Healthcare & Life Sciences

Integrating Supports to Promote PrEP for Black Adolescents Working With Apps - Atlanta

NIH has registered a clinical trial (NCT07535346) evaluating the Health MPowerment app as a behavioral intervention to promote PrEP adherence among Black adolescents and young adults in Atlanta. The study applies Social Cognitive Theory to assess feasibility and acceptability of the enhanced HMP app as a support tool. The trial targets Black AYAs and adult supports as participants, with data collection anticipated through April 2026.

Effect of Tai Chi and Multimodal Exercise in Overweight and Obese Women

NIH registered clinical trial NCT07536893 examines the effects of a 10-week Tai Chi and Multimodal exercise program on balance in overweight and obese women. The study found that both Tai Chi and multimodal exercise programs significantly improved balance parameters compared to baseline. The research addresses a gap in the literature regarding balance-focused interventions as a primary goal for improving physical mobility in overweight individuals.

Evaluation of Serum Autophagic Biomarkers in Acute Response to Walking and Cycling in Healthy Males

NIH ClinicalTrials.gov registered observational study NCT07536659 evaluating serum autophagic biomarkers in healthy male individuals responding to walking and cycling exercises. The study aims to assess acute cellular responses to different physical exercise modalities through peripheral blood analysis, building on limited existing human data in this area.

First-in-man Trial TRICENTO G2 Transcatheter Valve for Tricuspid Regurgitation

The NIH ClinicalTrials.gov registry has posted a first-in-man trial for the TRICENTO G2 Transcatheter Valve System (TRICENTO G2 TVSTR) intended to treat severe tricuspid regurgitation in adult patients. The early feasibility study will assess safety, performance, and clinical benefit through 1-year follow-up. Participants will undergo minimally invasive valve implantation with clinic visits at baseline, 30 days, 3 months, 6 months, and 1 year post-procedure.

Montelukast Phase 2 Trial for Acute Myocardial Infarction

NIH registered a Phase 2 randomized controlled trial (NCT07537868) evaluating Montelukast 10 mg oral tablets for acute myocardial infarction. The trial, sponsored by Mansoura University (Egypt), will enroll participants randomized to Montelukast or placebo to assess anti-inflammatory and cardioprotective effects via inflammatory markers and cardiac injury indicators. The study has an estimated start date of April 17, 2026.

IBM Dietary Surveillance Study at Manchester Metropolitan University

The NIH ClinicalTrials.gov registry has added a new observational study (NCT07535996) titled 'IBM Dietary Surveillance Study' at Manchester Metropolitan University. The study will investigate how diet affects muscle health and functional ability in adults with inclusion body myositis (IBM) compared to healthy volunteers aged 40 and older. Participants will complete dietary records, physical activity monitoring, body composition assessments, and muscle function tests over a four-week home monitoring period plus two university visits.

IPG11406 Phase 2 UC Trial, 144 Patients, 12 Weeks

NIH has registered a Phase 2 clinical trial (NCT07535489) for IPG11406, an investigational oral drug targeting the GPR183 receptor for ulcerative colitis. The randomized, double-blind, placebo-controlled study will enroll 144 adult patients across three active dose groups (10 mg, 20 mg, 40 mg twice daily) and one placebo arm over 12 weeks. The primary endpoint is clinical remission measured by modified Mayo Score at week 12, with secondary endpoints including clinical response, endoscopic remission, histological improvement, and safety evaluation.

First-in-human SRP-1005 Huntington's Disease Phase 1 Trial

NIH ClinicalTrials.gov registered a first-in-human Phase 1 trial (NCT07536061) studying SRP-1005, an investigational treatment for Huntington's Disease. The multi-center trial will evaluate the safety and tolerability of SRP-1005 versus placebo in participants with Huntington's Disease. The trial has an anticipated start date of April 17, 2026.

Mirror Therapy for Complex Regional Pain Syndrome in Post-Stroke Patients

The NIH ClinicalTrials.gov registry has registered a clinical trial (NCT07537465) evaluating mirror therapy for complex regional pain syndrome in post-stroke patients. The randomized controlled trial will compare mirror therapy to sham mirror therapy over 4 weeks. Participants will receive conventional rehabilitation therapy and be assessed using clinical scales, electrophysiological tests, and ultrasonographic measurements.

Observational Study, Adolescent Rights, Rural Assiut, Egypt

NIH registered observational study NCT07536555 on ClinicalTrials.gov, titled 'Adolescent Rights Fulfilment in Rural Assiut, Egypt'. The community-based cross-sectional study will assess fulfilment of adolescent rights in health, education, protection, and community participation among 300 adolescents aged 15-19 years in Beni Adi village, Assiut Governorate. Data collection is anticipated to begin April 17, 2026.

EUS-RFA for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors

NIH ClinicalTrials.gov has registered a clinical trial (NCT07536087) evaluating endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) as a treatment for pancreatic cystic neoplasms and pancreatic neuroendocrine tumors in patients ineligible for or refusing surgery. The primary endpoints assess technical feasibility and effectiveness, while secondary objectives evaluate safety and long-term efficacy including adverse events and disease progression over one year of follow-up.

Effects of Dual-Task Training on Upper Extremity Function in Parkinson's Disease

NIH has registered a clinical trial (NCT07536542) on ClinicalTrials.gov to study the effects of dual-task training on upper extremity function and muscle thickness in individuals with Parkinson's disease. The randomized controlled trial will enroll approximately 60 participants who will be assigned to either an 8-week dual-task training group (3 days per week) or a control group receiving routine care. Researchers will assess upper extremity function, grip strength, pinch strength, and muscle thickness via ultrasonography at baseline and post-intervention.

Insulin Insitu-Gel for Tympanic Membrane Perforations: Early Phase 1 RCT

NIH ClinicalTrials.gov registered Early Phase 1 trial NCT07535827 evaluating insulin insitu-gel formulation for tympanic membrane perforation healing. The randomized controlled study at Minia University Hospital enrolled participants from January 2025 to March 2026, comparing insulin insitu-gel (Humulin with chitosan, polyvinyl alcohol, and Pluronic F127) against foam control. Primary outcome was perforation healing at 1-week, 1-month, and 2-month follow-ups; secondary outcomes included hearing scores. Results showed significantly superior healing in the insulin group versus control.

Phase 2 FAPI-74 PET/CT Inflammatory Disorders Study

NIH registered Phase 2 clinical trial NCT07535554 to evaluate [18F]-AlF-FAPI-74 PET/CT diagnostic performance in three inflammatory disorder cohorts: fever of unknown origin, IgG4-related disease, and axial spondyloarthritis. The study will compare the new radiopharmaceutical against standard-of-care [18F]-FDG PET/CT imaging.

Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails

NIH has registered a new clinical trial (NCT07536581) comparing bioabsorbable intramedullary nails to titanium elastic intramedullary nails for treating displaced pediatric diaphyseal forearm fractures. The randomized controlled trial will assess fracture healing time on X-ray, complications, recovery, function, and family experience. Children requiring surgery will be randomly assigned to either treatment group.

Phase 2 Leucine-Restricted Diet, Gastric Cancer Study

NIH's ClinicalTrials.gov has registered Phase 2 trial NCT07537361 evaluating the safety and efficacy of a leucine-restricted diet combined with neoadjuvant chemotherapy and immunotherapy in gastric cancer patients. The study aims to assess whether dietary leucine restriction is safe, well-tolerated, and capable of promoting immune cell activation within the tumor microenvironment to improve patient outcomes. Estimated study completion date is April 17, 2026.

Signum Biosciences Chia Seed Extract Patent Granted

The USPTO granted patent US12599642B2 to Signum Biosciences Inc on April 14, 2026. The patent covers compositions derived from Salvia hispanica (chia) seeds and methods of preparation and administration. The 18 claims span dermatological applications including skin care and sunscreen formulations. Third parties face no compliance obligations from this patent grant.

House Wellness Foods Probiotic Therapeutic Patent Granted

The USPTO granted Patent US12599638B2 to House Wellness Foods Corporation for a feed and composition comprising Lactobacillus plantarum strain L-137 and a fatty acid. The patent covers compositions for enhancing IL-12 production, immunostimulation, and bacteriostasis. The patent application was filed on September 21, 2021, with 7 claims granted.

DOJ Sues NYPH Hospital for Antitrust Violations

The DOJ filed an antitrust lawsuit against The New York and Presbyterian Hospital on March 26, 2026, alleging the hospital used its Manhattan market power to force payors into favorable contractual terms that harmed patients and employers. The complaint closely follows a template used in a similar February 2026 lawsuit against OhioHealth, with approximately half of the 60 paragraphs being nearly identical. The NYPH lawsuit differs in that it does not include state law claims (the NY State AG did not join) but contains more documented evidence suggesting the DOJ has incriminating emails from NYPH representatives.

LEAD Replaces ACO REACH, 10-Year Model Starts 2027

The Centers for Medicare & Medicaid Services Innovation Center announced the Long-term Enhanced ACO Design (LEAD) model to replace the ACO REACH model. LEAD offers a 10-year commitment (2027-2036) with a fixed spending baseline, eliminating the benchmark rebasing that reduced savings under REACH. The model opens participation to smaller, rural, and independent practices and adds new payment tools including Non-Primary Care Capitation (NPCC) for specialists and CARA risk arrangements. ACOs must apply by May 17, 2026, for the first performance year starting January 1, 2027.

FDA Expands Home Devices, Seeks Statutory Authority Changes

This Mintz newsletter covers two FDA regulatory developments: (1) FDA's READI-Home innovation challenge inviting medical device manufacturers to submit home-health devices aimed at reducing hospital readmissions, with submissions due September 30, 2026 and selections by December 4, 2026; and (2) HHS's FY2027 budget request containing FDA legislative proposals including changes to compounded drug advertising rules, a new biological product licensure pathway, and an alternative IND pathway for Phase 1 clinical trials to encourage biotechnology investment.

Health Care Non-Compete Legislation Q1 2026 Update

Several states enacted new restrictions on non-compete agreements for healthcare workers in Q1 2026. Washington passed H.B. 1155 banning all non-compete covenants effective June 30, 2027. Virginia enacted a law prohibiting non-compete enforcement when employees are terminated without cause unless severance is provided, and passed legislation broadly prohibiting non-competes with health care professionals pending the governor's signature. Utah prohibited non-compete agreements with health care workers effective May 6, 2026. Montana expanded its physician non-compete ban effective January 1, 2026. California enacted legislation targeting private equity and hedge fund influence in healthcare practices.

Federal Circuit Reverses JMOL on Antibody Patent Claims for Method of Treatment

The Federal Circuit reversed a district court JMOL and held that Teva's method of treatment claims using anti-CGRP antagonist antibodies to treat headaches satisfied both written description and enablement requirements under 35 U.S.C. § 112. The court found that the prior art demonstrated the antibody genus was well known, humanization methods were routine, and all antagonistic anti-CGRP antibodies work for headache treatment. The decision clarifies that method-of-treatment claims with a specific indication differ from broad functional claims requiring disclosure of every species in a genus.

Storm Flood Cleanup Safety Precautions for Wisconsin Residents

The Wisconsin Department of Health Services has issued safety precautions for residents and crews engaged in storm and flood cleanup and recovery. The advisory covers multiple hazards including downed power lines, debris, carbon monoxide exposure, floodwater dangers, mold growth, private well contamination, and food safety. The guidance also informs FoodShare members they have 10 days to request replacement benefits for food lost due to storms or power outages.

BCD-261 Phase 1 Study, Healthy Chinese Volunteers

NIH ClinicalTrials.gov registered a Phase 1 study for investigational drug BCD-261, a single subcutaneous injection, to evaluate safety, pharmacodynamics, pharmacokinetics, and immunogenicity in healthy adult Chinese volunteers. The study (NCT07535775) represents early-stage clinical research.

Support Group Curriculum for Parents of Children With DLD

NIH registered clinical trial NCT07536217 titled 'Developmental Pilot of Support Groups for Caregivers of Children With DLD' to test a new support group curriculum designed for parents of children with Developmental Language Disorder. The study will evaluate support groups as the intervention approach for this population.

0.01% and 0.025% Atropine Eye Drops Combined With Auricular Acupoint Stimulation for Myopia Control in Children

NIH has registered a randomized, double-blind, placebo-controlled pilot trial (NCT07537166) evaluating low-dose atropine (0.01%, 0.025%) combined with auricular acupoint stimulation for myopia control in 420 children aged 6-12. Participants will be divided into six groups receiving different treatments or placebo over a 12-week follow-up period. The study aims to determine synergistic effects of combined therapy and establish safer treatment options for myopia, addressing corneal toxicity concerns associated with higher 0.05% atropine concentrations.

Radiofrequency Versus Cervical Fusion for Chronic Whiplash Observational Study

The NIH ClinicalTrials.gov registry has published registration details for NCT07535515, an observational study comparing cervical medial branch radiofrequency ablation versus anterior cervical discectomy and fusion (ACDF) for chronic post-traumatic whiplash patients. The retrospective study reviews medical records from a tertiary hospital spanning 2005-2025 to evaluate pain relief, functional disability, psychological symptoms, and need for repeat procedures.

Comparison of Effectiveness of Autobrush vs Manual Toothbrush, Children 9-12

The NIH National Library of Medicine registered clinical trial NCT07537803, a randomized crossover study comparing the effectiveness of an Autobrush U-shaped toothbrush versus a manual regular toothbrush in children aged 9-12 years. The study will measure Full Mouth Plaque Scores using disclosing tablets and assess both brushing techniques. Participants avoid oral cleaning procedures 12 hours before appointments.

Proton vs Photon IMRT Toxicity in Breast Cancer (NCT07537712)

NIH registered clinical trial NCT07537712, an observational study comparing acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients. The study will follow eligible patients for at least one year to assess incidence and severity of toxicities affecting the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues, as well as patient-reported outcomes, cosmetic outcomes, and quality of life. The trial has an estimated completion date of April 17, 2026.

Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill

The NIH registered a Phase 3 clinical trial (NCT07536763) comparing estetrol-drospirenone combined oral contraceptive pills against ethinylestradiol-levonorgestrel pills. The trial will evaluate effects on arterial vascular function including flow-mediated dilatation and pulse wave velocity, blood pressure, inflammatory markers, and metabolic indices over 12 months. Participants are randomized to receive either treatment with clinic visits at baseline, 6 months, and 12 months.

Effect of Sildenafil on Left Ventricular Function in Pediatric Primary Dilated Cardiomyopathy

NIH registered observational study NCT07536880 titled 'Effect of Sildenafil on Left Ventricular Function in Pediatric With Primary Dilated Cardiomyopathy.' The study examines sildenafil's effect on left ventricular function in pediatric patients with primary dilated cardiomyopathy, characterized by left ventricular dilation and impaired contraction. The study was registered on April 17, 2026.

Becotatug Vedotin Phase 2 Hepatocellular Carcinoma Study

NIH registered a Phase 2 clinical trial (NCT07536789) for Becotatug vedotin (MRG003) in previously treated advanced hepatocellular carcinoma (HCC). The study will evaluate efficacy and safety of MRG003 as an intervention. No compliance obligations or deadlines are imposed by this registration.

Diagnostic Accuracy and Prognostic Value of 18F FDG PET-CT in Follow-Up of Colorectal Carcinoma

NIH ClinicalTrials.gov registered observational study NCT07536321 evaluating the diagnostic and prognostic value of 18F FDG PET-CT imaging in the follow-up of patients with Stage III rectal cancer. The 5-year prospective study will enroll participants already undergoing routine PET-CT imaging and assess whether PET-CT contributes to treatment decision-making in colorectal cancer patients.

Lipid Triglyceride Surfactant Composition, Patent US12599580B2

The USPTO granted patent US12599580B2 to BASF AS on April 14, 2026, covering compositions comprising 2-((5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenyloxy)butanoic acid, a triglyceride, and a surfactant, as well as methods of using the same in self-emulsifying drug delivery systems such as SEDDS, SMEDDS, or SNEDDS. The patent contains 20 claims.

Enzyme-Cleavable Prodrug Compositions and Controlled Release Nafamostat Methods

USPTO granted patent US12599578B2 to Ensysce Biosciences Inc. for pharmaceutical compositions including enzyme-cleavable prodrugs providing enzymatically-controlled release of active agents, combined with controlled release nafamostat. The patent covers 12 claims and methods of use for these pharmaceutical compositions.

Nanoparticle Wound Healing Treatment Patent US12599698B2

USPTO granted patent US12599698B2 to Kismet Technologies Inc. on April 14, 2026, covering a therapeutic article with metal-modified cerium oxide nanoparticles (mCNPs) for wound healing and antimicrobial infection control. The patent includes 19 claims for the nanoparticle-treated fiber composition with particles sized 3-35nm.

Axcess Global Sciences LLC Patent - Ketone Bodies and Amino Acid Compositions

The USPTO granted patent US12599579B2 to Axcess Global Sciences LLC covering compositions of ketone bodies or ketone body precursors complexed with amino acids. The patent, effective April 14, 2026, contains 22 claims and names Gary Millet, Ryan Lowery, Jacob Wilson, and Terry Lacore as inventors. The compositions are directed toward uses including weight loss, blood glucose management, muscle performance, metabolic repair, neurological treatment, and anti-aging applications.

NLRP3 Modulators for Treating Interleukin 1β Diseases

USPTO granted patent US12599616B2 to Zydus Lifesciences Limited for novel substituted sulfonylurea and sulfoximineurea derivatives as NLRP3 modulators for treating interleukin 1β-mediated diseases and conditions. The patent contains 11 claims and 20+ CPC classifications spanning A61K, C07C, C07D, and A61P therapeutic categories.

Grand Forks County Measles Case Confirmed, 33 Total in ND 2026

North Dakota HHS confirmed one measles case in Grand Forks County on April 16, 2026, marking the first case in that county this year. The individual likely acquired the infection within the state with no reported travel. North Dakota has recorded 33 total measles cases in 2026, with five hospitalizations. Public exposure locations in Grand Forks County have been identified. HHS recommends MMR vaccination for all Grand Forks County residents and travelers as a precaution against potential community transmission.

Abdominal and Lower Extremity Adipose Tissue Elasticity in Patients With Lipedema

NIH has registered a new observational clinical trial (NCT07536646) investigating abdominal and lower extremity adipose tissue elasticity in patients with lipedema using shear wave elastography (SWE). The study will compare subcutaneous tissue stiffness between lipedema patients and healthy controls, and evaluate differences between abdominal and lower extremity measurements within the same patients. Lipedema is a chronic disorder predominantly affecting women and is often underrecognized or confused with obesity, venous insufficiency, and lymphedema.

Neural Mobilization vs Cervical Neuromodulation in Diabetic Peripheral Neuropathy: Randomized Pilot Trial, 75 Participants

NIH registered a three-arm, assessor-blinded randomized controlled pilot feasibility trial (NCT07537270) comparing Manual Neural Mobilization and Cervical Neuromodulatory Intervention against standard care in 75 participants with diabetic peripheral neuropathy over 12 weeks. The primary endpoints are recruitment rates, adherence, and safety; secondary endpoints include HbA1c, fasting blood glucose, and pain intensity. The trial is registered in ClinicalTrials.gov as a pilot feasibility study ahead of a potential full-scale RCT.

GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis

NIH registered the GALLVIA Trial (NCT07536191), a multicenter randomized controlled trial comparing endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with endoscopic transpapillary gallbladder drainage (EGBS) in poor surgical candidates with acute calculous cholecystitis. The 1:1 randomized trial uses lumen-apposing metal stents for EUS-GBD and transpapillary plastic stents for EGBS, with primary endpoint of clinical success. Secondary endpoints include technical success, adverse events, reintervention rate, procedure time, length of stay, and 30-day mortality.

Firsekibart, Tislelizumab, Lenvatinib for TP53-Mutated HCC

NIH registered Phase 2 clinical trial NCT07535840 evaluating combination therapy with Firsekibart, Tislelizumab, and Lenvatinib in patients with unresectable, TP53-mutated hepatocellular carcinoma who have failed prior systemic immunotherapy. The study's primary objective is objective response rate, with secondary objectives assessing overall efficacy, safety, and biomarker predictors.

Early Delirium Prediction Via Serial EEG Trajectories and Machine Learning

NIH registered observational study NCT07536854 on ClinicalTrials.gov. The study aims to develop a machine learning model predicting delirium in trauma ICU patients using serial EEG recordings. Researchers will analyze brainwave patterns across recording conditions to identify early delirium biomarkers before clinical onset.

EXTEND-TNK Registry, IV Tenecteplase, Acute Ischemic Stroke, China

The NIH ClinicalTrials.gov has registered NCT07536165, the EXTEND-TNK Registry, a prospective multicenter observational cohort study evaluating intravenous tenecteplase administered beyond 4.5 hours after last known well for acute ischemic stroke patients in routine clinical practice across China.

Right Ventriculo-Arterial Coupling During Fluid Loading in ICU Patients

NIH registered observational study NCT07537621 examining right ventriculo-arterial coupling during fluid loading in ICU patients. The study investigates the relationship between preload responsiveness, venous congestion, and right ventricular function in critically ill patients with shock and right ventricular dysfunction. Echocardiography will be used as the primary intervention to assess hemodynamic changes.

Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

NIH registered a prospective cohort study (NCT07535203) comparing Fontan procedure outcomes in patients with cyanotic congenital heart disease classified by pulmonary blood flow characteristics. Fifty-two patients will be divided into oligemia and plethora groups and followed for approximately 1.5 years post-procedure to assess mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.

Comparative Efficacy of Topical Clotrimazole Versus 2% Salicylic Acid in Otomycosis

NIH has registered a randomized controlled clinical trial (NCT07535424) comparing clotrimazole ear drops versus 2% salicylic acid ear drops for treatment of otomycosis (fungal ear canal infection). The study enrolled 60 patients randomized equally between the two treatment groups, with both interventions administered three times daily for two weeks. The primary outcome measure is relief of ear blockage reflecting improvement in canal patency.

RecoveriX BCI System Clinical Trial for Stroke Gait Rehabilitation

NIH's ClinicalTrials.gov registered a new clinical trial (NCT07537530) evaluating the recoveriX PRO Brain-Computer Interface system for gait rehabilitation in stroke patients. The recoveriX device combines motor imagination with functional electrical stimulation and virtual reality feedback, controlled via EEG signals. The trial will enroll stroke patients and compare BCI-assisted therapy (25 sessions over approximately 8 weeks) against standard FES+VR treatment without EEG monitoring to assess safety and functional improvement in gait ability.