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 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.

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.

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 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 investigating the safety of G207, an engineered herpes simplex virus-1 HSV-1 therapy, for children and young adults aged 3 to 21 with recurrent or progressive malignant cerebellar brain tumors. These tumors have poor outcomes after standard treatments fail. The study also evaluates combining G207 with a single low dose of radiation to enhance virus replication, tumor cell killing, and trigger an anti-tumor immune response. Participants receive a single dose of G207 infused directly into the tumor through catheters. If the initial safety is confirmed, subsequent groups will receive G207 followed by a 5 Gy radiation dose to active tumor areas within 24 hours to increase treatment effect. This phase I, open-label trial uses a traditional 3 3 design with four patient cohorts, starting with G207 alone and progressing to combined therapy. During the study, participants undergo MRI reviews to confirm tumor size and location suitable for treatment. Researchers monitor safety by tracking adverse events for up to 15 years, along with immune response, virus shedding, progression-free survival, overall survival, performance ability, and optional quality of life assessments. The trial involves careful evaluation of laboratory tests, performance scores, and long-term follow-up to understand treatment tolerability and preliminary effectiveness.

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 studying the Active Biopsy Guidance System, a new optical imaging device designed to assist doctors in deciding when and where to perform biopsies on mouth lesions. The study aims to evaluate and optimize the technical performance of this device and to provide an initial estimate of its accuracy compared to standard tissue pathology. This research is focused on adults with various oral lesions, including potentially malignant disorders and previous oral cancers. The Active Biopsy Guidance System consists of two main parts an optical mapping scope that shows a wide area of the mouth lining using colored light projections, and a high-resolution microendoscope that captures detailed images of small areas. A fluorescent dye called proflavine hemisulfate is applied to the mouth tissue to enhance image quality. This device is assessed as a diagnostic tool to improve biopsy guidance. Participants will undergo imaging with the device, where pictures of the mouth lining are taken with and without the dye. The study will measure the devices sensitivity and specificity in detecting abnormal tissue compared to biopsy results. The trial involves a single group of participants and continues through to study completion, with ongoing monitoring lasting about one year. The research team monitors participants carefully to understand the devices performance and safety.

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 2LHERPs 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.

Researchers are evaluating the effectiveness of kefir mouthwash in improving oral health by studying its impact on gingival inflammation, plaque, oral hygiene, and bad breath in adults with moderate gingivitis. This trial compares kefir mouthwash to the standard chlorhexidine 0.12% mouthwash over a 28-day period, with assessments at the start, day 14, and day 28. The study uses a triple-blind, randomized design involving healthy adults aged 18 to 28 years. Participants will be randomly assigned to use either kefir mouthwash or chlorhexidine. Kefir mouthwash is prepared from probiotic cultures mixed with 3% fat milk and used twice daily, 30 minutes after brushing, for one minute each time. The chlorhexidine group uses 0.12% chlorhexidine mouthwash following the same schedule and instructions. Both mouthwashes are provided in identical bottles labeled only by codes to maintain blinding. During the trial, researchers will measure oral health using the Gingival Index, Plaque Index, Simplified Oral Hygiene Index, and halitosis levels with a Hali Meter. Saliva samples will be collected to analyze inflammatory markers IL-1b2 and IL-10 at baseline, day 14, and day 28. Participants adherence will be monitored through daily logs, electronic reminders, and follow-up visits. Non-compliance may lead to exclusion from the study.