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NCT ID: NCT03145311 Completed - Clinical trials for Drug Induced Tardive Syndrome (DITS)

First rTMS for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

This study aims to evaluate the efficacy of rTMS on DITS. Twenty patients with DITS were recruited from the outpatient clinic of Aswan University Hospital. The patients were classified into two equal groups, 1st group received real high frequency rTMS at 100% RMT and the 2nd group received sham stimulation with the same pulse delivery but with the coil placed perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5 consecutive days each week for two weeks. All patients were assessed before rTMS and immediately after the end of the 10 sessions. This study is double blinded (the doctor and the patients). Assessment with AIMS scale and different parameters of cortical excitability were performed before and after the end of sessions treatment.

NCT ID: NCT03145298 Completed - Clinical trials for Pulmonary Arterial Hypertension (PAH)

ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy

ALPHA
Start date: October 1, 2017
Phase: Phase 1
Study type: Interventional

Pulmonary Arterial Hypertension or PAH is a progressive condition for which there is no cure. Even with substantial pharmacologic advances in the modern treatment era, survival still remains unacceptably poor, as reported in large PAH registries. Preclinical studies suggest that the administration of allogeneic CDCs have the potential to reduce adverse arteriolar remodeling in PAH which was the basis for the approved investigational new drug (IND). The use of CDCs as an adjunctive therapy in patients comprising 4 sub-groups of patients with PAH in which inflammation and immune dysfunction are key pathophysiologic drivers of PAH.

NCT ID: NCT03145246 Completed - Clinical trials for Regenerative Periodontal Treatment

Long-Term Outcome Following Regenerative Periodontal Treatment of Intrabony Defects

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

Many years ago, periodontal regenerative treatment has been done in Periodontics and Oral Medicine Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. However, there is still lacking of study about long-term result of periodontal regenerative treatment of intrabony defects.

NCT ID: NCT03144999 Completed - Clinical trials for Dry Age-related Macular Degeneration

Treatment of Advanced Dry Age Related Macular Degeneration With AAVCAGsCD59

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

Age related macular degeneration (AMD) is the leading cause of vision loss in individuals over age 60. AMD is classified as wet and dry. Wet AMD constitutes 10 to 15% of all cases of AMD and occurs when an abnormal blood vessel grows in or under the retina leading to central vision loss. Wet AMD is successfully treated with injections in the eye on a monthly basis that stop the blood vessel from growing and leaking. The most common form of AMD is the dry variant or dry AMD that affects 85 to 90% of all patients with AMD. In dry AMD, there is loss of retinal pigment, formation of deposits called drusen, and loss of the vessels in a layer of the retina called the choriocapillaris. In the most severe forms of dry AMD there is loss of retinal tissue called geographic atrophy. Over time retinal tissue degenerates in the area responsible for central vision leading to vision loss leading to legal blindness. Currently no treatment for dry AMD exists so that there is a significant unmet need in patients with this ocular disease. Recently, evidence has implicated an overactive inflammatory cascade called the complement system as playing a pivotal role in the development of dry AMD. The complement cascade consists of 3 arms that converge to form a pore-like complex on the surface of cells called the membrane attack complex (MAC). Accumulation of MAC on cell surfaces leads to cell damage and death causing the clinical findings seen in AMD. Normal cells within the human body produce a protein on their cell surfaces called CD59 that blocks the MAC from forming. In AMD, the complement cascade is upregulated and leads to more MAC formation than the body can protect itself against leading to cell destruction. AAVCAGsCD59, an ocular gene therapy product that is injected in to the eye in the physician's office, causes normal retinal cells to increase the expression of a soluble form of CD59 (sCD59). This soluble recombinant version of the naturally occurring CD59 is designed and intended to protect retinal cells that are responsible for central vision by inhibiting the formation of the membrane attack complex (MAC), the terminal step of complement-mediated cell lysis. In gene therapy the cells of the retina are potentially permanently altered to make sCD59 for the life of the patient. With gene therapy only one injection is needed for the drug to be effective for the patient's entire life. This study will evaluate the safety after a single injection of AAVCAGsCD59 administered in an office setting for patients whose enrolled eye has advanced dry AMD with geographic atrophy. The initial study is 26 weeks followed by an additional 18-month safety evaluation.

NCT ID: NCT03144778 Completed - Clinical trials for Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7

Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal Squamous Cell Cancer

Start date: July 12, 2017
Phase: Phase 1
Study type: Interventional

This phase I trial studies how well durvalumab with or without tremelimumab works in treating participants with stage II-IVA oropharyngeal squamous cell cancer. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03144739 Completed - Depression Clinical Trials

Collaborative Care for Children's Mental Health Problems

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Background: Mental health problems cause a disproportionate burden of disability among children and youth compared to adults. Primary care plays an important role in efforts to prevent and intervene early in the course of child and adolescent mental health problems. While research with adults has shown the feasibility of integrating mental health care into primary care settings, there have been few studies among children and youth. Evidence remains lacking that integration is feasible in diverse settings, that it improves outcomes, and that methods can be developed to address the mixed symptoms of emerging child/youth problems and their overlap with developmental and parental disorders. Goals: The purpose of this project is to test the effectiveness of adding a child/youth mental health component into an existing collaborative care program for adult mental health problems. The work will refine a framework for efficient cultural adaption and tailoring of an existing child/youth primary care mental health intervention and then test whether the tailored intervention results in improved child and parent outcomes. The work will also provide evidence about the mechanisms by which those outcomes are achieved and what factors influence uptake of the child/youth component by general practitioners (GPs). These results should be generalizable to low and middle income countries and to underserved areas of the US where there are minimal child mental health resources and family physicians provide the bulk of medical care for children and youth. Methods: The planned work involves the adaptation/tailoring process followed by a trial with 45 GPs already engaged in collaborative care for adults; the trial will study adding collaborative care for children ages 5-15. GPs will be randomly assigned in groups to begin 6-month control periods involving child mental health screening and referral. They will then receive child/youth training and begin second 6-month periods of screening plus ongoing coaching and booster sessions and collaborative management. Primary outcomes will be measured by recruiting and following for 6 months two cohorts of children/youth and their parents (one control, one collaborative care). Data collected from GPs, parents, youth, and the collaborative care data system will allow measurement of key factors that determine the program's success in helping children and families.

NCT ID: NCT03144687 Completed - Clinical trials for MPN (Myeloproliferative Neoplasms)

A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis

Start date: January 26, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of itacitinib combined with low-dose ruxolitinib or itacitinib alone in participants with myelofibrosis (MF).

NCT ID: NCT03144492 Completed - Clinical trials for Microgravity Exposed Endothelial Cells

Microgravity Effects on Co-cultured Vascular Cells Types

Start date: May 26, 2017
Phase:
Study type: Observational

The goal of this study is to assess the affect of ground based microgravity on co-cultured vascular cell types. Our goal is to better understand the cross-talk between vascular cell types grown under conditions such as microgravity as is seen in space. In this pilot study, the investigator proposes to assess changes in cell phenotype and function in microgravity as compared to normal gravity.

NCT ID: NCT03144310 Completed - Clinical trials for to Detect the Incidence of Atelectasis

To Evaluate the Role of Lung Ultrasonography for Detection of Atlelectasis in Robot Assisted Laproscopic Pelvic Sugeries

Start date: November 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis

NCT ID: NCT03144011 Completed - Clinical trials for Cardiopulmonary Bypass

Acute Kidney Injury in Children After Cardiopulmonary Bypass

Start date: February 8, 2017
Phase:
Study type: Observational

Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%. The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors. Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage. Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage. It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost. Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.