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NCT ID: NCT02164487 Completed - Eating Disorders Clinical Trials

Thiamin (Vitamin B1) Levels in Eating Disorder Adolescent Patients

Start date: March 2013
Phase:
Study type: Observational

Vitamin B1 (Thiamine) is a water soluble essential nutrient; it is synthesized by a variety of plants and microorganisms. Since animals usually cannot synthesis it, humans must be supplied with exogenous vitamin B1 in the diet. The human storage of thiamine is small- about 30mg, an intake of 1-2 mg a day is needed to maintain this pool. Deficiency might occur when the vitamin is depleted from the diet in a short period. Vitamin B1 has a role in energy metabolism and main biosynthetic pathways. Low thiamine causes illnesses in the central and peripheral nervous systems as well as affecting the heart and gastrointestinal systems. Deficiency may occur from malnutrition of different mechanisms such as alcoholism, lack in diet and recently secondary to anti-obesity surgery and few case reports described eating disorders as the reason for developing deficiency causing neuropathy, (1,2) and encephalopathy (3,4,5). One of the presentations of thiamine deficiency is peripheral neuropathy mimicking Guillain-Barre syndrome, and administering the lacking vitamin improves the symptoms. One study examined the prevalence of vitamin B1 deficiency in adult anorexia nervosa patients (6) by measurement of the activation of the enzyme erythrocyte transketolase following addition of thiamin pyrophosphate and comparing them to control of blood donors. This study found significant lower levels of vitamin B1 in the anorectic patient compared to the controls. Rational of the study: The investigators assume that these few cases described of overt neurologic impairment due to vitamin B1 deficiency because of distorted eating are just the "tip of the iceberg" and more eating disorders patients lack thiamine, that may have neuropsychiatric effect on the illness and identifying and treating the shortage may improve the symptoms of the disorder and maybe even the distorted thoughts that are fundamental in eating disorders.

NCT ID: NCT02163694 Completed - Clinical trials for Metastatic Breast Cancer

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

Start date: July 17, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.

NCT ID: NCT02163330 Terminated - Clinical trials for Motor Condition as Measured by Quantified Scale

Normal Pressure Hydrocephalus Treatment by Acetazolamide

Start date: June 2014
Phase: Phase 3
Study type: Interventional

Normal pressure hydrocephalus (NPH) is an uncommon cause of dementia possibly reversible with treatment. First described in 1965 it consists of a triad of gait disturbance, cognitive deterioration, and urinary incontinence together with enlarged cerebral ventricles and normal cerebrospinal fluid (CSF) pressure. Foregoing trauma and hemorrhage, infection, mass lesions, or aqueductal stenosis can contribute to hydrocephalus. These symptomatic or secondary forms of NPH are not considered here and the focus lies on the idiopathic type (iNPH). Prevalence of iNPH increases significantly with age. General estimates range from 21.9 per 100,000 in total population surveys but increase up to 181.7 per 100,000 for people 70 to 79 years of age. The clinical presentation varies significantly in severity and progression of symptoms. For diagnosis the entire triad does not have to be present. In typical cases gait and balance disturbances appear either before or concurrently with urinary incontinence or the onset of dementia. Current treatment recommendations are based on surgical diversion of CSF , with shunts placed either into the ventricular system or the lumbar subarachnoid space to a distal site, such as the peritoneal or the pleural cavity or the venous system, where the CSF can be reabsorbed . Even though immediate response rate to shunt treatment might be favorable and rates of 80% responders have been reported , the perioperative and long-term morbidity and mortality of CSF shunting procedures are significant. A meta-analysis of 44 articles found that the pooled, mean rate of shunt complication was 38% . Even though acute surgical complication rates are low, shunt dysfunctions and long-term complications are relatively common. Shunt malfunction (20%), subdural hematoma (2-17%), seizure (3-11%), shunt infection (3-6%) and intracerebral hematoma (3%) are the most common complications . In those with good long-term survival, sustained improvement is possible, with a rate of 39% documented after 5 years .In view of the complication rates, the lack of alternative treatment options and clinical studies is surprising. Even though iNPH per definition lacks raised intracranial pressure on spinal tap, monitoring of ICP prior to surgery reveals an increased amount of brief (usually 30 seconds to 1 minute) increases in the static ICP, called Lundberg B waves, in patients which improve by shunt placements . When patients are scheduled for shunt treatment there is a waiting period of several weeks between diagnosis and operation due to congested waiting list. Acetazolamide (Diamox) has been shown to reduce the production of CSF in clinical cases of raised intracranial pressure . It is considered the drug of choice for the treatment of idiopathic intracranial pressure (pseudotumor cerebri). Intuitively a connection between Acetazolamide as a treatment option in iNPH seems logical. Encouraging case studies have been published previously showing a fascinating improvement and success of treating iNPH with Acetazolamide. A systematic placebo controlled study concerning the use of Acetazolamide in iNPH is missing and would possibly pave the way to an alternative treatment option avoiding surgery and its complications.

NCT ID: NCT02162381 Completed - Visual Field Tests Clinical Trials

Methylphenidate Effect on Humphrey Visual Fields

Start date: June 2014
Phase: N/A
Study type: Interventional

Study will include adults with abnormal visual fields. Half of them will be given either methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as controls. All Subjects will also have a complete eye examination, a short questionnaire and a questionnaire to screen for attention deficit disorder. The investigators will compare the visual field results between the 2 tests.

NCT ID: NCT02162342 Enrolling by invitation - Clinical trials for Diagnosis and Follow up on Upper Extremity Interventions

Quantification of Kinematics and Muscle Activity Patterns of the Upper Extremities of Individuals With Motor Disabilities

Start date: July 2014
Phase: N/A
Study type: Observational

The subjet is sitting on a chair and in front of him an adjustable (height) table with a glass of water. 17 passive reflective markers are placed on his upper extremities and torso. The subject is requested to reach the glass (once with the right hand and then with the left hand) and bring it to the mouth and drink. Then the subject put the glass back at the starting position. This is performed twice for each hand. In the second part, the same trial is repeated but muscle activity is recorded with surface electromyography.

NCT ID: NCT02162290 Recruiting - Clinical trials for Coronary Artery Disease

Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program

Start date: May 2011
Phase: N/A
Study type: Interventional

The research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility. The main objectives are: 1. Functional capacity measures (VO2 max). 2. Cardiac risk factors 3. Quality of life assessments. Study hypothesis: Interval training will be more effective in improving functional capacity, cardiac risk factors and quality of life, compared to continuous training.

NCT ID: NCT02161497 Completed - Anesthesia Clinical Trials

Clinical History Taking Versus the Addition of an Electronic File Consultation in Pediatric Pre-operative Assessments

Start date: July 2014
Phase: N/A
Study type: Observational

The investigators are studying the difference between the history taken from parents prior to their child's anesthesia to information gleaned routinely from a patient information system called Ofek.

NCT ID: NCT02160145 Completed - Clinical trials for Chronic Kidney Disease

Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)

NCT ID: NCT02158936 Terminated - Thrombocytopaenia Clinical Trials

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Start date: June 10, 2014
Phase: Phase 3
Study type: Interventional

Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

NCT ID: NCT02156843 Terminated - Clinical trials for Diabetic Nephropathy

Pyridorin in Diabetic Nephropathy

PIONEER
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.