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NCT ID: NCT04247438 Completed - Biofilm Clinical Trials

Dentures Biofilm and Artificial Biofilm Substitute

KÜBI
Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The biofilm on oral surfaces can lead to oral diseases. The correlation between oral biofilm and diseases and general health is well known. Therefore, cleaning of teeth or dentures from biofilm is essential for the maintenance of oral and general health. Currently, the society is ageing, the number of elderly as well as home and institutionalized care patients is increasing. In particular, these suffer from higher tooth loss, wear removable dentures and have problems with independent oral and denture hygiene. Therefore, support from well-trained nursing staff or family members is important. The use of suitable artificial biofilm substitutes may be helpful, in order to efficiently and easily perform oral and denture hygiene education, as well as to carry out laboratory tests of oral and denture hygiene products. The absence of such appropriate substitutes for denture biofilm requires innovations in this field. The aim of this pilot study is to verify the feasibility of the study protocol, design and methods. Additionally, an innovative artificial biofilm substitute based on polysaccharides will be further developed. This pilot study includes five study parts. Two in vivo examinations and three in vitro tests. This pilot study creates the basis for further main studies and implements the development of validated artificial biofilm substitutes.

NCT ID: NCT04245995 Completed - Clinical trials for Blood Loss, Surgical

Blood Loss Evaluation Using a Novel Device

Start date: February 5, 2020
Phase:
Study type: Observational

The study´s aim is to evaluate the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario.

NCT ID: NCT04242498 Completed - Clinical trials for Hidradenitis Suppurativa

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

BE HEARD II
Start date: March 2, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

NCT ID: NCT04242446 Completed - Clinical trials for Hidradenitis Suppurativa

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

BE HEARD I
Start date: February 19, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

NCT ID: NCT04240717 Completed - Treatment As Usual Clinical Trials

Shared Decision Making on Immunotherapy in Oncology

PEF-Immun
Start date: February 7, 2020
Phase: N/A
Study type: Interventional

Patients with advanced melanoma are confronted with a serious treatment decision. The current guideline recommends considering the option of immunotherapy with checkpoint inhibitors. The substances approved for this purpose differ greatly in their efficacy and the risk for adverse events. Besides, in about half of the patients with advanced melanoma a BRAF V600 Mutation is found. In these patients, in addition to immunotherapy, treatment with BRAF/MEK inhibitors must be considered. Research on shared decision making suggests that patients achieve greater satisfaction with the decision if they are actively being involved in the decision-making process. To enable them to do so, an interactive, web-based patient decision aid (PtDA) informing about the treatment options for advanced melanoma will be developed and evaluated in a bicentric, prospective randomized controlled clinical trial. The use of PtDA is expected to lead to a higher level of information about the benefits and risks of the various treatment options (primary hypothesis).

NCT ID: NCT04238962 Completed - Obesity Clinical Trials

A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens

Start date: February 3, 2020
Phase: Phase 1
Study type: Interventional

The study will look at how 2 different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide - which version is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

NCT ID: NCT04238663 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

Start date: September 24, 2019
Phase: Phase 1
Study type: Interventional

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

NCT ID: NCT04237129 Completed - Clinical trials for Diabetes Mellitus, Type 1

PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Start date: August 27, 2019
Phase: Phase 1
Study type: Interventional

Primary objective: To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects Secondary objectives: To compare the PK and PD parameters of the three insulin aspart preparations To evaluate the single dose safety and local tolerability of the three insulin aspart preparations

NCT ID: NCT04236895 Completed - Clinical trials for Diabetes Mellitus, Type 1

PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

Start date: July 10, 2018
Phase: Phase 1
Study type: Interventional

Primary objectives: To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins. max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes Secondary objectives: To compare the pharmacokinetic and pharmacodynamic properties of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP) To assess the safety and tolerability of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

NCT ID: NCT04236245 Completed - Clinical trials for Chronic Venous Insufficiency

EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

Start date: May 11, 2020
Phase: N/A
Study type: Interventional

This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).