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Набира участници

The Key to Integrated Trauma Treatment in Psychosis Trial

Psychiatric Diagnosis Schizophrenia Disorders Psychological Trauma, Historical

Schizophrenia spectrum disorders (SSDs) have a significant trauma etiology: trauma has been reported in 65 - 80% in this patient group and have a negative impact on prognosis. Trauma treatment is currently not offered in SSDs due to a lack of evidence. KIT is a pragmatic trial comparing the effectiveness of added trauma focused therapy, Eye Movement Desensitization and Reprocessing (EMDR) to standard treatment in SSDs. The study will compare EMDR as add on to treatment as usual (TAU) to TAU in patients with schizophrenia spectrum disorders (SSDs). The overall aim is to examine the effectiveness of EMDR on trauma symptoms in SSDs. Participants will receive max. 26 sessions of EMDR, and complete assessments before, during and after the course of therapy, in addition to a period of time (6 months) after therapy to examine long-term effects.

Начало: 01.09.2024 Край: 31.12.2028 Възраст: от 16 г.

Norway Haukeland University Hospital NCT06608706

Набира участници

Effects of Body Composition on Vascular Health in Females With a Healthy Body Weight

Normal-weight Obesity BMI Stress

Most of the time, body weight is evaluated by looking at the ratio of your weight to your height. This measurement is called body mass index or BMI. However, BMI does not account for what your body is actually made up of (e.g., body fat versus muscle), which may be more important for determining cardiovascular disease risk. The investigators aim to understand vascular health in females with a "healthy" BMI with differing amounts of body fat and muscle mass. We will have participants come to the lab for two different study visits. At one visit, participants will eat a meal high in fat, and at the other visit, participants will undergo a stress task.

Начало: 01.09.2024 Край: 31.05.2027 Възраст: 18–50 г.

United States Ball State University NCT06818500

Набира участници

A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

Von Willebrand Disease (VWD) Von Willebrand Disease (VWD), Type 1 Von Willebrand Disease (VWD), Type 2 Von Willebrand Disease (VWD), Type 3 +3

The purpose of this screening study is to accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeds in participants with Von Willebrand Disease (VWD). Data from this study will be used to establish baseline bleeding and treatment rates in a population of participants with VWD and act as comparator data for future clinical study outcomes.(e.g. Velora Pioneer)

Начало: 30.08.2024 Край: 01.12.2026 Възраст: от 16 г.

Australia, United Kingdom, United States Hemab ApS NCT06610201

Набира участници Фаза 1

Study With [225Ac]Ac-FL-020 in mCRPC Participants

Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of \[225Ac\]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Начало: 30.08.2024 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, China, Turkey (Türkiye) +1 Full-Life Technologies GmbH NCT06492122

Набира участници

COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease

Retinal Disease

The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs). Participants will: * undergo pupillary dilation * have photographs taken of the inside of the eyes using three different cameras

Начало: 29.08.2024 Край: 01.12.2026 Възраст: от 18 г.

United States University of Wisconsin, Madison NCT06380075

Набира участници Фаза 3

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Advanced Non-small Cell Lung Cancer HER2 Mutation

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, sevabertinib, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well sevabertinib works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: * Sevabertinib twice every day as a tablet by mouth, or * Standard treatment in cycles of 21 days via infusion ("drip") into the vein. * Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant receiving the standard treatment has their disease get worse (this is called "disease progression"), they may have the opportunity to switch ("cross over") to receive sevabertinib. * Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the doctors and their study team will: * take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer * check the overall health of the participants by performing tests such as blood and urine tests, and checking * heart health using an electrocardiogram (ECG) * perform pregnancy tests for women * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Начало: 28.08.2024 Край: 27.06.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +29 Bayer NCT06452277

Набира участници Фаза 2/3

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

Myasthenia Gravis Generalized Myasthenia Gravis

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis

Начало: 28.08.2024 Край: 01.09.2028 Възраст: 18–75 г. Лечение

Australia, Brazil, Germany +1 Kyverna Therapeutics NCT06193889

Набира участници Фаза 1/2

First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)

Amyotrophic Lateral Sclerosis (ALS) Mutation in the Superoxide Dismutase-1 (SOD1) Gene

This study is researching an experimental drug called ALN-SOD (called "study drug"). This study is focused on people with Amyotrophic Lateral Sclerosis (ALS) caused by a change in a gene called the Superoxide Dismutase-1 (SOD1) gene. This type of ALS is known as "SOD1-ALS". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is. The study is looking at several other research questions, including: * The effect the study drug has on specific biomarkers, which are substances in the blood or in the fluid that surrounds the brain and spinal cord, known as Cerebrospinal Fluid (CSF) * How much study drug is in the blood and in the CSF, at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) * What effects the study drug has on ALS symptoms

Начало: 28.08.2024 Край: 05.06.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +3 Regeneron Pharmaceuticals NCT06351592

Набира участници Фаза 2

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

Multiple Myeloma

This phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel (a type of chimeric antigen receptor T-cell \[CAR-T\] therapy) for multiple myeloma. The usual approach after treatment with idecabtagene vicleucel is to monitor the multiple myeloma without giving myeloma medications. There is currently no medication approved specifically for use after idecabtagene vicleucel treatment. Upon administration, iberdomide modifies the immune system and activates immune cells called T-cells, which could enhance the effectiveness of idecabtagene vicleucel. Iberdomide may keep multiple myeloma under control for longer than the usual approach (disease monitoring) after idecabtagene vicleucel, and may help multiple myeloma patients live longer.

Начало: 27.08.2024 Край: 31.10.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06179888

Набира участници

Nutrition Practice in Critically Ill Adults

Critical Illness

To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing. The aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.

Начало: 26.08.2024 Край: 31.12.2027 Възраст: от 18 г.

Australia Australian and New Zealand Intensive Care Research Cent NCT06576895

Набира участници Фаза 4

Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma

Asthma

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab

Начало: 26.08.2024 Край: 31.12.2026 Възраст: 12–80 г.

Canada, Denmark, Germany +3 Regeneron Pharmaceuticals NCT06572228

Набира участници Фаза 3

Silexan in the Treatment Of Posttraumatic Stress Disorder Trial

Post Traumatic Stress Disorder

Posttraumatic stress disorder (PTSD) is a common and debilitating mental illness. Current treatments for PTSD include psychotherapy and antidepressant medications. Many patients are unable to tolerate psychotherapy for PTSD and drop out of it. In addition, its effectiveness is limited. Up to 50 percent of patients who receive psychotherapy do not benefit from it. Antidepressant medications have only small benefits in PTSD. They also have unpleasant side effects that can make patients unwilling to take them. There is an urgent need to develop new treatments for PTSD that work and are well-tolerated. Silexan has the potential to provide an important alternative treatment for PTSD. Silexan is derived from lavender oil. It is taken orally in the form of capsules. It is currently available over-the-counter in 14 countries, including Australia and the United States. Previous research has shown that it is an effective treatment for anxiety disorders, including Generalized Anxiety Disorder. It is also well-tolerated by patients. The only side effects that have been identified so far are mild gastrointestinal symptoms (including burping and breath odour) and these are uncommon. The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD. The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD. The trial will recruit 278 participants. Participants will be randomly assigned to take Silexan or a placebo (look-alike dummy pills) daily in addition to their usual medications for 12 weeks. The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period. The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD. If Silexan is found to be an effective treatment for PTSD, the pool of patients who could potentially benefit from this treatment includes any adults with PTSD. Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment.

Начало: 26.08.2024 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia Deakin University NCT06412757

Набира участници

The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation

Alveolar Bone Loss Edentulism Nos

Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months. The aim of this study is: * to evaluate the success of SFE surgery using BCS as graft material, * to compare the microarchitecture of the augmented bone depending on the healing period, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

Начало: 24.08.2024 Край: 01.09.2031 Възраст: от 18 г.

Hungary Semmelweis University NCT06533397

Набира участници Фаза 3

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Multiple Myeloma

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Начало: 23.08.2024 Край: 01.07.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +11 Kite, A Gilead Company NCT06413498

Набира участници Фаза 2

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

High Grade Glioma Diffuse Intrinsic Pontine Glioma Anaplastic Astrocytoma Glioblastoma +6

The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant. The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.

Начало: 22.08.2024 Край: 28.08.2034 Възраст: 12–39 г. Лечение

Australia, Canada, Germany +4 Nationwide Children's Hospital NCT05843253

Набира участници Фаза 1

A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors

Cancer Breast Cancer Endometrial Cancer Metastatic Cancer +1

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

Начало: 22.08.2024 Край: 29.12.2027 Възраст: от 18 г. Лечение

Australia, France, Japan +5 Alterome Therapeutics, Inc. NCT06533059

Набира участници

Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)

Uterine Fibroid

This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.

Начало: 22.08.2024 Край: 01.12.2026 Възраст: от 18 г.

Australia, United Kingdom, United States Merit Medical Systems, Inc. NCT06153667

Набира участници Фаза 3

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic Inflammatory Demyelinating Polyneuropathy

The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

Начало: 21.08.2024 Край: 12.01.2029 Възраст: от 18 г.

Argentina, Belgium, Brazil +20 Sanofi NCT06290141

Набира участници

To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.

Arrhythmias, Cardiac Atrial Fibrillation Heart Diseases

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.

Начало: 21.08.2024 Край: 31.10.2026 Възраст: от 18 г.

South Korea Starmed NCT06358391

Набира участници Фаза 2

EORTC-1525-LCG: Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym)

type B3 thymoma and thymic carcinoma

Trial status: Authorised Progression Free Survival Rate at 6 months (PFSR-6) according to RECIST 1.1 per local investigator assessment, Safety according to CTCAE v4.0, Overall Response Rate (ORR) according to RECIST 1.1 per local investigator assessment, Disease Control Rate according to RECIST 1.1 per local investigator assessment (DCR), Duration of response according to RECIST 1.1 per local investigator assessment, Progression Free Survival (PFS) according to RECIST 1.1 per local investigator assessment, Overall Survival (OS), Progression Free Survival for patients continuing treatment after progression Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review

Начало: 20.08.2024 Възраст: от 18 г.

Belgium, France, Netherlands +1 European Organisation For Research And Treatment Of Can 2023-508658-24-00

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