Bad Grönenbach, Germany

The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)

Idiopathic Nephrotic Syndrome is characterized by proteinuria, volume retention, hyperlipidemia, hypoalbuminemia. As Minimal Change Disease (MCD) represents by far the most prevalent underlying diagnosis in children older than 1 year, a kidney biopsy is usually deferred in these cases. In adolescence and adults, a kidney biopsy is crucial for the diagnosis because MCD and FSGS account for only 10-15 and 12-35 percent of all cases of nephrotic syndrome respectively. Pathomechanisms as well as optimal treatment remain elusive as systematic trials are scarce and hampered by low incidence and heterogenicity of the clinical presentation. To bridge this informational gap, the investigators identified the need for a German registry of pediatric and adult patients with idiopathic nephrotic syndrome (in children) and biopsy-proven MCD/FSGS (in adults). The registry will record clinical data of participants regarding basic demographics, initial presentation, hereditary traits, disease course and treatment modalities as well as quality of life, concomitant diseases, and comedication. During the initial visit and to a lesser intent on follow-up visits, biomaterials (blood, urine, DNA, feces, tissue) will be collected and stored in a state-of-the art biobank. This material will be available to collaborators to support research on idiopathic nephrotic syndrome and MCD/FSGS. By the time of completion, the registry will provide data on clinical courses and outcome of approximately 500 patients that can easily be correlated with biomaterials giving insight into risk factors, prognostic parameters, and association with comorbidities. Tissue sections of all patients that undergo kidney biopsy (all adult and some pediatric patients) will be digitalized, annotated, and analyzed by a panel of nephropathologists. Histopathologic features will be individually assessed and scored according to a set of descriptors that was developed and is used by the American NEPTUNE (Nephrotic Syndrome Study Network).

Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)

To compile characteristics of real-world outcomes using Deep Brain Stimulation (DBS) for the treatment of Essential Tremor to add to the evidence available for treatment of ET.

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)

Enterostomies in children may be created for different reasons. During the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the enterostomy) does not participate in the circulation of stool. Therefore it does not contribute to the resorption of enteral contents. As a consequence these children need additional parenteral nutrition. Due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. Consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (MFR) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. Several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this Treatment.The aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.

Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

The trial will consist of both a clinical and translational part. During the study, re-assessments (radiologic assessment, blood and QoL) will be conducted for all trial subject of the trial every 3 months. Tumor biopsies will be collected at screening (baseline sample) and in case of relapse of disease if a new tumor sample is obtained. The objective of the re-assessments is detection of relapse either radiologically or within the translational material (blood samples with ctDNA dynamics and tumor - if available from relapses). CT scans of thorax/abdomen and/or MRI scans will be performed every 3 months within the 2 years after randomization. After the first two relapse-free years, intervals should be stretched to 6 months in the third and following years after study start. Structured follow-up for up to 60 months after randomization should be maintained for both arms. Patients in Arm A receive additive study drug intervention (mFOLFOXIRI or mFOLFOX-6) for up to six months (12 cycles) after randomization with additional clinical and safety assessments.

The CATALINA Study

The initial objective is to recruit 1000 patients hospitalised for an acute COPD exacerbation by the end of CICERO's first lifecycle (3 years), from whom 1 year follow-up data and biological samples will be collected. By doing so, CICERO aims to develop a comprehensive European COPD patient data- and biobank phenotyped in relation to the exacerbation, to support the development of future EU-wide clinical intervention trials in COPD for specific patient subgroups, as well as new prognostication tools for COPD exacerbations. The clinical data and biological samples will be obtained during 6 scheduled study visits, during the hospitalization period of the index acute exacerbation as well as the outpatient setting after hospital discharge; and 3 additional unscheduled study visits should the patient be readmitted for respiratory reasons during study participation (i.e. first readmission only). - 3 study visits will be scheduled during the hospitalization period of the index acute exacerbation: - visit 1: within 48h of hospital admission, study inclusion (Day 1) - visit 2: at 72h after study inclusion (Day 3) - visit 3: at hospital discharge, at investigator's discretion (Day X) - 3 study visits will be scheduled during the outpatient setting: - visit 4: at 3 months after study inclusion (Day 90) - visit 5: at 6 months after study inclusion (Day 180) - visit 6: at 12 months after study inclusion (Day 365) - The first hospital readmission for respiratory reasons during the patient's study participation will undergo the same testing schedule as mandated during the hospitalization period of the index event: - unscheduled visit 1: within 48h of first hospital readmission - unscheduled visit 2: within 72h of first hospital readmission - unscheduled visit 3: at hospital discharge for first hospital readmission Resulting from CICERO's future lifecycles will be the continued expansion of the data- and bio-bank, both in cohort size and duration of follow-up.

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study with retrospective controls. The study will enroll patients that will be implanted with the Zimmer Natural Nail Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails. 500 tibias will be recruited at maximum 15 sites and allocated on a 1:1 ratio into an: - investigational group (prospective/consecutive series of 250 tibias treated with ZNN Bactiguard tibia) - a control group (retrospective series of 250 tibias treated with uncoated titanium-alloy tibia nail - data collection will be retrospective, these subjects will not have to undergo any study-related procedure). The primary endpoint is the Fracture Related Infection (FRI) rate in the study population 12 months after fracture fixation. The secondary endpoint is the confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation through the following measure systems: - Radiologic (RUST) & clinical (FIX-IT) fracture healing 12 months after fracture fixation (performance). - Patients' outcomes assessed by the Oxford Knee Score 12 months after fracture fixation (clinical benefits). - EQ5D-5L (patients' quality of life). - Incidence and frequency of adverse events (safety). Data will be collected at 2 weeks, 3 months, 6 months and 1 year after fracture fixation.