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NCT ID: NCT03512548 Completed - Healthy Clinical Trials

Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites

Start date: April 10, 2018
Phase: Phase 1
Study type: Interventional

This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days. If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.

NCT ID: NCT03524066 Completed - Healthy Clinical Trials

Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

The aim of the present study is to increase the general understanding of lung PK of selected compounds by sampling epithelial lining fluid ELF and lung tissue.

NCT ID: NCT03525886 Completed - Clinical trials for CAH - Congenital Adrenal Hyperplasia

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia

Start date: April 10, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in up to 30 adult female and male subjects (18 to 50 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH). The study will include a sequential-cohort design with four NBI-74788 dosing regimens, with each regimen administered for 14 days.

NCT ID: NCT03548493 Completed - Conscious Sedation Clinical Trials

Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH

CSDH
Start date: April 10, 2018
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.

NCT ID: NCT03561597 Completed - Adolescent Obesity Clinical Trials

Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

Background: The Expert Committee on the Assessment, Prevention and Treatment of Child and Adolescent Overweight and Obesity recommends a staged based approach to the management of adolescents with overweight and obesity from Stage 1-4 with increasing intensity of management in higher stages. Mobile health application is an attractive community based treatment for adolescent obesity due to its wide penetration and convenience. Early weight loss has been found to be the strongest predictor of good long term outcome in obesity. However there is currently no known study that use early weight loss as a predictor factor for a stepped up approach using a mobile health application. Clinical significance: The current study use a mobile health intervention to identify participants with early weight loss in a stepped up approach. Primary objective will be to examine the proportion of patients triaged to the low risk Weight Management Clinics (WMC) after brief intervention by a nurse coordination and completion of 4 sessions of Kurbo Program over a 12 month recruitment period. Secondary objectives will be to examine changes in BMI z-score, metabolic profile, examine program feasibility and fidelity and explore other predictors of poor response to program. Methodology: Children aged 13-17 years old with BMI percentile of above 90th percentile, who are referred to the WMC, will receive a brief intervention by the WMC nurse coordinator followed by introduction to Kurbo program, a multifunctional mobile application, for more detailed dietary and physical activity recommendations and implementation of behavioural changes. Patients that are able to engage with Kurbo intervention and showed a decrease in BMI percentile over 4 sessions of Kurbo will be offered the low risk weight management clinic. At baseline, month 3 and month 6, the patient's weight and height, body fat composition, waist circumference and blood pressure will be measured as per usual standard protocol. Questionnaires to assess eating, quality of life and dietary recall will be administered as part of the research. Accelerometers will also be fitted to assess physical activity. At baseline and month 6, metabolic blood tests (HbA1C, fasting lipid panel, oral glucose tolerance test, fasting insulin level and liver function test) were collected after a minimum 8 hour fasting period together with bloods for aromatic amino acid, branch chain amino acid and long chain acylcarnitines . Current low risk WMC patients will be offered 2 monthly follow up with optional dietician and exercise physiologists counselling and exercise sessions. The high risk WMC patients will be routinely offered the standard high risk follow up protocol consisting of weekly follow up with the multidisciplinary team for 4 weeks followed by 2 weekly appointments for 2 months and monthly appointment thereafter based on clinical response.

NCT ID: NCT03572218 Completed - Obesity Clinical Trials

Psychological Intervention to Reduce Weight Bias Internalization

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to test the effects on WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Participants will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass index (BMI) of 30 kg/m2 or above, a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 36) or the BWL + BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 weeks (12 visits). In the BWL + stigma intervention, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 12 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, every-other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance sessions in the BWL + stigma group will continue to incorporate discussion of WBI. Assessments - which include questionnaires and measurements of body weight - will occur at baseline and weeks 12 and 26. Weight will be measured at every group meeting for clinical purposes.

NCT ID: NCT03606902 Completed - Clinical trials for Postoperative Analgesia

Continuous Epidural Fentanyl- Low Dose Bupivacaine Infusion Analgesia for Precious Single Kidney Patient.

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

Open surgical nephrectomy is associated with sever postoperative pain mandating alternative strong ,renal safety, minimal side effects, and minimal rescue systemic analgesics , continuous Epidural Fentanyl infusion in a dose step down tapering manner would produce hemodynamic stability with effective analgesia in nephrectomy surgery without using nephrotoxic analgesic drugs such as NSAIDs .The study proposal: Continuous Epidural Fentanyl infusion in a dose step down tapering manner with the least analgesic LA dose is enough intraoperative non nephrotoxic analgesic modality with good intraoperative(IO) Hemodynamic stability & less postoperative complications in patients subjected to nephrectomy surgery with remaining single precious kidney. Aim of the work: Intraoperative analgesic technique avoiding polymodal analgesia that utilize the nephrotoxic NSAIDs, To have a NSAIDs free surgery by using a Continuous IO effective & safe lipophilic opioid analgesia especially in nephrectomy surgery that leaves the patient with a single precious healthy kidney that has to be well perfused and totally protected from any nephrotoxic drugs with rapid recovery and less PO complications

NCT ID: NCT03613779 Completed - Heart Failure Clinical Trials

CLUSTER-HF: Lung Ultrasound Guided Therapy in Heart Failure

CLUSTER-HF
Start date: April 10, 2018
Phase: N/A
Study type: Interventional

Introduction: Heart failure is the leading cause of hospitalization among adults >65 years of age. Discharge from a heart failure hospitalization is followed by a 30 day readmission rate of ≈24%. Readmissions for heart failure are typically preceded by a gradual rise in ventricular filling pressures that begins days or weeks before any detectable changes in clinical status. Lung ultrasound (LUS) is a tool that is easily available at bedside and shows superior sensitivity for the detection of pulmonary congestion when compared with X ray or physical examination, even in the absence of symptoms. Pulmonary congestion assessed by LUS identifies a subgroup with worse prognosis and a higher rate of readmission and mortality. Whether the implementation of lung ultrasound in the follow up of heart failure patients may reduce the rate of readmissions is unknown. Objective: The aim of this study is to evaluate a protocol of lung ultrasound guided therapy to prevent readmissions in heart failure outpatients. Study design: the design of the investigator's study is a single center, single blinded, randomized controlled clinical trial. Eligibility criteria: patients older than 18 years of age, who have been hospitalized for an acute heart failure syndrome. Exclusion criteria are life expectancy of less than 6 months, a surgically correctable cause of heart failure or uninterpretable lung ultrasound. Eligible patients will be randomized into either "LUS-guided therapy group" or "control group" at hospital discharge. Follow-up visits will be scheduled at 15 days, 45 days, 3 months and 6 months after hospital discharge. LUS will be performed in all patients at hospital discharge and in every follow-up visit, but only in those allocated to the "LUS-guided therapy group" the information will be provided to the treating physician. In the "LUS-guided therapy group", a prespecified diuretic dose will be administered to patients depending on the degree of ultrasonographic pulmonary congestion: if congestive (3 or more B lines, in total) a high dose (80-120mg furosemide PO/day) will be prescribed; if no congestive (less than 3 B lines, in total) a low dose (up to 40mg PO/day) will be prescribed. Primary outcome will be the composite of hospital readmission + mortality. This study complies with the Declaration of Helsinki and the study protocol is being evaluated by the Ethic Committee of our institution.

NCT ID: NCT03613948 Completed - Clinical trials for Inherited Retinal Dystrophy Primarily Involving Sensory Retina

Study on the Effects of Mutations Under Inherited Retinal Disease in Korean

Start date: April 10, 2018
Phase:
Study type: Observational

To develop comprehensive genetic maps of inherited retinal diseases in Korean - Establishment of comprehensive genetic database in Koreans with inherited retinal diseases including frequently mutated genes, genotype-phenotype correlations, and visual prognosis."

NCT ID: NCT03639961 Completed - Leadership Clinical Trials

The Effect of Integrated Leading, Managing and Governing for Result Model Towards Institutional Delivery

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

The need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. These disparities have remained worse in the health system of developing countries like Ethiopia. To date, Ethiopia put a goal of ending preventable child and maternal death, in achieving universal healthcare by 2035. Nevertheless, the investment on integrated leadership, management and governance is limited. Therefore, this study hypothesize that institutional delivery are expressively linked with integrated health system leading, managing and governing for results model among health facilities staff in northwest Ethiopia?