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NCT ID: NCT04138485 Withdrawn - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Start date: December 20, 2019
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

NCT ID: NCT04048187 Withdrawn - Hearing Loss Clinical Trials

Quality Control of CE-Certified Phonak Hearing Aids - 2019_23

Start date: August 20, 2019
Phase: N/A
Study type: Interventional

Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibiltiy studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interpendency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a pre-validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

NCT ID: NCT04013698 Withdrawn - Brain Injuries Clinical Trials

Influence of Respiratory Mechanics on Brain-specific Monitoring in Brain-injured Patients

ABIVENT
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Increase in intracranial pressure (ICP) could be associated with increase in positive end-expiratory pressure (PEEP) level. Data are however disparate and interactions between ventilation with high PEEP and intracranial circulation are still debated. Individual patient's chest wall elastance could have a key role in determining the effects of PEEP on ICP, since it dictates which proportion of the applied PEEP is transmitted to the pleural space, thus increasing central venous pressure (CVP) and reducing cerebral venous return. Measurement of esophageal pressure with a dedicated probe allows partitioning of respiratory system elastance into its lung and chest wall components, thus permitting to study this phenomenon. Multimodal intracranial monitoring permits to study the effects of PEEP on more advanced brain-specific indices such as brain tissue oxygen (PtiO2), cerebral microdialysis data, transcranial doppler ultrasound-derived flow measurements and automated pupillometry, besides ICP. This study aims to test the association between the ratio of chest wall to respiratory system elastance and PEEP-induced variations in ICP and brain-specific multimodal monitoring indices. This study will evaluate the relative role of other selected measures of respiratory mechanics, hemodynamic variables and intracranial compliance, in order to establish the role of individual respiratory mechanics in the interplay of physiological factors affecting the effects of positive pressure ventilation on the brain. Patients will undergo two periods of ventilation at two different levels of PEEP (5 and 15 cmH2O) in a randomized cross-over order. At the end of each period, cardiorespiratory clinical data, ICP and other advanced multimodal neuromonitoring data (brain tissue oxygen tension, cerebral microdyalisis analytes, transcranial doppler ultrasound and automated infrared pupillometry data) will be collected. Systematic respiratory mechanics assessment (including calculation of chest wall and lung elastances and estimation of the amount of recruitment versus overdistension due to PEEP by means of a single-breath derecruitment trial), echocardiography and arterial blood gas analysis will be performed.

NCT ID: NCT03962608 Withdrawn - Clinical trials for Non-Alcoholic Steatohepatitis

Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis

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

Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH. The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes. Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria. Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo). The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan. 70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

NCT ID: NCT03939650 Withdrawn - Decision Making Clinical Trials

Diagnosis Assessment With Diaana #3

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

Single-center, unblinded, 2:1 parallel pseudo-randomized efficacy trial. In the intervention group only, resident physicians will be assisted by the automated medical history-taking device "Diaana" during their consultations in outpatient ambulatory unit of the Geneva University Hospital. In both groups, the differential diagnosis of the resident physician will be compared to the gold-standard diagnosis of the senior physician.

NCT ID: NCT03932630 Withdrawn - Diabetes Clinical Trials

Looping Whilst Restricting Carbohydrates

LINEAR
Start date: December 2019
Phase: N/A
Study type: Interventional

To investigate the efficacy, safety and utility of hybrid closed-loop glucose control during a low carbohydrate vs. iso-energetic balanced diet in individuals with type 1 diabetes.

NCT ID: NCT03896451 Withdrawn - Knee Osteoarthritis Clinical Trials

Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS

Start date: February 2, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS. Primary outcome measures KOOS, Forgotten Knee Score and range of motion. Single-center, randomized trial

NCT ID: NCT03893110 Withdrawn - Spinal Tumor Clinical Trials

Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors

Start date: June 27, 2018
Phase: N/A
Study type: Interventional

Radiation therapy is a cornerstone in the treatment of spinal neoplasms as radical resections are often limited anatomically. Frequently, a surgical stabilization with implants is required. However, metallic implants not only make the CT-based planning of a subsequent radiation therapy more difficult, but might also have an uncontrolled dose modulating effect in adjuvant radiotherapy. At the spine, radiation is limited by the effective dose posed to the relatively radiosensitive spinal cord. While metallic implants might result in an inhomogeneous and uncontrollable dose distribution due to the interface effect, the use of new radiolucent implants consisting of carbon/polyether ether ketone (PEEK) might allow a more homogeneous and predictable dose distribution. This study aims to evaluate the potential benefits of the use of carbon/PEEK pedicle screws during adjuvant radiation therapy and follow-up imaging of spinal tumors. 60 patients will randomized 1:1 into either treatment arm (Pedicle System Carbon/PEEK vs. Pedicle System Titanium). The feasibility of planning the radiation therapy will be evaluated. The postoperatively administered total radiation dose is documented. The radiological visualization of the area of interest will be evaluated The surgical outcome is evaluated by fusion rate, implant integrity and anchorage. Patients will be followed up for 12 months according to local standards.

NCT ID: NCT03851276 Withdrawn - Clinical trials for Multivessel Coronary Artery Disease

A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on MSCT Imaging Utilizing GE Healthcare Revolution CT and HeartFlow FFRCT.

CABGRevolution
Start date: June 28, 2019
Phase: Phase 4
Study type: Interventional

The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Surgical revascularization strategy and treatment planning will be solely based on MSCT (with FFRCT) without knowledge of the anatomy defined by conventional cine-angiography.

NCT ID: NCT03815721 Withdrawn - Clinical trials for Spinal Cord Injuries

Carry-over Effects of Repetitively Applied Transcutaneous Spinal Cord Stimulation on Spasticity

SCS-CorE
Start date: January 7, 2019
Phase: N/A
Study type: Interventional

Spinal cord injury is a devastating condition, causing substantial impairment of vital body functions caudal to the lesion. A major cause of disability stems from spasticity, a common secondary sequelae. Its various clinical manifestations include spasms, clonus, and resistance to passive movements, and often present a major hindrance in rehabilitation, further deteriorate residual motor performance, and negatively impact independence and quality of life. Despite its high prevalence, successful management of spasticity has remained difficult. Standard-of-care treatment modalities are often insufficient or bear the risk of undesirable side effects further accentuating paresis. Epidural stimulation of the lumbar spinal cord via implanted electrodes provides for an alternative approach. It works through modifying the dysregulated neural signal processing of spared spinal circuitry caudal to the injury. Its ameliorative effects on severe lower-limb spasticity have been repetitively reported. Yet, epidural spinal cord stimulation in motor disorders is still off-label, applied in relatively few patients only, also because of its invasive character, the time consuming testing phase for its effective application, and the lack of markers to identify responders in advance. With the development of transcutaneous spinal cord stimulation, a method became available to activate the same input structures to the lumbar spinal cord as with epidural stimulation and hence to induce similar neuromodulatory effects, yet non-invasively, using standard equipment available at rehabilitation centers. A recent proof-of-concept study has shown that a single 30-minute session of transcutaneous spinal cord stimulation controlled various clinical signs of spasticity and augmented residual motor control in spinal cord injured individuals for several hours beyond its application. Further, in one subject, the stimulation was repetitively applied for six weeks, resulting in cumulative therapeutic effects persisting for 10 days after its discontinuation. These observations strongly suggest that the stimulation can induce beneficial neuroplastic adaptations of spared spinal systems and their interaction with residual supraspinal control. The proposed research aims at studying the reproducibility of these findings in a statistically sound cohort of individuals with spinal cord injury and testing the applicability and acceptance of transcutaneous spinal cord stimulation as a home-based therapy.