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NCT ID: NCT06454617 Recruiting - Osteoporosis Clinical Trials

Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans

Calibr-Ì
Start date: June 6, 2024
Phase:
Study type: Observational

Osteoporosis is a systemic disease characterized by a reduction in bone mineral density (BMD) and qualitative alteration of the skeleton, resulting in increased bone fragility and fracture risk. The epidemiological impact of osteoporosis is extremely high. Proper diagnosis and clinical management of osteoporosis are critical to reducing the incidence of fragility fractures and preventing their complications. The diagnosis is generally confirmed by instrumental analysis of bone mineral density. The standard method is X-ray bone densitometry (DXA), which allows diagnosis based on criteria defined by the World Health Organization (WHO) by virtue of the T-score. DXA is a relatively quick and inexpensive examination with low exposure to ionizing radiation. However, this method has limitations in detecting fracture risk, and in addition, not all patients are properly referred for DXA services, which, among other things, require specific criteria to be reimbursed by the National Health System. Currently, computed tomography (CT) scanning is the most widely used three-dimensional diagnostic modality in clinical practice, and the number of investigations performed in high-income countries is continuously growing. Quantitative assessment of bone mineral density by CT is possible by proper calibration of the machine for the purpose of converting the CT numbers (or Hounsfield units) measured by the scanner into BMD units.

NCT ID: NCT06439602 Recruiting - Gout Clinical Trials

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients

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

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

NCT ID: NCT06429930 Not yet recruiting - Clinical trials for Pulmonary Arterial Hypertension

Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults

Start date: September 1, 2024
Phase: Phase 1
Study type: Interventional

This is the second single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with higher dose levels, starting from 20 μg and escalating up to a planned maximum dose of 110 μg.

NCT ID: NCT06428591 Completed - Clinical trials for Diabetes Mellitus, Type 1

Tandem Freedom - Feasibility Trial 1

Start date: May 29, 2024
Phase: N/A
Study type: Interventional

This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting for 3 days/nights.

NCT ID: NCT06402786 Recruiting - Hydrocephalus Clinical Trials

First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.

HomeICP
Start date: May 27, 2024
Phase: N/A
Study type: Interventional

Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation. The investigators want to improve the lives of patients with hydrocephalus. They have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. The device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). This study is a first-in-human safety study to show it is safe for patient use.

NCT ID: NCT06400719 Recruiting - Healthy Clinical Trials

Pilot Study of AVT16 in Healthy Adult Subjects

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

This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.

NCT ID: NCT06385327 Not yet recruiting - Clinical trials for Recurrent Genital Herpes Simplex Type 2

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes

Start date: May 2024
Phase: Phase 1
Study type: Interventional

This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A.

NCT ID: NCT06384963 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF

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

The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. The main questions the trial aims to answer are: - Is the new type of pacemaker safe? - Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients.

NCT ID: NCT06381349 Recruiting - Gastroparesis Clinical Trials

Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

GPOEM-GEMS
Start date: May 30, 2024
Phase:
Study type: Observational

Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted <1 month prior to GPOEM. All subjects will then be followed up for 12 months.

NCT ID: NCT06368401 Not yet recruiting - Clinical trials for Tricuspid Regurgitation

A First in Human Study for the Versa Device for Tricuspid Regurgitation

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

This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.