Wesel

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

WAYFIND-R is a global registry focused on collecting high-quality real-world data from cancer patients diagnosed with solid tumors who have undergone next-generation sequencing (NGS) testing. The registry aims to support clinical and epidemiological research, generate evidence to better understand health outcomes and cancer care, and describe treatments and clinical courses for these patients. Participants must be adults diagnosed with any type of solid tumor at any disease stage and have had NGS testing within three months before enrollment. The study collects data without assigning specific treatments or interventions, instead tracking clinical characteristics and outcomes over time. During the study, researchers will gather information linking NGS results to treatments and patient outcomes, including overall survival for up to five years from enrollment. Participants provide informed consent, and data collected will help improve understanding of solid tumor cancers and their management in real-world settings.

Researchers are evaluating the effects of a partially hydrolyzed formula with synbiotics on improving skin barrier function in infants who are at risk of developing allergies, specifically atopic dermatitis. This study aims to stop one of the earliest steps in the allergic march by assessing how well this special formula helps protect the skin. The research will also monitor other safety and effectiveness factors related to the formula. Participants will receive either a test formula that contains partially hydrolyzed protein plus synbiotics or a control formula with intact protein but no synbiotics. Infants will be enrolled within the first 14 days of life and will be either exclusively or predominantly formula-fed or exclusively breastfed, depending on the group. The study compares these feeding groups to see how the formulas affect skin barrier function. During the study, researchers will measure trans-epidermal water loss (TEWL) at 3 months of age to evaluate skin barrier health. Parents will provide consent and support throughout the study, and infants will be monitored closely to assess safety and growth. The total participation includes follow-up through at least the first 3 months of life to gather all necessary data.

Researchers are investigating the safety and effectiveness of minimally invasive radical hysterectomy compared to the traditional abdominal radical hysterectomy in patients with early-stage cervical cancer. This trial aims to prove that the less invasive laparoscopic or robotic surgery is not worse than the abdominal approach. For patients meeting specific low-risk criteria (SHAPE criteria), a simple hysterectomy may be performed using either minimally invasive or abdominal methods. The main goal is to measure disease-free survival, with additional evaluations of overall survival, recurrence rates, quality of life, and complications. Patients will be randomly assigned to one of two groups: one undergoing standard abdominal radical or simple hysterectomy, and the other receiving laparoscopic or robot-assisted radical or simple hysterectomy. Both groups may have removal or preservation of ovaries with or without transposition, and pelvic lymph node dissection or sentinel lymph node biopsy according to guidelines. Protective surgical measures are required in the minimally invasive group to reduce cancer cell spread. The trial plans to enroll 756 patients over 4 years, with surgery followed by at least 5 years of follow-up. Participants will undergo surgery according to their assigned group and be monitored regularly to assess disease status and complications. Researchers will collect data on survival without disease recurrence for up to 5 years, along with other health outcomes and quality of life. Safety assessments will continue for one year after surgery, ensuring comprehensive monitoring of any adverse events or treatment effects over time.

This research aims to evaluate the quality of life of women who have undergone implant-based breast surgery, using the BREAST-Q questionnaire. It also seeks to assess the safety and effectiveness of the fully resorbable TIGR4 Matrix surgical mesh used during these procedures. The study focuses on implant-based breast reconstruction, including cases following mastectomy. The study is a national, multicenter, prospective, non-randomized post-market surveillance investigation. Participants will have received the TIGR4 Matrix device as part of their implant-based breast surgery, decided independently from study enrollment. Data on device safety and complication rates will be collected alongside quality of life measurements. The TIGR4 Matrix is a bioresorbable, synthetic surgical mesh used to support reconstructive breast surgery. Participants will be followed for at least 12 months after surgery, during which quality of life will be assessed using the BREAST-Q questionnaire. Researchers will also monitor for any complications related to the device. The study includes a comprehensive collection of patient-reported outcomes and clinical data to evaluate the long-term impact of the TIGR4 Matrix on quality of life and safety after reconstructive breast surgery.

Researchers are studying pre- and perimenopausal women with estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer who have an intermediate to high clinical risk but low genomic risk of recurrence based on MammaPrint4 testing. The study aims to understand the real-world use of ovarian function suppression (OFS) combined with endocrine therapy, with or without prior chemotherapy, and how secondary amenorrhea after chemotherapy might affect outcomes. It also focuses on treatment adherence and quality of life over time, given the importance of long-term endocrine treatment up to 10 years. The registry will follow patients receiving standard-of-care treatment, which may include endocrine therapy with or without ovarian function suppression, and potentially chemotherapy based on clinical decisions. Data on treatment choices, including the use of OFS and chemotherapy, will be collected along with tumor characteristics assessed by local pathology and genomic signatures. Quality of life assessments will be conducted at baseline and multiple time points up to five years, while treatment adherence and outcomes will be tracked over up to 10 years. Participants will provide baseline information including tumor and treatment details. Researchers will collect follow-up data on treatment adherence, quality of life using specific questionnaires, and disease outcomes such as the five-year distant recurrence-free interval. Monitoring will include hormonal status and clinical assessments to correlate treatment effects with genomic risk scores and clinical markers. The overall goal is to improve understanding of treatment patterns and outcomes in this specific breast cancer population under real-world conditions.

Researchers are studying severe asthma through the German Asthma Net e.V., which focuses on improving medical care and understanding of this condition. Since there is limited reliable data on how often severe asthma occurs, its characteristics, and treatment patterns, this clinical registry collects detailed information from patients across Germany. The aim is to better characterize severe asthma by gathering data from multiple clinics and practices, helping to optimize diagnosis and treatment over time. Participants in this registry have their sociodemographic details and medical information recorded, including diagnosis, therapy, lung function, laboratory values like IgE and eosinophil granulocytes, asthma symptoms, medication use, smoking status, and additional treatments. This data is collected at a baseline visit and then annually for up to 15 years. Each participant receives a unique study ID to protect privacy, with personal and health data stored securely on separate servers. During the study, patients will be regularly monitored for asthma symptom control, with assessments at baseline, four months, and yearly thereafter for up to 15 years. Researchers will track symptoms, medication use, exacerbations, lung function, and laboratory markers to better understand severe asthma's course and treatment outcomes. This long-term follow-up aims to improve care by providing robust data on severe asthma patients.