Yakutiye

Spinal anesthesia-induced hypotension is a common and significant complication affecting up to 50-80% of pregnant women undergoing elective cesarean section. This trial evaluates whether a brief 5-minute mindfulness-based breathing exercise given just before spinal anesthesia can influence blood pressure changes during surgery. The study compares this breathing technique to standard care in pregnant women aged 18 to 45 years scheduled for elective cesarean delivery. Participants will be randomly assigned to either perform the mindfulness-based breathing exercise or receive standard preoperative care. The breathing exercise involves slow diaphragmatic breathing at about six breaths per minute, guided by a trained anesthesiologist or nurse, with mindful repetition of the phrase My body is relaxing as I exhale. Both groups receive spinal anesthesia with specific medications, and careful monitoring of heart rate and blood pressure is performed. During the study, participants will be closely observed for changes in systolic blood pressure and heart rate within 10 minutes after spinal anesthesia. Anxiety levels, incidence of early hypotension, and medication use to support blood pressure will also be measured. The trial includes standard monitoring such as ECG and oxygen saturation, with safety and response data collected throughout the procedure. Participants involvement includes a short breathing exercise or equivalent wait time before anesthesia, with follow-up assessments during surgery.

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.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early anti-tumor activity of new drugs or combinations given before and after surgery in adults with locally advanced resectable gastric, gastroesophageal junction GEJ, or esophageal adenocarcinoma who have not had prior treatment for this disease. This Phase II, open-label study includes multiple sub-studies to test different novel drug combinations in participants. Participants will be assigned to one of three sub-studies where they receive combinations of investigational drugs such as AZD0901, Rilvegostomig, Trastuzumab Deruxtecan T-DXd, and chemotherapy agents like 5-Fluorouracil 5-FU, Capecitabine, or FLOT chemotherapy. Treatment is given as neoadjuvant before surgery and adjuvant after surgery therapy, with Rilvegostomig continuing as monotherapy after these phases. Drugs are administered mainly by intravenous infusion, except for Capecitabine, which is given orally. Participants will be closely monitored throughout the study for side effects and response to treatment, including assessments of surgical success, tumor response, event-free survival, and overall survival up to 38 months. Regular evaluations include clinical exams, laboratory tests, and pharmacokinetic measurements to track drug levels and immune response. The study aims to gather comprehensive safety and effectiveness data during the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as a first-line treatment for patients with advanced biliary tract cancer BTC. This phase III, randomized, open-label study aims to improve treatment options for patients with unresectable locally advanced or metastatic BTC who have not received prior therapy for advanced disease. The study focuses on overall survival and other important outcomes over approximately four years. Participants receive either rilvegostomig or durvalumab through intravenous infusion along with chemotherapy drugs gemcitabine and cisplatin. Durvalumab is given every three weeks for up to eight cycles, then every four weeks. Gemcitabine and cisplatin are administered intravenously on Days 1 and 8 of each 21-day cycle. The study compares these two treatment combinations to assess their effects on survival, disease progression, tumor response, and safety. During the study, participants undergo regular assessments including imaging scans like CT or MRI to measure disease status, laboratory tests to evaluate organ function, and evaluations of symptoms and quality of life. Researchers monitor drug levels and immune response markers. The study lasts about four years, with ongoing safety and health status monitoring throughout. Patient-reported symptoms and quality of life are assessed up to 12 weeks after disease progression.

Researchers are conducting a Phase 12, multicenter, randomized, open-label study to assess the safety and effectiveness of investigational agents used with or without pembrolizumab andor chemotherapy in participants with advanced esophageal squamous cell carcinoma ESCC who have previously received PD-1PD-L1 based treatment. This study aims to explore new treatment options for individuals whose cancer has progressed after initial immune therapy. Participants will be assigned to different treatment groups. Some will receive paclitaxel or irinotecan chemotherapy on specific schedules until disease progression or discontinuation. Others will receive combinations including pembrolizumab with MK-4830 plus paclitaxel, irinotecan, or lenvatinib. Additional groups will receive sacituzumab tirumotecan at varying doses on a 42-day cycle. Supportive medications may be given to manage side effects as needed. During the study, participants will undergo evaluations to monitor safety, including tracking dose-limiting toxicities and adverse events during an initial safety phase of about 3 weeks. Effectiveness will be assessed over up to 48 months by measuring tumor response and longer-term outcomes such as progression-free survival, duration of response, and overall survival up to approximately 70 months. Participants will have regular visits for treatment and monitoring throughout their involvement, which may last several years.

This trial studies participants with previously untreated, unresectable, or metastatic colorectal cancer. It evaluates the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy. The study includes participants who do not have specific genetic markers like dMMR, MSI-H, or BRAF V600E mutations, which may affect treatment response. Participants receive treatment with study drugs such as pumitamig, bevacizumab, and chemotherapy regimens including FOLFOX, FOLFIRI, and CAPOX. The treatments are given at specified doses on specific days. The study uses a randomized, double-blind design with multiple experimental and comparator arms to assess these combinations. Throughout the study, participants undergo regular assessments to measure tumor response and survival outcomes. Key evaluations include imaging tests using RECIST v1.1 criteria, monitored by both investigators and independent reviewers, over a period of up to 5 years. Researchers track objective response, progression-free survival, and overall survival to determine treatment outcomes and safety.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.