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NCT ID: NCT03704285 Recruiting - Anesthesia Clinical Trials

Development of pk/pd Model of Propofol in Patients With Severe Burns

Start date: September 29, 2018
Study type: Observational

Burn injuries are a prevalent problem. Actually, in Chile the Ministry of Health has recorded 6435 hospital burns and has reported 569 deaths from this cause. The specific mortality rate for burning in Chile was 4.5 per 100,000 inhabitants per year. Survival in extensive burns has progressively improved, thanks to advances in understanding the pathophysiology of the burn and its more aggressive treatment. This requires effective prehospital treatment, transportation, resuscitation, support of vital functions and repair of the skin cover. Much of the procedures performed in large burns require general anesthesia. Being Total Intravenous Anesthesia (TIVA) with propofol an alternative that would have advantages over inhalational anesthesia, as a decrease in postoperative nausea and vomiting and produce less environmental pollution 3 and the antihyperalgesic effect of propofol. Within TIVA - Target Control Infusion (TCI) - uses infusion systems that incorporate PK-PD models for predict the dose of drug required to reach a certain concentration in the target organ. The formulation of a PK model that considers the variables of this group of patients, such as: degree of injury, inflammatory state and compromised body surface; associated with general variables such as: age, weight and nutrition, it would allow to reduce the predictive error in this population, thus improving the dosing of these patients when using TCI. Given the lack evidence on the PK-PD of propofol is this group of patients burned, has led to raise the development of this study that seeks to develop a PK-PD model that fits them.

NCT ID: NCT03704090 Recruiting - Clinical trials for Postoperative Delirium

Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

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

In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs. Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD. The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries. The hypothesis is that the application of these measures decreases the incidence of delirium in this population.

NCT ID: NCT03704077 Not yet recruiting - Gastric Cancer Clinical Trials

An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Start date: October 13, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

NCT ID: NCT03683056 Active, not recruiting - Mental Health Clinical Trials

Mental Health Prevention Among Preschool Children Effectiveness Study

ICPS Chile
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Mental health in Chilean children and families is an urgent public health problem. Prevalence of psychiatric disorders among children between 4 and 11 years old is 27.8%, a higher percentage than was found in adolescents between 12 and 18 years old, which is 16.5%. The most frequent disorders in the population between 4 and 11 years old were disruptive disorders (20.6%), followed by anxiety disorders (9.2%). Mental health problems generate a high burden of disease on society in general; and there is an important treatment gap, especially among economically vulnerable populations. Prevention strategies appear to be the more recommendable options, mainly if these interventions can be implemented early in life and at low cost. Few preventive interventions aiming to increase resilience in the face of adversity, have been rigorously evaluated in Chile among preschoolers. There is substantial international evidence that shows that strengthening basic psychological skills, such as emotion regulation and social problem-solving, can reduce the incidence of mental pathology and improve various academic indicators. The curriculum of the Interpersonal Cognitive Problem Solving Program, also known as I Can Problem Solve (ICPS), is focused on the development of the cognitive process and children's social problem-solving skills. ICPS has been found to be effective in increasing pro-social behaviors and reducing aggressive behavior among preschoolers. No previous studies in Spanish-speaking Latin American countries have been conducted aiming to explore the acceptability and feasibility of ICPS to provide information to evaluate later the effectiveness of this intervention at a larger scale. The main objective of this study is the evaluation of the effectiveness of an adapted version of ICPS, in the national context at educational institutions with high socio-economic vulnerability, on increasing social-emotional competence and reducing emotional and behavioral problems in preschoolers.

NCT ID: NCT03668119 Not yet recruiting - Pan Tumor Clinical Trials

A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

CheckMate 848
Start date: October 23, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)

NCT ID: NCT03662659 Recruiting - Gastric Cancer Clinical Trials

An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

Start date: October 4, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

NCT ID: NCT03656718 Recruiting - Neoplasms by Site Clinical Trials

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Start date: September 24, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: - non-small cell lung cancer (NSCLC) - renal cell carcinoma (RCC) - unresectable or metastatic melanoma - hepatocellular carcinoma (HCC) - microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)

NCT ID: NCT03653468 Completed - Obesity Clinical Trials

Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians

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

Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).

NCT ID: NCT03636386 Active, not recruiting - Clinical trials for Myofascial Trigger Point Pain

Percutaneous Microelectrolysis in the Reduction of Myofascial Trigger Points Pain

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

The aim of the design is to investigate the value of percutaneous microelectrolysis (MEP) as an analgesic technique in myofascial trigger points. This research seeks to evaluate the influence of the polar effects of the cathode on the reduction of the threshold of painful pressure and intensity of pain in the myofascial trigger points of the trapezius muscle. An assessment with algometry and visual analog scale will be made in healthy subjects before applying the intervention. The study will evaluate the changes in kilograms per square centimeter of painful pressure threshold and millimeters of pain in a group exposed to the application to percutaneous microelectrolysis (MEP) compared to another group that will not receive the intervention. Both groups will be provided with a basic treatment of therapeutic ultrasound. The treatment will include three sessions with an interval of 3 days. Subsequently, the researchers will proceed to compare the painful pressure threshold and pain intensity obtained from the algometry test and visual analogue scale in each of the groups, and between groups, before and after the procedure. The changes obtained between sessions will be compared.

NCT ID: NCT03635138 Not yet recruiting - Caries, Dental Clinical Trials

Effect of the Incoportation of Copper and Zinc Nanoparticles Into Dental Adhesives

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

The hypothesis is that Addition of copper or zinc nanoparticles to a dental adhesive confers antimicrobial and enzymatic degradation-resistant properties, retaining its adhesion mechanical properties and biocompatibility. To corroborate this hypothesis two groups of a dental adhesive doped with copper or zinc nanoparticles should be develop with a respective structural characterization by SEM-EDX, AFM and FTIR. This should be followed by a test of the antimicrobial activity of adhesive and a study of the influence of adhesive nanocomposites on matrix metalloproteases levels and/or activity in vitro to determine some concentrations more relevant. These would proceed to next stage. With the selected adhesive doped concentrations should be evaluate mechanical properties of doped adhesives and assess the biocompatibility by assays in primary cultured gingival fibroblast and cells type odontoblasts. Finally, once the concentration of either Cu- or Zn-doped adhesives is known, these will be evaluated with a clinical design phase in an in vivo model to study antimicrobial properties, matrix metaloproteases levels and/or activity. We will also study biocompatibility of adhesive nanocomposites and mechanical properties to corroborate the in vitro and ex vivo properties determined. There are results using copper nanoparticle on biomaterials that corroborates some properties such as antimicrobial activity against various species and copper release. All the evidence suggests that at low concentrations of copper nanoparticles, there are no significant effects on mechanical properties but with added antibacterial properties on the adhesive