Clinical Trials Logo

Filter by:
NCT ID: NCT03046719 Completed - Retinal Detachment Clinical Trials

Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Start date: September 2016
Phase: N/A
Study type: Interventional

The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative analgesia in intravitreal silicone evacutaion surgery

NCT ID: NCT03046693 Completed - Clinical trials for Non-arteritic Anterior Ischemic Optic Neuropathy

Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

NAION
Start date: January 16, 2017
Phase: Phase 4
Study type: Interventional

Clinical trial.gov Brief summary : Non-arteritic anterior ischemic optic neuropathy (NAION) is an optic neuropathy due to acute or subacute ischemic event of anterior optic nerve axons retrolaminar part that was vascularized by posterior ciliary brevis artery. The incidence of ischemia will be followed by axonal edema and causing compartment syndrome and heighten the incidence of ischemic. In NAION, the main pathology occurs at the level of the optical nerve, the axons of retinal ganglion cells. Initial damage is on the optic disc ischemia resulting hypoxic injury of axons and manifest as disc edema. Axonal edema cause disturbances of retrograde axonal transport of neurotrophic factors, especially brain derived neurotrophic factor, to the retinal ganglion cells. This will trigger a secondary toxicity and apoptosis. In addition, the presence of oxidative stress, calcium influx and mitochondrial damage will also triggers apoptosis. After the apoptosis of retinal ganglion cells, there was a thinning of the retinal nerve fiber layer (RNFL) through Wallerian degeneration. Thinning of the RNFL will manifest as visual field defects and the decline in visual acuity in patients with chronic phase NAION. Though NAION include disease entity that has long existed, but until now, there has been no evidence-based study on medical or surgical procedures that is effective enough to overcome NAION. The main treatment is to manage the risk factor such as hypertension, dyslipidemia, diabetes mellitus, hypercoagulable state. In general, if the patient is in the acute phase (edema of optic nerve head), methylprednisolone administration may be considered, but if the patient is already on chronic phase (atrophy disc) which generally occurs 6-11 weeks after the onset, then steroids are no longer indicated. Neuroprotective agent was considered as treatment in NAION given primary pathology NAION is the retinal ganglion cell axons. Among the various neuroprotective substance, Citidine diphosphocoline (CDP-choline 5'-diphosphocholine or Citicoline) is a therapeutic option NAION. Citicoline is an endogenous mononucleotide consisting of ribose, cytosine, pyrophosphate, and choline. Citicoline is a component intermediates in the synthesis of phospholipids in cell membranes, ie phosphatidylcholine. Exogenous citicoline administered orally or intravenously, will be split into citidine and choline. Citicoline via oral administration can be absorbed completely and have a similar bioavailability in the blood compared to parenteral administration such as intravenous. Once absorbed, citicoline will be distributed throughout the body and enter the blood-brain barrier and the blood retinal barrier penetrate into the central nervous system. If there is damage to neurons, exogenous citicoline will participate in the synthesis of phospholipids in the neuronal cell membrane. Some studies show that citicoline may have a neuroprotective effect on retinal ganglion cells and supporting regeneration of damaged neurons in vitro. Previous research on the citicoline effect in chronic phase NAION give satisfactory results. Dopaminergic neurotransmitter systems known to occur in vast numbers in the retina and post-retinal visual pathway. Retinal ganglion cells using certain subtypes of dopamine as a means of communication with the visual cortex. Rejdak et al in animal models showed that citicoline administration could improve and strengthen the dopamine transmission in the retina. Citicoline also a safe medicine, without serious adverse effect. Electroretinogram (ERG) is a tool to measure the function of the retina. ERG examination can measure electrical changes in the retina after light stimulus. ERG examination that can detect changes in the activity of retinal ganglion cell is a pattern ERG. Spectral-domain optical coherence tomography is a tool that can measure the thickness of retinal ganglion cells. Thinning of the RNFL will manifest as visual field defects in patients with NAION. The typical visual field defects of NAION is altitudinal defects associated with segmental edema optic nerve head. Based on these descriptions question arises whether the citicoline supplementation can repair damage to the neurons of the retina, especially the retinal ganglion cells, in NAION resulting in improved retinal function which can be judged from the improvement of the value of the amplitude of the wave of P50 and N95 in the examination pattern ERG (PERG) when compared with placebo ? In addition whether citicoline supplementation can increase the thickness of retinal ganglion cells assessed using SD-OCT? Does citicoline supplementation give the effect of improving visual field defects in patients with NAION?

NCT ID: NCT03035032 Completed - Prostate Cancer Clinical Trials

A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients

Start date: June 23, 2017
Phase: Phase 4
Study type: Interventional

The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.

NCT ID: NCT03021954 Completed - Clinical trials for Pelvic Floor Disorders

Platelet Rich Plasma in Levator Ani Muscle Trauma

Start date: November 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.

NCT ID: NCT03017872 Active, not recruiting - HIV Infections Clinical Trials

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

D²EFT
Start date: November 23, 2017
Phase: Phase 4
Study type: Interventional

D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that one or both of the new regimens will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.

NCT ID: NCT02995772 Completed - Breast Cancer Clinical Trials

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT)

NCT ID: NCT02976701 Terminated - Clinical trials for ST Elevation Myocardial Infarction

Effect of DLBS1033 After Primary PCI in Patients With STE-ACS

Start date: November 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the study.

NCT ID: NCT02968264 Completed - Clinical trials for Congenital Heart Disease

Tetralogy of Fallot for Life

TOF-LIFE
Start date: June 8, 2015
Phase:
Study type: Observational [Patient Registry]

The aim is to conduct a prospective multi-centre international inception cohort study with an enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample size and methodology will result in statistically powerful results to allow for evidence-based change to current TOF surgical practices.

NCT ID: NCT02959125 Active, not recruiting - Pregnancy Clinical Trials

NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes

Start date: December 12, 2016
Phase: N/A
Study type: Interventional

This study evaluates the intervention of Nut Fish based food, micro nutrients supplementation and pregnancy class to improve maternal and birth outcome. This is cluster randomized trial with two arms. The intervention group will receive Nut Fish based supplementation, multiple micro nutrients, and pregnancy class. The control group will receive government food supplementation, iron folic acid supplementation, and pregnancy class.

NCT ID: NCT02957773 Completed - Depressive Symptoms Clinical Trials

Integration of Social Art Activities and Qigong for Older People in Nursing Home in Indonesia

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

This project will be a randomised controlled trial to investigate the effectiveness of an integrated programme by using social art activity (SA) and exercise, for instance, Qigong (QG, a traditional Chinese exercise) as a therapeutic medium. This integrated programme aims to increase the well-being and reduce the depressive symptoms that are frequently ascertained in older people who live in nursing homes. The combination of SA and QG might be more beneficial to older people than either individual activity on its own, given that they are addressing different areas of functioning. The art activity focuses on self-expression in non-verbal activity using fine motor movement, whereas physical exercise like Qigong focuses on awareness of breathing and a calm state of mind. This is to help the older person achieve mental and physical relaxation by using gross motor movement. When the interventions are combined by utilising Qigong ahead of the art activities (thus, including both fine and gross motor movements) older people will reach a state of mental and physical relaxation, and moreover, will be able to express their feelings more simply in the social art activities.