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Found 43 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a new oral medicine called vepugratinib compared with a placebo in adults with advanced or metastatic urothelial carcinoma, a type of bladder cancer that has a specific FGFR3 genetic alteration. This Phase 3 study aims to see if vepugratinib combined with two other drugs, enfortumab vedotin (EV) and pembrolizumab, can improve treatment outcomes for people who have not received prior systemic therapy for their cancer. Participants will receive either vepugratinib or placebo taken orally alongside enfortumab vedotin and pembrolizumab, both administered by intravenous infusion. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the vepugratinib and placebo groups. Treatment and monitoring will continue for up to approximately 6 years, allowing long-term assessment of safety and treatment effects. During the study, participants will be regularly evaluated for treatment-related side effects, response rates, and how long the cancer remains controlled without progression. Researchers will use established criteria to measure tumor response and will conduct thorough safety monitoring over the entire study period. Participation may last up to six years, during which participants will undergo laboratory tests, imaging, and clinical assessments to track their health and treatment response.
Actively Recruiting
Researchers are evaluating LY3537021, a drug given by injection, to see how well it controls nausea and vomiting caused by chemotherapy in adults with cancer. This Phase 2 study compares LY3537021 to a placebo while participants also receive standard anti-nausea treatments. The study aims to understand the safety and effectiveness of LY3537021 during the period 24 to 120 hours after chemotherapy starts. Participants will receive chemotherapy drugs such as cisplatin or anthracycline with cyclophosphamide through an intravenous line. They will be randomly assigned to get either LY3537021 or a placebo, both given by subcutaneous injection, along with standard antiemetic therapies including medications taken by mouth, IV, or skin patches. The treatment period lasts through the chemotherapy cycle. During the study, participants will be monitored for their response to the anti-nausea treatment, particularly looking at how many achieve complete control of nausea and vomiting in the delayed phase after chemotherapy. Researchers will also track safety and any side effects. The entire participation may take about two months, covering all study parts until completion.
Actively Recruiting
Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.
Actively Recruiting
Researchers are investigating whether using artificial intelligence (AI) to guide monitoring and timing of ovulation triggering in women undergoing ovarian stimulation for in vitro fertilization (IVF) can achieve clinical outcomes similar to those from traditional physician-led decisions. This study focuses on improving the number of mature eggs retrieved while managing clinic workload, especially by reducing weekend procedures, without compromising treatment success. AI is being explored as a tool to personalize treatment and optimize timing based on patient-specific responses, which can vary between cycles. The study compares two approaches: one where the physician makes ovulation trigger decisions based solely on clinical judgment and another where the physician uses recommendations from an AI software called STIMAI®. STIMAI® predicts the number of mature oocytes for different trigger days to assist the physician in deciding the best day for ovulation triggering. The physician retains final decision-making authority. Trigger timing is based on follicle size detected by ultrasound scans, with decisions made when 2-3 follicles reach 17 mm. Participants will be closely monitored with ultrasound scans at the study centers during their controlled ovarian stimulation cycles for IVF or fertility preservation. The primary outcome measured is the number of mature (MII) oocytes retrieved approximately 34-36 hours after ovulation trigger. The trial aims to assess if AI assistance can improve efficiency and outcomes without increasing clinical workload or compromising patient care. The study includes women aged 18 to 42 years undergoing ovarian stimulation with their own or donated eggs.
Actively Recruiting
Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.
Actively Recruiting
Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.
Actively Recruiting
Researchers are evaluating the effect of eating one avocado daily on biological aging in women who have survived breast cancer. This study focuses on breast cancer survivors aged 40 to 65 years who completed their cancer treatment at least 6 months ago but not more than 10 years ago. The study explores whether avocado consumption can influence telomere length, a marker of cellular aging, and also looks at other factors like inflammation, oxidative stress, cardiovascular markers, mental health symptoms, quality of life, fatigue, and diet quality. Participants will be randomly assigned to one of two groups: one group will consume one avocado per day as part of their usual diet for 4 months, while the control group will continue their habitual diet with fewer than two avocados per week. The study lasts for 4 months, during which both groups will be monitored for changes in telomere length and other health markers. During the study, participants will complete questionnaires and undergo various assessments at the start and end of the 4-month period. These include blood and urine sample collections, measurements of body size and blood pressure, and evaluations of diet, physical activity, symptoms of depression and anxiety, quality of life, and fatigue. Researchers will compare changes in these measures between the avocado group and the control group to understand the effects of avocado consumption on cellular aging and overall health in breast cancer survivors.
Actively Recruiting
Researchers are evaluating whether zongertinib, an oral medication targeting HER2 mutations, can improve outcomes compared to standard adjuvant treatments in adults with completely removed Stage II to IIIB non-small cell lung cancer (NSCLC) with activating HER2 tyrosine kinase domain mutations. Participants must have had surgery intended to cure the cancer and received standard systemic therapy around the time of surgery, including neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. This global, open-label Phase 3 study aims to assess if zongertinib can extend the time participants remain free from disease. After surgery and necessary systemic therapy, participants are randomly assigned to one of two groups. One group receives zongertinib orally once daily for up to three years. The other group receives standard care, which may include approved adjuvant immunotherapy drugs such as pembrolizumab, atezolizumab, durvalumab, or nivolumab, or observation depending on local medical practices and patient status. This comparison allows researchers to evaluate zongertinib against current treatment standards. Participants will be monitored regularly to assess disease-free survival over a period of up to eight years and five months. Researchers also evaluate overall survival, safety, tolerability, and patient-reported outcomes throughout the study. Tumor samples are collected to confirm HER2 mutation status, and participants' health and organ function are regularly assessed to ensure safety during the trial.
Actively Recruiting
Healthy Volunteer
Researchers are studying people aged 60 and older who have delirium and are in a subacute care unit. The goal is to see if non-drug therapies that improve sleep, mobility, and cognitive skills like memory, attention, and orientation help reduce delirium after one week. The study also compares two groups receiving slightly different therapies and looks at how individual factors such as existing diseases, blood test results, genetics, gender, age, and education affect delirium's onset, severity, and treatment response. Participants will be divided into two groups. Both receive usual care, which includes a thorough geriatric assessment and treatment for underlying health issues, along with non-pharmacological steps to improve orientation, cognitive stimulation, mobility, and sleep patterns. One group will also get a special cognitive stimulation therapy using a computer program on a tablet, led by an occupational therapist twice daily for up to 20 minutes each session, five days a week, focusing on attention, orientation, and visuospatial skills. During the study, researchers will assess delirium presence and severity at the start and after one week of treatment. They will observe clinical changes and core symptoms of delirium, and check if participants meet DSM-5 criteria for delirium after one week. The study involves monitoring treatment effects and changes in cognitive function through these assessments over the one-week period.
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