There are about 25560 clinical studies being (or have been) conducted in Germany. 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.
CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS Phase: IV TITLE OF STUDY Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery CONDITION Peripheral arterial occlusive disease (PAOD) OBJECTIVE(S) The objective of this study is to evaluate the safety and efficacy of two therapeutic strategies (operative versus endovascular) in the treatment of patients with complex atherosclerotic lesions of the superficial femoral artery. INTERVENTIONS Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available). Duration of intervention per patient: Dependent on the method of treatment Follow-up per patient: 24 months OUTCOMES Primary efficacy endpoint: Two primary efficacy endpoints will be considered simultaneously in this trial: (A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR). (B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford classification) at 24 months after primary intervention (regardless any performed re-intervention).
Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
In this study patients with 1. chronicle liver diseases - primary biliary cirrhosis - primary sclerosing cholangitis - alcoholic liver cirrhosis - hepatitis b or C - Wilson's disease - cryptogenic cirrhosis 2. Septic Inflammatory Response Syndrome (SIRS) - sepsis - septic shock 3. patients after lysis should be included Blood samples will be gathered from the patients to measure fibrinogen with 5 different methods. The methods are: - Clauss fibrinogen - PT-Derived fibrinogen - immunoturbidimetric method - heat-precipitated fibrinogen - Schulz fibrinogen The result of these tests will be correlated with laboratory values which are gathered in routine and the clinical outcomes.
1. Research aims The increasing prevalence of severe aortic valve defects is a corollary to increases in life expectancy. For many years, surgical valve replacement with extracorporeal circulation has been the gold standard in the treatment of severe aortic valve diseases. Every year, about 12,000 patients in Germany receive isolated aortic valve surgery. Several alternatives to established procedures have recently emerged: - V-TAVI, vascular transcatheter aortic valve implantation and - A-TAVI, apical transcatheter aortic valve implantation. For some time, percutaneous balloon valvuloplasty has been used as a palliative measure for specific patients. New developments have triggered assumptions that there will over the coming years be a certain reorientation to the treatment of patients with aortic valve defects. In a positioning paper published jointly by the German Cardiac Society (DGK) and the German Society for Thoracic and Cardiovascular Surgery (DGTHG), there is a consensus that these new techniques can be used on patients who have either contraindications against conventional surgery or who are at high risk of preoperative mortality, e.g. due to severe comorbidities. As there is as yet only limited experience in this field and neither randomised trials nor long-term-results are available, the use of new implantation techniques is therefore not recommended for younger patients or patients without comorbidities. There is accordingly an urgent need for any introduction of this innovative medical procedure to be stringently monitored according to scientific principles. The goal of the planned Germany Aortic Valve Register is to evaluate the new treatments from the point of view of benefits und risks with respect to the gold standard of conventional surgery, with a view to compiling evidence-based indication criteria. The register will furthermore allow for the first time a comparison of various operative procedures, such as Ross procedure, David procedure and various mechanical or biological aortic valve implants. 2. Rationale of the study design Randomised trials in controlled environments are considered best scientific practice for verifying the efficacy of a new method. The disadvantage is that only a small part of potential patients can be included in the trial, and results therefore reflect only a small section of the real world. Furthermore, a randomised study design is for ethical reasons not an acceptable approach to all questions, especially when contraindications exist for a certain branch of treatments and the spectrum of treatments is to be expanded. Nevertheless, new procedures have to be critically and scientifically analysed if the risk-benefit ratio is to be accurately determined. National heath authorities therefore request register data in addition to controlled trials in order to verify the safety and efficacy of new procedures across larger patient populations. 3. Objectives 1. Description of structure, process and outcome quality for the various techniques of aortic valve therapies 2. Definition of indication criteria (e.g. through scoring systems) 3. Collection of information on quality and safety for special medical devices 4. Evaluation of quality of care on the level of participating centres with a view to increasing quality 5. Health economic evaluation of the applied treatments 4. Study design Prospective, controlled, multicenter register study
Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection. For this purpose were randomized about 1200 patients with histological assured cervix carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy. Primary end point is overall survival; this for both groups must be equal. Secondary end point is peri- and postoperative morbidity inclusive quality of life, the benefits for women must be evident with sentinel- lymph node dissection, don't have to show for both groups any significant difference.
MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry) pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes the documentation of the respective FDG-PET and CT-image files in an online archive. Based on these documented clinical and imaging data, the MERIT study group centrally performs an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to prospectively identify yet unknown patient- and lesion specific prognostic factors predicting patient´s outcome in line with the therapeutic modality radioimmunotherapy.
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.
In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.
The aims of this study are - Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing - Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.