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Набира участници Фаза 2

Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements Recurrent Diffuse Large B-Cell Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified +11

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Начало: 07.10.2025 Край: 01.09.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06649812

Набира участници Фаза 1/2

A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer

Breast Cancer

The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.

Начало: 07.10.2025 Край: 31.08.2028 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +5 Genentech, Inc. NCT07100106

Набира участници Фаза 2

Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

Metastatic Non-Squamous Non-Small Cell Lung Cancer Adult Solid Tumor

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Начало: 07.10.2025 Край: 01.10.2031 Възраст: от 18 г.

Germany, Italy, Spain +2 CatalYm GmbH NCT07246863

Набира участници Фаза 2

Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma

Esophageal Squamous Cell Carcinoma (ESCC)

The goal of this clinical trial is to assess the percentage of patients alive at 6 months in elderly patients, not eligible to an platinum-based chemotherapy, but who can received the Tislelizumab treatment alone as first-line treatment for an advanced esophageal squamous-cell carcinoma (ESCC). Tislelizumab is a monoclonal antibody administred by intravenous infusion This study aims to anwer too at the questions: * the Safety of the drug * Overall survival (OS) at 6 months according the diagnostic of PD-L1 expression (PD-L1 is a protein present on the surface of immune cells) * Overall response rate (ORR) according to imagery criteria * Progression-free survival (PFS) at 3 and 6 months according to imagery criteria and depending on PDL1 expression * Patients' health-related quality of life * OS and PFS according to geriatric parameters * Prognostic value of immune biomarkers

Начало: 07.10.2025 Край: 01.10.2030 Възраст: от 70 г.

France University Hospital, Clermont-Ferrand NCT07205731

Набира участници

Intraoperative Margin Assessment in Breast Cancer With HSI-Raman

Breast Cancer

Breast-conserving surgery (lumpectomy) aims to remove cancer while preserving healthy tissue, but up to 20% of patients require a second operation because cancer cells remain at the edge (margin) of the removed tissue. The Spectra-BREAST study evaluates a new optical device that combines hyperspectral imaging (HIS) and Raman spectroscopy (RS) with artificial-intelligence analysis to quickly assess the entire surface of excised breast specimens during surgery. By flagging areas at risk of positive margins in real time, the device may help surgeons remove any remaining cancer in a single procedure. In this prospective, single-arm diagnostic study, surgeons will use the Spectra-BREAST system on freshly resected breast tissue from up to 99 women undergoing lumpectomy for invasive carcinoma or ductal carcinoma in situ. First, the device's cancer-detection algorithms will be trained on 74 specimens with known pathology. Then, in a separate group of patients, the fully integrated device will be tested on all six faces of each lumpectomy specimen and its predictions will be compared against the gold-standard histopathology margin assessment. Key measures include the sensitivity and specificity of the device's margin predictions, the time needed to generate results, and the device's usability in a clinical setting.

Начало: 06.10.2025 Край: 01.12.2028 Възраст: 18–85 г.

Italy Istituti Clinici Scientifici Maugeri SpA NCT07111728

Набира участници

PDAC-PATHWAYS: A Digital Informational and Supportive Care App for Patients Initiating Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma

PDAC - Pancreatic Ductal Adenocarcinoma

This study aims to refine and pilot test PDAC-PATHWAYS, a digital informational and supportive care app for patients who are initiating neoadjuvant therapy for pancreatic ductal adenocarcinoma (PDAC).

Начало: 06.10.2025 Край: 01.08.2027 Възраст: от 18 г.

United States Massachusetts General Hospital NCT07047807

Набира участници

Oxidative Stress in Autoimmune Rheumatic Diseases

Inflammatory Joint Diseases Rheumatoid Arthritis (RA) Psoriatic Arthritis (PsA) Ankylosing Spondylitis (AS)

Rheumatic diseases constitute a group of non-communicable diseases characterized by chronic inflammation. The most common autoimmune rheumatic diseases (ARDs) are rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, myositis, Sjogren's syndrome and systemic scleroderma. These autoimmune disorders lead to joint destruction and adversely influence the human body systemically. One of their characteristics is comorbidity, since patients usually suffer also from other pathologies such as cardiovascular diseases and obesity. In addition, their treatment requires a combination of both biological and conventional pharmaceutical interventions as well as other parameters such as physical activity programs, nutrition, and the use of smart electronic devices. Therefore, the ARDs burden health systems worldwide. Apart from the physiological manifestations of ARDs, specific changes are observed at the cellular and molecular level. A common biochemical/molecular symptom of these diseases is oxidative stress. This condition leads to the disturbance of blood and tissue redox status due to the excessive production of free radicals. Given that free radicals are highly reactive moieties with strong oxidative capacity against biomolecules (i.e., proteins, lipids, DNA), they compromise the efficacy of the intrinsic antioxidant mechanisms and, finally, induce the disruption of redox homeostasis. However, there is no sufficient data linking the levels of redox status of patients with the progression of ARDs over time. Indeed, the onset and symptoms of ARDs are intertwined with the disruption of the patient redox homeostasis and the induction of oxidative stress. Concurrently, the absence of a completely effective pharmaceutical treatment emerges the need for the adoption of novel biomarkers for monitoring the severity of the symptoms and the evolution of ARDs in general. To that end, this study aims at first to investigate the blood redox status of patients with ARDs. Thus, specific redox biomarkers will be evaluated in the blood of patients in three time points (i.e., at Days 1, 180 and 360), and they will be associated with the clinical manifestations of their diseases. The ultimate goal is to clarify whether these biomarkers could putatively exert clinical significance, namely whether they could constitute an additional tool for the monitoring of the progression of these diseases in clinical practice.

Начало: 06.10.2025 Край: 01.10.2026 Възраст: от 18 г.

Greece University of Thessaly NCT07536529

Набира участници

Impact of CMG vs VCMG in Recurrent Stress Incontinence- A Pilot Study

Stress Incontinence Female Urodynamic Exam Urodynamic Stress Incontinence

To asses feasibility of a prospective randomised trial comparing the outcomes of surgery for recurrent urinary incontinence after video-urodynamic(VCMG)and urodynamic(UDS)investigations. One of the greatest challenges for clinicians is the lack of correlation between bothersome urinary symptoms and the underlying urinary tract dysfunction. This has led to the development of several investigations aimed at improving diagnostic accuracy, with UDS and VUDS being the most noteworthy. Despite the heavy reliance on these invasive tests by clinicians, their indications and efficacy remain controversial and supporting literature data is scarce and nonvalidated. We will perform a prospective randomised study of 30 women referred to our tertiary urological services at UCLH for treatment of recurrent stress urinary incontinence. The women will be investigated with either UDS or VUDS prior to receiving medical and surgical treatment tailored to the identified underlying urinary tract dysfunction. Adult women with symptoms suggestive of recurrent stress urinary incontinence after failed continence surgery will be included. Women who are pregnant, unfit for surgery, have a background of pelvic radiotherapy or relevant neurogenic disease that would put them at risk of neurogenic bladder will be excluded. UDS/VUDS will be performed under the care of The Female, Functional and Restorative (FFR) Urology Service at UCLH adhering to standardised protocols. Treatment will be provided by FFR Team at UCLH. The primary outcome is assessment of symptoms of urinary incontinence by using validated questionnaires (PGII and ICIQ-UI-SF). Results will be correlated with patient characteristics, X-ray exposure, patient experience metrics, outcome and expenses to determine in which sub-populations performing UDS or VUDS has a higher impact on outcomes and when they should be avoided.

Начало: 06.10.2025 Край: 06.06.2027 Възраст: 18–100 г.

United Kingdom University College, London NCT07542080

Набира участници

The Effect of Art-Based Nursing Intervention Helping to Develop Healthy Digital Habits on Digital Addiction, Cyberbullying and Self-Efficacy in Adolescents

Digital Addiction Art Therapy Cyberbullying Self Efficacy +1

In today's world where digital technologies are integrated into every aspect of life, adolescents' unhealthy and uncontrolled use of digital media causes important psychosocial problems such as digital addiction and cyberbullying. This research aims to examine the effects of an art-based nursing intervention program in order to help adolescents born into the digital world gain healthy digital habits. The art-based nursing intervention program that helps gain healthy digital habits aims to increase adolescents' expressive expression skills, develop their skills in coping with challenging situations in the digital environment and strengthen their self-efficacy levels through creative art activities. The research is a randomized controlled trial designed as an experimental type, pre-test-post-test design. The research will be carried out in Prof. Dr. Fuat Sezgin Secondary School in Karatay district of Konya province. The sample group was determined as a total of 64 adolescents, 32 intervention and 32 control. Adolescents will be randomly assigned to the intervention and control groups. The pre-test data of the intervention and control groups were collected before the program started; The post-test data will be collected face-to-face by the researcher after the program is completed using the Personal Information Form, Digital Addiction Scale for Children, Revised Cyberbullying Scale (YSZE-II) and Self-Efficacy Scale for Children. It is expected that the digital addiction and cyberbullying levels of adolescents who are applied the art-based nursing intervention program that helps them gain healthy digital habits will be lower than the control group, and their self-efficacy levels will be higher than the control group. It is anticipated that the findings to be obtained as a result of the research will enable the development of creative and holistic intervention approaches that will increase the functionality of school health nurses against the risks posed by the digital age on young people. It is also thought that it can provide an evidence-based basis for the usability of art-based interdisciplinary practices in the field.

Начало: 06.10.2025 Край: 31.12.2026 Възраст: 11–15 г.

Turkey (Türkiye) Selcuk University NCT07123194

Набира участници

Parasternal vs. Combined Parasternal-Serratus Block in Cardiac Surgery

Postoperative Pain Cardiac Surgery

This randomized controlled trial aims to compare the analgesic efficacy of parasternal intercostal plane block (PIPB) alone versus the combination of parasternal intercostal plane block and serratus anterior plane block (SAPB) in adult patients undergoing elective cardiac surgery via sternotomy. Seventy patients will be randomly assigned to two groups: Group A will receive bilateral PIPB, while Group B will receive bilateral PIPB combined with unilateral SAPB on the side of chest drain placement. Postoperative pain will be assessed using the visual analog scale (VAS) at rest and during movement over the first 24 hours. Secondary outcomes include time to extubation, length of stay in the intensive care unit, and time to mobilization. The study is designed as a prospective, single-center, single-blind trial conducted at Akdeniz University Hospital, Antalya, Turkey. We hypothesize that the combined block technique will provide superior analgesia, reduce opioid consumption, and improve recovery parameters compared to PIPB alone

Начало: 05.10.2025 Край: 05.05.2026 Възраст: от 18 г.

Turkey (Türkiye) BEDİA MİNE HANEDAN NCT07522229

Набира участници

PRoducing Outcome Measures for OTP Quality Improvement

Opioid Use Disorder

This study tests ways to help opioid treatment programs (OTPs) keep patients in care. Staying on methadone or buprenorphine is linked to better outcomes, yet many people leave treatment early. The project will compare two approaches that provide clinics with retention/outcome quality measures and a quality-improvement (QI) toolkit-either alone or with added facilitation-against usual care. Forty-five BayMark OTPs in multiple states will be randomly assigned to one of three groups: (1) quality measures + QI toolkit; (2) quality measures + QI toolkit + external QI facilitation; or (3) usual care. The primary outcome is 90-day retention in treatment, measured from OTP electronic health records and Medicaid claims. Secondary outcomes include emergency department visits, hospitalizations, overdoses, and mortality. Findings will identify practical, scalable strategies to improve patient retention in OTPs.

Начало: 03.10.2025 Край: 01.12.2027 Възраст: от 18 г.

United States RTI International NCT07214389

Набира участници Фаза 2

Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia

Nonfluent Variant Primary Progressive Aphasia (nfvPPA)

The goal of this exploratory study is to evaluate the effect of neflamapimod in participants with nonfluent variant primary progressive aphasia (nfvPPA). We aim to evaluate the safety, pharmacokinetics and clinical effects of neflamapimod of participants with nfvPPA.

Начало: 02.10.2025 Край: 01.10.2026 Възраст: 40–85 г.

United Kingdom, United States EIP Pharma Inc NCT07033481

Набира участници

Accelerometer Measured Early Recovery After Prolapse Surgery

Pelvic Organ Prolapse Pelvic Organ Prolapse (POP) Pelvic Organ Prolapse Vaginal Surgery Pelvic Organ Prolapse, Patient Education

The AccelERate study will evaluate the physical recovery of patients who have undergone Pelvic Organ Prolapse (POP) surgery. This will be evaluated via a self-reported recovery questionnaire completed daily. Participants will wear an accelerometer device on their non-dominant wrist and be given either routine or exercise-focused postoperative instructions. The primary outcome will be a comparison of the number of days needed to reach self-reported "mostly recovered" status between randomly assigned instruction groups.

Начало: 02.10.2025 Край: 31.12.2028 Възраст: 18–99 г.

United States NICHD Pelvic Floor Disorders Network NCT07218016

Набира участници

The Multi-Omics Analysis of Lens Zonule Relaxation in The PACG Pathogenesis

Primary Angle-Closure Glaucoma

Compared with primary angle-closure glaucoma (PACG) patients without zonular laxity and the control group, there are differentially expressed molecules in PACG patients with zonular laxity, and a potential mechanistic network can be constructed therefrom.

Начало: 01.10.2025 Край: 30.09.2027 Възраст: от 50 г.

China Zhongnan Hospital NCT07539675

Набира участници Фаза 2

Study of COYA 302 for the Treatment of ALS

Amyotrophic Lateral Sclerosis (ALS)

The ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and efficacy of an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS). COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. It is comprised of low dose interleukin-2 (LD IL-2) and DRL\_AB (a biosimilar candidate for abatacept). Participants will be randomly assigned to receive one of 2 regimens of COYA 302 or placebo (an inactive substance) for 24-weeks in the double-blind (DB) period. Those who complete this part of the study may be eligible to receive one of the two regimens of COYA 302 for an additional 24 weeks in a blinded active extension phase (EXT). The study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), slow vital capacity (SVC), and neurological assessments. Additional objectives include evaluation of biomarkers and safety through routine clinical assessments and adverse event monitoring.

Начало: 01.10.2025 Край: 01.07.2027 Възраст: 18–80 г.

Canada, United States Coya Therapeutics NCT07161999

Набира участници

Visual Arts Interventions With Older Adults

Feasibility Study

The present study investigates the feasibility, acceptability, and preliminary effects of a novel visual arts-based intervention in an older adult population. In a randomized controlled design, two arts-based interventions will be evaluated with a group of 50 participants.

Начало: 01.10.2025 Край: 30.09.2026 Възраст: 55–85 г.

United States Northeastern University NCT06645652

Набира участници Фаза 1

Safety of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteer

Healthy Volunteers Non Diabetic Hyperglycemia

Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks.

Начало: 01.10.2025 Край: 24.09.2026 Възраст: от 18 г.

Thailand Chulalongkorn University NCT07532135

Набира участници

The Hyalex MTP Study

Hallux Valgus Hallux Limitus Hallux Rigidus

The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis . The system is composed of the HYALEX MTP Implant and instrumentation. The implant consists of the HYALEX Cartilage material bonded to a titanium backing.

Начало: 01.10.2025 Край: 31.12.2027 Възраст: 21–75 г.

Poland Hyalex Orthopaedics, Inc. NCT07538141

Набира участници Фаза 2

A Randomized Controlled Trial on the Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Therapy in Subjects With Moderate to Severe Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN)

This clinical trial aims to evaluate the efficacy and safety of human umbilical cord mesenchymal stem cell (hUC-MSC) injection in the treatment of adults with moderate to severe diabetic peripheral neuropathy. Researchers will compare hUC-MSCs injection combined with conventional therapy (experimental group) to conventional therapy alone (control group) to see if hUC-MSCs work to treat diabetic peripheral neuropathy. The experimental group will receive three injections of hUC-MSCs (on Day 0, Day 7, and Day 28) while continuing conventional therapy, whereas the control group will receive conventional therapy only. Participants will undergo regular follow-ups for checkups and tests over a 24-week period. The primary endpoint of the study is the change in the Toronto Clinical Scoring System (TCSS) score at Week 24. Safety assessments will be conducted throughout the entire study period, with extended follow-up until Week 104 to evaluate long-term safety.

Начало: 01.10.2025 Край: 30.08.2028 Възраст: 18–80 г.

China Min Long NCT07183761

Набира участници

The Multicentre Selective Lymphadenectomy Trial - 3

Cutaneous Melanoma, Stage III

The goal of this clinical trial is to demonstrate that there is no difference (non-inferiorty) in the 2 year recurrence-free survival (RFS) between 2 different surgical approaches for clinical Stage III melanoma. Following 6 weeks of standard neaodjuvant immunotherapy, patients will undergo either selective index lymph node resection (ILN) (identified at baseline as the largest affected lymph node) or the standard of care therapeutic lymph node dissection (TLND). The secondary aims are to assess if patients who are managed without TLND will have a reduction in surgical complications (less wound problems \& lymphoedema), an improved quality of life, at a lower healthcare utilisation.

Начало: 01.10.2025 Край: 01.08.2040 Възраст: от 18 г. Друго

Australia, Canada, Italy +2 Melanoma Institute Australia NCT07049276

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