Herpes Simplex

Researchers are studying a new treatment approach for patients with surgically removable head and neck squamous cell carcinoma HNSCC, a common and serious type of cancer in the head and neck region. The study evaluates the safety and tolerability of combining immune-targeted therapy with a lysogenic herpes simplex virus HSV as a neoadjuvant treatment to reduce tumor size before surgery. This innovative combination aims to improve surgery outcomes and lower the chances of cancer returning or spreading. Participants receive a combination of treatments including Tislelizumab given on days 1 and 22, and continuous daily Afatinib from days 1 to 42. They also receive injections of the lysogenic HSV virus directly into lymph nodes, with dosing based on lymph node size, given twice two weeks apart. After these treatments, patients undergo standard surgical removal of the tumor. The HSV virus injection includes an initial dose-escalation phase followed by a dose-expansion phase to find the most effective dose. During the study, patients are closely monitored for side effects and treatment tolerance, including checking for dose-limiting toxicities during surgery. Researchers will assess how well the tumor responds to treatment by examining major and complete pathological responses and overall tumor shrinkage up to eight weeks after treatment. They will also monitor adverse events for up to 12 weeks and follow disease-free survival for one year. The study duration and procedures are planned to provide detailed information on the safety and effects of this combined therapy.

Researchers are studying adults aged 18 to 70 years with herpes simplex virus type I stromal keratitis HSK to compare the safety and effectiveness of BD111 injection combined with standard therapy against standard therapy alone. This phase 1a, randomized, single-blind clinical trial aims to provide early evidence on how well BD111 works and how safe it is for treating HSK. BD111 is an investigational gene editing therapy designed to target the HSV-1 virus in the eye. The study involves two groups one receiving a single intrastromal injection of BD111 plus triple-drug therapy Ganciclovir eye gel, Valaciclovir tablets, and Prednisolone acetate eye drops for 3 weeks, and the other receiving a sham injection plus the same triple-drug therapy. The BD111 dose is 106 TU per eye in a 0.15 mL volume. Participants will be followed for 12 months to monitor safety and treatment effects. During the study, participants will undergo assessments including clinical cure rates at days 70 and 112, viral genome clearance in tears at multiple time points up to one year, recurrence monitoring, corneal inflammation scoring, and vision tests. Blood tests will check for antibodies and vector presence. Safety will be tracked through adverse event reporting. The total participation period is 12 months, with regular monitoring and evaluations throughout.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in participants with advanced solid tumors that have high antigen levels. This open-label, multicenter Phase 12 study aims to assess the safety, tolerability, and early clinical activity of STAR0602 given alone and in combination with chemotherapy for these tumors, which have limited effective standard treatments. The trial includes participants with unresectable, locally advanced, or metastatic solid tumors, including specific subtypes like NSCLC and colorectal cancer. The study has two parts Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine the maximum tolerated dose and safety profile. Phase 2 uses the recommended dose from Phase 1 to further evaluate safety and preliminary effectiveness, measuring tumor responses and disease control. Chemotherapy drugs like Irinotecan and Docetaxel may be combined with STAR0602, and treatments are administered by infusion following defined cycles. Participants will undergo multiple assessments including safety monitoring for adverse events and serious adverse events up to three years. Researchers will measure tumor response rates, duration of response, disease control rate, progression-free survival, and other pharmacokinetic parameters. Study visits will include treatment administration, laboratory tests, and evaluations to track the therapys effects and tolerability over time. The total participation period may extend up to three years for follow-up and monitoring.

Herpes simplex viruses HSV are carried by almost 90% of people and remain in the body for life, usually dormant. Reactivation occurs mainly when the immune system is weakened, causing mostly harmless cold sores but potentially serious infections like meningitis in immunocompromised individuals. This study is investigating whether treating HSV with acyclovir can improve survival in ventilated intensive care patients with pneumonia who have a high amount of HSV detected in their respiratory tract, as current evidence from retrospective studies is inconclusive. The trial compares two groups of ICU patients on mechanical ventilation with lower respiratory tract infection and HSV-1 detected in bronchoalveolar lavage BAL. One group receives intravenous acyclovir at 10 mgkg every 8 hours for up to 10 days or until ICU discharge, while the control group receives no antiviral therapy. The study is randomized and controlled to provide clear evidence on the effects of antiviral treatment in this patient population. Participants will be monitored for survival status at 30 days as the primary outcome. Secondary outcomes include ventilation-free days, vasopressor-free days, organ failure assessment scores, kidney function, length of ICU and hospital stay, quality of life measures, microbiological cure, and safety events. The study involves multiple assessments up to 180 days and tracks cost and adverse events, aiming to clarify the role of acyclovir therapy in improving outcomes for ventilated ICU patients with HSV-related pneumonia.

This research aims to improve the use of HIV, STI, and HCV prevention and care services among racially and ethnically diverse gay, bisexual, and other men who have sex with men GBMSM and transgender women living in rural Appalachia. By combining peer navigation with mobile health mHealth strategies, the study seeks to reduce health disparities in these vulnerable populations and inform public health practices and policies. Participants will be assigned to one of two groups an intervention group receiving a culturally compatible, bilingual approach that includes peer navigation and mHealth communication, or a delayed-intervention group. Community health leaders will raise awareness, support service access, and conduct in-person group sessions over 12 months. They will also use social media and apps to communicate and support participants throughout the intervention. During the study, researchers will track HIV, STI, and HCV testing rates at baseline, immediately after the 12-month intervention, and again 12 months later. They will also monitor the use of prevention methods like PrEP, syringe services, and gender-affirming care. Participants will be involved in group activities, receive ongoing support via mHealth platforms, and have their service use regularly assessed to measure the interventions impact through 24 months from baseline.

Researchers are evaluating a behavior change intervention program designed to reduce risky sexual behaviors among college students aged 16 to 24. This program was developed using the Behavior Change Wheel BCW theory and includes input from literature analysis, expert feedback, and pre-experiments. The goal is to improve students psychosexual health, social support, sexual self-efficacy, risk perception, and decision-making ability to lower the occurrence of risky sexual behaviors and related adverse outcomes. The intervention involves a behavioral program aimed at college students who have engaged in risky sexual behaviors such as multiple partners, unprotected sex, or casual sex. Participants are randomly assigned to either the intervention group receiving this program or a control group with no intervention. The intervention lasts 12 weeks, with evaluations before the intervention T0 and after its completion 12 weeks, T1. During the study, participants will be assessed using scales measuring sexual mental health, social support, and sexual self-efficacy at both T0 and T1. The study monitors changes in these areas to determine the interventions impact. Participation involves completing questionnaires and assessments related to psychosexual health and social factors, with the entire involvement spanning the 12-week intervention period.

Researchers are investigating the best ways to detect recurrence in women with vulva cancer. This Danish nationwide multicenter study aims to improve treatment and follow-up programs by combining patient-reported outcomes with clinical data. The team also plans to explore if circulating tumor-DNA ctDNA can be found in blood samples, which may help identify early signs of cancer returning. The study includes 295 patients in the clinical group and compares results to a historical control group of 1,000 patients diagnosed between 2011 and 2022. All participants will undergo regular collection of patient-reported outcome measures every four months during their surveillance period, along with liquid biopsies to measure ctDNA at baseline and throughout follow-up. Based on patient responses, nurse telephone interviews will be conducted using an algorithm to guide care. The historical control group data will be obtained from the Danish Gynecological Cancer Database for comparison. The study is non-randomized and open-label. Participants will be followed for up to two years or until cancer recurrence. Data collected will include symptom reports, ctDNA levels, and procedural actions taken during their care pathway. The study will assess recurrence-free survival and overall survival over two years, along with quality of life and symptom management. This comprehensive monitoring aims to detect relapse early and improve management of late effects from treatment.

Trigeminal herpetic neuralgia, a common form of Zoster-associated Pain ZAP, affects people of all ages and poses a significant burden worldwide. Researchers are conducting a randomized controlled trial to evaluate electroacupuncture EA as a treatment for ZAP, focusing on its effectiveness and safety compared to pregabalin. The study aims to determine if EA can be a substitute for pregabalin in managing this condition. Participants are randomly assigned to one of three groups a medication group taking 150 mg pregabalin capsules twice daily for 4 weeks an EA group receiving electroacupuncture treatments three times per week for 4 weeks total of 12 sessions, targeting specific acupoints on the affected side with electrical stimulation and a combined EA plus medication group receiving both treatments concurrently. Each group undergoes a 3-month follow-up period after the interventions. During the study, participants will be assessed using the Visual Analog Score at baseline, during treatment, and in follow-up visits up to 16 weeks. Additional evaluations include pain questionnaires, sleep quality scales, depression and anxiety ratings, and health surveys. Researchers will monitor safety and treatment adherence throughout the study, which lasts several months from enrollment to final follow-up assessments.

Researchers are evaluating the STRATICYTE12 predictive model to see how well it can predict the transformation of oral potentially malignant disorders OPMDs into oral squamous cell carcinoma OSCC. This study focuses on a retrospective group of patients who had biopsies taken for oral lesions. The main goals include assessing the models sensitivity and specificity, understanding which patient and clinical factors affect its accuracy, and estimating how STRATICYTE12 results relate to the time until a positive oral cancer diagnosis. The study involves analyzing biopsy tissue samples from patients with various grades of oral epithelial dysplasia, including no dysplasia, mild, moderate, severe dysplasia, and carcinoma in situ CIS. Participants are grouped based on whether their OPMDs progressed to OSCC or not. STRATICYTE12 testing is used to assess the risk of progression to oral cancer by reviewing archived biopsy tissue blocks from clinical centers. Participants archived biopsy data and clinical follow-up records over at least five years are reviewed. Researchers measure the STRATICYTE12 tests sensitivity, specificity, area under the curve AUC, and Harrells C-index, along with survival analysis over five years. The study tracks the correlation of STRATICYTE12 outcomes with oral cancer development timing. No new treatments or procedures are performed during this observational study, and the overall participation involves data analysis from past biopsies and clinical records.

Researchers are investigating whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce the risk of preterm birth and other poor birth outcomes in Botswana. The study also assesses if this screening approach is affordable and cost-effective for the health system. Approximately 2,000 pregnant women attending their first antenatal care visit at several government clinics will be invited to participate. Participants will be randomly assigned to either receive routine antenatal care or additional screening and treatment for chlamydia and gonorrhoea during pregnancy. Participants in the intervention group will be screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester between 28 and 32 weeks. Women who test positive will receive treatment following recommended guidelines, counseling on partner notification, and a test-of-cure about four weeks after treatment. The standard of care group will receive routine antenatal care, with urine specimens collected and tested retrospectively after delivery to assess infection prevalence. Both groups will undergo routine health checks, HIV and syphilis testing, ultrasounds, and other standard antenatal procedures. Throughout the study, participants will complete questionnaires about their health, socio-economic status, and pregnancy progress. Researchers will review medical records after birth to collect data on birth outcomes like preterm birth, birth weight, and maternal health conditions such as hypertension and preeclampsia. Study staff will support participant retention by providing reimbursements for time and travel and maintaining contact through multiple communication methods. The study will monitor outcomes until delivery and conduct detailed cost and cost-effectiveness analyses to evaluate the impact of screening and treatment on health and healthcare expenses.