Indianapolis

Researchers are evaluating the effect of a chewing gum containing an active compound called MIIP-E2 on dental plaque formation using a 4-day plaque accumulation model. This single-blind, randomized controlled trial involves 32 adult subjects who will participate in three treatment periods, each lasting four days. The study compares an active MIIP-E2 gum, a placebo gum without the active compound, and a no-gum control regimen to assess their impact on dental plaque buildup. The trial uses a 3-way crossover design where each participant experiences all three treatments in different sequences, with approximately 10-day washout periods between treatments. During each 4-day treatment period, participants will refrain from oral hygiene practices and use the assigned gum product three times daily for 10 minutes after meals, chewing on each side of the mouth for one minute before chewing freely. Compliance will be monitored using daily diaries. Participants will undergo oral examinations, plaque assessments, saliva sample collections, and intraoral photographs at baseline and after each treatment period. The primary outcome is the amount of dental plaque measured after four days of intervention. Additional assessments include DNA sequencing of oral bacteria and visual plaque evaluations. The study includes safety and compliance checks and lasts through the three treatment periods with washouts in between.

The purpose is to learn whether the over-the-counter amino acid supplement 5-hydroxytryptophan 5HTP, isolated from the plant Griffonia Simplifolia, can reduce allergic lung responses, improve lung function, and reduce anxiety and depression symptoms in children with allergic asthma. Participants will be randomly assigned to receive either 5HTP or a placebo and will later crossover to the other group. There are 5 study visits over about 12 weeks. The primary outcome is the change in FEV1. The investigators anticipate that 5HTP at the proposed doses will improve lung function as seen in preclinical studies using clinically relevant 5HTP. Other outcomes include blood eosinophil counts, eosinophil numbers in nasal fluid, lung inflammation, and changes in anxiety and depression scores measured using CES-DC and SCARED questionnaires. The study also examines whether 5HTP increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid 5-HIAA, and dopamine. The results have the potential to influence approaches to improve lung function and asthma-associated anxiety and depression.

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the effectiveness of three experimental denture adhesive creams in improving the hold of full maxillary dentures over a 13-hour period. This study is a randomized, controlled, single-blind, cross-over trial focused on measuring maximum maxillary bite force among full denture wearers. Up to 60 participants will be screened to ensure at least 54 complete the study. Participants will receive five different treatments during the study, including the application of one of three experimental denture adhesive creams, a marketed product, or no adhesive. Each treatment involves applying 1 gram of the adhesive cream topically, pressing the dentures into place, holding firmly, and biting down to secure the hold. The study design includes a 5 treatment-period cross-over, allowing each participant to try each adhesive and no adhesive. Throughout the study, participants will have their maximum incisal bite force measured up to 13 hours after application to assess denture hold and resistance to dislodgement. Bite force area over baseline will be compared across the adhesives and no adhesive. Researchers will monitor participants safety, compliance with study procedures, and overall well-being. The total study duration includes scheduled visits and procedures necessary to collect bite force data and complete all treatment periods.

Researchers are evaluating the safety, effectiveness, and how the body processes and responds to NXT007 prophylaxis compared with emicizumab prophylaxis in people aged 12 years and older who have severe or moderate congenital hemophilia A without factor VIII FVIII inhibitors, or any severity of hemophilia A with FVIII inhibitors. This phase 3, randomized, open-label study aims to compare these treatments to better understand their impact on bleeding rates and treatment burden. Participants will be randomly assigned to one of two main treatment groups. One group will receive NXT007 prophylaxis administered subcutaneously using an integrated drug-device combination product. The other group will receive emicizumab prophylaxis via subcutaneous injections, starting with weekly loading doses for 4 weeks, then maintenance dosing at various intervals depending on prior treatment status. After the main treatment period, participants from both arms can continue or switch to NXT007 in an open-label extension phase. Throughout the study, participants will be closely monitored with regular assessments, including measuring annualized bleed rates for different types of bleeds, treatment burden questionnaires, and safety evaluations such as adverse event monitoring and laboratory tests. These evaluations will continue throughout approximately 3.5 years of study participation to provide comprehensive data on treatment effects and safety.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or LatinoLatina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are evaluating the safety and effectiveness of a device called RD2 Ver.02 compared to a control treatment for managing transsphincteric and long intersphincteric anal fistulas. The study aims to assess the complication rate within 6 months, recurrence rates at 12 months after treatment, and the incidence of perirectal infection by 6 months. This is a prospective, multi-center, double-blind, randomized controlled trial conducted by RedDress Ltd. Participants will be randomly assigned to one of two groups. Both groups will undergo debridement of the fistula tract, suturing of the internal opening, and a water leak test to ensure sealing. In the treatment group, the patients own coagulating blood RD2 Ver.02 will be applied inside the fistula tract to serve as a provisional matrix. In the control group, the blood sample will be discarded, and saline will be applied instead. Treatments are performed in the operating room. Participants will be monitored for healing and complications through 6 to 12 months post-treatment. The primary outcome is the combined healing rate of anal fistulas at 6 months. Secondary outcomes include clinical recurrence at 12 months and incidence of perirectal infections at 6 months. Blood samples, clinical evaluations, and imaging pelvic MRI are used to assess eligibility and monitor safety and efficacy. The trial will continue enrollment and follow-up until June 2028.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of KK8123 in adults with X-linked hypophosphatemia XLH through a Phase 12, multicenter, open-label, dose-escalation study. This first-in-human study aims to better understand how KK8123 behaves in the body and its effects on patients with this condition. The study is sponsored by Kyowa Kirin Co., Ltd. and includes an optional safety extension period. The study includes a Screening Period of up to 28 days, followed by Part 1, which is a Dose Escalation Period consisting of a planned Treatment Period and an Observation Period lasting 32 to 44 weeks. Part 2 is an optional Extension Period for additional safety evaluation. Participants receive subcutaneous doses of KK8123 at different levels, including low dose single dose, mild dose multiple doses, and high dose multiple doses, with dosing confirmed for later cohorts. The study groups include several cohorts receiving escalating doses and an extension group. Participants will undergo multiple assessments during the study, including laboratory tests for hematology and clinical chemistry, measurement of serum phosphorus levels, echocardiograms, renal ultrasounds, and monitoring of vital signs such as heart rate and blood pressure. Researchers will track treatment-emergent adverse events TEAEs and measure KK8123 drug concentrations over time. Follow-up periods last up to 44 weeks in Part 1 and up to 52 weeks in Part 2. Participants are expected to adhere to study visit schedules and complete all assessments throughout their involvement.