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Disease Progression clinical trials

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NCT ID: NCT02753192 Recruiting - Parkinson's Disease Clinical Trials

Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison

FraLusoPark
Start date: January 2014
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is classically characterized by a symptomatic triad that includes rest tremor, akinesia and hypertonia and although the motor expression of the symptoms involves mainly the limbs, the muscles implicated in speech production are also subject to specific dysfunctions. Motor speech disorders, so-called dysarthria, can thus be developed by PD patients. The main objective of our project is to evaluate the physiological parameters (acoustics), perceptual markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree of impairment of such parameters should be associated with the pathology and be present universally in all patients, even if they speak different languages; that should be also the case of prosodic markers, whereas impairment of speech intelligibility may participate to the psychosocial impact in communication alteration. PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60). Their global motor disability will be assessed with dedicated clinical rating scales, without (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched volunteers will provide the normal reference for between-group comparisons. Along with the off and on medication clinical examinations, several speech tasks will be recorded. Moreover, speech organ functions will also be assessed during the same examination. The psychosocial impact of dysarthria will be evaluated via self-questionnaires; it will be analysed a posteriori, as well as the speech intelligibility evaluation, and both will strengthen the overall speech assessments. This global investigation will represent a unique opportunity to provide the most precise and reliable description of PD patients' speech and its impacts on intelligibility and quality of life. Challenging and interdisciplinary aspects are combined in our project, which original cross-linguistic approach involves an international collaboration definitely new in the field of motor speech disorders.

NCT ID: NCT02744976 Completed - Clinical trials for Coronary Artery Disease

Coronary Artery Disease Progression in Patients With Prediabetes

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent restenosis after bare metal and drug-eluting stent implantation more frequently is observed in patients with high fasting-insulin levels and IR. Although IR has a significant role in the progression of atherosclerosis in prediabetic patients, the importance of managing prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment has been officially approved for prediabetes. According to American Diabetes Association recommendations, metformin is the only drug that could be considered in the treatment of prediabetic patients with a high risk of developing diabetes. Metformin is a safe and inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events in patients with type 2 diabetes as well as the progression of atherosclerosis in non-diabetic animal models. This study was designed to analyze coronary plaque characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic patients at 24 month follow up. The study hypothesis is that more pronounced coronary atherosclerosis progression as well as in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin treatment attenuates the progression of atherosclerosis in patients with prediabetes.

NCT ID: NCT02742064 Completed - Depression Clinical Trials

Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

Start date: February 2015
Phase:
Study type: Observational

The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. Meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.

NCT ID: NCT02681809 Terminated - Clinical trials for Diabetic Retinopathy

A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR

CIRCLE
Start date: December 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).

NCT ID: NCT02654756 Completed - Clinical trials for Chronic Kidney Disease

Risk of Chronic Kidney Disease Progression

Start date: May 2013
Phase:
Study type: Observational

While there are proven therapies that slow CKD progression, these therapies can at times be harmful and costly. The ability to accurately predict the risk of CKD progression to ESRD would be extremely valuable. The short term versus lifetime risk of CKD progression should be taken into account when making risk based clinical decisions. In a representative CKD practice, the investigators compared the short term and lifetime risk assessment in our stage 3 CKD patients to determine whether decisions based on a short term risk assessment would underestimate the lifetime risk of CKD progression. The investigators also applied the short term risk assessment to our stage 4 CKD patients to determine the frequency with which ESRD risk may be overestimated in CKD stage 4.

NCT ID: NCT02644044 Not yet recruiting - Clinical trials for To Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MS

Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm Study

ITMTXPMS
Start date: January 2016
Phase: Phase 0
Study type: Interventional

Multiple sclerosis (MS) is characterized pathologically by demyelination, axonal loss, and glial scar formation. Clinically, most patients have a relapsing-remitting course of MS (RRMS) that over time may become progressive without remissions - a secondary progressive MS (SPMS). About 15% of patients have a progressive course from onset which is called primary progressive (PP). Currently, there is no approved treatment for PPMS and for SPMS only therapy with mitoxantrone showed mild effect. Thus, more effective therapies need to be developed for treatment of SPMS and PPMS. Methotrexate (MTX), an anti-metabolite, has been in clinical use since 1948 when it was found to produce temporary remission of acute childhood leukemia. There are accumulating evidences that in progressive MS patients there are follicular lymphoid structures in the meninges and in the Virchow-Robin spaces. Therefore, intrathecal therapy may target the pathological follicular lymphoid activity. The safety of intrathecal MTX (ITMTX) has been demonstrated by its widespread use in treating lymphoproliferative diseases and leptomeningeal metastases. Sadik et. Al. reported about the feasibility and safety of using intrathecal methotrexate (ITMTX) as a treatment for unresponsive patients with progressive forms of MS. In their open label study they found that ITMTX may have a beneficial effect in progressive forms of MS and that it was well tolerated with no serious adverse events. The investigators aim is to evaluate the efficacy , safety and tolerability of intrathecal methotrexate administration every 3 months in progressive 30 patients with progressive MS. The investigators will evaluate clinical, laboratory evaluation of the blood and cerebrospinal fluid as well as the MRI scans of the participants. Each patient will be treated 4 times for 1 year with the option to continue for another 1 more year with the same protocol.

NCT ID: NCT02643875 Completed - Myopic Progression Clinical Trials

Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters

Start date: February 26, 2016
Phase: N/A
Study type: Interventional

Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas permeable contact lens exerting positive pressure on the central cornea to temporary reduce refractive error. Researchers have shown that this treatment is effective for myopia control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses in the market are fitted based on the Jessen formula. The compression factor was introduced to compensate for the regression of the ortho-k effect during the no lens-wear period, so that the wearer can obtain clear distance vision throughout the day and most lens designs use a compression factor of 0.50-0.75 D. However, in a retrospective study (mixed brands of ortho-k lenses), it showed that most patients did not achieve an over-correction of 0.75 D. In order to achieve an over-correction of 0.75 D, an extra flattening power of about 1.50 D instead of 0.75 D should be be targeted. The increased compression factor is expected to increase the target reduction and it may play a role in myopic control and providing a higher successful rate in fitting ortho-k lenses.

NCT ID: NCT02643342 Completed - Myopic Progression Clinical Trials

A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye

Start date: June 18, 2016
Phase: N/A
Study type: Interventional

This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.

NCT ID: NCT02640339 Completed - Parkinson Disease Clinical Trials

Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease

Start date: February 2016
Phase:
Study type: Observational

- To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease. - To establish whether these measures can be used to identify patients with PD in the premotor phase. - To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure

NCT ID: NCT02628691 Terminated - HIV Clinical Trials

Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia

HCV-Monitoring
Start date: December 17, 2015
Phase: N/A
Study type: Observational

Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients. Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2. The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment. All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate. Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.