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NCT ID: NCT03599388 Completed - Metabolic Syndrome Clinical Trials

Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention

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

This pilot study will test acceptability and feasibility of a sleep extension intervention in community dwelling, short sleeping, racially/ethnically diverse middle aged adults with Metabolic Syndrome (METs). Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pre-test, post-test study design will test the efficacy of this 18 week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12 week intervention) on sleep duration, MetS factors (waist circumference, blood pressure, fasting glucose, trigycerides, HDL-c), MetS risk behaviors (poor affective well-being, fatigue) and self regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approach.

NCT ID: NCT03598582 Completed - Clinical trials for Myelodysplastic Syndromes

Biological Predictive Factors of Response to ESA in Low Risk MDS Patients

Start date: January 1, 2013
Phase: Phase 4
Study type: Interventional

In this trial, the investigators would like to understand why a small percentage of patients will be refractory to ESA (independently of International prognostic scoring system (IPSS) and % of blasts). In a retrospective study of the "Groupe Francophone des Myélodysplasies (GFM)" , the investigators showed that about 43% of patients are refractory or will relapse after initial response to ESA and it has been shown that these patients have a poorer survival. The investigators plan to give a 12-week treatment of Epoetin alfa or zeta in low risk MDS patients and measure different biological factors to predict response to ESA: - evaluation by flow cytometry before and after treatment of the degree of dyserythropoiesis and dysgranulopoiesis which could explain the primary resistance or loss of response of a subset of patients, - screening by molecular biology of predictive factors of response to ESA, - Iron homeostasis will be measured via hepcidin, GDF-15 and ferritin levels.

NCT ID: NCT03598374 Not yet recruiting - Infertility, Female Clinical Trials

Spontaneous Reproductive Outcomes After Oral Inositol Supplementation in Infertile Polycystic Ovarian Syndrome Women.

IROP-1
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS. Very few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited. Conversely, about infertility and assisted reproduction techniques (ART), improvements have been reported in PCOS women who underwent fertility treatment using inositol in different forms, combinations or doses. This data, considering the different tissue-specific ratios (i.e., 100:1 in the ovary) and the different physiological roles of inositol stereoisomers, suggest that DCI supplementation alone might not be the optimal or appropriate approach for improving IVF outcomes in PCOS patients, and drawn attention to the importance of MI and DCI supplementation in a physiological ratio in order to restore normal ovary functionality. Indeed, the combination of MI and DCI, at a more physiological ratio of 40:1, was able to more quickly restore to normal the hormonal and metabolic parameters in PCOS women than MI treatment alone or DCI treatment alone, improving the endocrine profile and IR of women with PCOS. Nevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in ART in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies.

NCT ID: NCT03598322 Completed - Clinical trials for Carpal Tunnel Syndrome

The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

Start date: June 30, 2018
Phase: N/A
Study type: Interventional

The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

NCT ID: NCT03598231 Completed - Rectal Cancer Clinical Trials

Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome

SANLARS
Start date: May 25, 2018
Phase: N/A
Study type: Interventional

Low anterior resection syndrome (LARS) is a complex disorder suffered by patients who undergo rectal resection mainly due to rectal cancer. It is characterized by fecal incontinence, fragmented defecation, constipation, defecatory urgency among others, which induce an impairment in quality of life. LARS treatment armamentarium is scarce and with no long-term relief, being a difficult challenge for surgeons. There is evidence showing that sacral neuromodulation (SNM) improves patients' symptoms and quality of life. However, no prospective randomized studies have supported this improvement. This is a prospective randomized cross-over study which evaluates the effectiveness of SNM in LARS, specifically analyzing intestinal, urinary, sexual symptoms as well as quality of life.

NCT ID: NCT03596983 Completed - Metabolic Syndrome Clinical Trials

P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention

Start date: April 10, 2019
Phase: N/A
Study type: Interventional

This pilot study will test the acceptability and feasibility of a sleep extension intervention in community-dwelling, short-sleeping, racially/ethnically diverse middle-aged adults with MetS. Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pretest-posttest study design will test the efficacy of this 18-week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12-week intervention) on sleep duration, MetS risk behaviors (reduced physical activity, increased sedentary behavior, poor diet quality), symptoms associated with MetS risk behaviors (poor affective well-being, fatigue), and self-regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approac

NCT ID: NCT03596944 Completed - Clinical trials for Acute Coronary Syndrome

Primary Prevention With Statin and Incidence of Recurrent MI and Cardiogenic Shock in Post-ACS Patients

Start date: August 1, 2017
Phase:
Study type: Observational

This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of recurrent myocardial infarction, cardiogenic shock and mortality in ACS patients.

NCT ID: NCT03596931 Completed - Heart Failure Clinical Trials

Prior Statin Use and Risk of CHF, ALO and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients

Start date: August 1, 2017
Phase:
Study type: Observational

This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of heart failure, acute lung edema, malignant arrhythmia and death in ACS patients.

NCT ID: NCT03596905 Recruiting - Clinical trials for Irritable Bowel Syndrome With Constipation

Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

(IBS-C)
Start date: June 30, 2018
Phase: Phase 2
Study type: Interventional

This study of the efficacy and safety of Plecanatide in children 6 to <18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C)

NCT ID: NCT03596437 Recruiting - Clinical trials for Ehlers-Danlos Syndrome

Study of Arterial Properties by Ultra-high Frequency Ultrasound in Fibromuscular Dysplasia and Vascular Ehlers-Danlos Syndrome

FUCHSIA-FR
Start date: January 7, 2019
Phase: N/A
Study type: Interventional

Ultra-high frequency ultrasound may be useful in the field of vascular research, given its ability to accurately characterize arterial wall thickness and ultrastructure. In patients with fibromuscular dysplasia (FMD), it may help identify the "triple signal" pattern in carotid arterial wall, while in Vascular Ehlers Danlos Syndrome (V-EDS) it may help to accurately measure carotid intima-media thickness, which may be extremely small and difficult to measure with standard equipment. Furthermore, novel features might be identified in small-to-medium sized arteries by ultra-high frequency ultrasound. The main aim of this study is to demonstrate that ultra-high frequency ultrasound has the same accuracy of standard ultrasound for the identification of "triple signal" in the carotid artery of FMD. Secondary aims of this study are to evaluate carotid, radial and digital intima-media thickness, wall ultrastructure and distensibility in 60 patients with FMD and in 30 patients with V-EDS.