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NCT ID: NCT03250793 Completed - Clinical trials for Hernia, DIaphragmatic, Congenital

Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation.

NAVA-DIAPH
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a synchronized proportional assisted ventilation. This technique has already been used in the newborn, especially premature and has shown many benefits. Only one study in the literature shows its feasibility in newborns with CDH. This technique seems interesting in the context of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating the clinical benefits, it seems important to describe the effects on the respiratory physiology, in particular on work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is an innovative physiologic pilot study with the objective to describe work of breathing in neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation using an esophageal transducer. It will provide the clinician with a physiological justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of these patients. This study is a prerequisite for the realization of studies demonstrating the clinical benefit of NAVA ventilation on reduction of duration of ventilation and more generally on morbidity and mortality in the population of neonate with CDH.

NCT ID: NCT03250728 Completed - Clinical trials for Congenital Disorders of Glycosylation

Role of the Endothelium in Stroke-like Episode Among CDG Patients

PECDG
Start date: November 23, 2017
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the role of the endothelial barrier in the occurrence of stroke-like episode. And to study the protein C system on the surface of the endothelium.

NCT ID: NCT03250676 Completed - Breast Cancer Clinical Trials

Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Start date: August 17, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene [ESR1] Y537S mutation).

NCT ID: NCT03250572 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among NAFLD Patients

Start date: June 2015
Phase: N/A
Study type: Observational

This study was designed to assess the relation between serum ferritin and hepatic fibrosis in patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its correlation with steatosis and fibrosis was done.

NCT ID: NCT03250520 Completed - Clinical trials for Brain Tumor, Pediatric, Recurrent

Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca

Start date: September 1, 2017
Phase: Early Phase 1
Study type: Interventional

This Protocol is a pilot, clinical interventional study to selected patients between five and fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade recurrent in the central nervous system tumors, in whom there has been no response to conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow treatment with conventional measures, and that already have an indication for a neurosurgical palliative procedure. It will be a close pharmacovigilance on possible adverse effects related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.

NCT ID: NCT03250013 Completed - Clinical trials for Attention Deficit Disorder With Hyperactivity

Long-term Effects of Medication for ADHD

LMA
Start date: April 2014
Phase: Phase 4
Study type: Interventional

Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17 years, who receive medication for ADHD of any subtype (presentation). Long-term results are evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales; WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional Impairment Scale; WFIRS), and quality of life (Child Health and Illness Profile-Child Edition Scale; CHIP-CE) during 24 months of ADHD treatment.

NCT ID: NCT03249740 Completed - Clinical trials for Neovascular Age-Related Macular Degeneration

A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

Start date: August 29, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.

NCT ID: NCT03249662 Completed - Clinical trials for Bilateral Total Knee Arthroplasty

Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty

Start date: September 27, 2017
Phase: N/A
Study type: Interventional

To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty. To study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.

NCT ID: NCT03249649 Completed - Clinical trials for Female Genital Mutilation Type II Status

Female Genital Cutting in the Arizona Somali Refugee Community

FGC
Start date: July 1, 2016
Phase:
Study type: Observational

The focus of this project is to elucidate the gaps in care and enhance the provision of FGC-related health care and social services for women in Arizona who have experienced FGC; engaging the Somali and Somali Bantu communities. As of 2012, Arizona ranked 7th in the US for Somali refugee resettlement. The Refugee Women's Health Clinic (RWHC) is a nationally recognized best practice model for refugee women's health, providing specialized care for women with FGC. The project will accomplish four outcomes throughout its three-year duration: 1: Identify specific FGC-related health care needs and available health and social services for women in Arizona who have experienced FGC to improve services to FGC-affected communities; 2: Identify gaps, barriers, and/or assets in FGC-related health care and social services for women in Arizona who have experienced FGC to provide improved services to FGC-affected communities; 3: Create and implement FGC education efforts so that providers improve culturally competent care for women who have experienced FGC in health care and social service settings; and, 4: Create and implement community outreach and educational programs among communities affected by FGC to increase awareness of FGC-related health issues, prevention and services available. To inform these initiatives, an established infrastructure exists through the Refugee Women's Health Community Advisory Coalition (RWHCAC), a team of more than 60 stakeholders from various local ethnic organizations, refugee resettlement and voluntary agencies, mental health and social services agencies, and academic partners and including local voluntary resettlement agencies (VOLAGs) and Ethnic Community-Based Organizations (ECBOs). RWHCAC will be (a) involved in the planning/design of the project, (b) encouraged to assume responsibility to identify additional Community Mobilizers, (c) engaged in aligning educational material content to cultural standards, and (d) engaged in evaluating the project processes and outcomes. Project strategies include: (1) identifying specific FGC-related health care needs and available health and social services for FGC-affected women including identification of gaps, barriers, and/or assets in FGC-related care (year 1); (2) utilizing results from the Community Health Needs Assessment (CHNA) to refine existing educational materials and implement educational outreach efforts across the state to improve culturally competent care among providers (years 2 and 3); (3) promoting outreach and education among FGC-affected communities through development of culturally appropriate materials and community education sessions (years two and three); and, (4) partnering with Arizona Department of Health Services, the University of Arizona, and African Women's Health Center, Brigham and Women's Hospital during year 2 to deliver inter-professional training workshops for health and social service providers on FGC, and with Johns Hopkins University for FGC teleECHO™ video conferencing clinics to promote sustainability via links to online resources, educational materials, and webinars (years 2 and 3). Emergent products include online learning components, community education sessions, FGC teleECHO™ sessions, and capacity building trainings for all partners.

NCT ID: NCT03249571 Completed - Clinical trials for Exercise and Gut-derived Phenolics

Flavonoids, Exercise, Gut-Derived Phenolics

Start date: June 5, 2017
Phase: N/A
Study type: Interventional

PURPOSE: 1. PRIMARY: Using a randomized, parallel group design, this investigation will determine if the combination of 2-weeks polyphenol supplementation (using the Reoxcyn flavonoid supplement in capsule form) and one acute 45-minute brisk walking bout enhances the translocation of gut-derived phenolics into the circulation. A comparator group of runners (N=20) ingesting the flavonoid supplement for two weeks will be included (2.5 h run, 70% VO2max). 2. SECONDARY: Data from this study will determine if 2-weeks supplementation of the Reoxcyn flavonoid supplement is a sufficient time period to increase circulating levels of gut-derived phenolics, extending data collected from the previous 12-week community trial. HYPOTHESIS: We hypothesize that an acute 45-minute brisk walking exercise bout (60% VO2max) following 2 weeks of increased polyphenol intake will be a sufficient exercise stimulus to increase gut permeability and the movement of gut-derived phenolics into circulation. If this hypothesis is confirmed, these data would have broad public health appeal, demonstrating that the combination of brisk walking and increased polyphenol intake augments circulating levels of health-restoring small phenolic molecules derived from bacterial breakdown in the colon.