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Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease

Breast Cancer Her 2 Positive Breast Cancer

The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. It also aims to assess pathological complete response (pCR), disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and safety and tolerability (adverse events according to CTCAE) across both cohorts.

Начало: 15.01.2026 Край: 15.01.2027 Възраст: от 19 г.

Algeria Société Algérienne de Formation et Recherche en Oncolog NCT07542496

Набира участници Фаза 3

Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

Multiple Sclerosis

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.

Начало: 14.01.2026 Край: 30.11.2028 Възраст: 18–60 г.

Belgium, United States Sanofi NCT07325292

Набира участници

Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment

Hematologic Malignancy

People with hematologic cancer often have sleep disturbance and symptoms of fatigue, stress, and pain. This study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after inpatient treatment (Nite2Day+). Participants will complete a baseline survey online, using a mobile application, or paper/pencil. Once the baseline survey is complete, participants will be randomized (like a flip of a coin) to receive Nite2Day+ or Standard Care. Nite2Day+ will include activities during and after inpatient treatment. During inpatient treatment, participants will use a mobile app to access: 1) mindfulness meditations, 2) brief sleep education videos, and 3) brief videos teaching strategies to improve sleep quality in the hospital. After inpatient treatment, participants will complete 6, videoconference sessions (45-60 minutes) with a trained therapist to learn mindfulness and behavioral coping strategies to self-manage nighttime sleep disturbance and daytime symptoms of fatigue, stress, and pain. Three follow-up surveys will occur at hospital discharge, and approximately 8, and 12 weeks after hospital discharge. Participants randomized to Nite2Day+ will be given the option to complete an exit interview to provide feedback on the Nite2Day+ program. Participants randomized to Standard Care will only complete the four surveys. All participants will continue to receive their usual medical care. The total study duration is about 16 weeks.

Начало: 14.01.2026 Край: 30.06.2029 Възраст: от 18 г.

United States Duke University NCT06532773

Набира участници

Active Mammography and Counseling

Breast Cancer Prevention

The Puerto Rico Community Engagement Alliance (PR-CEAL) is an NIH-funded initiative which aims to improve health literacy and healthcare access across Puerto Rico. In 2024, the program developed a new study which goal is to improve breast cancer screening rates in Puerto Rico titled Monitoreo Activo de Mamografía y Orientación (MAMO). This multi-level study will recruit non-adherent women based on residence, age (40 to 74 years old), and having had two or more years since their last breast cancer screening. The intervention will focus on 39 municipalities with screening rates below the median, through three different levels: educational, navigation, and integration. At the educational level, the intervention will employ a community-based recruitment strategy led by Community Health Workers (CHWs), who will identify eligible women at community venues and conduct follow-up via telephone to provide educational support. Drawing on findings from a previous pilot study and addressing barriers specific to non- adherent women, the navigation-level intervention will incorporate the role of a Community Navigator to deliver tailored support and facilitate breast cancer screening uptake through collaboration with local networks and partnerships. The integration-level intervention will build upon the educational and navigation components by enhancing knowledge, attitudes, skills, and organizational processes within Federally Qualified Health Clinics (FQHCs). This component is designed to foster a supportive healthcare environment that encourages routine mammography screening. The integration-level intervention will be implemented in four FQHCs across PR.

Начало: 14.01.2026 Край: 28.02.2028 Възраст: 40–74 г.

Puerto Rico University of Puerto Rico Comprehensive Cancer Center NCT07238088

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Registry for Bone Metastases

Bone Metastases

The purpose of this study is to learn more about symptomatic bone metastases. This study is an international patient registry of people with symptomatic bone metastases. A patient registry is a database - a collection of health information - about a group of people, and it is usually focused on a specific diagnosis or condition.

Начало: 13.01.2026 Край: 01.01.2031 Възраст: от 22 г.

United States Memorial Sloan Kettering Cancer Center NCT07391410

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Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.

Atopic Dermatitis Atopic Dermatitis, Unspecified Dermatitis, Atopic

This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States. The aim of this study is to measure the effectiveness of abrocitinib in a real-world setting in patients with moderate-to-severe atopic dermatitis, with inadequate response or intolerance to ≤2 biologic therapies.

Начало: 13.01.2026 Край: 15.02.2027 Възраст: от 12 г.

United States Pfizer NCT06899204

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis

CKD Metabolic Acidosis

The purpose of this 26 week study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.

Начало: 13.01.2026 Край: 01.06.2027 Възраст: от 18 г.

United States Renibus Therapeutics, Inc. NCT07355062

Набира участници

External Multicenter Validation of the APTTO Model for Prolonged APTT Using Clot Waveform Analysis

Coagulation Disorder, Blood Prolonged APTT

Prolonged activated partial thromboplastin time (APTT) is a frequent laboratory finding that may reflect a broad spectrum of underlying conditions, ranging from benign laboratory abnormalities to clinically relevant hemostatic disorders. Clot waveform analysis (CWA), automatically generated during routine APTT testing by optical coagulation analyzers, provides additional quantitative and qualitative information on clot formation dynamics. The APTTO model is a previously developed two-step predictive algorithm based on CWA features designed to estimate the probability of a pathological cause of prolonged APTT and to differentiate lupus anticoagulant from intrinsic pathway factor deficiency or von Willebrand disease. Internal validation has demonstrated good discrimination and calibration. This multicenter observational study aims to perform an external validation of the APTTO model in independent patient cohorts, assessing its discrimination, calibration, and decision-analytic performance without model updating.

Начало: 13.01.2026 Край: 01.03.2027

Spain Instituto de Investigación Sanitaria de la Fundación Ji NCT07418099

Набира участници

The Impact of Exercise on the Tumor Microenvironment in Patients With Lung Cancer

Lung Cancer - Non Small Cell

There is increased interest and knowledge about the lung cancer tumor microenvironment (TME). Investigators hypothesize that patients with better baseline physiologic health will have better post-operative outcomes and that strenuous exercise will alter the TME and genetic make-up of the tumor, improving the tumor immune response. Investigators aim to identify the peri-operative and clinical outcomes that differ based on pre-operative VO2max, HRV and resting heart rate following resection of early-stage lung cancer. The physiologic states that are individual and measurable with wearable devices include but are not limited to VO2max, heart rate variability (HRV), and average resting heart rate. Investgators hypothesize that a patient's pre-operative physiologic function with higher VO2max, HRV and lower resting heart rate will be associated with improved peri-operative and post-operative outcomes. Second, investigators will compare alterations in TME based on targeted pre-operative exercise (60-80% of their VO2 max for 75min/week x2 weeks) compared to normal activity adults following resection of early-stage lung cancer. Investigators hypothesize that strenuous exercise in the pre-operative period will impact the TME by increasing levels of cytokines.

Начало: 13.01.2026 Край: 15.01.2030 Възраст: от 18 г.

United States University of Arizona NCT07216209

Набира участници Фаза 1

A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)

Pneumococcal Infection

Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria. This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.

Начало: 13.01.2026 Край: 25.05.2029 Възраст: 2–15 г.

United States Merck Sharp & Dohme LLC NCT07300267

Набира участници

Terraflora Daily Care and Gastrointestinal Health

Gastrointestinal

A 12-week, randomized, double-blind, placebo-controlled clinical trial will be conducted evaluating the effectiveness of Enviromedica - Terraflora Daily Care on markers of gastrointestinal function and symptoms.

Начало: 12.01.2026 Край: 01.09.2026 Възраст: от 25 г.

United States OvationLab NCT07355634

Набира участници

Nigella Sativa Oil for Eczematous Otitis Externa

Eczema/Atopic Dermatitis Otitis Externa

Eczematous otitis externa is a common inflammatory condition of the external auditory canal characterized by itching, discomfort, discharge, and pain. Topical corticosteroids are widely used for treatment; however, alternative therapies with fewer side effects are of increasing interest. This study aims to compare the efficacy of Nigella sativa (black seed) oil and mometasone furoate ear drops in the treatment of eczematous otitis externa. Nigella sativa is a natural product with known anti-inflammatory and antimicrobial properties. In this randomized, controlled clinical trial, adult patients with eczematous otitis externa will be assigned to receive either Nigella sativa oil or mometasone furoate ear drops for 10 days. Clinical symptoms and inflammatory findings will be evaluated at baseline and after treatment. The objective of this study is to determine whether Nigella sativa oil is an effective and safe alternative to topical corticosteroid therapy.

Начало: 12.01.2026 Край: 01.07.2026 Възраст: от 18 г.

Turkey (Türkiye) Bezmialem Vakif University NCT07525505

Набира участници Фаза 3

A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis.

Plaque Psoriasis

This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis. Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period. During the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.

Начало: 12.01.2026 Край: 03.12.2027 Възраст: 18–70 г.

China InventisBio Co., Ltd NCT07326813

Набира участници

Fucoidan in the Treatment of Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint destruction and autoantibody production. Scavenger receptor-A (SR-A), a pattern recognition receptor primarily expressed on myeloid-derived cells, is significantly elevated in the serum of RA patients. Genetic knockout of SR-A completely protects mice from collagen-induced arthritis (CIA). As an SR-A inhibitor, fucoidan markedly suppresses the progression of CIA in mice. Given the potential role of SR-A in RA pathogenesis, the investigators hypothesize that fucoidan may exert therapeutic effects in RA by specifically targeting human SR-A. This study aims to investigate the efficacy of fucoidan in RA treatment through a multicenter, single-arm, open-label trial, providing original insights into its clinical application. The investigators plan to enroll 40 patients with a 12-week follow-up period. Clinical manifestations, laboratory parameters, and disease activity will be systematically evaluated to assess therapeutic outcomes. The findings will provide evidence-based medical data for RA treatment strategies.

Начало: 10.01.2026 Край: 01.07.2027 Възраст: 18–65 г.

China Peking University People's Hospital NCT07045896

Набира участници Фаза 3

A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders

Hyperphosphatemia Patients on Hemodialysis

A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

Начало: 09.01.2026 Край: 29.12.2026 Възраст: от 18 г.

Japan Taisho Pharmaceutical Co., Ltd. NCT07285291

Набира участници Фаза 1

A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis

The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \

Начало: 09.01.2026 Край: 31.03.2030 Възраст: 18–79 г.

United States Insmed Gene Therapy LLC NCT07290062

Набира участници Фаза 2

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults

Asthma

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA). Participants will take oral ENV-294 or placebo once daily for 12 weeks. The study includes a screening period of up to 28 days before randomization to confirm eligibility. Study visits and assessments will be conducted to monitor safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.

Начало: 09.01.2026 Край: 01.01.2027 Възраст: 18–75 г.

United States Enveda Therapeutics NCT07301255

Набира участници

Adult Disease Risk Prediction Using Wearables, Hearing, and Health Data

Chronic Disease Risk Assessment

This prospective cohort study aims to develop and validate a personalized disease risk prediction model for adults by integrating multiple sources of health data. The study will recruit community-dwelling adults aged 18 years and older in Taiwan. After providing informed consent, participants will complete a structured questionnaire, undergo pure tone hearing testing, and wear a smartwatch for 2 weeks to collect continuous physiological data, including heart rate and physical activity. With participant authorization, the study will also collect data from personal health records and national health insurance databases to allow longer-term follow-up of health outcomes. The main goals of the study are to examine the relationships among hearing, lifestyle factors, and wearable device data; to identify combinations of risk factors associated with progression from health to subclinical or chronic disease states; and to develop analytical methods for integrating heterogeneous health data from questionnaires, physiological monitoring, hearing tests, and medical databases. Machine learning methods will be used to identify important predictors and build risk prediction models. The study hypothesis is that combining hearing measures, lifestyle information, wearable physiological data, and longitudinal medical record data will improve the ability to identify individuals at higher risk of future disease compared with using a single source of information alone. The long-term objective is to support early risk identification, personalized health management, and prevention strategies in community adults.

Начало: 09.01.2026 Край: 01.01.2029 Възраст: от 18 г.

Taiwan National Health Research Institutes, Taiwan NCT07541547

Набира участници Фаза 1/2

Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression

Acute Lymphoblastic Leukaemia Acute Myeloid Leukaemia Higher-risk Myelodysplastic Syndromes

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.

Начало: 09.01.2026 Край: 15.02.2029 Възраст: от 16 г. Лечение

Australia, Canada, Denmark +6 AstraZeneca NCT07155226

Набира участници

DemonsTTRate: A Global, Observational, Multicenter, Long-term Study of Patients With ATTR-CM in a Real-World Setting

Transthyretin Amyloidosis With Cardiomyopathy

The purpose of this study is to: * Describe the clinical characteristics of adult patients with transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) treated with vutrisiran in routine clinical care * Describe treatment patterns of adult patients with ATTR-CM treated with vutrisiran in routine clinical care * Assess health-related quality of life (HRQOL) in adult patients with ATTR-CM treated with vutrisiran in routine clinical care * Assess healthcare resource use (HCRU) in adult patients with ATTR-CM treated with vutrisiran in routine clinical care Compare the long-term effectiveness of vutrisiran versus other approved ATTR-CM treatments in routine clinical care

Начало: 09.01.2026 Край: 23.10.2030 Възраст: от 18 г.

United States Alnylam Pharmaceuticals NCT07358078

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