Denizli Merkez

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 treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

This research aims to evaluate the safety, performance, and usability of Occlutech accessory medical devices used in cardiac implant procedures. It is an international, multicenter, non-randomized, non-invasive registry study focusing on devices such as the Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), and Occlutech Sizing Balloon (OSB). The study collects data through investigator-completed surveys to monitor device-related outcomes during and after catheter-based cardiac implant interventions. The study involves the use of the specified Occlutech accessory devices by experienced physicians skilled in cardiac catheterization and interventional operations. Investigators complete detailed questionnaires assessing the success of implantation procedures, any adverse events occurring during or after the procedures, user harm related to the accessories, and any device deficiencies. The surveys also evaluate performance, usability, and compatibility of the accessories with other devices. Participants are treated following the implants' and accessories' instructions for use and standard clinical practice. Participants' involvement includes undergoing implantation procedures with these accessory devices, after which investigators collect data via surveys. The study monitors safety events over six months, including any adverse outcomes linked to the accessories or procedures. The collected information helps assess the devices' safety profile and practical use in real-world clinical settings. The total duration of monitoring and follow-up is six months per participant to capture both immediate and longer-term effects.

Low back pain (LBP) is a common condition affecting people of various ages, causing significant personal and social challenges as well as increased healthcare costs. This research aims to compare the joint range of motion (ROM) between patients with chronic low back pain and healthy individuals, using artificial intelligence-supported analysis methods to detect differences. Chronic LBP often leads to reduced movement and activity, making it important to identify risk factors and improve treatment approaches. Participants will undergo joint range of motion measurements to assess how their joints move. This diagnostic testing will help in comparing the specific motion ranges of people with low back pain and those without. The study will use AI to analyze these measurements and detect variations between the groups. During the study, participants will be evaluated for pain levels and joint range of motion, with assessments lasting approximately 5 to 20 minutes. The researchers will measure pain and monitor joint flexibility to understand the impact of low back pain. Participants will be involved in these evaluations to help identify differences and potential factors linked to chronic low back pain.

Researchers are evaluating the effectiveness and safety of two oral drug combinations, Bemnifosbuvir-Ruzasvir (BEM/RZR) and Sofosbuvir-Velpatasvir (SOF/VEL), in adults with chronic Hepatitis C virus (HCV) infection. This Phase 3 trial compares these treatments to determine which is better at reducing the virus in the blood. Participants include adults aged 18 to 85 years, including those with compensated liver cirrhosis, and some with controlled HIV-1 infection under specific treatment conditions. Participants will receive either BEM/RZR tablets once daily for 8 weeks if they do not have cirrhosis, or for 12 weeks if they have compensated cirrhosis. Those in the comparison group will take SOF/VEL tablets once daily for 12 weeks. The study is randomized, controlled, and open-label, meaning both participants and researchers know which treatment is given. During the study, researchers will monitor patients to see how many achieve very low levels of HCV RNA in their blood by week 24. The study will include regular medical assessments, safety monitoring, and evaluation of treatment adherence. Participants will be followed from the start of treatment until 24 weeks later to assess outcomes and any side effects.

This research aims to study how a special breastfeeding support program based on a client health behavior interaction model affects first-time mothers' confidence in breastfeeding, their attitudes, and the problems they face. The study focuses on primiparous mothers between 32 and 40 weeks of pregnancy and compares outcomes between those receiving this program and those receiving standard care. Breastfeeding is important for infant and maternal health, but many mothers face challenges that reduce breastfeeding rates worldwide. The intervention group will receive educational sessions during the last trimester of pregnancy, motivational face-to-face interviews at several postpartum times (1-3 days, 15 days, 30 days, 45 days, and 60 days), and follow-up support through WhatsApp video calls at 4 and 5 months postpartum. The control group will receive routine breastfeeding education and support provided at Family Health Centers without these additional structured interventions. Participants will be assessed at multiple times starting from 32-36 weeks of gestation through 6 months postpartum. This includes questionnaires measuring breastfeeding self-efficacy and attitudes at baseline and at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months after birth. Researchers will track breastfeeding problems and use validated scales to measure outcomes. The study runs from September 2024 to December 2026 in Turkey and includes ongoing support and monitoring throughout the study period.

Researchers are evaluating the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) to treat spasticity in the wrist flexor muscles (flexor carpi ulnaris and flexor carpi radialis) of people who have had a chronic stroke. Spasticity after stroke can cause muscle stiffness, pain, and limit function, reducing quality of life. Current treatments like medications and injections have drawbacks such as side effects and high costs, so this study explores a new non-invasive approach. The study also aims to improve assessment by using objective ultrasound techniques, including strain elastography and echogenicity, alongside traditional clinical scales like the Modified Ashworth Scale (MAS).

Breast cancer is the most common cancer among women worldwide, and breast cancer-related lymphedema (BCRL) is a significant complication that can develop shortly after treatment or years later. BCRL causes swelling, heaviness, discomfort, reduced shoulder mobility, and impacts quality of life. The study aims to explore how intermittent pneumatic compression (IPC), either replacing or added to manual lymph drainage (MLD) within complete decongestive therapy (CDT), affects arm size, shoulder movement, and quality of life in women with BCRL. Participants will receive one of three treatments over three weeks with five sessions each week: standard CDT including MLD, compression, skin care, and exercise; CDT plus IPC where IPC is added to the standard treatment; or CDT where MLD is replaced by IPC. IPC is applied at 20-50 mmHg for 40 minutes per session. Treatment sessions last from 75 to 115 minutes depending on the group. Throughout the study, researchers will measure arm volume and circumference before and three weeks after treatment starts. They will also assess shoulder range of motion and quality of life. These measurements will help determine the effects of IPC compared to MLD within CDT. The study focuses on safety and treatment outcomes over this three-week period.