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Found 246 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the use of 18F-choline positron-emission-tomography - computed-tomography (18F-ch-PET-CT) compared to conventional imaging methods, ultrasonography and 99-technetium sestamibi scintigraphy, for locating diseased parathyroid glands in adults with primary hyperparathyroidism (pHPT). The study aims to determine if 18F-ch-PET-CT can more accurately identify these glands before surgery, which could improve surgical precision, increase cure rates, reduce complications, and shorten operation times. The study is a single-center, prospective, randomized clinical trial where patients diagnosed with pHPT and scheduled for surgery are randomly assigned to receive either 18F-ch-PET-CT imaging or the standard combination of ultrasonography and sestamibi scintigraphy. Patients undergo the assigned imaging before parathyroidectomy surgery. The 18F-ch-PET-CT method involves injecting a radiotracer and performing a PET-CT scan, while the conventional arm uses ultrasound and scintigraphy. The study does not blind patients or providers to the imaging method used. Participants will be monitored during surgery to measure the primary outcome, which is the operation time from incision to last suture. Additional assessments include cure rates evaluated by normal calcium levels without treatment one month after surgery, complication rates such as nerve damage and hypocalcemia, and the accuracy and costs of imaging methods. Safety monitoring includes tracking any adverse reactions to the radiotracer used in 18F-ch-PET-CT. The total study duration includes imaging, surgery, and follow-up evaluations approximately one month postoperatively.
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Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.
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Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread from the cervix to other parts of the body. This Phase 3 study aims to evaluate the safety and effectiveness of combining sacituzumab tirumotecan (sac-TMT), an antibody drug that targets cancer cells, with pembrolizumab and bevacizumab. The study seeks to find out if this combination can help people live longer or keep their cancer from worsening compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT together with pembrolizumab and bevacizumab to assess safety. In Part 2, after standard initial treatment, those whose cancer does not progress will be randomly assigned to maintenance treatment with either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may be added during maintenance treatment based on the doctor's decision. All treatments are given through intravenous infusions, and participants may receive rescue medications to manage side effects before sac-TMT infusion. Participants will be monitored for adverse events and treatment tolerability over several months. The study measures include progression-free survival and overall survival, assessed by independent review. Safety and treatment continuation rates are tracked during Part 1 for up to approximately 66-69 months, while Part 2 outcome measures extend up to 48-60 months. Various assessments, including laboratory tests and evaluations of cancer status, will be performed throughout the study to understand treatment effects and participant well-being.
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Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.
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Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.
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Researchers are evaluating whether adding ketamine tablets to standard antidepressant therapy can reduce depressive symptoms in adults diagnosed with Major Depressive Disorder (MDD). This pilot, open-label Phase II trial focuses on adults aged 18 to 75 years who have moderate to severe MDD without psychotic features and have not been depressed for longer than 12 months. The main goal is to measure changes in depression severity after one week of treatment using the Montgomery-Åsberg Depression Rating Scale (MADRS). Participants will receive four doses of Ketamine Hydrochloride Prolonged-Release Tablets (240 mg each) over an eight-day period alongside a new antidepressant chosen by their doctor. The ketamine treatment ends after the first week, while the antidepressant therapy continues. Throughout the study, blood samples will be collected at five visits to monitor side effects and look for biomarkers. After the treatment week, participants are followed for an additional three weeks without ketamine to observe ongoing effects. During the study, participants will complete various questionnaires and rating scales at screening, during treatment, and at follow-up visits. Researchers will monitor safety through blood tests and check for changes in depressive symptoms. The total participation time is about four weeks, including treatment and follow-up. The study aims to better understand the impact of ketamine added to antidepressants on depression symptoms and safety in this population.
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Researchers are studying people aged 50 and older with Covert Brain Infarcts (CBIs), which are small brain injuries found by chance on MRI scans. These brain infarcts do not cause symptoms initially but are linked to a higher risk of future strokes and death. The study aims to find out if treatments that prevent strokes, such as blood-thinning and cholesterol-lowering medications, can help people with CBIs. It will also explore whether having CBIs increases the risk of dementia and if treatment can reduce that risk. This is a Phase 3 randomized trial conducted in multiple centers across Europe. Participants will be randomly assigned to receive stroke-preventing treatments including daily doses of acetylsalicylic acid (75-100 mg), clopidogrel (75 mg), rosuvastatin (starting at 10 mg daily with possible increase to 20 mg), or atorvastatin (40 mg daily with possible reduction to 20 mg if not tolerated). The treatments are given orally and are studied either alone or in combination to evaluate their effects on preventing future vascular events in people with CBIs. During the study, participants will be monitored for major adverse cardiac and cerebral events as well as major and fatal bleeding at 12 and 36 months after starting treatment. Researchers will perform evaluations and track outcomes related to stroke prevention and safety. The total participation period includes follow-up visits over three years to assess the long-term effects and risks associated with these treatments.
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This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.
Actively Recruiting
Researchers are studying head and neck squamous cell carcinoma (HNSCC) patients with factors that increase the risk of treatment failure. The goal is to personalize treatment and improve outcomes for those receiving curative radiotherapy. This phase III trial compares the standard radiation dose to a higher dose given more frequently (hyperfractionated radiotherapy) to see if intensifying treatment benefits patients with advanced disease. The study also explores advanced imaging and genetic tests to better predict treatment response and cancer behavior. Participants will be randomly assigned to receive either the standard radiotherapy dose of 68.0 Gy in 34 fractions once daily or a higher hyperfractionated dose of 83.0 Gy in 68 fractions given twice daily over five days a week. Different radiation doses are targeted to the primary tumor and affected lymph nodes based on risk areas. The trial includes translational research using MRI, CT, and PET scans, as well as gene and protein analyses, to understand tumor characteristics and treatment effects. Patients with lower-risk tumors not eligible for randomization can still join the research parts that do not involve altered radiation schedules. During the study, participants will undergo regular monitoring including imaging and clinical assessments every three months for two years, then every six months up to five years to check local tumor control. Researchers will collect data from these visits along with tissue and blood samples for genetic and immune profiling. Safety, treatment adherence, and long-term outcomes will be closely followed to evaluate the impact of the different radiotherapy approaches and the predictive value of the biological tests.
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Healthy Volunteer
This research aims to improve the quality of life for older adults by addressing common issues like disturbed sleep, low physical activity, and limited daylight exposure that can affect their well-being. The study focuses on community-dwelling Swedish-speaking adults aged 70 and over who live alone in apartments. It evaluates a behavioral intervention designed to support healthier daily routines related to light exposure, outdoor walking, and sleep, hoping to promote active aging and independence. The intervention, called "Light, activity and sleep in my daily life" (LAS), is delivered as a web-based course with nine modules covering electric lighting, daylight, outdoor physical activity, and sleep habits. Participants receive a test kit containing light bulbs, a sleep mask, a room checklist, a cap, a notebook, and a sleep diary to help them engage with the material and try new routines. The course also includes four physical meetings held at a senior citizen meeting point, combining self-study with in-person support. Participants complete questionnaires, wear an accelerometer to track activity and rest, and take part in interviews about their daily routines and perceptions of outdoor walking. Measurements are taken before the course, immediately after, and at 3, 6, and 10 months afterward to assess usability, usefulness, and sustained changes. The study monitors quality of life, mood, sleep quality, and behavioral skills throughout, with the goal of refining the intervention for broader use in municipal health services.
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