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Набира участници Фаза 3

PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.

Androgen Axis Suppression Prostatectomy Prostate Cancer

1. Personalize treatment for prostate cancer based on how aggressive the disease is and 2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.

Начало: 10.09.2024 Край: 30.06.2029 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06274047

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Natural History of Depression, Bipolar Disorder and Suicide Risk

Behavioral Symptoms Suicide Self-Injurious Behavior Sensory System Agents +17

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation....

Начало: 09.09.2024 Край: 01.06.2030 Възраст: 18–120 г.

United States National Institute of Mental Health (NIMH) NCT06462196

Набира участници Фаза 2

Pinoxin for the Prevention of Radiation-Induced Skin Injury

Cancer Patients Undergoning Radiotherapy

The incidence of radiation-induced skin injury is high, and effective preventive measures are currently lacking. This study evaluates the role of the skin protective agent Pinoxin in preventing skin injury. Patients are randomly assigned into two prospective groups: treatment group and control group. In treatment group, patients will receive Pinoxin treatment. In control group，patients will receive placebo treatment. The rate of grade 2 or greater skin injury will be analyzed.

Начало: 05.09.2024 Край: 31.12.2026 Възраст: от 18 г.

China Fudan University NCT07545720

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Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD

Parkinson Disease Parkinsonian Disorders Brain Disease Basal Ganglia Diseases +1

This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed "Brain-First" and "Body-First" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability. Findings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.

Начало: 04.09.2024 Край: 01.05.2031 Възраст: от 18 г.

Italy Azienda USL Reggio Emilia - IRCCS NCT07187843

Набира участници Фаза 3

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

NASH - Nonalcoholic Steatohepatitis MASH - Metabolic Dysfunction-Associated Steatohepatitis

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Начало: 04.09.2024 Край: 01.03.2030 Възраст: 18–80 г. Лечение

Argentina, Australia, Brazil +16 Akero Therapeutics, Inc NCT06528314

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IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)

Sexually Transmitted Infections (Not HIV or Hepatitis) HIV Infections Sexual Behavior

The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence.

Начало: 02.09.2024 Край: 31.05.2028 Възраст: от 13 г.

United States University of Illinois at Chicago NCT06266416

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Arlington Aging Study

Aging

The goal of this observational study is to learn about the mechanisms causing functional decline with age, using magnetic resonance imaging, exercise science, integrative physiology, neuroscience, and remote monitoring. Specific aims include: Aim 1: Advance knowledge of the biology of aging and its impact on the prevention, progression, and prognosis of disease and disability. Aim 2: Determine the effects of personal and societal factors on aging. Aim 3: Examine the influence of racial/ethnic and sex differences on the biology of aging and its impact on the prevention, progression, and prognosis of disease and disability.

Начало: 01.09.2024 Край: 31.12.2030 Възраст: 18–85 г.

United States The University of Texas at Arlington NCT06857877

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Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients

Respiratory Failure Acute Hypoxemic Respiratory Failure Acute Hypoxic Respiratory Failure Hypoxemia +2

A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.

Начало: 01.09.2024 Край: 31.07.2026 Възраст: от 18 г.

United States University of Colorado, Denver NCT06501118

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Rural Illinois Lung Cancer Screening Initiative

Lung Cancer

The role of this observational study is to access the feasibility of providing lung cancer screening using a designated nurse navigator through lung cancer screening clinic. Eligible participants will be identified using medical records, eligibility will be confirmed through phone call, screening visits will be scheduled as in-person visit or telehealth visit. Computed tomography screening will be performed at an approved center closer to the individuals place of living and results will be discussed during follow-up in-person visit or telehealth visit.

Начало: 01.09.2024 Край: 31.08.2030 Възраст: 50–80 г.

United States Southern Illinois University NCT06084078

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Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

Rheumatoid Arthritis

Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy. This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48. This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines.

Начало: 01.09.2024 Край: 01.04.2030 Възраст: 18–65 г.

China Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University NCT06301373

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Pharmacist-led Continuous Glucose Monitoring

Type 2 Diabetes

This is a pilot study. The goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. The main questions it aims to answer are: 1. to assess change in hemoglobin A1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no continuous glucose monitoring (only self-monitoring blood glucose with a glucometer). 2. to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group) 3. to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)

Начало: 01.09.2024 Край: 30.06.2026 Възраст: от 18 г.

United States University of South Florida NCT06572306

Набира участници Фаза 1

Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy

Acute Myeloid Leukemia Personalized Active Immunotherapy Maintenance Therapy

Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk groups and 80% for high-risk groups - with a long-term survival rate \

Начало: 01.09.2024 Край: 01.09.2026 Възраст: 18–70 г.

China Fujian Medical University Union Hospital NCT07551037

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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

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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

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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

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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 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 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

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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 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

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