ClinicalTrials.gov Studies

Phase 2 Dapagliflozin Spironolactone Aortic Valve Replacement Trial

NIH registered a Phase 2 randomized controlled trial (NCT07539259) evaluating dapagliflozin and spironolactone in patients with severe aortic stenosis undergoing aortic valve replacement. The four-arm trial will assess whether these heart failure medications improve left ventricular mass regression, myocardial health, and patient-reported outcomes compared to standard-of-care alone over 12 months.

Suzetrigine Phase 3 Trial for Cardiac and Bariatric Surgery Patients NCT07539623

NIH registered Phase 3 clinical trial NCT07539623 on ClinicalTrials.gov, evaluating Suzetrigine as an addition to multimodal pain regimens for post-operative pain management in bariatric and cardiac surgery patients. The prospective, randomized study will assess whether Suzetrigine reduces opioid consumption and pain scores compared to placebo in participants undergoing weight-loss surgery or sternotomy.

Study Compares Caries Removal Methods, Oral Microbiome Effects

The National Institutes of Health registered a clinical study on ClinicalTrials.gov (NCT07538089) evaluating how selective and non-selective caries removal methods affect oral microbiome composition using 16S rRNA gene sequencing. The study targets dental caries patients and will assess microbial diversity outcomes from two intervention approaches.

Oral Probiotics vs Placebo Pakistani Moderate Acne Study

ClinicalTrials.gov registered a randomized controlled trial (NCT07539129) evaluating oral probiotics versus placebo in 64 Pakistani patients with moderate Acne Vulgaris over 12 weeks. The primary endpoint is reduction in total acne lesion count; secondary endpoint is change in serum Interleukin-6 levels. The study will use GAGS scoring and standardized photography for clinical assessment.

Phase 3 RCT of GAPP Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma

NIH registered a Phase 3 randomized controlled clinical trial (NCT07540390) evaluating GAPP induction therapy combined with concurrent chemoradiotherapy and toripalimab maintenance for high-risk locoregionally advanced nasopharyngeal carcinoma (Stage III, AJCC 9th edition). The experimental arm combines PD-1 antibody (toripalimab), anlotinib, cisplatin, gemcitabine, and radiation, while the control arm uses the current guideline-recommended GPP induction chemotherapy regimen. The multicenter open-label study aims to generate evidence-based data on the efficacy and safety of this novel combination.

MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)

NIH registered a Phase 2 clinical trial (NCT07538284) titled MIDDIES on ClinicalTrials.gov. The trial will study whether nighttime self-administration of nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patients undergoing major abdominal surgery, compared with placebo.

QIPB in Hip Surgery - Opioid Consumption Measurement Study

This single-center retrospective study registered on ClinicalTrials.gov examines patients who underwent hip surgery between May 2025 and November 2025. The study compares patients receiving Quadro Iliac Plane Block (QIPB) plus patient-controlled analgesia against a control group using only patient-controlled analgesia. Primary endpoint is total opioid consumption over 24 hours, with secondary endpoints including pain scores and rescue analgesia requirements.

Observational Case Series of Futsal Goalkeeper Barrier-Step Movement

NIH ClinicalTrials.gov registered observational study NCT07539246 examining barrier-step movement in three elite male futsal goalkeepers. The study used high-speed video analysis to characterize movement phases and body angles during standardized low ball stimulus responses. No compliance obligations or regulatory requirements are created by this registration.

Serplulimab, Chidamide, and Rituximab Followed by Sequential R-CHOP for Newly Diagnosed Elderly MYC/BCL2 Double-Expressor DLBCL

NIH ClinicalTrials.gov registered a Phase 2 clinical trial (NCT07538180) evaluating a three-stage treatment protocol for newly diagnosed elderly patients with MYC/BCL2 double-expressor DLBCL. The protocol consists of chemotherapy-free SCR therapy (Serplulimab, Chidamide, Rituximab), followed by R-CHOP chemotherapy, then maintenance therapy. The trial enrolls elderly patients and allows R-miniCHOP for frail patients over 75 years.

Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression Phase 2 Randomized Controlled Trial

The NIH National Library of Medicine has registered a Phase 2 multicenter randomized controlled trial (NCT07539805) evaluating sertraline combined with Lactobacillus crispatus versus sertraline combined with placebo in adolescents aged 12-18 with major depressive disorder. The 8-week trial includes clinical assessments and safety monitoring every 4 weeks. No compliance obligations or deadlines are imposed on external parties.

Social Media Support Groups for Adolescent Vaping Cessation - Pilot

NIH has registered a pilot study (NCT07540780) on ClinicalTrials.gov evaluating the Quit the Hit Toolkit, a social media-based nicotine vaping cessation program adapted for teens and young adults in community settings. The study will assess feasibility and acceptability of the intervention targeting vaping, vaping cessation, and nicotine dependence. No compliance obligations or regulatory deadlines are created by this study registration.

Optimizing Weblink Design in Digital Vaccination Invitations to Raise Trust and Booking Intention: Online Experiment 3

NIH registered a behavioral research study (NCT07538349) examining how weblink design in digital vaccination invitation emails affects recipient trust and appointment booking intention. The study plans to enroll 4,000 participants (2,000 from the UK and 2,000 from the US) testing three link formats: an NHS control link and two experimental weblink variants including an improved version and a text-embedded hyperlink. This is a clinical trial registration entry documenting study design rather than a regulatory action or compliance requirement.

Observational Study on ADEM Outcome Predictors in Children

The National Institutes of Health has registered an observational study (NCT07540182) aimed at determining outcome predictors in children diagnosed with acute disseminated encephalomyelitis (ADEM). The study will observe patients with ADEM, encephalomyelitis, and encephalopathy conditions. No new compliance obligations or regulatory requirements are established by this study registration.

oXiris Hemofilter in Septic Shock With AKI Trial

NIH registered a multicenter retrospective observational study (NCT07539883) evaluating the clinical effectiveness of the oXiris® hemofilter in patients with septic shock and acute kidney injury requiring continuous renal replacement therapy. The study uses a Target Trial Emulation approach to compare patients treated with oXiris® filters against standard CRRT filters, examining in-hospital mortality, fluid balance, and vasopressor requirements. The study addresses inconsistent evidence regarding whether oXiris® improves survival through endotoxin and cytokine removal.

CHW Diabetes Program for Rural, Low-Income Patients

NIH has registered a clinical trial (NCT07538505) evaluating a Community Health Worker (CHW) program for patients with type 2 diabetes in rural and low-income settings. The study will assess whether monthly diabetes education classes and weekly mobile health check-ins improve blood sugar control, program sustainability, and feasibility. Participants will be recruited from rural clinics remote from the research team.

WISE Trial: Therapist-Supervised Wrist Exercise vs Usual Care for Fracture Recovery

NIH registered Clinical Trial NCT07538323, the WISE (Wrist Injury Strengthening Exercise) study, a randomized controlled trial comparing therapist-supervised exercise therapy against usual care self-management advice for adults aged 50 and older recovering from wrist fractures. The trial will measure pain and functional improvement using the Patient Rated Wrist Evaluation questionnaire at 6 months post-injury. Participants receive either supervised therapy sessions (one 60-minute session plus two 30-minute sessions) plus usual-care advice, or usual-care advice alone.

Adductor Canal Block With Tourniquet for Posterior Knee Pain After Total Knee Arthroplasty

NIH registered clinical trial NCT07539467, a randomized study comparing Tourniquet-Assisted Adductor Canal Block (T-ACB) versus Standard Adductor Canal Block (S-ACB) for managing posterior knee pain after total knee arthroplasty. The trial enrolled patients with gonarthrosis and tested whether applying a thigh tourniquet postoperatively alongside the adductor canal block improves pain control at the back of the knee. Results from this Phase 4 trial may inform regional anesthesia protocols for knee replacement recovery.

AI-Assisted Staging and Treatment Decision-Making for Hepatocellular Carcinoma

NIH's ClinicalTrials.gov has registered NCT07538882, a prospective observational study evaluating an AI model's ability to assist clinical physicians in staging hepatocellular carcinoma (HCC) and making treatment decisions. The Multi-Rater Multi-Case crossover study will compare physician accuracy under unassisted versus AI-assisted conditions across different hospital tiers to determine whether AI can reduce diagnostic and therapeutic heterogeneity in HCC care.

MG-K10 Phase III Trial, Adolescents, Moderate-to-Severe Atopic Dermatitis

NIH registered a Phase III clinical trial (NCT07540442) for MG-K10, a humanized monoclonal antibody injection, in adolescents with moderate-to-severe atopic dermatitis. The randomized, double-blind, placebo-controlled, parallel-group study aims to confirm the efficacy and safety of MG-K10 monotherapy. Trial conditions are limited to atopic dermatitis; no other indications are listed.

TUVA BX and iCover Stent Grafts BEVAR Observational Study

ClinicalTrials.gov registered an observational study collecting retrospective patient data on TUVA BX and iCover stent grafts used during branched endovascular aortic repair (BEVAR) to treat complex aortic aneurysms. The multi-center, single-arm study will review medical records from the original procedure through the 1-year follow-up visit for patients with thoracoabdominal aortic aneurysms or abdominal aortic aneurysms. No patient groups are assigned to specific interventions.

Web-Based Stroke Diagnostic Tests Validation Study (Observational, NCT07538076)

The NIH registered observational study NCT07538076 to validate two web-based diagnostic tests — the Star Cancellation Test and Line Bisection Test — for assessing visuospatial neglect in hemiplegic stroke patients. The study will compare digital tablet-and-stylus versions of these tests against conventional paper-and-pencil assessments to evaluate diagnostic accuracy and clinical usability. Participants include stroke patients who will complete both conventional and digital versions of each test along with routine cognitive assessments.

Pilot Study: Mental Health Treatment Toolkit for Autistic Individuals

The Organization for Autism Research (OAR) registered a pilot study (NCT07539519) to improve mental health treatment for autistic individuals. The study will conduct remote focus groups to identify barriers and develop a prototype therapist resource, which will then be pilot tested in a community clinic setting. Participants will receive either enhanced psychotherapy or treatment as usual.

ADEPT Diarrhea Prediction Tool Pilot, LMICs

NIH has registered a pilot before-after feasibility trial testing the Accessible Diarrhea Etiology Prediction Tool (ADEPT), a mobile phone-based clinical decision-support application, among informally trained healthcare providers in low- and middle-income countries. The study aims to assess the tool's acceptability, feasibility, and utility in reducing inappropriate antibiotic prescribing for pediatric diarrhea. Participants will use the ADEPT application during routine patient care, with outcomes measured before and after implementation.

Sup19 CAR-T Phase 1 Trial for CD19 Therapy Failures and B-Acute Lymphoblastic Leukemia

NIH registered a Phase 1 clinical trial (NCT07539610) evaluating Sup19 CAR-T cells in patients with B-Acute Lymphoblastic Leukemia or B-ALL/Lymphoma where prior CD19-targeted therapy has failed or CD19 is weakly expressed. The single-arm prospective study will assess safety and efficacy of the investigational cell therapy product.

Multi-Omics Analysis of Lens Zonule Relaxation in PACG Pathogenesis

NIH registered observational clinical study NCT07539675 on ClinicalTrials.gov examining differential molecular expression in Primary Angle-Closure Glaucoma patients with zonular laxity compared to those without and controls. The study involves no experimental interventions and seeks to construct a mechanistic network from identified molecules.

Phase 2 Trial of Absorbable and Moldable Skull Base Support Plates in Endoscopic Endonasal Surgery

NIH registered a Phase 2 clinical trial (NCT07539792) on April 20, 2026, to evaluate the efficacy and safety of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery for sellar tumors. The primary endpoint is the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery; secondary endpoints include intracranial infection rates, surgery duration, hospital stay length, and nasal complications. The study is a prospective, randomized, controlled trial.

Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC

NIH registered a Phase 2 clinical trial (NCT07540832) evaluating WGI-0301 in combination with Lenvatinib in patients with advanced hepatocellular carcinoma (HCC) at multiple hospital sites. The open-label study will assess safety, tolerability, pharmacokinetics, and early efficacy signals of the combination therapy.

Phase 1 Mirdametinib Trial for CNS Tumors

NIH registered Phase 1 trial NCT07539441 to evaluate mirdametinib as a treatment for central nervous system tumors, specifically glioma and neurohistiocytosis. The study is listed on ClinicalTrials.gov as a Phase 1 safety and efficacy assessment. No compliance obligations or deadlines are associated with this registration notice.

Phase 1 PK Study of HRS9531 Injection in Mild to Normal Hepatic Function

The NIH ClinicalTrials.gov registry has published a Phase 1 clinical study (NCT07540754) to evaluate the pharmacokinetics of HRS9531 Injection in participants with mild and moderate hepatic impairment compared to participants with normal hepatic function. The study will also assess safety. Participants have conditions of Diabetes Mellitus and Weight Loss. The study was registered with an anticipated date of April 20, 2026.

Effects of Low-Intensity Blood Flow Restriction Training on Strength and Kicking Performance in Taekwondo Athletes

NIH registered a new clinical trial (NCT07538037) on ClinicalTrials.gov investigating the effects of low-intensity blood flow restriction training (LI-BFRT) on lower-limb strength and kicking performance in taekwondo athletes. The study examines physical performance and athletic performance conditions using LI-BFRT and HIRT interventions. This is an informational study registration; it creates no compliance obligations for external parties.

Real-World Cohort Study Comparing Adjuvant HP vs T-DM1 in HER2+ Breast Cancer Non-pCR Patients

NIH's ClinicalTrials.gov registered a multicenter, retrospective, real-world cohort study (NCT07540520) comparing two adjuvant treatment regimens for HER2-positive breast cancer patients with non-pCR after neoadjuvant therapy: trastuzumab combined with pertuzumab (HP group) versus ado-trastuzumab emtansine (T-DM1 group). The study will analyze data from patients treated between July 2019 and July 2025 with a planned enrollment of 2,000 cases.

AL001 vs Lithium Carbonate Phase 1 Bipolar I Disorder Trial

NIH registered Phase 1 trial NCT07540338 to assess safety and brain/plasma pharmacokinetics of investigational drug AL001 (a crystallized lithium formulation) compared to marketed immediate-release lithium carbonate in subjects with Bipolar I Disorder. The crossover study will enroll participants who take each drug for 14-day periods at MGH research unit with MRI and blood draw monitoring. No compliance obligations are imposed by this registry entry.

Connected Toothbrush Study for Children Post-Operating Room Treatment

NIH ClinicalTrials.gov has registered an observational study (NCT07539064) titled 'Children in the Operating Room: Kids That go Thru Operating Room Will be Given a Connected Health Toothbrush, Kids Anticavity Toothpaste and Behavioral Health Intervention to Reduce Claim Costs.' The study examines whether compliance and brushing adherence using a connected toothbrush with a behavioral health intervention can improve oral health outcomes for children previously treated for caries in an operating room setting.

Effect of AI Critical Appraisal Training on Critical Thinking in Nursing Students

NIH registered a new cluster randomized controlled trial (NCT07538986) evaluating an AI Critical Appraisal Training method against traditional case-based learning for undergraduate nursing students. The study measures critical thinking disposition, AI literacy, and clinical reasoning skills pre- and post-intervention, with no stated compliance obligations for external parties.

Safety Evaluation of Bioactive Glass Based Bone Cement Combined With Ultrasound in Implantation for Metastatic Bone Tumors

The NIH ClinicalTrials.gov registry has recorded a Phase safety trial (NCT07540468) evaluating the use of bioactive glass-containing bone cement combined with intraoperative ultrasound for patients with metastatic bone tumors. The study aims to assess safety and feasibility of this combined treatment approach for bone stabilization and pain reduction. All participants will receive standard care plus the study intervention with close safety monitoring.

Benmelstobart, Anlotinib, and Chemotherapy for Extensive-stage Small Cell Lung Cancer

NIH ClinicalTrials.gov registered a Phase 2 single-center study at Shanghai Pulmonary Hospital evaluating benmelstobart plus anlotinib and platinum-etoposide chemotherapy with sequential thoracic radiotherapy in 33 adult patients with previously untreated extensive-stage small cell lung cancer. The open-label, non-randomized trial uses objective response rate as the primary endpoint.

Adiponectin Biomarker Trial for Metabolic Disorders

NIH registered an open-label randomized controlled trial (NCT07539584) evaluating whether high-molecular-weight adiponectin levels predict treatment response in 130 adults aged 40-65 with type 2 diabetes and metabolic dysfunction-associated fatty liver disease. Patients are randomized to SGLT2 inhibitor monotherapy, GLP-1 receptor agonist monotherapy, combination therapy, or no drug therapy. The primary outcome is change in serum HMW-adiponectin levels over 6 months; secondary outcome is change in liver steatosis measured by Controlled Attenuation Parameter.

MOCHA Perinatal Mental Health Integration Study Registration

NIH registered observational study NCT07540585 examining a Collaborative Mental Health Care Program integrated into high-risk obstetric inpatient settings. The single-arm implementation study will assess feasibility, acceptability, and fidelity of delivering brief inpatient psychotherapy, symptom monitoring, and three-month post-discharge follow-up for pregnant and postpartum patients with depression, anxiety, ADHD, and PTSD symptoms.

Effects of Menstrual Cycle on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery

The National Institutes of Health registered observational study NCT07539831 on April 20, 2026. The study evaluates the effect of menstrual cycle phase (follicular vs. luteal) on optic nerve sheath diameter measurements in women undergoing elective laparoscopic gynecologic surgery. Researchers will assess perioperative ONSD measurements and postoperative outcomes including nausea, vomiting, and cognitive function.

Turkish Sex Pain Questionnaire Validation for Chronic Pain Conditions

NIH registered observational study NCT07536672 on ClinicalTrials.gov to validate the Turkish version of the Sex Pain Questionnaire developed by Rafael Ballester-Arnal in 2022. The study evaluates sexual function problems in patients with chronic pain conditions including fibromyalgia, neck pain, and lower back pain. The questionnaire consists of 17 items across two factors measuring sexual dissatisfaction and the effect of chronic pain on sexual life. No regulatory obligations or compliance requirements are imposed by this registration.

GLP-2 (Teduglutide) Phase 2 Trial for Environmental Enteric Dysfunction in Undernourished Women, Dhaka

The NIH ClinicalTrials.gov registry published a Phase 2 clinical trial (NCT07537686) evaluating teduglutide (a GLP-2 analog) for treatment of environmental enteric dysfunction (EED) in 40 undernourished women aged 18-35 in Dhaka, Bangladesh. The randomized study will assess whether 30 days of daily subcutaneous teduglutide injections improve intestinal damage (via biopsy) and gut inflammation markers. icddr,b (Bangladesh) is a collaborating institution.

Turkish Version of the Eksterociptive Body Awareness Questionnaire Validation Study NCT07536685

The National Institutes of Health registered an observational study (NCT07536685) to validate the Turkish version of the Eksterociptive Body Awareness Questionnaire (EBA-Q). The study involves 70 healthy adult participants who will complete a survey using the questionnaire. The study aims to establish the validity and reliability of the instrument for use in Turkish research.

Measurement of Ocular Blood Flow and Retinal Oxygen Extraction in Diabetic Patients

NIH has registered a clinical trial (NCT07536516) investigating the impact of GLP-1 receptor agonists (semaglutide, liraglutide) and GIP/GLP-1 dual agonists (tirzepatide) on ocular blood flow and retinal function in diabetic patients. The study will use Laser Speckle Flowgraphy (LSFG), Optical Coherence Tomography (OCT), and Optical Coherence Tomography Angiography (OCT-A) as diagnostic interventions. The trial focuses on patients with diabetes mellitus to evaluate potential neuroprotective effects on retinal microvasculature.

AI-ECG Observational Study for Acute Aortic Dissection

NIH registered a prospective multicenter observational study (NCT07536932) evaluating an AI-ECG model for diagnosing acute type A aortic dissection in emergency department patients with chest pain. The study will enroll adults at five tertiary hospitals and compare AI model predictions against CTA-confirmed diagnoses. Clinical and ECG data will be collected as part of standard care to assess diagnostic performance across centers.

Telerehabilitation vs Conventional Rehab Non-Inferiority Trial for Subacromial Pain

NIH has registered a clinical trial (NCT07536009) on ClinicalTrials.gov evaluating whether a telerehabilitation program is non-inferior to conventional in-person physical therapy for patients with subacromial pain syndrome. The prospective, randomized, parallel-group, single-center controlled non-inferiority trial will measure primary outcome of shoulder function using the QuickDASH questionnaire at 12 weeks. Secondary outcomes include pain intensity, range of motion, treatment adherence, and long-term functional outcomes.

ALN-4915 Phase 1 Trial, Healthy Volunteers

Alnylam has registered a Phase 1 clinical trial for ALN-4915 on ClinicalTrials.gov (NCT07535606). The study will evaluate safety, tolerability, pharmacodynamics, and pharmacokinetics of ALN-4915 in adult healthy volunteers. The trial involves approximately 60 participants receiving ALN-4915 or placebo.

Open Label SKY-0515 Huntington's Disease Trial Phase 2

NIH ClinicalTrials.gov registered a Phase 2 open-label extension study (NCT07537075) for SKY-0515, an oral medication being evaluated for Huntington's Disease. The trial will enroll adults aged 25 and older with genetically confirmed HD to assess whether SKY-0515 can lower harmful proteins associated with the disease and improve symptoms. The study is registered as Phase 2 with an anticipated start date.

Observational BMPR2-Activin Pathway Study in Group II Pulmonary Hypertension

The NIH registered a prospective observational study (NCT07537517) on ClinicalTrials.gov evaluating the BMPR2-activin signaling pathway in Group II pulmonary hypertension associated with left heart disease. The study will enroll 150 heart failure patients undergoing hemodynamic assessment with a 1-year follow-up, plus a nested substudy of 40 heart transplant candidates for vascular morphometric analysis. Results may inform PH-LHD classification, precision-medicine models, and targeted therapies such as activin inhibitors.

ESPB vs ICNB Postoperative Pain VATS Randomized Trial

NIH's ClinicalTrials.gov has registered study NCT07535697, a prospective randomized trial comparing ultrasound-guided erector spinae plane block (ESPB) to thoracoscopically-guided intercostal nerve block (ICNB) for postoperative pain management in adults undergoing video-assisted thoracoscopic surgery (VATS). The study will evaluate analgesic consumption over 24 hours, pain levels at predefined time points, and procedure duration to determine whether ESPB provides comparable analgesia to ICNB.

KIA-Korekt: Staged Unimodal-to-Multimodal AI Evaluation for Perioperative Risk Prediction in Colorectal Cancer

NIH ClinicalTrials.gov registered NCT07537491 (KIA-Korekt study), an observational study conducted at University Hospital Brandenburg investigating whether multimodal AI analysis of medical imaging can predict perioperative complications in colorectal cancer patients. The study integrates digital histopathology (H&E-WSIs), CT/MRI radiomics, and multiplex tissue imaging across a retrospective cohort of approximately 750 CRC patients (2011–2021) and a prospective validation cohort of approximately 210 patients (2026–2028).