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4361. Providers Against Cavities in Children's Teeth

) prescription to visit the dentist and a list of dentists accepting Medicaid; 2. Integration of oral health assessments into EMR for the provider to document in the child's medical record; versus B) Control arm of medical providers receiving the American Academy of Pediatrics (AAP) based oral health education and providing usual AAP-based care for oral health. Each arm will consist of 9 practices. Children will be followed for 24 months to determine dental utilization and changes in oral health status (...) Intervention/treatment Experimental: CSM theory-based Arm CSM theory-based didactic education and skills training Practice EMR changes Behavioral: CSM theory-based didactic education and skills training Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document

2017 Clinical Trials

4362. Treating Pain in Children With Cancer: Pain Buddy

, and parents get the information they need to give children treatments for pain and symptom management that work. Using Pain Buddy, we aim to quantify the prevalence and intensity of daily pain and symptom episodes in children at home, data that will be used to develop a psychosocial intervention to be delivered electronically to children at home with a goal of improving quality of life. Secondary aims also include examining children's quality of life pre- and post- Pain Buddy and satisfaction with the use (...) Official Title: Mobile Technology to Improve Pain and Symptoms in Children With Cancer Actual Study Start Date : March 2013 Estimated Primary Completion Date : May 2023 Estimated Study Completion Date : May 2023 Arms and Interventions Go to Arm Intervention/treatment Experimental: Pain Buddy Children in this condition will continue with the care that has been prescribed for cancer- and chemotherapy-related pain and symptoms, which may include medications, medical visits, physical interventions, etc

2017 Clinical Trials

4363. COPD Discharge Bundle Delivered Alone or Enhanced Through a Care Coordinator

Primary Completion Date : March 31, 2019 Estimated Study Completion Date : March 31, 2019 Arms and Interventions Go to Arm Intervention/treatment No Intervention: Usual Care During the initial stepped wedge phase, all sites will receive usual care. There is currently no standardized discharge care bundle for COPD in Alberta. Some electronic patient information sheets do exist; however, their content is general and use is limited. It is expected that a vast majority of patients will transition (...) to the community on a sub-optimal medication regimen, with limited referral to additional outpatient programs and no formal follow-up organized with a primary care provider (e.g., "F/U prn" or "F/U with Fam MD"). Active Comparator: COPD discharge care bundle COPD discharge care bundle: Ensure patient has demonstrated adequate inhaler technique Send discharge summary to family physician office and arrange follow-up Optimize and reconcile prescription of respiratory medications Provide a written discharge

2017 Clinical Trials

4364. The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma

: Change from Baseline in the percentage of rescue-free daytime periods during the 12-week treatment period [ Time Frame: Baseline and up to Week 12 ] Subjects will be issued an electronic diary for use during the study. Subjects will record daytime asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the daytime period. Symptoms and rescue use will be recorded between Visits 1 (Week-4) and 4 (Week 12), once in the evening (reporting daytime (...) normal daily activities. Change from Baseline in the percentage of rescue-free night time periods during the 12-week treatment period [ Time Frame: Baseline and up to Week 12 ] Subjects will be issued an electronic diary for use during the study. Subjects will record night time asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the night time period. Symptoms and rescue use will be recorded twice a day between Visits 1 (Week-4) and 4

2017 Clinical Trials

4365. Long-term Observational Study of the Safety of Roflumilast

provided by (Responsible Party): AstraZeneca Study Details Study Description Go to Brief Summary: This is a retrospective cohort study comparing COPD patients aged 40 years and older with new exposure to roflumilast with up to 5 unexposed (ie, not roflumilast-exposed) COPD controls matched by propensity score (PS), age, sex, and year of cohort entry. The study is using electronic healthcare databases in the US (Military Health System database), Germany (GER) (German Pharmacoepidemiological Research (...) between roflumilast exposed and unexposed COPD patients and adjusted hazard ratios (HRs) of the primary and secondary outcomes were calculated in GER and SWE, while in the US adjusted HRs were only calculated for the primary outcome and are not yet available for secondary outcomes. Reported adjusted HRs for secondary outcomes therefore only refer to GER and SWE. Setting Electronic healthcare databases in the United States (US), Germany (GER), and Sweden (SWE) holding demographic data, data on health

2017 Clinical Trials

4366. Health TAPESTRY Ontario

Date : November 1, 2020 Arms and Interventions Go to Arm Intervention/treatment Experimental: Health TAPESTRY Intervention This patient group will begin receiving the TAPESTRY interventions from time zero Other: Health TAPESTRY Intervention The patient will receive in-home visits from trained volunteers who will collect information electronically using a tablet computer. The volunteers will collect information about the client's health goals, health risks, and needs using a specifically designed (...) application (TAP-App). Once the data is gathered, it is summarized into a report (TAP-report) which is securely and electronically sent to the health care clinic (TAP huddle). The team can leverage clinic supports and/or community supports as they deem appropriate to help clients reach their health goals and address any needs and risks which were reported during the volunteer visits. Active Comparator: Usual Care This patient group will receive the intervention after a 6 month waiting period. In the first

2017 Clinical Trials

4367. Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

with Sponsor's Responsible Medical Officer's approval, and the social reasons must be documented in the electronic case report form (eCRF). Patient with a score of > 20 on the PANSS negative subscore (the original PANSS scale [ Sum of N1+N2+N3+N4+N5+N6+N7]) at Screening (Visit 1) and Baseline (Visit 3) AND < 4 points absolute difference between 2 visits. Patients can be on any psychotropic before the trial if the psychotropics can be discontinued at the beginning of the washout phase without risking (...) , and barbiturates), tricyclic antidepressants (TCA), and alcohol (except for prescription benzodiazepines). Patient who cannot be discontinued from psychotropics other than those allowed. Patient who received clozapine within 6 months of the Screening visit. Patient receiving treatment with long-acting or depot antipsychotic medication unless his/her next scheduled dose will occur during the protocol Screening period and can be omitted to allow for sufficient washout before receiving the study drug. Patient

2017 Clinical Trials

4368. NRT Sampling and Selection to Increase Medication Adherence

NRT products, or prescribed bupropion or varenicline; d) Known allergy to any of the nicotine replacement products or sensitivity to adhesive used in nicotine patches; e) Trouble breathing, a pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such as unable to use nicotine gum; h) Cognitive impairment or unstable psychiatric condition that interferes with the informed consent (...) process (individuals stable on psychiatric medications will be included); or i) Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.). 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 ClinicalTrials.gov identifier (NCT number): NCT03276780 Contacts

2017 Clinical Trials

4369. Binge Eating Liraglutide Intervention

hunger, quality of life, and depressed mood at treatment end. Condition or disease Intervention/treatment Phase Binge-Eating Disorder Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml Drug: Placebo Phase 3 Detailed Description: All applicants will be initially screened by phone and/or electronically to determine whether they potentially meet eligibility criteria. Those who appear to meet eligibility criteria and remain interested in the trial will be scheduled for an in-person interview. The in-person (...) , including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week) Diagnosis current or past psychosis Use in past 3 months of medications known to treat BED (such as lisdexamfetamine), induce significant weight loss (i.e., prescription weight loss medications), or induce weight gain (e.g., chronic use of oral steroids, second generation antipsychotics) Currently receiving behavioral or pharmacological treatment for BED Loss of ≥ 10 lb of body weight within the past 3 months Known

2017 Clinical Trials

4370. Effect of Smear Layer on Endodontic Outcome

was done and all canal orifices identified.Working length was obtained with the help of electronic apex locator and confirmed radiographically.Hand files number 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path.Canal preparation was done with the help of rotary NiTi files. In both groups, 2.5% sodium hypochlorite was used as irrigant after each instrument. All the irrigation procedures were performed using a 27 gauge side vented needle. After root canal (...) instrumentation, 17% Ethylenediaminetetraacetic acid (EDTA) solution was also used to remove smear layer in smear layer negative group, while teeth in smear layer positive group was simply rinsed with 2.5% sodium hypochlorite. In both the groups ultrasonic activation of irrigant was done. An inter-appointment dressing of calcium hydroxide was given. The access cavity was then restored with intermediate restorative material (Dental Products of India). Patients were prescribed Ibuprofen 400mg

2017 Clinical Trials

4371. Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

At 6 months, intervention participants who have no change or any increase in their HbA1c based on point of care (POC) testing will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day. Other Name: Glucophage No Intervention: Control Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited. ECS does not have a recruitment (...) Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk. physical activity level [ Time Frame: 6 months ] self-reported using the WHO Physical Activity Questionnaire fruit and vegetable intake [ Time Frame: 6 months ] self report via electronic

2017 Clinical Trials

4372. EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking

be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline (...) = moderate risk; 27+ = high risk) and urine toxicology screen (both at intake): Cannabis: ASSIST=27+ (tox screen not used) Cocaine: ASSIST=7+ OR positive tox screen Methamphetamine: ASSIST=7+ OR positive tox screen Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+ Prescription stimulants: With prescription, ASSIST 27+; Without prescription, ASSIST 7+ Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is for buprenorphine or methadone); Without prescription

2017 Clinical Trials

4373. Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function

Criteria Inclusion Criteria: Male or female, age 18-45 In good health as determined by OMSO General Medical Clearance Passed his/her most recent Army Physical Fitness Test (APFT) (military volunteers only) or exercise at least 2 times per week (civilian volunteers) Ability to comprehend and willingness to sign informed consent Exclusion Criteria: Females who are pregnant or planning to become pregnant during the study Taking prescription or over the counter medication, other than a contraceptive (...) (unless approved by OMSO and PI) Physical problems/injuries associated with walking or cycling Allergy to sulfa drugs (Lasix™ or sulfonamide antibiotics such as Septra™) Allergy to skin adhesive Hemoglobinopathy (sickle cell trait) Heart, lung, kidney, muscle, or nerve disorder(s) History of heat or orthostatic intolerance Diagnosed and/or treated for fluid/electrolyte imbalance within the last 30 days Presence of metal implants/electronic medical devices in lower extremities Current or previous

2017 Clinical Trials

4374. Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008

, primitive tumour, relapses, pathology reports, metastatic disease, therapeutic care/settings and withdrawal reasons when applicable, and clinical events. Treatment Database: Pharmacy records-related data is a structured database including all data pertaining to medications prescribed and dispensed by pharmacies within each French Comprehensive Cancer Centers (FCCC), specifically chemotherapy and co-prescriptions. It does not contain information on products that are prescribed or delivered outside (...) See Sponsor: UNICANCER Collaborators: Roche Pharma AG Pierre Fabre Laboratories Pfizer AstraZeneca Merck Sharp & Dohme Corp. Information provided by (Responsible Party): UNICANCER Study Details Study Description Go to Brief Summary: The Epidemiological Strategy and Medical Economic (ESME) Ovarian cancer Data Platform is a multi-center real life database using a retrospective data collection process (18 FCCCs over 20 sites). This database compiles data from Patient's Electronic medical records (EMR

2017 Clinical Trials

4375. Evolution of the Therapeutic Care in Ovarian Cancer From 2011

Database: Pharmacy records-related data is a structured database including all data pertaining to medications prescribed and dispensed by pharmacies within each FCCC, specifically chemotherapy and co-prescriptions. It does not contain information on products that are prescribed or delivered outside of the center. From each center's pharmacy database, information on systemic treatment patterns (dates, pharmaceutical forms, treatment protocols, etc.) can be obtained. Hospitalization Database (...) Information provided by (Responsible Party): UNICANCER Study Details Study Description Go to Brief Summary: The ESME OVR Data Platform is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records. Condition or disease Ovarian Cancer Detailed Description: This database compiles data from

2017 Clinical Trials

4376. Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome

Syndrome and assessment of compliance and adherence, optionally with the aid of an electronic app or patient diary. Condition or disease Intervention/treatment Growth Disorders Drug: Zomacton Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 4 participants Observational Model: Cohort Time Perspective: Prospective Official Title: A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence (...) using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: up to 18 Years (Child, Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Study Population Pediatric outpatient clinic Criteria Inclusion Criteria: Pediatric patients (< 18 years) with growth hormone deficiency or growth retardation due to Ullrich-Turner-Syndrome Patients already receiving or who have been prescribed

2017 Clinical Trials

4377. Overweight in patients with chronic obstructive pulmonary disease needs more attention: a cross-sectional study in general practice (Full text)

Overweight in patients with chronic obstructive pulmonary disease needs more attention: a cross-sectional study in general practice Guidelines for management of chronic obstructive pulmonary disease (COPD) primarily focus on the prevention of weight loss, while overweight and obesity are highly prevalent in patients with milder stages of COPD. This cross-sectional study examines the association of overweight and obesity with the prevalence of comorbid disorders and prescribed medication (...) for obstructive airway disease, in patients with mild to moderate COPD. Data were used from electronic health records of 380 Dutch general practices in 2014. In total, we identified 4938 patients with mild or moderate COPD based on spirometry data, and a recorded body mass index (BMI) of ≥21 kg/m2. Outcomes in overweight (BMI ≥ 25 and <30 kg/m2) and obese (BMI ≥30 kg/m2) patients with COPD were compared to those with a normal weight (BMI ≥ 21 and <25 kg/m2), by logistic multilevel analyses. Compared to COPD

2017 NPJ primary care respiratory medicine PubMed abstract

4378. Vaccinations in immunosuppressive-dependent pediatric inflammatory bowel disease (Full text)

Vaccinations in immunosuppressive-dependent pediatric inflammatory bowel disease To determine the vaccination rates in pediatric immunosuppression-dependent inflammatory bowel disease (IBD) and review the safety and efficacy of vaccinations in this population.The electronic medical records from October 2009 to December 2015 of patients diagnosed with IBD at 10 years of age or younger and prescribed anti-tumor necrosis factor alpha (anti-TNF-α) therapy were reviewed for clinical history

2017 World Journal of Gastroenterology PubMed abstract

4379. Effects of Flavors on Nicotine Reinforcement in Smokers

by (Responsible Party): Yale University Study Details Study Description Go to Brief Summary: To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be administered intravenously. The reinforcing drug effects will be measured with the drug effects questionnaire (DEQ). Condition or disease Intervention (...) : green apple and menthol flavor American e-liquids Outcome Measures Go to Primary Outcome Measures : The reinforcing drug effects will be measured with the drug effects questionnaire (DEQ). [ Time Frame: up to 3 hours ] To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit flavor plus menthol, alone or in combination with nicotine in smokers. Menthol and fruit flavor will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine

2017 Clinical Trials

4380. Spinal Cord Stimulation to Augment Activity Based Therapy

mild "spasticity" affecting leg muscles You may participate if you use prescription medications, including baclofen for control of spasticity Exclusion Criteria: Inability or unwillingness to consent and/or authorization for use of protected health information Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord Neurologic level at or below spinal level T12 History of cardiovascular irregularities Problems (...) with following instructions Orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees) Women who are pregnant, or who have reason to believe they are or may become pregnant due to unknown risks to the fetus associated with tcSCS Persons who have implanted stimulators/electronic devices of any type will be excluded due to unknown potential of tcSCS effects Active infection of any type, as infection may exacerbate spasticity

2017 Clinical Trials

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