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NCT ID: NCT06297668 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C).

Start date: April 29, 2024
Phase: Phase 1
Study type: Interventional

This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.

NCT ID: NCT06295640 Recruiting - Clinical trials for Glucose Metabolism Disorders

Relative Contribution of Brain Insulin Action for Postprandial Metabolism

BrainInsPPM
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women. Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

NCT ID: NCT06295276 Recruiting - Low Back Pain Clinical Trials

Effect of Teletherapy-supported Training on Nursing Students

Start date: January 31, 2024
Phase: N/A
Study type: Interventional

Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group. The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week. The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale

NCT ID: NCT06295094 Not yet recruiting - Gastric Cancer Clinical Trials

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

EPICURE
Start date: September 2024
Phase: Phase 2
Study type: Interventional

The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.

NCT ID: NCT06294925 Recruiting - Colitis, Ulcerative Clinical Trials

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

EFFECT-UC
Start date: May 8, 2024
Phase:
Study type: Observational

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past. All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device. The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer. The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.

NCT ID: NCT06294405 Recruiting - Lens Opacities Clinical Trials

Intraocular Lens Implant Registry Study

Start date: February 21, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

NCT ID: NCT06293170 Not yet recruiting - Clinical trials for Irreversible Loss of Brain Function (ILBF)

Automated Screening for Clinically Ascertained Loss of Cerebral Functions

DETECT-IVE
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF. Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support. Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trial Study population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge. Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination. Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization. Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT.

NCT ID: NCT06292143 Not yet recruiting - Dementia Clinical Trials

AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2)

AI4HOPE-P2
Start date: July 2025
Phase: N/A
Study type: Interventional

This pilot study will test a digital care planning decision support system for patients with dementia.

NCT ID: NCT06292013 Recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease (ASCVD)

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

Start date: March 5, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).

NCT ID: NCT06291935 Recruiting - Clinical trials for Retinitis Pigmentosa

Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene

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

The goal of this phase 1 clinical trial is to learn about the safety and efficacy of a gene therapy, VG901, in patients with a rare disorder of the eye called Retinitis Pigmentosa. The main questions the study aims to answer are: - What is the best tolerated dose and are there any side effects, in particular any inflammatory reactions post drug administration? - Are there any early signs of efficacy on visual function? Participants will be administered a single intravitreal dose of VG901 into the most affected eye through a syringe and followed up for a year to monitor safety and efficacy. There will be two cohorts of participants in this study. Study Cohort 1 will receive the low dose and Study Cohort 2 will receive the high dose as specified in the Protocol.