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  • Research data . Clinical Trial . 2010
    Open Access
    Authors: 
    Kooi, Eline;
    Publisher: nct

    The possibility of the identification of the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. Firstly, in symptomatic patients with a 30-69% stenosis, who are currently not operated upon according to the current guidelines, identification of the risk of rupture plaque could identify patients who have a high risk of recurrent stroke, and would benefit of carotid intervention, such as endarterectomy or stent placement. This could potentially prevent a substantial number of strokes. Secondly, in all symptomatic patients with a 70-99% stenosis carotid intervention should be considered, according to the guidelines. However, only one out of six patients with a 70-99% stenosis benefits from a carotid intervention. Identification of patients with a high risk of a recurrent stroke would reduce the number of unnecessary interventions substantially. The main objective is to show whether imaging characteristics assessed at baseline can predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.

  • Open Access
    Authors: 
    Jackson, Matthew C; Fischer, Christine;
    Publisher: nct

    Subjects who join the study will receive a shortened course of radiation treatment that will last approximately four (4) weeks, instead of the traditional six (6) week course that women have typically received in this situation. The shorter course subjects will receive is designed in a way that it is thought to be equivalent to the longer course. This shorter course has already been shown to be very safe and effective when treating breast cancer in the breast tissue only. However, because cancer cells were found in the lymph nodes that drain their breast, subjects require radiation to a larger area of their chest, armpit, and shoulder than has been completely tested with this experimental dose. The proposed study is being done to learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer. Subjects are being asked to be in this research study because they have already had surgery for breast cancer and some cancer cells were found in their lymph nodes that drain the breast tissue.

  • Open Access
    Authors: 
    Lin, Yin-Ku;
    Publisher: nct

    Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified. The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.

  • Research data . Clinical Trial . 2015
    Open Access
    Authors: 
    Kelly, Ciaran;
    Publisher: nct

    The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to: 1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet. 2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.

  • Open Access
    Authors: 
    Grube, Eberhard;
    Publisher: nct

    The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact with the vessel surface, thus potentially reducing the incidence of untoward side effects. The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and reduces the amount of required polymer. Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a 2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the efficacy of the product.

  • Research data . Clinical Trial . 2009
    Open Access
    Authors: 
    Knudsen, Eva C;
    Publisher: nct

    Background: A high prevalence of impaired glucose tolerance (IGT) and unknown diabetes mellitus (DM) in patients with cardiovascular disease has been shown. European guidelines recommend screening of patients with AMI for DM and IGT by performing an oral glucose tolerance test (OGTT). The prevalence of IGT and DM in a Norwegian population of patients with AMI is unknown. Evidence are lacking regarding the reliability of an OGTT performed early after an AMI. The present study was designed to detect unknown IGT and DM in patients with AMI and the main challenge of the study was timing and reproducibility of the OGTT. In addition, mechanisms (inflammation, haemostasis) involved in impaired glucose regulation will be studied. Design: The study is designed as an observational cohort study prospectively including 200 patients with a primary PCI treated acute STEMI admitted to the coronary care unit at Ullevål university hospital. An OGTT is performed in-hospital and repeated after 3 months and a glucometabolic classification was performed according to the results. The patients will be followed for a minimum of two-years with regards to clinical endpoints. Aims of the study: 1. Study the prevalence of IGT and DM in a Norwegian population with acute STEMI. 2. Validate the results of an OGTT performed early after myocardial infarction, by repeating the test after three months. 3. Elucidate possible interactions between biomarkers of inflammation and coagulation, and the glucometabolic status. 4. Study the relationship between impaired glucose tolerance and prognosis after STEMI. 5. Contribute to an increased focus on undiagnosed DM and IGT in patients with coronary heart disease in Norway and the results may lead to an increased use of routine OGTT in the follow-up of patients with myocardial infarction. Investigate how patients with myocardial infarction and known glucometabolic state are followed up "in real-life" by their physicians. Clinical implications: The study may detect a large proportion of undetected DM and IGT in patients with AMI and change present guidelines on the follow-up of patients after AMI with increased focus on impaired glucose tolerance. The study will provide new insights about the association between inflammation, haemostasis and impaired glucose tolerance in patients with acute ST-elevation myocardial infarction. The present study was designed to determine the prevalence of previously unknown impaired glucose tolerance and type 2 diabetes in patients with acute ST-elevation myocardial infarction subjected to acute PCI. Secondary, a possible association between inflammation, haemostasis and abnormal glucose regulation was studied.

  • Open Access
    Authors: 
    Misiukiewicz, Krzysztof;
    Publisher: nct

    Patients will be offered the option to consent for enrollment to receive care based on the personalized treatment plan developed under the separate Tumor Genomic Analysis and Molecular Testing for Personalized Caner Therapy protocol. Each patient enrolled in this therapeutic study will be consented using an individualized consent form which addresses their respective personalized treatment plan and its associated risks. No genetic sequencing, and no testing involving flies or animals will be conducted under this therapeutic protocol. This protocol applies only to the treatment phase of personalized medicine. Study participation is expected to last 2-3 years. Personalized Treatment Plan Since each personalized treatment plan may, and probably will be, different from respected registration label and from FDA indication, a body of experts established as the Pharmacology Committee will review the ADMET data for the drugs from each of the selected regimens. For each case, a referring medical oncologist will provide a clinical presentation of the patient`s history of cancer and previous therapy, as well as other important medical history to a Multidisciplinary Tumor Board of Experts (MTBE) consisting of two pharmacologist scientists selected for experience in drug selection, a research clinical pharmacist, 2 medical oncologists with expertise with phase 2 clinical trials, a member of the IRB, two medical oncologists with expertise in the patient's tumor type including the treating physician and two scientists who performed the drug prediction tests. Except for clinicians and other investigators directly involved with the patient's care, the members of the MTBE will be an independent group as to avoid the risk of bias. The composition of this committee will vary and other individuals may be added as the process moves forward. A study subject will only be allowed to start the personalized therapeutic plan once the final informed consent is approved by the IRB and signed by the study subject. Once enrolled in a personalized therapy, the study subject will receive treatment based on the PTP and any dose adjustment will be according with the manufacturer label information and/or the PDR Electronic Library. Any controversial, incidental, or unexpected findings while on the treatment will be presented to the MTBE-called ad hoc, and the board will decide on continuation, dose adjustment or any modification of the study subject`s personalized therapeutic treatment plan. The Personalized Treatment Plan (PTP) will be stopped upon disease progression. However, if there is no standard therapy or no other clinical trial available at the time of progression, subjects with progressive disease will have the option of being treated with one of the graded therapies discussed at the initial MTBE meeting (there will be up to 5 therapeutic plans. They will be required to sign a separate informed consent but will not be included in statistical analysis of this protocol. All the statistics will be descriptive in nature and will be exploratory. Medullary thyroid cancer (MTC) is an uncommon thyroid malignancy comprising of up to 5% of all thyroid cancers. The National Cancer Institute (NCI) estimates that 56,460 Americans will be diagnosed with thyroid cancer and 1,780 will die from the disease in 2012. Early disease is usually only confined to the thyroid and can be cured with surgery. Unfortunately, more than 50% of cases are diagnosed with locally advanced or metastatic disease, and a 10-year survival for them is about 40%. In most tumors, as well as in MTC, single-agent inhibitor therapy has faced numerous problems and has often provided patients with only limited benefits. In this study, the investigators will be using the results of a previous study in which the Drosophila animal model combined with extensive pretesting genetic analysis of samples taken from patients' individual tumors was used to potentially develop personalized therapeutic plans for those enrolled. In this study, the investigators will offer to treat those patients with their personalized therapeutic plan (if they were able to develop one in the prior study). This is a therapeutic clinical trial in which the investigators will provide personalized therapy to patients with medullary thyroid cancer based on a Personalized Therapeutic Plan (PTP) developed under the separate Tumor Genomic Analysis and Molecular Testing for Personalized Cancer Therapy protocol (GCO# 14-0054 (0001) MSSM). This therapeutic protocol applies only to the treatment period of Personalized Medicine. The objective is to establish superiority of Personalized Medicine in terms of efficacy (Overall Response Rate) in MTC patients, or substantially similar efficacy but with reduced toxicity, when compared to the best standard of care option for recurrent/metastatic MTC (currently cabozantinib) as was demonstrated in a phase III trial.

  • Research data . Clinical Trial . 2012
    Open Access
    Authors: 
    Redding, Colleen A;
    Publisher: nct

    Smoking remains one of the biggest causes of premature morbidity and mortality. Nicotine addiction continues to challenge researchers to optimize their best interventions, and these challenges increase with efforts to integrate smoking cessation into multiple behavior change research and dissemination. Tailored intervention strategies have demonstrated effectiveness, yet much research remains to be done exploring optimal tailoring strategies. Transtheoretical model (TTM) tailored feedback on all 14 variables has been demonstrated to be a robust population cessation strategy across studies, producing 22-25% quit rates at 18-24 month final timepoints. This proposal sought to find a subset of these variables that is optimal for tailoring, both minimizing response burden while maximizing effectiveness. Addiction variables have been demonstrated to predict smoking outcomes across studies as well, so we will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring group. Enhanced addiction tailored feedback that both helps unmotivated smokers reduce their addiction and helps motivated smokers quit could lead to a breakthrough in population cessation. This proposal tests four types of TTM-tailoring for smoking cessation in an additive design: assessment-only control group; Minimal tailoring (stage only); Moderate tailoring (stage, pros, cons, efficacy); Full TTM tailoring (all 14 TTM variables); and Enhanced TTM tailoring plus addiction variables. Smokers will be randomized to one of five treatment groups and evaluated at baseline, 6 months, 12 months, and 24 months. Treatment groups will receive tailored feedback at baseline, 6 months, and 12 months. Analyses will compare treatment groups on quit rates at the final timepoint to see how effectively each treatment helps smokers to quit. A series of mediation and moderation analyses will examine how each treatment works. This study has the potential to find an optimal tailoring strategy for population cessation that could accelerate future multiple behavior change research and dissemination efforts. This study explored optimal tailoring strategies for population tobacco cessation in 4 treatment groups and a control group over 24 months. Transtheoretical model (TTM) tailored feedback on all 14 variables has been found to be a robust population cessation strategy across studies. This proposal sought to find a subset of these variables that is optimal for tailoring, both minimizing response burden while maximizing effectiveness. Addiction variables have been demonstrated to predict smoking outcomes across studies as well, so we will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring group. Optimally tailored feedback that both helps unmotivated smokers reduce their addiction and helps motivated smokers quit could lead to a breakthrough in population cessation.

  • Open Access
    Authors: 
    Silverman, Robert;
    Publisher: nct

    Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis. The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.

  • Research data . Clinical Trial . 2016
    Open Access
    Authors: 
    Knudsen, Gitte M;
    Publisher: nct

    Study population and study program: Patients will be recruited through a unique new central referral site for "depression packages" in The Mental Health Services in the Capital Region of Denmark. 100 patients with MDD, 18-65 years of age, with moderate to severe single or recurrent episode of MDD (Hamilton 17 item (HAMD-17) score > 17) will be recruited through this portal. All diagnoses will be confirmed by a specialist in psychiatry. Before initiation of pharmacological antidepressant treatment with escitalopram, patients will receive baseline examinations as follows: 1) 5-HT4R imaging with 11C-SB207145 PET-scan, 2) EEG examinations, 3) structural MRI, 4) functional MRI , 5) neuropsychological testing, 6) peripheral markers of immune-active cell responses, oxidative stress, cortisol-levels, RNA, genotypes and epigenetic factors will be measured in urine, saliva and peripheral blood at baseline and across the study period. Repeated measures across the study period include: 7) psychometrics by using self-reported questionnaires covering trait and state, including mental distress related to depression and other psychopathology, 8) neuropsychological examinations as well as 9) clinical follow-up with interview based ratings of mental status. Patients will be treated with escitalopram at flexible doses of 10-20 mg/day adjusted depending on effects and side effects, and participate in clinical follow-up sessions at week 1, 2, 4 and 8. Patients with no response to escitalopram after 4 weeks will be shifted to a secondary pharmacological treatment (duloxetine). A final visit to determine longer-term clinical outcome will be performed at week 12. Compliance, side-effects to antidepressant treatment, and depressive symptoms will be monitored at each follow-up session. The Hamilton 6 items (HAMD-6) subscale has recently shown to be more sensitive to antidepressant response (Østergaard et al), and will be used to identify treatment response in patients. Patients with > 50 % reduction in HAMD-6 after 4 weeks will be defined as early responders, and those with additional 7) predicts poor antidepressant treatment outcome. 18. We expect urinary markers of oxidatively generated DNA/RNA damage to increase more in responders than in non-responders. 19. With an exploratory approach it will be possible to identify a set of predictors of antidepressant treatment outcome. This explorative analysis includes genetics, epigenetics, peripheral and central neurobiological characteristics, neuropsychology testing outcomes, psychometry including self-reported mental distress, both cross-sectional at baseline and as longitudinal measures. Ethical Aspects: The study protocol complies with the Declaration of Helsinki II and approval by all relevant authorities will be obtained before initiation. All human volunteers will receive oral and written information about the given study and provide written informed consent before enrolment. The trial is monitored by a Good Clinical Practise unit for the relevant domains. Major Depressive Disorder (MDD) is one of the most severe and frequently occurring brain disorders worldwide. It has been linked to serotonergic dysfunction, sexual dysfunction, vulnerability to stress and neuro-inflammation. However, at the same time the etiological understanding is limited. Most antidepressants act on the serotonin (5- HT) system, yet between 30-50 % of patients with MDD does not respond successfully to 5-HT acting drugs. Recent experimental models from our group suggest that cerebral 5-HT levels in vivo can be indexed through molecular brain imaging of the 5-HT 4 receptor (5-HT4R) with a novel Positron Emission Tomography (PET) ligand (11C-SB207145). Also, our human studies have confirmed that cerebral synaptic 5-HT is inversely related to 5-HT4R binding and this technique thus can be used to investigate the role of 5-HT tone in the brain in MDD with differential responses to standard antidepressant treatment. By using multimodal neuroimaging technology, we aim to determine the status of the 5-HT system prior to and after either successful or failed neuropharmacological intervention in a non-randomized longitudinal open clinical trial. 100 untreated patients with moderate to severe MDD will be included. Data collection from various neurobiological domains (i.e, 5-HT4R PET imaging, Magnetic Resonance Imaging (MRI), functional MRI (fMRI), electroencephalogram (EEG), psychometrics, neuropsychological tests, and peripheral biomarkers) will be conducted before, during and after 12 weeks of antidepressant treatment. The objective is to identify predictors of pharmacological antidepressant treatment response in depressed individuals before and after 8 weeks of antidepressant treatment.

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