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NCT ID: NCT04524364 Completed - Atrial Fibrillation Clinical Trials

A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

inspIRE
Start date: August 23, 2020
Phase: N/A
Study type: Interventional

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

NCT ID: NCT04523220 Completed - Hemodialysis Clinical Trials

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

CONVERT
Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT04509011 Completed - Clinical trials for Hypoparathyroidism Postprocedural

Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

Start date: January 5, 2021
Phase: N/A
Study type: Interventional

The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy

NCT ID: NCT04507724 Completed - Wound Infection Clinical Trials

The Use of Biochemical Analyzes to Monitor the Development of Wounds

NPWW
Start date: October 19, 2018
Phase:
Study type: Observational

Chronic wounds represent a growing challenge in medical care. Part 1: The aim of this part of the study was to collect wound swabs and to answer the question whether the rapid diagnostic tool using enzyme activities can display an infection prematurely. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) measured overed 3 days, would indicate a change in the wound bed (infection, Inflammation) earlier than the regularly performed clinical assessment. Part 2: The aim of this part of the study was to evaluate (I) the possibility of wound fluid acquisition by means of an "additional collector" during ongoing NPWT and to answer if (II) this secretion can be biochemically analyzed for enzyme activities in order to be able to detect a change in the wound situation at an early stage.

NCT ID: NCT04507061 Completed - Clinical trials for Chronic Kidney Disease

Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.

CONCORD
Start date: September 1, 2020
Phase: Phase 2
Study type: Interventional

Researchers in this study want to learn more about the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by the individual patient whose kidneys are not working properly and suffering at the same time from high blood sugar and/or high blood pressure and a disease of the heart and the blood vessels. Runcaciguat is a new drug under development for the improvement of kidney function. It works by activating proteins that helps to dilate blood vessels, including vessels in the kidneys. This can improve blood flow in kidney and may slow down the progression of kidney disease. This dilative effect can also influence the heart rate and blood pressure. Researchers also wants to find the best dose of the drug during the study. Participants in this study will receive either runcaciguat or placebo tablets every morning for 8 weeks. A placebo looks like the study drug but does not have any active medicine in it. On a weekly basis, the dose of the runcaciguat will be increased step by step. In total, participants will visit the doctors about 10 times, and the observation will last for about 16 weeks. Blood and urine samples will collected from the participants.

NCT ID: NCT04504383 Completed - Clinical trials for Ulcerative Colitis Chronic Moderate

PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

Start date: August 5, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).

NCT ID: NCT04501666 Completed - Prurigo Nodularis Clinical Trials

An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

Start date: September 11, 2020
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.

NCT ID: NCT04501432 Completed - Clinical trials for Cardiac Rehabilitation

Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

CODIS
Start date: July 14, 2020
Phase:
Study type: Observational

The current Coronavirus Disease 2019 (COVID-19) pandemic has resulted in extraordinary public health orders of social distancing and self-isolation, leading to widespread disruption and discontinuation of cardiac rehabilitation programmes and other social opportunities for cardiovascular disease (CVD) patients to exercise. In Austria, the government initiated drastic public health measures (national lockdown) on March 16, 2020, leading to closure of all outpatient cardiac rehabilitation facilities and restriction of inpatient rehabilitation to patients with urgent medical indications only. This study aims to explore the impact of COVID-19-related national lockdown and public health restrictions on cardiac rehabilitation patients, with respect to maintenance of physical activity for secondary CVD prevention. The study poses three research questions, which will be addressed in a mixed-methods study with sequential quantitative-qualitative (QUANT-QUAL) design: 1. What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage) 2. What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage) 3. Which insights and learning points may be drawn from patients' experiences during COVID-19 public health restrictions with respect to the provision of home-based digital support for physical activity? (QUAL stage) The study will recruit a cohort of up to 40 cardiac rehabilitation patients from one outpatient cardiac rehabilitation centre in Salzburg, Austria, whose rehabilitation programme was interrupted by COVID-19 public health orders, including "lockdown". Patients will undergo re-assessment of physical fitness in cycle ergometry test and re-assessment of cardiovascular risk profile. This will be compared with patients' most recent available test results from before the COVID-19 lockdown (i.e. prior to mid-March 2020) from patient records. Additionally, patients will take part in a semi-structured qualitative interview in which they will be invited to reflect on their personal experiences during the COVID-19 lockdown and thereafter.

NCT ID: NCT04497597 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis

UPHOLD
Start date: October 16, 2020
Phase:
Study type: Observational

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the treatment patterns, achievement of treatment targets and maintenance of response. Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide. Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months. There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

NCT ID: NCT04492371 Completed - Multiple Myeloma Clinical Trials

COVID-19 Infection and Multiple Myeloma

EMN-COVID
Start date: July 1, 2020
Phase:
Study type: Observational

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.