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NCT ID: NCT04480164 Suspended - Neuropathic Pain Clinical Trials

Evaluation of the Safety and Efficacy of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain

NDMC-201
Start date: June 24, 2020
Phase: Phase 2
Study type: Interventional

Neuropathic pain (NP) affects up to 8% of the general population and its successful management is an unmet medical need. Half of the patients report inadequate response to therapy and unwanted side effects such as sedation and cognitive impairments, limiting drug use in daily practice and significantly accounting for the high incidence of treatment failure. Dysfunction of synaptic inhibition within the spinal cord is known to be one of the main contributing factors to central sensitization that governs NP. Facilitation of GABAergic inhibition in the dorsal horn through GABAA receptors allosteric modulation would be a rational approach to NP management. New insights on the associations between GABAA receptors α subunits and function have opened new perspectives in preclinical research. Data from genetically modified mice demonstrates the possibility, through selective allosteric modulation of the GABAA receptor, to induce its beneficial antihyperalgesic effects without inducing its cognitive and sedative effects. N-Desmethylclobazam (NDMC), clobazam's main active metabolite, demonstrated in vitro and in vivo a high selectivity profile with a clear preference for GABAA α2-subtypes receptors (antihyperalgesia) over α1 receptors responsible for sedative effects across a wide concentration range. Taking into consideration the high prevalence and burden of neuropathic and chronic pain worldwide and the fact that these patients are nowadays left with sedative and only partially effective drugs, NDMC qualifies as a good molecule to seek confirmation of the clinical utility of selective GABAA allosteric modulators in NP patients.The main objective is to assess the efficacy of repeated doses of NDMC on neuropathic pain compared to placebo.

NCT ID: NCT04474587 Suspended - Clinical trials for Resting Energy Expenditure

Resting Energy Expenditure in Patients With OHS Treated With Long-term NIV

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

This study aims to compare, in subjects with obesity-hypoventilation syndrome (OHS) treated by long-term non-invasive ventilation (NIV), resting energy expenditure (REE) in spontaneous breathing and under NIV. The hypothesise of this study is that REE will be lower under NIV than under spontaneous breathing.

NCT ID: NCT04385264 Suspended - COVID-19 Clinical Trials

#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19

#StayHome
Start date: January 2022
Phase: Phase 2/Phase 3
Study type: Interventional

BACKGROUND Despite drastic quarantine measures, COVID-19 continues to propagate and threatens global healthcare systems by saturating their capacity with high transmissibility and the particularly protracted length of stay needed by those requiring intensive care. Indeed, once patients advance to the ICU, prognosis is poor and it is thus critical to test medications that may prevent complications and reduce viral shedding. i.e. to protect ambulatory patients and their families from complications and transmission and allow them to #StayHome. To date, no treatment has been reliably demonstrated as effective in COVID-19 patients. Hydroxychloroquine (HCQ), a common and well tolerated medication, has shown promise in vitro for reducing viral replication (for SARS-CoV-2 as well as other coronaviruses with pandemic potential such as SARS-CoV-1 and MERS). Since then, several small-scale hospital-based clinical studies have indicated the potential for reduced viral shedding and hospitalisation as well as favourable evolution of lung pathology. If started earlier, this treatment could prevent complications requiring hospitalisation and intensive care, which may not be available in low-income countries. Robust clinical trials are required to assess the potential of HCQ in COVID-19. OBJECTIVES This trial assesses the efficacy of early treatment with HCQ in COVID-19 outpatients to reduce the incidence and severity of complications including secondary hospitalisation, ICU admissions, lung pathology and death. Secondarily, this trial will also assess its efficacy to reduce viral transmission among household contacts during self-quarantine. The clinical data collected in this trial will also be critical in creating early prognostication models to better predict healthcare needs and have evidence-based prioritization of resource allocation, which is especially critical in low-resource settings. METHODS The trial will recruit 800 SARS-CoV-2+ patients and their household contacts at triage sites across Switzerland. Patients included are 1) at risk of poor outcome (comorbidities or >65y) and 2) well enough to self-isolate at home. These patients will be randomised 1:1 in HCQ:Placebo and given 6 days of early treatment (within 24 hours of the SARS-CoV-2 test). Intensive pragmatic multiparameter at-home follow-up (including point-of-care lung ultrasound in some sites) will continue until their outcome (resolution, or complications, such as hospitalisation, ICU admission, death). Household contacts will have before and after serological testing and social distancing knowledge and practices questionnaires to assess risk factors for infections. The household attack rate of new-onset infections can then assess the efficacy of HCQ to prevent transmission.

NCT ID: NCT04065685 Suspended - Palliative Care Clinical Trials

A Nurse-led Patient-centred Intervention to Increase Written Advance Directives

anticip@imad
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Background and rationale: Since 2013, with the new Swiss Adult Protection Law, Anticipated Directives (ADs) have been used to identify patients' wills in case they cannot express them later. This instrument is considered to improve care quality, reduce conflicts in decisions between patients, relatives and healthcare teams and utilisation of health resources. Despite their perceived utility, political and institutional campaigns have failed to make ADs common among the population. Discussing life threatening diseases evolution and end-of-life (EOL) issues remains difficult for patients, relatives and professionals. Several interventions were developed to improve advance care planning (ACP) and lead to ADs. However, most of them are cognitively demanding or requiring high levels of literacy. People in 'early stage palliative care' (i.e. with chronic degenerative conditions) could benefit from a simple, adjusted, and acceptable intervention to address the problem outside the hospital setting before the crisis and the appearance of other complications. For a dialogue about EOL to take place, it is necessary to engage in a trustful therapeutic relationship constructed on favourable care conditions. The intervention with a serious card game (Go Wish) is a patient-centred approach developed to help people discuss their wishes of EOL care and to formalize them in ADs. Compared to previous interventions, it has some major advantages: it is accessible (no literacy barriers), it is specific (it is centred on the needs and wishes about care priorities), and it is adaptable depending on how patients feel ready to engage in such discussions. And most important of all, it is compatible with the Terror Management theory (TMT) that provides explanations on reluctance to write ADs and how to work around this problem. The TMT is a theoretical rationale that posits that death thoughts, occurring during EOL care discussions, operates as barriers by creating an existential anxiety and defence mechanisms. From the TMT perspective, it is possible to reduce the perceived health-related anxiety by helping people to become aware of their own death. This can be achieved by facilitating discussions about EOL preferences and on psychosocial, cultural, and spiritual values of life. The Go Wish intervention focuses on these individual's important life dimensions which could reduce anxiety in the process of ACP and ADs completion and alleviate defensive behaviours present in EOL care. Primary objective: To test the efficacy of the Go Wish intervention for increasing the proportion of ADs completed in outpatients receiving early stage of palliative care services compared to usual care (i.e. standardized information on ADs). Secondary objectives: To explore the role that TMT defence mechanisms plays in the process of end-of-life discussions in nurses, patients and relatives (mixed method).

NCT ID: NCT03641963 Suspended - Stroke, Acute Clinical Trials

aICP Measurement in Patients With Cerebral Artery Infarction / aICP MCA Infarction

aICPStroke
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients. It is reported that early hemicraniectomy leads to a substantial decrease in mortality at 6 and 12 months and is likely to improve functional outcome. Thus, this study investigates if non-invasive intracranial pressure (ICP) measuring could represent an objective value to determine the time point to indicate decompressive craniectomy surgery. However, there are still important questions about the individual indication for decompressive surgery. In consideration of a variable clinical course (some patients develop fatal brain edema early, whereas other patients do not show severe brain swelling for several days), achieving a way to measure, control and predict malignant brain edema formation would be of extremely important value.

NCT ID: NCT03456635 Suspended - Surgery Clinical Trials

Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System

eSATP
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis

NCT ID: NCT03334162 Suspended - Pediatric Cancer Clinical Trials

Playful Sensorimotor Training in Pediatric Brain Tumor Patients

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

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically relevant side-effect of cancer treatment. The severe symptoms such as loss of sensation, numbness, pain, absent reflexes or loss of balance control not only diminish children's quality of life but also affect the medical therapy. To date, there are no effective treatment options to reduce the symptoms of CIPN. Promising results have so far been achieved with specific exercise interventions. The investigators would therefore like to conduct a prospective, multicenter, two-armed trial (RCT with follow-up). Patients (N=20) will be recruited from the Hospital for Children and Adolescents, Kantonsspital Aarau. Prior to randomization, all primarily eligible patients that have received a platin derivate or vinca-alkaloid, will be screened for symptoms of CIPN. Eligible patients with a neurologically confirmed CIPN will then be randomized either into an intervention group or a control group (CG). Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for 12 weeks in addition to usual care, while the control group receives treatment as usual. The CG will be given the opportunity to participate in the intervention after study completion. Data change will be assessed at 3 time points: At baseline (T0), after 12 weeks (post intervention testing, T1), and after 12 weeks of follow-up (T2). Primary endpoint is the Ped-mTNS score in order to subjectively as well as objectively assess the severity of CIPN symptoms. It contains a short questionnaire as well as more objective parameters such as light touch sensation, pin sensibility, vibration sensibility, deep tendon reflexes and muscular strength. Additionally, the CIPN symptom pattern will be assessed via nerve conduction studies, CIPN related pain, dorsiflexion and knee extension as well as postural control. Furthermore, investigators will be evaluating patients' level of physical activity, walk to run transition time, lower limb power as well as patients integration in physical education (PE) in school and sport club activities. The investigators hypothesize that patients in the intervention group will be able to reduce relevant symptoms of CIPN, improving related physical functions and enhancing children's social reintegration.

NCT ID: NCT03256656 Suspended - Clinical trials for Diuresis Under Eletrical Stimulation

The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (Diuresis)

EFFLUENT
Start date: January 2017
Phase: N/A
Study type: Interventional

In previous studies, in which the perception threshold and / or sensory evoked potentials at different points of the lower urinary tract were examined and measured by means of electrical stimulation, a clear increase in the volume of the bladder and thus the urine excretion under the stimulation could be observed. This observation is now to be investigated more closely in a separate study, in order to strengthen the observation with further measured data and to find possible physiological connections. A detectable influence of electrical stimulation in the lower urinary tract on renal urine production would have a significant relevance both therapeutically and for the neurophysiological understanding of interactions between the lower and upper urinary tracts.

NCT ID: NCT03249220 Suspended - Brain Injuries Clinical Trials

Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients

CBMS FIH
Start date: January 18, 2018
Phase: N/A
Study type: Interventional

Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.

NCT ID: NCT02778997 Suspended - Clinical trials for Shunt; Complications, Ventricular (Communicating)

Prospective Shunt Complication Study

ShuCS
Start date: April 1, 2017
Phase:
Study type: Observational

Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the symptoms of a SD are often unspecific and the required diagnostics are time consuming, expensive, invasive and may involve radiation exposure. In a prospective observational study it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns specific for certain shunt dysfunctions.