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NCT ID: NCT01675843 Completed - Infertility Clinical Trials

Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

OSIPS
Start date: May 2010
Phase: Phase 4
Study type: Interventional

The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)

NCT ID: NCT01675323 Completed - Clinical trials for Restless Legs Syndrome

Glutamate, Hyperarousal and Restless Legs Syndrome

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

Restless Legs Syndrome (RLS) research has focused on the sensory features and failed to address an important aspect of RLS; i.e. a 'hyperarousal' or profound chronic sleep loss without significant excessive daytime sleepiness. This hyperarousal produces RLS symptoms by overwhelming the normal inhibitory processes needed to decrease sensory and motor cortical activity for resting and sleep. Thus the hyperarousal produces both the RLS need to move when trying to rest and the inability to maintain sleep. The biological consequences of this hyperarousal process on sleep (increased wake time) and cortical excitability (as demonstrated by transcranial magnetic stimulation (TMS)) are postulated to reflect increased degree of excitatory glutamatergic activity, and therefore affected brain regions will show relatively increased glutamate (Glu) and glutamine (Gln) on MR spectroscopy (MRS). Changes in inhibitory activity and GABA may also occur, but less significantly than the increase in Glu/Gln. Our pilot MRS data discovered a new abnormality in RLS: increased Thalamic Glx (Glu + Gln) that correlated well with sleep measures of hyperarousal. Glx levels are not specific for the neurotransmitter role of Glu. In this project RLS and matching controls subjects will be studied using polysomnograms (PSG) and TMS and 7T MRI for MRS that provides accurate measurement of Gln levels, which reflect mostly neurotransmitter Glu activity. The first aim is to confirm that Gln is increased in the thalamus and to determine if this also occurs in the motor and sensory cortices. The relation between Glu, Gln and GABA will also be evaluated. Second, assessments will be made of the degree of relation between Gln increase and the hyperarousal effects on sleep and cortical excitability (TMS). This would demonstrate that abnormally increased Glu activity is primary to RLS hyperarousal and radically changes the emphasis in RLS to be less on dopamine and more on Glu-hyperarousal as a major feature of RLS.This is an entirely new direction for RLS research and treatment development. The new concept of hyperarousal adds a missing dimension to understanding RLS, namely the discovery of the Glu abnormality and its central relation to the other hyperarousal features.

NCT ID: NCT01674985 Completed - Clinical trials for Myelodysplastic Syndromes

Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.

NCT ID: NCT01673308 Active, not recruiting - Clinical trials for Myelodysplastic Syndrome

Lenalidomide After Failure of Hypomethylating Agents in Myelodysplastic Syndrome

VIOLET
Start date: August 2012
Phase: Phase 2
Study type: Interventional

This is a Phase II study to evaluate the efficacy of second-line lenalidomide monotherapy for myelodysplastic syndrome (MDS) patients who failed to hypomethylating agents.

NCT ID: NCT01672918 Withdrawn - Lymphoma Clinical Trials

Fluorodeoxyglucose Imaging Studies to Detect Lymphoma

Start date: August 6, 2012
Phase:
Study type: Observational

Background: - Autoimmune lymphoproliferative syndrome (ALPS) is a genetic disorder of the lymph system. People with ALPS often have swollen lymph nodes, especially in the neck and armpit. They also have a much higher risk of developing lymphoma. It is not always easy to determine whether the swollen lymph nodes are caused by ALPS or by lymphoma. Researchers want to see whether different imaging studies can show the difference between ALPS and lymphoma. The studies used will be positron emission tomography (PET) and computed tomography (CT). Researchers will use a drug called fluorodeoxyglucose (FDG) to look at the lymph nodes. Objectives: - To see how well imaging studies can distinguish between swollen lymph nodes caused by ALPS or by lymphoma. Eligibility: - Individuals must be 5 years of age or older and enrolled on the National Institutes of Health natural history study of ALPS. - Participants should either have lymphoma or have symptoms that suggest possible lymphoma. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - Participants will have an FDG-PET/CT scan. It will be performed according to standard procedures. - If the results of the scan do not show lymphoma, participants will stay on the study for 1 year for clinical follow up. They may have a second FDG-PET/CT scan if there is a change in symptoms. Such changes include further enlargement of lymph nodes, unexplained fevers, or weight loss. - If the results of the scan show evidence of new or worsening lymphoma, treatment on this study will end. Further tests based on clinical symptoms, including a lymph node biopsy, may be done under the ALPS natural history study to rule out or make a diagnosis of lymphoma.

NCT ID: NCT01671410 Completed - Clinical trials for Neonatal Abstinence Syndrome

Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

MOPPlus
Start date: August 2012
Phase: Phase 1
Study type: Interventional

The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.

NCT ID: NCT01670747 Completed - Clinical trials for ARDS: Acute Respiratory Distress Syndrome

Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Acute Respiratory Distress Syndrome (ARDS)

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

In this study gas-exchange and respiratory mechanics variations to PEEP change will be correlated to CT lung morphological modifications assessed at different airway pressures (5, 15, 30 and 45 cmH2O).

NCT ID: NCT01670357 Completed - Dry Eye Syndrome Clinical Trials

Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome

DES
Start date: April 2012
Phase: Phase 2
Study type: Interventional

This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

NCT ID: NCT01669889 Completed - Clinical trials for Healthy Volunteer, Autistic Disorder, Asperger's Syndrome

A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome

Start date: January 2013
Phase: N/A
Study type: Observational

This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.

NCT ID: NCT01668667 Completed - Clinical trials for Restless Legs Syndrome

Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study

CONCORD
Start date: June 2012
Phase: Phase 4
Study type: Interventional

Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a condition of the approval of HORIZANT tablets (NDA 022399).