There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)
To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.
To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).
The purpose of this study is to determine the clinical effectiveness and cost-effectiveness of a written expert advice for GPs on additional diagnostic, treatment, and referral of patients based on half-yearly monitoring routines for patients with COPD or ashtma with a persistent obstruction in primary care based on a multicentre randomised nested clinical trial
For the administration of insulin, different needles are available with a length from 5 to 12.7mm. Insulin injections with a needle of 8 mm is injected in a lifted skinfold, a 5 mm needle can by used without lifting a skinfold (1). In the Netherlands obese people (BMI ≥ 30) are usually advised to use an 8mm or even longer needle (1). Increased BMI and the thickness of the subcutaneous tissue slow insulin absorption (2, 3, 4), possibly related to reduced subcutaneous blood flow. Furthermore, the capillaries are located just under the skin and between the fat and muscle layer. This could possibly determine the absorbing speed (2). It is not know if the administration of insulin with a 5mm needle by obese people has a different influence on the HbA1c compared to longer needles. The hypothesis of this study is that for the purpose of insulin injections, a 5 mm needle can be used without negative effects on metabolic parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index (BMI) ≥ 30.
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.
Rationale: Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (wire guided localization [WGL]) is difficult to perform and has a high rate of tumour positive margins in the resected specimen, requiring a second operation. A new approach in the localization and resection of non-palpable malignant breast lesions is 'radio guided occult lesion localization' (ROLL). ROLL was introduced as a possible replacement for WGL at the `European Institute of Oncology' in Milan in 1996. This technique utilizes the intratumourally injected radiotracer, that is generally used for the lymphatic mapping and SNB, to localize the primary tumour guided by the gamma probe. Five studies so far have proven the applicability of this method. Objective: To evaluate the efficacy of Radio Occult Lesion Localisation (ROLL) versus Wire guided Localisation (WGL) in breast conserving surgery for non-palpable breast cancer Study design: A multicenter, prospective randomized clinical trial. Patients with proven non-palpable breast cancer will be randomized for either ROLL or WGL. Study population: 316 women with a core biopsy proven non palpable cT1 breast carcinoma that are eligible for a breast conserving treatment and sentinel node biopsy (SNB). Intervention (if applicable): Patients in the WGL group will undergo intra tumoural injection of a nuclear radiotracer under stereotactic or ultrasonographic guidance. After scintigraphic imaging, to monitor the migration of the radiotracer, a guide wire will be inserted under stereotactic or ultrasonographic guidance. The excision of the primary tumour is guided by the inserted wire and the sentinel node procedure is performed using a gamma probe and intratumoural injection of patent blue. Patients in the ROLL group will undergo the same procedure except for the guide wire insertion. The excision of the primary tumour is guided by the gamma probe. Main study parameters/endpoints: Primary study endpoints; ROLL vs WGL: 1. The percentage of tumour-free margins (invasive and in situ) 2. The volume and maximum diameter of the lumpectomy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no pre-, per- or post operative extra burden. The radiofarmacon is already used in the standard care of breast cancer patients for the sentinel node biopsy. The used radio-active substance does not damage the patient. A specific burden questionnaire, aimed at evaluating the burden of the cosmetic result, will be administered. To further assess the net impact in terms of Health Related Quality of Life (HRQoL) also the EQ5D will be obtained at T = 0, 6, 12 and 26 weeks after the initial diagnostic work-up. Should the results indicate that overall the WGL procedure lead to better clinical outcome a cost-effectiveness analysis is foreseen using bootstrapping to assess the uncertainty with regard to the balance between costs and effects. All analyses will be limited to a half year time horizon. Accordingly, discounting of costs or effects is not applicable.
The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal aortic aneurysm (AAA) initiation. Doxycycline has direct MMP-9 inhibiting properties in vitro, and it effectively suppresses AAA development in rodents. Observed inhibition of AAA progression, and contradictory findings in human studies evaluating the effect of doxycycline therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9 inhibition, and that the effect may be dose dependent.
Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.