Yakutiye

Spinal anesthesia-induced hypotension is a common and significant complication in pregnant women undergoing elective cesarean section, affecting up to 80% of cases. This condition is influenced by sympathetic nervous system changes and can be worsened by preoperative anxiety, which increases hemodynamic instability. Researchers are evaluating whether a brief mindfulness-based breathing exercise before spinal anesthesia can improve hemodynamic responses in this population. The study compares two groups of pregnant women scheduled for elective cesarean section under spinal anesthesia. One group practices a standardized 5-minute mindfulness-based breathing exercise involving slow diaphragmatic breaths and a calming phrase repeated silently during exhalation. The control group receives standard preoperative care. All participants receive spinal anesthesia with a specific combination of medications, and blood pressure and heart rate are monitored closely. During the study, participants will undergo assessments including measurements of maximum systolic arterial pressure decrease within 10 minutes after spinal anesthesia. Additional monitoring includes anxiety scores, incidence of early spinal hypotension, heart rate changes, and vasopressor use. The study is conducted with careful safety monitoring and aims to enroll 150 participants, with detailed statistical analysis planned to evaluate the outcomes.

Researchers are investigating how different oral care methods affect oral health in patients receiving non-invasive mechanical ventilation (NIMV) in an intensive care unit. This randomized controlled trial compares three groups to determine which oral care approach is most effective in improving oral health. The study focuses on patients with oral complications who are stable, communicative, and expected to stay in intensive care for at least 48 hours. Participants will be randomly assigned to one of three groups: a control group receiving only a 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 along with a manual toothbrush and toothpaste. The interventions are provided during the patients' stay in intensive care while receiving NIMV. During the study, oral health status will be assessed daily for three consecutive days using tools such as the Oral Assessment Guide, saliva pH measurements, and salivation evaluation with the Schirmer Tear Test Strip. Researchers will also collect demographic information and monitor the effects of the different oral care methods. The study aims to identify the most effective oral care technique to support patients on NIMV in intensive care settings.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) 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 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are investigating the safety, tolerability, pharmacokinetics, and early anti-tumor effects of new drugs or drug combinations given around the time of surgery (perioperative treatment) for people with locally advanced, operable gastric, gastroesophageal junction, or esophageal adenocarcinoma who have not previously been treated for their cancer. This Phase II study involves multiple centers and evaluates different novel treatments within separate sub-studies tailored to specific patient groups. Participants will be assigned to one of three sub-studies, each testing different novel agents or combinations approved by a Safety Review Committee. Treatments include intravenous infusions of drugs such as AZD0901, Rilvegostomig, and Trastuzumab Deruxtecan, as well as standard chemotherapy agents like Capecitabine (oral), 5-Fluorouracil (IV), and FLOT chemotherapy (IV). The study aims to find the recommended doses and assess the effects of these treatments given before and after surgery. Throughout the study, researchers will monitor participants for adverse events and serious side effects up to 38 months. They will also measure the percentage of participants who achieve a complete tumor response. Participants undergo regular assessments including physical exams, laboratory tests, and imaging to evaluate treatment effects and safety. The study is designed to provide detailed information on how well these new treatments work and how safe they are over a prolonged follow-up period.

Researchers are investigating the effectiveness and safety of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as first-line treatments for patients with advanced biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma. This is a global, phase III, randomized, open-label study focused on patients with unresectable locally advanced or metastatic disease who have not previously received treatment for advanced cancer. The study includes patients with known PD-L1 status and measurable tumors suitable for repeated evaluation. Participants will receive either rilvegostomig intravenously every three weeks along with gemcitabine and cisplatin given intravenously on days 1 and 8 of each 21-day cycle, or durvalumab intravenously every three weeks for up to eight cycles, followed by dosing every four weeks, along with the same chemotherapy regimen. Treatment is designed to evaluate first-line therapy effects, comparing these two immunotherapy combinations alongside standard chemotherapy. Throughout the study, patients will be closely monitored for overall survival, especially in those with PD-L1 expression of 1% or higher, over approximately four years. Assessments will include tumor measurements by CT or MRI using RECIST 1.1 criteria, performance status evaluations, and ongoing safety monitoring. The study aims to understand the impact of these treatments on survival and disease progression in advanced biliary tract cancer patients.

Researchers are investigating the safety and effectiveness of several new treatments, with or without pembrolizumab and chemotherapy, for adults with advanced esophageal squamous cell carcinoma who have previously received PD-1/PD-L1 based therapies. This Phase 1/2 multicenter, randomized, open-label study focuses on participants whose cancer has progressed after one prior standard treatment including a platinum agent and PD-1/PD-L1 immune therapy. The study aims to better understand how these investigational agents perform in this specific patient group. Participants may receive different combinations of treatments including intravenous infusions of pembrolizumab, MK-4830, paclitaxel, irinotecan, and sacituzumab tirumotecan, as well as oral lenvatinib daily. The dosages and schedules vary, for example, paclitaxel is given on days 1, 8, and 15 every 28 days, while irinotecan is administered every 14 days. Supportive care and medications such as antihistamines, corticosteroids, and acetaminophen are allowed to manage side effects. Some arms of the study involving pembrolizumab plus MK-4830 with paclitaxel/irinotecan or lenvatinib are no longer enrolling. During the study, participants will be monitored for adverse events and dose-limiting toxicities, especially during an initial safety lead-in phase of about three weeks. Researchers will also track treatment discontinuation due to side effects and measure the tumor response over up to 48 months. Assessments include clinical evaluations, imaging, and tissue sample analyses. The study is designed to gather detailed safety and efficacy data to inform future treatment options for esophageal cancer patients.

This research aims to evaluate the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with previously untreated, unresectable, or metastatic colorectal cancer. The study is a blinded, randomized Phase 2/3 trial targeting participants with histologically confirmed recurrent or metastatic colorectal adenocarcinoma that cannot be cured with surgery. Participants must not have certain genetic markers such as mismatch repair deficiency, microsatellite instability-high status, or BRAF V600E mutation. Participants will receive either pumitamig or bevacizumab along with chemotherapy regimens including FOLFOX, FOLFIRI, or CAPOX at specified doses and schedules. The interventions involve administering these drugs on specified days, though exact dosing details are not provided. The study compares these two treatment combinations to assess their safety and efficacy in this patient population. Throughout the study, participants will be monitored for tumor response using RECIST v1.1 criteria, progression-free survival, and overall survival for up to five years. Researchers will evaluate confirmed complete or partial tumor responses, survival rates, and disease progression. The study includes regular assessments to track treatment effects and safety over a long-term follow-up period, ensuring comprehensive monitoring of participant outcomes.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.