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NCT ID: NCT03796078 Recruiting - OSA Clinical Trials

Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea

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

ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them. METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center. During the study period: - Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1). - Assessment of PAS/PAV stability (relapse) at short term (1 month). 3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery. - Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist) - Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12). - Record of body mass index (BMI) (cm/Kg2) Main Objective: • Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA. Specific objectives: • Interrelate the degree of dentofacial deformity with the IAH. - Study the potential correlation between the volume of the VAS and the IAH. - Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS). - Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA. Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA. - To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA. - Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA. - Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term. - Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery. Hypothesis - H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term. - H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.

NCT ID: NCT03793478 Recruiting - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

Start date: August 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.

NCT ID: NCT03788733 Recruiting - Clinical trials for Sleep Disorders, Circadian Rhythm

The Efficacy of Melatonin in the Burning Mouth Syndrome

BMS
Start date: December 14, 2018
Phase: N/A
Study type: Interventional

Burning mouth ( BMS) syndrome is the oral disorder characterized by an intraoral burning sensation for which no medical or dental cause can be found. The Headache Classification Committee of the International Headache Society (IHS) defines (BMS) as an ''intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions''. (BMS) is a common, chronic problem that has a negative impact on quality of life. A wide variety of medications have been proposed for treating (BMS) both topical and systemic. Unfortunately, no treatment seems to offer assured results. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep Melatonin also may help sleep disturbances associated with (BMS) ; however, this remains to be proven.

NCT ID: NCT03788473 Recruiting - Clinical trials for Periodontitis During Pregnancy

"Periodontal Disease as a Possible Risk Factor for Complications During Pregnancy and Childbirth

PERIOEM
Start date: March 15, 2018
Phase:
Study type: Observational [Patient Registry]

Pregnancy is a physiological state that is part of the reproductive life of women, establishing their fertile age between 15 and 45 years mainly. This stage will not only mark the birth of the baby but also cause various changes both immunological and physiological, to accommodate the growing fetus. Maternal periodontitis has direct and indirect potential to influence the health of the fetus-maternal unit. According to the literature reviewed, the first evidence that oral bacteria influenced pregnancy outcomes was reported by Collins et al. The injection of P. gingivalis into pregnant hamsters caused intrauterine growth retardation and smaller fetuses, together with an increase in the levels of proinflammatory mediators (IL-1b and PGE2) in the amniotic fluid. Two hypotheses have been pointed out regarding the link between oral health and the adverse outcome of pregnancy. The first states that periodontal disease causes abnormal systemic immune changes, leading to complications in pregnancy. While the second hypothesis suggests that oral bacteria directly colonize the placenta, causing localized inflammatory responses, resulting in prematurity and other adverse outcomes.

NCT ID: NCT03787966 Recruiting - Breast Neoplasms Clinical Trials

Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program

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

The aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.

NCT ID: NCT03787602 Recruiting - Clinical trials for Merkel Cell Carcinoma

Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma

Start date: March 19, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC.

NCT ID: NCT03786250 Recruiting - Aging Clinical Trials

Comprehensive Geriatric Assessment in an Emergency Department

CGA_ED
Start date: December 1, 2018
Phase:
Study type: Observational

Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows. Objective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years). Two periods are compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017

NCT ID: NCT03784508 Recruiting - Morbid Obesity Clinical Trials

Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients

PREDI-BAR
Start date: April 1, 2018
Phase:
Study type: Observational

The prevalence of obesity in Spain is about 21.6%. The discouraging results provided by dietary treatment, together with the lack of funding for pharmacological treatment, have led to the progressive use of bariatric surgery (CB). Besides weight loss, CB associates a beneficial effect on metabolic comorbidities. However, 25-30% of operated patients present a weight response considered inappropriate, they do not resolve their comorbidities and/or present a weight-regain shortly after surgery. Therefore, predictive strategies are necessary to allow a correct selection of obese patients who are candidates for CB. The main hypothesis of the study is that various factors such as psychopathological profile, body composition and metabolic alterations related to morbid obesity can influence the response to bariatric surgery.

NCT ID: NCT03784131 Recruiting - Clinical trials for Chronic Venous Insufficiency

Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

TECVI-1
Start date: December 15, 2021
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the safety (incidence of adverse events including serious adverse events and clinical significant laboratory abnormalities) of personalized tissue engineered veins (P-TEV) with valves implanted in patients with severe chronic venous insufficiency (CVI). For each patient a segment of the femoral vein containing the non-functioning valve will be surgically replaced with a single P-TEV containing a functioning valve.

NCT ID: NCT03780595 Recruiting - Clinical trials for Benzodiazepine Withdrawal (Disorder)

Passiflora Extract for Benzodiazepine Withdrawal

SEDISTRESS
Start date: September 27, 2018
Phase: Phase 4
Study type: Interventional

The aim of this clinical trials is compare the percentage of patient who achieve a reduction equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.