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NCT ID: NCT03972891 Withdrawn - Clinical trials for Speech Sound Disorder

Influence - Intervention Break - Children - Speech Sound Disorders

Start date: February 2024
Phase: N/A
Study type: Interventional

Many of the children with speech and language disorders have speech sound disorders. In German-speaking countries, it is estimated that around 16% of children between the ages of three and eight are affected by school entry. The treatment of speech sound disorders aims to enable the transfer of the learned into spontaneous speech. The purpose of this study is to ascertain, whether children, by means of a break in therapy, succeed in transferring, the target phoneme or target consonant cluster - from a certain threshold - to spontaneous language. The researchers compare the effect of the transfer to spontaneous speech situations by means of a twelve-week break from therapy with a continuous therapy. In addition, the researchers would like to find out whether the acquisition of the grapheme has an additional positive influence on the generalization of the target phoneme or target consonant cluster in spontaneous speech situations. The researchers also seek to understand individual differences in the generalization effects on the production of the target phoneme / target consonant cluster in spontaneous speech situations, in which the researchers document and evaluate information on the treatment method and treatment duration before the therapy break.

NCT ID: NCT03955796 Withdrawn - Cataract Clinical Trials

Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design

Start date: May 9, 2019
Phase: N/A
Study type: Interventional

Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric

NCT ID: NCT03933657 Withdrawn - Clinical trials for Peripheral Arterial Occlusive Disease

Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs

PROSPECTORII
Start date: December 30, 2022
Phase: N/A
Study type: Interventional

This study aims at assessing additional performance characteristics of the SoundBite™ Crossing System with regards to the luminal passage of complex Chronic Total Occlusions (CTO) by evaluating clinically relevant efficacy, safety, cost benefit and treatment pathway endpoints.

NCT ID: NCT03924063 Withdrawn - Rotator Cuff Tear Clinical Trials

Safety of the Hemiverse Shoulder Prothesis

Hemiverse
Start date: May 14, 2021
Phase: N/A
Study type: Interventional

This clinical trial investigates the safety and the preliminary clinical benefit of the hemiverse shoulder prosthesis. Implantation of this newly developed hemi-prosthesis is intended for patients who do not qualify for a regular reverse or hemi-prosthesis due to severe medical conditions, poor bone stock or critical status of the rotator cuff. The expected benefit is, that patients will have a minimally invasive surgical procedure, only addressing the humeral shaft, however with the biomechanical advantage of a total reverse shoulder prosthesis, meaning, that with a minimally invasive surgery a comparable result as with a regular total shoulder prosthesis is accomplished. Patients will be closely monitored within the study protocol for 18 months and thereafter in regular interval was as with a normal prosthetic followup.

NCT ID: NCT03829215 Withdrawn - Cardiac Arrest Clinical Trials

Prehospital Non-invasive Cooling of Comatose Patients After Cardiac Arrest

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

Single centre randomized controlled two arm clinical trial of patients after out of hospital cardiac arrest with return of spontaneous circulation. The trial objective is to investigate external cooling of cardiac arrest patients after cardiac arrest with the CAERvest cooling device. After checking inclusion and exclusion criteria and immediately after return of spontaneous circulation, the CAERvest device will be filled and placed on the supine patient's chest. A recording oesophageal temperature probe will be inserted and connected to the defibrillator. Then the patient will be transported to the Emergency Department. After admission to the emergency department, an additional endovascular cooling device will be placed and the patient will be cooled to 33°C for 24 hours (starting after reaching the target temperature range of under 34°C) with the endovascular cooling device. Then the patient will be rewarmed at 0.25 °C/h. The CAERvest device will be removed, when a temperature below 34°C is reached. After rewarming, the temperature will be controlled to be below 37.5°C for until 48 hours after cardiac arrest. After this time point pyrexia (core temperature above 37.5°C) will be treated with common pharmaceutical measures. Sedation, analgesia and relaxation will be discontinued at 36.5°C. Neurologic evaluation will be started not before 72 hours after cardiac arrest with a predefined evaluation protocol. During follow up the following secondary outcomes will be recorded: Survival to hospital discharge, survival to 30 days, survival to 6 months, best neurologic function within 30 days, best neurologic function within 6 months, and quality of life at 6 months.

NCT ID: NCT03761511 Withdrawn - Friedreich Ataxia Clinical Trials

Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich Ataxia

NICOFA
Start date: April 2023
Phase: Phase 2
Study type: Interventional

Friedreich ataxia is the most frequent early-onset autosomal recessive hereditary ataxia. It is caused by a pathological expansion of a GAA repeat in the first intron of the frataxin gene (FXN) and results in decreased levels of FXN protein. FXN deficiency results in a relentlessly progressive neurodegenerative condition which frequently presents around puberty. Patients gradually lose coordination, become dysarthric and are frequently wheel-chair bound as adolescents. There is no disease modifying therapy and many patients die prematurely of cardiomyopathy. It was subsequently found that the FXN gene is silenced at the chromatin level by the formation of heterochromatin and that this heterochromatin formation can be antagonized by histone deacetylase inhibitors (HDACi) (Chan et al., 2013). A recent proof-of-concept clinical study on ten patients with Friedreich ataxia demonstrated that FXN levels can be restored to those seen in asymptomatic carriers using the class III HDACi nicotinamide at a dose that is well tolerated by patients (Libri et al., 2014). Since carriers are asymptomatic, this degree of restoration of FXN expression might be expected to halt disease progression. Nicotinamide readily crosses the blood brain barrier and has previously been given at high doses for long periods to normal individuals without serious adverse effects (Gale et al., 2004; Knip et al., 2000). This study will be the first to provide clinical evidence for the efficacy and safety of nicotinamide in patients with Friedreich´s ataxia.

NCT ID: NCT03675438 Withdrawn - Presbyopia Clinical Trials

Safety and Efficacy of a Sub-epitheilal Transform™ Corneal Allograft (TCA) for Presbyopia Correction

Start date: October 2018
Phase: N/A
Study type: Interventional

The objective of this clinical study is to evaluate the safety and effectiveness of subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.

NCT ID: NCT03671096 Withdrawn - Hyperopia Clinical Trials

Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction

Start date: October 2018
Phase: N/A
Study type: Interventional

The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TCA for improving distance vision in hyperopic subjects. The overall objective with respect to visual outcome is to provide improved vision without the requirement of additional visual aids.

NCT ID: NCT03575741 Withdrawn - Concussion, Brain Clinical Trials

Postural Control in Children and Adolescents After Suffering From a Concussion

Start date: October 8, 2018
Phase:
Study type: Observational [Patient Registry]

Sport-related concussions occur during different types of sport and are still an underestimated brain injury. Especially children are affected due to their lacking movement control and thereby at higher risk of situations leading to concussion. However, research about the rehabilitation of balance and coordination in children after sustaining a concussion is lacking. Therefore, the return-to-sport question cannot be answered reliable due to the missing understanding of the underlying mechanisms disturbing coordination, yet. Analyzing postural control, meaning the ability of the body controlled by the brain to maintain balanced, is suggested to be a valid method to investigate movement coordination. A newer method to analyze postural control using reflective marker data will be used to study the rehabilitation process. The findings may help to improve concussion treatment and give implication to the return-to-sport decision. The investigators expect to see an altered postural control after sustaining a concussion visible in the movement amplitude especially short after the injury. Moreover, the researchers assume coordination patterns which are not visible to be altered for an extended time period of up to 30 days as well. Participants will be children aged 10 to 16 years and the aim is to recruit 30 children and adolescents who suffer from a concussion. The data of the concussed participants will be compared with data of healthy volunteers.

NCT ID: NCT03417037 Withdrawn - Lung Cancer Clinical Trials

An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

Start date: May 24, 2018
Phase: Phase 3
Study type: Interventional

This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.