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Nijmegen

Nijmegen city is located in Netherlands. Currently, 20 clinical trials are being conducted in this city.

Nijmegen, nestled in the Netherlands, is the country’s oldest city, with its origins tracing back over 2,000 years to Roman times. This historical gem is renowned for its vibrant cultural scene, hosting the International Four Days Marches, the world’s largest multiple-day walking event. The city is also home to Radboud University, a prestigious institution that contributes to Nijmegen’s lively student population. The Valkhof Museum, with its Roman artifacts, and the remnants of the ancient city walls, offer a glimpse into Nijmegen’s rich past.

  • CT-EU-00112545

    Evaluating the Safety and Effectiveness of DYNE-101 for Myotonic Dystrophy Type 1 Patients

    This clinical trial is focused on evaluating a new treatment called DYNE-101 for individuals with Myotonic Dystrophy Type 1 (DM1). The main goal is to see how safe and tolerable this treatment is when given through an intravenous (IV) infusion, which means directly into the vein. The study is designed to carefully monitor how participants respond to multiple doses of DYNE-101 over time.

    The trial is structured into four main phases. It starts with a Screening Period that lasts up to 8 weeks to determine eligibility. Following this, there is a multiple-ascending dose (MAD) Placebo-Controlled Period that goes on for 24 weeks, where the safety and effectiveness of different doses of DYNE-101 are compared against a placebo (a treatment with no active drug). This is to ensure that any changes in participants’ health can be accurately attributed to the treatment. After this phase, there is a Treatment Period of another 24 weeks, where all participants receive DYNE-101. The study concludes with a Long-Term Extension (LTE) Period lasting 96 weeks, aimed at understanding the long-term impacts of the treatment.

    One of the key aspects being monitored throughout the study, up to Week 145, is the number of participants who experience any treatment-emergent adverse events (TEAEs), which are any new or worsening health issues that occur during the trial.

    This study represents an important step towards finding a new treatment option for those living with Myotonic Dystrophy Type 1, with a strong focus on safety and the overall well-being of the participants.

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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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  • Study on the effectiveness of Givinostat in Non-Walking Duchenne Muscular Dystrophy Patients

    This clinical trial is focused on testing the effectiveness, safety, and how well patients can tolerate a medication called Givinostat for those who have Duchenne Muscular Dystrophy (DMD) and can no longer walk. The study is designed for male pediatric patients aged between 9 to less than 18 years. A total of 138 participants will be involved, and they will be divided into two groups. One group will receive Givinostat, and the other group will receive a placebo, which is a substance with no therapeutic effect, designed to mimic Givinostat. This division will be done randomly and both the patients and the doctors will not know who is receiving the actual medication and who is receiving the placebo, making this a double-blind study.

    The main goal of this study is to see if Givinostat can help reduce muscle decline in patients with DMD who cannot walk, by looking at changes in upper limb function after 18 months of treatment. The safety and tolerability of Givinostat in these patients will also be closely monitored.

    Participants will be involved in the study for about 20 to 21 months, which includes a 4-week screening period to confirm eligibility, 18 months of treatment, and a follow-up period. At the end of the treatment period, all participants, regardless of which group they were in, will have the option to join a long-term safety study where they will receive Givinostat.

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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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  • Testing the effectiveness of new drugs in the treatment of age-related macular degeneration

    The study is investigating a potential breakthrough in treating age-related vision loss, specifically neovascular age-related macular degeneration (nAMD). It introduces a novel therapy, OPT-302, and pairs it with Aflibercept, comparing this combination’s effectiveness against the standard treatment. Participants undergo a series of thorough eye examinations and treatments to monitor the progression of their vision health. The research aims to offer a clearer understanding of how these treatments can better manage and possibly improve vision for individuals dealing with nAMD, contributing valuable knowledge to the field of eye health care.

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  • Investigating efficacy and safety of new therapy in early-stage Parkinson’s disease

    This clinical trial aims to examine BIIB122, a new medication considered to potentially slow down the progression of early-stage Parkinson’s disease in patients aged between 30–80 years old. Participants will undergo treatment with either BIIB122 or a placebo equal in appearance but devoid of actual medicine. The trial’s routine includes a single daily medication intake for a timeframe between 48 and 144 weeks. To evaluate the medication’s efficacy, patients’ symptoms and their impact on everyday life will be observed using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). In addition to this, safety assessment of BIIB122 will be a main focus of the study. The trial treats this as a double-blind study, anonymizing whether a patient takes the BIIB122 drug or a placebo.

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  • Exploring the safety of seladelpar in treating primary biliary cholangitis

    This is a long-term study on a drug named seladelpar for people with a liver disease called Primary Biliary Cholangitis (PBC). The main goal is to see if this drug is safe and easy for patients with PBC to use over a long period. A secondary goal is to see if seladelpar can effectively treat PBC and improve the patient’s quality of life. The study will track a few things, like if there are changes in the patient’s liver health which may lead to hospitalization or if the patient’s liver enzymes like alkaline phosphate and bilirubin level normalize or not after taking this drug.

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  • A study to test the safety and impact of new drugs on advanced solid tumors

    This study is testing a new treatment called [177Lu]Lu-FF58 in patients with advanced or late-stage serious cancers. The aim of treatment is to target proteins in the body called integrins, which are mainly found in these cancers. The study is divided into two parts: “escalation” and “expansion”. The escalation section will test different doses of the new treatment to find the most appropriate dose. The “expansion” part will assess whether the treatment is safe and can help control the disease using the best dose found in the first part. During the study, researchers will perform regular tests to understand the effects of the treatment on the body and how effective the treatment is against the cancer.

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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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  • Exploring treatment options for newly diagnosed Multiple Myeloma

    This clinical trial investigates two treatment paths for newly diagnosed multiple myeloma patients who are not planned for stem cell transplant initially. The first group receives a combination of bortezomib, lenalidomide, and dexamethasone (VRd) followed by cilta-cel, an innovative therapy. The second group receives VRd followed by continued treatment with lenalidomide and dexamethasone (Rd). The study evaluates the effectiveness of these treatments by monitoring disease progression, treatment response, and patient survival rates. It also assesses the safety and side effects of the treatments, aiming to improve the quality of life and outcomes for patients with multiple myeloma. The trial’s objective is to provide valuable data on the potential benefits of integrating cilta-cel in the treatment regimen, compared to the more traditional approach, offering insights for better management of this challenging cancer.

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  • Understanding trastuzumab deruxtecan treatment for advanced lung cancer

    This study is testing a new lung cancer treatment, Trastuzumab Deruxtecan, to see if it’s effective and safe for patients with a certain type of advanced lung cancer (Non-Small Cell Lung Cancer with HER2 mutations). Patients in the study either receive this new treatment or standard care (cisplatin or carboplatin + pembrolizumab + pemetrexed). The main goal is to see if the new treatment helps patients live longer without their cancer getting worse and to monitor any side effects.

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  • Evaluating dostarlimab for treating stage III colon cancer

    This research is focused on the investigation of the effect of dostarlimab on patients with severe, untreated colon cancer (T4N0 or Stage III dMMR/MSI-H). The primary objective is to assess whether dostarlimab yields superior outcomes for the patients in comparison to standard treatments. Patient monitoring will be based on tumor response and the potential impact on their quality of life resulting from the drug or disease progression.

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  • Investigating safety and efficacy of new drug in spinocerebellar ataxia and Huntington’s disease

    In the search for better treatment options for neurodegenerative diseases like spinocerebellar ataxia and Huntington’s disease (HD), a new drug referred to as VO659 is currently being tested. The main goals are to observe how safe this new medicine is for patients and understand how it behaves in the body (this is often called pharmacokinetics). In this trial, patients who can still walk and have mild to moderate spinocerebellar ataxia or early Huntington’s disease will receive up to five doses of VO659. The application of the drug is not oral; instead, it will be administered via injections into the lower spine. It’s important to understand that the entire process will last for about 42 weeks per patient, consisting of initial screening, dosing, and post-dosing stages. All throughout the trial, suitable samples will be collected to monitor safety and drug responses.

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  • Evaluating the efficacy of macitentan in the treatment of high pulmonary artery blood pressure

    This study is checking if a 75 mg dose of a medicine called Macitentan can do a better job for patients with a lung condition called Pulmonary Arterial Hypertension (PAH) compared to a 10 mg dose. The main goal is to see if the 75 mg dose can better delay the patient’s first major health event related to PAH. Major events include things like unplanned hospital stays related to PAH, or their PAH getting worse. The researchers will check if patients’ PAH gets worse by looking at things like their physical exercise ability and signs of heart failure. The study also looks at how patients’ symptoms change from day to day.

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  • Sotatercept treatment study for new Pulmonary Hypertension patients

    This study is an important test where doctors are looking at how a drug called Sotatercept can help people struggling with Pulmonary Arterial Hypertension (or PAH for short). The goal is to see whether this drug can delay or prevent the condition from getting worse. PAH makes it really hard for patients to breathe because it affects lungs and heart. The testing process is being done in a fair and careful way. Half of the patients will get the drug, and the others will get a ‘placebo’ which doesnt contain any medicine. The doctors will look at the effect on patients over time. The study is looking specifically at patients who were recently diagnosed with PAH and are at risk for the disease to get worse.

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  • A study on the effect of zanamivir in babies with influenza

    This study tests the medicine zanamivir in hospitalized babies under 6 months with severe flu. It’s an open-label trial, meaning everyone knows they’re getting zanamivir. The medicine is given through an IV for up to 10 days. Researchers will check how the medicine moves in the body, its safety, and how it affects flu symptoms. Babies will be followed for 24 days, including after the treatment ends. The aim is to understand if zanamivir can safely help very young babies with serious flu.

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  • Testing the effectiveness of a new drug compared with standard therapy in the treatment of asthma

    This medical research is a year-long study that tests a new asthma medication, called GSK3511294 (Depemokimab), against two other asthma medicines, Mepolizumab and Benralizumab. The trial is intended for teens and adults who have a severe form of asthma called ‘eosinophilic phenotype.’ The aim is to see if switching to GSK3511294 from Mepolizumab or Benralizumab keeps the severity and frequency of asthma attacks under control equally or better. Participants will keep taking their regular non-biological asthma medications throughout the trial. The study will look at the number of severe asthma attacks a patient experiences in a year, which is defined here as any worsening of asthma requiring steroids, a hospital visit, or an emergency room trip. They will also check for changes in their quality of life and their asthma control using questionnaires, and measure the capacity of their lungs with a breathing test.

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  • Testing new treatment for Geographic Atrophy treatment

    This research study pertains to a condition affecting the eyes known as Geographic Atrophy (GA), stemming from the aging process (Age-related Macular Degeneration). The investigation aims to assess the potential efficacy of a new drug (JNJ-81201887), administered through intraocular injection, in improving the aforementioned condition. A comparative analysis will be conducted between individuals receiving the drug and those subjected to a placebo procedure (a simulated intervention lacking an actual drug). Specialized photographs will be taken to quantify any alterations in the condition over an 18-month period. Additionally, observations will be made regarding changes in distant visual acuity, reading ability, and the requirement for aids during these activities over time. Ultimately, the study will examine the impact of the eye condition on daily activities.

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  • Comparing Imlifidase with standard treatment in anti-glomerular basement membrane disease

    This clinical trial is testing a medication called Imlifidase in patients who have a serious disease called anti-GBM (Goodpasture syndrome). The researchers are doing this study to compare two groups: people who take Imlifidase along with the usual treatment, and people who only get the usual treatment. This typical treatment consists of plasma exchange (PLEX), Cyclophosphamide and glucocorticoids. This study will last for 2 years. Researchers will measure things like kidney function, levels of harmful anti-GBM antibodies, breathing symptoms, drug interaction and patients’ quality of life.

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  • Testing new potential therapy for safeness in treating solid tumors

    This clinical trial revolves around the investigation of a novel medication called GEN1047 and its application in individuals with various types of cancer. Given that this marks the initial utilization of GEN1047 in human subjects, the primary objective is to assess its safety and tolerability. The study aims to gather crucial insights into the optimal dosage and its impact on the human body. The trial is structured into two distinct phases. The initial phase involves a gradual escalation of GEN1047 doses, while the second phase focuses on testing the most effective dose identified during the initial phase. Throughout the study, any unfavorable changes in health associated with the study medication will be meticulously documented and analyzed. This comprehensive approach aims to ascertain both the safety profile and potential therapeutic efficacy of GEN1047 in the context of cancer treatment.

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