Cankaya

Researchers are evaluating remibrutinib (LOU064) in adolescents aged 12 to under 18 years who have chronic spontaneous urticaria (CSU) that is not well controlled by H1-antihistamines. This Phase 3 trial aims to assess the effectiveness, how the drug is processed in the body, and safety of remibrutinib compared to a placebo. The study also intends to gather long-term data on how well remibrutinib works and its safety over several years after treatment ends. The trial includes three periods. First, the core period is a 24-week double-blind phase where about two-thirds of participants receive remibrutinib and one-third receive placebo, with about 10 site visits over approximately 32 weeks. Next is an optional open-label extension lasting from one to three years, where participants who completed the core period may receive remibrutinib or enter an observational treatment-free phase depending on their symptoms. Participants may cycle through treatment and observational periods up to six times. Finally, an optional long-term treatment-free follow-up can last up to three years with one site visit and up to four phone calls. During the study, participants undergo assessments including changes in urticaria activity scores (UAS7), itching severity (ISS7), and hive severity (HSS7) measured from baseline to 12 weeks. Regular visits monitor safety, symptoms, and drug effects. The study tracks these measures to understand remibrutinib's impact on CSU symptoms and overall safety profile during and after treatment, with total participation potentially lasting several years.

Researchers are evaluating two different methods for making night guards (occlusal splints) to help adults with bruxism, a condition where people grind or clench their teeth. This study compares a 3D-printed splint made from a photopolymer resin called Voco V-Print with a conventional acrylic splint made using standard techniques. The goal is to see if the newer 3D-printed splints provide similar patient satisfaction and clinical durability as traditional acrylic splints in adults aged 18 to 25 years. Participants will be randomly assigned to receive either the 3D-printed splint or the conventional acrylic splint. Each custom-made splint will be worn during sleep for three months, with all participants following standardized instructions for use and care. The splints will be delivered with clear guidance, and both groups will have their splints assessed at the end of the study period. Throughout the study, patient satisfaction and oral health-related quality of life will be measured using a questionnaire based on the Oral Health Impact Profile (OHIP). The clinical durability of the splints will be evaluated by 3D scanning each splint at the start and after three months to measure wear as volumetric material loss. This careful monitoring will help determine if 3D-printed splints perform as well as conventional acrylic ones over short-term use.

Posture is defined as the arrangement or orientation of body parts in relation to each other. This alignment depends on the effect of gravity, muscle tension and the integrity of the bony structures. Posture disorders, which are now common among healthy young adults, are caused by a number of factors that have emerged in combination with the effects of modern lifestyle.In this study, it was aimed to examine the effect of an 8-week artificial intelligence-based structured exercise program in healthy adults. It performs measurements on frontal and lateral images of the individual in normal posture Photo of a participant showing how the Posture Screen Mobile app evaluates the horizontal tilt and inclination of the head, shoulders and hips from a frontal view.The craniovertebral angle (CVA) is a measurement of upper cervical posture obtained by calculating the angle between the ear tragus and a horizontal line passing through the spinous process of C7). KVA will be done with Posture Screen Mobile Phone application.Thoracic kyphosis is the anteroposterior curve of the thoracic spine in the sagittal plane and is defined using the Cobb angle.Thoracic kyphosis is the hunching of the spine in the upper back into an extreme external curve due to deformity.Lumbar lordosis is the natural inward curve of the spine in the lumbar region. It is an important anatomical feature that maintains the height of the discs in front of the lumbar vertebrae and ensures the stability of the spine.An artificial intelligence application called "Musclewiki" will be used for healthy adults to continue their exercise training at home. For 8 weeks, exercise will be practiced 3 times a week in the company of a physiotherapist, accompanied by a physiotherapist through artificial intelligence.

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.

Researchers are investigating sacituzumab tirumotecan (MK-2870) alone or combined with other treatments to treat certain gastrointestinal cancers. These include colorectal cancer that cannot be removed by surgery or has spread, advanced pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and measure how many participants respond to the treatment by having their cancer shrink or disappear. Participants may receive sacituzumab tirumotecan by intravenous infusion alone or with other anticancer drugs such as fluorouracil (5-FU), leucovorin or levoleucovorin, cisplatin, and pembrolizumab. Rescue medications like diphenhydramine, H2 receptor antagonists, acetaminophen, dexamethasone, and a steroid mouthwash are given to prevent infusion reactions and oral side effects. Supportive care treatments for side effects, including antidiarrheal and antiemetic agents, are allowed throughout the study. During the study, researchers monitor participants for dose-limiting toxicities within about 4 weeks and track adverse events, treatment discontinuations, and tumor response over up to approximately 63 months. Assessments include safety evaluations and measuring cancer response using standardized criteria. This long-term follow-up helps evaluate both the effectiveness and safety of the treatments being studied.

Researchers are evaluating new treatment options for high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that affects the tissue lining the bladder but has not spread to the muscle or beyond. The study aims to assess the safety and tolerability of MK-3120, a biological treatment given directly into the bladder. This phase 1/2 study focuses on patients who have undergone a surgical procedure called transurethral resection of bladder tumor (TURBT) to remove tumors. Participants receive MK-3120 through intravesical administration, which means the medicine is delivered directly into the bladder at one of three doses as outlined by the study protocol. The treatment is given after TURBT, and the study includes patients who are either new to Bacillus Calmette-Guérin (BCG) therapy or have been previously treated with BCG. The study does not include a control group but monitors participants for side effects and tolerability during treatment. Throughout the study, researchers closely observe participants for any dose-limiting toxicities within about 5 weeks, adverse events up to 24 months, and treatment discontinuation due to side effects for up to 12 months. Participants undergo regular assessments to monitor safety and treatment effects. The total duration of follow-up may extend up to two years to ensure thorough safety monitoring and evaluation of the treatment's impact.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.