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Found 8 Actively Recruiting clinical trials

A

Actively Recruiting

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Age: 18Years +All Genders
40 locations
A

Actively Recruiting

This research focuses on patients with Relapsed/Refractory Multiple Myeloma (RRMM) who have been treated with the T-cell redirectors teclistamab or talquetamab outside of clinical trials. The study aims to describe the clinical outcomes and safety management of these treatments in a real-world setting, analyzing how patients respond and survive after receiving these therapies. The study does not administer any new interventions but instead collects and analyzes retrospective data from medical records of patients who have received teclistamab or talquetamab. Participants are grouped based on when they received their first dose, covering different time periods up to the end of 2025. This allows the study to assess outcomes for patients treated with these drugs over several years. Throughout the study, researchers will monitor various outcomes, including overall response rates, time to response, duration of response, minimal residual disease status, overall survival, progression-free survival, and time to next treatment. Safety management during treatment is also described. Data will be collected from baseline (day 1) through up to 40 months following treatment initiation, using medical records to understand treatment effects and patient characteristics over time.

Age: 18Years +All Genders
68 locations
A

Actively Recruiting

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

Age: 18Years +All GendersPhase 3
316 locations
E

Actively Recruiting

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy for people aged 12 to 65 who have mild to moderate allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. Participants are sensitized to grass and olive pollen, and the study is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. The study aims to measure combined symptoms and medication scores over 12 months to assess treatment impact. The study includes three groups receiving different treatments: two doses of purified and polymerized allergen extracts from a mixture of grasses and olive pollen (10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517) and a placebo group receiving a similar solution without active ingredients. Treatments are administered subcutaneously over one year. The study is double-blinded and controlled to compare safety and efficacy across groups. Participants will be involved for one year, during which they will record their symptoms and medication use via a smartphone app. Researchers will conduct clinical evaluations, skin tests, and measure specific IgE levels to monitor allergic responses. The main outcome is the Combined Symptoms and Medication Score (CSMS) after 12 months. Safety and treatment adherence will be closely monitored throughout the study period.

Age: 12Years - 65YearsAll GendersPhase 3
32 locations
E

Actively Recruiting

Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in people aged 12 to 65 who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, sensitized to cupressaceae and grass pollens. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to compare active treatments with a placebo over an 18-month period. The study focuses on reducing symptoms and medication use during the pollen seasons of cupressaceae (January to March) and grasses (May to June). Participants will receive one of three treatments: two different doses of purified and polymerized allergen extracts from a mix of grasses and cupressaceae, or a placebo that looks the same but contains no active ingredients. These treatments are given as subcutaneous injections. Each participant will be treated and monitored for 18 months, covering multiple pollen seasons with continuous dosing. During the study, participants will track their symptoms and medication use daily using an electronic diary on their smartphone. Researchers will assess combined symptom and medication scores to measure treatment effects during pollen seasons. Safety and adherence will be monitored throughout the 18 months. The study involves 180 participants and includes various clinical assessments to ensure accurate evaluation of treatment impact and participant wellbeing.

Age: 12Years - 65YearsAll GendersPhase 3
27 locations
G

Actively Recruiting

The study focuses on patients with splenomegaly or those who have undergone splenectomy without a clear diagnosis, as well as patients with thrombocytopenia. Researchers aim to improve diagnosis sensitivity for Gaucher disease (GD) and Acid Sphingomyelinase Deficiency (ASMD) among these patients, especially in those with monoclonal gammopathies of undetermined significance (MGUS) or multiple myeloma (MM). Previous research suggests increased frequency of MGUS and MM in GD and ASMD patients, but many cases of splenomegaly remain unexplained despite standard evaluations. The study involves the use of usual clinical diagnostic procedures alongside collecting blood samples for a dry drop test (DBS) to measure enzymatic and genetic activity related to GD and ASMD. Analysis of specific markers LisoGl1 and LisoSM will also be conducted. The investigation seeks to identify the prevalence of these diseases in the patient population over a 36-month period. Participants will undergo clinical evaluation, blood testing, and enzymatic/genetic assessments to help identify GD and ASMD. Researchers will monitor the prevalence of these diseases and related conditions throughout the study. The study includes adult patients aged 18 to 99 years, and those who participate will provide consent for assessments and follow-up. Safety and diagnostic results will be observed during the entire study duration.

Age: 18Years - 99YearsAll Genders
23 locations
I

Actively Recruiting

Researchers are evaluating how inflammatory bowel disease (IBD) activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study also aims to understand how frailty influences the risk of hospitalization and death in this population. The study seeks to determine if frailty and its related complications can be reversed with proactive treatment and which frailty index best predicts these risks in patients with active IBD. At the start of the study, four clinical frailty indices will be calculated along with clinical information about IBD, including diagnosis, disease characteristics, treatments, and comorbidities. Patients will be followed for 12 months with three visits at 3, 6, and 12 months. During these visits, frailty, comorbidities, disease activity, changes in medical treatments, adverse effects, hospitalizations, and mortality will be reassessed to monitor progress and outcomes. Participants will have detailed assessments including frailty scales and clinical data collection at the beginning and during follow-up visits. Researchers will track hospitalizations and mortality over the year-long period. This monitoring will help evaluate the impact of both IBD activity and frailty on patient health outcomes in a real-world setting.

Age: 60Years +All Genders
34 locations
T

Actively Recruiting

This trial focuses on adult patients aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph-negative ALL). The study evaluates treatment approaches based on measurable residual disease (MRD) and genetic analysis done at the start. The goal is to determine the best continuation therapy after initial consolidation treatment to improve overall survival over three years. Participants first receive a uniform four-drug induction chemotherapy including vincristine, prednisone, pegylated asparaginase, and daunorubicin. Patients who do not respond adequately receive a second induction with fludarabine, Ara-C, G-CSF, and idarubicin (FLAG-IDA). Those with good MRD clearance proceed through early consolidation, delayed intensification, reinduction, and maintenance phases with pediatric-type chemotherapy drugs. Patients with less favorable MRD or genetic profiles may receive early or delayed allogeneic hematopoietic stem cell transplantation (alloHSCT). Throughout the study, participants undergo regular monitoring of disease status and response to therapy. Researchers assess overall survival at three years as the primary outcome. Patients' health status, treatment adherence, and side effects are closely followed. The study aims to personalize treatment plans based on MRD and genetics to optimize outcomes for adults with Ph-negative ALL.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
108 locations
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