Candidiasis (Yeast Infection)

Researchers are studying the effects of different oral care methods on oral health in patients receiving non-invasive mechanical ventilation NIMV in the intensive care unit. This randomized controlled trial compares three groups to find the most effective oral care method. The study is led by SMEYYE BLGL TEKN and focuses on preventing oral complications in these patients. Participants will be randomly assigned to one of three groups a control group receiving the standard chlorhexidine oral care kit an electric toothbrush group receiving the chlorhexidine kit plus an electric toothbrush and toothpaste and a manual toothbrush group receiving the chlorhexidine kit with a manual toothbrush and toothpaste. Treatments are given during the intensive care stay while patients are on NIMV. During the study, participants oral health will be assessed daily for three consecutive days using tools like the Oral Assessment Guide, saliva pH measurements, and salivation tests with Schirmer Tear Test Strips. Researchers will monitor oral health status and saliva pH to evaluate the effects of the different oral care methods. The study starts September 2025 and runs through April 2026.

The trial investigates vaginal dysbiosis in premenopausal women with elevated vaginal pH, aiming to see if a non-hormonal topical product can improve vaginal microbiota and help prevent future infections. The study includes women aged 18 to 45 with regular menstrual cycles and examines both symptomatic and asymptomatic cases of dysbiosis. The research is conducted as a multicenter, open, comparative study with random assignment to groups, sponsored by Procare Health Iberia S.L. Participants are divided into three groups symptomatic women receiving Palomacareae vaginal gel for 6 days, asymptomatic women receiving the same treatment for 6 days, and asymptomatic women under monitored follow-up without treatment. The study involves two visits an initial visit between days 9 and 15 of the menstrual cycle and a final visit within 5 days after treatment or equivalent timing for the monitoring group. The trial consists of a pilot phase with 30 patients and an extension phase adding 60 more, totaling 90 participants. During the approximately 11-12 day study period, researchers will assess the effect of Palomacareae vaginal gel on vaginal microbiota, symptoms, vaginal pH, user satisfaction, and safety. Evaluations include diagnostic tests and symptom monitoring at both visits. Participants will be closely followed for tolerability and response to treatment, with outcomes measured by vaginal microbiota changes and symptom improvement recorded through the study duration.

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drugs safety profile. Participants will be divided into two main groups single ascending dose SAD and multiple ascending dose MAD cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating the safety and effects of a medicine called fosmanogepix for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida yeast. This Phase 3 clinical trial compares fosmanogepix to the standard treatment using caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard treatment by a margin of 15%. The study includes adult patients diagnosed with these infections and is sponsored by Basilea Pharmaceutica. Participants are randomly assigned to one of two groups two-thirds receive fosmanogepix intravenously, with an option to switch to oral tablets, while one-third receive caspofungin intravenously followed by oral fluconazole. Matching placebos are given to maintain blinding. Treatments are given daily, first by IV infusion at the clinic and then orally either at the clinic or at home if discharged. Treatment duration can be up to six weeks, depending on infection clearance and symptom improvement. Participants will be monitored through multiple study visits, with assessments including survival status at 30 days, treatment success at the end of treatment, and follow-up evaluations six weeks after stopping treatment. Additional evaluations include clinical and mycological responses, blood cultures, safety monitoring such as adverse events, lab tests, neurological exams, ECGs, and drug concentration measurements. The total study duration for each participant may be approximately 12.5 weeks, considering treatment and follow-up periods.

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.

Researchers are evaluating the effectiveness and safety of an investigational drug called WXSH0102 compared to the active drug fluconazole for treating vulvovaginal candidiasis VVC. This multicenter, randomized, double-blind, active-controlled, dose-ranging Phase II clinical trial involves female patients aged 18 to 64 years who have been diagnosed with VVC. The study aims to determine which dosing regimen of WXSH0102 might best treat this condition by comparing it with fluconazole, a standard treatment. Participants are randomly assigned to one of four groups three groups receive different doses of WXSH0102 tablets1400 mg on the first day followed by 700 mg on days 2 and 3 1000 mg followed by 500 mg or 600 mg followed by 300 mgand the fourth group receives a single dose of fluconazole capsules on day 1. All medications are given orally during a treatment period lasting three days. The study consists of three phases screening and enrollment before treatment, the treatment period from day 1 to day 3, and a follow-up period with visits on days 4, 11 plus or minus 2 days, and 25 plus or minus 3 days. During the study, participants will be assessed for cure rates, clinical improvement, and clearance of the fungal infection at follow-up visits, particularly on day 11 and day 25. Researchers will also monitor vaginal health, adverse events, and drug concentration levels in the body. Participants agree to avoid sexual activity and use condoms throughout the study. The total study duration includes screening, treatment, and follow-up visits over approximately 25 days from the first treatment dose.

Researchers are studying sexual health and vulvovaginal health in premenopausal and perimenopausal women with hormone receptor positive breast cancer who are receiving ovarian suppression. The study aims to find out if starting sexual health counseling and using non-hormonal moisturizers early can prevent or reduce side effects like vaginal dryness and sexual dysfunction. This is compared to the usual care approach where treatment begins only after symptoms appear. Participants will be randomly assigned to one of two groups. One group will receive sexual health counseling and start using non-hormonal moisturizers 3 to 5 times weekly from the beginning of ovarian suppression, along with education about vaginal dilators and a consultation with a pelvic floor physical therapist. The other group will start treatment only after developing symptoms and will receive a list of recommended moisturizers to purchase themselves. Both groups will complete various questionnaires to monitor sexual health and vaginal symptoms. During the study, participants will be monitored through surveys and subjective and objective assessments of vaginal dryness and sexual function. Researchers will track the number of participants who have a score of 4 or higher on the Vaginal Assessment Scale within one year. The study includes regular completion of validated questionnaires and a weekly diary about moisturizer use. The total participation time corresponds with one year of follow-up to evaluate the interventions impact.

The trial investigates whether a single intravenous infusion of Amimestrocel injection, a cell therapy made from human umbilical cord mesenchymal stem cells, can help reduce severe mouth sores called oral mucositis in adults undergoing myeloablative allogeneic hematopoietic stem cell transplantation HSCT. This painful side effect commonly occurs due to strong chemotherapy regimens containing total body irradiation TBI andor melphalan. The study is a Phase 2, single-center, open-label exploratory trial involving about 22 adult patients aged 18 to 65 years. Participants will receive a single fixed dose of Amimestrocel injection 6.0 107 cells in 12 mL intravenously within 24 to 48 hours after the last dose of cyclophosphamide, which is part of the standard conditioning regimen, and before the stem cell infusion Day 0. All patients will also undergo standard myeloablative conditioning containing TBI andor melphalan, followed by allogeneic stem cell transplantation and standard supportive care. During the study, patients will be closely monitored daily for the presence and severity of oral mucositis and pain for 28 days after transplant. Researchers will assess pain levels, opioid use, diarrhea, and time until blood counts recover. Safety will be followed for 100 days post-transplant, including adverse events and serious adverse events. The main outcome is the incidence of severe Grade 3-4 oral mucositis within 28 days after transplant.

Researchers are evaluating the use of dexamethasone mouthwash as a preventive treatment for stomatitis related to Datopotamab Deruxtecan Dato-DXd in patients with metastatic or inoperable locally recurrent breast cancer or advanced or metastatic EGFR-mutated non-small cell lung cancer. This Phase IV, open-label, single-arm study aims to describe how often and how severe grade 2 or higher stomatitis occurs in participants receiving this prophylactic mouthwash during the first 12 weeks of Dato-DXd treatment. Participants will receive dexamethasone 0.5 mg5 mL alcohol-free mouthwash, swishing 10 mL four times daily for about 2 minutes and then spitting it out without swallowing. They must avoid food or drink for at least 30 minutes after use. This mouthwash will be used throughout their standard care treatment with Dato-DXd. The study includes two groups one with breast cancer and one with lung cancer patients, enrolling about 100 participants total over 18 months. During the study, participants will be monitored for stomatitis incidence and severity up to 12 weeks after starting treatment, with additional assessments up to about 21 months for onset and resolution timing. Researchers will also track adherence to the mouthwash, any dose changes in Dato-DXd due to stomatitis, and overall safety. Follow-up for safety continues for 28 days after the last study dose, with various evaluations including clinical assessments throughout the treatment period.

The aging population worldwide is growing rapidly, with more elderly people retaining their natural teeth than before. Maintaining oral health is crucial for older adults, as poor dental condition can lead to complications like infections and reduced quality of life. This research evaluates the use of antibacterial photodynamic therapy aPDT combined with antibacterial blue light aBL using the Lumoral device, alongside regular dental care, to help improve oral hygiene in elderly people living at home or in care homes. Participants will be divided into two groups one group will use the Lumoral Treatment device at home combined with standard oral hygiene methods, while the other group will follow only standard oral hygiene practices. The Lumoral device uses a photosensitive mouthwash activated by light to target harmful bacteria in dental plaque. The study will last 9 months, during which participants will receive regular dental appointments and instructions on oral care. Throughout the study, participants will be monitored with dental examinations measuring bleeding on probing, plaque levels, periodontal pocket depth, oral bacterial flora, mouth dryness, and quality of life related to oral health. Safety will be tracked by recording any adverse events. The study aims to assess how the Lumoral Treatment affects oral hygiene, inflammation, and mouth dryness in elderly individuals over this period.