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NCT ID: NCT03755310 Not yet recruiting - Clinical trials for Restless Legs Syndrome

Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

Start date: February 2019
Phase: Phase 2
Study type: Interventional

Suvorexant improves sleep latency and wake after sleep onset in patients with primary insomnia, and is FDA approved for this condition. However, no data exist on its effects in RLS, so far. The investigators consider that suvorexant might provide a stable therapeutic efficacy for the long treatment, avoiding the risk of augmentation of symptoms commonly seen under dopamine agonists.

NCT ID: NCT03729895 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea Syndrome

Clinical Study of Customized Adjustable Oral in Treatment of Patients With Obstructive Sleep Apnea Syndrome

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

The oral appliances (OAs) are considered to be an effective treatment modality for snoring and various forms of obstructive sleep apnea syndrome (OSAS). They facilitate the displacement of the mandible anteriorly and widen the upper airway during sleep. Lateral cephalometry has been used for the two-dimensional evaluation of upper airway form with several limits.The purpose of present study is to investigate an accurate three-dimensional (3D) volume analyses with cone beam computed tomography (CBCT) scans to confirm the effects of OAs on the upper airway in patients with OSAS.The investigators aim to enroll twenty-four patients with mild,moderate or severe OSAS, intolerant to continuous positive air pressure therapy and rejection a surgical approach,who will be treated with adjustable customized OAs and evaluated with CBCT and polysomnography. Upper airway form was examined and the volume was measured in two different areas. Specific planes have been considered to match the data and calculate the benefit obtained with therapy.

NCT ID: NCT03721809 Not yet recruiting - Clinical trials for Macrophage Activation Syndrome

Characterization of the Inflammatory Profile of Patients With Macrophage Activation Syndrome Secondary to Bacterial Sepsis

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

The pathophysiology of macrophage activation syndrome has been mainly studied in pediatric genetic primary forms. There is little data in secondary forms related to bacterial sepsis. Because of the seriousness of this entity (43% of deaths in intensive care in the largest cohort published so far by the medical resuscitation team of Rouen University Hospital), it is necessary to better understand the physiopathological mechanisms to be able to propose a suitable therapy. For now, the management of this syndrome is far from consensual. Some authors advocate a single etiological treatment, while others suggest the need for intensive management of anti-inflammatory and immunosuppressive type. The fragility of resuscitation patients does not allow intensive immunosuppressive therapies as proposed by some authors. In the era of immunotherapy, the precise knowledge of physiopathological data would make it possible to propose a targeted therapy with little risk of adverse effects. Recent work has indeed shown excellent tolerance of immunotherapy during sepsis and could be applied eventually in patients with macrophage activation syndrome.

NCT ID: NCT03709849 Not yet recruiting - Clinical trials for Polycystic Ovarian Syndrome

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

Start date: February 1, 2019
Phase: Phase 2
Study type: Interventional

This study is to evaluate the effectiveness and safety of Bushen Culuan Decoction in the treatment of anovulatory infertility, including anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency, through a randomised, double-blinded, double-dummy, parallel positive controlled, adaptive multicenter clinical trial.

NCT ID: NCT03690024 Not yet recruiting - Clinical trials for Hemolytic Uremic Syndrome of Childhood

Outcame of Cases With Hemolytic Uremic Syndrome Attending Assiut University Child Hospital

Start date: October 1, 2018
Phase:
Study type: Observational

Diarrhea-associated hemolytic uremic syndrome (D+HUS) is defined as a prodrome of enteritis followed by thrombocytopenia (< 150,000/mm3), microangiopathic hemolytic anemia, and signs of variable degrees of renal damage (increase in serum Cr, proteinuria, and/or hematuria) . Our aim is to detect the most reliable early predictors of poor prognosis to identify children at major risk of bad outcome who could eventually benefit from early specific treatments.

NCT ID: NCT03655145 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

HLA 10/10 Matched Unrelated Donor vs Haploidentical Allogenic Hematopoietic Stem Cell Transplantation

MacHaploMud
Start date: August 2018
Phase: Phase 3
Study type: Interventional

The MAC-HAPLO-MUD trial is a randomized prospective phase III trial comparing HLA 10/10 matched unrelated donor and haploidentical allogeneic hematopoietic stem cell transplantation after myeloablative conditioning regimen in patients, age 15 years or older, with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) or Myeloproliferative Syndrome (SMP) or Myelodysplastic Syndromes (SMD) and requiring allogeneic hematopoietic stem cell transplantation. Primary endpoint is the 1-year progression free survival without acute grade II-IV GvHD and without moderate and severe chronic GvHD.

NCT ID: NCT03651726 Not yet recruiting - Tourette Syndrome Clinical Trials

A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome

Start date: August 2018
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy and safety of THX-110 in the management of tics and other symptoms (e.g. rage attacks, anxiety, depression, sleep difficulties) in patients with Tourette syndrome. In the first part of the study, half of the patients will receive THX-110, while the other half will receive a placebo. After completion of the first study part, patients will have the opportunity to continue into the second part of the study. In this part, all participants will receive THX-110.

NCT ID: NCT03630523 Not yet recruiting - Clinical trials for PTEN Hamartoma Tumor Syndrome

Response of Immune System to Flu Vaccination in PHTS

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

this study evaluates the cellular and humoral immune response to seasonal influenze vaccination in PTEN Hamartoma Tumor Syndrome. All subjects will be administered flu vaccination, half of the subjects will be control subjects.

NCT ID: NCT03614299 Not yet recruiting - Clinical trials for Primary Sjögren Syndrome

Eye Dryness Evaluation in Primary Sjögren's Syndrome

PEPSS
Start date: October 1, 2019
Phase:
Study type: Observational

The objective of this observational study is to develop new tools to assess primary Sjögren's syndrome (pSS) symptoms and to measure the severity of eye involvement in these patients.

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.