Batman Merkez

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are investigating the frequency of Neuronal Ceroid Lipofusinosis Type 2 CLN2 in children aged 2 to 6 years who have nonspecific neurological symptoms such as idiopathic seizures, speech disorders, and motor dysfunctions. This multicenter, non-drug screening study focuses on children without hypoxic ischemic encephalopathy, head trauma, or developmental brain anomalies, aiming to better understand the demographic and clinical features of those with possible CLN2 disease. Children first undergo assessments including recording demographic and medical history, seizure frequency, cognitive and language development evaluations, physical exams assessing muscle strength, gait, and coordination, as well as neurological evaluations using EEG and MRI scans. Those showing specific signs like speech disorder with seizures, movement problems, particular EEG responses, or MRI findings will have blood samples taken to measure Tripeptidyl Peptidase 1 enzyme levels. If enzyme activity is low, genetic testing is performed to investigate CLN2 disease. Participants are involved for up to one year during which various clinical, neurological, and imaging evaluations are done. Blood samples are collected for enzyme and genetic analyses. The main outcome measured is the frequency of CLN2 disease in this group. The study tracks each childs symptoms, neurological findings, and imaging results to better identify and understand CLN2 in children with these symptoms.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Autism Spectrum Disorder ASD is a neurodevelopmental condition that causes challenges in social interaction, communication, and repetitive behaviors. Mothers of children with ASD often face intense caregiving demands that can lead to high levels of stress, burnout, and depression, impacting family life and well-being. This trial evaluates a positive psychology approach aimed at helping these mothers cope better by focusing on positive daily experiences to improve their happiness, family functioning, and reduce caregiver burden. Participants are divided into two groups one group of mothers will write down three positive events they appreciate each day for four weeks using a journaling app called the Three Things Journal, while the control group will not receive any intervention. This behavioral intervention is designed to increase positive emotions and psychological resilience through regular reflection on positive moments. During the study, researchers will measure changes in happiness levels, caregiver burden, and family functioning using validated questionnaires at the start and after five weeks. Mothers will be monitored for emotional well-being and family dynamics to assess the interventions impact. The study is randomized and double-blinded, with participation lasting at least five weeks from baseline to follow-up assessments.

Researchers are evaluating the use of a surgical incision drape to secure endotracheal tubes in preterm infants born between 28 and 34 weeks of gestation who are hospitalized in the neonatal intensive care unit. The study aims to reduce unplanned extubation events and skin damage caused by tube fixation, as well as to assess related complications. This randomized controlled trial compares the surgical drape method with the standard use of silk plasters. Participants will be randomly assigned to one of two groups one group will have their endotracheal tube secured using a surgical incision drape, and the other group will have the tube secured with silk plasters. The study collects data on skin moisture, skin pH, and neonatal skin condition using specialized devices and rating scales. Data will be gathered every 24 hours during the intubation period to compare the effects of the two fixation methods. During the study, researchers will record demographic data and monitor skin condition and moisture levels at the tube fixation site. These assessments will be done daily throughout the intubation period. The study aims to provide insights into skin wounds, unplanned extubation rates, skin pH, and moisture differences between the two groups. Data analysis will be performed using statistical software to evaluate these outcomes.