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NCT ID: NCT03375034 Recruiting - Neuropathic Pain Clinical Trials

Exploring the Role of the GABAergic Modulation in Pain Transmission in Human

NDMC-101
Start date: March 30, 2017
Phase: Phase 1
Study type: Interventional

Neuropathic pain affects about 7% of the general population in European countries. Meta-analyses indicate that only a minority of neuropathic pain patients has adequate response to drug therapy and management of neuropathic pain is still an unmet medical need. New insights into the contribution of defined subtypes of GABAA receptors (GABAARs) to the different clinical effects of benzodiazepines, including analgesia, have suggested that α1-sparing selective benzodiazepines, such as N-desmethylclobazam (NDMC), may be a new realistic alternative for the treatment of neuropathic pain. Results from our previous study in healthy volunteers assessing the antihyperalgesic and sedative effects of benzodiazepines on a UVB-induced pain model of central sensitization showed that, at the time of maximum effect, clobazam and clonazepam antihyperalgesic effect was greater than placebo by respectively 15.7% (95% CI 0.8 - 30.5) and 28.6% (95% CI 4.5 - 52.6), p<0.05. Moreover difference in sedation (VAS), as compared to placebo, was only significant for clonazepam 26.3mm (95%CI 15.0-37.7), p<0.001. Our preclinical data also demonstrate that, in recombinant receptors, NDMC has a better α2- over α1GABAARs activity ratio than clobazam and diazepam. And, unlike diazepam, NDMC caused no or modest sedation at antihyperalgesic doses in two strains of wild-type mice. In addition NDMC α2/α1 in vitro activity profile and long term clinical experience from its marketed parent compound (clobazam) make it an advisable clinical candidate for further proof-of-concept assessments in human. Therefore the Geneva University Hospitals have manufactured a new chemical entity and initiated a drug development program for NDMC starting with this proof-of-concept phase 1b randomized double-blind crossover (4 arms) study that will assess the analgesic and sedative effects of NDMC 20mg and 60mg compared to clonazepam 1.5 mg or placebo on a UVB-induced erythema pain model in healthy volunteers.

NCT ID: NCT03370094 Recruiting - Stroke, Acute Clinical Trials

Tele-Stroke: Prehospital Identification of Patients With Suspected Stroke Using Onsite Mobile Telemedicine - Feasibility

Tele-Stroke
Start date: August 23, 2017
Phase: N/A
Study type: Observational

Observational Study to investigate the technical feasibility, implementation into current diagnostic and treatment pathways and the diagnostic accuracy of the remote patient assessment by using mobile telecommunication ahead of hospitalization.

NCT ID: NCT03369470 Recruiting - Multiple Sclerosis Clinical Trials

App Based Dexterity Training in Multiple Sclerosis

AppDext
Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the most common cause of non-traumatic disability in young adults (Kamm et al. 2014; Vanbellingen & Kamm, 2016). It is a heterogeneous disease, which is associated with long-term disability, leading to reduced quality of life (QoL). Disease-modifying pharmacological therapies (DMT) decrease activity and progression of the disease, and symptomatic pharmacological treatments reduce complaints to a certain extent, however MS patients often still suffer from various neurological deficits during the course of their disease (Kamm et al. 2014). Consequently, specific non-pharmacological therapies are needed in order to further reduce disability, eventually resulting in better QoL (Lamers et al. 2016; Vanbellingen & Kamm, 2016). Impaired dexterity is a frequently observed impairment, affecting up to 76% of patients with MS (Johannson et al. 2007). The different neurological deficits caused by MS, such as ataxia, spasticity, sensory-motor deficits, and apraxia may be alone or in combination, impair manual dexterity (Kamm et al. 2012; Heldner, Vanbellingen et al. 2014). MS patients experience impairments in the performance of several activities of daily living (ADL), such as grooming, cooking, etc. Sometimes these problems are even associated with loss of work, and lack of social integration (Chruzander et al. 2013). The effectiveness of the app based exercises still needs to be proven. With respect to dexterity, a first new app has been developed called "Finger Zirkus", by a team of experts including an occupational therapist, graphic designer, and IT expert. The app is already available to be downloaded from google play store or apple store (see for more details: www.fingers-in-motion.de).

NCT ID: NCT03369340 Recruiting - Pharmacokinetics Clinical Trials

Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

Start date: November 7, 2017
Phase: N/A
Study type: Interventional

This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants, following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product acceptance and product use.

NCT ID: NCT03369288 Recruiting - Vertebral Fracture Clinical Trials

Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up

Start date: December 5, 2017
Phase: N/A
Study type: Interventional

3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.

NCT ID: NCT03367221 Recruiting - Clinical trials for Ventilator-Induced Lung Injury

Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist

TRANS-NAVA
Start date: November 23, 2017
Phase: N/A
Study type: Interventional

Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode that could allow to adopt this strategy. Aim of the study is to assess the feasibility of NAVA in the early post-LTx phase and to describe the breathing pattern and the physiological relationship between neural respiratory drive and different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback.

NCT ID: NCT03365440 Not yet recruiting - Atrial Fibrillation Clinical Trials

Esophageal 3D Mapping System for Cardiac Arrhythmias

esoECG-3D
Start date: December 2017
Phase: N/A
Study type: Observational

The aim of the study is to develop and validate a novel esophageal mapping system to improve the diagnostics of cardiac arrhythmias. Using a newly designed esophageal ECG catheter, esophageal ECGs (eECGs) will be recorded in 40 patients during an electrophysiological (EP) study and/or ablation procedure and in 12 healthy volunteers. In parallel acquired intracardiac electrograms will serve as reference for the developed mapping systems accuracy. Additionally, the esophageal mapping system will be compared to that of the standard 12-lead surface ECG in regard to its diagnostic performance.

NCT ID: NCT03362359 Recruiting - Prostate Cancer Clinical Trials

Ga-68-PSMA-11 in High-risk Prostate Cancer

Start date: October 9, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 PET/CT imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will be eligible. Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to EAU guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 21 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy. In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.

NCT ID: NCT03361579 Recruiting - Acute Pain Clinical Trials

Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults

POLAP
Start date: November 11, 2017
Phase: N/A
Study type: Interventional

Open Label Placebo application has been shown to be effective in treatment of chronic pain (low back pain) and disease like the irritable bowel Syndrome. Data about effects on acute pain are spare. The study investigates the effect of an open-label Placebo (substance without a medical active component) application on acute pain, evoked via a artificial pain model in healthy male volunteers. 32 healthy male volunteers are recruited.

NCT ID: NCT03361527 Completed - Clinical trials for Sensory Hearing Loss

Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life

Start date: September 1, 2015
Phase: N/A
Study type: Observational

The goal of the study is to determine the benefit in speech intelligibility of the BBF and the MBF compared to an omni-directional microphone in different noise conditions. Secondary objective is to determine if there is a subjective preference for one of the microphone settings in different noise conditions.