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NCT ID: NCT05747820 Completed - Heart Failure Clinical Trials

Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure

EVOLUTION
Start date: September 28, 2022
Phase:
Study type: Observational

This observational study is conducted to assess the evolution of multiple markers of congestion over 4 weeks after a worsening heart failure (WHF) event treated in an outpatient unit

NCT ID: NCT05638906 Completed - Clinical trials for This Study is Obtained Under Inclusion/ Exclusion Criteria

Minimally Invasive Nasal Trabeculostomy - Performance and Safety Evaluation Study

Start date: April 11, 2022
Phase: N/A
Study type: Interventional

Minimally Invasive Nasal Trabeculostomy System is intended for the reduction of elevated Intraocular Pressure (IOP). The system is a powered surgical device, designed to create trabeculostomy openings of ~100 microns diameter each, via an ab-interno approach, directly from the anterior chamber (AC) into Schlemm's canal (SC) by removing segments of the trabecular meshwork (TM) (i.e., an ab-interno nasal trabeculostomy). The ab-interno approach aims to decrease IOP by increasing aqueous outflow through a direct communication from the AC to the outer wall of SC and the collector channels. The opening in the nasal TM to the SC is created by a sterile surgical instrument (the Surgical Device) made of stainless steel and plastic, which is coupled to a rotating system (the Activation Device). The Surgical Device of the Minimally Invasive Nasal Trabeculostomy System consists of a stainless steel micro trephine, covered by a small needle-shaped sleeve with a rotating mechanism behind it. While being rotated, the Surgical Device enters and moves along the TM, removing TM tissue with minimal collateral damage. Mechanical rotation of the Surgical Device is achieved by the rotating system (i.e., Activation Device), which is comprised of: (1) Controller which dictates the activation pulse duration, the rotations per minute (RPM) and the forwards and backwards movement of the micro trephine; (2) Motor; and (3) Footswitch.

NCT ID: NCT05638321 Completed - Clinical trials for This Study is Conducted Under Inclusion/ Exclusion Criteria

Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure - Performance Evaluation Study

Start date: April 11, 2022
Phase: N/A
Study type: Interventional

Minimally Invasive Micro Sclerostomy (MIMS®) device is intended for the reduction of elevated Intraocular Pressure (IOP). MIMS® is a powered surgical device, designed to create a drainage channel of 100 microns diameter at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjunctival space), at the inferonasal quadrant of the eye (i.e., inferonasal sclerostomy). The drainage channel is created by a sterile surgical device made of stainless steel and plastic, which is coupled to a rotating system. The surgical device consists of stainless steel micro trephine, covered by a small needle and rotating mechanism behind it. Mechanical rotation of the surgical device is achieved by the rotating system which is comprised of a 1) Controller which dictates the activation pulse duration and RPM, 2) a Motor, and 3) Footswitch.

NCT ID: NCT05506709 Completed - Allergic Rhinitis Clinical Trials

Sterimar Allergic Rhinitis

Start date: July 13, 2022
Phase: N/A
Study type: Interventional

The study aims to confirm the safety and performance of a hypertonic seawater-based nasal spray enriched with manganese and calcium, in relief/reduction of nasal symptoms (congestion, itchy nose, runny nose and sneezing) among subjects with symptomatic allergic rhinitis. This will be a prospective, longitudinal, single-cell and product blinded clinical trial. A sufficient number (65-70) of adult subjects with allergic rhinitis meeting all eligibility criteria will be enrolled in this study to ensure that approximately 50 subjects complete the study. Subjects will be enrolled during allergy season. The study will consist of four visits with a total duration of 3 weeks (1 week of pre-screening and 2 weeks for investigational product use). The full schedule of events is presented in the CIP. Subjects recruited for this study will be screened for inclusion/exclusion criteria after reading and signing the informed consent form. Eligible subjects who show a positive reaction to the skin prick test at Visit 1/ Day -7 will be enrolled for a one-week pre-run screening period. At baseline (Visit 2/Day 0), those subjects meeting all inclusion criteria including the results of the Total Nasal Symptoms Score will be enrolled in the active study phase. The subjects will use the product during two weeks (from Day 7 to Day 14), applying at least once and maximum 6 times daily per instructions for use. At each visit within intervention period (Visits 2, 3 and 4), the subjects will be asked to assess their nasal and ocular symptoms (using Nasal Symptom Score and Ocular Symptom Score grading tools) before product application, as well as at 1 minute, 10 minutes and 1-hour post-product application. Besides, they will complete Weekly Rhinitis questionnaire for the past week. Additionally, the subjects will complete Daily Diaries to record their nasal and ocular symptoms, sleep disturbance, and need for use of other medication.

NCT ID: NCT05157711 Completed - Hemorrhoids Clinical Trials

Clinical Trial of Anusol Ointment for Symptom Relief in Patients With Haemorrhoids

Start date: November 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of Anusol topical ointment for the relief of internal and external haemorrhoid symptoms in people with Grades I-III haemorrhoids compared to a placebo (the study medication without the active ingredients) and a benchmark product.

NCT ID: NCT04615273 Completed - Clinical trials for Growth Hormone Deficiency

A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

foresiGHt
Start date: December 3, 2020
Phase: Phase 3
Study type: Interventional

A 38 week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. Approximately 240 adults (males and females) with growth hormone deficiency will be included. Randomization will occur in a 1:1:1 ratio (lonapegsomatropin : placebo : daily somatropin product). This is a global trial that will be conducted in, but not limited to, the United States, Europe, and Asia.

NCT ID: NCT04503590 Completed - Glaucoma Clinical Trials

Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study

Start date: May 29, 2019
Phase: N/A
Study type: Interventional

Eligible Glaucoma patients will undergo pre-surgery examination including: medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered . The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] . MIMS procedure may be combined with cataract surgery. Patients will be followed up to 52 weeks post operation.

NCT ID: NCT04459429 Completed - TTN Clinical Trials

Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns

Start date: June 26, 2020
Phase: N/A
Study type: Interventional

Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns. Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure. To the best of our knowledge, this is the first study to investigate the effect of using different NHF cannula size on peripheral oxygen saturation in newborns with respiratory distress.

NCT ID: NCT04235062 Completed - Heart Failure Clinical Trials

NATriuretic Response to Expansion and dIUretics in huMans With Heart Failure

NATRIUM-HF
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

NATRIUM-HF is a multicenter, non-randomized, pre-post intervention study designed to assess renal response to intravascular fluid expansion and diuretics after sacubitril/valsartan (Entresto®) in euvolemic heart failure patients with reduced ejection fraction. Approximately 230 eligible patients will attend one visit prior to and visits 2 and 3 months after starting Entresto®. At each visit, the patient's responses to extravascular fluid expansion with Ringer's solution and to a loop diuretic bolus will be measured. Biomarkers measured in blood and urine samples will include natriuretic peptides (NP) B-type NP (BNP) and N-terminal proBNP (NT-proBNP), NP fragments, neprilysin activity and concentration, and other biomarkers related to heart failure.

NCT ID: NCT04183842 Completed - Anxiety Clinical Trials

Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers

LACIME
Start date: July 4, 2019
Phase: N/A
Study type: Interventional

The primary objective of the study is to test whether the tested Product LACIME Anti-hangover is effective in preventing the signs and symptoms of alcohol-induced hangover (such as headache, impaired memory, depression, anxiety, weakness, trouble sleeping and concentrating, nausea, dizziness, sleepiness, thirsty, dry mouth, sweating, sensitivity to light and sounds, vision problems) in healthy subjects.