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NCT ID: NCT03418012 Not yet recruiting - Preterm Birth Clinical Trials

Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB

Prometheus
Start date: September 2020
Phase: N/A
Study type: Interventional

Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well. The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity < 34 week of gestation (WoG). The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.

NCT ID: NCT03138486 Not yet recruiting - Clinical trials for Various Advanced Cancer

A Study of the Effectiveness in Patients With Gastric or Gastroesophageal Junction Cancer With Nivolumab by Itself or in Combination With Ipilimumab and in Patients With Esophageal Cancer With Combination of Nivolumab and Ipilimumab.

CheckMate 648
Start date: June 1, 2017
Phase: Phase 2
Study type: Interventional

The main purpose of this study for patients with gastric or gastroesophageal cancer is to evaluate how well the tumor is responding to treatment with nivolumab by itself, or in combination with ipilimumab. For patients with esophageal cancer, the main purpose is to evaluate how well the tumor is responding to treatment with the combination of nivolumab and ipilimumab.

NCT ID: NCT03038802 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection

HBV003
Start date: September 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has confirmed this vaccine to be more effective at inducing seroconversion as measured by development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be able to induce HBV viral control and/or seroconversion in chronically infected subjects

NCT ID: NCT02262416 Not yet recruiting - Infertility Clinical Trials

GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles

GALA
Start date: January 2015
Phase: Phase 3
Study type: Interventional

In-Vitro Fertilisation (IVF) is the term commonly applied to a form of treatment for infertility that involves controlled ovarian hyperstimulation, egg maturation, egg collection, fertilisation, embryo culture and finally embryo transfer. The period after egg collection is called luteal phase. In Australia, vaginal progesterone is routinely used to support the lining of the uterus so that it is susceptible to implantation of the embryos. More recently, there has been some suggestion that additional supplementation of luteal phase with GnRH agonist increases clinical pregnancy and live birth rate. These studies are however heterogeneous and results were inconsistent. This study is a prospective randomised controlled trial of additional GnRH agonist in luteal phase of antagonist cycle. The primary hypothesis is that GnRH agonist increases the number of live birth . The secondary hypothesis is that this increases the clinical pregnancy rate, on-going pregnancy rate, without affecting the miscarriage rate, ovarian hyperstimulation rate and multiple pregnancy rate.

NCT ID: NCT01985347 Not yet recruiting - COPD Clinical Trials

The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study

SAD
Start date: November 2013
Phase: N/A
Study type: Interventional

The prevalence of anxiety and depression in our OSA population is more than in COPD and the general population of North West Adelaide. (principal hypothesis). CPAP therapy in OSA population produces a positive effect on the anxiety and depression scale. The Investigators intend to study the prevalence of anxiety and depression in patients with sleep disorders in comparison to patients with COPD and subsequently, to assess whether CPAP has a role in controlling anxiety and depression in depressed and anxious patients with sleep apnoea. This is a two phase study, in first phase; investigator will assess the prevalence of anxiety and depression, in a population with sleep disorders to check whether it is different to the prevalence in the COPD population. The prevalence of depression in Sleep Disorder population will also be compared with the Adelaide North Western general population, which was reported in The North West Adelaide Health Study. According to this epidemiological survey, which was conducted from 2008 to 2010, the prevalence of depression in Adelaide North Western general population was 20%.During the second phase of the study investigator will evaluate the effect of CPAP on anxiety and depression scores in the depressed and anxious patients with sleep apnoea by comparing the pre and post CPAP anxiety and depression status. The Hospital Anxiety and Depression (HAD) scale will be used to assess Anxiety and Depression, which is a well-documented tool for assessing symptoms of anxiety and depression in patients with somatic diseases.

NCT ID: NCT01949168 Not yet recruiting - Chronic Hepatitis C Clinical Trials

A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV

HCV-6
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy for the treatment of genotype 6 chronic hepatitis C infection. Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic hepatitis C infection. The investigators therefore hypothesise that: i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo. ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C infection.

NCT ID: NCT01926418 Not yet recruiting - HIV Clinical Trials

Using Implementation Intentions to Increase Safe Sex Practices in MSM

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the utility of the Theory of Planned Behavior in predicting condom use among men who have sex with men. It also aims to assess the utility of two interventions, one known as "implementation intentions", the other involves the practice of a planning task known as "the tower of Hanoi", in increasing condom use in this population.

NCT ID: NCT01869140 Not yet recruiting - Back Pain Clinical Trials

the Hypoalgesic Effect of Spinal Manual Therapy

Start date: November 2013
Phase: N/A
Study type: Interventional

To study the immediate effect of spinal manual therapy on pain perception in normal subjects

NCT ID: NCT01771042 Not yet recruiting - Obesity Clinical Trials

The Effects of Weight Loss on Neuroadrenergic Function

Start date: April 2013
Phase: N/A
Study type: Interventional

Elevated subconscious nervous system activity is a characteristic of the obese state and contributes importantly to the risk of heart disease and diabetes. This project will compare sympathetic nervous system activity and function in a group of obese persons with differing levels of sugar tolerance (normal, impaired and type 2 diabetic). Inter-relationships with insulin action, blood pressure, heart and kidney function will be determined before and after a 4-month weight loss and 3-month weight loss maintenance program. It is hypothesized that the transition from normal sugar tolerance to impaired sugar tolerance to type 2 diabetes will be accompanied by escalating sympathetic nervous system dysfunction. Furthermore, that weight loss will favorably improve sympathetic function, with greatest benefits occurring in those subjects who are insulin resistant with high blood insulin concentration.

NCT ID: NCT01642797 Not yet recruiting - Gastric Carcinoma Clinical Trials

Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

Start date: August 2012
Phase: N/A
Study type: Interventional

i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol. ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield. iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.