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NCT ID: NCT04025710 Completed - Syncope Clinical Trials

Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)

Start date: October 17, 2019
Phase: N/A
Study type: Interventional

This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.

NCT ID: NCT04025385 Active, not recruiting - Rehabilitation Clinical Trials

High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study

Start date: July 30, 2019
Phase: N/A
Study type: Interventional

Study with Patients (40-60 participants) above the age of 65. There will be a comparison of regular training on ergometer (10 trainings within 2 weeks, 40 min each) to high intensity interval training on ergometer (6 trainings within 2 weeks, 25 min each). At the beginning and at the end will be a spiroergometer to measure the individual limits and vO2max, which will be compared amongst the two groups. To receive a subjective feedback, there will be a series of questionnaires at the beginning, after one week and at the end. The goal of this study is to get more information about whether a HII-Training is feasible with elderly patients and whether they can profit form it.

NCT ID: NCT04024943 Active, not recruiting - Heart Failure Clinical Trials

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

ASQ
Start date: August 21, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

NCT ID: NCT04024475 Active, not recruiting - Prostatic Neoplasms Clinical Trials

Prostate Cancer Biobank

Start date: November 4, 2014
Phase:
Study type: Observational [Patient Registry]

Carcinoma of the prostate is the second most commonly diagnosed cancer and occurs predominantly in older men - almost two-thirds of those affected are over 65 years of age. In a significant proportion of patients, the disease is harmless and progresses only very slowly. As a result, there is a risk of overdiagnosis and overtreatment. The main diagnostic tool for prostate cancer is the prostate-specific antigen (PSA) test, but its specificity is minimal. It is important to look for other biological characteristics (biomarkers) that provide pointers to the need for a diagnosis and treatment. Even after treatment and in advanced stages of disease, decisions are often difficult, because it is not necessarily clear which patient needs a specific treatment. In this study, a multicenter biobank of patient sera, plasma and tissue is being established together with information of relevance to the disease, in order to provide a basis for the testing of biomarkers. The aim is to identify markers that offer diagnostic and treatment-selective pointers and thus make a decisive contribution to the optimum care of patients.

NCT ID: NCT04024293 Not yet recruiting - Glaucoma Clinical Trials

Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry

Start date: November 2023
Phase: N/A
Study type: Interventional

While elevated intraocular pressure (IOP) is no longer part of the definition of glaucoma it remains the sole proven modifiable risk factor for the onset and progression of glaucoma. IOP is known to vary with the time of day as well as with daily activities. The importance of the nycthemeral IOP pattern for successful management of glaucoma has been well documented, especially for patients who experience visual loss despite apparently normal and/or controlled IOP during office hours. The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, once per hour in the best cases. Since its development in the 50s, Goldmann applanation tonometry (GAT) has remained the gold standard method for measuring IOP, despite its limitations. However, tonometry may be an imperfect method for measuring changes in IOP because it allows only snapshot and non-continuous measurements, it is not physiologic and disturbs the sleep architecture. There have been many efforts in the past decades to search for an ambulatory and frequent method to monitor IOP for 24 hours. In this context, Sensimed AG has recently developed a sensing contact lens-based device intended to measure IOP over 24 hours, the Goldfish (GF). First-in-man data obtained with this device showed agreements between IOP measured by GF and values obtained by standard tonometry in the same eye, comparable to literature results for routinely used tonometry devices. However, this pilot study included 9 subjects only with improvable safety, tolerability and efficacy profiles. The main goal of this study is to assess IOP measurements with the GF and compare the values with those obtained by standard tonometry in patients with open angle glaucoma (OAG) and ocular hypertension (OHT).

NCT ID: NCT04024267 Recruiting - Breast Cancer Clinical Trials

Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients

ERYT
Start date: March 10, 2020
Phase: N/A
Study type: Interventional

Cancer related fatigue (CRF) is the most burdening symptom in breast cancer patients, and prevalence exceeds 75% in patients with metastatic disease. CRF is described as the symptom that has the largest impact on quality of life, with negative effects on work, social activities, and daily activities, and may lead to treatment discontinuation. Currently, there is no gold standard for the treatment of CRF. Drug therapies are not satisfactory. Since physical activity is associated with significant reduction in CRF, patients are encouraged to engage in an at least moderate level of physical activity. However, for many metastatic breast cancer patients this is too burdensome. Finally, there is some evidence that non-pharmacological mind-body techniques may be beneficial in reducing CRF, yet the available data do not allow for final recommendations. Given the high prevalence of CRF and the substantial distress for patients, advancing treatment options for patients with CRF is highly desirable. In the present study, patients with metastatic breast cancer will be randomly assigned to two different non-pharmacological treatments for fatigue: Eurythmy therapy (ERYT), a standardized active mindful movement therapy, or a movement program without mindfulness features (CoordiFit). It will be tested, if ERYT has a superior benefit on fatigue compared to CoordiFit over the period of the intervention (20 weeks). Further, the benefit of ERYT on quality of life, sleep quality, anxiety, depression, pain, mobility of the arm, rate of return to work, compliance with ERYT, and targeted metabolomics will be investigated. Both groups will have equal frequency and duration of the training sessions. Each patient will receive 13 standardized therapy sessions of 45 min (once a week for 6 weeks and once every second week) during the total period of 20 weeks. The proposed study has been developed in the Breast Cancer Project Group of the Swiss Group for Clinical Cancer Research (SAKK) and is supported by many breast centers, because they realize that the patients value non-pharmacological treatment options and would be keen to participate in such a trial. If ERYT proves to be beneficial, the impact of this trial will be high and will have implications not only for metastatic breast cancer patients but also for other cancer patients, health care personnel, scientists and funding and regulatory bodies.

NCT ID: NCT04023552 Active, not recruiting - Clinical trials for Cardiovascular Disease and Lipoprotein(a)

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Lp(a)HORIZON
Start date: December 12, 2019
Phase: Phase 3
Study type: Interventional

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

NCT ID: NCT04023526 Active, not recruiting - Clinical trials for Leukemia, Myeloid, Acute

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

CULMINATE
Start date: July 29, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.

NCT ID: NCT04021732 Completed - Homocystinuria Clinical Trials

Effects of Exercise on Metabolic Parameters in Classical Homocystinuria

Start date: July 1, 2019
Phase:
Study type: Observational

The aim of this research project is to compare the effect of an aerobic exercise session in two different populations. Sampling biological material and collecting health-related personal data entails minimal risks and burdens. Participants will be asked to perform 30 minutes of an aerobic exercise on an ergocycle at a fixed power output to correspond to a moderate intensity for a sedentary population.

NCT ID: NCT04021576 Completed - Athletics Clinical Trials

Fitness- and Health-related Effects of a Sports Injury Prevention Program in Competitive Alpine Skiers

ISPA
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Overall Goal: Elaboration of an evidence-based, national prevention strategy to protect the health of competitive alpine skiers, with a particular focus on youth athletes. Background: Competitive alpine skiing has a relatively high injury risk. 60% of all athletes suffer from a severe knee injury in the early stages of their career, and 20% struggle with recurrent overuse problems of the knee and lower back. Research Aims: (1) to investigate the effects of a 12-month sports injury prevention program on training attitudes, eccentric hamstring strength, leg axis-/hip-/core-stability and general fitness in competitive alpine skiers; (2) to assess the effectiveness the aforementioned prevention program to lower the occurring health problems in competitive alpine skiers; (3) to identify different pain conditions (knee, back, no pain) based on data measured with smartphones; and (4) to investigate the agreement of self-reported questionnaire data with measured smartphone data and pain as an affecting factor. Methods: 12-month intervention a sports injury prevention program, a prospective health- and training/activity-monitoring, as well as assessments of eccentric hamstring strength, leg axis/hip/core stability and general fitness at baseline and follow-up.