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Syndrome clinical trials

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NCT ID: NCT03839771 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

HOVON150AML
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.

NCT ID: NCT03839069 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

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

This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.

NCT ID: NCT03838562 Completed - Vestibular Syndrome Clinical Trials

Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes.

EquiRV
Start date: April 23, 2019
Phase: N/A
Study type: Interventional

Context and justification: Vertigo leads to medical consultation, interruption of daily activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and adaptation exercises. The technology of three-dimensional head-mounted provides a strong immersion allowing optokinetic stimulation but studies interested in virtual reality in the context of balance rehabilitation have not been able to highlight the superiority of this therapy. The investigators therefore propose a non-inferiority trial because of the affordable price and small size of three-dimensional head-mounted. Objectives : The objective of this study is to evaluate whether a rehabilitation program using virtual reality is as effective as a reference program using Smart Equitest and an optokinetic stimulator to improve the balance of patients with vestibular syndrome after 3 or 4 weeks of rehabilitation. The investigators also assess the disability related to vertigo and balance disorders as well as the tolerance of virtual reality Methodology: Prospective, randomized controlled non-inferiority trial, monocentric, 2 parallel arm, with blind assessed after 3 or 4 weeks of follow-up. The inclusion criteria are the pathologies eligible for a vestibular rehabilitation program and the possible standing position. The criteria for non-inclusion are visually impaired or blind subjects, lack of relief vision, history of epilepsy, significant strabismus, permanent bilateral vestibular areflexes and Ménière's disease. The main evaluation criterion is the balance score obtained with eyes closed on an unstable plane during a sensory organization test performed on a dynamic posturology platform, obtained during the final evaluation. The secondary judgment criteria are: - The balance scores obtained in the sensory organization test under other conditions. - The Dizziness Handicap Inventory obtained during the final evaluation and three months after the end of the program. - The tolerance of virtual reality will be measured weekly by the Simulator Sickness Questionnaire. Statistics: The number of subjects to be included is 76, the analysis will first be performed per-protocol, the difference in scores between the two groups will be calculated, as well as its 95% confidence interval. If the lower bound of this interval is above the non-inferiority threshold, the same analysis will be performed on the population intending to treat (all randomized patients). Process: Recruitment and rehabilitation take place at the CH Coste Floret. The duration of inclusions is 27 months, The duration of patient participation in the protocol is 4 months. Patients are cared for 21 or 28 days with two sessions of physiotherapy per day, five days a week, then resolved by telephone 3 months after the rehabilitation Feasibility: CH Coste Floret has the human and material resources necessary to carry out the protocol. The PMSI data show that the department receives about 40 patients per year who are likely to participate in the protocol. Outcomes / perspectives: In the event of a result validating the non-inferiority of virtual reality, this study could provide further evidence of the value of this type of tool for the rehabilitation of subjects suffering from vestibular disorders. In addition, a medico-economic study would be possible in order to reinforce the advantages of virtual reality helmets.

NCT ID: NCT03838107 Recruiting - Clinical trials for Complex Regional Pain Syndromes

Markers of Trajectory in Pediatric CRPS

Start date: August 27, 2018
Phase:
Study type: Observational

Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between these cerebral changes and trajectory of recovery has been seldom investigated to date. Furthermore, interactions between cerebral changes and psychosocial factors, which might affect trajectory of recovery, are unknown. The aim of this study is to identify the psychosocial factors and cerebral changes that predict the trajectory of recovery from CRPS. Children between the ages of 10 and 17 years will be enrolled with one of their parents or legal guardians for this study. Three populations will be recruited: patients with CRPS undergoing treatment at the Functional Independence Restoration Program (FIRST), patients with CRPS undergoing treatment at the Pain Management Center and matching healthy controls. Participants will undergo three sessions: the first session will be scheduled immediately before or as soon as possible at the beginning of the patients' treatment; the second session will take place at the end of the patients' treatment; the last session will be scheduled six months post-treatment. The timing of the sessions of the healthy participants will follow a schedule similar to the FIRST patients. Each session will last approximately three hours and include acquisition of psychosocial, psychophysical, and brain imaging data in the child participants, as well as acquisition of psychosocial data in the parent participants.

NCT ID: NCT03837483 Active, not recruiting - Clinical trials for Wiskott-Aldrich Syndrome

A Clinical Study to Evaluate the Use of a Cryopreserved Formulation of OTL-103 in Subjects With Wiskott-Aldrich Syndrome

Start date: January 21, 2019
Phase: Phase 3
Study type: Interventional

This is an open-label, single arm study to evaluate the cryopreserved formulation of OTL-103 Gene Therapy. OTL-103 consists of autologous CD34+ hematopoietic stem cells in which the gene encoding for the Wiskott-Aldrich Syndrome is introduced by means of a third generation lentiviral vector.

NCT ID: NCT03836651 Completed - Metabolic Syndrome Clinical Trials

Dietary Intervention in Persons With Metabolic Syndrome

MetLDI
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis of metabolic syndrome and CVD can be influenced by dietary changes. Strategic and novel interventions that include changing dietary patterns to include more antioxidant rich fruit and vegetables are pragmatic for primary prevention of CVD. Antioxidant rich fruits and vegetables, especially those with carotenoids (lycopene, lutein, zeaxanthin, alpha-carotene, and beta-carotene) have been efficacious in reducing the risk of CVD by decreasing inflammation and oxidative stress. The purpose of this study is to test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in persons diagnosed with metabolic syndrome. The sample will be randomized into one of two groups. Group one (intervention) will drink an 11.5 ounce serving of V8 100% vegetable juice once per day for 30 days. The second group (control) will continue to consume their normal diet. We will measure biomarkers of inflammation (C-reactive protein) and oxidative stress (malondialdehyde) in the two groups at baseline and the end of the 30-day intervention.

NCT ID: NCT03836482 Suspended - Clinical trials for Cardiorenal Syndrome

Selective Cytopheretic Device (SCD) Trial

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the selective cytopheretic device on the immune dysregulated state of congestive heart failure(CHF) with CRS and to assess the benefit of the device to improve cardiovascular and renal function. The study will enroll eligible patients in the ICU with acute on chronic systolic heart failure and worsening renal function due to cardiorenal syndrome while awaiting LVAD implantation. In this study patients who are eligible and agree to participate will receive treatment with the SCD. The treatment will be for 6 hours a day up to 6 days. Additionally, participants will have additional study procedures and be evaluated to determine if their kidney function improves enough to undergo LVAD implantation.

NCT ID: NCT03836300 Enrolling by invitation - Clinical trials for Duchenne Muscular Dystrophy

Parent and Infant Inter(X)Action Intervention (PIXI)

Start date: November 30, 2018
Phase: N/A
Study type: Interventional

The objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed diagnosis of a neurogenetic disorder with associated developmental delays or intellectual and developmental disabilities. The proposed project will capitalize and expand upon existing empirically based interventions designed to improve outcomes for infants with suspected developmental delays. Participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) within the first year of life and their parents/caregivers. The intervention, called the Parent and Infant Inter(X)action Intervention (PIXI) is a comprehensive program inclusive of parent education about early infant development and the neurogenetic disorder for which they were diagnosed, direct parent coaching around parent-child interaction, and family/parent well-being support. The protocol includes repeated comprehensive assessments of family and child functioning, along with an examination of feasibility and acceptability of the program.

NCT ID: NCT03834792 Active, not recruiting - Opioid Use Clinical Trials

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Start date: December 30, 2018
Phase:
Study type: Observational

The primary purpose of the proposed study is to validate our previously developed predictive model for adults with obstructive sleep apnea using (i) clinical data from multiple large academic centers, (ii) a longer follow-up period, and (iii) an extended definition of outcomes of interest. The TOH sleep database was created as a part of the project: "Validation of provincial health administrative data algorithms to identify patients with obstructive sleep apnea (OSA): Feasibility project". Protocol ID: 20170591-01H (AMENDMENT APPROVED on December 19, 2018) to be used for future clinical, research, educational and quality improvement purposes.

NCT ID: NCT03833388 Completed - Dry Eye Syndrome Clinical Trials

Study of TOP1630 for Dry Eye Syndrome

THEIA-1
Start date: February 13, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

In subjects with Dry Eye Syndrome (DES): The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.