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Electronic Prescription

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4121. Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled

endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit. Secondary Outcome Measures : Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis (...) Pain [ Time Frame: Baseline and Weeks 4, 8, and 12 ] The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit. Change

2008 Clinical Trials

4122. Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion

the adjacent decorticated vertebral processes on each side of the vertebrae. [ Time Frame: Imaged by CT at 6 months after surgery ] To assess surgeon's evaluation of radiographic healing at the site of surgery based on flexion and extension radiographs, as well as 2AP and lateral radiographs, and of clinical resolution [ Time Frame: Baseline, Month 6 and Month 12 ] To assess reduction in pain scores at site of back surgery [ Time Frame: First 3 months post-treatment ] To assess use of prescription and non (...) -prescription pain control and other drugs in treatment patients as compared to control patients [ Time Frame: Throughout duration of study ] To assess restoration of function for return to activities of normal daily living [ Time Frame: Month 6 and Month 12 ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about

2008 Clinical Trials

4123. Web-delivered Provider Intervention for Tobacco Control

of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Information Prescription Providers will give usual care to patients who smoke and a paper prescription with the name and url of the "Smoking Coach" website. The smoking coach website is a tailored, public health intervention for smoking cessation. Behavioral: Smoking Coach Control Patients will be referred by paper prescription to the control- "Smoking Coach" website. Experimental: QUIT-PRIMO Providers (...) will give usual care to patients who smoke and then refer patients to the online smoking cessation system electronically. Behavioral: Decide2Quit Patient intervention website that includes 1) interactive calculators to assess readiness to quit, symptoms and quit plan, 2) motivational content, and 3) links to other high quality information. Outcome Measures Go to Primary Outcome Measures : Physician performance on refering patients that smoke cigarettes to the web intervention [ Time Frame: pre

2008 Clinical Trials

4124. Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)

) interdisciplinary team we have designed an innovative, scientifically rigorous, and highly feasible implementation research project in partnership with two Kaiser Permanente (KP) research centers. Kaiser Permanente, one of the Nation's largest Healthcare Organizations, uses an integrated electronic medical record (EMR), with full capture of pharmacy, clinical (including BMD results), and claims data, and cares for a racially/ethnically, socio-economically, and geographically diverse population. To address (...) Outcome Measures : Osteoporosis prescription medications [ Time Frame: 12 months ] Patient-Physician communication regarding osteoporosis treatment and testing [ Time Frame: 12 months ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff

2008 Clinical Trials

4125. Reducing the Unnecessary Use of Heavily Marketed Medications: A Randomized Controlled Trial

of the pharmaceutical industry, advertisements in medical journals and requests for specific treatments from patients, who are increasingly exposed to direct-to-consumer (DTC) advertising. These influences, often based on biased or inaccurate information, contribute to a variety of problems in prescribing, including the unnecessary use of expensive, heavily marketed medications. Overcoming these influences requires innovative approaches. The movement toward widespread adoption of electronic health records (EHRs (...) ) and electronic prescribing presents new opportunities to educate both clinicians and patients at the time of medication prescribing. This project, endorsed by the AHRQ-supported Centers for Education and Research on Therapeutics (CERTs; www.certs.hhs.gov) and the U.S. Food and Drug Administration (FDA), aims to test the effectiveness of computerized prescribing alerts and state-of-the-art educational outreach to reduce the unnecessary use of heavily marketed medications. A second goal is to improve

2008 Clinical Trials

4126. Improving Osteoporosis Care in High-Risk Home Health Patients

to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and fracture risk; (2) automated prompts within the home health agency's electronic medical record system to promote appropriate osteoporosis management; and (3) implementation of osteoporosis-related standardized care pathways and order sets. Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to promote initial use of osteoporosis medications and adherence to treatment after (...) discharge from home health. We hypothesize that: H1: Patients in the intervention group will have increased initial receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis compared to patients receiving usual care; H2: Patients in the intervention group will demonstrate increased persistence in the use of these therapies compared to those receiving usual care. Secondary Aims (SA) will include exploratory analyses of fracture related morbidity

2008 Clinical Trials

4127. Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study

will receive the same elements as the Usual Care patients. In addition, these patients will receive six, bi-weekly, 1-hour individual sessions with the PI, including 3 sessions of Cognitive-Behavioral Therapy for Insomnia (CBT-I) and 3 sessions of Imagery Rehearsal Therapy (IRT). CBT-I consists of education designed to correct unrealistic sleep expectations, a prescription for an individually-tailored behavioral regimen, standard sleep hygiene recommendations, and the identification and restructuring (...) Measures : Nightmare Frequency [ Time Frame: 12 weeks after Baseline ] Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants

2008 Clinical Trials

4128. Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions Drug: Fluorouracil 0.5% Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions Other Name: Carac Outcome Measures Go to Primary Outcome Measures : Adherence (...) to topical Carac® in the subject. Inability to complete all study-related visits. Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study. Subjects should not receive surgical or cryotherapy while participating in the study. Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control Contacts and Locations Go to Information from the National Library

2008 Clinical Trials

4129. Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use

Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail (...) Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government

2008 Clinical Trials

4130. Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms

: 18 Years to 70 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Subject able to read and write US english and able to use electronic devices Subjects who have experienced GERD symptoms for at least six months Subjects currently taking a prescription or over-the-counter PPI medications for GERD Body Mass Index (BMI) 18.5-35.0, inclusive Exclusion Criteria: Subjects that have not experienced any GERD symptoms improvement at all (...) : Lesogaberan Drug: Gelusil® Chewable tablets taken as needed Placebo Comparator: Placebo Drug: Placebo capsule. administered as a single dose twice daily for 4 weeks Drug: Gelusil® Chewable tablets taken as needed Outcome Measures Go to Primary Outcome Measures : Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary [ Time Frame: Run-in period of 8-12 days and treatment period of 26-30 days ] Symptom intensity rated on a six-graded Likert scale (Did

2008 Clinical Trials

4131. Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age

and Interventions Go to Arm Intervention/treatment open label Biological: Moroctocog alfa Patients will receive Moroctocog alfa according to their investigator's prescription. Outcome Measures Go to Primary Outcome Measures : Percentage of Participants With Factor VIII (FVIII) Inhibitor Development [ Time Frame: Baseline to 24 months or early withdrawal. ] Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using (...) (ABR) [ Time Frame: Baseline to 24 months or early withdrawal. ] An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25. Number of Xyntha Infusions Needed to Treat Each New Bleed [ Time Frame: Baseline to 24 months or early withdrawal. ] The data from the electronic Infusion Log

2008 Clinical Trials

4132. Effect of Systematic Medication Review in Elderly Patients Admitted to an Orthopedic Department

notes Within 24 hours of admission a pharmacist retrieve medication histories from patients included in the intervention group. Medication histories will be obtained from - medical records, medication charts, patients electronical medication profile, interview with patients and if necessary contact to the patients general practitioner. The obtained medication history will be discussed with a physician specialized in pharmacology and an advisory note with suggested changes to the patients medication (...) Posted: August 21, 2008 Last Update Posted: December 14, 2010 Last Verified: December 2010 Keywords provided by University of Aarhus: Medication review Patient Safety Drug Prescriptions Drug-use

2008 Clinical Trials

4133. Implementation of Real-time ADE Surveillance and Decision Support

Information provided by (Responsible Party): VA Office of Research and Development Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if an electronic alerting technology improves time to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and whether there is a cost benefit associated with the alerting technology. Condition or disease Intervention/treatment Phase Adverse Drug Events Behavioral: ADE alert assistant Not Applicable (...) alert assistant A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories. No Intervention: Arm 2: Control/No Alerts The second arm is the control. Alerts will not be displayed for these patients. Outcome Measures Go to Primary Outcome Measures : Time to Intervention Once an ADE Alert Has Fired in CPRS [ Time Frame: From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours

2008 Clinical Trials

4134. Project Diabetes: Prescription for Healthy Living

Project Diabetes: Prescription for Healthy Living Project Diabetes: Prescription for Healthy Living - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Project Diabetes: Prescription for Healthy Living (...) on the proposed intervention activities and materials. Qualitative findings and feasibility testing will be the basis for modifying the intervention. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 13 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention Official Title: Project Diabetes: Prescription for Healthy Living Study Start Date : October 2008 Actual

2008 Clinical Trials

4135. Feasibility of Depression Care Management by E-mail

by (Responsible Party): Kaiser Permanente Study Details Study Description Go to Brief Summary: This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment. Condition or disease Intervention/treatment Phase Depression Other: Depression care management by secure messaging Not Applicable Detailed Description: Symptoms of depression, such as persistent sadness, problems sleeping (...) : Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Health Services Research Official Title: Pilot Trial of Depression Care Management by Electronic Secure Messaging Study Start Date : April 2009 Actual Primary Completion Date : April 2010 Actual Study Completion Date : April 2010 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 Participants

2008 Clinical Trials

4136. Duloxetine for Multiple Sclerosis Pain

: LY248686 Cymbalta Outcome Measures Go to Primary Outcome Measures : Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase) [ Time Frame: Baseline, 6 weeks ] 24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average (...) ] Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity. Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase) [ Time Frame: Baseline, 6 weeks ] The BDI-II is completed

2008 Clinical Trials

4137. Multi-arm Intervention Diabetes Adherence Study

information with pharmacy data. The trial will be conducted among 1,436 patients with diabetes and poor blood glycemic and/or lipid control. Patients will be randomized to one of the following three study arms: 1) Usual care - PCPs will write prescriptions electronically but will not be provided patient adherence information or Ml support; 2) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system; and 3) Intervention - PCPs (...) Comparator: Adherence Plus Behavioral: Adherence information plus motivational interviewing Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications

2008 Clinical Trials

4138. Prevention Study in Adult Patients Suffering From Migraine Headaches

Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ] The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary. Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use [ Time Frame: Baseline (...) and last 4 weeks of treatment prior to taper (up to Week 17) ] The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary. Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia [ Time Frame: Baseline and last 4 weeks of treatment prior to taper (up to Week 17) ] The endpoint is defined

2008 Clinical Trials

4139. Support for People Undergoing Chemotherapy

Behavioral: Exercise Training Home-based exercise (walking) program: brief introduction by staff (10 minutes) and provision of packet with DVD, brochure, workbook, pedometer (electronic step counter) along with instructions on initiating and maintaining a walking program. Dose Recommendations: 3-5 exercise session per week for at least 20-30 minutes at maximum intensity of 50 to 75% of their estimated heart rate reserve (RPE of 11-13) which is calculated based on their age and resting pulse. Other Names (...) ) . severe osteoporosis (> 2.5 SD below age and gender norms) . thrombocytopenia (platelets < 20 x 10(9th)/L) . hyponatremia (Na+ < 130 mmol/L) . hypokalemia (K+ ≤ 3.0 mmol/L) . hypercalcemia (Ca++ > 6.5 mmol/L) . abnormal ECG . sensorimotor deficits sufficient to impede unassisted walking Receipt of intravenous chemotherapy administration in the past 2 months Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications Presence of other contraindications as determined

2008 Clinical Trials

4140. Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

cardioverter/defibrillator Subjects with an implantable electronic device. Subjects with a history of diabetes. Subjects with a history of onychomycosis or an abnormal appearing nail on the great toe Subject using systemic antifungal medications within 6 months prior to study enrollment. Subject using prescription topical antifungal medications for toenail fungus within 3 months or other commercially available medications for toenail fungus applied directly to the toenail within 1 week prior to study

2008 Clinical Trials

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