Dulkadiroglu

Researchers are evaluating the effects of two types of free gingival graft surgeriesconventional free gingival graft FGG and modified free gingival graft ModFGGon soft tissue thickness, volume, and creeping attachment in the lower front teeth. This trial involves 34 healthy, non-smoking adults with localized Cairo Class II gingival recession. The goal is to understand how the modified technique may improve soft tissue stability and volume compared to the conventional method, using advanced three-dimensional digital analysis. Participants will be randomly assigned to receive either the conventional FGG procedure or the modified ModFGG procedure. The ModFGG involves creating a connective tissue flap from the recession area to cover the exposed root before placing a graft from the palate, aiming to enhance blood supply and healing. The conventional FGG involves placing a graft from the palate directly onto the prepared site without this flap. Both procedures will be followed by digital and clinical assessments at baseline, and at 1, 3, and 6 months after surgery. During the study, participants will undergo clinical measurements including gingival recession depth, keratinized tissue width, and probing depth, alongside three-dimensional digital scans with an intraoral scanner to evaluate soft tissue thickness and volume changes. These evaluations at multiple time points will help assess tissue stability and healing progress. The study will last at least six months post-surgery, providing detailed information on soft tissue outcomes and healing after these grafting procedures.

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.

Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease CKD and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio UACR to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.

Researchers are evaluating AZD4144 in adults aged 18 to 80 years who have sepsis caused by a suspected or confirmed bacterial infection and have developed acute kidney injury within 72 hours of sepsis onset. This Phase IIa study is randomized, double-blind, and placebo-controlled, aiming to assess the efficacy, safety, and tolerability of AZD4144 compared to placebo. The main goal is to compare kidney function measurements between participants receiving AZD4144 and those receiving placebo. Participants will be randomly assigned to receive either intravenous AZD4144 or a matching placebo once daily for a fixed treatment period according to the study protocol. The study includes a screening period, followed by the treatment period during which the study drug or placebo is administered daily. After treatment, participants will be monitored daily while hospitalized and will have up to two outpatient follow-up visits after discharge. During the study, participants will undergo daily safety monitoring, blood and urine sample collection, and various assessments to evaluate kidney function and other health outcomes. Researchers will measure specific kidney function markers such as creatinine clearance and serum cystatin C during treatment, and monitor participants for up to about 30 days for additional health outcomes including kidney replacement therapy use and survival. Safety and tolerability will also be assessed throughout the study period.

This research focuses on young earthquake survivors aged 20 to 25 to understand the long-term risk of trauma-induced stress. It evaluates how non-invasive sound therapy affects the vagal nerve by monitoring cardiovascular and neural activity. The study aims to explore biofeedback methods that could help manage stress-related responses in these individuals, considering the psychological and physical impacts of trauma such as wars and natural disasters. Participants will be divided into three groups one group receives no stimulation during mental stress, another undergoes phonocardiographic PCG auditory stimulation, and the third group receives metronome-like stimulation matching the heart rhythm MHR. These interventions are applied during mental stress to assess their effect on stabilizing the autonomic nervous system. The study uses advanced data processing methods like deep learning to analyze biological signals collected during these interventions. During the study, various biological signals will be recorded, including electrocardiography ECG, phonocardiography PCG, electrodermal activity, respiratory rhythm, and near-infrared spectroscopic imaging fNIRS. Participants emotional and psychological states will be evaluated through these signals at baseline and throughout the 2-month study period. Researchers will monitor cardiovascular and neuro-cardiac responses to assess biofeedback effects and stress coping. The total study duration includes baseline measures and follow-up assessments over two months.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are evaluating how different educational approaches affect knowledge and intention to receive the HPV vaccine among young women aged 18 to 24 who live in the Af5fin district of Kahramanmara5f, Tfcrkiye. Human papillomavirus HPV is a leading cause of cervical cancer, and vaccination rates remain low due to lack of knowledge and misconceptions. This randomized controlled trial aims to compare the impact of video-based education, face-to-face education, and no education on participants understanding and willingness to get vaccinated. Participants will be randomly assigned to one of three groups the video-based education group, which receives HPV information via a pre-recorded online video the face-to-face education group, which receives the same information in person from a researcher or a control group, which receives no education during the study. The educational content covers HPV infection, transmission, prevention, and vaccination following national health guidelines. Participants will complete surveys at three time points before the education pre-test to assess baseline knowledge and intention, immediately after the education session post-test to measure immediate impact, and one month later follow-up test to evaluate lasting effects. Data collected includes the HPV Knowledge Scale and Vaccination Attitude and Intention Form. The study monitors how education methods influence knowledge and vaccination intention over time, with no masking or blinding involved.

Advances in neonatal care have improved survival rates for very low birth weight infants but have led to increased rates of conditions such as cerebral palsy, cardiorespiratory disorders, blindness, cognitive delays, and hearing impairments. Early diagnosis and intervention programs in neonatal intensive care units NICU aim to support the development of these at-risk infants by normalizing their motor, cognitive, and sensory skills. This study focuses on evaluating the effects of early family-involved physiotherapy on motor development in infants at risk after NICU discharge, using tools like Prechtls General Movements Assessment and the Motor Optimality Score - Revised MOS-R. Participants will be randomly assigned to either an early physiotherapy program or a control group. The intervention group will receive a tailored family collaborative physiotherapy program including education on handling, carrying, positioning, and sucking facilitation to stimulate postural responses, integrated into daily routines. The control group will receive routine developmental NICU care plus a one-time instruction on positioning and carrying at discharge. The program continues with family recommendations until the infant reaches the studys evaluation points. Participants will be assessed for motor skills using the Motor Optimality Score and Prechtls General Movements Assessment between 12 and 20 weeks postterm. Additional evaluations include neurological exams Hammersmith Neonatal and Infant Neurological Examinations and cognitive and language development assessments BAYLEY-III at 3 and 6 months corrected age. Sociodemographic data will be collected at baseline. The study aims to measure the impact of early physiotherapy on neurological and developmental outcomes in at-risk infants within a 4-month age range.