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NCT ID: NCT05111379 Not yet recruiting - Clinical trials for Peripheral Arterial Occlusive Disease Fontaine Stage IIa

Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication

Start date: November 2021
Phase:
Study type: Observational

The most common clinical presentation of lower extremity arterial disease is intermittent claudication. Current understanding of the pathophysiology of intermittent claudication, as well as its treatment options are limited. The progression of the disease may lead to lower limb amputation, which is devastating for patients' quality of life and is a huge socio-economic burden to society. Current study allows to determine the acute local metabolomic alterations in the ischaemic limb of the patient with intermittent claudication, and investigate the associations between the metabolomic alterations and the patient's maximal walking distance. This provides potentially valuable insight into the pathophysiology of this disease, and helps lay the groundwork for identifying potential novel targets for instituting more effective therapies for this high-risk population.

NCT ID: NCT05044195 Active, not recruiting - Influenza, Human Clinical Trials

A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age. The aim of the study is to demonstrate a noninferior immune response for aQIV versus the comparator vaccine for all four vaccine strains, and a superior immune response for at least two of the four vaccine strains.

NCT ID: NCT04967508 Active, not recruiting - Psoriasis Clinical Trials

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

Start date: July 6, 2021
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.

NCT ID: NCT04957719 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

SOS-AMI
Start date: August 14, 2021
Phase: Phase 3
Study type: Interventional

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

NCT ID: NCT04947748 Recruiting - Acute Appendicitis Clinical Trials

Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous is a prospective randomized controlled trial comparing 24 hour intravenous antibacterial therapy to 24 hour oral antibacterial therapy after surgery in complicated appendicitis.

NCT ID: NCT04939636 Recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Supplementation in Estonian Conscripts

Start date: July 19, 2021
Phase: N/A
Study type: Interventional

A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022

NCT ID: NCT04934072 Recruiting - Clinical trials for Postmenopausal Osteoporosis

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Start date: July 5, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period. For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.

NCT ID: NCT04930042 Active, not recruiting - Psoriasis Clinical Trials

Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis

Start date: June 3, 2021
Phase: Phase 3
Study type: Interventional

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

NCT ID: NCT04916574 Completed - Covid19 Clinical Trials

Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

Start date: March 20, 2021
Phase: N/A
Study type: Interventional

For an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. A "first-in-man" clinical study of the nasal spray containing anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. In addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. The volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. The concentration of antibodies from patient samples was measured using ELISA analysis. In addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

NCT ID: NCT04908683 Recruiting - Clinical trials for Respiratory Syncytial Viruses

A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

EVERGREEN
Start date: July 21, 2021
Phase: Phase 3
Study type: Interventional

The study will enroll up to 23000 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.