Bã¶rnsen, Germany

Abbott Medical - VERITAS Study

Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

NeoRad Breast Cancer Study

The standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). In case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. Adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. The optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (NACT) has never been addressed in a randomised controlled trial. The Study Chairman of the NEORAD trial is Prof. Dr. med. Christiane Matuschek. The deputies of the Study Chairman are Prof. Dr. med. Wilfried Budach and Prof. Dr. med. Tanja Fehm.

A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study

Glioblastoma (GBM) is the most common malignant primary tumor of the brain with an annual incidence of approximately 3/100.000. Since 2005 the treatment for newly diagnosed GBM consisted of maximal surgical resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ), followed by 6 cycles of maintenance chemotherapy. This treatment regimen demonstrated increased median overall survival (OS) from 12.1 to 14.6 months in comparison to surgery and radiotherapy alone in 2005. Since 2005, despite plenty of clinical phase III trials conducted, Tumor Treating Fields (TTFields) therapy was the first treatment shown to significantly increase median progression-free survival (PFS), OS and one to five year survival rates compared to the previous standard of care. These results led to FDA approval of TTFields for newly diagnosed GBM and were acknowledged since then by several guidelines recommending TTFields for GBM therapy (e.g. NCCN guidelines for CNS cancers V.1.2018, RCC guideline tumörer I hjärna och ryggmärg 2020-01-14 V3.0, DGHO guideline for glioma in adults ICD-10 C71 March 2019). Today, several national committees in Europe already list TTFields as reimbursed treatment (e.g. Austria, Sweden, Germany). Data with TTFields therapy in real-world setting is limited and therefore further evaluation of different treatment aspects of TTFields therapy in clinical routine are of interest. In particular the QoL-related aspects neurocognitive functioning, daily activity and sleep quality in this patient cohort is of major interest, given the limited life expectancy with this disease. This non-interventional study aims to investigate change over time in neurocognitive functioning, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance even further in the long-term.

Prospective, Randomized Trial of Personalized Medicine with Pentaglobin® After Surgical Infectious Source Control in Patients with Peritonitis

The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to 1. Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival. 2. Identification of biomarkers (including immunoglobulin levels, HLA-DR, Nf-kB1 and other immunological biomarkers) to identify patient subpopulations that benefit most from IgGAM treatment. These patients will form the basis for a further randomized, controlled, double-blind Phase III trial (RCT) to demonstrate the benefit of this treatment. 3. In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis. The control group receives Standard-of-Care treatment. The intervention group is additionally treated with IgGAM (Pentaglobin®) as an add-on treatment to Standard-of-Care. Pentaglobin® is administered by continuous intravenous infusion over a period of 5 days of 0.4ml/kg body weight/hour until the total dose of 7mL/kg body weight/day is reached. Primary outcome: Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis. The MOF score is determined in the morning. The following score points are distributed per organ: Normal organ function: 0 score points; organ dysfunction: 1 score point; single organ failure: 2 score points. A score > 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score was obtained are assigned a score of 10 score points. Secondary outcome: - Death within 28 days - Death within 90 days - Change in MOF score from baseline to day 5 - Multi-organ Failure ( > 4 MOF score points on day 7) Exploratory objectives: - Effects of Pentaglobin® therapy on the SOFA score (determined in the organs lung, CNS, circulation, liver, coagulation and kidney). - Interaction of the biomarkers "NF-kB1" (steady), "CRP (≥ 70 mg/L), IgA (< 150 mg/dl), IgG (< 300 mg/dl), IgM (< 35 mg/dl) and HLA-DR expression (≤ 8,000 molecules per monocyte) with therapy in terms of change in MOF score from baseline to days 5 and 7 and death within 28 and 90 days.

BAROSTIM THERAPY™ In Resistant Hypertension

Summary: The CVRx BAROSTIM THERAPY in Resistant Hypertension Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted. After 12 months, data may be obtained in six month intervals for up to three years after implant, at which time each subject will be exited from the registry. Eligibility: Subjects must sign an Ethics Committee (EC) approved informed consent form for the registry to participate. Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension. These include: - Indications - Systolic blood pressure greater than or equal to 140 mmHg, and - Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications - Contraindications - Bilateral carotid bifurcations located above the level of the mandible - Baroreflex failure or autonomic neuropathy - Uncontrolled, symptomatic cardiac bradyarrhythmias - Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50% - Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation

Effect of Lipoprotein(a) Elimination by Lipoprotein Apheresis on Cardiovascular Outcomes