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NCT ID: NCT05556863 Completed - Healthy Volunteers Clinical Trials

Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers

Start date: October 18, 2021
Phase: Phase 1
Study type: Interventional

ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Adults.

NCT ID: NCT05543096 Completed - Clinical trials for Coronary Artery Disease

PMCF Study for Cardiology Access Procedures

Start date: May 23, 2022
Phase:
Study type: Observational

This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the procedure and to provide a reasonable enrolment period for the required data to be collected. The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 200 patients who underwent an endovascular intervention within standard-of-care (SOC) where at least 1 of the products (named above) from Cordis US Corp were used.

NCT ID: NCT05540717 Completed - Clinical trials for Seasonal Allergic Rhinitis

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

The PQGrass306 (G306) clinical trial is the pivotal Phase III efficacy clinical trial of PQ Grass. The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak grass pollen season (GPS).

NCT ID: NCT05525000 Completed - Clinical trials for Health Care Utilization

Validity and Reliability of Optical Heart Rate Sensors

ValOpti
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

To evaluate validity and reliability of consumer-grade optical heart-rate devices we aim to compare these devices with medical-grade ECG. The design includes an extended and practical validation protocol for consumer-grade optical heart rate devices in laboratory and ambulatory free-living conditions using a medical-grade ECG device as a criterion measure.

NCT ID: NCT05516771 Completed - Clinical trials for Hypothermia; Anesthesia

Evaluation of a Licensed Double-sensor-heat-flux (DHF) Non-invasive Core Temperature Sensor in Small Children and Toddlers Undergoing Surgery

Start date: October 1, 2022
Phase:
Study type: Observational

Title: Evaluation of a licensed double-sensor-heat-flux (DHF) non-invasive core temperature sensor in small children and toddlers undergoing surgery. CI/PS identification code: DHF-TaSC Device Name: Tcore™ system (Tcore-Adapter MP00999 & Tcore-Sensor MP 00989) Manufacturer: Drägerwerk AG & CO KGaA Study design: Prospective, single arm, clinical study Patients: - Number: 72 - Age / gender: females and males between 0 and 7 years - Patients of a tertiary referral, university-affiliated hospital undergoing surgery Exclusion Criterions: - Operation site, rash or infection that prevents the application of the heat flux thermometers. - Patients and/or legal guardians not willing to participate in the trial. - Patients older than 7 years Setting: ORs of a tertiary referral, university-affiliated hospital. Study variables: measurement triplets measured via two double-sensor-heat-flux (DHF) thermometer the Tcore™ (Dräger, Drägerwerk AG & Co KG, 23558 Lübeck, Germany) one placed on the forehead and one on the upper belly and temperature measured by a rectally placed temperature probe.

NCT ID: NCT05512689 Completed - Clinical trials for Lung-protective Ventilation

Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.

NCT ID: NCT05500040 Completed - Ulcerative Colitis Clinical Trials

Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation

Start date: August 9, 2022
Phase:
Study type: Observational

For many people affected by inflammatory bowel disease (IBD), their quality of life and their ability to participate in their professional and social lives are severely restricted. Rehabilitation measures based on the biopsychosocial ICF model aim to support the restoration of these abilities. Physiological parameters (e.g. biomarkers) as well as patient-reported outcomes (PROs) can be used to assess the success of ICF-based rehabilitation measures and to optimize them. A suitable biomarker to monitor inflammation in IBD patients is faecal calprotectin. In addition, PROs that support patients in providing information, for example on their health-related quality of life or on their subjective ability to work, can provide information on the individual social and occupational participation ability of the patients. The aim of this project is to investigate changes in a biomarker (calprotectin) as well as in selected PROs after a three-week inpatient phase II rehabilitation.

NCT ID: NCT05496842 Completed - Post-COVID-19 Clinical Trials

Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation

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

The aim of this project is to provide insight into the relatively new group of post-COVID patients. On the basis of data collected in routine practice, function- and participation-related patient characteristics of post-COVID patients are first described descriptively. Subsequently, the extent to which selected function- and participation-related parameters change following a pneumological phase II rehabilitation in this group of patients is investigated. Furthermore, the extent of these possible changes will be compared between post-COVID patients who received respiratory muscle training and post-COVID patients who did not receive respiratory muscle training. Patients were not randomized but assigned to conditions based on medical criteria (e.g., initial respiratory muscle strength). The present project provides insight into participation- and function-related characteristics of a relatively new patient population, enables the observation of changes in these following pneumological phase II rehabilitation and provides differentiated insights into the course of health-related parameters for specific subgroups (respiratory muscle training vs. no respiratory muscle training).

NCT ID: NCT05494892 Completed - Clinical trials for Conditions Influencing Health Status

Development of a Research Agenda for Rehabilitation Research

Start date: April 1, 2021
Phase:
Study type: Observational

An internal research department was established in the course of an organisational reform of the Pension Insurance Institution in 2020 for the evidence-based development of its own services in Austria. The focus is on the transfer of findings into practice and the scientific community. As part of an initial assessment of the current situation, an organisation-specific research agenda is being systematically developed. The project design is based on a multi-perspective and multi-method approach. After obtaining experts' opinions (interview) from different settings and areas, a consensus on necessary fields of action will be worked out after synthesising the results via a Delphi survey.

NCT ID: NCT05493306 Completed - Oncology Clinical Trials

Evaluation of Telerehabilitation Following Inpatient or Outpatient Rehabilitation Phase II

Start date: April 8, 2021
Phase:
Study type: Observational

Telerehabilitation is implemented in the Pensionsversicherungsanstalt (PVA) as an independent rehabilitation offer following a rehabilitation phase II. This offer primarily includes physiotherapeutic training units in group settings and in individual counselling, as well as health-related educational sessions and doctor's consultations via video conferencing, initially for rehabilitation patients with diseases of the musculoskeletal system or oncological diseases. The first stage of the implementation process was evaluated with a focus on acceptance, usability and feasibility from the perspective of patients and treatment team. The evaluation was based on a convergent mixed methods design (Creswell & Plano Clark, 2017) to draw on the strengths of qualitative and quantitative research approaches (Creswell & Creswell, 2018). Qualitative and quantitative data were generated in parallel and treated equally. The perspective of the patients (N = 86) was collected through online questionnaires and in-depth telephone interviews (N = 22) and that of the treatment team through a questionnaire survey (N = 32) and focus group interviews (N = 24). The administrative team (N = 8) was asked for their assessment in a focus group interview. Technical difficulties in the implementation of telerehabilitation were documented by the treatment team. The consolidation of these multi-perspective results took place at the level of interpretation.