Candidiasis (Yeast Infection)

This research aims to evaluate how full-arch implant-supported prostheses affect lip support in patients undergoing complex dental rehabilitation. The study focuses on how different clinical and laboratory decisions between diagnosis and prosthesis delivery may influence the prosthetic design and the patient's facial profile. Advanced 3D facial scanning and superimposition techniques allow precise measurement of vertical occlusion and lip support. Participants will undergo removal of their full-arch implant-supported prostheses, with digital facial images captured before and after this procedure using a facial scanner. This observational study leverages modern digital technology to measure changes objectively and does not involve experimental treatments. During the study, researchers will assess changes in the volume around the mouth area, distances between the lips and esthetic lines on the facial profile, and angles related to the nose and lips. These measurements occur on the same day as the prosthesis removal. The study helps improve understanding of facial changes related to dental prostheses and involves participants collaborating with the research protocol through imaging and clinical assessments.

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 SÜMEYYE BİLGİLİ TEKİN 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 drug's 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 investigating 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 study compares Fosmanogepix with standard treatments to understand how well it works and if it is as effective as current therapies for adults with these infections. Participants will be randomly assigned to receive either Fosmanogepix or a standard treatment of caspofungin followed by fluconazole. Both Fosmanogepix and caspofungin start as intravenous (IV) infusions given daily at the clinic. When well enough, patients may switch to oral tablets or capsules taken at the clinic or home. Placebos matching the active drugs are also used to maintain blinding. During the study, patients will be treated for up to 6 weeks depending on infection clearance and symptom improvement. Researchers will evaluate survival at 30 days and treatment success at the end of therapy. Follow-up visits will occur 6 weeks after treatment stops. Patients will undergo assessments including blood cultures, laboratory tests, neurological exams, ECGs, and drug level monitoring to track safety and treatment response throughout the study period.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.

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 tablets—1400 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 mg—and 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 intervention's impact.

Researchers are studying the effects and safety of an intravenous drug called HRS9432 in adults diagnosed with candidemia and/or invasive candidiasis, which are serious fungal infections. This Phase II, multi-center trial aims to compare HRS9432 to an active control drug in patients showing systemic signs related to these infections. The study is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. and uses a randomized, double-blind design to assess treatment outcomes. Participants will receive either HRS9432 intravenously once a week or Caspofungin Acetate intravenously with a loading dose followed by daily doses. The study involves parallel groups and evaluates treatments over several time points, including early and extended follow-up periods. The main goal is to observe the overall success of treatment by checking fungal eradication and resolution of infection symptoms. During the study, participants will undergo various assessments including microbiological tests, clinical evaluations, and safety monitoring. These evaluations occur at specific days during treatment and follow-up, extending up to 56 days after the last dose. Researchers will monitor adverse events and measure outcomes such as clinical cure, fungal clearance, mortality, and recurrence of infection. Participation involves scheduled visits for testing and observation to track treatment effects and safety.

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) and/or 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 × 10^7 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 and/or 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.