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NCT ID: NCT03939741 Recruiting - Clinical trials for Chronic Kidney Diseases

SVF (Adipose Tissue Derived MSC) Based Therapy for CKD.

StemCell&CKD
Start date: April 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

1. To assess the safety of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD). 2. To assess the efficacy of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD).

NCT ID: NCT03940885 Recruiting - Abdominoplasty Clinical Trials

Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery

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

Abdominoplasty is one of the most popular body-contouring procedures. Patients that undergo body-contouring abdominoplasty usually have important analgesic requirements. Given the substantial incision and soft-tissue undermining associated with this procedure, postoperative pain is a concern for patients and surgeons. Previous studies have typically incorporated multiple nerve blocks to improve analgesia after abdominoplasty. Different anesthetic techniques have been developed to overcome this problem such as Epidural anesthesia, Transversus abdominis plane block either open technique or ultrasound-guided, Paravertebral block and Erector Spinea plane block. Improving postoperative pain control in this kind of surgery leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. The ultrasound-guided erector spinae plane (ESP) block is a recent block described for various surgeries for postoperative analgesia. It is reported that it have an analgesic effect on somatic and visceral pain by affecting the ventral rami and rami communicantes that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia. The transversus abdominis plane (TAP) block is a technique of locoregional anesthesia that blocks the sensorial afferent nerves localized between the transversus abdominis muscle and the internal oblique muscle. In this study, the analgesic efficacy and duration of ultrasound (US) guided Erector spinea plane block and Transversus abdominis plane block when Lidocaine HCL is added as an adjuvant to bupivacaine will be compared.

NCT ID: NCT03950778 Recruiting - Sepsis Clinical Trials

The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients

Start date: April 1, 2019
Phase: Early Phase 1
Study type: Interventional

There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients. The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon.

NCT ID: NCT03951818 Recruiting - Thalassemia Major Clinical Trials

Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major

Start date: April 1, 2019
Phase:
Study type: Observational

Patient with thalassemia major have many endocrine diseases, such as hypopituitarism, hypothyroidism, hypoparathyroidis, osteoporosis, and etc.. These problems may be due to anemia itself or related to iron deposition. This study aimed to investigate the endocrine aspect of thalassemia major patients in Taiwan in order to introduce early intervention or treatment in the future.

NCT ID: NCT03953729 Recruiting - Pain Clinical Trials

Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH)

Start date: April 1, 2019
Phase: Early Phase 1
Study type: Interventional

Pain is defined by IASP (International Association for the Study of Pain) as "an unpleasant sensory and emotional experience associated with the damage actual or potential tissue or described in terms that suggest such harm". Episodes of pain and discomfort experienced by children are one of the main factors for fear and anxiety in dentistry, especially those that present the condition of Molar-Incisive Hipomineralization, where we observed increased levels of anxiety in relation to the treatment. In order to improve the painful sensation that patients with Molar-Incisor Hipomineralization present as well as anxiety demonstrated by these patients in face of dental treatment, the objective of present study will be to evaluate the occurrence and degree of pain after procedures dentists with administration of pre-emptive analgesia or placebo, in children with Molar-Incisive Hipomineralization. Fifty patients will be selected in the Pediatric Dentistry courses of the FORP-USP undergraduate course, aged 6 to 12 years, of both sexes, who present at least 2 (two) upper and / or lower molars affected by Molar- Incisors that need some kind of restorative treatment, extraction or endodontic treatment. Also, these patients should present enamel and dentin fractures caused by MIH, atypical restoration and / or atypical caries, and that present pain above the moderate degree (6>), after stimulation with air/water jet for 5 seconds.

NCT ID: NCT03955107 Recruiting - Clinical trials for Gestational Diabetes

The Effect of Continuous Glucose Monitoring on Glycemic Control and Pregnancy Outcomes in Gestational Diabetes Mellitus

Start date: April 1, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if Continuous glucose monitoring improves glycemic control and pregnancy outcomes of Gestational Diabetes Mellitus

NCT ID: NCT03955484 Recruiting - Clinical trials for Prostatic Hyperplasia

Benign Prostatic Hyperplasia and Glycosaminoglycan

Start date: April 1, 2019
Phase:
Study type: Observational

Lower urinary tract symptoms (LUTS) are one of the most common conditions in the urology clinic, affecting at least one in four men after 40 years of age. Benign prostatic hyperplasia is the most common cause of LUTS. Bladder dysfunction (hypersensitivity or detrusor overactivity) and bladder outlet obstruction are two main pathologies involved in the etiology of LUTS. In men aged 40-49, moderate and severe LUTS are reported as 26%, while this ratio is doubled in the age group of 70 years and older. Clinically, BPH is defined as an international symptom score of more than 8, a prostate volume of more than 30 ml, and a maximum flow rate of less than 15 ml / sec. Alpha blockers are recommended as the first-line medical treatment according to European Urology Guidelines (EAU Guidelines 2018) for patients diagnosed with BPH clinically. In recent years, many studies have been published on the relationship of urinary biomarkers with LUTS. Nerve growth factor and brain derived neurotrophic factor have been shown to be closely related to neurogenic or non-neurogenic detrusor overactivity and significant improvements were observed after treatment.The relationship between urinary glycosaminoglycan and overactive bladder has been shown and it has been reported that the values have decreased after treatment.Male patients with LUTS caused by BPH often have symptoms of overactive bladder. However, as far as we know, there is no study in the literature about the meaning of urinary GAG levels in this patient group. The aim of this study was to investigate the relationship between urinary glycosaminoglycan levels and patients who had benign prostatic hyperplasia with and without overactive bladder symptoms.

NCT ID: NCT03958526 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis

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

Transcranial Direct Current Stimulation (tDCS) is a promising non-invasive brain stimulation technique in chronic pain. There is no study investigating the effectiveness of tDCS in radiating chronic lower extremity pain related to lumbar spinal stenosis (LSS). The aim of this study is to investigate the effects of tDCS on pain, walking capacity, functional status and quality of life in patients with chronic pain related to LSS. 32 patients diagnosed with chronic pain related to LSS will be enrolled in this prospective, randomized, double blind, placebo-controlled study according to inclusion/exclusion criteria. Patients in active group will receive 10 sessions of anodal tDCS delivered over primary motor cortex (M1) with a constant current of 2 miliAmpers for 20 minutes. Patients will be evaluated at baseline, on day 1, 5 and 10 (after the session) and 5 days, 1 month and 3 months after treatment.

NCT ID: NCT03959839 Recruiting - Rectal Neoplasms Clinical Trials

Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias

DSETAMIS2018
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

A multicenter non-inferiority randomized clinical trial to compare Endoscopic treatment (ESD) and Minimally Invasive Laparoscopic Local Surgical Treatment (TAMIS or TEO) for early rectal neoplastic lesions (adenoma & T1CRC) Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) Secondary aims: Compare en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate, safety (rate of complications), morbidity and cost-effectiveness analyses.

NCT ID: NCT03960047 Recruiting - Child Behavior Clinical Trials

Testing Training Programs to Improve Children's Pedestrian Behaviors

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

Motor vehicle pedestrian injury is a critical issue for school children.1-4 Each year in the US, over 4900 pedestrians are killed and another 207,000 are injured, and about 25% of these pedestrian events involve school-age children. This research focuses on 7-8 year olds, who constitute a high-risk group for pedestrian injury. At these ages children regularly cross streets without supervision and they struggle both with selecting where to cross and determining how to cross. Research has shown, however, that children are capable of benefiting from effective behavioral training in pedestrian behavior. The proposed research addresses the issue of crossing skills deficits and will: (1) implement a randomized controlled trial (RCT) to test two alternative training programs to teach 7-8 year-olds where and how to cross streets safely; and (2) conduct an economic analysis to reveal cost:benefit indices for both. Meta-analyses of pedestrian training programs reveal that behavioral training in a traffic environment most reliably produces some degree of improvement in crossing skills. Thus, 'street-side training' is often described as the gold standard. Implementation, however, poses many practical problems related to implementation. The investigators have addressed this issue by developing a training system that uses a virtual pedestrian environment and extends past VR systems by having children fully cross the street and offering the unique capability of teaching both where and how to cross, with skills in each domain measured separately so exactly what is learned and what component crossing behaviors improved can be precisely determined for each individual child. Children (7-8 years) will be randomized to one of three groups (balanced for sex): street-side training, virtual-reality training, and a no-intervention control, with the same pre- and post- measures taken across groups. Primary analyses will test for changes in indices of where and how to cross, as well as attention to traffic when crossing. An economic analysis of the two programs will reveal their relative cost effectiveness. These results will provide essential knowledge to inform future decisions about 'best practices' in child pedestrian injury prevention through behavioral training.