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NCT ID: NCT04292691 Not yet recruiting - Anesthesia, Local Clinical Trials

High Ankle Block in Ankle Fractures

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

The aim of the herein presented double-blinded is to compare the effectiveness of the high foot block against placebo infiltration in simple, uni- and bimalleolar ankle fractures. Included will be all adult patients (>18a) treated surgically at our department. The standard peri-operative procedure at our clinic will no be altered but the additional high ankle block. The intraoperative opioid requirement, the Visual Analogue Scale for Pain (VAS) and the postoperative opioid requirement will be assessed and compared between the two groups

NCT ID: NCT04293263 Not yet recruiting - Dementia Clinical Trials

The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia

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

This study is of great importance because it uses a method that has not been tested in the past. To date, various interventions have been examined that use music for patients with dementia. At the same time, no intervention was conducted that integrates an additional person who shares personalized music with the patient. If the combination of another person who shares the positive effect of the music with the patient is found to enhance the positive effect of the music, it can change the routine of work with dementia patients and may even reduce the use of tranquilizers among them. In many cases, it has been found that one of the biggest challenges for family members who treat patients with dementia is the lack of content in the sessions and as a result, the growing sense of alienation between the patient and his family. Listening to music can be a significant tool in the hands of the family, the main caregiver, the medical staff, and any person who comes in contact with the patient, a tool that can strengthen the sense of connection and connection between them.

NCT ID: NCT04294992 Not yet recruiting - Spinal Anaesthetic Clinical Trials

Granisteron Versus Ondansetron for Prophylaxis Against Post-Spinal Anesthesia Shivering: a Randomized Controlled Study

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

3. Scientific committee approval (Was it scientifically approved by the department?) Yes Date of approval: Sunday ,1ST September,2019 Background and Rationale: Regional anesthesia is commonly associated with intraoperative shivering which reaches 40-60%. Spinal anesthesia contributes in impairment of thermoregulation, and predisposes patients to hypothermia, which reduces the threshold for shivering and vasoconstriction. Other mechanisms responsible for shivering include increased sympathetic tone, pain, and systemic release of pyrogens. Shivering causes increase in metabolic activity, oxygen consumption, intracranial, and intraocular pressure. Shivering is also responsible for increasing cardiac output, peripheral resistance, carbon dioxide production, and lactic acidosis. Furthermore, shivering interferes with electrocardiogram (ECG) and pulse oximetry. 1 Post anaesthetic shivering is one of the most frequent problems in the early recovery phase following general anaesthesia. It was considered as the sixth most important problem of current clinical anaesthesiology among 33 low morbidity clinical outcomes. Previous studies have found that shivering occurs up to 60% of patients in the postoperative period and varies according to sex, age, drugs used for anaesthesia and the duration for the surgery.2 Since shivering is a response to hypothermia, body temperature should be maintained within 36.5-37.5°C, however, shivering may be also seen in normothermic patients undergoing regional anesthesia. A number of factors responsible for developing of hypothermia in regional anesthesia including age, level of sensory block, temperature of the operating room and infusion solution.3 Perioperative hypothermia and shivering can be prevented by physical methods like surface warming or pharmacologically by drugs such as pethidine, tramadol, clonidine, doxapram, opioids, neostigmine, magnesium sulfate and ketamine.4 Pethidine is the most commonly used drug for post spinal anesthesia shivering. The disadvantage of pethidine is that it can cause respiratory depression in the presence of previously administered opioids or anaesthetics. Moreover, hypotension, nausea and vomiting are also important side effect of pethidine.5 Pethidine, which is considered as a time-tested drug for control of shivering, can have adverse effects such as respiratory depression, nausea, and vomiting. which begs to investigate the efficacy of other drugs.6 5-HT antagonists had been effectively introduced for management of perioperative shivering by inhibiting thermoregulatory response by central mechanism. Ondansetron is a 5-HT antagonist which had been effectively used in treatment of postoperative shivering.7 Granisteron, a new generation of 5-HT antagonists, had been also reported effective in the prevention of Postoperative shivering.9-10 No data are available about the comparison of both drugs, ondansetron and granisteron, for prophylaxis against post-spinal shivering The aim of the investigator's study is to compare the efficacy of granisteron to ondansetron for prevention of intra- and post spinal anaesthesia shivering.

NCT ID: NCT04299529 Not yet recruiting - Blood Pressure Clinical Trials

Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform

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

UPRIGHT-HTM will compare risk stratification, treatment efficiency and health economic outcomes of a diagnostic approach based on home blood pressure telemonitoring combined with urinary proteomic profiling with home blood pressure telemonitoring alone

NCT ID: NCT04301908 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis

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

This was a retrospective observational cohort study. The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled. Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study. Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment. The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality. Secondary evaluation index: the influence factors of different clinical outcomes. To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.

NCT ID: NCT04302233 Not yet recruiting - Clinical trials for Health Education, Joint Prosthesis, Breast Implants

A Randomized Study of Superiority of POSToperative Pharmaceutical Support on Patients' Knowledge of Their IMPlant

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

Recently joint and breast prostheses were placed under special post-marketing surveillance in order to prevent new occurrence of serious incidents by agency for medicines and health products safety. Few of french patient are able to identify their prosthesis in the event on health security alert. An usual postoperative pharmaceutical support (UPS) for patients with joint prosthesis has been implemented to prepare them for return home. At the request of surgeons, a new pharmaceutical support (NPS) has been developed to improve the ability of these patients to recall or find information that identify their prosthesis. Objectives : The main objective is to demonstrate that the new pharmaceutical support (NPS) increase the ability to memorize then find correct information of their prosthesis 6 months post-implantation Material and method : This study, approved by an ethic committee, takes place in the orthopedic and plastic surgery departments. The 236 adult patients included are hospitalized following the scheduled placement of either a breast or a hip or knee prosthesis. They are randomized, either in the NPS group or in the UPS comparator group. In both cases, patients benefit from the same written information: a patient-implant file and an information booklet specific to their prosthesis, validated by specialist surgeons, to prepare for their return home. The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization. In NPS group, pharmacist use specific photo and quiz. A telephone follow-up at the 6th month of the patients is carried out by a pharmacist to assess the patient's knowledge, using a standardized questionnaire. Expected results : Based on retrospective data already published, the main hypothesis is that the NPS is associated with an improvement in patient ability to remember the correct model or manufacturer of their prosthesis, compared to the UPS, 6 months after the operation.Secondary hypotheses are that NPS compared to UPS leads to an improvement in patients ability to preserve and find correct items related to theirs prosthesis at 6 months as well as an improvement in their knowledge of medical device vigilance and patient satisfaction declarations and a decrease in anxiety associated with prosthesis.

NCT ID: NCT04302506 Not yet recruiting - Clinical trials for Drug-induced Liver Injury

Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury

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

This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

NCT ID: NCT04303234 Not yet recruiting - Pain Clinical Trials

Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique

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

The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.

NCT ID: NCT04303598 Not yet recruiting - HIV-infection/Aids Clinical Trials

Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

Start date: April 1, 2020
Phase: Phase 3
Study type: Interventional

Azvudine,(FNC), new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.

NCT ID: NCT04305938 Not yet recruiting - Clinical trials for Calibration and Validation of Analyte Testing System

A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1

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

The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients. The KBS Systems 1.0(b) device avoids the common practice of accessing the vein to draw blood for conventional laboratory analysis. Instead, the KBS Systems 1.0(b) device uses Raman Spectroscopy to acheive the measurement of various blood analytes through the use of only approximately 40µl of blood. Such a small volume of blood can be sampled via a finger prick procedure rather than needing a larger volume of blood sampled via a venipuncture. The spectra contain information of all the molecules present in the blood (RBCs, hemoglobin, glucose, sodium, potassium, etc.). From these spectra, the system is able to analyze the blood and provide results in a matter of minutes, rather than hours or even, in some cases, days.