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NCT ID: NCT05992142 Completed - Ulcerative Colitis Clinical Trials

ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

CARUC-ASA
Start date: January 17, 2023
Phase: Phase 4
Study type: Interventional

For the last years the aim of the management of ulcerative colitis (UC) has become more ambitious including not only clinical remission but also the achievement of biological remission, endoscopic and histological healing, which are associated with less flares, hospitalizations and surgeries. About 50% of the patients with UC followed in routine are treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to describe the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, that report to be in clinical remission during a routine follow-up visit. The factors associated with different levels of remission (demographic, 5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of life will be examined through patient questionnaires.

NCT ID: NCT05991635 Completed - Suicide Clinical Trials

Evaluation of a Gatekeeper Training for Pharmacists

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

This study aims to investigate to what extent a gatekeeper training (e-learning) for pharmacists and PTA is effective in changing the attitudes, knowledge, and self-efficacy. Moreover, it aims to examine how they evaluate the training and whether they were able to apply the learned skills in practice.

NCT ID: NCT05991284 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation

PRAISE-MR
Start date: February 14, 2024
Phase: Phase 4
Study type: Interventional

The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with heart failure with preserved ejection fraction and at least moderate atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho) at baseline and after six months of therapy. The patients included in this study will be randomly assigned to receive sacubitril-valsartan as an adjunct to standard medical care, as opposed to adhering solely to the standard of care which involves sodium-glucose cotransporter-2 (SGLT-2) inhibitor and mineralocorticoid receptor antagonist (MRA).

NCT ID: NCT05987800 Recruiting - Premature Birth Clinical Trials

Non-invasive Ventilation in Preterm Infants

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.

NCT ID: NCT05987527 Enrolling by invitation - Clinical trials for End Stage Renal Disease

Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

Start date: August 15, 2023
Phase:
Study type: Observational

This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.

NCT ID: NCT05987332 Recruiting - Clinical trials for Metastatic Uveal Melanoma

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Start date: October 31, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

NCT ID: NCT05985915 Recruiting - Sjogrens Syndrome Clinical Trials

A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

NEPTUNUS-Ext
Start date: October 27, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection. All participants will receive ianalumab either monthly or every 3 months. - The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. - The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: - ianalumab 300 mg monthly or - ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe. Participants will be given the opportunity to self-inject at home on some visits after receiving training.

NCT ID: NCT05985655 Recruiting - Clinical trials for Advanced Solid Tumor

Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors

ELUCIDATE
Start date: July 6, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 in patients with advanced solid tumors.

NCT ID: NCT05985200 Active, not recruiting - Healthy Clinical Trials

A Study in Healthy People to Test How Well Repeated Doses of BI 3032950 Are Tolerated

Start date: September 5, 2023
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising intravenous doses of BI 3032950 in healthy male subjects and postmenopausal or surgically sterilised female subjects (women not of child bearing potential (WNOCBP)).

NCT ID: NCT05984277 Recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

eVOLVE-Lung02
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.