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NCT ID: NCT03872622 Completed - Clinical trials for CD - Crohn's Disease

Intestinal Response Patterns to Microbial Signals

Start date: November 27, 2018
Phase: N/A
Study type: Interventional

A cohort of CD patients (total n=300) and a cohort of controls (healthy individuals and family members of CD patients, total n=200) will be recruited. We will analyze gut host pattern of tissue immune system and epithelial responses to putative exposome and microbial triggers, expression data in the gut using mRNA expression studies and genetic analysis of the resident bacterial flora are necessary to identify specific molecules and signal pathways as well as specific bacterial taxa involved in aberrant response and instigation of inflammation that is the driver of Crohn's disease. Therefore, We will obtain stool & blood samples and intestinal biopsy and/or resection specimens from CD patients, and blood, stool and intestinal biopsy samples from healthy individuals and a-symptomatic family relatives undergoing colonoscopy for reasons un-related to the study (e.g screening colonoscopy). Patients from both cohorts will also undergo environmental and dietary exposure survey. For environmental exposure, we will use the questionnaire developed by the International Organization of IBD (IOIBD), with some modification. Questions relate to five main different areas: (i) Childhood factors up to 20 years; (ii) food habits including daily, weekly or less frequent consumption; (iii) smoking habits; (iv) sanitary conditions such as the availability of in-house water tap, hot water tap or flush toilet; and (v) others factors including physical activity, oral contraceptive pill and stressful events before diagnosis. For mapping dietary habits we will employ an interview conducted by a trained dietician and using the validated structured FFQ (Food frequency Questionnaire).

NCT ID: NCT03871816 Completed - Clinical trials for Metastatic Prostate Cancer

A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

Start date: April 22, 2019
Phase:
Study type: Observational

The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.

NCT ID: NCT03869242 Recruiting - Glioblastoma Clinical Trials

NovoTTF-200A Together With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed GBM

NovoTTF-200A
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Study Objectives: To compare the efficacy and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to RT and TMZ to those treated with RT and TMZ alone Study Design: Prospective, randomized, open label, standard of care control Study Hypothesis: The hypothesis of this study is that addition of NovoTTF-200A treatment to RT and TMZ will significantly increase progression free survival of newly diagnosed GBM patients compared to patients treated with RT and TMZ alone Sample Size: 60 patients with newly diagnosed GBM Study Population: Patients with tissue based diagnosis of GBM, above 18 years of age, of both genders after surgery or biopsy amenable for radiation therapy (RT) with concomitant TMZ (Stupp protocol1) Primary endpoint: Rate of progression-free survival at 12 months (PFS12) Secondary endpoints: - Overall survival (OS) - Progression-free survival (PFS) - Progression free survival at 6 months (PFS6) - 1 and 2-year survival rates - Overall radiological response (ORR, per RANO criteria) - Safety (adverse events severity and frequency)

NCT ID: NCT03867084 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)

Start date: May 28, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).

NCT ID: NCT03867019 Completed - Vertigo Clinical Trials

The Cardiac Autonomic Control System Response to Vestibular Stimulation in Subjects With and Without BPPV

Start date: April 28, 2019
Phase:
Study type: Observational

The vestibular system in the inner year is an important system in the body which is responsible for balance. In addition, there is evidence that the vestibular system plays a role in maintaining blood pressure while changing body position, such as moving from lying down in bed to sitting. Dysfunction of the vestibular system may affect the ability to maintain blood pressure, therefore the aim of this study is to assess if a specific problem in the vestibular system (Benign Paroxysmal Positional Vertigo- BPPV) may cause changes in the interaction between the vestibular system and the cardiovascular system. We assume that patients with this medical condition (BPPV) will have different heart rate parameters in comparison with healthy patients.

NCT ID: NCT03866772 Terminated - Pregnancy Related Clinical Trials

Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both

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

The aim of this study is to compare the rate of cesarean delivery between 3 methods of labor induction: double balloon device, oral misoprostol and combination of the two.

NCT ID: NCT03866603 Recruiting - Parkinson´s Disease Clinical Trials

Rostock International Parkinson's Disease Study (ROPAD)

ROPAD
Start date: May 30, 2019
Phase:
Study type: Observational

Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.

NCT ID: NCT03865030 Completed - Psoriasis Clinical Trials

The Inner Ear Function in Psoriatic Patients

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

Psoriasis in a systemic disease that effects many systems of the body. few studies examined the hearing function of these patients but the results were inconclusive. No study, however, investigated the vestibular function of psoriatic patients. In a prospective study, the investigators will compare audiovestibular function between psoriatic patients and healthy volunteers. .

NCT ID: NCT03864549 Completed - Clinical trials for Gestational Diabetes Mellitus

The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus

Start date: January 8, 2020
Phase: N/A
Study type: Interventional

Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections. Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated. Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM. Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects. Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are: 1. The rate of women requiring medications for glycemic control 2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.

NCT ID: NCT03864055 Completed - Otitis Media Clinical Trials

Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

CSVT PCR
Start date: December 2, 2018
Phase:
Study type: Observational

The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT).