Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial...
DiabetesEndocrine System Diseases15 moreThe Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: Change care delivery Improve health outcomes Improve the experiences of young adult transition to adult care
Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
Growth Hormone DeficiencyTreatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD. Secondary • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of three different doses of MOD-4023 in Japanese pre-pubertal children with GHD.
7 Day Continuous Parathyroid Hormone IV Infusion
OsteoporosisBone Diseases2 moreStudy consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: To define the maximum safe dose of a seven day continuous administration of parathyroid hormone [PTH(1-34)] in healthy human volunteers. To estimate the effect of a seven day continuous administration of parathyroid Hormone (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and fractional excretion of urine.
Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma
Adenocarcinoma of the PancreasPancreatic Cancer7 moreThe investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
CarcinomaOvarian Neoplasm14 moreOur hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.
Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an...
Endocrine System DiseasesGastrointestinal DiseasesPatients admitted to internal medicine care environments have complex care needs and must be treated as persons with resources and responsibilities. Person-centred care is defined as care in which the caregiver aims to get to know the patient as a person, and the care comprises a holistic approach to assess patients' needs and resources. There is strong motivation for future health care to transform into an approach that acknowledges and endorses every patient's resources, interests and needs. There is limited existing research on the benefit of implementing person-centred care in internal medicine care environments for all patients regardless of diagnosis or care pathway. Little is known about the effects of person-centred inpatient care on patients' satisfaction with care. This study includes adult patients admitted to an internal medicine inpatient unit regardless of reason for admission. The aim of the study is to evaluate effects of person-centred inpatient care on care processes, in terms of satisfaction with care and person-centred content in medical records and to evaluate effects on self-reported health and self-efficacy.
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal...
Hormone DisturbanceThis is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency...
Growth Hormone DeficiencyTo evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.
Effects of the Addition of Metyrapone to Antidepressant Therapy in Depression With Dexamethasone...
Depressive DisorderHormone DisturbanceThe hypothesis of a link between depression and Hypothalamic-Pituitary Axis (HPA) dysfunction is now experienced. Since a first description in 1949 this link has made the HPA one of the most investigated hormonal axis in depression. Many studies have demonstrated quantitative variations of circulating cortisol in situation of depression including increasing of basal concentration of blood cortisol or Adrenocorticotropic Hormone (ACTH). Furthermore there is an attenuated negative feedback performance of the blood cortisol on the release of ACTH and cortisol. This attenuation seems to be a consequence of a bluntness of sensibility of the hypothalamic cells and their Glucocorticoids Receptors type 2. Actually it seems that these phenomena are included in a diversion of the cortisol's action. From a function of acute stress management, with short-time exposures, the cortisol become one of the factors increasing an allostatic load, or resulting of this increase, maintaining a permanent state of stress, an inertia delay to adaptation and facilitating the emergence of psychiatric disorders. This lack of function can be estimated by the Dexamethasone Suppression Test (DST) which, by stimulation attempting of feedback mechanisms by Dexamethasone (which has cortisol-like properties), can show a non-suppressor population with HPA bluntness. If this biological feature isn't a biological marker of depression, because of a lack of specificity and sensibility, is notably associated with a poor outcome and higher risks of suicidal behaviors and pharmacological resistance. Many studies have explored possibilities of action on the HPA to treat depression or improve antidepressant specific therapeutics, with inconstant results. One of the most promising molecule seems to be Metyrapone, a reversible inhibitor of the 11ß-hydroxylase enzyme which transform desoxycorticosterone and 11deoxycortisol to respectively corticosterone and cortisol. There have been several open label studies which aim to explore the possibility of an effect of the combination between Metyrapone and antidepressant molecules. This led to two randomized double blind controlled versus placebo studies whose conclusions are divergent. These conclusions and their heterogeneity lead to think that there is a sub-population which could be better responder to this type of association. Physiopathological knowledges and preliminary observations in DST non-suppressor population by using anti-glucocorticoids therapies , makes it possible to consider possible that responsive sub-population can be defined by the feature " DST non-suppressor ".
Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia...
Endocrine System DiseasesNutritional and Metabolic Diseases3 moreTo compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).