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7861. GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets

to receive education on the IDF-WPR guidelines or to receive no trial-related education. GPs in both groups will be required to recruit 4 of their own patients meeting the eligibility criteria. The complete entry criteria are detailed in a following section. GPs in both groups will manage the recruited patients according to their own clinical judgement. Frequency of patient visits to the GP's clinic will be determined by the GP. All medication prescribed by the GPs should already be registered (...) will: Combine didactic and interactive sessions. Involve opinion leaders, i.e. the national lead investigator Aim to resolve barriers to practical implementation of guidelines already identified from previous studies (e.g. discuss starting insulin) Present the evidence for the guidelines. Highlight any conflicts between the guidelines and local prescribing regulations, and confirm the need to follow the local prescribing regulations in these instances Involve an initial educational symposium and a follow-up

2007 Clinical Trials

7862. Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was >500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 msec, the participant was withdrawn from the study. Number of Participants (...) ventricular tachycardia. Symptomatic valvular heart disease or valvular heart disease requiring therapy other than endocarditis prophylaxis. Congestive heart failure (CHF, New York Heart Association (NYHA) Class II to IV) requiring pharmacologic treatment. NYHA Class I may be included in accordance with the local prescribing information for pioglitazone. Blood pressure (BP) >150/100mmHg. If a subject is receiving permitted antihypertensive therapy, then they must be on stable dose(s) of therapy

2007 Clinical Trials

7863. Study of Safety, Blood Levels and Brain Receptor Occupancy of GSK598809 Using PET Imaging in Health Males.

of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety. History of regular alcohol consumption averaging >14 drinks/week for men. One drink is equivalent (...) or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its identifier (NCT number): NCT00468806 Locations Layout table for location information Canada, Ontario GSK Investigational Site

2007 Clinical Trials

7864. Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals

(via electronic pill caps [MEMS or Medication Event Monitoring System]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.) To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms. [ Time (...) the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-negative urines and by self-report of methamphetamine use in the aripiprazole versus placebo group. To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps and self-report) medication adherence to aripiprazole and placebo

2007 Clinical Trials

7865. Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children

of amblyopia. Bonsall randomized 14 patients, 3 to 10 years old, with previously untreated strabismic/anisometropic amblyopia to either 6 hours of daily patching or full-time Bangerter filters. Baseline amblyopic eye acuity was 20/30 to 20/400 for the patching group and 20/30 to 20/200 for the Bangerter group. The Bangerter filter prescribed was the minimum density foil needed to elicit a switch in fixation from the sound eye to the amblyopic eye. Visual acuity was measured every 6-8 weeks until (...) resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR). Mean (SD) of Amblyopic Eye Visual Acuity at 24

2007 Clinical Trials

7866. An Imaging Study to Investigate the Distribution of GSK239512 in the Brain.

Exclusion Criteria: The subject has used or is using regular prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within fourteen days or five half lives (whichever was the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication would not have interfered with the study procedures or compromised subject safety. Medications considered to be unlikely to interfere with the study (...) , vascular dementia, transient ischemic attack, schizophrenia, major depression etc) that may influence the outcome or analysis of the scan results or compromise subject safety. Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire. History of known or suspected seizures, unexplained significant loss of consciousness or history of significant head trauma with loss of consciousness. Subjects

2007 Clinical Trials

7867. Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma

of screening. Inhaled corticosteroids are allowed on day of screening. Documented reversibility of > 15% in FEV1 in the screening phase. Demonstrate satisfactory technique in the use of the pressurized MDI. Willing and able to enter information in the electronic diary and attend all study visits. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study. Written informed consent obtained. Exclusion Criteria: Life-threatening asthma within

2007 Clinical Trials

7868. Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma

of combination asthma therapy on day of screening. Inhaled corticosteroids are allowed on day of screening. Documented reversibility of ≥ 15% in FEV1 during the screening phase. Demonstrate satisfactory technique in the use of the pressurized MDI and spacer device. Willing and able to enter information in the electronic diary (parental help is acceptable for young children) and attend all study visits. Willing and able to substitute study medication for their pre study prescribed asthma medication

2007 Clinical Trials

7869. Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin

measurements occurred up to 3 months after last cisplatin treatment. ] Computed maximum increase relative to baseline for each subject = (max MDA during treatment) - baseline MDA level. Total Amount of Prescribed Cisplatin Dose Administered [ Time Frame: cisplatin treatment period between 10 weeks and up to 16 weeks. ] Maximum cumulative dose of cisplatin (mg/m^2) administered during the course of chemotherapy. Eligibility Criteria Go to Information from the National Library of Medicine Choosing (...) and no concurrent radiotherapy for head and neck tumors Concurrent radiotherapy targeted below the neck allowed More than 1 month since prior alpha-lipoic acid supplements Exclusion Criteria: No aggressive behavior as indicated in electronic chart notes No documented dementia No Alzheimer's disease No severe psychosocial disorder No active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance, or notes in patient chart No renal disease No Meniere's disease or retrocochlear

2007 Clinical Trials

7870. Evaluating the Impact on Quality and Costs of Regional Clinical Data Exchange Programs in New York State

Actual Study Start Date : January 2009 Actual Primary Completion Date : December 2010 Actual Study Completion Date : December 2010 Groups and Cohorts Go to Group/Cohort Intervention/treatment 1 Those exposed to health information technology or health information exchange Other: Health information technology and exchange Health information technology includes electronic health records, electronic prescribing, and electronic results notification and/or viewers. Health information exchange includes use (...) Health Care Costs Other: Health information technology and exchange Detailed Description: In 2004, the federal government set an ambitious goal of ensuring that most Americans have electronic health records within 10 years and the presence of a widespread clinical information exchange capability will greatly facilitate this goal. Through HEAL NY, New York State is currently awarding millions of dollars in grants to support health information technology initiatives across the state through regional

2007 Clinical Trials

7871. Evaluating Ways to Improve Medication Use Among People With Osteoporosis

and Musculoskeletal and Skin Diseases (NIAMS) Information provided by (Responsible Party): Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital Study Details Study Description Go to Brief Summary: Osteoporosis is a common bone disease in older adults in which the bones become weaker and prone to fracture. Medications are available to slow or even stop disease progression. However, very few adults who are prescribed osteoporosis medications actually follow through with filling their prescriptions and taking (...) will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among patients. Doctors will also receive alerts about any of their participating patients who are not filling medication prescriptions. The alert message will be provided in both paper and electronic format. The electronic format can be easily formatted, allowing the doctor to send a personalized letter to their patients. At the end of the study, all

2007 Clinical Trials

7872. A Cluster Randomized Controlled Trial in Primary Oral Care

in practice Outcome Measures Go to Primary Outcome Measures : Number of patients per GDP with assigned recall interval (months) based on individual recall assessment. For high risk children and adolescents <7 months, in case of low risk > 7 months. For adults 9 months or more for low risk profiles, and ≤ than 9 mo [ Time Frame: September 2006 and June 2007 ] Secondary Outcome Measures : Number of patients per GDP with prescribed individual frequency of BWs (months). For high-risk children and adolescents (...) of regular attendees, and patient recordkeeping was conducted electronically. GDPs had to give their informed consent to assess and evaluate electronically patient records. Patient data were collected anonymously. Patient's inclusion criteria To be eligible for inclusion, patients should meet (fulfil) several criteria, depending on the IQual's CPG to be used (ROE or MIM): ROE: All patients regularly visiting their dentist (at least once a year) over the past three years for ROEs will be included

2008 Clinical Trials

7873. Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia

alone. While it appears that patching and/or atropine, combined with near activities, can improve visual acuity in some patients ages 7-<18, most patients in the study were left with residual visual acuity deficits. To further improve visual acuity and binocularity in children with amblyopia some eye care providers augment these traditional therapies with vision therapy. Vision therapy is prescribed initially if there is moderate amblyopia with stereopsis. Vision therapy can be added (...) therapy is a sequence of prescribed activities typically performed on a daily basis at home and weekly in-office, and is directed toward an individual patient's deficient skills. Visual skills are practiced under conditions that provide the patient with feedback. The feedback, along with a gradual increase in the demand of the activities as improvement occurs, enables the patient to improve visual functions such as visual acuity, fixation, accommodation, and vergence skills. There have been case

2007 Clinical Trials

7874. Longitudinal Assessment of Clinical Course and BIOmarkers in Severe Chronic AIRway Disease

started before smoking. Specific for patients with mild to moderate asthma (group 1) The patient has stable disease with minimal symptoms, no exacerbations or hospitalisations during the last year. The patient uses inhaled steroids regularly, but not more than 800 microg/day budesonide or beclomethasone, or up to 500 microg/day fluticasone. The patient uses prescribed short-acting beta agonists as needed. The patient does not require treatment with long-acting beta-agonists. Specific for patients (...) from being obtained. Exclusions because of pulmonary disorders The patient is unable to perform acceptable spirometry, peak flow measurements and/or complete diary cards in a satisfactory way during the period between visit 1 and visit 3B (optimisation period and prednisolone/placebo trial). If the patient is unable to use the electronic Peak Flow meters/Diary cards, it is acceptable to use an ordinary mechanical meter (e.g. Mini-Wright) together with a paper version of the diary card. Patients

2007 Clinical Trials

7875. Using Informatics to Enhance Care of Older Emergency Department Patients

) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department. Interventions: The interventions in this study are computer reminders. When releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the Regenstrief Medical (...) -Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients Study Start Date : January 2005 Actual Primary Completion Date : June 2010 Actual Study Completion Date : June 2010 Arms and Interventions Go to Arm Intervention/treatment No Intervention: 1 Experimental: 2 Electronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance) Procedure: Computer-Assisted

2006 Clinical Trials

7876. Radiotherapy

: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients with primary gliomas visible on MRI who are planning to receive radiotherapy or Patients with brain metastases>1cm who are planning to receive radiotherapy Karnofsky Performance Status >60 Age 18 years Patients must be willing to visit Toronto Western Hospital for at least one MRI scan prior radiotherapy Exclusion Criteria: Seizures not controlled with medications, or non compliance with prescribed anti-seizure medication (...) electronic devices not compatible with MRI) Other medical conditions deemed by the PI or associates to make the patients ineligible for protocol procedures Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its identifier (NCT number): NCT00297024 Locations Layout table for location

2006 Clinical Trials

7877. Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients

, a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse to heroin and cocaine seeking in rats. Researchers are interested in studying whether a combination of clonidine and buprenorphine may be more effective in preventing drug relapse than administering one of the medications alone. Objectives: - To determine whether clonidine, given to abstinent patients maintained on buprenorphine, is more effective than placebo (...) to receive either clonidine or placebo along with the buprenorphine. During this part of the study, participants will keep electronic diaries to record drug use or craving and to record data on mood, stress levels, and activity. Weeks 23 28: Participants will stop taking the clonidine or placebo, but will continue the buprenorphine treatment. Participants will continue to keep electronic diaries. Weeks 29 36: Participants will have the choice of transferring to a community clinic transfer or gradually

2006 Clinical Trials

7878. Involving Community Pharmacies in Improving Asthma Outcomes in an Urban Pediatric Population

been shown to improve outcomes. (1) Outcomes will be assessed by blinded and structured patient phone interview at 1, 3, and 6 months. Patients randomized to usual pharmacy care will fill prescriptions by their usual preferred method, whereas patients randomized to enhanced pharmacy care will have these same prescriptions electronically transmitted to specifically trained pharmacists at one of the participating community pharmacies. Both "usual pharmacy care" and "enhanced pharmacy care (...) " will be provided within all participating pharmacy sites. Community pharmacies located in five zip codes in Northeast and Southeast DC with the highest absolute numbers of pediatric ED asthma visits to hospital in the District (20019, 20020, 20032, 20002, 20011) will be selected for the program based on their geographic distribution and ability to meet programmatic expectations. Pharmacies will receive electronically transmitted, faxed or verbal prescriptions from the IMPACT DC Asthma Clinic staff for patients

2007 Clinical Trials

7879. VALIDATE Valsartan and Supportive Measures

of Medicine related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed) Secondary Outcome Measures : Compliance and persistence between randomized groups over time. To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy To assess

2006 Clinical Trials

7880. RCT of a Written Action Plan vs. Usual Care in Children With Acute Asthma

education and medical follow-up). main outcome is adherence to prescribed inhaled preventive medication measured by an electronic counter. Secondary outcomes include attendance to asthma education and to medical follow-up, serving by pharmacy of prescription of oral steroids, as well as asthma control measured by questionnaire (Asthma Quiz for Kidz),2 use of rescue ß2-agonists, relapse to emergency room. Condition or disease Intervention/treatment Phase Asthma Procedure: Written Action Plan for Acute (...) instructions to follow in case of an exacerbation, we propose to test a new written action plan based on the innovative concept that emphasises the key elements associated with good asthma care: (1) use of preventive medication, (2) need for asthma education, (3) need for regular medical review, (4) environmental control and (5) instructions for use of rescue medication. The main outcome is adherence to prescribed inhaled preventive medication measured by an electronic counter. Secondary outcomes include

2006 Clinical Trials

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