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NCT ID: NCT04356560 Completed - COVID-19 Clinical Trials

COVID-19 Surveillance of Patients and Healthcare Workers in a Hospital Department

Start date: March 23, 2020
Phase:
Study type: Observational

Doctors, nurses and staff members of ear-nose and throat (ENT) departments are at high risk due to aerosol-inducing diagnostic procedures and surgery during the COVID-19 epidemic. Reports from China, Spain, Italy and England report of fatal cases among ENT specialists. With a concurrent lack of personal protection, it is of paramount importance to identify patients and healthcare workers at an early stage to prevent a COVID-19 outbreak in the department. A baseline study of all healthcare workers has been performed. Follow-up will be accomplished by interval testing, antibody measurements and REDcap Covid-19 questionnaires. All patients at risk of carrying SARS-CoV-2, or who are candidates for high-risk airway surgery will be tested. Infection control measures at the department will be implemented progressively according to the real-time surveillance results from both patients and healthcare workers.

NCT ID: NCT04354948 Completed - Pain Clinical Trials

Influence of Pain on Exercise-induced Hypoalgesia

Start date: June 19, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate how acute pain induced by hypertonic saline prior to exercise influence the magnitude of exercise-induced hypoalgesia after a 3 min isometric wallsquat exercise in healthy subjects. The study is a single blinded (investigator) randomized cross-over trial The results from the study may be of great importance to the understanding of exercise-induced hypoalgesia, and whether the presence of pain affects the effects of exercise.

NCT ID: NCT04354584 Completed - COVID-19 Clinical Trials

Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19

COV2ICU-DK
Start date: April 6, 2020
Phase:
Study type: Observational

The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.

NCT ID: NCT04353817 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes

Start date: June 19, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).

NCT ID: NCT04351581 Completed - Covid-19 Clinical Trials

Effects of Discontinuing Renin-angiotensin System Inhibitors in Patients With and Without COVID-19

RASCOVID-19
Start date: May 18, 2020
Phase: N/A
Study type: Interventional

Recent data from some of the earliest and worst affected countries of COVID-19 suggest a major overrepresentation of hypertension and diabetes among COVID-19-related deaths and among patients experiencing severe courses of the disease. The vast majority of patients with hypertension and/or diabetes are taking drugs targeting the renin-angiotensin system (RAS) because of their blood pressure-lowering and/or kidney-protective effects. Importantly, the virus causing COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) binds to the transmembrane protein angiotensin converting enzyme 2 (ACE2) - an important component of RAS - for host cell entry and subsequent viral replication. ACE2 is normally considered to be an enzyme that limits airway inflammation via effects in RAS and increased ACE2 activity seems to alleviate acute respiratory distress syndrome (ARDS). Importantly, evidence from human studies as well as rodent studies suggests that the inhibition of RAS by angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) leads to upregulation of ACE2, and treatment with ARB leads to attenuation of SARS-CoV-induced ARDS. This is of interest, as the vast majority of deaths from COVID-19 are due to ARDS and expression of ACE2 has previously been shown to be reduced by the binding of SARS-CoV to ACE2. Thus, ACE inhibitors and ARBs have been suggested to alleviate the COVID-19 pulmonary manifestations. In contrast to these notions, concern has been raised that ACE2 upregulation (by RAS-inhibiting drugs) will multiply the cellular access points for viral entry and might increase the risk of severe progression of COVID-19. The multiplied viral entry points could perhaps explain the alarmingly high morbidity and mortality among COVID-19 patients with diabetes and/or hypertension. Thus, a delineation of the role of RAS for the course of COVID-19 is of crucial importance for the management of COVID-19 patients. Aim: This randomised clinical trial will investigate whether to continue or discontinue treatment with ACE inhibitors or ARBs in hospitalised patients with COVID-19.

NCT ID: NCT04350749 Completed - Tooth-loss Clinical Trials

The Use of Platelet-rich Fibrin (PRF) Membranes in Lateral Alveolar Ridge Augmentation When Jaw Bone is Missing Before Dental Implant Installation. A Study Comparing an Autogenous Bone Block Graft Covered Either by a (PRF) Membrane (Test) or Bone Substitute and a Barrier Membrane (Control)

Start date: January 15, 2015
Phase: Phase 4
Study type: Interventional

Tooth loss can in many cases be treated with an artificial titanium root (dental implant) and subsequent manufacture of a porcelain crown. After the tooth is lost bone resorption of the existing jaw bone often occurs making implant placement difficult. Therefore, bone augmentation is often necessary before implant placement. Six months after the bone augmentation has been performed, the implant can be inserted into the jaw bone and after additionally 6 months the final porcelain crown can be mounted. Reconstruction of the jaw bone is often done by harvesting a bone block from the patient's own jaw. The bone block is harvested typically from the posterior part of the lower jaw, where after it is placed and fixated by screws in the part of the jaw where the bone is missing. Finally, the bone graft is covered with artificial bone substitute and a collagen membrane. Recent studies have suggested that adding platelet-rich fibrin (PRF) membranes will have an advantageously effect in reconstruction of the jaw bone and bone healing. PRF membranes are derived from a blood sample of the patient and has been introduced to accelerate soft tissue as well as bone healing. No comparative studies have been conducted in humans for the time being evaluating the effect of PRF in conjunction with bone augmentation. Therefore, the purpose of this study is to compare a control group with a test group in which the control group is treated in a standardized manner, while PRF is added to the bone graft in the test group. After 6 months of bone healing, a dental implant can be inserted in both groups using a standard technique. For the two groups, the following is examined: 1. The final treatment outcome of the dental implant focusing on clinical outcome, radiologic outcome, aesthetic outcome, patient satisfaction. 2. Bone changes over time with a focus on volume changes. In addition, focus on soft tissue healing. 3. Bone healing assessed using bone biopsies taken in connection with the implant installation. All included patients is missing a tooth where bone augmentation is needed before an implant can be inserted. A general study is conducted and patients are randomly assigned to a control group (20 patients) and a test group (20 patients). The control group is treated with a standard bone augmentation procedure. This is done in local anesthesia, where initially a bone graft is removed from the back of the lower jaw. The gingiva corresponding to the toothless area is loosened and the bone graft is fixed with 2 titanium screws before being covered with a artificial bone substitute and a membrane to protect the bone graft during the healing period. The test group is treated in the same way, however, a PRF-membrane is used instead of the bone substitute material and the membrane. The PRF-membrane is prepared by taking a blood sample from the arm (80 ml) as with a regular blood sample. The blood is centrifuged, which transforms the blood into a platelet-rich membrane. Thus, the membrane is produced 100% natural without any additives. However, the membranes contain growth factors that have the potential to promote mucosal and bone healing. In both groups, common penicillin (Amoxicillin / Clavulanic acid, 1000/250 mg) and painkillers (Ibuprofen, 400 mg x 4, supplemented with Panodil 1000 mg x 4) are given before surgery. After six months, the dental implant is inserted using standard procedure in both groups. The gingiva is set aside and perpendicular to the bone grafted area, a cylindrical bone tissue biopsy (2 mm in diameter, approximately 8 mm long) is taken containing the applied bone graft and the original jaw comb (for study 3). Then the previously inserted 2 titanium screws are removed and the implant is inserted. After another six months, the final porcelain crown is made. The implant is exposed and a healing cap is applied. After 2-3 weeks, the gum is healed, after which the final impression is made to the crown, which the patient will have installed 1-2 weeks after. The bone augmentation procedure, the implant installation and manufacturing of the porcelain crown are characterized by minimal risks and complications. In bone augmentation, there is minimal risk of altered sensation similar to the lower lip. It is typically of a temporary nature but can be permanent in very rare cases. The implant operation, including subsequent crown manufacturing, is performed in both groups by a standardized procedure, which is also characterized by minimal risk of side effects and complications. Thus, numerous studies have shown that implant treatment is characterized by a high implant survival of approx. 95% after 10 years. As part of the treatment, a total of 3 scans of the jaw (for study2) as well as 3 ordinary dental films are made for assessment of the jaw bone volume and as a control of the bone around the implant. This radiation dose equals approximately 60 days of background radiation in Denmark.

NCT ID: NCT04349566 Completed - Clinical trials for Becker Muscular Dystrophy

Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases

Start date: June 1, 2020
Phase:
Study type: Observational

The purpose of the study is to explore the biomarker Fast Troponins response to exercise in patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease

NCT ID: NCT04348305 Completed - Covid-19 Clinical Trials

Hydrocortisone for COVID-19 and Severe Hypoxia

COVID STEROID
Start date: April 17, 2020
Phase: Phase 3
Study type: Interventional

We aim to assess the benefits and harms of low-dose hydrocortisone in patients with COVID-19 and severe hypoxia.

NCT ID: NCT04346186 Completed - COVID Clinical Trials

COVID-19: Investigation of Transmission and Immunisation Among Hospital Staff

Start date: April 15, 2020
Phase:
Study type: Observational

During the COVID-19 pandemic several countries have seen a high risk of transmission for health care personnel, with some countries having as many 20-25% of nurses and doctors either infected or showing symptoms of COVID-19. In this prospective cohort study, we will systematically screen all hospital staff in the Capital Region of Denmark for IgM and IgG antibodies against SARS-CoV-2 using a point of care tests and an Elisa kit. Testing will be offered 3 times: In April 2020, Maj 2020 and September 2020. All participants will submit a questionnaire regarding exposures, risk factors and symptoms of COVID-19 in relation to each testing. Follow-up will be through electronic patient records and national registries. We will compare the group of health care personnel with data from a control group of healthy volunteer blood donors from the Danish Blood Donor Study. The aim of the study is to investigate the proportion of hospital staff with SARS-CoV-2 antibodies during the study period compared to a control group representing the Danish population. We will compare the test characteristics of the two methods of testing, a point of care test and Elisa. Further, we will investigate the extent to which prior immunization or infection is protective for future infection with COVID-19.

NCT ID: NCT04339985 Completed - Atopic Dermatitis Clinical Trials

Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD

Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis