Country: Sweden

Currently showing 20 clinical trials. Use pagination links to see more trials.

  • CT-EU-00117478

    Long-term melatonin intake and evaluation of the effect on melanoma patients

    The aim of this study is to test a new treatment for an eye cancer called uveal melanoma. This cancer can spread to other parts of the body, and once it does, it is extremely difficult to treat. Therefore, the aim of this study is to test whether melatonin for 5 years after the initial cancer diagnosis can help prevent or delay the spread of cancer.

    Half of the study participants will take melatonin tablets (20 mg) at bedtime every day for 5 years, and the other half will take nothing. Researchers will monitor both groups closely, checking for any signs of spread of the cancer with regular imaging and blood tests.

    Sweden
  • Infusion of tumor-infiltrating lymphocytes into the liver of melanoma patients with liver metastases

    This is a clinical trial for a new type of treatment — tumor-infiltrating lymphocytes (TIL). This study will test whether this treatment can help fight melanoma that has spread to the liver. Tumor infiltrating lymphocytes (TILs) are immune system cells that accumxulate around and inside the tumor. They can recognize and attack cancer cells, as well as prevent cancer cells from spreading to other organs. Scientists plan to multiply them in the laboratory and then introduce them back into the patient’s body through the main artery supplying the liver.

    Before this, patients will receive a single dose of melphalan chemotherapy to help prepare their body. After lymphocyte infusion (TIL), patients will also receive interleukin-2, a protein that helps lymphocytes do their job better. The goal is to see if this treatment is safe and effective. Doctors will watch closely for any side effects or serious problems that may arise during treatment.

    Sweden
  • A study comparing the combination of lifileucel plus pembrolizumab with pembrolizumab alone in the treatment of unresectable, advanced melanoma

    The aim of this study is to test a new treatment for people with advanced melanoma, a serious form of skin cancer that has spread to other parts of the body. The new treatment combines two different therapies: lifileucel, made from the patient’s own immune cells called tumor-infiltrating lymphocytes, and pembrolizumab, a type of immunotherapy drug that helps the body’s immune system fight cancer.

    The study will compare the effectiveness and safety of this combination treatment with pembrolizumab alone. Patients who initially received only pembrolizumab and whose cancer worsened will have the option to switch treatment and receive lifileucel monotherapy.

    The main goals of the study are to see whether the combination treatment can improve the objective response rate, which measures how many patients have had their tumors shrink, and progression-free survival, which is how long patients live without their cancer getting worse. To evaluate the results of the study, patients will be followed for up to 5 years.

    To be eligible for this trial, patients must have advanced melanoma that cannot be surgically removed or has spread to other organs. Additionally, patients cannot be previously treated for metastatic disease, although some prior therapies for earlier stages of melanoma are permitted.

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  • Study of Fidrisertib/IPN60130 in the treatment of Fibrodysplasia Ossificans Progressiva (FOP)

    The aim of this study is to test a new drug called fidrisertib (also known as IPN60130) to treat a rare disease called Fibrodysplasia Ossificans Progressiva, or FOP. FOP is a grave disease that causes bones to start growing in places they shouldn’t, such as muscles and soft tissues. This causes a lot of pain, swelling, and stiffness in the joints, making movement difficult.

    In the study, some participants will be given the new drug fidrisertib at two different doses, and others will be given a dummy treatment called a placebo. Researchers will monitor the situation closely, performing special tests called low-dose whole-body computed tomography (WBCT) to measure new bone growth. For some older participants, they may also use another type of test called fluorine-18-labeled sodium fluoride positron emission tomography – computed tomography to check bone growth.

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  • Study of the drug combination mRNA-4157/V940 and Pembrolizumab in the treatment of melanoma

    The aim of this clinical trial is to test whether a new drug called mRNA-4157/V940 in combination with pembrolizumab can help prevent the recurrence of melanoma in people who have already had it. Currently, mRNA-4157/V940 is what is called “individualized neoantigen therapy,” which means it is a therapy created specifically for each patient based on their cancer cells. Doctors give this drug along with pembrolizumab, a drug that helps the immune system fight cancer cells.

    The main goal of this study is to determine whether taking V940 and pembrolizumab together is more effective in preventing melanoma recurrence than taking pembrolizumab alone. Researchers will closely monitor how long it takes for the cancer to return or spread. The study will last for approximately 74 months.

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  • Evaluating Ianalumab for active Sjogren’s syndrome

    The NEPTUNUS-2 study is a significant research project aimed at exploring the effectiveness and safety of a medication called ianalumab (VAY736) for individuals suffering from active Sjogren’s Syndrome. This study is designed as a three-arm, randomized, double-blind, placebo-controlled trial, which means participants will be randomly assigned to one of three groups: two will receive ianalumab at different intervals, and one will receive a placebo, with neither the participants nor the researchers knowing which group participants are in to ensure unbiased results.

    The main goal of this study is to determine how well ianalumab can improve the symptoms of Sjogren’s Syndrome compared to a placebo. This will be measured by the change in a specific score called the EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) from the start of the study to week 48. The ESSDAI score helps doctors understand how active the disease is, with a higher score indicating more active disease. A decrease in this score over time would suggest an improvement in the condition.

    Participants in this study will receive ianalumab injections either once a month or every three months, depending on the group they are assigned to. The study emphasizes not only the potential benefits of ianalumab in treating Sjogren’s Syndrome but also its safety and tolerability, ensuring that the treatment is not only effective but also safe for patients.

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  • Comparison of zibotentan/dapagliflozin with dapagliflozin alone in the treatment of chronic kidney disease with high proteinuria

    The study aims to understand how to better treat people with chronic kidney disease (CKD) and high proteinuria. This study is in its third phase and involves multiple centers where participants will be closely monitored. The main goal is to compare the effectiveness, safety, and how well participants tolerate a combination treatment of zibotentan/dapagliflozin versus dapagliflozin alone.

    During this study, participants will be randomly assigned to one of two groups. One group will receive the combination of zibotentan and dapagliflozin, while the other group will receive only dapagliflozin. Both treatments aim to slow down the decline in kidney function, which is a major concern for people with CKD and high proteinuria. The key measure of success for this study is the change in eGFR from baseline, which is a test used to check how well the kidneys are working, specifically by measuring the estimated glomerular filtration rate (eGFR). This will be assessed at the 24-month mark of the study.

    This research is crucial because it could lead to better treatment options for those suffering from CKD and high proteinuria, potentially improving their quality of life and health outcomes.

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  • Comparing Acupuncture and Metformin with Lifestyle Changes for PCOS and Insulin Resistance

    This clinical trial is designed to explore the effectiveness of two different treatments for women with Polycystic Ovary Syndrome (PCOS) who are also experiencing insulin resistance. The study aims to compare the impact of combining lifestyle management with either acupuncture or metformin (a medication), against the effects of lifestyle management alone. The main goal is to see how these treatments can improve the body’s ability to manage glucose, which is crucial in preventing the development of type 2 diabetes.

    The trial will last for 4 months, during which the researchers will closely monitor changes in insulin sensitivity, glucose regulation, and overall health markers including hormone levels, body fat distribution, and mental health aspects such as anxiety and depression. One of the unique aspects of this study is its focus on not just the physical health outcomes, but also on the quality of life and emotional well-being of the participants.

    For those considering the metformin treatment, it’s important to note that the medication will be gradually introduced to minimize side effects, starting with a lower dose and increasing to the target dose over the first three weeks. The study also places a strong emphasis on the potential benefits of acupuncture, hypothesizing that it could be equally effective as metformin but with fewer negative side effects.

    This trial is particularly significant for women with PCOS and insulin resistance, as it seeks to provide evidence-based insights into managing these conditions, improving fertility, and potentially preventing the onset of more serious health issues down the line.

    Sweden
  • Study of belzutifan for treating advanced cancers

    This clinical trial aim is to test out a new drug called belzutifan, also known as MK-6482 or WELIREG™. It’s a pill patient can take once a day, and the main goal is to see if it can shrink or get rid of tumors in folks with certain types of cancer.

    The cancers the researchers are looking at are pheochromocytoma and paraganglioma, which are tumors that start in the adrenal glands or nervous system. Pancreatic neuroendocrine tumors, tumors related to von Hippel-Lindau disease, advanced gastrointestinal stromal tumors, and other solid tumors with certain genetic changes that involve a protein called HIF-2α, there will be also tested.

    The big thing the researchers are  keeping an eye on is the objective response rate, which means how many folks see their tumors shrink or disappear completely while taking this drug. The researchers will be watching closely for any side effects too, of course, to make sure this new medicine is safe.

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  • Sparsentan Treatment Study for Children with Kidney Diseases

    We are excited to introduce a clinical trial focused on the study of Sparsentan treatment in children and adolescents with certain types of kidney diseases that lead to protein loss in urine, known as proteinuric glomerular diseases. This includes conditions like Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin A Nephropathy (IgAN), IgA Vasculitis (IgAV), and Alport Syndrome (AS).

    The main goal of this study is to understand how safe, effective, and tolerable Sparsentan is when given as an oral suspension or tablet. We are particularly interested in seeing how this treatment can change the levels of protein in the urine over a period of 108 weeks.

    This study is designed as a Phase 2, Open-Label, Single-Arm trial, meaning all participants will receive the treatment, and there will not be a comparison group receiving a placebo. We are looking to enroll approximately 67 pediatric subjects, aged 1 year to less than 18 years, who have been diagnosed with one of the specified conditions. The study is divided into three populations based on the specific disease and age groups, with different dosages of Sparsentan being tested across these groups.

    The safety of the participants will be closely monitored throughout the study, with a special focus on any treatment-emergent adverse events, serious adverse events, and any adverse events that may lead to discontinuation of the treatment. Additionally, we will measure the change in the urine protein/creatinine ratio (UP/C) from the start of the study to week 108 to assess the effectiveness of Sparsentan in reducing proteinuria.

    This study represents an important step towards finding a potentially effective treatment for children and adolescents suffering from these challenging kidney diseases. If you or your child are dealing with one of these conditions and are interested in participating, we encourage you to consider this unique opportunity.

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  • Testing a new drug for advanced prostate cancer

    This trial compares a new drug called AZD5305 with a placebo in men who have a specific kind of prostate cancer that has not responded to usual treatment methods. It’s a large trial, with around 1800 participants, and the main aim is to see whether the new treatment can help slow down the disease for longer than current treatments. Participants will be assigned to two different groups, and they will not know whether they’re receiving the real drug or the placebo. Their health will be monitored closely, with regular scans to check the progress of the cancer. The trial will also look at any side effects of the treatment and how it affects the patients’ ability to do their daily activities.

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  • Continued Parsaclisib treatment for B-cell cancer patients

    This is a phase II clinical trial focused on providing continuation of treatment with a drug called parsaclisib to people diagnosed with B-cell malignancies. The main goal of this study is to expand the treatment regimen established in the previous study. Study participants will receive parsaclisib as a stand-alone therapy (monotherapy) or in combination with other therapeutic agents, which may include itacitinib, ruxolitinib or ibrutinib. The study aims to facilitate participants’ ongoing care and contribute to the broader field of medical research by collecting data on the effectiveness and safety of prolonged use of parsaclisib.

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  • Testing the safety and effectiveness of astegolimab for chronic lung disease

    The aim of this study is to see if a drug called astegolimab will be effective and safe in people with a lung disease called chronic obstructive pulmonary disease, or COPD. During this study, patients will be divided into 2 groups. One group of patients will receive the drug, the remaining patients will receive a placebo to compare the results. Both groups will not know what they are getting. The study was particularly interested in people suffering from COPD (chronic obstructive pulmonary disease) who smoked or still smoke and often get sick because of it.

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  • Study on new combination therapy for aggressive lymphoma

    This study is about a less common but severe form of cancer known as Diffuse Large B-Cell Lymphoma (DLBCL). It is testing if a new medication called epcoritamab, given with a mix of other commonly used cancer medicines, can help control the disease better. These other medicines include rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, which are often collectively referred to as R-CHOP. The study includes about 900 adults from around the world who have recently been diagnosed with this type of lymphoma. They will be split into two groups. One group will get epcoritamab with R-CHOP and then continue with epcoritamab. The other group will get R-CHOP followed by rituximab. Doctors will carefully watch for changes in the disease and for any side effects. There will be many checks on health, including medical exams, blood tests, questionnaires, and monitoring of any side effects.

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  • Assessing imatinib inhalation therapy for pulmonary arterial hypertension

    This clinical study aims to evaluate the safety and efficacy of an inhaled treatment called imatinib (AV-101) for patients with Pulmonary Arterial Hypertension (PAH). The trial is divided into two parts: Phase 2b and Phase 3. In Phase 2b, researchers will test three doses of AV-101 to identify the optimal dose for Phase 3. They will check this by measuring the resistance of the lung vessels — less resistance means the medicine is working. In the following Phase 3, the primary outcome will be the change in the 6-minute walk distance after 24 weeks of treatment compared to a placebo. Participants must be between 18 and 75 years old, have a diagnosis of PAH, and meet specific criteria regarding their disease severity and concomitant therapy.

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  • Testing a new combination therapy with Divarasib for advanced lung cancer

    This study wants to find out how safe and effective a drug called divarasib is, especially when used with other cancer-fighting drugs (pembrolizumab, carboplatin, cisplatin, pemetrexed), for people who have a specific type of lung cancer (non-small cell lung cancer) that has not been treated before and has spread to other parts of the body. This particular cancer cells have a special mutation called KRAS G12C. The study will check how well the drug works in people’s bodies and what kind of side effects it brings. The effectiveness will be gauged by partial response or complete response.

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  • Study of the effectiveness of a new drug in the treatment of heart failure and pulmonary hypertension

    This clinical trial explores the potential benefits of AZD3427 for individuals with heart failure (HF) and pulmonary hypertension (PH) Group 2, a condition characterized by increased blood pressure in the lungs due to heart disease. Around 220 participants will be randomly assigned to receive either AZD3427 or a placebo through subcutaneous injections every two weeks for 24 weeks. The trial aims to assess the impact of AZD3427 on reducing pulmonary vascular resistance (PVR) and improving various heart and lung health indicators. Participants will undergo multiple study visits, with the total duration of the study being approximately 32 to 37 weeks.

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  • Testing a new inhaled drug for pulmonary arterial hypertension

    This study focuses on the efficiency and safety of a new inhaled drug – MK-5475 – for patients suffering from Pulmonary Arterial Hypertension (PAH). The study is divided into two parts: phase 2 and phase 3. In phase 2, the researchers will compare three different doses of MK-5475 with a placebo over a base period of 12 weeks. The goal is to find out if any of the doses can decrease the patient’s pulmonary vascular resistance (PVR), which is the resistance that the heart must overcome to pump blood through the lungs. In Phase 3 of the study, the best performing dose from Phase 2 will be used to confirm its long-term effectiveness, safety, and tolerability over a 12-week base period with a follow-up period of up to five years. The focus is to see if this dose is better than a placebo in improving the patient’s walking distance over 6 minutes. The study aims at improving the quality of life and physical health of PAH patients with the help of the new drug.

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