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NCT ID: NCT04681001 Completed - COVID-19 Clinical Trials

Prophylactic Treatment With Carragelose Nasal Spary to Prevent SARS-CoV-2, COVID-19, Infections in Health Care Workers

Start date: December 20, 2020
Phase: N/A
Study type: Interventional

This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Treatment will be 3times a day for 84 days one puff into each nostirl and 3 puffs into mouth. Daily a symptom score will be recorded. The primary objective of the trial is to demonstrate that prophylactic treatment of health care workers managing COVID-19 patients with iota-carrageenan reduces symptoms of SARS-CoV-2 infections as well as infections with other respiratory viruses when compared to a placebo-treated control group.

NCT ID: NCT04677803 Completed - Hemophilia A Clinical Trials

BT200 in Hereditary Bleeding Disorders

Start date: December 14, 2020
Phase: Phase 2
Study type: Interventional

BT200 is a PEGylated aptamer that binds to the A1 domain of human von Willebrand factor (VWF). At low doses, BT200 blocks the clearance of VWF antigen (VWF Ag) from the circulation and causes an increase in concentrations of both VWF Ag and Factor VIII (FVIII), but has negligible effect on the activity of either. At higher doses, BT200 blocks clearance of VWF and also inhibits its activity, but still does not inhibit FVIII activity. Therefore, low dose BT200 could potentially be used to correct deficiency of VWF and/or FVIII in patients with hereditary bleeding disorders. This study is designed as a "basket design" pilot study to determine the relevant dose and pharmacological activity of BT200 in such patients. In this open basket study up to 25 patients with the following congenital blood-clotting disorders are to be included: Patients with hemophilia A, heterozygous carriers of hemophilia A with subnormal FVIII levels; patients with von Willebrand syndrome (VWD) type 1, "Vicenza type", and with VWD type 2b. Participants will receive BT200 subcutaneously on day 0, day 4 and day 7 in the first week and then once a week for a total of five weeks - initially in a dose of 3 mg, then in week 3 individually after response in a dose of 3 to 9 mg. Subsequently, blood samples are taken once a week for a further three weeks (wash-out phase). Patients may be enrolled in an additional pharmacokinetics sub-study. For this purpose, approximately three blood samples are taken to estimate the half-life of substituted FVIII under the influence of BT200. The primary objective of this study is to obtain clinical proof of mechanism for BT200 in one or more hereditary bleeding disorders.

NCT ID: NCT04677543 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ARISE
Start date: December 22, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.

NCT ID: NCT04676945 Completed - Clinical trials for Myelodysplastic Syndromes

Analysis of Risk in MDS Over Time - Comparison of Treated vs Untreated Patients

Start date: August 21, 2020
Phase:
Study type: Observational

A comparison of treated vs untreated patients with MDS with a sample size of approximately 8000 patients in 11 countries.

NCT ID: NCT04675957 Completed - Heart Failure Clinical Trials

Cardiac Rehab Retrospective Review (CR3)

CR3
Start date: February 1, 2021
Phase:
Study type: Observational

All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients. Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.

NCT ID: NCT04672135 Completed - Alzheimer Disease Clinical Trials

A Phase 1 (First in Human) Randomized, Double-blind, Placebo-controlled SAD, MAD Study With Oral REM0046127

Start date: November 9, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1 randomized double blind, first in human (FIH) study with the novel oral Alzheimer drug candidate REM0046127, which consists of two main parts, a single ascending dose (SAD) study with 7 cohorts followed by a multiple ascending dose (MAD) study with 2 cohorts.

NCT ID: NCT04664868 Completed - Faecal Incontinence Clinical Trials

SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Start date: August 1, 2018
Phase:
Study type: Observational

Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.

NCT ID: NCT04662827 Completed - Pain, Acute Clinical Trials

The Effect of Palmitylethanolamide on Central and Peripheral Sensitization After Heat-induced Hyperalgesia

Start date: February 9, 2020
Phase: N/A
Study type: Interventional

This planned study is based on a randomized, placebo-controlled cross-over design. Palmityhlethanolamide (PEA) is an endogenous fatty acid amide from the group of N-Acetylethanolamides, which analgesic, anti-inflammatory and neuroprotective effects can be attributed to this. In clinical studies, PEA has mainly been used as an adjuvant in pain therapy. The previous data show clinical efficacy without conclusions that can be drawn about the underlying mechanisms - these have not yet been investigated in a human experiment. The planned study, which demonstrates the mode of action of PEA using an established pain model on healthy volunteers, will help to assign the efficacy to peripheral or central nervous systems. These mechanisms allow to establish mechanism-oriented therapy approaches. These findings are essential for a better understanding of the clinical efficacy and to evaluate the correct fields of application.

NCT ID: NCT04660721 Completed - Hemostasis Clinical Trials

A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

Start date: May 12, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.

NCT ID: NCT04660305 Completed - Clinical trials for Diabetes Mellitus, Type 1

AT278 and NovoRapid® in Glucose Clamp Study

Start date: December 2, 2020
Phase: Phase 1
Study type: Interventional

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.