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Recruiting Phase 4

A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Ulcerative Colitis Crohn's Disease

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.

Начало: 27.03.2025 Край: 01.06.2028 Възраст: 18–80 г.

United States Takeda NCT06581328

Recruiting Phase 3

Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

Metastatic Head and Neck Squamous Cell Carcinoma Metastatic Hypopharyngeal Squamous Cell Carcinoma Metastatic Laryngeal Squamous Cell Carcinoma Metastatic Oral Cavity Squamous Cell Carcinoma +17

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

Начало: 27.03.2025 Край: 30.11.2029 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06589804

Recruiting Phase 2

Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer

Lung Cancer - Non Small Cell Squamous Lung Cancer - Non Small Cell Non-Squamous

The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.

Начало: 27.03.2025 Край: 27.02.2031 Възраст: от 18 г. Treatment

Australia, United States Merus B.V. NCT07353957

Recruiting Phase 3

DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

Endometrial Cancer

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Начало: 27.03.2025 Край: 19.02.2031 Възраст: от 18 г. Treatment

Australia, Belgium, Brazil +17 AstraZeneca NCT06989112

Recruiting Phase 1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA)

This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201. The study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.

Начало: 27.03.2025 Край: 25.06.2029 Възраст: 18–75 г. Treatment

Australia, Bosnia and Herzegovina, New Zealand +1 Sanofi NCT06647069

Recruiting Phase 1/2

Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years

Chlamydia Trachomatis Immunization

The purpose of this study is to evaluate the safety, efficacy, and immunogenicity of different dose levels (low, medium, and high) of Chlamydia messenger ribonucleic acid (mRNA) Vaccine candidate in adult participants aged 18 to 29 years. This study will consist of 3 Sentinel Cohorts and a Main Cohort, with the Sentinel Cohorts assessing the safety of the different dose levels in a stepwise manner. All participants will be followed up to 12 months after the last study intervention administration. Thus, the expected duration of the participant's involvement will be 18 months.

Начало: 27.03.2025 Край: 03.01.2028 Възраст: 18–29 г. Prevention

Australia Sanofi NCT06891417

Recruiting Phase 3

Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

Hemophilia

This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor

Начало: 26.03.2025 Край: 01.03.2027 Възраст: 12–70 г.

China Jiangsu BioJeTay Biotechnology Co., Ltd. NCT06922045

Recruiting Phase 2/3

Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS

Amyotrophic Lateral Sclerosis

Phase II/III multicenter, randomized, double-blind, placebo-controlled trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS). Primary study aim: The clinical objective consists of assessing the efficacy of ALCAR (two different dosages will be tested: 1.5g/day and 3g/day) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale. Secondary study aims: 1. The effect of ALCAR treatment on different clinical aspects: functional decline as measured by ALSFRS-R total score; the decline of forced vital capacity (FVC); quality of life as measured by ALSAQ-40 scale; cognitive function as measured by Edinburgh Cognitive and Behavioural ALS Screen (ECAS) scale; survival (being alive and without tracheostomy). 2. To measure the effects of ALCAR treatment on disease biomarkers potentially involved in the drug's mechanisms of action. These include PGC-1 alpha, 3-nitrotyrosine (3-NT), acetyl cyclophilin A (acetyl-PPIA), neurofilament light chain (NFL), creatine kinase (CK), Musclin/osteocrin, MyomiRNA (MiR-206), Uric acid, Matrix metalloproteinase-9 (MMP-9), Monocyte Chemoattractant Protein-1 (MCP-1), 4-Hydroxynonenal (HNE). 3. The tolerability and safety of ALCAR treatment by identifying unexpected adverse events. Study population: 246 subjects will be enrolled on one Australian and ten Italian ALS sites. Inclusion criteria: subjects aged 18+ years with a diagnosis of ALS according to Gold Coast Criteria; disease duration \= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening, treatment with Riluzole in the last four weeks. Exclusion criteria: antecedent polio infection; other motor neuron disease; involvement of other systems possibly determining a functional impairment; other severe clinical conditions; unwillingness or inability to take riluzole; previous use of ALCAR for any reason; inability to understand and comply with the study requirements, and to give written informed consent personally or via their legally authorized representative. All eligible participants will be randomized to receive ALCAR (1,5 or 3 g/day) or placebo in addition to riluzole 50 mg b.i.d. Permuted block (with a block size of 6), 1:1:1 centralized randomization scheme will be used. The overall treatment duration will be 48 weeks. After enrolment, each participant will be followed up until death. Eligible subjects will be seen after 4, 12, 24, 36 and 48 weeks. At each visit, a general assessment will be made, including vital signs, body mass index (BMI), neurological examination (including quantitative and qualitative evaluation of the motor system), comorbidity, concomitant treatments and adverse events. Blood samples will be collected at baseline -Day 1 (randomization)-, 4, 12, 24, 36 and 48 weeks to test biomarkers. Functional disability will be assessed at each visit using the ALS-FRS-R scale. The respiratory function will be assessed using a spirometer to measure FVC before starting treatment (baseline visit) and at 4, 12, 24, 36 and 48 weeks. Cognitive function will be evaluated at baseline, weeks 24 and 48, using ECAS scale. Health-related quality of life, measured by the ALSAQ-40, will be tested at baseline, 24 and 48 weeks. Compliance will be tested by the local investigators, counting unused packages at each follow-up visit. Pre-planned statistical analyses will be done on Intention-to-treat and Per-protocol (PP) populations. The statistical plan will include descriptive statistics and a comparison of the proportions of self-sufficient participants at week 48 using the chi-square or Fisher's exact test for the primary endpoint. Secondary endpoints measured by numerical scores obtained from clinical scales will be analyzed using repeated measures mixed models, while biomarkers using repeated measures ANOVA. Time-to-event endpoints, such as survival and the probability of remaining self-sufficient over 48 weeks, will be analyzed with Kaplan-Meier curves. The number of adverse events and serious adverse events after 48 weeks will be compared between treatment arms.

Начало: 26.03.2025 Край: 01.09.2027 Възраст: от 18 г. Treatment

Australia, Italy Mario Negri Institute for Pharmacological Research NCT06126315

Recruiting

Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

Stroke Hemorrhagic Stroke

The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available. EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.

Начало: 26.03.2025 Край: 28.11.2026 Възраст: от 22 г.

Australia, United States EMVision Medical Devices Ltd NCT06999122

Recruiting Phase 2

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

HIV-1-infection

The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill. The primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.

Начало: 26.03.2025 Край: 01.09.2027 Възраст: до 17 г.

South Africa, United States Gilead Sciences NCT06749054

Recruiting Phase 3

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)

Urothelial Carcinoma

This trial is a registered phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic urothelial carcinoma after failure of PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy.

Начало: 25.03.2025 Край: 01.12.2027 Възраст: от 18 г.

China Sichuan Baili Pharmaceutical Co., Ltd. NCT06857175

Recruiting

MOLECULAR BASIS OF LANGUAGE DEVELOPMENT AND ASSOCIATED DISORDERS

Developmental Language Disorder

Developmental Language Disorder (DLD) refers to children who present with language difficulties that are not due to a known biomedical condition or associated with autism spectrum disorder (ASD) or intellectual disability. The prevalence of DLD is \~7%-8% or 2% if severe forms are considered. However, the clinical heterogeneity of language disorders, the presence of co-morbidities and the inconsistent terminology used for many years have hindered research and clinical practice. Distinguishing sub-groups of children with language problems is crucial when tackling the underlying genetic causes of this disease. Recently, several studies using high-throughput sequencing have better define the genetic basis of CAS but such studies focusing on DLD are limited. The investigation of more homogeneous cohorts of individuals that clearly distinguish DLD cases, from ID and not including children with CAS should improve our understanding of the genetic basis of this disorder. In this study, we aim to built and investigate a well-characterized cohort of DLD patients using pangenomic approaches to better define the molecular basis of this disorder. All individuals will be analyzed using chromosomal microarray analysis and whole genome sequencing. Multiple observations and preliminary results suggest strong links with the genetic basis of other neurodevelopmental disorders. The goal is to identify CNV or SNV as causative allele or risk factor and already known to be involved in other neurodevelopmental disorders as well as potential new variants.

Начало: 25.03.2025 Край: 25.03.2028 Възраст: от 5 г.

France Institut National de la Santé Et de la Recherche Médica NCT06660108

Recruiting

Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma

Metastatic Sarcoma Radiation Therapy Patient Ewing Sarcoma Rhabdomyosarcoma

This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation.

Начало: 25.03.2025 Край: 01.03.2030 Възраст: до 39 г.

United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopk NCT06796543

Recruiting Phase 2

Liposomal Irinotecan, 5-fluorouracil/Calcium Folinate, Oxaliplatin, and Adebrelimab in Combination With Radiotherapy for Resectable or Borderline Resectable Pancreatic Cancer With Risk Factors：A Prospective Exploratory Study

Pancreatic Cancer

Pancreatic cancer is a highly malignant digestive system tumor with a very poor prognosis. In recent years, both the incidence and mortality rates of pancreatic cancer have shown a marked upward trend worldwide. Global cancer statistics from 2020 indicate that approximately 495,000 new cases of pancreatic cancer are diagnosed annually, with about 466,000 deaths attributed to this disease each year. Based on the anatomical relationship between the tumor and blood vessels, pancreatic cancer is classified into three types: resectable, borderline resectable, and unresectable. The onset of pancreatic cancer is often insidious, with approximately 80% of patients presenting with advanced disease at the time of initial diagnosis, thereby losing the opportunity for radical surgical resection. Only 15-20% of patients are eligible for radical surgery at the time of initial diagnosis. However, even after surgical resection, many patients still experience early recurrence, leading to a very poor prognosis. This highlights the significant limitations of relying solely on surgery for disease control. Currently, there is no standard neoadjuvant treatment protocol for pancreatic cancer. Recent neoadjuvant clinical trials have primarily referenced chemotherapy regimens used for advanced pancreatic cancer, which may include chemotherapy and/or radiotherapy. Recommended chemotherapy regimens include the FOLFIRINOX regimen, gemcitabine plus nab-paclitaxel, gemcitabine plus cisplatin (for BRCA1/2 mutations), and gemcitabine plus S-1. At the 2023 ASCO Annual Meeting, updated data from the NAPOLI-3 study showed that the NALIRIFOX regimen (irinotecan liposome, oxaliplatin, 5-fluorouracil, and leucovorin) achieved overall survival (OS) endpoints in first-line treatment of metastatic pancreatic cancer patients compared to the AG regimen, with clinical significance. Based on this study, the NCCN guidelines have included the NALIRIFOX regimen as a recommended first-line treatment for advanced pancreatic cancer. Given the therapeutic and safety advantages of irinotecan liposome over irinotecan in pancreatic cancer, this study aims to further explore the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors. The goal is to identify a more effective treatment option for patients with borderline resectable pancreatic cancer (BRPC) and resectable pancreatic cancer (RPC), thereby improving survival outcomes. This study is a prospective, single-arm, exploratory trial designed to evaluate the efficacy and safety of irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab combined with radiotherapy for resectable or borderline resectable pancreatic cancer with high-risk factors, with a planned enrollment of 37 patients. After screening and meeting the inclusion and exclusion criteria, eligible patients will provide informed consent and undergo neoadjuvant treatment with irinotecan liposome, 5-fluorouracil/leucovorin, oxaliplatin, and adabelimab (with a 2-week cycle) for a total of four cycles of preoperative chemotherapy combined with immunotherapy, along with five sessions of short-course radiotherapy.

Начало: 25.03.2025 Край: 31.05.2026 Възраст: 18–75 г.

China Ningbo Medical Center Lihuili Hospital NCT07542002

Recruiting Phase 1

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo

Vitiligo

A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.

Начало: 25.03.2025 Край: 31.12.2026 Възраст: 18–75 г. Treatment

Australia, New Zealand Forte Biosciences, Inc. NCT06905873

Recruiting Phase 2

Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.

Atopic Dermatitis (Eczema) Atopic Dermatitis Eczema Atopic Dermatitis Atopic Dermatitis (AD) +2

A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).

Начало: 25.03.2025 Край: 28.11.2025 Възраст: от 2 г. Treatment

Australia Alphyn Biologics NCT06855745

Recruiting Phase 4

Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

Ophthalmology

Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).

Начало: 25.03.2025 Край: 31.12.2027 Възраст: 20–85 г.

Taiwan National Taiwan University Hospital NCT06886373

Recruiting Phase 3

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Chronic Obstructive Pulmonary Disease (COPD)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Начало: 25.03.2025 Край: 05.06.2029 Възраст: 40–80 г. Treatment

Argentina, Australia, Belgium +19 AstraZeneca NCT06878261

Recruiting Phase 3

Nicotine Patch Plus Nicotine Mouth Spray Versus Nicotine Reduction for Vaping Cessation

Vaping Cessation

This research focuses on maximizing the chances of successfully quitting vaping. A large, pragmatic community-based clinical trial is planned in New Zealand to build on existing evidence from previous vaping and smoking cessation research undertaken by the study team. The effectiveness of combination nicotine replacement therapy (NRT) compared to nicotine tapering on vaping abstinence has not yet been investigated, but both provide an opportunity to increase success with vaping cessation, especially when combined with written behavioural support to further boost quit rates. The planned trial will test whether using combination NRT will help more New Zealanders to quit vaping long-term, compared with a vape nicotine tapering plan. Participants in both groups will also receive written vaping cessation behavioural support.

Начало: 25.03.2025 Край: 30.04.2027 Възраст: от 16 г. Treatment

New Zealand University of Auckland, New Zealand NCT06832098

Recruiting Phase 4

An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction

Ophthalmology Cataract Surgery Anesthesia Oral Anxiolytic Satisfaction Survey

Phacoemulsification is one of the most used surgical methods for cataract surgery today, and the surgeries are under the anesthetic and sedative to make it comfortable and safe for patients. The most important issue is which method is the best for reducing the patient's anxiety, pain, and discomfort during surgery. Previous studies have analyzed the impact of intravenous injection of sedative on the quality of phacoemulsification surgery; however, the impact of oral anti-anxiety drugs (Alprazolam) on cataract surgery has not been intensively studied. Therefore, the purpose of this study is to investigate the impact of Alprazolam on satisfaction in cataract surgery. Oral sedation is more convenient and safer than intravenous sedation. Therefore, the investigators will further analyze whether patients using oral anti-anxiety drugs will have an improvement in the pain, anxiety, overall satisfaction, and side effects related to nausea and dizziness in the phacoemulsification surgery. This study will detailed record the patient's status in various aspects using questionnaire scales and scores. Through this research, the investigators will have the opportunity to comprehensively improve the surgical quality of cataract patients in a safe and convenient manner. The investigators plan to collect data from patients who participated in the study "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB) from October 2023 to August 2025, and plan to undergo phacoemulsification and intraocular lens implantation surgery in their second eye with local anesthetic at the Department of Ophthalmology, National Taiwan University Hospital. The sample size of 250 participants was determined based on the type of intervention, expected effect size, outcome variability, desired statistical significance, trial power, and experiences from similar studies. Vulnerable populations and those with any relevant contraindications will be excluded during the enrollment process. All medical records and surgical process data, including privacy-related information, will only be accessible to professional medical personnel for analysis. The focus of this study will be on intraoperative satisfaction, pain scores, relevant discomfort symptoms during the surgery, and postoperative anxiety assessment scales.

Начало: 25.03.2025 Край: 31.12.2027 Възраст: 18–80 г.

Taiwan National Taiwan University Hospital NCT06874452

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