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Clinical trials located in

Milan

Milan city is located in Italy. Currently, 20 clinical trials are being conducted in this city.

Milan, Italy’s second-largest city, is a global capital of fashion and design. Founded by the Insubres, a Celtic people, it was later captured by the Romans in 222 BC. Milan is renowned for its rich historical heritage, including the iconic Duomo di Milano, a marvel of Gothic architecture, and the Santa Maria delle Grazie, which houses Leonardo da Vinci’s “The Last Supper.” The city is also a financial hub, home to the Italian Stock Exchange. Its vibrant cultural scene is reflected in its numerous museums, theaters, and galleries.

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    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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  • Study on the effectiveness and safety of BBP-418 for Limb Girdle Muscular Dystrophy 2I patients

    This clinical trial is focused on a new treatment option for individuals diagnosed with Limb Girdle Muscular Dystrophy 2I (LGMD2I). This study is designed to explore the efficacy and safety of a medication called BBP-418 (Ribitol), which is administered as an oral solution. The medication is in the form of granules that are mixed with water to create a drinkable solution.

    The aim is to include participants aged 12 to 60 years old, covering a wide range of individuals affected by LGMD2I. Throughout a 36-month period, the study will closely monitor changes in the muscle function and overall health of the participants to determine the effectiveness and safety of BBP-418 in treating LGMD2I.

    A key aspect being observed is the change from baseline in the North Star Assessment for Limb Girdle Muscular Dystrophy after 36 months of treatment. This will aid in understanding the impact of BBP-418 on muscle function. In addition, the frequency and severity of any treatment-emergent adverse events will be tracked to ensure the medication’s safety over the long term.

    This study is a randomized, placebo-controlled, double-blind study, meaning participants will be randomly assigned to receive either the BBP-418 treatment or a placebo, with neither the participants nor the study staff aware of which group they are in. This approach helps ensure the reliability of the study results.

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  • A study of relacorilant in the treatment of hypercortisolism (Cushing’s syndrome) in patients with adrenal adenoma

    This clinical trial focuses on testing the effectiveness and safety of a drug called relacorilant in the treatment of patients with hypercortisolism (Cushing’s syndrome). Hypercortisolism is a condition in which there is too much cortisol in the body, which may occur due to an adenoma or hyperplasia of the adrenal glands that secrete cortisol. This condition can lead to diabetes or impaired glucose tolerance and/or uncontrolled high blood pressure.

    The study is in phase III, which means that the effectiveness and safety of the drug are compared with placebo. This is a double-blind, placebo-controlled study, which means neither participants nor researchers know who is receiving the actual drug and who is receiving the placebo to ensure unbiased results.

    Participants in this study will be randomly assigned to receive relacorilant or placebo for 22 weeks. The main goals of the study are to see how well relakorilant can improve blood sugar levels in patients with diabetes or impaired glucose tolerance, and how it affects blood pressure in people with high blood pressure. Additionally, the study will monitor the safety of relacorilant by recording any adverse events that occur.

    People who complete the study may have the opportunity to continue with a follow-up study, which may provide further information on the long-term effects and benefits of relacorilant.

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  • Exploring tirzepatide as a new treatment for Wolfram Syndrome type 1

    The researchers introduce a pioneering clinical trial aimed at exploring a new treatment option for individuals with Wolfram Syndrome Type 1 (WS1), a rare genetic disorder. This study focuses on the use of tirzepatide, a medication that has shown promise in addressing some of the critical aspects of WS1, including diabetes and possibly other symptoms related to the disease.

    Wolfram Syndrome is a challenging condition that typically emerges in childhood, leading to diabetes, vision loss, hearing problems, and sometimes diabetes insipidus. Currently, there is no cure or treatment known to halt or slow down the progression of WS1. However, this trial aims to change that by investigating the effectiveness of tirzepatide, a drug that targets specific bodily functions to potentially improve insulin production and stabilize blood sugar levels.

    The trial is designed as a phase 2 study, meaning the researchers will closely monitor the effects of tirzepatide over time in a group of participants with WS1.  Main goal is to see if this treatment can increase the body’s natural insulin production and help manage blood sugar more effectively. It will be assessed  by measuring changes in insulin production and response during the study.

    Participants will receive tirzepatide through a weekly injection, and  team of specialized clinicians and researchers will provide comprehensive care and follow-up.

    By joining this trial, patients will be at the forefront of research that could offer a new therapeutic option for  Wolfram Syndrome and contribute to our understanding of how to manage this and similar diseases more effectively.

    Italy
  • Understanding the Genetic Link Between Beckwith-Wiedemann Syndrome and Female Reproductive Health

    This study focuses on understanding the connection between certain genetic variations and reproductive issues, including difficulties in getting pregnant, recurrent pregnancy loss, and a condition known as Beckwith-Wiedemann Syndrome (BWS) in children. BWS is a growth disorder that can cause large body size, large organs, and other health problems in babies. Researchers have found that changes in genes related to the subcortical maternal complex (SCMC) might play a role not only in BWS but also in women who face challenges with pregnancy.

    The main goals of this research are to find out how common these genetic changes are in women who have trouble getting pregnant or who have children with BWS, to look for patterns in DNA methylation (a process that affects how genes work) in these women, and to study these effects in a mouse model to better understand the underlying causes of infertility and BWS.

    Participants in the study will be divided into three groups: healthy women with BWS children and a unique reproductive history, women under 35 undergoing assisted reproductive technology (ART) treatments without success, and women under 35 with recurrent pregnancy loss. The study will use whole-exome sequencing (WES) to look for genetic changes and whole-genome methylation analysis to study DNA methylation patterns. Some participants, especially those with BWS children and no identified genetic changes from WES, will also undergo whole-genome sequencing (WGS) to explore more areas of their DNA.

    By joining this study, participants will contribute to a deeper understanding of how genetic variations and epigenetic changes can impact reproductive health and the development of conditions like BWS. This research could lead to better diagnosis, treatment, and support for women facing these challenges.

    Italy
  • Exploring New Treatments for Brain Tumors Targeting Cancer Stem Cells

    This clinical trial focuses on developing new treatments for brain tumors, specifically targeting a type of cell called cancer stem cells (CSCs) that play a crucial role in the aggressiveness and resistance to current treatments of these tumors. Brain tumors, such as Glioblastoma (GBM), are among the most aggressive and have a low survival rate, making the need for new therapeutic approaches urgent.

    The study is particularly interested in how a lipid called Sphingosine-1-phosphate (S1P) influences these cancer stem cells. S1P is involved in the tumor’s ability to grow, resist drugs, and spread, making it a potential target for new treatments. By understanding how the environment around the tumor affects these cells and their metabolism, especially under low oxygen conditions (hypoxia), researchers hope to find new ways to stop the tumor from growing and resisting treatment.

    The main goal of this project is to identify new molecular and metabolic targets that are crucial for the survival and resistance to chemotherapy of tumor stem cells. This could lead to the development of new drugs that can inhibit the proliferation of CSCs and, consequently, tumor progression.

    For patients participating in this study, researchers will be investigating specific markers related to the development and progression of brain tumors to improve diagnosis, treatment, and monitoring. This research could significantly improve the prognosis for patients suffering from brain tumors by identifying new therapeutic strategies and potential biomarkers.

    Italy
  • Stomach cancer treatment comparison: trastuzumab deruxtecan vs. ramucirumab & paclitaxel

    This is a thorough comparison study to measure the effectiveness and safety of two treatment paths. It’s designed for individuals who have experienced progression regarding a stomach (gastric) cancer, or cancer of the gastro-esophageal junction (GEJ). The study focuses on those with HER2-positive gastric or GEJ who have previously undergone a trastuzumab-containing regime but have not received further systemic therapy.The research compares the use of trastuzumab deruxtecan, a potent anti-cancer agent, and the combined use of ramucirumab and paclitaxel. The study’s primary goal is to evaluate the overall survival rate, while secondary aims involve examining progression-free survival, response duration, disease control, safety, pharmacokinetics, and immunogenicity.In the study, participants are fairly and randomly assigned to receive one of two treatments. This is crucial in understanding the superiority and safety of these treatment paths, and this knowledge may inform future approaches to treating these types of cancer.

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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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  • 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 acalabrutinib for a specific type of lymphoma

    This clinical trial is investigating a new combination therapy for diffuse large B-cell lymphoma, a type of lymphoma. The treatment combines Acalabrutinib, a targeted therapy drug, with R-CHOP, a chemotherapy mix consisting of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, a standard chemotherapy regimen. The aim of the study is to evaluate the safety and effectiveness of this combination in improving patient outcomes. It focuses on patients who have not been previously treated for lymphoma. The study aims to find better treatment strategies for this particular type of lymphoma.

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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 sotatercept with regular treatment in severe pulmonary arterial hypertension patients

    This investigation seeks to assess the effect of a new drug named Sotatercept on people who are suffering from a serious lung disease called ‘Pulmonary Arterial Hypertension’ (PAH). The trial is intended for individuals with high-risk PAH who are facing significant danger of death. The main goal is to find out if incorporating Sotatercept into the standard treatment can improve outcomes and potentially enhance the chances of survival. Participants who enroll will receive either Sotatercept in addition to their current medication or a placebo alongside their regular treatment.

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  • Examining repotrectinib vs crizotinib in advanced lung cancer treatment

    This trial is named TRIDENT-3, it’s for people who have a particular type of lung cancer that has spread beyond the lungs (advanced or metastatic). The lung cancer for this study is called ‘Non-Small Cell Lung Cancer’ (NSCLC) and it’s positive for an important part of the cells called ‘ROS1.’ The trial will compare two medicines: repotrectinib and crizotinib. People participating in the trial have not been treated with a group of drugs called ‘Tyrosine Kinase Inhibitors’ (TKIs) before. The main goal of this study is to see how effective and safe these two drugs are for these patients.

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  • Research on medicine combination for B-cell Non-Hodgkin Lymphoma

    This study is about testing epcoritamab, a new drug for a type of blood cancer called B-cell Non-Hodgkin Lymphoma. The goal is to see if the drug is safe for people and can successfully fight the cancer. Doctors will combine this drug with other medicines that are typically used to treat this cancer. The combined treatment will vary for different groups of patients, depending on factors like their specific type of cancer or their overall health. Some patients will be given epcoritamab on its own, while others will receive it with other cancer medicines. The study has two parts. The first part is to find a safe dose of the drug. The second part is to determine how well this drug helps in treating the cancer. Side effects will be closely monitored during the study.

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  • Testing the safety and effectiveness of a new drug on patients with Duchenne muscular dystrophy

    This study aims to test DYNE-251, a new medicine for people with a specific type of Duchenne muscular dystrophy (amenable to exon 51 skipping)- a muscle weakening disease. The goal is to evaluate if it’s safe, if people can tolerate it well, and if it helps produce a crucial muscle protein called dystrophin. Participants will be given DYNE-251 intravenous in the increasing doses in several stages. The study includes different phases, starting with a 24-week test period, followed by long-term observation. To measure the effects, the researchers will use a functional scale for motor abilities and a score for upper limb function.

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  • Fianlimab and cemiplimab: a new treatment for melanoma patients

    The study is underway to determine the most effective treatments in preventing the recurrence of melanoma, a form of skin cancer, following surgical removal. The medicines being tested are Fianlimab and Cemiplimab together or another medicine called Pembrolizumab. The trial aims to assess whether the Fianlimab and Cemiplimab combination outperforms Pembrolizumab in preventing cancer recurrence and if patients administered Fianlimab and Cemiplimab live longer. Additionally, the study seeks insights into the impact of treatments on patients’ quality of life, the occurrence of minor or major side effects, and how these drugs behave inside the patient’s body.

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  • Testing inhaled imatinib for pulmonary arterial hypertension

    This study is about a new medicine called imatinib (AV-101) which you breathe in as a dry powder. It’s for people who have a health problem called Pulmonary Arterial Hypertension (PAH) – when blood pressure is too high in the arteries that go from the heart to the lungs. The imatinib study will go through two stages. In the first stage, the researchers will try three different amounts of the medicine to find the best one. It will be based on how much it can reduce the resistance in the blood flow in the lungs. In the second stage, they it will be seen how far patients can walk in 6 minutes after taking the medicine for 24 weeks. The study also uses scoring systems to measure how much risk or symptoms a patient has. A higher score means more risk or symptoms.

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  • Osimertinib effectiveness study for early-stage lung cancer post-surgery

    This study is examining the effects of osimertinib on patients with a specific type of early-stage lung cancer (EGFRm stage IA2-IA3 non-small cell lung cancer) after complete tumor removal surgery. It’s a Phase III trial comparing osimertinib, a new drug, with a placebo. Participants, who have already had surgery for their lung cancer, will either receive osimertinib or a placebo daily for three years. The goal is to see if osimertinib can prevent cancer from coming back and improve patients’ survival rates.

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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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