Cold Sore (Herpes Labialis)

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 evaluating a combination of immune-targeted therapy and lysogenic herpes simplex virus (HSV) virotherapy as a neoadjuvant treatment for patients with surgically resectable head and neck squamous cell carcinoma (HNSCC). This study aims to improve surgical success and reduce the risk of recurrence and metastasis by using these therapies before surgery. The trial is a prospective, single-arm study focused on the safety and tolerability of this innovative approach for patients with locally advanced HNSCC without distant metastasis. Participants will receive tislelizumab on days 1 and 22, afatinib daily from days 1 to 42, and injections of lysogenic HSV virus into lymph nodes in two doses spaced two weeks apart. The virus dose will be adjusted based on lymph node size, with a dose-escalation phase followed by a dose-expansion phase using the most effective dose. After these treatments, patients will undergo standard surgery to remove the tumor. During the study, researchers will monitor participants for dose-limiting toxicities during surgery and evaluate responses such as major pathologic response and complete pathologic response. Additional assessments include adverse events up to 12 weeks, objective response rate up to 8 weeks, and one-year disease-free survival. Participants will attend scheduled visits for treatment administration, surgery, and follow-up to assess safety and treatment effects throughout the trial period.

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 10^6 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.

Herpes simplex viruses (HSV) are very common, affecting nearly 90% of people, and stay in the body for life in a dormant state. When the immune system is weakened, HSV can reactivate and cause infections like cold sores or more serious conditions such as meningitis. In intensive care patients on mechanical ventilation with pneumonia, HSV is often detected in the respiratory tract. This research aims to determine whether treating HSV with acyclovir improves survival in these critically ill patients. The study randomly assigns 616 ventilated ICU patients with pneumonia and HSV detected in their lung fluid to receive either acyclovir treatment or no antiviral therapy. Acyclovir is given intravenously at a dose of 10 mg per kg of body weight every 8 hours for up to 10 days or until ICU discharge if earlier. The trial compares survival rates after 30 days between the two groups and also looks at ventilation-free days, vasopressor-free days, and safety outcomes. Participants will be closely monitored during the study with regular assessments including organ function scores, kidney function tests, microbiological cure, length of ICU and hospital stay, and quality of life measures up to 180 days. Safety will be tracked by recording serious adverse events. This comprehensive evaluation will help clarify whether antiviral therapy benefits ventilated patients with pneumonia and HSV in their lungs.

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 model's 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 test's sensitivity, specificity, area under the curve (AUC), and Harrell's 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 evaluating the safety of using the galea and pericranium (fascio-periosteal) temporal flap for reconstructing mandibular gingival defects. This approach aims to improve function and appearance after surgical removal of oral cavity tumors. The study builds on previous experiences where similar flaps have been used successfully for head and neck reconstruction, including bone regeneration and treatment of pharyngeal fistulas. The study involves patients who need reconstruction following partial removal of the mandibular gingival region. Surgeons will use periosteum, galea, or pericranium flaps harvested from the cranial temporal region, which has good blood supply, to repair soft and hard tissue defects. This method is being assessed as a reliable option for oral cavity reconstruction after tumor excision. Participants will be followed for at least 18 months to monitor outcomes. Researchers will evaluate the function and safety of the flap reconstruction, including bone and tissue healing. Patients will have regular follow-up visits for assessments, and their progress will be closely monitored to measure the success of the surgical procedure and any related complications.

Researchers are studying the safety of G207, an experimental virus therapy, for children and young adults aged 3 to 21 years with recurrent or progressive cerebellar brain tumors. This phase 1 clinical trial evaluates G207 alone or combined with a low dose of radiation to enhance virus replication, tumor cell killing, and stimulate an anti-tumor immune response. The study aims to find safe treatment options for patients with poor outcomes after standard therapies have failed. Participants receive a single dose of G207 infused directly into tumor regions via catheters. If the first group tolerates G207 alone, subsequent groups will receive G207 followed by a 5 Gy radiation dose to tumor areas within 24 hours to potentially increase treatment effects. The study uses a 3 + 3 design with four patient groups to gradually test increasing doses and combinations. During the study, participants are monitored for safety by tracking adverse events and treatment effects. Researchers will also assess immune response, viral shedding, tumor progression, survival, daily functioning, and optional quality of life up to several years after treatment. The total monitoring period ranges from months to 15 years, ensuring long-term safety and effectiveness data collection.

Herpesvirus infections can be very serious, especially for children with blood cancers or those who have received a hematopoietic stem cell transplant (HSCT). These infections carry a high risk of complications and death. Although herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV) are common worldwide, antiviral medicines like acyclovir have helped reduce infection rates in children who are at risk. This research studies how acyclovir behaves in the body of children receiving it through an intravenous (IV) or oral route for preventing or treating herpes virus infections. The study involves children with blood cancers or those undergoing high-intensity chemotherapy, as well as HSCT recipients. It uses therapeutic drug monitoring to analyze acyclovir levels in the blood during routine care. Participants will receive acyclovir either by IV or orally as part of their regular treatment. Researchers will collect blood samples to track acyclovir levels and study how the drug is processed by the body. The main measurement is the percentage of patients who reach a minimum acyclovir blood concentration after six months of treatment. Data from this study aims to help improve acyclovir dosing in children with cancer. The study is expected to continue until March 2026.

Researchers are evaluating a new imaging device called the Active Biopsy Guidance System to help doctors decide when and where to perform invasive biopsies of mouth lesions. The study aims to assess and improve the technical performance of this system and to provide preliminary estimates of its sensitivity and specificity compared to traditional tissue analysis (histopathology). The device uses optical imaging techniques and an optical contrast agent called proflavine. The Active Biopsy Guidance System consists of two parts: the optical mapping scope and the high-resolution microendoscope (HRME). The optical mapping scope captures wide-area images of the mouth lining by shining different colors of light, while the HRME takes detailed pictures of very small areas at high magnification. During the study, a fluorescent dye called proflavine hemisulfate is applied to mouth areas to enhance image quality. Participants with oral lesions will be involved in imaging sessions using these devices. Researchers will collect images and compare them to biopsy results to measure how accurately the system detects abnormalities. The study will continue for about one year, monitoring the device's performance. Safety and participant consent will be carefully managed throughout the trial.

Herpes simplex virus (HSV) infection is very common and often causes sores at any age. There is currently no treatment that completely cures or eradicates the virus. This trial evaluates the efficacy of 2LHERP®, an immune regulator used for over 20 years in treating herpetic infections, in adults with recurrent orofacial herpes infections. The study is placebo-controlled and aims to assess 2LHERP®'s impact on reducing herpes recurrences. The study will last 36 months, including 24 months for patient enrollment and 12 months of follow-up. Participants aged 16 to 80 with at least six episodes of orofacial herpes in the past year will be randomly assigned to receive either 2LHERP® or a placebo for 6 months. Both treatments involve taking one capsule daily, 15-30 minutes before breakfast on an empty stomach, following a sequential capsule order. After the treatment phase, participants will be followed for an additional 6 months. During the trial, participants will be monitored for the number of herpes episodes, time to first recurrence, episode duration, symptom severity, use of rescue medication, and quality of life. Safety will also be assessed through adverse event reporting. The primary outcome is the reduction in recurrent herpes episodes at 12 months. Participants will complete daily diaries and questionnaires, with regular evaluations throughout treatment and follow-up.