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NCT ID: NCT03703869 Recruiting - Diabetes Clinical Trials

Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

ATOS
Start date: March 6, 2018
Phase:
Study type: Observational

Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives: - Assess effectiveness in achieving glycemic goal measured by HbA1c; - Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; - Assess requirement for intensification of therapy by additional antidiabetics. - Assess incidence of hypoglycemia; - Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); - Assess change in body weight.

NCT ID: NCT03702959 Not yet recruiting - Hypoglycemia Clinical Trials

Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

A single "supraphysiological" course of exogenous corticosteroids is recommended between 24-34 weeks' gestation to minimize the adverse sequelae associated with prematurity. The 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.

NCT ID: NCT03702933 Recruiting - Schizophrenia Clinical Trials

D-serine in Schizophrenia

DSRSZ
Start date: September 1, 2018
Phase:
Study type: Observational

This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.

NCT ID: NCT03702361 Recruiting - Primary Disease Clinical Trials

Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) in Treatment-naive Patients With Type 1 Gaucher Disease

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

During the past two years, we have performed succsefuly an IIR wherein patients with GD, previously treated with velaglucerase alfa ERT were gradually switched to a 10 minutes (rapid) administration of the same ERT. The success was expressed as safety (no clinically meaningful AEs, no antibodies detected, home therapy), efficacy ("lack of deterioration") and patients' satisfaction. The latter was based not just on specific questionnaires and analog scales, but particularly by the patients' sharing the experience with other patients and consequently repeated requests by many to switch to a rapid administration of their ERT. Therefore, we are hereby proposing to investigate the safety and efficacy of a 10 minutes administration of velaglucerase alfa in a cohort of treatment-naive patients. Since the goal of this trial is eventually to allow a change in label and since the current VPRIV label is restricted to a dosage of 60 units/kg body weight every other week (60 units/kg EOW) - this dose will be used throughout the study period. The enzyme will be provided by Shire, which will also provide a research grant for the conduction of the trial.

NCT ID: NCT03701633 Not yet recruiting - Breastfeeding Clinical Trials

Uterine Artery Doppler Changes Prior and After Breastfeeding

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

We aim to determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.

NCT ID: NCT03700918 Recruiting - Clinical trials for Functional Tricuspid Regurgitation (TR)

FiH Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation

Start date: November 13, 2017
Phase: N/A
Study type: Interventional

The DaVingi™ TR System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ TR System is designed for performing ring annuloplasty by using a Ring Delivery System (RDS) to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.

NCT ID: NCT03696732 Not yet recruiting - Phenylephrine Clinical Trials

Anxiety and Phenylephrine Dosage

Start date: October 20, 2018
Phase:
Study type: Observational

Spinal anesthesia is considered gold standard anesthetic technique of choice for cesarean delivery (1). However its use is frequently associated with maternal hypotension, which occurs in up to 71% of cases, without prophylactic treatment(2) Spinal hypotension can lead to unpleasant maternal side effects such as nausea, vomiting and dizziness. In addition, adverse effects on the neonate occur because of reduced uteroplacental blood flow resulting in impaired fetal oxygenation and fetal acidosis. As such, current research recommends the prophylactic use of vasopressors for improved maternal and fetal outcomes(3). The international consensus statement on the management of hypotension during cesarean delivery states, that a prophylactic phenylephrine infusion is superior to bolus administration and should be dose titrated according to blood pressure parameters (4). In according to the international guidelines, in our obstetric anesthesia unit, we use a standardized spinal anesthetic regime protocol with a standardized prophylactic phenylephrine infusion at a rate of 50 mcg/min, with the vasopressor dose titrated according to every minute blood pressure parameters. Spinal anesthesia causes maternal hypotension, resulting from a blockade of sympathetic efferent neurons. Patients with higher baseline sympathetic activation have been known to have more marked hypotension after spinal anesthesia (5, 6) Anxiety causes generalized sympathetic activation (7). In a previous research the investigators showed that preoperative anxiety assessed by VAS had a significant effect on hypotension after spinal anesthesia (8). Study objective: In this study the investigators aim to evaluate the effect of anxiety on the cumulative phenylephrine dosage in women undergoing cesarean delivery under spinal anesthesia with prophylactic phenylephrine infusion. The primary hypothesis is that parturients who suffer from preoperative anxiety measured by a verbal numerical scale (VNS) anxiety score and Spielberger State-Trait Inventory questionnaire, will receive higher cumulative doses of phenylephrine (resulting from higher incidence of maternal hypotension).

NCT ID: NCT03696719 Not yet recruiting - Anesthesia Clinical Trials

Anesthetic Method and Cerebral Outcomes

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

Research regarding the effects of anesthesia on the central nervous system remain controversial with some studies suggesting a neurotoxic effect and others indicating a neuroprotective effect. In recent years numerous neuronal proteins have been found to be useful tools for diagnosis and prognosis of cerebral tissue damage. Among these neuronal proteins are the following markers: Neuron Specific Enolase (NSE), Tau protein, Glial Fibrillary Acidic Protein (GFAP), Ubiquitin Carboxy-Hydrolase L1 (UCH-L1). BIS is a non-invasive brain monitoring technology which monitors the depth of anesthesia. In this randomized clinical trial, we aim to examine the effect of anesthetic method (General anesthesia and neuroaxial anesthesia) on neuronal damage as measured by NSE serum levels. One hundred and forty patients aged 18 and above undergoing Transurethral resection of the prostate, Trans Urethral Resection of the Bladder Tumor, Tension Free Vaginal Tap , Trans Obturator Tension Free Vaginal Tap and pelvic floor repair surgeries will be enrolled in the study. Patients will randomly be assigned to undergo the study either under general anesthesia or with neuroaxial anesthesia. Participants will be monitored using the BIS monitor, to measure the depth of anesthesia. Additionally, 9 cc of venous blood be collected from each participant in the surgery room prior to anesthesia induction, throughout anesthesia and one hour following surgery in the PACU in order to assess NSE levels.

NCT ID: NCT03696485 Not yet recruiting - Clinical trials for Secondary Progressive Multiple Sclerosis (SPMS)

Study to Assess the Safety and Efficacy of an IT Administration of ADSC in SPMS

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

Prospective, single center, open label, phase I/IIa escalating dose study. To evaluate the safety and efficacy of escalating doses of SCM-010 in subjects with SPMS.

NCT ID: NCT03689985 Not yet recruiting - Clinical trials for Aspiration Pneumonia

Functionality and Accuracy of the smART System in Real-Life ICU Settings

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

This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).