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NCT ID: NCT05473299 Recruiting - Clinical trials for End-stage Renal Disease

Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Start date: November 4, 2022
Phase: N/A
Study type: Interventional

A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.

NCT ID: NCT05471856 Recruiting - Solid Tumors Clinical Trials

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

Start date: January 19, 2023
Phase: Phase 1
Study type: Interventional

This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time. Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks. Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.

NCT ID: NCT05471843 Recruiting - Clinical trials for Mantle Cell Lymphoma

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Start date: September 5, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

NCT ID: NCT05471804 Recruiting - Clinical trials for Stress, Psychological

Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract

ZEMBRIN
Start date: May 18, 2022
Phase: N/A
Study type: Interventional

This study employs a randomized controlled trial to test the cognitive enhancing and stress relieving potential of the product Zembrin® in healthy adults when consumed over an 8 week period.

NCT ID: NCT05471583 Recruiting - Clinical trials for Coronary Artery Disease

Endothelial Glycocalyx Damage in Acute Kidney Injury

Start date: November 16, 2021
Phase:
Study type: Observational

Abstract Significance: Cardiac surgery-associated acute kidney injury (CSA-AKI) is common and has serious immediate and long-term sequelae. Better early prediction of those at highest risk and greater understanding of underlying pathological processes are needed to prevent or minimise damage. Hypotheses - Dynamic changes in systemic endothelial glycocalyx (Glx) and microcirculatory parameters during coronary artery bypass graft (CABG) surgery are predictive of CSA-AKI. - Mechanisms for Glx degradation during CABG surgery are akin to those during sepsis Aims - Investigate Glx and microcirculatory health throughout CABG surgery and recovery and their association with CSA-AKI. - Explore association between inflammation and Glx degradation during CABG surgery. Methodology 1. Prospective cohort study: serial sampling and microcirculatory perfusion imaging of 70 patients undergoing CABG surgery with evaluation of CSA-AKI predictors, including plasma Syndecan-1. 2. Examination of inflammation and cardiometabolic proteome and association with vascular changes 3. In vitro mechanistic assessment of Glx degradation and relative timing of organelle exocytosis in cultured endothelial cells in response to patient serum, targeting identified candidate mediators. Impact: Enhancing CSA-AKI risk stratification with new mechanistic biomarkers will enable individualised management of at-risk patients, and pathophysiological insights will create possible therapeutic targets, thus reducing morbidity, mortality and cost of CSA-AKI.

NCT ID: NCT05470985 Recruiting - Crohn Disease Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

Start date: August 22, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.

NCT ID: NCT05469789 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

Start date: June 29, 2023
Phase:
Study type: Observational

The main aim of this study is to compare the HAE attack rate requiring on-demand treatment before and within 2 years after participants with HAE have been treated with lanadelumab. This study is conducted in the United Kingdom where participants were treated or about to be treated with landelumab according to their routine practice at hospitals. Data will be directly collected from participants via study diaries, questionnaires, their medical records, and study doctors treating them. Participants will be contacted every 3 months during study participation (via phone).

NCT ID: NCT05469555 Recruiting - Asthma Clinical Trials

Azithromycin and Oesophageal Function in Respiratory Disease

Start date: June 29, 2023
Phase:
Study type: Observational

Symptoms such as cough, wheeze, and breathlessness are among the most common reasons for general practitioner or emergency department visits in the UK. Such symptoms have a profound impact on patients' ability to live a fulfilled life, often rendering people unable to work and socialise. Azithromycin (a type of antibiotic) improves symptoms and reduces flare-ups of diseases such as asthma and chronic obstructive pulmonary disease (COPD). The reason why it works is unclear. Many people believe that it either decreases the number of bacteria in the lungs or reduces inflammation in the lungs and the upper airways. Neither theory is proven. Another possible mechanism that has been much less studied is that Azithromycin encourages the body to move food and fluid through the gut more quickly, thus preventing reflux and aspiration of small food particles and stomach acid. It has been shown that lung damage can occur when gut contents enter the airways, which may contribute chronic lung disease patients' symptoms In this study the investigators will test the effect of azithromycin on the gut in patients with chronic lung diseases. The investigators will measure the strength of a patients swallow by measuring the pressures in their gullet, using high-resolution oesophageal manometry (HROM), before and after treatment, in people being started on azithromycin as part of their routine care. The investigators will also measure the effect that azithromycin has on their symptoms and observe whether there is a relationship between the strength of their swallow and their symptoms. At the end of this study, the investigators hope to better understand the way in which azithromycin helps to improve the symptoms of patients with chronic lung diseases. The investigators also hope to open the door to investigate the effect of other drugs that improve gut function in patients with chronic lung diseases.

NCT ID: NCT05468320 Recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura

Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

MAYARI
Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.

NCT ID: NCT05466799 Recruiting - Clinical trials for Locally Advanced Pancreatic Cancer

FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma

TRIPP-FFX
Start date: April 26, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer