Rheine

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.

This research aims to compare the outcomes and patient satisfaction of two commercially available trifocal toric intraocular lenses used in cataract surgery. The study focuses on measuring the distance-corrected intermediate visual acuity and assessing the safety of these lenses, which are designed to improve vision at near, distance, and intermediate ranges while reducing the need for glasses. These lenses also correct astigmatism and are part of an advanced premium range with specialized optical features. Participants will receive one of two types of trifocal toric intraocular lenses: the Optiflex TRIO or the AcrySof IQ PanOptix. Both are single-piece, foldable lenses implanted in the posterior chamber of the eye. Each lens has advanced aspheric optics and is designed to provide clear vision across all distances while correcting astigmatism. Patients are randomly assigned to receive one of these lenses during their cataract surgery. During the study, participants will be monitored to evaluate their visual acuity at intermediate distances six months after implantation. Researchers will also assess patient satisfaction and lens safety throughout the study. Various clinical evaluations and follow-ups will be conducted to gather data on the lenses' performance, with the goal of comparing the benefits and potential risks of each lens type.

This research evaluates two types of phakic toric implantable lenses, EYECRYLTM Phakic Toric and Visian4 Toric ICL, in patients with moderate to high myopia and astigmatism. These lenses are designed to correct vision by being implanted without removing the natural lens, allowing light to focus properly on the retina. The study aims to compare how effective each lens is and to assess their safety in improving uncorrected visual acuity for patients with these eye conditions. Participants will be randomly assigned to receive either the Eyecryl Phakic IOL or the Visian4 Toric Implantable Contact Lens. Both devices are surgically implanted in the eye's anterior or posterior chamber and are designed to correct both myopia and astigmatism. The study focuses on measuring the residual refractive error six months after implantation to compare the outcomes of these two treatments. During the study, participants will undergo regular evaluations to monitor their vision and eye health. Researchers will assess uncorrected visual acuity, refractive stability, and safety outcomes throughout the follow-up period. Patients must attend all scheduled visits and provide informed consent. The study includes a detailed assessment of visual outcomes and safety to determine the performance of each lens over time.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with hormone receptor positive, HER2 negative metastatic breast cancer. This includes both premenopausal and postmenopausal patients receiving first-line treatment. The trial also explores biomarker research to understand responses and resistance to this combined endocrine therapy. Participants receive Abemaciclib 150 mg orally every 12 hours along with either an Aromatase Inhibitor (Anastrozole, Letrozole, or Exemestane) taken once daily in 28-day cycles, or Fulvestrant given by injection on days 1 and 15 of the first cycle, then on day 1 of subsequent 28-day cycles. Side effects and patient-reported outcomes are monitored using the CANKADO digital health app, allowing daily tracking alongside standard clinical documentation. During the study, patients regularly report symptoms and side effects through the app, and undergo laboratory tests, imaging, and clinical assessments to monitor disease progression and treatment safety. The main outcome measured is progression-free survival over up to 48 months. Safety and quality of life are also closely observed throughout the trial period.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.