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Recruiting

Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone

Oncological Disease Fertility Preservation

Fertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Among available techniques, oocyte cryopreservation is well-established with high survival rates but requires controlled ovarian stimulation and may not be suitable for prepubertal patients or those needing urgent cancer therapy. Ovarian tissue cryopreservation offers advantages by preserving a larger number of primordial follicles, can be performed anytime in the menstrual cycle regardless of age, and also helps restore ovarian endocrine function. Combining ovarian tissue cryopreservation followed by oocyte cryopreservation may maximize fertility preservation by safeguarding more follicles and ensuring availability of mature oocytes. This study will collect data from two patient groups: Group 1: patients undergoing ovarian tissue cryopreservation followed by oocyte cryopreservation (combined treatment) Group 2: patients undergoing oocyte cryopreservation alone. Group assignment is based on planned gonadotoxic therapy and available time before treatment initiation, according to clinical practice. The study aims to compare the number of oocytes retrieved per ovarian stimulation cycle between the two groups, along with the oocyte retrieval rate (number of oocytes retrieved/number of aspirated follicles), number of mature oocytes (metaphase II), incidence of moderate ovarian hyperstimulation syndrome within 7 days post-retrieval, and correlations between serum estradiol and luteinizing hormone levels on trigger day and oocyte yield. Approximately 127 patients aged 18 to 46 will be consecutively enrolled at the UO Gynecology and Human Reproduction Pathophysiology, IRCCS AOUBO Policlinico di Sant'Orsola. This is a cross-sectional, single-center, observational study with both retrospective and prospective enrollment. The retrospective period considered is from January 1, 2022, to the study start date. The study duration is 4 years and 3 months.

Начало: 25.08.2025 Край: 01.09.2029 Възраст: 18–46 г.

Italy IRCCS Azienda Ospedaliero-Universitaria di Bologna NCT07546123

Recruiting Phase 1

IDOV-Immune for Advanced Solid Tumors

Colorectal Cancer Pancreatic Cancer Melanoma Ovarian Cancer +12

This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor. The purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors. Participants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer. This study is being conducted at multiple sites in the United States and Australia.

Начало: 25.08.2025 Край: 31.05.2027 Възраст: от 18 г. Treatment

Australia, United States ViroMissile, Inc. NCT06910657

Recruiting

An International Observational Study of Adults With Acute Infection

Infectious Disease

Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.

Начало: 25.08.2025 Край: 08.06.2027 Възраст: от 18 г.

Argentina, Australia, Brazil +13 University of Minnesota NCT07069400

Recruiting Phase 3

BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies

Healthy

BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies. This study is seeking healthy pregnant participants: * aged 49 or younger who can join. * between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is) * had a fetal ultrasound examination performed with no major fetal abnormalities observed * documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone. A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.

Начало: 25.08.2025 Край: 02.03.2029 Възраст: 1–49 г.

Argentina, Brazil, Canada +10 Pfizer NCT07160244

Recruiting

NIRS MONITORING OF SPINAL CORD ISCHEMIA IN AORTIC SURGERY

Spinal Cord Injury

This prospective observational study aims to evaluate the feasibility and clinical utility of near-infrared spectroscopy (NIRS) monitoring applied to paraspinal muscles as a surrogate marker of spinal cord perfusion in patients undergoing major noncardiac surgery. Spinal cord ischemia represents a rare but devastating complication, often difficult to detect in real time. NIRS provides a non-invasive, continuous monitoring of regional tissue oxygen saturation (rSO₂), potentially reflecting microcirculatory changes in paraspinal tissues and indirectly spinal cord perfusion. The study will enroll adult patients undergoing major surgery requiring advanced hemodynamic monitoring. NIRS sensors will be placed over paraspinal regions, and rSO₂ values will be continuously recorded throughout the perioperative period. Hemodynamic parameters, including arterial pressure, cardiac output, and other relevant clinical variables, will be simultaneously collected. The primary objective is to assess changes in paraspinal rSO₂ during perioperative management and their relationship with systemic hemodynamic variables. Secondary objectives include the evaluation of the association between rSO₂ variations and postoperative neurological outcomes, as well as the feasibility and reliability of this monitoring technique in routine clinical practice. This study may provide preliminary evidence supporting the use of NIRS as a bedside, non-invasive tool for early detection of impaired spinal cord perfusion and for guiding hemodynamic optimization strategies.

Начало: 23.08.2025 Край: 30.03.2027 Възраст: от 18 г.

Italy Monaldi Hospital NCT07541612

Recruiting Phase 3

A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

Chronic Inflammatory Demyelinating Polyneuropathy CIDP CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months). More information can be found here: https://clinicaltrials.argenx.com/emvigorate

Начало: 22.08.2025 Край: 01.09.2030 Възраст: от 18 г.

Czechia, Estonia, Germany +12 argenx NCT06920004

Recruiting Phase 1

A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Urothelial Carcinoma Bladder Triple Negative Breast Cancer (TNBC) Hormone Receptor Positive Breast Adenocarcinoma Non Small Cell Lung Cancer +3

This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

Начало: 22.08.2025 Край: 01.06.2032 Възраст: от 18 г.

United States Aktis Oncology, Inc. NCT07020117

Recruiting Phase 3

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

Cardiovascular Disease

The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).

Начало: 22.08.2025 Край: 20.10.2031 Възраст: 50–105 г. Treatment

Australia, Canada, United States Amgen NCT07136012

Recruiting Phase 2/3

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Heterozygous Familial Hypercholesterolemia (HeFH)

This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood. The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.

Начало: 21.08.2025 Край: 23.01.2037 Възраст: 6–17 г. Treatment

Australia, Belgium, Brazil +9 Merck Sharp & Dohme LLC NCT07058077

Recruiting

AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions

Coronary Arterial Disease (CAD) de Novo Lesions in Native Coronary Arteries

AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.

Начало: 21.08.2025 Край: 01.03.2032 Възраст: от 18 г. Treatment

Australia, Germany, Ireland +3 Boston Scientific Corporation NCT06959524

Recruiting Phase 2

A Study of SPY072 in Rheumatic Disease

Rheumatoid Arthritis Psoriatic Arthritis Axial Spondyloarthritis Rheumatic Diseases +4

This is a multi-center, double-blind, placebo-controlled, Phase 2, proof-of-concept basket study with the goal of assessing the efficacy and safety of SPY072 compared to placebo in adults (aged ≥18 years) with rheumatic disease (RD).

Начало: 21.08.2025 Край: 31.03.2028 Възраст: от 18 г.

Bulgaria, Czechia, Georgia +5 Spyre Therapeutics, Inc. NCT07148414

Recruiting Phase 1

Study of BHV-1300 in Graves' Disease

Graves Disease

The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.

Начало: 21.08.2025 Край: 01.09.2026 Възраст: 18–65 г. Treatment

Australia, United States Biohaven Therapeutics Ltd. NCT06980649

Recruiting

Transoral and Cervical Ultrasound of Patients With Suspected Oropharyngeal Cancer

Oropharyngeal Carcinoma Ultrasound

Introduction The current diagnostic approach for patients with suspected oropharyngeal cancer involves a combination of clinical examination, tissue sampling, and relevant cross-sectional imaging. Previous studies have shown that transoral and cervical ultrasound (US) of the palatine and lingual tonsils has a better diagnostic accuracy than clinical investigation and magnetic resonance imaging (MRI) in patients with suspected oropharyngeal cancer, but it has not been established whether adding this scan to the diagnostic workup has a clinical impact. Methods A randomized controlled study, including 170 patients at four different Head and Neck Hospital departments in Denmark. One group receives standard diagnostics (control group), and the other group receives standard diagnostics supplemented by transoral and cervical ultrasound of the lingual and palatine tonsils. The diagnostic accuracy, number of correct biopsies, number of imaging modalities ordered, and time to final diagnosis are noted. Conclusion This randomized controlled study examines whether the implementation of transoral and cervical ultrasound of the palatine and lingual tonsils in patients with suspected oropharyngeal cancer will improve the diagnostic accuracy and have a clinical impact. This concerns more accurate initial diagnoses, more correct biopsies, fewer unnecessary scans, and fewer visits to the outpatient clinic.

Начало: 20.08.2025 Край: 01.05.2027 Възраст: от 18 г.

Denmark Tobias Todsen NCT07548268

Recruiting Phase 1

A Study of YP05002 in Healthy Participants

Weight Management

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants

Начало: 19.08.2025 Край: 30.06.2026 Възраст: 18–65 г. Treatment

Australia Yaopharma Co., Ltd. NCT07089823

Recruiting Phase 1

A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults

Chronic Hepatitis B Infection

This is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001.

Начало: 19.08.2025 Край: 01.04.2027 Възраст: 18–55 г. Treatment

Australia Chimivac INC NCT07059403

Recruiting Phase 1

A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis

Spinal Metastasis

This clinical research study is to learn about the safety of the NovoTTF-200M and Novo TTF-200A Systems, when used either alone or in combination with standard therapy, in patients with tumors that did not respond to treatment.

Начало: 18.08.2025 Край: 17.02.2029 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06906900

Recruiting Phase 1

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

NSCLC (Advanced Non-small Cell Lung Cancer) HNSCC CRC (Colorectal Cancer) ESCC +3

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

Начало: 18.08.2025 Край: 01.12.2027 Възраст: от 18 г.

United States ALX Oncology Inc. NCT07085091

Recruiting

The Ladera Suture-Mediated Large Bore Closure Study

Vascular Closure Femoral Arteriotomy Closure

This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath.

Начало: 18.08.2025 Край: 31.12.2025 Възраст: от 18 г. Treatment

Australia, Belgium, Netherlands Ladera Medical NCT06851481

Recruiting Phase 3

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Major Depressive Disorder

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Начало: 18.08.2025 Край: 01.07.2028 Възраст: от 18 г. Treatment

Australia, Bulgaria, Canada +8 Neurocrine Biosciences NCT07196501

Recruiting Phase 3

PSMA PET Combined With MRI for the Detection of PCa

PCA Prostate Cancer Prostatic Neoplasm PSMA PET +5

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).

Начало: 18.08.2025 Край: 01.11.2026 Възраст: от 18 г. Diagnostic

Australia Telix Pharmaceuticals (Innovations) Pty Limited NCT07052214

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