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NCT ID: NCT03901560 Completed - Clinical trials for Functional Abdominal Pain

Music Therapy: Sickle Cell and Pain Crisis

Start date: June 30, 2016
Phase:
Study type: Observational

This study will assess whether participants who receive music therapy during inpatient care report a decrease in pain and whether music therapy influences factors such as family satisfaction.

NCT ID: NCT03899467 Completed - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

Start date: May 30, 2019
Phase: Phase 2
Study type: Interventional

This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment. The objective of the study is to evaluate the safety and tolerability of proxalutamide and determine the RP2D for Ph III and/or other confirming studies. Subjects will be randomized into the 2 treatment arms.

NCT ID: NCT03899441 Completed - Clinical trials for Perioperative/Postoperative Complications

Multimedia Aid Gynecologic Counseling and Consent

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

This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently. The investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.

NCT ID: NCT03899168 Completed - Depression Clinical Trials

Confirmation Bias Towards Treatments of Depressive Disorders in Social Tagging

Start date: November 14, 2014
Phase: N/A
Study type: Interventional

The study examines whether people primarily want to confirm their prior attitudes in health-related information search, in an online environment using social tags for navigation. Participants were looking for information on the treatment of depression with antidepressants and psychotherapy. They were randomly assigned to two groups with either high or low credibility of the community who provides social tags, and two groups where participants' confidence in prior attitudes was heightened or lowered, and to two groups where either antidepressant tags were more popular or psychotherapy was more popular. The investigators measured attitude change toward the treatments and also navigation behavior.

NCT ID: NCT03898609 Completed - Clinical trials for Multifactorial Chylomicronemia (MCM)

Effect of Low-Fat Compared to Low-Carbohydrate Diet in Subjects With Multifactorial Chylomicronemia

MCMdiet
Start date: January 21, 2019
Phase: N/A
Study type: Interventional

Introduction. The multifactorial chylomicronemia ((MCM), also known as type V hyperlipoproteinaemia or mixed hyperlipidaemia) is an oligogenic or polygenic disorder that is associated with a reduction in lipoprotein lipase activity which leads to chylomicronemia. In this disease, very high concentrations of serum triglycerides (≥10 mmol/l (≥880 mg/dL)) can be observed in the fasting state due to the accumulation of both VLDL-C and chylomicron. In patients with MCM, chylomicronemia typically occur in adulthood and is exacerbated by the presence of secondary factors such as a diet rich in dietary fats and simple sugars, obesity, alcohol intake and uncontrolled diabetes. It has been estimated that chylomicronemia can be found in 1:600 adults. However, it is likely that the prevalence of MCM may increase in the future due to the increasing prevalence of obesity, metabolic syndrome and type 2 diabetes. This condition increases the risk of acute pancreatitis, which can be recurrent and potentially fatal. Indeed, the risk of acute pancreatitis is 10-20% for TG levels > 22.58 mmol/L (>2000 mg/dL). Furthermore, because MCM patients often present with other lipid disturbances as well as a worse metabolic profile, these patients are at increased risk of cardiovascular disease (CVD). Fortunately, MCM patients generally respond well to modifications in lifestyle, to treatment of secondary factors and to triglycerides lowering therapies such as fibrates. However, it is still unknown which kind of diet has the greatest effect on triglycerides level and on the metabolic profile in MCM patients. The nutritional recommendations can be very different according to the nature of the patient's population to be treated. In order to reduce and manage triglycerides level in the general population, the American Heart Association guidelines recommend reduction of simple carbohydrates intake. On the other hand, the nutritional intervention strategy is quite different for subjects affected by familial chylomicronemia syndrome (FCS), for which the treatment focuses on restriction of dietary fat. FCS is a very rare autosomal recessive disease that leads to a drastic reduction of chylomicrons clearance leading to chylomicronaemia. Therefore, a very strict lipid-controlled diet low in long-chain fatty acid (10-30g/day or 10%-15% of total energy intake) is required in order to lower chylomicron formation. MCM is a complex condition in which both an increased VLDL formation by the liver and a decreased chylomicrons and VLDL clearance are present. Furthermore, triglycerides values are fluctuating from day to day but generally remain very high. Therefore, the best dietary approach for these patients remains to be elucidated. Primary Objective. The primary objective of this study is to compare the effects of low-fat vs low-carbohydrate diets on fasting serum triglyceride concentrations. Secondary Objectives. 1. To compare the effects of low-fat vs low-carbohydrate diets on other fasting cardiometabolic parameters: measured LDL-C, total cholesterol, HDL-C, glucose, insulin, HOMA-IR, apoB, non-HDL-C, hs-CRP, PCSK9 and free fatty acids (FFA). 2. To compare the effects of low-fat vs low-carbohydrate diets on SBP, DBP and waist circumference. 3. To compare the effects of low-fat vs low-carbohydrate diets on lipoprotein subfractions (fasting). 4. To compare the effects of low-fat vs low-carbohydrate meals on postprandial triglycerides, insulin, glucose, FFA and PCSK9 after a standardized test meal. 5. To assess the patients' appreciation, compliance and tolerability for each experimental diet (feedback questionnaire).

NCT ID: NCT03898219 Completed - Osteomyelitis Clinical Trials

Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

Start date: January 1, 2015
Phase:
Study type: Observational

To our knowledge, few cases of relapse in adulthood are described in the literature except in patients with sickle cell disease and the epidemiological, clinical, laboratory, radiological features and the management of osteomyelitis relapsing in adulthood are not described. The aim of this retrospective multicentric cohort study : in France is to describe the epidemiological, clinical, laboratory, and radiological features and the management of adult patients who experienced a relapse between 2003-2015 of an acute hematogenous osteomyelitis acquired in the childhood (description of characterization of the period between the first episode of osteomyelitis and the second episode, description of signs of relapse and description of treatments used in the relapse). The data are analysed with non-comparative descriptive statistics.

NCT ID: NCT03898115 Completed - Clinical trials for Central Line-associated Bloodstream Infection (CLABSI)

Implementation Program to Improve CHG Bathing Compliance

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This study will be a multicenter, cluster randomized, step-wedged design. The unit of randomization will be the inpatient units admitted critically ill patients, with the interventions being carried out over 4 months. The study plans to enroll 14 units at 2 sites. Four sequences will be enrolled into the intervention each month; each sequence will have 3-4 units (see figure 1). Units eligible for the study will have patients that are critically ill admitted and have had at least 1 CLABSI events over the past 12 months (fiscal year). Given the pragmatic nature of the study design, there will be limited additional inclusion and exclusion criteria. Prior to the beginning the study, all nursing staff (RNs and nursing assistants [NAs]) will receive a survey link (RedCAP) to understand their perceptions of CHG bathing. After all units have been enrolled (approximately 4 months), nursing staff will be sent a post-survey to see if their perceptions have improved after the program. Further, the Context Assessment Index (used with permission; via RedCAP) will also be used to assess the context (i.e., culture) in which clinicians works and the effect this has on using evidence in practice. This will be provided to infection prevention champions on each unit one time, at the beginning of enrollment. All hospitals in the trial will receive access to site-level quality reports on CLABSI data. The interventions will include a "direct engagement" at the site level; this strategy will build upon current quality improvement interventions developed from the Agency for Healthcare Research & Quality for optimization of care for critically ill patients at risk for CLABSIs. The multidisciplinary teams will include national key opinion leaders in quality improvement working with local infection prevention specialists and support staff to help healthcare systems and hospitals design or revise quality improvement plans. Units will receive feedback on quality improvement efforts, including audit and feedback reviewing their CHG bathing compliance and CLABSI rates. Duke will serve as the primary statistical center and analysis will be generated by Duke. The only risk in this study is the possibility of breach of confidentiality. The primary objective of this study is to assess the effect of a customized, multifaceted quality improvement [QI] program on compliance with daily chlorhexidine gluconate (CHG) bathing per the AHRQ protocol in inpatient units that admit critically ill patients. Further, we will assess the effect of this program on nursing staffs' perception of the importance of CHG bathing. The Context Assessment Index (used with permission) will also be used to assess the context (i.e., culture) in which clinicians works and the effect this has on using evidence in practice. The secondary objective of this study is to examine the effect of the QI program on central line-associated bloodstream infection (CLABSI) rates. Primary outcomes and CLABSI rates will be measured at 12 months to assess sustainability.

NCT ID: NCT03897855 Completed - Clinical trials for Post-Traumatic Stress Disorder in Old Age

Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects

I-TSPT-R
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

In the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested. This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment. The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.

NCT ID: NCT03897738 Completed - Clinical trials for Perimenopause, Climacteric Syndrome

Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.

Start date: April 30, 2019
Phase: N/A
Study type: Interventional

To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart B in women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms in perimenopause.

NCT ID: NCT03897400 Completed - Crohn Disease Clinical Trials

Ovarian Reserve in Crohn's Disease

Start date: March 1, 2019
Phase:
Study type: Observational

Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated with disease treatment. Anti-mullerian hormone (AMH) is a reliable indicator of ovarian reserve in women. The aim of this study was to compare serum AMH levels in women with Crohn's disease and healthy controls. In this study, the investigators aimed to investigate AMH and ovarian capacity in the study group with crohn's disease and in the control group without disease.