
Canola Oil, Fibre and DHA Enhanced Clinical Trial
Metabolic SyndromeThe purpose of this study is to examine the effects of consumption of a novel food supplement consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives, including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and soluble dietary fibre, aiming at the management of heart disease risk factors in people with metabolic syndrome and to test its efficacy and safety in humans.

Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal...
Alcohol Withdrawal SyndromeAlcohol DependenceBenzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam in the treatment of alcohol withdrawal symptoms (AWS).

Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
Fragile X Tremor/Ataxia SyndromeThe objective of this study is to determine if citocoline is effective for balance abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months in an open label pilot study, with study visits at baseline, 3, 6, and 12 months.

Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant...
Acute Myeloid LeukemiaHematologic Malignancies9 moreThis phase I trial studies the side effects and best dose of targeted marrow irradiation when given with fludarabine phosphate and busulfan before donor progenitor cell transplant in treating patients with hematologic malignancies. Targeted marrow irradiation is a type of specialized radiation therapy that delivers a high dose of radiation directly to the cancer cells, which may kill more cancer cells and cause less damage to normal cells. Giving targeted marrow irradiation and chemotherapy drugs, such as fludarabine phosphate and busulfan, before a donor progenitor cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's progenitor cells. When the healthy progenitor cells from a donor are infused into the patient they may help the patient's bone marrow make progenitor cells, red blood cells, white blood cells, and platelets.

Effects of Yoga on Metabolic Syndrome
Metabolic SyndromeMetabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has been a useful tool in prognosing the development of cardiovascular disease and diabetes mellitus. Importantly, interventions applied at the pre-pathologic stage with MetS would be of great clinical and health significance in achieving better preventive and therapeutic outcomes. Yoga, a mind-body exercise, has been suggested to have beneficial effects on dyslipidemia, hypertension and diabetes. A pilot study has demonstrated the trends in the improvement of metabolic parameters in middle-aged adults with MetS but the findings are inconclusive because of the small sample size and brief yoga follow-up period (i.e., 2-month). In addition to the needs of a better designed randomized controlled trial in studying the beneficial effect of yoga in controlling MetS in middle-aged individuals, the investigation on yoga and MetS in elderly population has been lacking. This is important as the potential use of yoga as lifestyle modification in elderly individuals with MetS will result in significant reduction of the prevalence of cardiovascular disease and diabetes. Thus, this study aims to examine the efficacy of yoga exercise in improving metabolic abnormalities in middle-aged and older adults with MetS. In addition to elderly, middle-aged adults are included in the present investigation because of the idea that cardiovascular diseases and diabetes with aging can be mostly prevented by intervention at the middle-age. A randomized controlled trial with repeated measure design will be conducted to examine the effect of 1-year regular yoga training on the MetS parameters in middle-aged and older individuals who are 30-60 and 60-80 years of age, respectively. Primary outcome measures include waist circumference, systolic/diastolic blood pressure, blood glucose, triglyceride, and lipid cholesterol profile whereas secondary outcome measures include self-reported stress and depression levels. This study is anticipated to provide valuable information in exploring the therapeutic role of yoga in managing MetS. As yoga exercise is an economical regimen which can be easily and readily applied to large scale of target population, it is of hope to be practically useful to relieve the burden on cardiovascular disease and diabetes by introducing yoga lifestyle to the management of MetS.

Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome
Carpal Tunnel SyndromeCompression NeuropathyStudy Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe carpal tunnel syndrome. Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In severe cases, nerve regeneration and functional recovery are incomplete even with surgery. The goal of this pilot project is to test a potentially promising medication, acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled study design. Along with surgery, those in the treatment group will also receive ALCAR while the other half in the control group will be given placebo. To gauge the effects of ALCAR, we will compare motor and sensory nerve growth as well as functional outcomes. The data from this study will provide crucial information when designing a full scale clinical trial. If successful, this will represent an important first step in finding a novel treatment to improve functional outcomes in patients with severe CTS.

Study of TCP-ATRA for Adult Patients With AML and MDS
Acute Myelogenous LeukemiaMyelodysplastic Syndromes1 moreAcute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect. Consequently, 85% of these patients will succumb to their disease despite conventional approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This knowledge gap limits the use of ATRA in a disease that already has few effective therapies. The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators' publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP), unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA and TCP markedly diminished the engraftment of primary human AML cells in murine models, indicating that the combination may target leukemia-initiating cells (LIC). The investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that ATRA combined with TCP will be safe and effective in a clinical population, and that this approach will suppress LICs and restore myeloid differentiation programs in patients with non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer effects of ATRA to all AML subtypes.

Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS)...
Neurologic Neglect SyndromeFollowing stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term. Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term. Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.

Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic...
Acute Myeloid Leukemia (AML)Acute Lymphoblastic Leukemia (ALL)2 moreThe purpose of this study is to test the safety of selinexor (KPT-330) and to find the highest dose of selinexor (KPT-330) that can be given safely when it is combined with two chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase I and Phase II. The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine. The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with leukemia or MDS. The investigators will examine the effect of this combination treatment. PRIMARY OBJECTIVE: Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric patients with relapsed or refractory hematologic malignancies included acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia (MPAL) and myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: To characterize the pharmacokinetics of selinexor, when administered in tablet form, after the first dose and at steady-state, as well as in combination with fludarabine and cytarabine To estimate the overall response rate of selinexor given with fludarabine and cytarabine in patients with relapsed or refractory hematologic malignancies

Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Irritable Bowel SyndromeIn patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.