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NCT ID: NCT04391855 Completed - Pain, Postoperative Clinical Trials

Wound Infiltration With Tramadol, Dexmedetomidine, or Magnesium Plus Ropivacaine for Pain Relief After Spine Surgery

Start date: May 10, 2020
Phase: Phase 4
Study type: Interventional

The rationale for multimodal analgesia is to achieve additive or synergistic analgesic properties while decreasing the incidence of side effects by reducing the dose of each agent. Nociceptive stimuli are known to activate the release of the excitatory amino acid glutamate in the dorsal horn of the spinal cord. The resultant activation of NMDA receptors causes calcium entry into the cell and triggers central sensitization. This mechanism is involved in the perception of pain and mainly accounts for its persistence during the postoperative period. Peri-incisional injection of local anesthetics is an effective method for pain relief after many surgical procedures, as it can reduce postoperative analgesic consumption. Ropivacaine is a propyl analog of bupivacaine with a longer duration of action with a much safer cardiotoxicity profile than bupivacaine. Thus, a combination of local anesthetic with other analgesic factors, such as opioids, dexmedetomidine, clonidine, ketamine, magnesium sulfate, dexamethasone is suggested for a better analgesic outcome. Dexmedetomidine, a highly selective a2-adrenergic receptor agonist, has been the focus of interest for its broad spectrum (sedative, analgesic, and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications. The intravenous, intramuscular, intrathecal, epidural, and perineural use of this agent enhances analgesic effects. Tramadol hydrochloride is a synthetic analog of codeine that acts on both opioid (weak m receptor agonist) and nonopioid receptors (inhibits the reuptake of noradrenaline and serotonin as well as release stored serotonin from nerve endings) which play a crucial role in pain inhibition pathway. It also blocks nerve conduction which imparts its local anesthetics like action on peripheral nerves. It was reported that NMDA antagonists could prolong the analgesic effect of bupivacaine to even a week, as well as inhibit hyperalgesia. Magnesium sulfate (MGS) is a non-competitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect and is essential for the release of acetylcholine from the presynaptic terminals and, similar to calcium channel blockers (CCB), can prevent the entry of calcium into the cell. Aim of the study is to evaluate and compare the postoperative analgesic efficacy of tramadol, dexmedetomidine, and magnesium when added to ropivacaine as an adjuvant for wound infiltration following spine surgery.

NCT ID: NCT04390321 Completed - Down Syndrome Clinical Trials

Application of LLM Care and Related Affective Computing Systems on Persons With Special Needs

dsLLM
Start date: February 22, 2017
Phase: N/A
Study type: Interventional

Down syndrome (DS) is a genetic disorder characterized by specific physical characteristics (muscle degeneration) and cognitive phenotype (neurodegeneration caused by gene-overexpression that has affected memory, language, and other executive functions). DS is the most prevalent reason for intellectual impairment but is also often accompanied by other medical conditions such as Alzheimer's disease. Given the increased cognitive decline inherent to DS, especially in the later years, the development of a non-invasive intervention protocol to counterbalance this prevalence is imperative. This study is an adaptation of the Long Lasting Memories (LLM) (NCT02267499) and the subsequent LLM Care (NCT02313935) projects, specifically tailored to meet the needs and capacity of people with DS. The study aims to examine the effectiveness and any potential benefits of cognitive and physical training, as offered via the ICT-based (non-pharmacological) intervention of LLM Care, on people with DS. It is worth investigating whether this intervention can aid the development of independent living skills in DS individuals and the possibility of counterbalancing the degeneration, both physical and cognitive, caused by the expression of the extra genes. To evaluate any physical, cognitive, behavioral, and neuroplastic benefits/effects and measure the influence (affective status of participant) of the training, the study utilizes psycho-somatometric assessments and neuroscientific (electroencephalographic, EEG-related) indices, as well as affective computing systems.

NCT ID: NCT04385368 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)

MERMAID-1
Start date: July 17, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

NCT ID: NCT04381000 Completed - Chronic Pain Clinical Trials

Quarantine and Telerehabilitation in Chronic Pain Patients During COVID-19 Pandemic.

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The quarantine during COVID-19 pandemic has changed daily routine. Staying at home for prolonged periods of time can pose a significant challenge for patients with chronic pain. The purpose of the current study is to investigate how the quarantine effects of psychosocial factors, quality of life, sleep, nutrition and physical activity in patients with chronic musculoskeletal pain. Another purpose is to examine whether a telerehabilitation exercise program is effective during the lockdown period.

NCT ID: NCT04379713 Completed - Clinical trials for Pneumococcal Disease

20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

Start date: May 21, 2020
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.

NCT ID: NCT04375163 Completed - Clinical trials for Athletic Performance

Effects of Massage Between Sets of an Intense Isokinetic Exercise- Protocol of Knee Extensors in Tae Kwon Do Athletes

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (NMG) the break was passive.

NCT ID: NCT04368845 Completed - COVID-19 Clinical Trials

Telerehabilitation in Patients With COVID-19 After Hospitalization. The ATHLOS Study

ATHLOS
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals, in order to offer telehealth services at home in patients with COVID-19, after hospital discharge. At the first phase an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms (early fatigue, muscle weakness, eating difficulties, etc). At the second phase a randomized control trial study will evaluate a 6-month telerehabilitation program for 100 adults (aged 20-65 years) diagnosed with COVID-19, who completed the first phase of this study. At this phase, the study will randomize (1:1 allocation) 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care. The intervention program includes individualized prescribed endurance exercises, low intensity aerobic exercises, upper and lower extremity strength training, breathing exercises as well as a three times per month online support with 1:1 supervision via video conferencing with an expert physiotherapist.

NCT ID: NCT04364711 Completed - COVID-19 Clinical Trials

EuRopean Study of MAjor Infectious Disease Syndromes Related to COVID-19

MERMAIDS 2
Start date: June 18, 2020
Phase:
Study type: Observational

Background Rapid European COVID-19 Emergency Research response (RECoVER), is a project involving 10 international partners that has been selected for funding by the European Union under the Horizon 2020 research framework responding to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic. MERMAIDS 2.0 is the hospital care study within RECOVER. Rationale Detailed patient-oriented studies are needed to determine the spectrum of SARS-CoV-2 disease and the combined influences of age, comorbidities and pathogen co-infections on the development of severe disease, together with virological and immunological profiles. This research is key to understanding the pathophysiology and epidemiology of this new disease, as well as to identifying potential targets for therapeutic or preventive interventions. Objective To establish the prevalence, disease spectrum and severity, clinical features, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care. Study design Prospective observational cohort study in selected European countries. Study population Children and adults with 1) acute respiratory illness (ARI) presenting to hospital care during the SARS-CoV-2 epidemic (including both COVID-19 and non-COVID-19 patients) and 2) patients with confirmed COVID-19 infection, but with atypical presentation (non-ARI) or with nosocomial acquisition. Sites can optionally participate in the following tiers: Tier 1 (Clinical data and biological sampling) - Clinical samples and data will be collected on enrolment day and then at scheduled time points. Tier 2 (Clinical data an extended biological sampling). - incl. PBMC collection Optional add-on study In a subset of sites and patients, COVID-19 positive patients will be followed post-discharge for 6 months to study clinical recovery and long-term sequelae Main study parameters/endpoints: Prevalence of COVID-19 among patients with acute respiratory illness. COVID-19 disease spectrum and host and pathogen risk factors for severity. Long-term sequelae of COVID-19 requiring hospital care. Proportion hospital-acquired COVID-19 infections and characteristics of nosocomial transmission. Study Duration Scheduled 2 years and based on COVID-19 dynamics. Nature and extent of the burden associated with participation, benefit and group relatedness This study is observational in nature. There will be no direct benefit to research participants. The study may include biological sampling in addition to sampling required for medical management. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.

NCT ID: NCT04364269 Completed - Beta-Thalassemia Clinical Trials

Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia

VITHAL
Start date: June 11, 2020
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo-controlled parallel group trial to investigate the safety, tolerability and efficacy of multiple doses of VIT-2763 versus placebo in participants with non-transfusion-dependent Beta-thalassemia (NTDT).

NCT ID: NCT04362982 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Αn Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder (ADHD360)

ADHD360
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

ADHD360 will be an innovative integrated platform for early ADHD diagnosis and intervention against its symptoms. In the core of the platform design there will be a serious game along with a mobile application to monitor behavior and to evaluate the intervention.