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NCT ID: NCT04803552 Recruiting - Stroke Clinical Trials

Non-contact Sleep Apnea Identification in Neurological Rehabilitation

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients. The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic. The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI >= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.

NCT ID: NCT04796337 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

SOTERIA
Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

NCT ID: NCT04794023 Recruiting - Myopia Clinical Trials

LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism

AQUARIUZ2020
Start date: March 31, 2021
Phase: N/A
Study type: Interventional

The AQUARIUZ ablation laser is a solid-state laser and has been CE approved for corneal surgery since March 2020 for the treatment of short- and longsightedness with and without astigmatism. The aim of this study is to collect the first clinical data. Safety and performance are examined here. The treatment with AQUARIUZ is comparable to treatments with an excimer laser, with the difference that these are operated with gas. Solid-state lasers and excimer lasers use the same process for tissue ablation, with a small difference in wavelength. This difference manifests itself in the lower involvement of water in the ablation process with the result of a gentler and safer treatment. Similar to excimer lasers for corneal surgery, the AQAURIUZ system (Ziemer Ophthalmic Systems AG) is equipped with a fast eye tracker (eye tracking system) to correct eye movements during the treatment. The shape of the removed portion of the cornea has an aspherical profile corresponding to the state of the art. The primary objective is to assess the safety of use of the AQUARIUZ corneal ablation laser for LASIK procedures in myopia and myopia with astigmatism. The secondary objective is to compare the predicted visual and refractive outcomes of LASIK procedures using the AQUARIUZ Ablation with clinical data. The study is planned in 3 phases to mitigate the inherent risk of a first in man study and to allow for verification and confirmation of the system correction factor at an early stage.

NCT ID: NCT04793438 Recruiting - Anhedonia Clinical Trials

Motive-specific Intervention for Negative Symptoms in Schizophrenia

MoNSS
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to test a therapeutic intervention to reduce negative symptomatic among schizophrenia patients. Since the intervention can take place within an inpatient stay, it is a short intervention. Three appointments are made with the patients within two weeks. With an adaptation of the Autobiographical Memory Test (AMT) participants will be asked to recall events from the past and to imagine future events. Patients are additionally asked to complete tasks between the sessions. One pre- and one post-measurement of negative symptoms, motives, level of functioning, hope for recovery and other co-variables are part of the study. A follow-up appointment four weeks later is intended to provide information on the longer-term impact.

NCT ID: NCT04790370 Recruiting - Pulmonary Embolism Clinical Trials

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

HI-PEITHO
Start date: August 2, 2021
Phase: Phase 4
Study type: Interventional

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

NCT ID: NCT04790266 Recruiting - Cardiotoxicity Clinical Trials

Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients

CARDIOTOX
Start date: September 15, 2020
Phase:
Study type: Observational

To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%) measured on CMR and ECHO over the time window of 12 months from the end of radiation therapy.

NCT ID: NCT04790253 Recruiting - Clinical trials for Extensive-stage Small-cell Lung Cancer

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

PRIMALung
Start date: October 27, 2022
Phase: N/A
Study type: Interventional

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

NCT ID: NCT04788888 Recruiting - Clinical trials for Symptomatic Severe Aortic Stenosis

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

VANTAGE
Start date: June 13, 2021
Phase: N/A
Study type: Interventional

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

NCT ID: NCT04786262 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Start date: March 29, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

NCT ID: NCT04781543 Recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.