The Effectiveness of Heat Treatment on Knee Pain in Patients with Osteoarthritis - an International, Multicenter Clinical Investigation. Prospective, Open-label, One-arm, Post-market, Effectiveness Clinical Investigation

This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h/d).

开始日期2024-10-21

申办/合作机构

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA

[+1]

NCT05926258 / Recruiting临床3期

A Prospective, Observer-blind, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia for Clinical Practice in Pediatric Population

The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients.
74 Participants (male and female, aged 0-17 yrs) will be 1:1 randomized for receiving either the test drug (Chloroprocaine) or the reference drug (Oxybuprocaine) before undergoing to ocular exam who needs ocular surface anesthesia.
The successful surface anesthesia will be evaluated 5 minutes after receiving 2 drops (1 minute apart) of either test or reference drug by an eye spear sponge

开始日期2024-05-23

申办/合作机构

Sintetica SA

[+1]

NCT05695157 / RecruitingN/A

Clinical Performance and Safety of Suture-TOOL for Abdominal Wound Closure in Men and Women Patients Undergoing Elective Open Abdominal Surgery

The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery. The study population consists of 38 patients selected for open abdominal procedures for malignant and benign colorectal disease.
The main question it aims to answer is:
• If the device facilitates a Suture-Length to Wound-Length (SL/WL) ratio of 4:1
Participants laparotomy wound will be closed with the device at the end of the operation and closure related data as closure time and SL/WL ratio will be calculated. The wound will be assessed for infection during the postoperative stay and the chart will be reviewed for wound dehiscence and wound infection.

开始日期2023-01-10

申办/合作机构

Suturion AB初创企业

[+1]

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0 项与 Cross Research LLC 相关的专利（医药）

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2002-12-01·Journal of Neural Transmission4区 · 医学

Pharmacodynamic studies on the central mode of action of S-adenosyl-L-methionine (SAMe) infusions in elderly subjects, utilizing EEG mapping and psychometry

4区 · 医学

Article

作者: C. di Padova ; B. Saletu ; G. M. Saletu-Zyhlarz ; L. Linzmayer ; A. Assandri ; E. Lindeck-Pozza ; H. V. Semlitsch ; P. Anderer

In a double-blind, placebo-controlled cross-over study, the acute and subacute effects of S-adenosyl-L-methionine (SAMe), or ademetionine, on brain function and behavior of 10 elderly normal healthy volunteers (5 males and 5 females, aged 56-71 years, mean: 59.3 years) were investigated by means of EEG mapping and psychometry. In random order they received infusions of 800 mg SAMe and placebo, administered over 30 minutes for 7 days, with a wash-out period of 3 weeks in between. EEG recordings and psychometric tests were carried out 0, 1, 3 and 6 hours after drug administration on days 1 and 7. Multivariate analysis based on MANOVA/Hotelling T(2) tests demonstrated significant central effects of SAMe as compared with placebo after acute, subacute and superimposed drug administration. Acute SAMe-induced changes were characterized by a decrease in total power, an increase in absolute delta and a decrease in absolute alpha power, further by an increase in relative delta and a decrease in relative alpha power, a slowing of the delta/theta centroid as well as a slowing of the centroid of the total power spectrum. These changes are typical of classical antidepressants of the thymoleptic type such as imipramine and amitriptyline. After one week of daily infusions there was a marked increase in total power, reminiscent of nootropic drug effects. One additional superimposed dosage mitigated these effects in the direction of an antidepressant profile, with the inter-drug differences waning in the 6(th) hour. Our pharmaco-EEG findings suggest both inhibitory and excitatory drug effects underlying the antidepressant properties of SAMe well-documented in clinical trials. Psychometric tests concerning noopsychic and thymopsychic measures as well as critical flicker frequency generally demonstrated a lack of differences between SAMe and placebo, which again reflects a good tolerability of the drug in elderly subjects.

Nature Communications1区 · 综合性期刊

Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection

1区 · 综合性期刊

ArticleOA

作者: Rappuoli, Rino ; Phogat, Adhuna ; Frosini, Andrea ; Gentili, Alessandra ; Hyseni, Inesa ; Ippolito, Giuseppe ; Plazzi, Maria Maddalena ; Torelli, Alessandro ; Antinori, Andrea ; Vaia, Francesco ; Nosari, Sarah ; Nicastri, Emanuele ; Leonardi, Margherita ; Paolini, Andrea ; Milleri, Stefano ; Lanini, Simone ; Piccini, Giulia ; Montomoli, Emanuele ; Della Cioppa, Giovanni ; Paciello, Ida ; Andreano, Emanuele ; Girardi, Enrico

AbstractThe emerging threat represented by SARS-CoV-2 variants, demands the development of therapies for better clinical management of COVID-19. MAD0004J08 is a potent Fc-engineered monoclonal antibody (mAb) able to neutralize in vitro all current SARS-CoV-2 variants of concern (VoCs) including the omicron variant even if with significantly reduced potency. Here we evaluated data obtained from the first 30 days of a phase 1 clinical study (EudraCT N.: 2020-005469-15 and ClinicalTrials.gov Identifier: NCT04932850). The primary endpoint evaluated the percentage of severe adverse events. Secondary endpoints evaluated pharmacokinetic and serum neutralization titers. A single dose administration of MAD0004J08 via intramuscular (i.m.) route is safe and well tolerated, resulting in rapid serum distribution and sera neutralizing titers higher than COVID-19 convalescent and vaccinated subjects. A single dose administration of MAD0004J08 is also sufficient to effectively neutralize major SARS-CoV-2 variants of concern (alpha, beta, gamma and delta). MAD0004J08 can be a major advancement in the prophylaxis and clinical management of COVID-19.

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