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Набира участници

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Esophagitis (EoE)

This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE. Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward. Patient questionnaires will measure the following: * How EoE makes one feel * EoE signs and/or symptoms, eg, how difficult it is to swallow * How EoE affects quality-of-life * How EoE impacts aspects of daily life * How EoE symptoms have changed throughout the study

Начало: 22.11.2024 Край: 22.05.2030 Възраст: от 1 г.

United States Regeneron Pharmaceuticals NCT06693531

Набира участници Фаза 3

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Gastroesophageal-junction Cancer Monoclonal Antibody Gastric Cancer HER2-positive Gastric Cancer

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Начало: 22.11.2024 Край: 01.09.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +14 Shanghai Henlius Biotech NCT06532006

Набира участници Фаза 2

A Basket Study of Vosoritide in Children With Turner Syndrome, Short Stature Homeobox-Containing Gene Deficiency, and Noonan Syndrome With Inadequate Growth During or After Human Growth Hormone Treatment

Short Stature Homeobox- Containing Gene SHOX Deficiency Noonan Syndrome Turner Syndrome

The purpose of this basket study in children with Turner syndrome, SHOX deficiency, and Noonan syndrome is to evaluate the effect of 3 doses of vosoritide on growth as measured by AGV after 6 months of treatment. The long-term efficacy and safety of vosoritide at the therapeutic dose will be evaluated up to FAH.

Начало: 22.11.2024 Край: 01.09.2041 Възраст: 3–11 г. Лечение

Australia, France, Italy +2 BioMarin Pharmaceutical NCT06668805

Набира участници Фаза 2/3

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

Начало: 22.11.2024 Край: 30.08.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Washington University School of Medicine NCT05552157

Набира участници Фаза 2/3

A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Начало: 22.11.2024 Край: 01.08.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Washington University School of Medicine NCT06647498

Набира участници Фаза 1

Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

Breast Cancer Ovarian Cancer

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.

Начало: 21.11.2024 Край: 01.12.2028 Възраст: от 21 г.

United States University of Colorado, Denver NCT06430541

Набира участници Фаза 3

Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer (APTneo)

Invasive Breast Cancer

Trial status: Authorised Pathological Complete Response (pCR), Relationship between pCR and EFS, Clinical Overall Response (cOR) at the end of neo-adjuvant treatment, Disease-Free Survival (DFS), Distant Event Free Survival, Overall Survival Event Free Survival (EFS)

Начало: 21.11.2024 Възраст: от 18 г.

Austria, Belgium, Germany +3 Fondazione Michelangelo 2024-518026-32-00

Набира участници

International CRDS Registry

Calcium Release Deficiency Syndrome

Calcium Release Deficiency Syndrome (CRDS) is a newly discovered genetic arrhythmia syndrome that confers a risk of life-threatening arrhythmias secondary to RYR2 loss-of-function. The International CRDS registry has been designed to facilitate large-scale evaluation of CRDS, including its phenotypic spectrum, approaches to risk stratification, and optimal treatment strategies.

Начало: 21.11.2024 Край: 31.12.2050

Australia, Belgium, Canada +5 Population Health Research Institute NCT06508164

Набира участници Фаза 1/2

Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

Healthy Volunteers Alcohol Use Disorder (AUD)

Background: Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain. Objective: To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people. Eligibility: People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed. Design: Participants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD. Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking. Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay. Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan. Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies. Imaging scans and other tests will be repeated at the end of the study. Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week. ...

Начало: 21.11.2024 Край: 31.12.2029 Възраст: 18–75 г.

United States National Institute on Alcohol Abuse and Alcoholism (NIA NCT06484075

Набира участници Фаза 2

Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy

Prostate Cancer (Post Prostatectomy)

The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are: * Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans. * What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator. * Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11). Participants will: * have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only * have standard of care blood test either at Visit 1 or Visit 2

Начало: 21.11.2024 Край: 01.11.2025 Възраст: от 18 г. Диагностика

Australia St Vincent's Hospital, Sydney NCT06907641

Набира участници Фаза 2

CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.

Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Endometrioid Ovarian Cancer

A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.

Начало: 20.11.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +8 TORL Biotherapeutics, LLC NCT06690775

Набира участници Фаза 1/2

A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age

Urinary Tract Infections

The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and including 18-64 years of age (YOA), and to perform a preliminary evaluation of clinical efficacy in females between and including 18-64 YOA.

Начало: 19.11.2024 Край: 31.05.2027 Възраст: 18–64 г.

South Africa, United States GlaxoSmithKline NCT06702449

Набира участници Фаза 4

Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)

Obesity Knee Osteoarthritis Osteoarthritis, Knee

This is a trial of tirzepatide in people with obesity and knee osteoarthritis. The main purpose of this study is to see if tirzepatide can reduce number of these participants who require a knee replacement. Participants will be randomized to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.

Начало: 19.11.2024 Край: 01.05.2037 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT06191848

Набира участници Фаза 3

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Leukemia

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Начало: 19.11.2024 Край: 26.06.2030 Възраст: 18–70 г. Лечение

Australia, Belgium, Brazil +22 Daiichi Sankyo NCT06578247

Набира участници Фаза 1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Epilepsy

Background: \- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects. Objective: \- To see if mangafodipir is well tolerated and safe. To see if it can show, on an MRI, areas of the brain that epilepsy affects. Eligibility: * People ages 18-60 who: * Have epilepsy not controlled by drugs * Prior or concurrent enrollment in 18-N-0066 is required Design: * Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Participants will have up to 6 visits in 1-3 months. Those with epilepsy will have an inpatient stay lasting 2-10 days. Visits may include: * Video-EEG monitoring for participants with epilepsy * An IV catheter put in place: a needle guides a thin plastic tube into an arm vein. * Getting mangafodipir through the IV. * 5 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides into a metal cylinder. They are in the cylinder for 45-90 minutes, lying still for up to 10 minutes at a time. The scanner makes loud knocking sounds. Participants will get earplugs. * A final MRI at least 2 weeks after receiving mangafodipir. Gadolinium is given through an IV catheter....

Начало: 19.11.2024 Край: 01.07.2026 Възраст: 18–60 г.

United States National Institute of Neurological Disorders and Stroke NCT02531880

Набира участници

A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer

Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Low-volume Metastasis

This is an observational study in which medical records of Japanese men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC), who received treatment with a combination therapy of darolutamide with an androgen deprivation therapy (ADT) and docetaxel, will be collected and studied. The study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for another type of prostate cancer. To better understand the impact of this combination therapy on low-volume mHSPC and make better treatment choices, more knowledge is needed. ADT is a hormone therapy that lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Darolutamide blocks androgen signals to slow the growth of the cancer cells. Docetaxel is a type of chemotherapy used to treat different types of cancer. It works by stopping the growth and spread of cancer cells. The prostate gland is a male reproductive gland found below the bladder. Low-volume mHSPC is a cancer of the prostate gland that has spread beyond the gland to three or fewer bones but has not reached organs like the lungs and liver. The prostate cancer is considered hormone sensitive when it responds to an anti hormonal therapy. In this study, only observations from routine clinical practices will be made. Participants will receive darolutamide, in combination with ADT and docetaxel as prescribed by their doctors during routine medical care. The participants will not receive any advice on treatment or any changes to healthcare as a part of the study. The main purpose of this study is to learn more about how safe darolutamide is and how well it works in combination with ADT and docetaxel in adult Japanese men with mHSPC in routine medical care. To do this, researchers will assess the following information about participants after one year of receiving the combination therapy by their doctors: • the number of participants who achieve normal levels of prostate specific antigen (PSA). PSA is a protein found in the blood that helps doctors monitor prostate cancer. • the number of participants who have adverse events (AEs), serious adverse events (SAEs), and adverse events of special Interest (AESIs) that lead to discontinuation or change in the dose of darolutamide or docetaxel during the study. AEs are medical problems that the participants had during the study that may or may not be related to the study treatment. SAEs are AEs that lead to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby to be born with medical problems, or is medically important. AESIs are specific medical problems the participants had during the study that may be related to heart, lung, liver etc. The data will come from the participant's medical records and will be collected between October 2024 and June 2031. Researchers will only look at the health records from adult men with mHSPC in Japan. No separate visits are required as part of the study. The participants will only visit their doctor at the study clinic as part of their routine medical care.

Начало: 18.11.2024 Край: 31.08.2031 Възраст: от 18 г.

Japan Bayer NCT06661122

Набира участници Фаза 2

CAR T-cell Therapy in Patients With Renal Dysfunction

Non-hodgkin Lymphoma,B Cell Multiple Myeloma Acute Lymphoblastic Leukemia, Adult

This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.

Начало: 18.11.2024 Край: 31.08.2027 Възраст: от 18 г.

United States Northside Hospital, Inc. NCT05909059

Набира участници Фаза 3

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Obesity Overweight

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Начало: 18.11.2024 Край: 01.03.2027 Възраст: 6–17 г.

Brazil, Israel, Italy +5 Eli Lilly and Company NCT06672549

Набира участници Фаза 1

A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

Healthy

The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.

Начало: 18.11.2024 Край: 01.10.2025 Възраст: 18–55 г. Друго

New Zealand Shanghai Huaota Biopharmaceutical Co., Ltd. NCT06612970

Набира участници Фаза 3

The effect of phoSPHocreatine on mEdical emergency team (met) tREated patients: a randomized clinical trial protocol – SPHERE

respiratory arrest threatened airways tachycardia bradypnea +5

Trial status: Authorised How to calculate DAH30 (days alive and out-of-hospital at day 30): Has patient died in hospital or after discharge on any day within the first 30-days after randomization? If YES we will give 0 points Is the patient discharged from hospital on Day 5 after randomization but is subsequently readmitted for 5-days before their second hospital discharge? If YES we will give 20 points Is patient in a post- discharge nursing facility? If YES: we won’t consider as days at home.

Начало: 18.11.2024 Възраст: от 18 г.

Italy Ospedale San Raffaele S.r.l. 2024-518474-14-00

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