, Type I and II tumours should be stage II to stage IVa (T1N1, T2N1, T3N0-1, but not T2N0). T4 tumours are eligible if they involve the crura or invade the mediatinal pleural only. The tumour should be operable MedDRA version: 18.0 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- United Kingdom
- 2007-01-07
Authorised
- Gene therapy for patients with Junctional Epidermolysis Bullosa (JEB)
- JEB is genetically and clinically heterogeneous characterized by mutations in COL17A1,encoding for Collagen17 protein. COLXVII is a collagenous transmembrane type II protein component of the hemidesmosomes and plays a key role in the adhesion of epidermis to the basement membrane. JEB is characterized by a wide range of severity: skin blistering, which can be generalized or localized, different degrees of mucosal involvement, enamel defects, dystrophy or loss of nails, and alopecia can occur.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Austria
- 2017-06-07
Authorised
- Wound catheter infusion after abdominal surgery in baby's.
- Children 1 year of age undergoing major open abdominal surgery. MedDRA version: 20.1 Level: PT Classification code 10021298 Term: Ileal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10010526 Term: Congenital large intestinal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10002120 Term: Anal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10010626 Term: Congenital small intestinal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10062022 Term: Intestinal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10013812 Term: Duodenal atresia System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10028210 Term: Multiple gastrointestinal atresias System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Netherlands
- 2017-04-12
Authorised
- The efficacy of intravenous versus rectal paracetamol: A randomized, prospective, double-blind placebo-controlled study
- Aims of the study 1)to compare the analgesic efficacy of intravenous versus rectal paracetamol versus placebo as assessed by VAS scores and PCA morphine consumption. 2)To assess the pharmacokinetic profile of intravenous and rectal paracetamol by intravenous plasma paracetamol concentrations.
- Netherlands
- 2006-09-01
Authorised
- The effect of milk thistle extract (Legalon) versus tea on serum iron increase after a meal containing non-haem iron in hereditary haemochromatosis - Dietary management of hereditary haemochromatosis: A pilot study
- Type 1 hereditary haemochromatosis is associated with homozygous inheritance of the C282Y mutation in the HFE gene. The phenotype is characterised by increased serum iron levels, tissue iron accumulation and may result in liver fibrosis, cirrhosis, and liver carcinomas. Treatment initially involves removal of one unit of blood per week to remove body iron burden, then removal of one unit of blood 2-6 times per year to prevent the re-accumualtion of iron stores. MedDRA version: 8.1 Level: LLT Classification code 10057873 Term: Hereditary haemochromatosis
- United Kingdom
- 2006-07-23