Akdeniz

This research aims to assess how abdominal massage affects gastrointestinal functions in patients who are mechanically ventilated and receiving enteral nutrition in intensive care units. The study focuses on issues like frequency of bowel movements, gastric residual volume, and abdominal distension, which are common problems in critically ill patients on mechanical ventilation and tube feeding. The goal is to provide scientific evidence supporting the use of abdominal massage in this patient group to improve their gastrointestinal comfort and function. Participants will be randomly assigned to either an intervention group receiving abdominal massage or a control group receiving routine nursing care. The abdominal massage will be performed twice daily for 15 minutes over three days using specific techniques such as effleurage, petrissage, and vibration applied clockwise on the abdomen. The intervention will take place at the patient's bedside in the intensive care units, while the control group will only receive standard care during the same period. Throughout the study, researchers will monitor and record bowel movement frequency twice daily, abdominal distension through palpation, and gastric residual volume by aspiration. Stool consistency will be evaluated using the Bristol Stool Form Scale. Data will be collected using specialized forms, and patient clinical status will be assessed with tools like the Glasgow Coma Scale and APACHE II score. The study includes careful ethical considerations, informed consent from relatives, and statistical analysis of the results to determine the effects of abdominal massage on gastrointestinal function in these patients.

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.

Researchers are conducting a Phase I/II, multi-site, open-label study to evaluate the safety, effectiveness, and optimal dosing of the investigational treatments BNT323 combined with BNT327 in adults with advanced breast cancer. This includes those with hormone receptor-positive or negative types, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study aims to understand how these treatments work alone and together in this patient population. The study has two parts: Part 1 involves dose escalation where participants with chemotherapy-pretreated advanced breast cancer receive BNT323 and BNT327 together to find the recommended Phase 2 dose. Part 2 is an expansion phase that tests the safety and effectiveness of the chosen dose, including randomized comparisons of combination therapy at different doses and monotherapies. Participants may be assigned to one of four treatment arms, with dosing administered via intravenous infusion. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment, as well as adverse events up to 90 days after the last dose. Tumor response will be assessed for up to 36 months. Evaluations include heart function tests, tumor imaging, safety assessments, and tracking of side effects. The study carefully monitors treatment safety, effectiveness, and participant health throughout the trial duration.

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

This research aims to investigate the frequency of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) in children aged 2 to 6 who exhibit nonspecific neurological symptoms such as idiopathic seizures, speech disorders, and motor dysfunctions. The study targets children without hypoxic ischemic encephalopathy, head trauma, or developmental brain anomalies who visit Pediatric Metabolism, Neurology, and Developmental Pediatrics clinics over a 12-month enrollment period. It is a multicenter, non-drug screening study designed to better understand CLN2 disease among this population. During the study, demographic data, medical and family history will be collected at the first visit. Assessments will include seizure frequency, cognitive and language development evaluations, physical exams focusing on muscle strength, gait, and coordination, as well as neurological tests such as EEG and MRI scans. Children showing specific neurological signs or imaging findings will have blood samples taken for Tripeptidyl Peptidase 1 enzyme measurement. Those with low enzyme activity will undergo genetic testing to investigate CLN2 disease. Participants will be monitored for disease frequency over one year. Researchers will measure clinical and demographic characteristics including speech impairment, motor symptoms, EEG responses, and brain imaging changes. Safety monitoring includes obtaining informed consent and following up on enzyme and genetic test results. Total participation spans from initial screening through diagnostic testing and data collection during the 12-month study period.

Researchers are evaluating the safety and effectiveness of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CP-CML) who have not responded well or cannot tolerate previous treatments with tyrosine kinase inhibitors (TKIs) including Imatinib. This Phase 3, multinational, multicenter, open-label study aims to enroll 173 participants to better understand Radotinib's impact on this condition. Participants will receive Radotinib capsules at a dose of 400 mg twice daily in a single treatment arm. Radotinib is provided as hard capsules containing 100 mg or 200 mg doses of the drug. Treatment will be administered continuously, and the study includes monitoring for safety and efficacy throughout the course. The study does not include a comparator group but follows participants closely for response to therapy. During the study, participants will be regularly evaluated to monitor their response, including measuring the major cytogenetic response at 6 months. Assessments will include laboratory tests to check organ function and disease status, as well as safety monitoring for side effects. The study requires participants to attend scheduled visits and comply with study procedures, including pregnancy testing for women of childbearing potential and contraception use. The overall participation duration and follow-up details are based on the study protocol.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are evaluating the long-term safety and effectiveness of etavopivat, a new oral medicine being developed to treat inherited blood disorders such as sickle cell disease and thalassemia. These disorders affect hemoglobin, the protein responsible for carrying oxygen in the body. This phase 3 study aims to monitor how well etavopivat works and its safety profile over an extended period. Participants will receive one of three forms of etavopivat (A, B, or C) as oral doses. The study is open-label and multicenter, involving adults, adolescents, and children who have previously completed treatment in an etavopivat parent study and continue to benefit clinically. The treatment period can last up to 264 weeks but may end earlier if etavopivat is approved in the participant's country. During the study, researchers will track the number of treatment-emergent adverse events and adverse reactions for each participant by indication and age group from baseline through the end of the study, which can last up to 316 weeks. Participants' safety and response to long-term treatment will be closely monitored throughout this period.