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NCT ID: NCT05638906 Recruiting - 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 Recruiting - 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: NCT05430971 Recruiting - Clinical trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry

Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.

NCT ID: NCT05338398 Enrolling by invitation - Oral Mucositis Clinical Trials

Study for the Prevention of Oral Mucositis (SPOM)

SPOM
Start date: April 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

1. Study Design - Prospective, Randomized, Questionnaire-Based Study - Study Type: Phase 1/Phase 2 Interventional Clinical Trial - Intervention Model: Parallel Assignment - Masking: None (Open-label) - Actual Enrollment: 88 participants - Allocation: Randomized - Primary Purpose: Supportive Care/Treatment - Study groups - Control Group (Group 1): Saline or baking soda mouthwash (±Bocaliner™) - Intervention Group (Group 2): Benzydamine mouthwash (±Bocaliner™) 2. Settings - Single-center (a specialized hematology center) - Location: Hematology Center after Prof. R. Yeolyan, 7 Nersisyan St, Yerevan 0014, Armenia - Subjects will initially be enrolled, consented, examined, and complete initial questionnaires in the healthcare provider's office Subjects will undergo initial evaluation and follow-up examinations to determine WHO Oral Mucositis Scores - Subjects will complete questionnaires at the medical center with the Research Coordinator 7, 14, and 21 days after study enrollment. Subjects using Bocaliner™ will additionally complete a follow-up questionnaire. - Application of Bocaliner™ will be carried out first at the hospital followed by self-administration at home.

NCT ID: NCT05257369 Recruiting - Jaundice, Neonatal Clinical Trials

Broad Band Emission LED Phototherapy Source Versus Narrow Band

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device.

NCT ID: NCT05236439 Recruiting - Clinical trials for Glaucoma, Open-Angle

Study of an Interposition Supraciliary Implant SV22 in Patients With Primary Open Angle Glaucoma

SAFARI 3
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

NCT ID: NCT05212922 Not yet recruiting - HCC Clinical Trials

A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC

YH001
Start date: June 2023
Phase: Phase 2
Study type: Interventional

This is an Open-label, Non-Randomized, Multi-center Phase 2 study of YH001 in Combination with Toripalimab,The study is designed to determine the safety ,tolerability and antitumor activity of YH001 in combination with Toripalimab in subjects with advanced NSCLC and HCC.

NCT ID: NCT05190991 Recruiting - Clinical trials for Familial Mediterranean Fever

Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever

Start date: October 5, 2021
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the safety of the long-term treatment with RPH-104 at doses 80 mg or 160 mg once every 2 weeks in a population of patients with colchicine resistant or colchicine intolerant familial Mediterranean fever (FMF) who completed the core study, during which they received at least one dose of RPH-104. Long-term efficacy of RPH-104, the immunogenicity of the RPH-104, the pharmacokinetics of the RPH-104 and quality of life change in the population of patients receiving long-term treatment with RPH-104 will be assessed as well.

NCT ID: NCT05159817 Enrolling by invitation - Clinical trials for Glaucoma, Open-Angle

Study of an Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

SAFARI FU
Start date: December 15, 2021
Phase:
Study type: Observational

The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.