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Recruiting Phase 3

Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer.

Small Cell Lung Carcinoma

Lung cancer is a highly prevalent disease worldwide in women and men. In 2022, lung cancer stood as the most frequently diagnosed cancer with approximately 2.48 million new cases on a global scale, followed by cancers of the female breast (11.6%), colorectum (9.6%), prostate (7.3%), and stomach (4.9%). Lung cancer is the leading cause of cancer death worldwide according to data provided by the International Agency for Research on Cancer. In 2022 they estimated a 1.8 million deaths across the world. Specifically in Spain, from 1980 to 2022, lung cancer led to 745,182 deaths. Histologically, lung cancer (LC) can be classified into two major subtypes: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), accounting for 85% and 15% of LC patients, respectively. Smoking is the major risk factor for SCLC. There are two stages of SCLC: limited-stage SCLC (LS-SCLC) and extensive-stage SCLC (ES-SCLC). Limited-stage (LS) means that the cancer is located on the ipsilateral hemithorax that can be encompassed within a radiation port while extensive-stage (ES) means that the cancer has spread widely throughout the lungs, to non-regional lymph nodes or to other organs. At present, LS is identified in \~30% of patients, and ES is identified in \~70% of patients with SCLC. With a 5-year survival rate of less than 7%, SCLC is still one of the most lethal malignancies and it is also characterized by early metastatic spread. Reflecting this high metastatic capacity, two thirds of patients already have tumor cell dissemination outside the chest at the time of initial diagnosis (ES-SCLC). Therefore, the number of patients with LS-SCLC who can benefit from multimodality therapy with potentially curative intent is limited. SCLC is a highly aggressive form of LC that typically recurs and progresses rapidly despite initial response to chemotherapy and radiotherapy in patients with LS-SCLC. The etoposide/platinum (EP) combination was the standard of care (SoC) for patients with ES-SCLC until 2019, when the addition of immunotherapy to EP chemotherapy was shown to improve survival, with up to 17% of patients remaining alive at 3 years. On the other hand, the SoC for patients with LS-SCLC is concurrent platinum-based chemoradiotherapy (cCRT) ± prophylactic cranial irradiation (PCI) that remained unchanged for decades. Several studies have shown that concurrent chemoradiotherapy (cCRT) is more effective than sequential CRT (sCRT) in LS-SCLC. Nonetheless, subject to the lymph node regions involvement and treatment-related toxicities, some patients do not undergo concurrent CRT and instead receive sequential CRT. In a non-interventional, retrospective cohort study of limited-stage SCLC patients conducted in France, Italy and the UK, sequential chemoradiotherapy accounts for 37.6% of all treatment patterns while concurrent chemoradiotherapy accounts for 35.1% of the whole therapies used as first line. ADRIATIC (NCT03703297) is a phase 3, randomized, double-blind, placebo-controlled, multicenter, global study evaluating durvalumab ± tremelimumab as consolidation therapy for patients with LS-SCLC who have not progressed after cCRT. Positive high-level results of the ADRIATIC clinical trial showed durvalumab demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with LS-SCLC who had not progressed following cCRT compared to placebo. Durvalumab was well tolerated, and AEs were consistent with the known safety profile. These data support the consolidation of durvalumab as a new SoC for patients with LS-SCLC who have not progressed after cCRT. There is limited information on the effectiveness and safety of durvalumab in a broader patient population with LS-SCLC, including those who received sequential CRT. Therefore, there remains an unmet need for additional data to help support and inform the healthcare decisions on the use of durvalumab as consolidation treatment for patients with LS-SCLC in real-world clinical practice. In addition, ADRIATIC study did not allow to include patients with ECOG PS 2 assessed after CRT. The present phase IIIb study will assess the safety and effectiveness of durvalumab in real world like LS-SCLC population. Furthermore, this trial will focus on patient characteristics, treatment exposure, administration, quality of life (QoL), effectiveness and safety providing insights into durvalumab use.

Начало: 15.09.2025 Край: 30.06.2029 Възраст: 18–130 г.

Spain AstraZeneca NCT06992609

Recruiting Phase 3

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

Osteoarthritis

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.

Начало: 15.09.2025 Край: 01.05.2028 Възраст: от 18 г.

Canada, China, Germany +5 Eli Lilly and Company NCT07153471

Recruiting Phase 3

A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

Interstitial Lung Diseases Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Начало: 13.09.2025 Край: 30.07.2027 Възраст: от 18 г. Treatment

Australia, Austria, China +13 Boehringer Ingelheim NCT06806592

Recruiting Phase 3

RADA16 for Adult Tonsillectomy

Postoperative Pain

The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy procedures. Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage. Participants will: * Undergo tonsillectomy procedure. * Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.

Начало: 12.09.2025 Край: 01.12.2026 Възраст: от 18 г.

United States Rutgers, The State University of New Jersey NCT07060495

Recruiting Phase 2

Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study

Breast Cancer

This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.

Начало: 11.09.2025 Край: 11.09.2029 Възраст: от 80 г.

United States Dana-Farber Cancer Institute NCT07123649

Recruiting Phase 3

Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC

Esophageal Cancer Chemoradiotherapy

Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Our previous prospective phase II trial (EC-CRT-001) demonstrated that the addition of toripalimab to definitive CRT improved the complete response rate in patients with locally advanced esophageal squamous cell carcinoma (ESCC), showing potential for enhanced long-term survival with a manageable safety profile. Nevertheless, the risk of recurrence requires further reduction. Metronomic capecitabine chemotherapy can modulate the tumor immune microenvironment and may synergize with PD-1 antibodies to enhance antitumor efficacy, potentially further prolonging survival in ESCC. Based on current research advances and our preliminary findings, this randomized, controlled, multicenter, phase III clinical trial aims to evaluate the efficacy and safety of toripalimab combined with capecitabine as maintenance therapy for patients with locally advanced ESCC who have not progressed after definitive CRT.

Начало: 10.09.2025 Край: 31.05.2030 Възраст: 18–75 г.

China Sun Yat-sen University NCT07177794

Recruiting

STATIC - Statin Termination in Cancer

Cancer

There are many guidelines on when to start drug treatment, but surprisingly few guidelines on how and when to stop drugs. For example, there are currently no clear guidelines on when to stop preventive medications such as statins in patients in palliative cancer care. According to previous studies, these drugs are often deprescribed far too late in the process, often close to death. This can lead to unwanted side effects, such as muscle weakness, increased fatigue, and also contribute to unnecessary drug costs and unnecessary environmental impact. In the STATIC I study the safety and effects of early deprescribing of statins in palliative cancer care is explored. The primary aim of the STATIC study is to study the change in LDL-levels (mmol/L) after statin termination. The secondary outcomes includes change in levels of other steroids (cholesterol, HDL, Q10, 25-hydroxyvitamin D, lanosterol), change in muscle strength, cardiovascular events, fatigue and quality of life after statin deprescribing. STATIC I is a pilot study to optimize the design for the randomized study STATIC II. The study aim at including 40 patients with advanced cancer within specialized palliative care with an expected survival time \>1 month to \

Начало: 10.09.2025 Край: 31.12.2027 Възраст: от 18 г.

Sweden Stiftelsen Stockholms Sjukhem NCT07543432

Recruiting Phase 2

Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Myelodysplastic Syndromes Acute Myeloid Leukemia Myelodysplastic/Myeloproliferative Neoplasm

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life changing blood cancers. Patients with MDS and AML commonly experience complications related to bleeding, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of tranexamic acid (TXA; a medication that prevents clots from dissolving) to prevent bleeding. In this study, 50% of patients will be randomized (like the flip of a coin) to receive TXA; the other 50% of patients will receive placebo. The investigators will monitor both groups of patients to see if the medication improves the risk and/or severity of bleeding. If tranexamic acid were to safely reduced the frequency of bleeding, this would broadly influence how doctors provide care for patients with MDS and AML around the world.

Начало: 10.09.2025 Край: 01.04.2027 Възраст: от 18 г.

Canada University of Manitoba NCT06599762

Recruiting Phase 2

A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

Carcinoma, Non-Small-Cell Lung

The purpose of this study is to evaluate the safety and efficacy of BMS-986504 monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.

Начало: 09.09.2025 Край: 30.12.2031 Възраст: от 18 г. Treatment

Australia, China, France +9 Bristol-Myers Squibb NCT06855771

Recruiting

Fatigue and Mental Well-Being in MS Patients(Multiple Sclerosis)

Multiple Sclerosis

This study will be conducted to evaluate the effects of Quran recital on fatigue and mental well-being in patients with multiple sclerosis. Hypotheses: 1. Quran recital reduces fatigue in MS patients. 2. Quran recital increases mental well-being in MS patients. The patients will be called by the researcher to ask whether they continue this practice. The control group will continue their routine treatment and care and no additional intervention will be applied. The final test measurements will be made by meeting with the patients in the hospital at the end of the 4th week.

Начало: 09.09.2025 Край: 15.05.2026 Възраст: 18–80 г.

Turkey (Türkiye) Artvin Coruh University NCT07544303

Recruiting

Digital Telecytology for Triage of HPV-Positive Women in Cameroon

Human Papillomavirus Infection Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Cervical Cancer Screening Methods

This study evaluates the diagnostic accuracy and feasibility of a same-day cervical cancer screening strategy using HPV self-sampling followed by digital telecytology triage among HPV-positive women in Cameroon. Women aged 30-49 years (or 25-49 years if HIV-positive) will undergo primary HPV testing using the GeneXpert system. HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including immediate treatment, telecytology triage, or follow-up. Histological assessment serves as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary objectives include evaluation of AI-assisted telecytology and visual inspection with acetic acid (VIA), as well as the acceptability of screening and treatment strategies among women and healthcare providers. The study aims to generate evidence to support scalable, WHO-recommended test-triage-treat approaches in low-resource settings

Начало: 08.09.2025 Край: 08.09.2027 Възраст: 25–50 г.

Cameroon University Hospital, Geneva NCT07550010

Recruiting

Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial

Childhood Cancer Survivor Chronic Pain

The purpose of the study is to determine if an adapted mobile cognitive behavioral therapy (CBT) app (WebMAP Onc) is more effective than standard pain education in reducing chronic pain and improving daily functioning in adolescent survivors of pediatric cancer. This randomized study led by St. Jude Children's Research Hospital will involve 228 participants (114 adolescent survivors and 114 caregivers) across four U.S. hospitals. Outcomes include pain reduction, improved function, and the role of social determinants of health. Assessments occur at baseline, post-treatment, and 3-month follow-up.

Начало: 05.09.2025 Край: 01.02.2029 Възраст: 10–17 г.

United States St. Jude Children's Research Hospital NCT07160621

Recruiting Phase 3

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Начало: 04.09.2025 Край: 17.04.2028 Възраст: от 18 г. Treatment

Australia, Austria, Belgium +18 BeOne Medicines NCT06973187

Recruiting Phase 4

Intraosseous vs. Intravenous Vancomycin Prophylaxis for Diabetic Foot Amputations: A Randomized Trial

Diabetic Foot Disease Diabetic Foot Infection Diabetic Amputation Foot Wound

he purpose of this study is to compare the effects of two different ways of giving the antibiotic vancomycin to prevent infections in patients undergoing amputation due to diabetic foot infection. Patients with diabetes often have poor blood circulation in their legs, which may prevent standard intravenous (IV) antibiotics from reaching the surgical site in high enough concentrations. This study compares: Intraosseous (IO) Administration: Giving the antibiotic directly into the bone at the amputation site during surgery. Intravenous (IV) Administration: Giving the antibiotic through a standard vein infusion before surgery. The researchers want to find out if the intraosseous method: Reduces the rate of surgical site infections compared to the standard IV method. Causes fewer changes in kidney function (measured by serum creatinine levels). Decreases the need for additional surgeries (reoperations) within 90 days. Patients will be randomly assigned to either the IO or IV group and will be followed for up to 90 days to evaluate their recovery and clinical outcomes

Начало: 03.09.2025 Край: 19.06.2026 Възраст: от 18 г.

Turkey (Türkiye) Başakşehir Çam & Sakura City Hospital NCT07338773

Recruiting

Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study

Early Colorectal Cancer Non-curative Endoscopic Resection

This multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection. Patients with non-curative resection following endoscopic treatment will be enrolled across multiple centers and managed according to real-world clinical decisions, including additional surgery or surveillance. Baseline demographic, endoscopic, and pathological characteristics will be systematically collected. The primary objective is to compare recurrence and survival outcomes between different management strategies. Secondary objectives include identifying prognostic factors associated with recurrence and developing a risk stratification model to guide individualized treatment decisions. All participants will undergo standardized follow-up according to clinical guidelines. This study is expected to provide real-world evidence to refine risk assessment, reduce unnecessary surgery, and improve personalized management for patients with early colorectal cancer after non-curative endoscopic resection.

Начало: 03.09.2025 Край: 01.12.2028 Възраст: 18–75 г.

China Nanfang Hospital, Southern Medical University NCT07542171

Recruiting Phase 3

Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)

Elevated Lp(a) Atherosclerotic Cardiovascular Disease (ASCVD)

The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.

Начало: 02.09.2025 Край: 01.03.2031 Възраст: от 18 г. Treatment

Argentina, Australia, Austria +24 Eli Lilly and Company NCT07157774

Recruiting Phase 3

Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

Brain Tumor, Pediatric Cancer-related Fatigue Methylphenidate

Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking. The researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit/hyperactivity disorder (ADHD). If methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.

Начало: 02.09.2025 Край: 01.12.2029 Възраст: 6–27 г.

Denmark Odense University Hospital NCT06905587

Recruiting

Using Exercise to Enhance Fear Extinction Learning

PTSD Exercise Intensity Fear Extinction Fear Conditioning

The goal of the current project is to establish the efficacy and mechanisms of exercise-enhanced fear extinction retrieval and generalization in posttraumatic stress disorder (PTSD). Exposure therapy is the gold standard treatment for PTSD, yet is only associated with remission rates of \~55% and in clear need of improvement. Exposure therapy is hypothesized to work through mechanisms of fear extinction learning, and as such, laboratory-based fear extinction paradigms are widely used as models of exposure therapy. Recent data demonstrates that moderate-intensity aerobic exercise, delivered specifically during or after fear extinction learning, can boost the consolidation of fear extinction learning. Consistent with emerging models of exercise's pro-extinction effect, our pilot data among women with PTSD found that moderate intensity aerobic exercise delivered after fear extinction learning leads to a reduction in subsequent fear responding 24hrs later, an effect that was mediated by exercise-induced increases in peripheral brain derived neurotrophic factor (BDNF). Our pilot data using multivariate pattern analyses (MVPA) also identified divided neurocircuitry organization of fear vs safety memories, and that this divided neural organization was altered in PTSD. Building on our pilot data, the current project would 1) compare the impact of different intensities of exercise delivered following fear extinction learning on multimodal measures of fear extinction retrieval and generalization, 2) identify the impact of exercise on MVPA representations of fear vs safety memories, and 3) demonstrate that spontaneous reactivations of extinction encodings in the acute consolidation window operate as candidate mechanisms by which exercise enhances extinction retrieval and generalization. Using a 3-day fear conditioning, fear extinction, and fear extinction retrieval and recognition task during functional magnetic resonance imaging (fMRI), 200 adults with PTSD would be randomly assigned to either resting control or 30min of either light, moderate, or high intensity exercise. Testing dose-response relationships between exercise intensity and fear extinction will inform translation of this research to clinical settings. A one week-follow-up extinction retrieval test would investigate the impact of exercise on longer-term retention. This project would provide a critical evaluation of the impact of aerobic exercise on consolidation and recall of extinction learning in PTSD samples, thereby providing a strong foundation to translate this research to clinical care and enhance clinical outcomes for PTSD. The project would also provide general knowledge regarding dose-response relationships and neural mechanisms that support enhanced extinction, thereby informing development of additional novel treatments.

Начало: 02.09.2025 Край: 01.05.2030 Възраст: 18–55 г.

United States Josh Cisler NCT07548125

Recruiting Phase 1/2

Bushen Yiqi Formula Combined With Dehydroepiandrosterone in Women With Diminished Ovarian Reserve

Diminished Ovarian Reserve

The purpose of this clinical trial is to evaluate the efficacy and safety of Bushen Yiqi formula combined with dehydroepiandrosterone (DHEA) in the treatment of women with diminished ovarian reserve (DOR). The study also aims to assess the safety profile of this combined therapy. The main questions this study aims to answer include: 1. Can the Bushen Yiqi formula combined with DHEA improve ovarian reserve in women with DOR? 2. Does the combined treatment improve hormone levels, ovarian follicle parameters, and clinical symptoms? 3. What safety issues may occur during treatment with the Bushen Yiqi formula combined with DHEA? Researchers will compare the Bushen Yiqi formula combined with DHEA to DHEA plus placebo to determine whether the combined therapy is more effective in treating diminished ovarian reserve. Participants will: 1. Be randomly assigned to either the treatment group or the control group 2. Receive DHEA combined with the Bushen Yiqi formula or DHEA combined with placebo for 12 weeks 3. Undergo regular clinical assessments during the study period 4. Have ovarian reserve markers (including AMH and antral follicle count), sex hormone levels (FSH, LH, E2, and testosterone), traditional Chinese medicine symptom scores, Kupperman menopausal index scores, inflammatory markers (CRP and IL-6), and safety indicators evaluated before and after treatment

Начало: 01.09.2025 Край: 01.12.2027 Възраст: 20–40 г.

China Jiangxi University of Traditional Chinese Medicine NCT07535983

Recruiting

Chronic Obstructive Pulmonary Disease and Asthma in Workers at Navanakorn Industrial Zone, Thailand

Asthma COPD

The goal of this observational study is to determine the prevalence of asthma and chronic obstructive pulmonary disease (COPD) among workers in an industrial zone in Thailand. The main question the study aims to answer is: What is the prevalence of asthma and COPD among workers in Thailand? Participants will complete a questionnaire on respiratory symptoms and undergo pulmonary function testing.

Начало: 01.09.2025 Край: 31.05.2026 Възраст: от 18 г.

Thailand Thammasat University NCT07383896

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