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NCT ID: NCT06402786 Not yet 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 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 Not yet recruiting - Healthy Clinical Trials

Pilot Study of AVT16 in Healthy Adult Subjects

Start date: May 15, 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: 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.

NCT ID: NCT06356129 Not yet recruiting - Clinical trials for Large B-cell Lymphoma

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

GOLSEEK-1
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

NCT ID: NCT06327295 Not yet recruiting - Onychomycosis Clinical Trials

A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

Start date: March 30, 2024
Phase: Phase 2
Study type: Interventional

The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis

NCT ID: NCT06262399 Not yet recruiting - Clinical trials for Hereditary Angioedema

Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002

Start date: April 2024
Phase:
Study type: Observational

This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.

NCT ID: NCT06259006 Not yet recruiting - Rheumatic Fever Clinical Trials

TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children

TREAT-SC
Start date: May 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out whether an early three-day course of an oral steroid medication (dexamethasone) can improve the physical and mental recovery and wellbeing for children with Sydenham's chorea. Sydenham's chorea is a condition that impacts approximately 12% of children with acute rheumatic fever. It is caused by inflammation in the brain following an abnormal immune response to Group A streptococcus bacterial infection. Sydenham's chorea is a movement disorder that causes children's faces, hands, and feet to move quickly and uncontrollably, and can also affect mood and concentration. The physical recovery from Sydenham's chorea can take two to six months but the mental recovery (e.g. mood and concentration) can take longer to resolve. Sydenham's chorea remains endemic in Māori, Pacific Islander, Aboriginal and Torres Strait Islander children in New Zealand and Australia. There is limited evidence to direct treatment of Sydenham's chorea, and clinical practice differs widely around the world. Dexamethasone is an oral steroid which targets the abnormal immune response and successfully treats other immune-mediated brain disorders, with good tolerability. TREAT-SC is a randomized, double-blinded, placebo-controlled trial which will investigate whether a three day course of oral dexamethasone safely and effectively treats the movement disorder and psychiatric symptoms of Sydenham's chorea. The trial will recruit 80 participants from study sites in Australia and New Zealand.

NCT ID: NCT06166979 Not yet recruiting - Clinical trials for Microbial Colonization

Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the scalp from a serum format in healthy adults.