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Набира участници Фаза 2

A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer

Breast Cancer Metastatic Triple-Negative Breast Cancer

The researchers are doing this study to find out whether the study drug, SDX-7320, when combined with the standard chemotherapy eribulin, is an effective treatment for people with TNBC and metabolic dysfunction. The researchers will also look at whether the study treatment (SDX-7320 combined with eribulin) is safe and causes few or mild side effects in participants. The researchers will compare this treatment approach to eribulin alone.

Начало: 03.10.2022 Край: 01.10.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT05570253

Набира участници

Rocket Study: A Study to Characterize Biomarkers and Disease Progression in Participants With Pelizaeus-Merzbacher Disease

Pelizaeus-Merzbacher Disease

The purpose of the study is to prospectively assess longitudinal changes in proteolipid protein 1 (PLP1) protein, disease-related biomarkers in cerebral spinal fluid (CSF) and blood, neuroimaging parameters relevant to Pelizaeus-Merzbacher disease (PMD) and longitudinal changes in performance on clinical, participant, and caregiver-reported outcome assessments to inform the development of therapies for PMD.

Начало: 03.10.2022 Край: 01.03.2029 Възраст: 6–17 г.

France, Germany, Israel +4 Ionis Pharmaceuticals, Inc. NCT05659901

Набира участници

Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease

Dupuytren's Disease

Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence. Various medical and surgical treatments are available.

Начало: 29.09.2022 Край: 29.03.2030 Възраст: от 18 г.

France Elsan NCT05067764

Набира участници Фаза 2

Collagen-targeted PET Imaging for Early Interstitial Lung Disease

Interstitial Lung Disease

The goal of this study is to investigate the ability of \[68Ga\]CBP8 to detect collagen deposition in early interstitial lung disease.

Начало: 28.09.2022 Край: 01.12.2026 Възраст: от 40 г.

United States Massachusetts General Hospital NCT05417776

Набира участници Фаза 1

A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer

Bladder Cancer

The purpose of this study is to see whether 68Gallium PSMA-PET/CT scans are an effective way to detect sites of cancer in people with metastatic bladder cancer or skin cancer. The study researchers want to learn if a 68Gallium PSMA PET/CT scan will work better, the same, or not as well as the PET/CT scans doctors usually use for imaging bladder cancer or skin cancer (FDG-PET/CT scan).

Начало: 28.09.2022 Край: 01.09.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT05562791

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A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)

Nephrotic Syndrome in Children Minimal Change Disease Focal Segmental Glomerulosclerosis

Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated noninvasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.

Начало: 19.09.2022 Край: 01.08.2027 Възраст: 3–17 г.

United States Northwell Health NCT05583942

Набира участници Фаза 1

Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Head and Neck Carcinoma of Unknown Primary Locally Advanced Head and Neck Squamous Cell Carcinoma Locally Advanced Hypopharyngeal Squamous Cell Carcinoma +22

This phase I/Ib trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy ("chemo-radiation") in patients with head and neck cancer. Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Cisplatin, which is a chemotherapy used in this trial, is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.

Начало: 19.09.2022 Край: 01.07.2027 Възраст: от 18 г.

Canada, United States National Cancer Institute (NCI) NCT05172245

Набира участници Фаза 1/2

A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer

Advanced Non-small Cell Lung Cancer

This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.

Начало: 15.09.2022 Край: 01.12.2026 Възраст: 18–75 г.

China Jiangsu HengRui Medicine Co., Ltd. NCT05482568

Набира участници Фаза 3

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Acute Myeloid Leukemia

A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2

Начало: 13.09.2022 Край: 01.02.2032 Възраст: 18–75 г.

Austria, Belgium, Estonia +5 University of Ulm NCT04628026

Набира участници Фаза 2/3

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: * How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? * How many participants have their skin disease activity go down by at least 70% as measured by CLASI? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: * After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. * Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. * The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. * During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. * After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. * The total study duration for participants will be up to 80 weeks.

Начало: 13.09.2022 Край: 14.12.2027 Възраст: от 18 г.

Argentina, Belgium, Brazil +27 Biogen NCT05531565

Набира участници Фаза 2

Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults

Craniopharyngioma, Child Craniopharyngioma Recurrent Craniopharyngioma

The current study assesses the tolerability and efficacy of monotherapy with pan-RAF-kinase (Tovorafenib) inhibition for the treatment of children and young adults with craniopharyngioma.

Начало: 12.09.2022 Край: 01.03.2028 Възраст: 1–39 г. Лечение

Australia, United States Sabine Mueller, MD, PhD NCT05465174

Набира участници

Positive Emotions Following Acute Cardiac Events

Acute Coronary Syndrome Physical Inactivity

The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity.

Начало: 12.09.2022 Край: 31.03.2028 Възраст: 18–95 г.

United States Massachusetts General Hospital NCT05412862

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Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators

Sleep Sleep Deprivation Cognitive Change

This study aims to investigate the effect of a 15-minute meditation practice on sleep architecture and high-frequency Heart Rate Variability (HF-HRV), as well as cognitive performance after both a well-rested and sleep-deprived night.

Начало: 12.09.2022 Край: 31.12.2026 Възраст: 18–60 г.

United States Beth Israel Deaconess Medical Center NCT05026541

Набира участници

Paediatric Syncope in the Emergency Department

Syncope, Vasovagal Postural Orthostatic Tachycardia Syndrome Orthostatic Intolerance

The investigators will assess the efficacy of clinically recommended counterpressure maneuvers (CPM) in preventing syncope for paediatric patients. Participants presenting to the emergency department (ED) will first provide written informed consent. In stage I, they will be asked to complete a brief survey documenting the presentation of their syncopal episode, and any prodromal symptoms they experienced. Participants that consent to the second stage of the study will either receive usual care (control arm) or training in counter pressure maneuvers alongside usual care (intervention arm; leg crossing, bending, arm tensing). These patients will be followed for one years time, and will be asked to complete monthly surveys detailing their syncopal and presyncopal recurrence. Medical records will be accessed over the duration of the study to identify any changes in medical diagnosis.

Начало: 03.09.2022 Край: 30.09.2027 Възраст: 6–18 г.

Canada Dr. Victoria Claydon NCT05555771

Набира участници Фаза 1

Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc

Glioblastoma Multiforme

The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma. CAR.B7-H3T cells treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administration for glioblastoma.

Начало: 02.09.2022 Край: 30.05.2030 Възраст: от 18 г.

United States UNC Lineberger Comprehensive Cancer Center NCT05366179

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Tissue and Metabolic Characterization of Arrhythmogenic Cardiomyopathies by Hybrid PET-MRI Imaging, Impact of the Observed Profiles on the Phenotype and on the Evolution of Cardiomyopathy

Arrhythmogenic Cardiomyopathies

Status of the research project: The main complications of arrhythmogenic cardiomyopathies (AC) are sudden death, more rarely heart failure. Recently, data are emerging in favor of an associated role of myocardial inflammation and myocarditis in this pathology, but the impact of inflammation on the presentation and prognosis of the cardiomyopathy, as well as its mechanisms, are not clearly elucidated. To date, endomyocardial biopsy is the gold standard for documenting myocardial inflammation. Aim of the research: To evaluate the interest of a new hybrid PET-MR imaging tool for tissue and metabolic characterization of AC associating MRI and 18F-FDG PET, already used in inflammatory pathologies (cardiac sarcoidosis). Project description: Multicentric observational study of 80 patients with genetic AC undergoing PET-MR. Description of the observed profiles and their impact on the phenotype of the cardiomyopathy and its evolution, study of associated immunological mechanisms, correlation with available anatomopathological data. Expected results and perspectives: first non-invasive description of tissue and metabolic phenotype of AC by PET-MR imaging and its prognostic role, basis for pathophysiological and therapeutic research in case of confirmation of the performances of this imaging for the detection of myocardial inflammation.

Начало: 01.09.2022 Край: 31.12.2026 Възраст: 16–99 г.

France Nantes University Hospital NCT05450783

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A Study to Learn More About the Safety of the Drug Vericiguat in Japanese People With Chronic Heart Failure Who Will be Receiving Vericiguat Under Real-world Conditions

Chronic Heart Failure

This is an observational study in which data from Japanese people with chronic heart failure who will be receiving vericiguat is studied. Chronic heart failure (HF) is a long-term condition where the heart does not pump blood as well as it should. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death. The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. Vericiguat is already available and approved for doctors to prescribe to people who have heart failure. A limited number of patients have been treated with vericiguat. Therefore information about its safety in a broader population and especially among Japanese people as well as for prolonged periods of treatment is still missing. In this study, the researchers want to learn more about how safe vericiguat is if used in Japanese people with long term HF. To see how safe vericiguat is, the researchers will collect the medical problems the participants have during the treatment with vericiguat under real-word conditions. They will particularly focus on the following: * high blood pressure * any medical problems due to combination of the study treatment vericiguat with nitrates and nitric oxide (NO) donors or with PDE5 inhibitors * medical problems in participants with liver problems or with reduced kidney function * medical problems in participants with low blood pressure below \

Начало: 31.08.2022 Край: 31.12.2028

Japan Bayer NCT05666518

Набира участници Фаза 1/2

Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

HR+/HER2-negative Breast Cancer Metastatic Breast Cancer

This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy. The purpose of this study is: * to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat, * to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and * to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population.

Начало: 26.08.2022 Край: 01.03.2027 Възраст: от 18 г.

United States SynDevRx, Inc. NCT05455619

Набира участници Фаза 3

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

Psychosis Associated With Alzheimer's Disease

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Начало: 23.08.2022 Край: 05.10.2026 Възраст: 55–90 г.

Bulgaria, Croatia, Czechia +8 Karuna Therapeutics, Inc., a Bristol Myers Squibb compa NCT05511363

Набира участници

International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Congenital Disorders Cerebral Desaturation Neonatal Surgery

The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1. The perioperative factors associated with occurrence of cerebral desaturation 2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions. Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.

Начало: 12.08.2022 Край: 31.12.2027 Възраст: до 60 г.

Australia, Brazil, China +4 Children's Hospital of Philadelphia NCT05673499

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