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NCT ID: NCT01505270 Not yet recruiting - Autism Clinical Trials

The Prevalence of Psychological and Medical Comorbidities Among Children Suffering From Autistic Spectrum Disorder and the Differences Between Ethnic Groups in Israel

Start date: March 2012
Phase: N/A
Study type: Observational

It is known that several psychological and medical comorbidities are frequently found among children suffering from autistic spectrum disorders. Our aim is to investigate which comorbidities are most common among those children and whether there are differences among the different ethnic groups found in Israel.

NCT ID: NCT01503788 Not yet recruiting - Clinical trials for Post Dural Puncture Headache

Bedside Sedation for the Prevention of Post Dural Puncture Headache

Start date: February 2012
Phase: Phase 2
Study type: Interventional

Dural or lumbar puncture (LP), the passing of a needle into the space of the spinal cord, is a common procedure in everyday clinical practice. The most common use for LP is to measure the spinal fluid pressure and sample spinal fluid for laboratory analysis. However, it is also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia. A notorious side effect of dural puncture is headache that ranges from mild to debilitating and may last for several days following the procedure. Among diagnosed patients, 39% experience at least 1 week of impaired ability to perform activities of daily living. The likelihood of developing a headache after dural puncture depends on a number of factors. As fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize the leak seem to offer the best path to lowering the incidence of headache after diagnostic LP, the commonest clinical context of dural puncture in medical practice. Lumbar puncture is a highly stressful event for most patients. As both pain and anxiety cause adrenergic stimulation, they also cause an increase in ICP. We believe that this mild increase in ICP, occurring before the puncture as well as during the puncture itself may exacerbate the pressure difference between the CSF space and the epidural space and so worsen the CSF leak Furthermore, this excess pressure, although mild, might cause the dural puncture hole to widen slightly and so further augment the leak and possibly even prolong it. Furthermore, the very anticipation of pain causes a rise in neurotransmitters that may cause a sensitization effect and worsen pain. This increase in adrenergic drive as well as the sensitization to pain can be effectively blunted by the periprocedural use of mild IV sedation. Benzodiazepines, with their sedative-hypnotic qualities are well suited for this task. This study aims to test the effect of mild peri-procedural IV sedation using Midazolam on the rates of headache after diagnostic LP. Patients undergoing a diagnostic LP will be randomized into two groups. Group 1 will undergo the procedure as routinely practiced. Group 2 will be given Midazolam IV 10-5 minutes prior to the procedure and undergo the same diagnostic procedure. All patients in the study will remain under observation in the hospital for at least 6 hours. Patients will be evaluated for headache and specifically for headache. Clinical follow up will continue for 72 hours by administering a short questionnaire over the telephone.

NCT ID: NCT01503697 Not yet recruiting - Breast Cancer Clinical Trials

The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast Cancer

Start date: January 2012
Phase: N/A
Study type: Observational

Technetium-99m NC100692 Injection is under development as a diagnostic radiopharmaceutical for targeting angiogenesis associated with diseases such as primary and metastatic cancer, and for targeting active fibrosis in cardiac diseases such as developing heart failure and developing hypertrophic cardiomyopathy. A principle goal of imaging is identification of disease processes early in their development, at times prior to symptoms. In cancer, angiogenesis is essential for a tumour to exceed approximately 1-2 mm3 in size.As markers of angiogenesis are often expressed early in the growth of a tumour it is postulated that imaging of angiogenesis can assist in early diagnosis of cancer, relapse or spread, and monitoring response to therapy. Technetium-99m NC100692 Injection will be tested on 3 populations of pts: 1.30 patients at high risk For breast cancer 2.30 patients with breast cancer 3.15 patients with locally advanced breast cancer undergoing treatment.

NCT ID: NCT01503476 Completed - Clinical trials for Gastro Esophageal Reflux Disease

Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance

Start date: February 2012
Phase: Phase 4
Study type: Interventional

Study Hypothesis: This study is designed as an integral part of the development of new or improved features or components of the Bravo® pH Monitoring System and may serve verification and validation purposes The study population will include a group of healthy volunteers (Group A) and a group of symptomatic patients with known or suspected gastroesophageal reflux disease (Group B). Group A: Healthy volunteers will not undergo invasive procedure. These volunteers may be asked to carry the capsule and\or Bravo Recorder. These procedures will serve to evaluate different technical matters such as human interface, ergonomic aspects and communication performances of the system Group B: Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery, positioning and attachment. Confirmation of capsule attachment may be done by endoscopically. These procedures will serve to evaluate overall system performance in actual clinical setup, for instance: Bravo Recorder performance including communication quality, human interface and similar, ergonomics of delivery device, pH Capsule performance, etc. Subjects from both study groups as well as physician may be asked to provide feedback on the procedure and/or document their activities during the procedure.

NCT ID: NCT01503151 Completed - Social Phobia Clinical Trials

Cognitive Biases Modification Treatment for Social Anxiety

CBMSP
Start date: January 2012
Phase: Phase 2
Study type: Interventional

Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns. Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on DSM-IV criteria. The investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.

NCT ID: NCT01502384 Not yet recruiting - Parkinson's Disease Clinical Trials

A Longitudinal Study in 1st Degree Relatives of Parkinson's Disease (PD) Patients

Start date: January 2012
Phase: N/A
Study type: Observational

This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for PD. The purpose of this study is to explore the association between genetic mutations in the known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and cognitive functions.

NCT ID: NCT01501890 Withdrawn - Premature Birth Clinical Trials

Progesterone for First Trimester Vaginal Bleeding

Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes.

NCT ID: NCT01501825 Not yet recruiting - Depression Clinical Trials

A Prospective, Comparative Study to Explore the Efficacy and Safety of the Five Channels Multiway Deep Transcranial Magnetic Stimulation (TMS) Device in Subjects With Major Depression Disorder (MDD)

Start date: August 2012
Phase: N/A
Study type: Interventional

The Multiway stimulator is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The Multiway stimulator includes five channels which can operate up to five independent TMS coils, either simultaneously or sequentially. The Multiway device may be used to obtain a differential activation of various brain regions. For instance it can be used to induce high frequency stimulation of a certain brain region, thus inducing facilitation, while simultaneously stimulate at low frequency in another brain region, leading to inhibition. The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in comparison to a single channel DTMS treatment in subjects with MDD. Subjects will be treated with one of two designs of the study device (the Multiway Coil TMS Device): 1. Single Channel with a coil placed over the left PFC (10 Hz). 2. Four channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. c. 10 Hz over the left parietal cortex. d. 1 Hz over the right parietal cortex.

NCT ID: NCT01501812 Recruiting - Bipolar Disorder Clinical Trials

Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders

Start date: March 2011
Phase: N/A
Study type: Observational

Learning includes the ability to generalize to new situations and respond to similar, yet not identical stimuli. In previous work, focused on stimulus generalization in healthy volunteers, tones that were negatively reinforced induce wider generalization curves than tones that were positively reinforced, and these in turn induce wider curves than neutral memory (Schechtman et al, 2010). The current study aimed to evaluate those patterns in different clinical disorders (including Schizophrenia, Bipolar disorder, MDD, Anxiety disorders (Panic and GAD) and PTSD, and healthy subjects that would be used as a control), with consideration whether those patterns are unique to any specific disorder or state. The generalization patterns evaluation would conduct twice though enable to compare the stability of those patterns during the course of the illness (i.e during remission compared to acute state). The basic paradigm based on conditioning of a tone (sound) with unpleasant noise, and extinction of that conditioning afterword. During the 60 minutes of evaluation, the capability to discriminate between the original tone and similar but not identical tones, and the tendency to categorize similar tones as identical to the original tone. A neutral tone without conditioning will be used as reference. The clinical diagnosis will conduct by a senior psychiatrist, and the state would be evaluated using standard questionnaires

NCT ID: NCT01501734 Recruiting - Clinical trials for Symptomatic Congestive Heart Failure

Bilevel Positive Pressure Ventilation (BIPAP)in Patients With Sleep Disorders Breathing (SDB)and Congestive Heart Failure (CHF):Comparison of Two Diagnostic Methods

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Successful treatment of pulmonary edema was first published in 1938 by A. L. Barach. Since then, this has been the accepted method of treating acute respiratory failure due to left heart failure and edema. The question was raised if pressure supported ventilation during sleep is used to eliminate sleep apneas, would it be useful also for improving congestive heart failure (CHF). Recent studies assessed the role of continuous positive airway pressure (CPAP) in patients with advanced CHF and found the treatment useful. A possible explanation for these results is that central sleep apnea frequently coexists with severe CHF and is not treated or suppressed by CPAP. The frequency of central sleep apnea increases with the severity of CHF and can be found in more than 30% of patients. A few recent studies showed the usefulness of bilevel positive airway pressure (BIPAP) or adaptive servo-ventilation (ASV). ASV led to improvement in ejection fraction as well as in 6 min walking distance testing, and was associated with decreased BNP levels. In another study, bilevel PAP increased LVEF by 7.9%. The limitations of these studies are the small number of patients and that they were conducted on inpatients only. These factors make it difficult to include BIPAP in the guidelines for chronic heart failure therapy. Recently, two outpatient modalities have been introduced to diagnose sleep disordering breathing (SDB). However, no study has directly compared the results of both studies in patients with CHF. Moreover, no studies have assessed improvement in CHF after BIPAP treatment. In addition, the investigators plan to assess the endothelial function in this population before and after BIPAP treatment with the EndoPAT, a noninvasive technology