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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Wheelock, Vicki;

    This observational study will establish a clinical baseline and measure changes over time in movement, thinking, behavior, brain imaging, blood and spinal fluid markers in subjects with early stage Huntington's disease. Participants enrolled in this study may be eligible to participate in a future planned study of stem cell therapy for Huntington's Disease (HD). In-person study visits occur at screening, baseline, and every 6 months thereafter for a minimum of 12 months, with interim phone call assessments. In PRE-CELL the investigators propose to enroll a cohort of early-stage HD patients in a prospective observational study designed to characterize clinical, neuro-imaging, laboratory and biomarker correlates of disease progression over 12-18 months. Subjects who complete a minimum of 12 months' participation in this trial will be candidates for enrollment in the future planned Phase 1 trial of intrastriatal delivery of mesenchymal stem cell (MSC)/Brain-derived neurotrophic factor (BDNF).

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    OpenTrials
    Clinical Trial . 2013
    Data sources: OpenTrials
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      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ OpenTrialsarrow_drop_down
      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      OpenTrials
      Clinical Trial . 2013
      Data sources: OpenTrials
  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Schoorens, Dirk;

    This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. The goal of this study is to compare ultrasound-guided selective shoulder block (regional anesthesia of the suprascapular and axillary nerves) with ultrasound-guided interscalene block after arthroscopic shoulder surgery. More specific, this study is designed to compare postoperative pain scores, use of opioids, pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied). Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery). Overall satisfaction with pain therapy will be assessed 48hours after surgery. Continuous interscalene brachial plexus block is considered to be the standard treatment for postoperative pain after shoulder surgery. With interscalene block a local anesthetic is injected around the nerve plexus supplying motor and sensory innervation to the upper limb. Disadvantages are an extensive motor and sensory block of the upper limb and paresis of the diaphragm sometimes provoking dyspnea. Since 2007 newer techniques are described, for example selective block of the suprascapular nerve and the axillary nerve. These two nerves supply most of the shoulder joint with motor and sensory innervation, but have no function in the distal part of the upper limb. The risk of loss of innervation to the diaphragm is avoided with this selective shoulder block. Hence, possible breathing disorders are avoided. Previous studies have concluded that the selective shoulder block is a safe technique and is effective to reduce postoperative pain after arthroscopic shoulder surgery. Moreover, studies also suggest that selective shoulder block has a longer duration, less fluctutations in pain score and less rebound pain after fading of the regional anesthesia. With this study the investigators want to compare the effect of this newer technique with the single shot interscalene plexus block. Therefore the investigators will allocate the patients to two groups for comparison. One group will receive interscalene plexus block and the other group will receive a selective shoulder block. The used local anesthetic will be the same in both groups, that is ropivacaine 0,75% with a total volume of 20 ml. Both blocks will be placed using an ultra-sound guided technique. In previous studies a blind technique, based on anatomical reference points or nerve stimulation, has been used to place the selective shoulder block. As both blocks will be placed with an ultrasound-guided technique, the anesthesiologist will have a direct view of the location of the needle. With this technique there is less risk for accidental intravascular injection or nerve injury. Also there is greater probability of success and faster implementation of the block. Indepent of the technique used, the pain that the patient may experience will be reduced to a minimum. Therefore the patient wlll be supplied with a PCIA system (patient controlled intravenous analgesia), next to the standard pain relievers (paracetamol, anti-inflammatory medication). This PCIA system is a pump system with piritramide (Dipidolor®, an opioid) connected with the infusion line. The system is set up in a way that, within certain limits, the patient can decide for him/herself when pain treatment is provided. This is a monocentric, prospective, randomised and observer-blinded study. Patients included will be randomised in two groups. One group will receive the ultrasound-guided single shot interscalene block, the other group will receive the ultrasound-guided selective shoulder block (axillary nerve and suprascapular nerve). The patient is not strictly blinded as there are two injections needed for the selective shoulder block, compared to only one injection for the interscalene block. The data collector (per- and postoperative) will be blinded, as he will not be informed about which block is performed. This in order to avoid bias. This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. Both blocks will be placed using an ultra-sound guided technique. Primary outcome measures will be postoperative pain scores and use of rescue opioids. Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction with pain therapy as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied). Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery). Overall satisfaction with pain therapy will be assessed 48hours after surgery. An interscalene block is a block of the plexus brachialis in the interscelene triangle (by injecting a local anesthetic around the nerve plexus). A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting a local anesthetic around these nerves).

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ OpenTrialsarrow_drop_down
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    OpenTrials
    Clinical Trial . 2015
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2015
      Data sources: OpenTrials
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    Authors: Maresta, A.;

    This is a multicenter (11 centers), prospective, randomized single blind study. This study has a 2-arm design assessing the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version to the bare metal Bx SONICTM stent. A total of 250 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to the Sirolimus-eluting stent or the bare metal Bx SONIC stent. The investigator cannot be blind because the outer appearance of the system for the implant of the Sirolimus-eluting stent differs from that of the bare metal stent and will therefore immediately be recognized by the surgeon. However the patient will not know which stent will be implanted. Patients will be followed at 30 days, 9 and 12 months post-procedure, with all patients undergoing repeat angiography at 8 months. Additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 1 year follow-up period will be collected and analyzed. The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic patients as compared to the bare metal Bx SONIC balloon-expandable stent. The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year).

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    OpenTrials
    Clinical Trial . 2007
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2007
      Data sources: OpenTrials
  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Gojo, Ivana;

    PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) of pomalidomide when given at the time of early lymphocyte recovery following intensive induction timed sequential therapy (TST) with cytarabine (cytosine arabinoside), daunorubicin hydrochloride (daunorubicin) and etoposide (AcDVP-16) in patients with newly diagnosed intermediate- and poor-risk acute myeloid leukemia and high-risk myelodysplastic syndrome (MDS). II. To evaluate the safety, tolerability and toxicity of pomalidomide given at the time of early lymphocyte recovery following induction AcDVP-16 chemotherapy in adults with newly diagnosed intermediate- and poor-risk acute myeloid leukemia and high-risk MDS. SECONDARY OBJECTIVES: I. To evaluate the safety, tolerability and toxicity of pomalidomide given as a continuation therapy following induction and/or consolidation chemotherapy in adults with newly diagnosed intermediate- and poor-risk acute myeloid leukemia and high-risk MDS. II. To document responses (complete remission [CR], CR with incomplete count recovery [CRi], partial remission [PR]) to AcDVP-16 followed by pomalidomide at the time of lymphocyte recovery in newly diagnosed adults with intermediate- and poor-risk acute myeloid leukemia (AML) and high-risk MDS, including duration of response, disease-free and overall survival. III. Correlative pharmacodynamics studies: a) to characterize the effects of pomalidomide on the functional dynamics of different lymphocyte subpopulations (effector T [Teff], regulatory T [Treg], natural killer [NK] cells) and its impact on tumor-associated antigen (TAA)-specific T cell immunity when given following induction and as a maintenance; b) to examine for the presence of minimal residual disease (MRD) before and after pomalidomide administration during induction and continuation therapy; c) to examine cereblon expression in primary leukemia cells at diagnosis and in sorted T cells prior to and after pomalidomide treatment. OUTLINE: This is a dose-escalation study of pomalidomide. INDUCTION: Patients receive cytarabine intravenously (IV) continuously and daunorubicin hydrochloride IV on days 1-3 (patients may otherwise receive idarubicin hydrochloride IV over 10-15 minutes on days 1-3 if daunorubicin hydrochloride is unavailable), and etoposide IV over 3 hours on days 8-10. At the time of early lymphocyte recovery (after day +14), patients also receive pomalidomide orally (PO) for 10-21 days. CONSOLIDATION: Patients achieving CR or CRi receive cytarabine based treatment at the discretion of the treating investigator, with possible regimens comprising cytarabine IV continuously on days 1-3, and 10-12 and daunorubicin hydrochloride IV on days 1-3, or high- or medium-dose cytarabine IV every 12 hours on days 1, 3, and 5 for 1-4 courses. CONTINUATION: Patients achieving CR or CRi who did not undergo allogeneic stem cell transplant receive pomalidomide PO daily on days 1-21 beginning 6 weeks following blood count recovery. Treatment repeats every 4-6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years. This phase I trial studies the side effects and best dose of pomalidomide after combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pomalidomide may kill cancer cells by stopping blood flow to the cancer and by stimulating white blood cells to kill cancer cells. Giving more than one drug (combination chemotherapy) and pomalidomide may kill more cancer cells.

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    OpenTrials
    Clinical Trial . 2014
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2014
      Data sources: OpenTrials
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    Authors: Burton-Freeman, Britt;

    The study is single-center, randomized, 2-arm, and crossover design. Twelve healthy men and women aged 20-45 will be recruited for the study. Interested subjects will be asked to come to the Clinical Nutrition Research Center (CNRC) on the IIT Campus, Chicago, IL, where the study will take place for a screening visit to determine if they are eligible to participate in the study. The screening visit will take 2-2.5 hours. Prospective subjects must read, sign and date a written Institutional Review Board (IRB) approved Informed Consent Form prior to performing any study procedure. At the on-site screening visit, subject will be asked to arrive after overnight fasting for 10-12 hours and be well-hydrated. Subject will be instructed to aim for a water intake of at least 8-10 cups for the 24 hours before the screening visit. Determine eligibility to participate includes having subjects to complete a series of questionnaires related to their health, medication use, dietary habits, and physical activity history. Anthropocentric (height, weight and waist circumference), ear temperature, and vital signs (blood pressure and heart rate) will be measured. Body mass index (BMI) will be calculated from height and weight measurements. BMI is an estimate of body fat based on height and weight that applies to both adult men and women. Fasting blood glucose level by capillary blood from finger prick will be tested. For vital sign measurements, subjects will sit in a comfortable chair, feet uncrossed and on the floor and will be asked to rest quietly for 5 minutes before measuring blood pressure and heart rate. Arm vein will be assessed using a vein access scale test. Subject will be instructed to complete a 24-hour food recall. Based on the results of the questionnaires, BMI calculation, health evaluation and 24-hour food recall, subjects who meet the inclusion and exclusion criteria will be invited to participate in the study. Eligible subjects will be trained and instructed to record all food and beverages consumed for a 3-day period on food record diaries. Study staff will provide the food record forms and training to the subjects. Eligible participants will be asked to come to the center for two test days. Test Day 1 will follow the screening visit by at least a 7 day washout adhering to diet instructions. At each Test Day visit, subjects will arrive at the clinic between 7 am and 9 am after fasting for 10 to 12 hours and in a well-hydrated and well-rested state. If they are taking medication(s) each morning, they will be asked not to take the medication(s) at home and instead to bring to the clinical nutrition center to be taken in the presence of the study investigator so the medications(s) is taken at the same time before each Study Day visit. Study protocol adherence will be corroborated by asking about the period of fasted state. Subject will also be asked about their limitation/avoidance of polyphenolic diet the last one week and detailed food intake the 24-hour period prior to the visit to ensure consistency and compliance with the protocol requirements. Subjects experiencing unusual stressful events (such as loss of job, loss of loved one, divorce, etc…) will be rescheduled to a later time agreed upon by the subject and investigator. Subject will be asked about their medication intake and health status since their last visit to ensure that subjects are maintaining their good health and medication intake. After confirming compliance with protocol, anthropometric measurements and vital signs (blood pressure, heart rate and ear temperature) will be taken. A finger prick for fasting blood glucose will be taken to confirm if subject is fasting. A licensed healthcare professional (LHCP) will evaluate and place a catheter on antecubital site of subject's non-dominant arm. A catheter is a thin flexible tube that allows sampling of blood through one port throughout the Study Day. Once the catheter is placed, a baseline blood sample will be taken (Time point T -5). Subject will be asked to rest for 5 minutes, and then another baseline blood sample will be taken (T 0). After completing 2 baseline blood sampling, subjects will receive a serving of 100% orange juice or 100% orange juice with orange pomace fiber based on computer generated randomization sequence. The randomization sequence will be assigned to each subject on the first Study Day visit (Test Day 1). Additional blood samples will be taken at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after the start of the orange juice. Subjects are allowed to drink water after 60 min and the amount will be recorded. After completion of all study procedures and data/sample collection for the day, the catheter will be removed and subjects will be evaluated for safety and/or discomfort/symptoms before leaving the study site. They will be given a snack and written instructions in preparation for the next visit. Study day visits will be scheduled at least 3 days apart, but not more than 7 days. Test Day 2 will be exactly the same as Test Day 1 except the treatment, which will be the other of 100% orange juice or 100% orange juice with orange pomace fiber based on computer generated randomization sequence. Primary object is to determine if 100% orange juice with enzyme-treated orange pomace fiber compared to a 100% orange juice will reduce 2 hr glycemic response as measured by glucose area under the curve. Secondary object is to assess if 100% orange juice with enzyme-treated orange pomace fiber compared to a 100% orange juice will reduce 2 hr insulin iAUC response.

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    OpenTrials
    Clinical Trial . 2016
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2016
      Data sources: OpenTrials
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    Authors: Gann, Peter H;

    The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

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    OpenTrials
    Clinical Trial . 2011
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2011
      Data sources: OpenTrials
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    Authors: Spetzler, Robert F.;

    Infections that occur as a direct result of patients' stays in a hospital are called "nosocomial infections." One of the most common types of nosocomial infections occur as a result of surgical procedures that patient undergo while they are in the hospital. These nosocomial infections that occur as a result of surgical procedures are referred to as surgical site infections (SSI), and they are associated with increased patient morbidity as well as approximately $1.5 billion of added healthcare expenses annually. Under the nascent Patient Protection and Affordable Care Act (PPACA), SSI rates will be used by the government to justify the alteration of reimbursement rates to hospitals and physicians for patient care. As a result, SSIs are of the utmost interest to both surgeons, hospitals and healthcare providers, in general. One of the suspected causes of SSI's is increased personnel traffic thru operating rooms during surgeries. The logic involves the fact that bacteria capable of causing SSI's are present in normal air. The air within operating rooms is constantly filtered, in order to decrease the bacterial load within the air and hopefully decreasing the likelihood that a patient will develop a SSI. When personnel open doors connecting the operating rooms to the outside hallways, the dirty, unfiltered air from the hallways is able to mix with the clean, filtered air within the operating rooms. This increases the bacterial load within the operating room, and potentially increases the risk of the patient developing a SSI. However, no class I data exist demonstrating that the level of personnel traffic thru operating rooms during surgery has any significant effect on SSI's. Nevertheless, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Accreditation Manual for Hospitals, as well as the United States' Centers for Disease Control (CDC) guidelines for infection control emphasize the importance of traffic patterns in the surgical suite, as well as limiting the number of personnel involved in the procedure. Other national organizations such as the Association of Operating Room Nurses (AORN) have made similar recommendations that personnel traffic thru the operating room should be limited during surgical procedures. Although these recommendations appear logical, they create significant performance pressure for the operating room personnel, because it limits their abilities to do carry out the duties during surgery by limiting their mobility in-and-out of the operating rooms. These restrictions are especially difficult to implement for teaching institutions like the Barrow Neurological Institute (BNI) that attract international observers who travel from other countries, in order to stand inside of our operating rooms so they can watch and learn from our neurosurgeons. Therefore, prior to instituting any restrictions on personnel movement thru the operating rooms, the investigators feel it is imperative that class I data be generated, in order to either prove or disprove that the level of personnel traffic in the operating room correlates with infection rates. In order to generate class 1 data, the investigators propose that a prospective, randomized trial, hereafter referred to as the BRITE Trial, be conducted at the Barrow Neurological Institute (BNI) at St Joseph's Hospital & Medical Center (SJHMC), Phoenix, Arizona. The BRITE Trial will enroll all eligible patients undergoing a surgical procedure within the BNI Operating Rooms for a period of one year, starting on January 1, 2013. The BNI Operating Rooms contain 11 operating rooms where surgeries are conducted on a daily basis. The investigators plan to divide the 11 BNI operating rooms into 2 different groups: Group A and Group B. Group A will be operating rooms #1 thru #5. Group B will be operating rooms #6 thru #11. Investigators plan to randomize both Group A and Group B to either "Normal O.R. Traffic" or "Low O.R. Traffic" protocols. The randomization will occur in a dichotomous fashion so Group A and Group B are never simultaneously randomized to the same O.R. Traffic protocol. The randomization will occur at 6 a.m. on the Monday morning of each new week, and the randomization designation will last for 7 consecutive days. Randomization will occur thru a standard randomization computer program (www.random.org) and weekly designations will be placed within sealed envelopes. The sealed envelope for each week will be opened at 6 a.m. on the Monday morning of that week. The group of operating rooms that is designated as being under the "Low O.R. Traffic" protocol will have signs on the inside and outside of all doors connected to these operating rooms. The "Low O.R. Traffic" protocol group will also be required to adhere to a new set of rules and regulations. The group of operating rooms that is designated as being under "Normal O.R. Traffic" protocol will have no signs on their doors and they will follow the normal standards for O.R. personnel traffic, per routine. Data reflecting personnel movement will be collected via a proprietary "personnel counting system" (Traf-Sys, Pittsburgh, PA). The "personnel counting system" operates via infrared beams mounted on the outside of every operating room door. When a person walks thru the operating room door, the infrared beam is broken and the system records the movement of a single person. These data will be tracked 24 hours a day, 7 days a week for a 365 day period. An interim analysis will be conducted at 6 months. Primary outcome will be return to the BNI operating room for wound washout within 12 months. Secondary outcome will be return to BNI operating room for any reason. Our goal for the BRITE Trial is 2-fold. First, the investigators want to determine whether or not instituting a Low O.R. Traffic protocol actually leads to decreased O.R. personnel traffic thru the operating rooms. Second, the investigators want to determine whether or not increased levels of O.R. personnel traffic thru the operating rooms leads to increased rates of SSI's. All eligible patients who will have neurosurgery at Barrow Neurological Institute (BNI) between March 1, 2013 and February 28, 2014 will be enrolled as part of this study that will look at the flow of staff people in and out of the operating room during surgeries and the effect that the number of people may have on the rate of infections in the surgical sites.

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    Clinical Trial . 2013
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      Clinical Trial . 2013
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    Authors: Bakhda, Dr.Rahul;

    Toxemia of pregnancy is a recognized entity for over 2000 years with its known complications and fatality. Nowadays, a most accepted terminology for the following defined syndrome is "hypertensive disorders in pregnancy" given by American College of Obstetrics and Gynecology. It is an important cause of maternal and fetal morbidity and mortality. Pregnancy induced hypertension (PIH) was classified as gestational hypertension, preeclampsia, severe preeclampsia and eclampsia. PIH is a hypertensive disorder in pregnancy that occurs after 20 weeks of pregnancy in the absence of other causes of elevated blood pressure (BP) (BP >140/90 mmHg measured two times with at least of 4 hour interval) in combination with generalized edema and/or proteinuria (>300 mg per 24 hrs). When there is significant proteinuria it is termed as preeclampsia; seizure or coma as a consequence of PIH is termed as eclampsia. Preeclampsia was classified into mild and severe preeclampsia. Mild eclampsia—BP >140/90 mmHg, proteinuria+, and/or mild edema of legs, Severe preeclampsia—BP >160/110 mmHg,proteinuria++ or ++++, headache, cerebral or visual disturbances, epigastric pain, impaired liver function tests and increase in serum creatinine. Proteinuria was tested using dipstick method as +=0.3 gm/L, ++=1 gm/L, and +++=3 gm/L. The pathological changes of this disease appear to be related to vascular endothelial dysfunction and its consequences (generalized vasospasm and capillary leak). Ocular involvement is common in PIH.Common symptoms are blurring of vision, photopsia, scotomas and diplopia. Visual symptoms may be the precursor of seizures.Progression of retinal changes correlates with progression of PIH and also with the fetal mortality due to similar vascular ischemic changes in placenta.Vasospastic manifestations are reversible and the retinal vessels rapidly return to normal after delivery. Ophthalmoscope should be rated next to the sphygmomanometer as an instrument of diagnostic importance in cases of PIH. Ophthalmoscopy does not only helps in diagnosing the disease but repeated observations assist in assessing the severity, progress of disease, response to treatment if any and ultimate outcome or prognosis. An observational study in which the patients for the study are selected from antenatal clinic, antenatal ward and "preeclampsia and eclampsia room" in Department of Obstetrics and Gynecology and general Ophthalmic Out Patient Department(OPD) in case of ambulatory patients during the period of November 2003 to June 2006 randomly.In every case, detail obstetric history including a detail antenatal history was taken. General examination and relevant pathological investigations like routine blood count, HIV, HBsAg, renal function tests, TORCH complex etc., were carried out. In every case, pupil was dilated with homatropine (2%) eye drops. Then detailed ophthalmic examination was carried out with special emphasis on direct ophthalmoscopy apart from visual acuity of both eyes and anterior segment examination. Fundus findings were noted in detail, changes in the color of the disc, disc margin, physiological cup, changes in retinal blood vessels especially caliber of vessels, arterio‑venous (AV) ratio,changes in vessel wall, blood column, appearance of vascular light reflex, changes at AV crossings, changes in macular area and changes in background, overall appearance, presence of hemorrhages, exudates or any pathology were recorded. Fundus changes were graded as per modified Keith, Wagner and Barker classification.Assessment of prognosis as regards to vision and life (mortality) was made.

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    Clinical Trial . 2016
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      Clinical Trial . 2016
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    Authors: Abrams, Steve;

    We plan to stratify subjects for randomization to either vitamin D supplements or placebo by serum 25-hydroxyvitamin D (25 OHD) into three groups: 0-20 ng/mL, 20-32 ng/mL, and >32 ng/mL. There is no group assignment or randomization for the magnesium and zinc aspects of the study. SCREENING VISIT: At the time of enrollment, subjects and their families will be asked to come to the General Clinical Research Center (GCRC) of Texas Children's Hospital for a screening visit. Prior to this visit, demographics from the parent/guardian will be recorded including the child's approximate height and weight, and the study dietitian will obtain two 24-hour dietary recalls from the parent to determine calcium intake for enrollment. During this screening visit, informed written consent will be obtained, a medical history taken, and a physical examination performed. The study dietitian will instruct the parent/guardian and child on the use of a food scale to weigh and record dietary intake for a 3-day period (ie, 3-day weighed diet record). The 3-day weighed diet record will begin the following day. This method has been shown to provide the best estimate of dietary intakes in children (Crawford PB et al, J Am Diet Assoc. 1994; 94:626-630; Fisher JO et al, Am J Clin Nutr. 2008; 88:407-415). Upon analysis of their child's intake, parents will be instructed to maintain a similar nutrient intake throughout the study. Compliance will be monitored via 3-day weighed home diet records timed with their other study visits. If analysis shows that the child's intake has significantly changed (± 20% of a nutrient), the parent will be counseled by the study dietitian on readjusting the child's intake back to the usual level determined at baseline. In addition, the study dietitian will prepare sample menus based on the child's food preferences and dietary intake levels and provide them to the parent. Parents can use the sample menus to assist them in maintaining the child's usual mineral intake. STUDY VISIT 1: Subjects and a parent/guardian will return to the GCRC for a 24-hour overnight stay, arriving in the morning for a baseline stable isotope study. We will utilize the dual-tracer stable isotope technique as in our previous studies. At this visit subjects will receive intravenous isotope doses 1 mg 42Ca, 6 mg 25Mg, and 0.4 mg 70Zn. At the time of the IV isotope, we will collect a blood sample (10mL for serum calcium, phosphorus, alkaline phosphatase, magnesium, 25OHD, 1,25-dihydroxyvitamin D, hepcidin, ferritin, TIBC, transferrin saturation, hemoglobin, hematocrit, and RBC indices). Topical numbing cream or spray to minimize pain at the injection site will be offered to all subjects. A dual-energy x-ray absorptiometry (DEXA) measurement of total body bone mineral content/density and body fat will be made. This is done to use as a covariate in evaluating vitamin D levels and calcium absorption. A 24-hr urine collection while they stay inpatient will begin with the timing of the first isotope. After they are discharged, subjects will be instructed on collecting another 48-hr urine collection (72-hr total) at home as well as a final spot urine at 96 hours after the first isotope. Subjects will receive oral isotopes (20 mcg 46Ca, 12 mg 26Mg, and 2 mg 67Zn) mixed with 120 mL of calcium and vitamin D-fortified orange juice or milk. The breakfast will be a fixed meal providing a total of ~300 mg calcium. Lunch will provide ~300mg calcium; dinner will provide ~300mg calcium (totaling ~900mg calcium). All meals at the GCRC will be pre- and post-weighed to determine actual intake. After discharge, subjects will record dietary intake using another 3-day weighed diet record. Approximately one week after Study Visit 1, the results from the serum 25OHD test will be back and we will stratify subjects accordingly into three groups: 0-20 ng/mL, 20-32 ng/mL, and >32 ng/mL. Subjects will return to the CNRC to be provided supplemental vitamin D3 (1000 IU) or placebo, given once daily (based on the stratification noted above). Vitamin D/placebo will be provided using a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks. They will be provided with study calendars to mark daily when they remember to take the supplement. Calendars and remaining supplements will be returned to the study center for counting to determine compliance. Subjects will return urine samples, food scales, and diet records to the study personnel at the CNRC. The CNRC driver may also be utilized for the purpose of picking up samples or delivering the supplement. Periodic phone calls will be made to the home of the subject to monitor compliance with taking the supplement. STUDY VISIT 2: Eight (8) weeks after the subjects began taking their supplement, subjects will return to the GCRC for a repeat study of absorption. Prior to this visit, subjects will receive a food scale and will perform another 3-day weighed diet record to demonstrate consistency of diet throughout the study period. Subjects will again arrive in the morning to the GCRC for a 24-hr inpatient study visit. They will bring with them all study calendars and remaining supplements for compliance monitoring. Study Visit 2 is similar in all aspects of Study Visit 1 regarding the calcium and vitamin D portion of the study. Magnesium and zinc measurements will not be repeated at Study Visit 2. At this visit subjects will receive an intravenous isotope dose of 1 mg 42Ca. At the time of the IV isotope, we will collect a blood sample (same labs as in Study Visit 1). Topical numbing cream or spray to minimize pain at the injection site will be offered to all subjects. A 24-hr urine collection while they stay inpatient will begin with the timing of the first isotope. After they are discharged, subjects will not be required to continue any additional urine collections. Subjects will receive 20 mcg 46Ca stable isotope mixed with 120 mL of calcium and vitamin D-fortified orange juice or milk. The breakfast will be a fixed meal providing a total of ~300 mg calcium. Lunch will provide ~300mg calcium; dinner will provide ~300mg calcium (totaling ~900mg calcium). All meals at the GCRC will be pre- and post-weighed to determine actual intake. Upon discharge, subjects will discontinue the supplementation and the study will be complete. In interpreting the results, we will note ethnicity, the season of measurement and qualitative descriptions of sun exposure by considering the amount of time spent outside. However, we will not specifically assess sun exposure as this is not practical in small children. In general, we would not expect large changes in these in Houston during the 8 weeks of the study, but will ensure that the two studies do not cross a period of major change such as having the first study done before summer camp and the second right afterwards. Urine and serum samples will be prepared for mass spectrometric analysis using an oxalate precipitation technique. Samples will be analyzed for isotopic enrichment using a magnetic sector ICP-MS. This is a high-speed instrument capable of analysis of the desired ratio with precision and accuracy of 0.3-0.5%. Contingencies: We do not anticipate any problems with this study that would require changing or altering the protocol. Our sample size does not allow us to evaluate gender or ethnicity separately to determine differences in effects among these. There is no reason to expect differences in vitamin D effects on calcium absorption based on these (Weaver, personal communication). Additionally, dietary recommendations reflect the diversity of our population and if we identify trends towards specific ethnic or gender effects we can study this further in future population studies. This study will look at absorption only as an endpoint. If a benefit is found, we will develop a long-term trial evaluating bone mineral outcomes. However, this would require larger groups and a full year of study and is beyond the scope of this initial study. If no difference in calcium absorption is shown with 1000 IU/d of vitamin D, it is extremely unlikely that an effect on bone mineral would be found justifying a long-term study. Magnesium absorption studies require a full 72-hour urine collection for accuracy. It is not practical to keep children this age in-patient for this time so after 24 hours, collections will be done at home. We have extensive experience with assisting families in home urine collections. There is the possibility of some loss of urine in a 72-hour collection. However, in that case we would continue the collection as the method's accuracy is not highly sensitive to the loss of a single or a small number of urine specimens in small children. Magnesium balance is not regulated by endogenous excretion (similar to calcium) and thus the absorption studies will provide adequate information to estimate net balance. Subjects may be told their weight and height measurements at each visit to the GCRC. All other study related information will be held until the end of the study. The goal of our research is to provide data to enhance the development of nutritional guidelines, especially as related to mineral nutrition, in children. Using human experimentation, we are studying methods of delivering the key minerals of calcium, zinc and iron in the diet so as to optimize health outcomes. We will conduct a controlled trial of vitamin D supplementation to assess the effects of vitamin D status on calcium absorption in small children. We will evaluate the effects of differing intakes of zinc on zinc and copper absorption. These studies will utilize stable isotope techniques so as to provide accurate, practically applicable information which may be obtained from the study populations in a safe manner. These data will have global application and provide a strong basis for evidence-based nutritional recommendations to be developed. Objective #1: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. Objective #2: Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age.

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    Authors: Hillebrecht, Andree;

    Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training (Sigal, RJ, et al.: Effects of Aerobic Training, Resistance Training, or Both on Glycemic Control in Type 2 Diabetes, Ann Intern Med. 2007 Sep 18;147(6):357-69). Therefore, aim of the current study is to compare the effects of aerobic endurance training or resistance endurance training or the combination of aerobic endurance training and resistance endurance training in diabetes type 2 patients without any other lifestyle or dietary interventions. The purposes of the study are - to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients - to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life - to assess what kind of intervention induces highest effects in long term persistence of these positive changes

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    Authors: Wheelock, Vicki;

    This observational study will establish a clinical baseline and measure changes over time in movement, thinking, behavior, brain imaging, blood and spinal fluid markers in subjects with early stage Huntington's disease. Participants enrolled in this study may be eligible to participate in a future planned study of stem cell therapy for Huntington's Disease (HD). In-person study visits occur at screening, baseline, and every 6 months thereafter for a minimum of 12 months, with interim phone call assessments. In PRE-CELL the investigators propose to enroll a cohort of early-stage HD patients in a prospective observational study designed to characterize clinical, neuro-imaging, laboratory and biomarker correlates of disease progression over 12-18 months. Subjects who complete a minimum of 12 months' participation in this trial will be candidates for enrollment in the future planned Phase 1 trial of intrastriatal delivery of mesenchymal stem cell (MSC)/Brain-derived neurotrophic factor (BDNF).

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      Clinical Trial . 2013
      Data sources: OpenTrials
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    Authors: Schoorens, Dirk;

    This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. The goal of this study is to compare ultrasound-guided selective shoulder block (regional anesthesia of the suprascapular and axillary nerves) with ultrasound-guided interscalene block after arthroscopic shoulder surgery. More specific, this study is designed to compare postoperative pain scores, use of opioids, pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied). Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery). Overall satisfaction with pain therapy will be assessed 48hours after surgery. Continuous interscalene brachial plexus block is considered to be the standard treatment for postoperative pain after shoulder surgery. With interscalene block a local anesthetic is injected around the nerve plexus supplying motor and sensory innervation to the upper limb. Disadvantages are an extensive motor and sensory block of the upper limb and paresis of the diaphragm sometimes provoking dyspnea. Since 2007 newer techniques are described, for example selective block of the suprascapular nerve and the axillary nerve. These two nerves supply most of the shoulder joint with motor and sensory innervation, but have no function in the distal part of the upper limb. The risk of loss of innervation to the diaphragm is avoided with this selective shoulder block. Hence, possible breathing disorders are avoided. Previous studies have concluded that the selective shoulder block is a safe technique and is effective to reduce postoperative pain after arthroscopic shoulder surgery. Moreover, studies also suggest that selective shoulder block has a longer duration, less fluctutations in pain score and less rebound pain after fading of the regional anesthesia. With this study the investigators want to compare the effect of this newer technique with the single shot interscalene plexus block. Therefore the investigators will allocate the patients to two groups for comparison. One group will receive interscalene plexus block and the other group will receive a selective shoulder block. The used local anesthetic will be the same in both groups, that is ropivacaine 0,75% with a total volume of 20 ml. Both blocks will be placed using an ultra-sound guided technique. In previous studies a blind technique, based on anatomical reference points or nerve stimulation, has been used to place the selective shoulder block. As both blocks will be placed with an ultrasound-guided technique, the anesthesiologist will have a direct view of the location of the needle. With this technique there is less risk for accidental intravascular injection or nerve injury. Also there is greater probability of success and faster implementation of the block. Indepent of the technique used, the pain that the patient may experience will be reduced to a minimum. Therefore the patient wlll be supplied with a PCIA system (patient controlled intravenous analgesia), next to the standard pain relievers (paracetamol, anti-inflammatory medication). This PCIA system is a pump system with piritramide (Dipidolor®, an opioid) connected with the infusion line. The system is set up in a way that, within certain limits, the patient can decide for him/herself when pain treatment is provided. This is a monocentric, prospective, randomised and observer-blinded study. Patients included will be randomised in two groups. One group will receive the ultrasound-guided single shot interscalene block, the other group will receive the ultrasound-guided selective shoulder block (axillary nerve and suprascapular nerve). The patient is not strictly blinded as there are two injections needed for the selective shoulder block, compared to only one injection for the interscalene block. The data collector (per- and postoperative) will be blinded, as he will not be informed about which block is performed. This in order to avoid bias. This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. Both blocks will be placed using an ultra-sound guided technique. Primary outcome measures will be postoperative pain scores and use of rescue opioids. Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction with pain therapy as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied). Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery). Overall satisfaction with pain therapy will be assessed 48hours after surgery. An interscalene block is a block of the plexus brachialis in the interscelene triangle (by injecting a local anesthetic around the nerve plexus). A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting a local anesthetic around these nerves).

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    OpenTrials
    Clinical Trial . 2015
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2015
      Data sources: OpenTrials
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    Authors: Maresta, A.;

    This is a multicenter (11 centers), prospective, randomized single blind study. This study has a 2-arm design assessing the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version to the bare metal Bx SONICTM stent. A total of 250 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to the Sirolimus-eluting stent or the bare metal Bx SONIC stent. The investigator cannot be blind because the outer appearance of the system for the implant of the Sirolimus-eluting stent differs from that of the bare metal stent and will therefore immediately be recognized by the surgeon. However the patient will not know which stent will be implanted. Patients will be followed at 30 days, 9 and 12 months post-procedure, with all patients undergoing repeat angiography at 8 months. Additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 1 year follow-up period will be collected and analyzed. The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic patients as compared to the bare metal Bx SONIC balloon-expandable stent. The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year).

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    OpenTrials
    Clinical Trial . 2007
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2007
      Data sources: OpenTrials
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    Authors: Gojo, Ivana;

    PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) of pomalidomide when given at the time of early lymphocyte recovery following intensive induction timed sequential therapy (TST) with cytarabine (cytosine arabinoside), daunorubicin hydrochloride (daunorubicin) and etoposide (AcDVP-16) in patients with newly diagnosed intermediate- and poor-risk acute myeloid leukemia and high-risk myelodysplastic syndrome (MDS). II. To evaluate the safety, tolerability and toxicity of pomalidomide given at the time of early lymphocyte recovery following induction AcDVP-16 chemotherapy in adults with newly diagnosed intermediate- and poor-risk acute myeloid leukemia and high-risk MDS. SECONDARY OBJECTIVES: I. To evaluate the safety, tolerability and toxicity of pomalidomide given as a continuation therapy following induction and/or consolidation chemotherapy in adults with newly diagnosed intermediate- and poor-risk acute myeloid leukemia and high-risk MDS. II. To document responses (complete remission [CR], CR with incomplete count recovery [CRi], partial remission [PR]) to AcDVP-16 followed by pomalidomide at the time of lymphocyte recovery in newly diagnosed adults with intermediate- and poor-risk acute myeloid leukemia (AML) and high-risk MDS, including duration of response, disease-free and overall survival. III. Correlative pharmacodynamics studies: a) to characterize the effects of pomalidomide on the functional dynamics of different lymphocyte subpopulations (effector T [Teff], regulatory T [Treg], natural killer [NK] cells) and its impact on tumor-associated antigen (TAA)-specific T cell immunity when given following induction and as a maintenance; b) to examine for the presence of minimal residual disease (MRD) before and after pomalidomide administration during induction and continuation therapy; c) to examine cereblon expression in primary leukemia cells at diagnosis and in sorted T cells prior to and after pomalidomide treatment. OUTLINE: This is a dose-escalation study of pomalidomide. INDUCTION: Patients receive cytarabine intravenously (IV) continuously and daunorubicin hydrochloride IV on days 1-3 (patients may otherwise receive idarubicin hydrochloride IV over 10-15 minutes on days 1-3 if daunorubicin hydrochloride is unavailable), and etoposide IV over 3 hours on days 8-10. At the time of early lymphocyte recovery (after day +14), patients also receive pomalidomide orally (PO) for 10-21 days. CONSOLIDATION: Patients achieving CR or CRi receive cytarabine based treatment at the discretion of the treating investigator, with possible regimens comprising cytarabine IV continuously on days 1-3, and 10-12 and daunorubicin hydrochloride IV on days 1-3, or high- or medium-dose cytarabine IV every 12 hours on days 1, 3, and 5 for 1-4 courses. CONTINUATION: Patients achieving CR or CRi who did not undergo allogeneic stem cell transplant receive pomalidomide PO daily on days 1-21 beginning 6 weeks following blood count recovery. Treatment repeats every 4-6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years. This phase I trial studies the side effects and best dose of pomalidomide after combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pomalidomide may kill cancer cells by stopping blood flow to the cancer and by stimulating white blood cells to kill cancer cells. Giving more than one drug (combination chemotherapy) and pomalidomide may kill more cancer cells.

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    OpenTrials
    Clinical Trial . 2014
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2014
      Data sources: OpenTrials
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    Authors: Burton-Freeman, Britt;

    The study is single-center, randomized, 2-arm, and crossover design. Twelve healthy men and women aged 20-45 will be recruited for the study. Interested subjects will be asked to come to the Clinical Nutrition Research Center (CNRC) on the IIT Campus, Chicago, IL, where the study will take place for a screening visit to determine if they are eligible to participate in the study. The screening visit will take 2-2.5 hours. Prospective subjects must read, sign and date a written Institutional Review Board (IRB) approved Informed Consent Form prior to performing any study procedure. At the on-site screening visit, subject will be asked to arrive after overnight fasting for 10-12 hours and be well-hydrated. Subject will be instructed to aim for a water intake of at least 8-10 cups for the 24 hours before the screening visit. Determine eligibility to participate includes having subjects to complete a series of questionnaires related to their health, medication use, dietary habits, and physical activity history. Anthropocentric (height, weight and waist circumference), ear temperature, and vital signs (blood pressure and heart rate) will be measured. Body mass index (BMI) will be calculated from height and weight measurements. BMI is an estimate of body fat based on height and weight that applies to both adult men and women. Fasting blood glucose level by capillary blood from finger prick will be tested. For vital sign measurements, subjects will sit in a comfortable chair, feet uncrossed and on the floor and will be asked to rest quietly for 5 minutes before measuring blood pressure and heart rate. Arm vein will be assessed using a vein access scale test. Subject will be instructed to complete a 24-hour food recall. Based on the results of the questionnaires, BMI calculation, health evaluation and 24-hour food recall, subjects who meet the inclusion and exclusion criteria will be invited to participate in the study. Eligible subjects will be trained and instructed to record all food and beverages consumed for a 3-day period on food record diaries. Study staff will provide the food record forms and training to the subjects. Eligible participants will be asked to come to the center for two test days. Test Day 1 will follow the screening visit by at least a 7 day washout adhering to diet instructions. At each Test Day visit, subjects will arrive at the clinic between 7 am and 9 am after fasting for 10 to 12 hours and in a well-hydrated and well-rested state. If they are taking medication(s) each morning, they will be asked not to take the medication(s) at home and instead to bring to the clinical nutrition center to be taken in the presence of the study investigator so the medications(s) is taken at the same time before each Study Day visit. Study protocol adherence will be corroborated by asking about the period of fasted state. Subject will also be asked about their limitation/avoidance of polyphenolic diet the last one week and detailed food intake the 24-hour period prior to the visit to ensure consistency and compliance with the protocol requirements. Subjects experiencing unusual stressful events (such as loss of job, loss of loved one, divorce, etc…) will be rescheduled to a later time agreed upon by the subject and investigator. Subject will be asked about their medication intake and health status since their last visit to ensure that subjects are maintaining their good health and medication intake. After confirming compliance with protocol, anthropometric measurements and vital signs (blood pressure, heart rate and ear temperature) will be taken. A finger prick for fasting blood glucose will be taken to confirm if subject is fasting. A licensed healthcare professional (LHCP) will evaluate and place a catheter on antecubital site of subject's non-dominant arm. A catheter is a thin flexible tube that allows sampling of blood through one port throughout the Study Day. Once the catheter is placed, a baseline blood sample will be taken (Time point T -5). Subject will be asked to rest for 5 minutes, and then another baseline blood sample will be taken (T 0). After completing 2 baseline blood sampling, subjects will receive a serving of 100% orange juice or 100% orange juice with orange pomace fiber based on computer generated randomization sequence. The randomization sequence will be assigned to each subject on the first Study Day visit (Test Day 1). Additional blood samples will be taken at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after the start of the orange juice. Subjects are allowed to drink water after 60 min and the amount will be recorded. After completion of all study procedures and data/sample collection for the day, the catheter will be removed and subjects will be evaluated for safety and/or discomfort/symptoms before leaving the study site. They will be given a snack and written instructions in preparation for the next visit. Study day visits will be scheduled at least 3 days apart, but not more than 7 days. Test Day 2 will be exactly the same as Test Day 1 except the treatment, which will be the other of 100% orange juice or 100% orange juice with orange pomace fiber based on computer generated randomization sequence. Primary object is to determine if 100% orange juice with enzyme-treated orange pomace fiber compared to a 100% orange juice will reduce 2 hr glycemic response as measured by glucose area under the curve. Secondary object is to assess if 100% orange juice with enzyme-treated orange pomace fiber compared to a 100% orange juice will reduce 2 hr insulin iAUC response.

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    OpenTrials
    Clinical Trial . 2016
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2016
      Data sources: OpenTrials
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    Authors: Gann, Peter H;

    The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

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    OpenTrials
    Clinical Trial . 2011
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2011
      Data sources: OpenTrials
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    Authors: Spetzler, Robert F.;

    Infections that occur as a direct result of patients' stays in a hospital are called "nosocomial infections." One of the most common types of nosocomial infections occur as a result of surgical procedures that patient undergo while they are in the hospital. These nosocomial infections that occur as a result of surgical procedures are referred to as surgical site infections (SSI), and they are associated with increased patient morbidity as well as approximately $1.5 billion of added healthcare expenses annually. Under the nascent Patient Protection and Affordable Care Act (PPACA), SSI rates will be used by the government to justify the alteration of reimbursement rates to hospitals and physicians for patient care. As a result, SSIs are of the utmost interest to both surgeons, hospitals and healthcare providers, in general. One of the suspected causes of SSI's is increased personnel traffic thru operating rooms during surgeries. The logic involves the fact that bacteria capable of causing SSI's are present in normal air. The air within operating rooms is constantly filtered, in order to decrease the bacterial load within the air and hopefully decreasing the likelihood that a patient will develop a SSI. When personnel open doors connecting the operating rooms to the outside hallways, the dirty, unfiltered air from the hallways is able to mix with the clean, filtered air within the operating rooms. This increases the bacterial load within the operating room, and potentially increases the risk of the patient developing a SSI. However, no class I data exist demonstrating that the level of personnel traffic thru operating rooms during surgery has any significant effect on SSI's. Nevertheless, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Accreditation Manual for Hospitals, as well as the United States' Centers for Disease Control (CDC) guidelines for infection control emphasize the importance of traffic patterns in the surgical suite, as well as limiting the number of personnel involved in the procedure. Other national organizations such as the Association of Operating Room Nurses (AORN) have made similar recommendations that personnel traffic thru the operating room should be limited during surgical procedures. Although these recommendations appear logical, they create significant performance pressure for the operating room personnel, because it limits their abilities to do carry out the duties during surgery by limiting their mobility in-and-out of the operating rooms. These restrictions are especially difficult to implement for teaching institutions like the Barrow Neurological Institute (BNI) that attract international observers who travel from other countries, in order to stand inside of our operating rooms so they can watch and learn from our neurosurgeons. Therefore, prior to instituting any restrictions on personnel movement thru the operating rooms, the investigators feel it is imperative that class I data be generated, in order to either prove or disprove that the level of personnel traffic in the operating room correlates with infection rates. In order to generate class 1 data, the investigators propose that a prospective, randomized trial, hereafter referred to as the BRITE Trial, be conducted at the Barrow Neurological Institute (BNI) at St Joseph's Hospital & Medical Center (SJHMC), Phoenix, Arizona. The BRITE Trial will enroll all eligible patients undergoing a surgical procedure within the BNI Operating Rooms for a period of one year, starting on January 1, 2013. The BNI Operating Rooms contain 11 operating rooms where surgeries are conducted on a daily basis. The investigators plan to divide the 11 BNI operating rooms into 2 different groups: Group A and Group B. Group A will be operating rooms #1 thru #5. Group B will be operating rooms #6 thru #11. Investigators plan to randomize both Group A and Group B to either "Normal O.R. Traffic" or "Low O.R. Traffic" protocols. The randomization will occur in a dichotomous fashion so Group A and Group B are never simultaneously randomized to the same O.R. Traffic protocol. The randomization will occur at 6 a.m. on the Monday morning of each new week, and the randomization designation will last for 7 consecutive days. Randomization will occur thru a standard randomization computer program (www.random.org) and weekly designations will be placed within sealed envelopes. The sealed envelope for each week will be opened at 6 a.m. on the Monday morning of that week. The group of operating rooms that is designated as being under the "Low O.R. Traffic" protocol will have signs on the inside and outside of all doors connected to these operating rooms. The "Low O.R. Traffic" protocol group will also be required to adhere to a new set of rules and regulations. The group of operating rooms that is designated as being under "Normal O.R. Traffic" protocol will have no signs on their doors and they will follow the normal standards for O.R. personnel traffic, per routine. Data reflecting personnel movement will be collected via a proprietary "personnel counting system" (Traf-Sys, Pittsburgh, PA). The "personnel counting system" operates via infrared beams mounted on the outside of every operating room door. When a person walks thru the operating room door, the infrared beam is broken and the system records the movement of a single person. These data will be tracked 24 hours a day, 7 days a week for a 365 day period. An interim analysis will be conducted at 6 months. Primary outcome will be return to the BNI operating room for wound washout within 12 months. Secondary outcome will be return to BNI operating room for any reason. Our goal for the BRITE Trial is 2-fold. First, the investigators want to determine whether or not instituting a Low O.R. Traffic protocol actually leads to decreased O.R. personnel traffic thru the operating rooms. Second, the investigators want to determine whether or not increased levels of O.R. personnel traffic thru the operating rooms leads to increased rates of SSI's. All eligible patients who will have neurosurgery at Barrow Neurological Institute (BNI) between March 1, 2013 and February 28, 2014 will be enrolled as part of this study that will look at the flow of staff people in and out of the operating room during surgeries and the effect that the number of people may have on the rate of infections in the surgical sites.

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    Clinical Trial . 2013
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      OpenTrials
      Clinical Trial . 2013
      Data sources: OpenTrials
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    Authors: Bakhda, Dr.Rahul;

    Toxemia of pregnancy is a recognized entity for over 2000 years with its known complications and fatality. Nowadays, a most accepted terminology for the following defined syndrome is "hypertensive disorders in pregnancy" given by American College of Obstetrics and Gynecology. It is an important cause of maternal and fetal morbidity and mortality. Pregnancy induced hypertension (PIH) was classified as gestational hypertension, preeclampsia, severe preeclampsia and eclampsia. PIH is a hypertensive disorder in pregnancy that occurs after 20 weeks of pregnancy in the absence of other causes of elevated blood pressure (BP) (BP >140/90 mmHg measured two times with at least of 4 hour interval) in combination with generalized edema and/or proteinuria (>300 mg per 24 hrs). When there is significant proteinuria it is termed as preeclampsia; seizure or coma as a consequence of PIH is termed as eclampsia. Preeclampsia was classified into mild and severe preeclampsia. Mild eclampsia—BP >140/90 mmHg, proteinuria+, and/or mild edema of legs, Severe preeclampsia—BP >160/110 mmHg,proteinuria++ or ++++, headache, cerebral or visual disturbances, epigastric pain, impaired liver function tests and increase in serum creatinine. Proteinuria was tested using dipstick method as +=0.3 gm/L, ++=1 gm/L, and +++=3 gm/L. The pathological changes of this disease appear to be related to vascular endothelial dysfunction and its consequences (generalized vasospasm and capillary leak). Ocular involvement is common in PIH.Common symptoms are blurring of vision, photopsia, scotomas and diplopia. Visual symptoms may be the precursor of seizures.Progression of retinal changes correlates with progression of PIH and also with the fetal mortality due to similar vascular ischemic changes in placenta.Vasospastic manifestations are reversible and the retinal vessels rapidly return to normal after delivery. Ophthalmoscope should be rated next to the sphygmomanometer as an instrument of diagnostic importance in cases of PIH. Ophthalmoscopy does not only helps in diagnosing the disease but repeated observations assist in assessing the severity, progress of disease, response to treatment if any and ultimate outcome or prognosis. An observational study in which the patients for the study are selected from antenatal clinic, antenatal ward and "preeclampsia and eclampsia room" in Department of Obstetrics and Gynecology and general Ophthalmic Out Patient Department(OPD) in case of ambulatory patients during the period of November 2003 to June 2006 randomly.In every case, detail obstetric history including a detail antenatal history was taken. General examination and relevant pathological investigations like routine blood count, HIV, HBsAg, renal function tests, TORCH complex etc., were carried out. In every case, pupil was dilated with homatropine (2%) eye drops. Then detailed ophthalmic examination was carried out with special emphasis on direct ophthalmoscopy apart from visual acuity of both eyes and anterior segment examination. Fundus findings were noted in detail, changes in the color of the disc, disc margin, physiological cup, changes in retinal blood vessels especially caliber of vessels, arterio‑venous (AV) ratio,changes in vessel wall, blood column, appearance of vascular light reflex, changes at AV crossings, changes in macular area and changes in background, overall appearance, presence of hemorrhages, exudates or any pathology were recorded. Fundus changes were graded as per modified Keith, Wagner and Barker classification.Assessment of prognosis as regards to vision and life (mortality) was made.

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    Clinical Trial . 2016
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      OpenTrials
      Clinical Trial . 2016
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    Authors: Abrams, Steve;

    We plan to stratify subjects for randomization to either vitamin D supplements or placebo by serum 25-hydroxyvitamin D (25 OHD) into three groups: 0-20 ng/mL, 20-32 ng/mL, and >32 ng/mL. There is no group assignment or randomization for the magnesium and zinc aspects of the study. SCREENING VISIT: At the time of enrollment, subjects and their families will be asked to come to the General Clinical Research Center (GCRC) of Texas Children's Hospital for a screening visit. Prior to this visit, demographics from the parent/guardian will be recorded including the child's approximate height and weight, and the study dietitian will obtain two 24-hour dietary recalls from the parent to determine calcium intake for enrollment. During this screening visit, informed written consent will be obtained, a medical history taken, and a physical examination performed. The study dietitian will instruct the parent/guardian and child on the use of a food scale to weigh and record dietary intake for a 3-day period (ie, 3-day weighed diet record). The 3-day weighed diet record will begin the following day. This method has been shown to provide the best estimate of dietary intakes in children (Crawford PB et al, J Am Diet Assoc. 1994; 94:626-630; Fisher JO et al, Am J Clin Nutr. 2008; 88:407-415). Upon analysis of their child's intake, parents will be instructed to maintain a similar nutrient intake throughout the study. Compliance will be monitored via 3-day weighed home diet records timed with their other study visits. If analysis shows that the child's intake has significantly changed (± 20% of a nutrient), the parent will be counseled by the study dietitian on readjusting the child's intake back to the usual level determined at baseline. In addition, the study dietitian will prepare sample menus based on the child's food preferences and dietary intake levels and provide them to the parent. Parents can use the sample menus to assist them in maintaining the child's usual mineral intake. STUDY VISIT 1: Subjects and a parent/guardian will return to the GCRC for a 24-hour overnight stay, arriving in the morning for a baseline stable isotope study. We will utilize the dual-tracer stable isotope technique as in our previous studies. At this visit subjects will receive intravenous isotope doses 1 mg 42Ca, 6 mg 25Mg, and 0.4 mg 70Zn. At the time of the IV isotope, we will collect a blood sample (10mL for serum calcium, phosphorus, alkaline phosphatase, magnesium, 25OHD, 1,25-dihydroxyvitamin D, hepcidin, ferritin, TIBC, transferrin saturation, hemoglobin, hematocrit, and RBC indices). Topical numbing cream or spray to minimize pain at the injection site will be offered to all subjects. A dual-energy x-ray absorptiometry (DEXA) measurement of total body bone mineral content/density and body fat will be made. This is done to use as a covariate in evaluating vitamin D levels and calcium absorption. A 24-hr urine collection while they stay inpatient will begin with the timing of the first isotope. After they are discharged, subjects will be instructed on collecting another 48-hr urine collection (72-hr total) at home as well as a final spot urine at 96 hours after the first isotope. Subjects will receive oral isotopes (20 mcg 46Ca, 12 mg 26Mg, and 2 mg 67Zn) mixed with 120 mL of calcium and vitamin D-fortified orange juice or milk. The breakfast will be a fixed meal providing a total of ~300 mg calcium. Lunch will provide ~300mg calcium; dinner will provide ~300mg calcium (totaling ~900mg calcium). All meals at the GCRC will be pre- and post-weighed to determine actual intake. After discharge, subjects will record dietary intake using another 3-day weighed diet record. Approximately one week after Study Visit 1, the results from the serum 25OHD test will be back and we will stratify subjects accordingly into three groups: 0-20 ng/mL, 20-32 ng/mL, and >32 ng/mL. Subjects will return to the CNRC to be provided supplemental vitamin D3 (1000 IU) or placebo, given once daily (based on the stratification noted above). Vitamin D/placebo will be provided using a softgel or liquid. Subjects will be instructed to take the supplement daily for 8 weeks. They will be provided with study calendars to mark daily when they remember to take the supplement. Calendars and remaining supplements will be returned to the study center for counting to determine compliance. Subjects will return urine samples, food scales, and diet records to the study personnel at the CNRC. The CNRC driver may also be utilized for the purpose of picking up samples or delivering the supplement. Periodic phone calls will be made to the home of the subject to monitor compliance with taking the supplement. STUDY VISIT 2: Eight (8) weeks after the subjects began taking their supplement, subjects will return to the GCRC for a repeat study of absorption. Prior to this visit, subjects will receive a food scale and will perform another 3-day weighed diet record to demonstrate consistency of diet throughout the study period. Subjects will again arrive in the morning to the GCRC for a 24-hr inpatient study visit. They will bring with them all study calendars and remaining supplements for compliance monitoring. Study Visit 2 is similar in all aspects of Study Visit 1 regarding the calcium and vitamin D portion of the study. Magnesium and zinc measurements will not be repeated at Study Visit 2. At this visit subjects will receive an intravenous isotope dose of 1 mg 42Ca. At the time of the IV isotope, we will collect a blood sample (same labs as in Study Visit 1). Topical numbing cream or spray to minimize pain at the injection site will be offered to all subjects. A 24-hr urine collection while they stay inpatient will begin with the timing of the first isotope. After they are discharged, subjects will not be required to continue any additional urine collections. Subjects will receive 20 mcg 46Ca stable isotope mixed with 120 mL of calcium and vitamin D-fortified orange juice or milk. The breakfast will be a fixed meal providing a total of ~300 mg calcium. Lunch will provide ~300mg calcium; dinner will provide ~300mg calcium (totaling ~900mg calcium). All meals at the GCRC will be pre- and post-weighed to determine actual intake. Upon discharge, subjects will discontinue the supplementation and the study will be complete. In interpreting the results, we will note ethnicity, the season of measurement and qualitative descriptions of sun exposure by considering the amount of time spent outside. However, we will not specifically assess sun exposure as this is not practical in small children. In general, we would not expect large changes in these in Houston during the 8 weeks of the study, but will ensure that the two studies do not cross a period of major change such as having the first study done before summer camp and the second right afterwards. Urine and serum samples will be prepared for mass spectrometric analysis using an oxalate precipitation technique. Samples will be analyzed for isotopic enrichment using a magnetic sector ICP-MS. This is a high-speed instrument capable of analysis of the desired ratio with precision and accuracy of 0.3-0.5%. Contingencies: We do not anticipate any problems with this study that would require changing or altering the protocol. Our sample size does not allow us to evaluate gender or ethnicity separately to determine differences in effects among these. There is no reason to expect differences in vitamin D effects on calcium absorption based on these (Weaver, personal communication). Additionally, dietary recommendations reflect the diversity of our population and if we identify trends towards specific ethnic or gender effects we can study this further in future population studies. This study will look at absorption only as an endpoint. If a benefit is found, we will develop a long-term trial evaluating bone mineral outcomes. However, this would require larger groups and a full year of study and is beyond the scope of this initial study. If no difference in calcium absorption is shown with 1000 IU/d of vitamin D, it is extremely unlikely that an effect on bone mineral would be found justifying a long-term study. Magnesium absorption studies require a full 72-hour urine collection for accuracy. It is not practical to keep children this age in-patient for this time so after 24 hours, collections will be done at home. We have extensive experience with assisting families in home urine collections. There is the possibility of some loss of urine in a 72-hour collection. However, in that case we would continue the collection as the method's accuracy is not highly sensitive to the loss of a single or a small number of urine specimens in small children. Magnesium balance is not regulated by endogenous excretion (similar to calcium) and thus the absorption studies will provide adequate information to estimate net balance. Subjects may be told their weight and height measurements at each visit to the GCRC. All other study related information will be held until the end of the study. The goal of our research is to provide data to enhance the development of nutritional guidelines, especially as related to mineral nutrition, in children. Using human experimentation, we are studying methods of delivering the key minerals of calcium, zinc and iron in the diet so as to optimize health outcomes. We will conduct a controlled trial of vitamin D supplementation to assess the effects of vitamin D status on calcium absorption in small children. We will evaluate the effects of differing intakes of zinc on zinc and copper absorption. These studies will utilize stable isotope techniques so as to provide accurate, practically applicable information which may be obtained from the study populations in a safe manner. These data will have global application and provide a strong basis for evidence-based nutritional recommendations to be developed. Objective #1: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. Objective #2: Assess the absorption of magnesium and zinc in healthy children 4 to 8 yrs of age.

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    Clinical Trial . 2009
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      OpenTrials
      Clinical Trial . 2009
      Data sources: OpenTrials
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    Authors: Hillebrecht, Andree;

    Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training (Sigal, RJ, et al.: Effects of Aerobic Training, Resistance Training, or Both on Glycemic Control in Type 2 Diabetes, Ann Intern Med. 2007 Sep 18;147(6):357-69). Therefore, aim of the current study is to compare the effects of aerobic endurance training or resistance endurance training or the combination of aerobic endurance training and resistance endurance training in diabetes type 2 patients without any other lifestyle or dietary interventions. The purposes of the study are - to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients - to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life - to assess what kind of intervention induces highest effects in long term persistence of these positive changes

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    Clinical Trial . 2011
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      Clinical Trial . 2011
      Data sources: OpenTrials