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Cardiac Amyloidosis pRevaleNce of in OLDer Subjects Affected by Heart Failure

Cardiac Amyloidosis

Tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography

Начало: 01.07.2024 Край: 02.02.2028 Възраст: от 80 г.

France Gérond'if NCT06427304

Набира участници

Mechanistic Insights From Bronchoscopy Airway Samples

Asthma

The purpose of this study is to examine the mechanisms of asthma. The investigators are comparing the cells of individuals with and without asthma and looking at the roles various parts of the cell play in the production and secretion of mucus.

Начало: 01.07.2024 Край: 01.12.2028 Възраст: 18–70 г.

United States University of California, San Francisco NCT06105710

Набира участници Фаза 1

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

Metastatic Solid Tumor Recurrent Solid Tumor Advanced Solid Tumor Urinary Bladder Neoplasm +10

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Начало: 01.07.2024 Край: 01.05.2027 Възраст: от 18 г. Лечение

Australia, China, France +5 Eli Lilly and Company NCT06465069

Набира участници

BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment

Idiopathic Intracranial Hypertension (IIH)

1. To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments. 2. To establish the BMI at which this disease occurs. 3. To establish how much the BMI must be reduced to cure this disease. 4. To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion

Начало: 27.06.2024 Край: 01.05.2028 Възраст: от 18 г.

Spain University of Valencia NCT06913712

Набира участници Фаза 1

Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

Breast Cancer Relapse Resistant Cancer Triple Negative Breast Cancer

This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).

Начало: 27.06.2024 Край: 01.05.2028 Възраст: от 18 г.

United States UNC Lineberger Comprehensive Cancer Center NCT06347068

Набира участници Фаза 1

A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation.

Carcinoma, Pancreatic Ductal Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung

The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose. This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that: * are advanced (cancer that doesn't disappear or stay away with treatment) and * have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers). This includes (but limited to) the following cancer types: Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body. Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control. Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels. All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles. Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle. Participants can continue to take the study medication (PF-07934040) and the combination anti-cancer therapy until their cancer is no longer responding. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective. Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.

Начало: 27.06.2024 Край: 18.01.2029 Възраст: от 18 г.

China, Puerto Rico, United States Pfizer NCT06447662

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Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study

Uncontrolled Asthma

This study is a multi-centre, non-interventional, observational, ambispective registry. Planned study population consists of 9 000 adult patients with uncontrolled asthma receiving treatment according to standard of care (except biologics). Planned number of study site is 70 outpatient centers with experience of uncontrolled asthma treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled asthma in different regions in the most comprehensive way).

Начало: 27.06.2024 Край: 30.09.2026

Russia AstraZeneca NCT06521229

Набира участници Фаза 3

Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

Generalized Myasthenia Gravis

The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period.

Начало: 25.06.2024 Край: 19.08.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +19 Merck Healthcare KGaA, Darmstadt, Germany, an affiliate NCT06463587

Набира участници Фаза 1

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic Solid Tumors

This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.

Начало: 24.06.2024 Край: 01.10.2027 Възраст: от 18 г.

Canada, China, United States Avistone Biotechnology Co., Ltd. NCT06307795

Набира участници Фаза 2/3

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

Advanced Esophageal Adenocarcinoma Advanced Gastric Adenocarcinoma Advanced Gastroesophageal Junction Adenocarcinoma Clinical Stage II Esophageal Adenocarcinoma AJCC v8 +12

This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

Начало: 24.06.2024 Край: 31.10.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06203600

Набира участници Фаза 3

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Triple-Negative Breast Cancer

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Начало: 24.06.2024 Край: 14.12.2037 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +28 Merck Sharp & Dohme LLC NCT06393374

Набира участници

External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial

Severe Traumatic Brain Injury Intracranial Hypertension

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \

Начало: 24.06.2024 Край: 30.06.2028 Възраст: 18–65 г.

United States Brain Trauma Foundation NCT05889650

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Cera™ Vascular Plug System Post-Market Clinical Follow-Up

Aneurysm Endoleak Pulmonary Arteriovenous Malformation Portal Hypertension +2

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks

Начало: 21.06.2024 Край: 01.12.2027 Възраст: 18–85 г.

Germany, Italy, Turkey (Türkiye) Lifetech Scientific (Shenzhen) Co., Ltd. NCT06099015

Набира участници Фаза 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

Healthy Participants Healthy Subjects Healthy Volunteers Autoimmune Diseases +3

This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.

Начало: 20.06.2024 Край: 23.05.2026 Възраст: 18–75 г. Лечение

Australia, China, New Zealand BeiGene NCT06342713

Набира участници Фаза 3

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Polymyositis, Dermatomyositis

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.

Начало: 20.06.2024 Край: 04.08.2028 Възраст: 18–75 г. Лечение

Argentina, Australia, Austria +26 AstraZeneca NCT06455449

Набира участници Фаза 2

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm Acute Myeloid Leukemia Post Cytotoxic Therapy Acute Myeloid Leukemia, Myelodysplasia-Related +1

This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).

Начало: 18.06.2024 Край: 15.05.2029 Възраст: от 18 г.

Canada, Puerto Rico, United States National Cancer Institute (NCI) NCT05564390

Набира участници Фаза 2/3

A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

Generalized Myasthenia Gravis

The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \

Начало: 14.06.2024 Край: 17.08.2026 Възраст: 2–17 г.

Italy, Japan, Poland +3 UCB Biopharma SRL NCT06149559

Набира участници Фаза 3

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

Diabetes Mellitus, Type 1

This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.

Начало: 14.06.2024 Край: 01.10.2026 Възраст: от 18 г.

United States vTv Therapeutics NCT06334133

Набира участници Фаза 1

Study of APR-1051 in Patients With Advanced Solid Tumors

Advanced Solid Tumor

The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.

Начало: 13.06.2024 Край: 01.06.2028 Възраст: от 18 г.

United States Aprea Therapeutics NCT06260514

Набира участници Фаза 1/2

Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma

Diffuse Large B-Cell Lymphoma High Grade B-Cell Lymphoma

This phase Ib/II clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and/or effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.

Начало: 13.06.2024 Край: 01.04.2027 Възраст: 18–75 г.

United States OHSU Knight Cancer Institute NCT06249191

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