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NCT ID: NCT05176535 Recruiting - Clinical trials for Microbial Colonization

Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)

PROSALVAG
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.

NCT ID: NCT05176483 Recruiting - Colorectal Cancer Clinical Trials

Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors

STELLAR-002
Start date: December 14, 2021
Phase: Phase 1
Study type: Interventional

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in subjects with advanced solid tumors. In the Expansion Stage, the safety and efficacy of XL092 as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

NCT ID: NCT05176145 Recruiting - Clinical trials for Non-muscle Invasive Bladder Cancer (NMIBC)

Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test

DMIA
Start date: April 5, 2022
Phase: N/A
Study type: Interventional

European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.

NCT ID: NCT05175885 Recruiting - Clinical trials for Kidney Transplantation

Ex Vivo Normothermic Perfusion in Kidney Transplantation.

KidneyARK
Start date: November 14, 2023
Phase: N/A
Study type: Interventional

A multicenter, prospective and open-label clinical investigation to evaluate the viability, performance and safety of ex vivo normothermic perfusion in kidney transplantation from DCD and DBD donors.

NCT ID: NCT05175105 Recruiting - Clinical trials for Pediatric Pyruvate Kinase Deficiency

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

ACTIVATE-Kids
Start date: June 6, 2022
Phase: Phase 3
Study type: Interventional

Study ACTIVATE-Kids (AG348-C-023) will evaluate the efficacy and safety of orally administered mitapivat as compared with placebo in pediatric participants with pyruvate kinase deficiency (PKD) who are not regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to < 6 years, 6 to < 12 years, 12 to < 18 years). Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 12-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat for up to 5 years in the open-label extension (OLE) period.

NCT ID: NCT05174910 Recruiting - Clinical trials for Anastomotic Leak Rectum

Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery

ORSY
Start date: December 23, 2021
Phase: N/A
Study type: Interventional

Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of hospital stay and higher costs. This study is an investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian ASG®) for treatment of anastomosis during rectal surgery - a single-blind, randomized, multicenter pilot study with enrollment of 2x220 patients The main objective of the study is to investigate on an exploratory basis whether the use of Obsidian ASG® during rectal resection reduces the frequency of postoperative anastomotic insufficiency compared to standard anastomotic technique. The secondary objectives of the study are to investigate on an exploratory basis: - The frequency of anastomotic insufficiency (ISREC Criteria) severity - Staple line bleeding requiring surgical intervention - The duration of postoperative hospitalization are reduced when using Obsidian ASG ® compared with standard anastomotic treatment alone. are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.

NCT ID: NCT05171725 Recruiting - Healthy Clinical Trials

Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders

MES-CoBraD
Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

The Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders (MES-CoBraD) is an interdisciplinary project combining Real-World Data (RWD) from multiple clinical and consumer sources through comprehensive, cost-efficient, and fast protocols towards improving diagnostic accuracy and therapeutic outcomes in people with Complex Brain Disorders (CoBraD), as reflected in Neurocognitive (Dementia), Sleep, and Seizure (Epilepsy) disorders and their interdependence. It brings together internationally recognized experts in medicine, engineering, computer science, social health science, law, and marketing and communication from across Europe, and combines clinical information and scientific research in CoBraD with technical innovation in secure data-sharing platforms, artificial intelligence algorithms, and expert systems of precision and personalized care, with a primary focus on improving the quality of life of patients, their caregivers, and the society at large. It leverages RWD from diverse CoBraD populations across cultural, socioeconomic, educational, and health system backgrounds, with special attention on including vulnerable populations and minorities in an equitable manner and engaging key stakeholders to maximize project impact.

NCT ID: NCT05171270 Recruiting - Psoriatic Arthritis Clinical Trials

AsseSSing Impact in pSoriatic Treatment

ASSIST
Start date: July 12, 2021
Phase:
Study type: Observational

Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice. This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA. This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

NCT ID: NCT05171075 Recruiting - Pulmonary Embolism Clinical Trials

A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

MAGNOLIA
Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

NCT ID: NCT05171049 Recruiting - Pulmonary Embolism Clinical Trials

A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE

ASTER
Start date: May 5, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)