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NCT ID: NCT04957641 Completed - Clinical trials for Hereditary Angioedema

A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema

BOISTERN
Start date: April 21, 2022
Phase:
Study type: Observational

This study is about teenagers and adults with hereditary angioedema (HAE) type I and type II. In this study, the burden of illness means the impact of HAE in terms of long-term health outcomes and the financial cost. The main aims of this study are as follows: - to learn how often, how severe and where on the body HAE attacks occur. - to describe how HAE prophylaxis and on-demand medicines are prescribed and used. (Prophylaxis medicines prevent a bleed from happening and on-demand medicines treat a bleed when it occurs.) This study is about collecting data only; participants will not receive treatment as part of this study. Existing data available in the participant's medical records will be collected. Participants will be asked to complete an electronic questionnaire either on a website or by using an app on their mobile phone; data from this questionnaire will also be collected. Participants do not need to visit their doctor in addition to their normal visits.

NCT ID: NCT04939636 Completed - 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 Completed - 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 Completed - 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 Completed - 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 27,200 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.

NCT ID: NCT04881461 Completed - Allergy Clinical Trials

A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

Rhapsody
Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS) The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS. The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

NCT ID: NCT04867499 Completed - Clinical trials for Acute Mesenteric Ischemia

Epidemiology of Acute Mesenteric Ischemia

Start date: October 5, 2021
Phase:
Study type: Observational

Retrospective population-based study on epidemiology of acute mesenteric ischemia in Estonia Study objective is to describe epidemiologic features in adult patients with acute mesenteric ischemia during years 2016-2020. Patients from all hospitals in Estonia are included.

NCT ID: NCT04865744 Completed - Healthy Clinical Trials

The Effect of Semaglutide on Pituitary Function

Start date: May 19, 2021
Phase: Phase 4
Study type: Interventional

The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.

NCT ID: NCT04811157 Completed - Healthy Clinical Trials

The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota

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

The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier. Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants. Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.