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NCT ID: NCT06447506 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

AtDvance
Start date: June 4, 2024
Phase: Phase 2
Study type: Interventional

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

NCT ID: NCT06445673 Enrolling by invitation - Clinical trials for Pulmonary Arterial Hypertension

A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients

TripleTRE-NIS
Start date: June 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study. The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial. Planned observation duration per patient is a minimum of 3 years.

NCT ID: NCT06443502 Not yet recruiting - Pouchitis Clinical Trials

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

When some people have their large bowel removed, a surgeon can make a "pouch" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab. Participants will receive up to 6 infusions of vedolizumab. First 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in total. After completing treatment with vedolizumab, participants will visit their clinic for a health check at Week 34. One final health check will be scheduled 4.5 months (18 weeks) after the last vedolizumab infusion. Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study (Vedolizumab-3042).

NCT ID: NCT06442319 Recruiting - Knee Osteoarthritis Clinical Trials

The Efficiency and Safety of PRP Treatment After Anterior Cruciate Ligament Reconstruction.

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The anterior cruciate ligament (ACL) is the main stabilizer of the knee joint, as it controls anteroposterior and rotatory knee laxity. The number of ACL injuries has increased in the past three decades because more and more people participate in recreational and competitive sporting activities. Injury to the ACL often leads to functional instability, damage to the meniscus and articular cartilage, and an increased risk for osteoarthritis (OA). Emphasizes the fact that ACL has limited healing potential 'The gold standard' treatment is ACL reconstruction, with over 200,000 reconstruction surgeries performed annually in the United States. However, despite the success of surgery in restoring functional stability, it has been found so far in several studies that the prevalence of moderate to severe arthritis in long-term radiographic follow-up is more than 50% after ACL reconstruction within 5 to 15 years or sooner. ACL-injured knees had at least 3 times higher risk of arthritis than uninjured contralateral knees. Early osteoarthritis was observed on magnetic resonance imaging (MRI) up to 11 years following ACL injury after operative and nonoperative management. Because ACL injuries predominantly occur in individuals between the ages of 15 and 25 years, symptoms of OA most often affect patients during their most productive years. This is worrisome because most patients who sustain ACL tears are free of the risk of other factors for developing OA.Consequently, posttraumatic OA after ACL reconstruction ultimately translates into a large economic effect on the healthcare system owing to the young age of this population. Platelet-rich plasma is an autologous solution of highly concentrated platelets dispersed in a small capacity of plasma. Enthusiasm for the therapeutic potential of platelets is based on its rich omplement of anabolic growth factors and anti-inflammatory cytokines in the platelets, which induce cellular proliferation, migration, differentiation, angiogenesis, and extracellular matrix synthesis. In addition, the functional mechanisms of PRP in OA treatment have been explained by its effect on modulating critical pro-inflammatory mediators and catabolic enzymes, as well as maintaining joint homeostasis. The reasons for this early incidence of post-traumatic OA remain unclear, but the underlying mechanisms have been speculated to involve some combination of cartilage damage at the time of injury, and posttraumatic molecular changes in the joint, including immune reactions or persistent secondary inflammation. We hypothesized that PRP injection after ACL reconstruction could prevent cartilage damage, act anti-inflammatory, and provide better clinical and radiological outcomes seen in MRI.

NCT ID: NCT06440291 Recruiting - Syncope, Vasovagal Clinical Trials

Cardioneuroablation for Reflex Syncope and Exercise Capacity

Roman3
Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Cardioneuroablation (CNA) is a new promising method to treat reflex syncope which is due to vagally-induced functional sinus arrest or atrio-ventricular block (AVB). Although the procedure is effective in > 80% of patients, there are potential adverse effects associated with the lack of vagal protection. One of them is increased sinus rate and possible worsening of exercise capacity. However, it is not known how often this happens. Moreover, the most accurate tool to asses exercise capacity - cardiopulmonary exercise testing (CPET), has not yet been used in this group of patients. Therefore, the aim of the study is to assess one-year effects of CNA-induced total vagal denervation on cardiorespiratory fitness in patients undergoing CNA due to reflex asystolic syncope. The study group consists of patients undergoing CNA in our institution. All patients give informed written consent to undergo CNA and to participate in the study (Ethics Committee approval # 22/2024). CNA is performed according to standard protocol used in our institution. A symptom-limited cardiopulmonary exercise (CPET) is performed twice, at baseline (1-2 days before CNA) and after one year of follow-up. Standard CPET parameters are measured. Quality of life is measured using a dedicated questionnaire. Also, a control group of healthy volunteers will undergo CPET to answer the question whether subjects with reflex syncope differ in exercise capacity from healthy people.

NCT ID: NCT06440148 Recruiting - Mastocytosis Clinical Trials

Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis

Start date: September 1, 2019
Phase:
Study type: Observational

Mastocytosis is very rare and highly heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs and tissues. Bones are the most frequent localization of systemic mastocytosis. The aim of our research was to explain the potential role of sclerostin in the pathogenesis of bone disease in mastocytosis.

NCT ID: NCT06435130 Completed - Obesity Clinical Trials

The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Chokeberry can be used both in the prevention and treatment of various metabolic disorders due to its high antioxidant properties. The study assessed for the first time the synergistic effect of chokeberry juice and chokeberry fiber on selected metabolic and anthropometric parameters. 102 people (67 women and 35 men) took part in the intervention study. After 8 weeks of intervention with chokeberry juice and another 4 weeks of intervention with chokeberry juice and fiber, a change in waist circumference, blood pressure, glucose, glycated hemoglobin, LDL cholesterol, aspartate transaminase (AST) and the level of antioxidant potential was observed.

NCT ID: NCT06435117 Not yet recruiting - Cancer Clinical Trials

Cancer Prevention Among Individuals With Mental Ill-health: Patient Navigation for Primary Cancer Prevention

CO-CAPTAIN
Start date: June 2024
Phase: N/A
Study type: Interventional

Prevention is essential for reducing cancer-related mortality. However, people with mental ill-health often face difficulties in accessing cancer prevention services. The EU-funded CO-CAPTAIN project aims to co-adapt and implement the Patient Navigation Model for primary cancer prevention in this underserved population. This evidence-based and patient-centred intervention aims to support patient empowerment through removal of systemic barriers, provide social support and promote timely access to primary prevention services.

NCT ID: NCT06433492 Completed - Clinical trials for Osteoarthritis, Knee

Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.

Start date: December 30, 2020
Phase: N/A
Study type: Interventional

The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.

NCT ID: NCT06431230 Active, not recruiting - Physical Activity Clinical Trials

School-based HIIT and Dose-Response Effects

PEER-HEART
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

There are experimental evidences of the importance of high intensity exercises in health outcomes improvement. However, there are limited knowledge about possibility to affect health outcomes in adolescents through exercises programs introduced into physical education (PE) lesson. Moreover, there is lack of the studies identifying people who do not respond to stimuli, as well as examining potential determinants of non-responsiveness. Thirdly, there are no studies examining the modification of exercise dose that should be reflected in the response in such individuals. Aim of this human experiment is to examine the effects of one cycle of 8-weeks high-intensity interval training (HIIT) implemented in physical education lesson on: (1) body composition (proportions of the body fat to the body muscles), (2) resting blood pressure, (3) physical efficiency. Study are conducted for two years (two cycles). Each year 300 students of two secondary schools, are involved in project: 15-16-year-olds in first year, 18-19-year-olds in second year. Students are divided in experimental groups -performing 8-weeks (twice a week) cycle of HIIT implemented into PE lesson, and the control groups - students following a typical PE programme. Each cycle consists of two parts. First part is related to the 8 weeks of HIIT training, while second part is related to the dose-expose study. All participants are examined during project before (Pre), after (Post) and Follow-Up intervention. Second part is planned after a break of several months. Persons who do not respond to the exercise stimulus in the first part will follow individually modified programmes. They will be measured before and after this additional training. To examine the assumed HIIT-induced changes in participants the investigators will apply: (1) anthropometric measurements: body height and weight, and BMI will be calculated, (2) body mass composition (fat and muscle mass), (3) resting blood pressure, (4) beep test which is field motor specific test to assess physical efficiency. The results of this project will help to answer the fundamental questions about HIIT induced morphological and physiological effects in adolescents, what is important from scientific and public health point of view. Particularly, in view of the growing pandemic of obesity, common elevated blood pressure and steadily declining physical fitness in children and adolescents.