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NCT ID: NCT06325943 Completed - Clinical trials for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

CIDPRIT
Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy. Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization.

NCT ID: NCT02967250 Completed - Parkinson Disease Clinical Trials

Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment

Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

The objective of this study is to understand the bioenergetic impairments that underlie Parkinson's disease (PD) and evaluating treatments that may improve abnormal mitochondrial function that is present in PD. The hypothesis is that repeated oral dosing of UDCA will result in increased brain ATP levels in individuals with Parkinson's disease (PD). The specific aims are 1.) to measure plasma UDCA levels in individuals with PD at baseline and after four weeks of repeated high doses of oral UDCA (50mg/kg/day) and 2.) to measure cortical bioenergetic profile and ATPase activity (as ascertained through MRS) in those with PD at baseline and at four weeks after repeated high doses of oral UDCA (50mg/kg/day) simultaneously. Secondary aims are to characterize oral UDCA pharmacokinetics and develop a pharmacokinetic/pharmacodynamic model to characterize the relationship between peripheral measurements of UDCA (and associated conjugates) and peripheral measures and/or central (brain) bioenergetic measurements.

NCT ID: NCT03762460 Completed - Depression Clinical Trials

A Pilot Study of eHealth Tools in a Tertiary-care Setting

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

This feasibility study investigates the use of eHealth tools within routine medical treatment for patients with depression in an outpatient psychiatric setting. The study investigates whether patients find a mobile-optimized online eHealth tool to be acceptable and feasible, and whether clinical and functional outcomes improve with use of the online eHealth tool, compared to informational online resources for mental health.

NCT ID: NCT03884647 Completed - Stroke Clinical Trials

DELPHI in Subjects at Risk for Stroke and Dementia

Start date: April 1, 2020
Phase:
Study type: Observational

The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories. Standard electro-physiological acquisition is performed using TMS to evoke regional neuronal potentials measured as EEG data. TMS-EEG data is analyzed with regards to conventional, well established characteristics of neuronal network plasticity and connectivity.

NCT ID: NCT03920995 Completed - Multiple Sclerosis Clinical Trials

Multi-center Database Registry to Study Thalamus Changes Using AI in MS

Start date: April 1, 2020
Phase:
Study type: Observational

In this study the Investigator's propose to validate a newly developed approach, DeepGRAI (Deep Gray Rating via Artificial Intelligence), to simplify the calculation of thalamic atrophy in a clinical routine and allow academic and community neurologists to plan, perform, and publish novel and influential clinical research using data from clinical routine, by employing deep machine learning (DML) pattern recognition (PR) information through use of artificial intelligence (AI).

NCT ID: NCT03951350 Completed - Depression Clinical Trials

Lifestyle Modification Program in the Prevention and Treatment of Depression

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Introduction: Major depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programs, taking into account personal factors and facilitators. The main objective of this work is to analyze the utility and cost-effectiveness of an adjunctive treatment program for subclinical, mild or moderate depression in Primary Care patients, based on healthier lifestyle recommendations. Secondary objectives include the analysis of the effectiveness of the intervention in comorbid chronic pathology and the measurement of the influence of personal factors on lifestyle modification. Methods and analysis: A randomized, multicenter pragmatic clinical trial with 3 parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: 1. Usual antidepressant treatment with psychological advice and/or psychotropic drugs prescribed by the General Practitioner (treatment-as-usual, TAU). 2. TAU + Lifestyle Modification Program (LMP). A program to be imparted in 6 weekly 90-minute group sessions, intended to improve the following aspects: behavioral activation + daily physical activity + adherence to the Mediterranean diet pattern + sleep hygiene + careful exposure to sunlight. 3. TAU + LMP + ICTs: healthy lifestyle recommendations (TAU+LMP intervention) + monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal variables related to program adherence (patient activation in their own health, self-efficacy, sense of coherence, health literacy and procrastination) and chronic comorbid pathology. Data will be collected before and after the intervention, with 6- and 12-month follow-ups.

NCT ID: NCT03958695 Completed - Clinical trials for Stress Urinary Incontinence

A Tunable-tension Transobturator Tape vs Standard Transobturator Midurethral Tape for Stress Urinary Incontinence

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

This is the prospective randomized parallel groups trial with two participating centers (Department of Urology, Saint Petersburg State University Clinic of advanced medical technologies n.a. N.I.Pirogov, Saint Petersburg, Russia; Department of Urology, Regional Hospital №3, Chelyabinsk, Russia) designed to assess the efficacy and safety of tunable-tension transobturator tape and its ability to reduce the rate of postoperative voiding dysfunction comparing to standard transobturator midurethral sling.

NCT ID: NCT04009863 Completed - Clinical trials for High Intensity Focused Ultrasound

HIFU Ablation vs Fixed-dose RAI-131 Therapy in Moderate-sized Non-toxic MNG

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

After obtaining informed consent, eligible subjects will be assigned randomly into either High intensity focused ultrasound group (HIFU) or Radioactive iodine (131I) therapy group (RAIT). After treatment, they will be followed up for 4 visits (1-month, 3-month, 6- month, 12-month of post treatment). At each visit, they will have physical examination, regular blood test and questionnaire to evaluate their quality of life. The collected data will be used to compare the effectiveness between HIFU and RAIT for non-toxic multi-nodular goiter (NMNG). The primary purepose is to find out the best non-invasive way in treating NMNG. For HIFU, you may experience: 1. Mild bruising and redness at the site of treatment 2. Edema of the skin tissue 3. Pain/discomfort during the procedure 4. Skin burns but rare (<1%) 5. Vocal cord paresis on the side of the treated lobe but rare (<1%) 6. Unintentional damage to the surrounding tissue (outside the planned treatment area). For RAIT, you may experience neck tenderness or sore throat in the following few days as developing moderate inflammation in the thyroid and producing discomfort in the neck or throat area. Your symptoms may turn worse for first few week, but will improve over weeks.

NCT ID: NCT04057534 Completed - Clinical trials for Substance Use Disorders

Neurobiological Mechanisms of Chess as an Add-On Treatment Against SUD

Chess_SUD
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Neurobiological and neuropsychological approaches to investigate the potential mechanism of action of chess as an add-on therapy (chess based - cognitive remediation treatment, CB-CRT) to reduce cognitive deficits in individuals with alcohol use disorder (AUD) or tobacco use disorder (TUD).

NCT ID: NCT04065880 Completed - Prolonged Air Leak Clinical Trials

Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.