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
- Pilot Study: Evaluating the effect of 300microgram testosterone patches in addition to Hormone Replacement Therapy on arterial compliance, insulin resistance and sexual desire - Testosterone Patch's effects on cardiovascular system & libido (pilot)
- Arterial compliance Insulin sensitivity Decreased sexual desire after menopause MedDRA version: 9.1 Level: LLT Classification code 10020112 Term: Hirsutism MedDRA version: 9.1 Level: LLT Classification code 10001763 Term: Alopecia, reversible br>MedDRA version: 9.1 Level: LLT Classification code 10000496 Term: Acne MedDRA version: 9.1 Level: LLT Classification code 10059294 Term: Oily skin MedDRA version: 9.1 Level: LLT Classification code 10028813 Term: Nausea MedDRA version: 9.1 Level: LLT Classification code 10040880 Term: Skin irritation
- United Kingdom
- 2009-09-04
Authorised
- Propofol and Tiopentone in paediatric sedation for fRMI study. - ND
- chirldren aged from 1 to 4 years old undergoing fMRI for convulsive crisis or delay in growth MedDRA version: 12.0 Level: LLT Classification code 10010914 Term: Convulsions
- Italy
- 2009-07-22
Authorised
- Immunomonitoring by virus-specific T cells and evaluation as a prognostic marker for virus-induced diseases after kidney transplantation
- After solid organ transplantation immunosuppressive treatment disrupts the individual balance between virus-replication and cellular immune response. This can lead to an elevated risk of severe viral complications. 1) Immunosuppressive therapy might better be steered by measuring of virus-specific T cells than by blood levels of immunosuppressants solely. 2) The antiviral treatment should be restricted to patients with high risk of viral diseases (high costs, severe side effects). MedDRA version: 19.1 Level: PT Classification code 10052279 Term: Renal and liver transplant System Organ Class: 10042613 - Surgical and medical procedures
- Germany
- 2009-07-07
Authorised
- The effect of allopurinol on carotid ultrasound intima-media thickness and markers of endothelial function in patients with recent stroke - a pilot study. - Allopurinol and Carotid Artery Wall Thickness
- Ischaemic stroke or transient ischaemic attack (TIA) (ICD Classification Code I63.0-9 and G45.0-1). MedDRA version: 9.1 Level: LLT Classification code 10061256 Term: Ischaemic stroke
- United Kingdom
- 2009-04-15
Authorised
- A 24-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with a DPP-4 inhibitor (Sitagliptin) in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone
- Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
- Austria, Czech Republic, Germany, Slovakia, United Kingdom
- 2008-10-17
Authorised
- A Phase I/II Study of HKI-272 in Combination With Vinorelbine in Subjects With Solid Tumors and Metastatic Breast Cancer.
- Solid tumors (part 1) and metastatic breast cancer (part 2). MedDRA version: 13.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Belgium, France, Netherlands, Poland, Sweden, United Kingdom
- 2008-03-13
Authorised
- Polyoma BK-virus nephropathy is a viral complication after renal transplantation attacking up to 10% of renal transplants and causing transplant failure in 45% of cases. No virustatic treatment exists. Modifying the infection is usually tried by lowering immunosuppression, which may lead to transplant failure by rejection as well. A randomized switch of immunosuppression to everolimus vs general lowering of immunosuppression has to be tested (prospect. random. parallel group comparison).
- Germany
- 2010-12-29
Authorised
- A Randomized Phase II Study Of Reirradiation And Hyperthermia Versus Reirradiation And Hyperthermia Plus Chemotherapy For Locally Recurrent Breast Cancer In Previously Irradiated Area - Rehypci
- All patients with a local regional recurrence of invasive breast cancer in previously irradiated area with measurable lesions not suitable for resection are eligible for this trial. Patients with metastases are allowed if their life expectancy is considered 1 year or more, i.e. a limited bone metastases. MedDRA version: 12.1 Level: LLT Classification code 10008456 Term: Chemotherapy single agent systemic
- Netherlands
- 2010-04-21
Authorised
- Cardioprotective effect of sevoflurane versus propofol used during anesthesia and the postoperative period in patients undergoing coronary bypass surgery. Impact on critical care unit stay. A double-blind, randomized, controlled, prospective clinical study. Efecto cardioprotector del sevoflurano frente al propofol, utilizados durante la anestesia y el periodo postoperatorio en pacientes sometidos a cirugía de bypass coronario. Repercusión sobre la estancia en la unidad de críticos. Estudio clínico, prospectivo, controlado, randomizado y doble ciego.
- This study will evaluate the cardioprotective effects of sevoflurane versus propofol during anesthesia and sedation of patients undergoing coronary bypass surgery in terms of maintenance of cardiac function and reduction of stay in these units. Secondary Objectives: 1. To compare the possible advantages and disadvantages of both regimens in terms of preservation/improvement or pulmonary, hepatic and renal side effects. MedDRA version: 8.1 Level: LLT Classification code 10002323 Term: Anesthesia general
- Spain
- 2010-03-05
Authorised
- Efficacité de la rapamycine topique dans le traitement des lichens érosifs chroniques de la muqueuse buccale:Etude en double aveugle randomisée rapamycine vs corticoïdes - RALIB
- Patients atteints de lichen buccal érosif depuis plus de 6 semaines vus en consultation spécialisée dans des hôpitaux universitaires. Comparer l’effet de deux stratégies thérapeutiques, (1) rapamycine topique versus (2) corticoïdes topiques, sur la mise en rémission complète du lichen érosif après 3 mois de traitement chez des personnes atteintes d'un lichen plan érosif de 18 à 85 ans suivies en consultation. MedDRA version: 9.1 Level: LLT Classification code 10030983 Term: Oral lichen planus
- France
- 2007-03-26
Authorised
- Therapy for metastatic colorectal cancer
- This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in mCRC. MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000016864 ;Therapeutic area: Diseases [C] - Cancer [C04]
- Austria
- 2011-12-06
Authorised
- A phase I/II multicentric Belgian prospective novel sequential chemo-immunotherapy regimen for adjuvant treatment in non-muscle invasive bladder cancer. - Novel chemo-immunotherapy for non-muscle invasive bladder cancer
- Patients with intermediate/high risk non-muscle invasive bladder cancer (NMIBC) • intermediate risk tumours – Ta, T1 Grade 1, Grade 2, multifocal and tumours larger than 3 cm • high risk tumours – T1, Grade 3, multifocal or highly recurrent tumours and all cases of CIS (Carcinoma in situ) MedDRA version: 14.1 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Belgium
- 2011-02-11
Authorised
- A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD).
- Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis) MedDRA version: 19.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Germany
- 2016-03-14
Authorised
- Liraglutide for obese patients with knee osteoarthritis
- Adult (= 18 years of age) overweight or obese patients (BMI = 27 kg/m2 ) above 18 years of age with knee osteoarthritis (OA) defined by clinical diagnosis of knee OA according to the American College of Rheumatology (ACR) criteria confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3) MedDRA version: 19.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 19.0 Level: LLT Classification code 10029885 Term: Obesity, unspecified System Organ Class: 100000004861 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Denmark
- 2016-03-02
Authorised
- Therapy withdrawal in REcovered DCM – TRED
- Dilated Cardiomyopathy with recovered cardiac function MedDRA version: 18.1 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- United Kingdom
- 2016-01-19
Authorised
- A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone
- Paediatric cancer patients (aged 1 to <18 years) with Ewing’s sarcoma/soft tissue sarcoma, lymphoma, neuroblastoma and all other malignancies (excluding leukaemia) who are planned to undergo high dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HSCT) rescue;Therapeutic area: Diseases [C] - Cancer [C04]
- Belgium, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom
- 2010-07-19
Authorised
- A 24-week study to evaluate the effect of dapagliflozin (10 mg once daily) plus exenatide (2.0 mg once weekly) on type 2 diabetic patients awaiting for bariatric surgery.
- Type 2 Diabetes mellitus MedDRA version: 20.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 100000004861 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Spain
- 2017-06-22
Authorised
- Phase 4 clinical trial to evaluate the effect on immune recovery of antiretroviral treatment of three drugs versus two in in HIV-infected patients but not dectactable in blood.
- Adult patients with HIV infection on stable therapy (= 6 months) with triple therapy and undetectable viremia for = 1 year. MedDRA version: 19.1 Level: LLT Classification code 10049838 Term: HIV viral load undetectable System Organ Class: 100000004848 MedDRA version: 19.1 Level: PT Classification code 10077716 Term: HIV viraemia System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Not possible to specify
- Spain
- 2017-01-25
Authorised
- A Phase 2a Study To Investigate The Effects of Repeated Administration of AeroDerm in subjects with Atopic Eczema.
- Atopic Eczema: a chronic inflammatory pruritic skin disease that follows a relapsing course and is often associated with elevated serum immunoglobulin E (IgE) levels and a personal or family history of allergies, allergic rhinitis and asthma. It is thought that atopic eczema results from an overactivity of T helper 2 (Th2) lymphocytes and down-regulation of T helper 1 (Th1) activity.
- United Kingdom
- 2005-05-27
Authorised
- Protocol for taking pharmacogenetic testing of tacrolimus into the clinical arena: patient tailored anti-rejection therapy
- The study is to determine whether MDR-1 genotyping correlates with tacrolimus dose in individual patients and could therefore be used in future to predict tacrolimus dose. All patients will have undergone or be about to undergo a kidney transplant and require treatment with tacrolimus immunosuppression. MedDRA version: 8.1 Level: LLT Classification code 10021510 Term: Immunosuppression NOS
- United Kingdom
- 2006-12-21
