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NCT ID: NCT05131477 Completed - Atopic Dermatitis Clinical Trials

Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

STREAM-AD
Start date: December 13, 2021
Phase: Phase 2
Study type: Interventional

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the LTE (Long-Term Extension) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.

NCT ID: NCT05131373 Completed - Acne Vulgaris Clinical Trials

Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris

OREA
Start date: September 28, 2021
Phase: Phase 1
Study type: Interventional

Acne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden. Despite being one of the most prevalent diseases worldwide, the most widely used treatments in acne have changed little in the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The currently available acne therapies have been discovered several decades ago, and almost no progress was made in developments of novel, breakthrough treatment approaches. The present randomized, placebo-controlled, dose escalation, Phase 1 trial (ORI-101-PAC) is intended to investigate the safety, tolerability and immunogenicity of an acne vulgaris vaccine (ORI-A-ce001) at three different dose levels in subjects aged ≥18 years suffering from moderate facial acne vulgaris who are otherwise healthy. The present study will also generate preliminary data on efficacy (inflammatory and non-inflammatory acne lesion counts, acne severity), immunogenicity and functionality of the vaccine, as well as a possible impact on skin microbiome composition. Control groups receiving placebo are included. Data from this trial will be used to inform the design of future studies.

NCT ID: NCT05130970 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Start date: January 27, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT05129891 Completed - Healthy Volunteers Clinical Trials

A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

Start date: November 3, 2021
Phase: Phase 1
Study type: Interventional

In this study, four new tablet versions of two compounds will be investigated. The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance. Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days. The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)

NCT ID: NCT05129241 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

MARS
Start date: November 18, 2021
Phase:
Study type: Observational [Patient Registry]

Primary objectives: - To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment - To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector Secondary objective: Safety and tolerability

NCT ID: NCT05127473 Completed - Clinical trials for Healthy Volunteers - Haemophilia A

A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People

Start date: July 14, 2021
Phase: Phase 1
Study type: Interventional

NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly). This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body. Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle. The study will last for about 17 - 21 weeks.

NCT ID: NCT05126511 Completed - Anxiety Clinical Trials

Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19

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

The aim of the study is to investigate the effect of cranial electrotherapy stimulation (CES), for one hour a day over 3 weeks pulmonary rehabilitation (PR) program on symptoms of anxiety in post-Covid patients.

NCT ID: NCT05126407 Completed - Sinusitis Clinical Trials

A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage

Start date: December 17, 2021
Phase:
Study type: Observational

The purpose of this study is to proactively collect customer feedback on the performance aspects and risk factors of Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray.

NCT ID: NCT05124834 Completed - Diabetes Mellitus Clinical Trials

System Accuracy of the Blood Glucose Monitor for Personal Use JT100

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

NCT ID: NCT05124821 Completed - Clinical trials for Central Venous Catheter

Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed

Start date: May 19, 2023
Phase:
Study type: Observational

Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.