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NCT ID: NCT02365896 Not yet recruiting - Clinical trials for Locally Advanced Gastric Cancer

Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

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

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

NCT ID: NCT02363569 Not yet recruiting - Clinical trials for Vaginal Bleeding During Pregnancy

The Prognosis of Early Pregnancy With Post Coital Bleeding

Start date: February 2015
Phase: N/A
Study type: Observational [Patient Registry]

This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women- E.R." at "Meir" Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.

NCT ID: NCT02354560 Not yet recruiting - Clinical trials for FAP-Familial Adenomatous Polyposis

Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version

Start date: June 2015
Phase: Phase 4
Study type: Interventional

Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world with a lifetime risk of 6%. Etiology is complex, while genetic background significantly affects the risk. Around one third of all genetic disorders as well as most cases of Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that prematurely halt the protein translation process, producing a shortened, nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop codon signal, the resulting protein may be able to ameliorate or stop the disease. Recently, members of the aminoglycoside family of antibiotics have been found to induce ribosomal read-through of nonsense mutations, leading to expression of a full length, functional protein. Investigators have recently shown that members of the aminoglycoside and macrolide antibiotic families can induce read-through of the nonsense mutations in the APC gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models. The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin to induce read-through of the nonsense mutations in the APC gene and to induce expression of a full length, functional APC protein in patients suffering from FAP and to tests its effect on adenoma number and size and on desmoid tumors in these patients. The future goal is to maximize the effect of stop-codon suppressors on APC while minimizing side effects. In this study investigators will select FAP patients which carry APC nonsense mutations, treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as well as abdominal desmoid tumors, that will be documented before during and after treatment. In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as blood samples from these patients for changes in expression levels of the APC protein and related oncogenic markers. Suppression of nonsense mutations within the APC gene should be of benefit for patients suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or diffuse CRC. Furthermore, given the rapid progress being made in the identification of different nonsense mutations in human genes that lead to mostly un-curable disease, the identification of clinically approved compounds that suppress nonsense mutations and that can be administered long-term without significant side effects would open new venues in the treatment of genetic human diseases that arise from pre-mature stop codons in important coding sequences. Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation in FAP patients. The read-through effect of erythromycin will be clinically tested by counting and measuring the number and size of both colonic and duodenal adenomas before and over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry for restoration of APC expression and changes in oncogenic markers. These experiments should be conducted within 6 month. Long term objective: 1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia and CRC in patients expressing a truncated APC protein due to nonsense mutations. 2. Examine the ability of a panel of additional macrolide antibiotics to induce APC nonsense mutation suppression using in-vitro methods. Investigators will focus on macrolide antibiotics that are currently in clinical use and are administrated for long terms. These objectives should take around 6 month and will be conducted in parallel.

NCT ID: NCT02347358 Not yet recruiting - Clinical trials for Ischemic Cerebrovascular Accident

Mechanical Opening Device Implantation Following Intravenous r-tPA for Recanalization in Acute Ischemic Stroke

Start date: February 2015
Phase: Phase 2
Study type: Interventional

This study is to test a hypothesis that temporary implantation of JRecanTM blood flow recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a major intracranial artery occlusion following IV r-tPA can provide a greater rate of early successful recanalisation than treatment of IV r-tPA alone.

NCT ID: NCT02341833 Not yet recruiting - Clinical trials for Post-transplantation Liver Allograft Function

Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts

Start date: January 2015
Phase: Phase 4
Study type: Interventional

The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.

NCT ID: NCT02338505 Not yet recruiting - Clinical trials for Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX

OB-ALFX
Start date: February 2015
Phase: Phase 2
Study type: Interventional

Phase II prospective single-institutional study.

NCT ID: NCT02334189 Not yet recruiting - Clinical trials for Avoidable Emergency Department Attendances

Targeted Letters to Reduce Avoidable Emergency Department Attendances

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

The study aims to test whether it is possible to reduce pressure on Emergency Departments by sending a personal feedback letter to people who have recently attended an Emergency Department and whose health issues could likely have been dealt with elsewhere. These attendances clearly have many causes. However, it is likely that some attendances are due to behavioural factors - in other words, the various ways in which users interact with services. This study focuses on one particular behavioural factor: lack of feedback to users making avoidable visits. The study will take place in collaboration with an NHS hospital trust. Each week during the trial, the hospital trust will identify those Emergency Department attendances in the last seven days which, according to clinical judgement, could have been dealt with elsewhere. Patients will then be randomly selected to receive a letter containing information on alternative healthcare options for non-emergency health concerns. Patient records will be analysed to determine whether the patients who received the letter are less likely to make an avoidable repeat visit to the Emergency Department in the future, compared with patients who received no letter.

NCT ID: NCT02332382 Not yet recruiting - Clinical trials for Breast Milk, Composition, Microbiome

The Influence of Mother Nutrition on Breast Milk Microbiome

Breast Milk
Start date: February 2015
Phase: N/A
Study type: Observational [Patient Registry]

The research subject Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. A mother's breast milk contains unique nutritious components and other nonnutritive elements that help promote healthy baby growth and development (1, 2). Recent studies show that a mother's breast milk contains components that vary from each specimen. There are great evidences that maternal and environmental factors have a strong influence on the composition of breast milk. Fatty acids, the second most common component found in breast milk, show extreme sensitivity to maternal nutrition (3, 4). Latest studies show that breast milk also contains bacterial communities that may have health implications of newborn. The structure of these bacterial communities also varied greatly between subjects (5) . In the research, we propose to investigate the connection between maternal nutrition, different fatty acids and their role in the growth and development of bacterial populations existing in breast milk.

NCT ID: NCT02329236 Not yet recruiting - Clinical trials for Attention-deficit/Hyperactivity Disorder

Prevalence of Attention Deficit Disorder Among Patients With Constitutional Growth Delay

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

The aim of the our study is to investigate whether there is an increased incidence of ADHD ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature.

NCT ID: NCT02326610 Not yet recruiting - Clinical trials for Infant, Premature, Diseases

Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

hGH
Start date: December 2014
Phase: Phase 2
Study type: Interventional

SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency. Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months. The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects. The study will take place at the Tel Aviv Medical Center only.