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4421. Promoting Partnership and Improving Self-Management for Children With Persistent Asthma

and their caregivers) about asthma, provide clearly written information about how to manage asthma, and discuss how to manage asthma at home with cooperation between caregivers and children. Families will also receive current asthma prescriptions in clinic, and colored labels will be attached to medications in order to match the color scheme of asthma action plans (green labels for controller medications, red labels for rescue medications). Families will be followed for 3 months after the first clinic visit (...) with nighttime symptoms iv. ≥2 episodes of asthma during the past year that have required systemic corticosteroids b. If the child is 12-14 years old: i. An average of >2 days per week with asthma symptoms ii. >2 days per week with rescue medication use iii. Nighttime symptoms 1-3 times per week iv. ≥2 episodes of asthma during the past year that have required systemic The child must have a current prescription (within the past year) of an inhaled asthma controller medication, such as an inhaled

2017 Clinical Trials

4422. Dietary Carbohydrate and Internal Body Fat

and increasing health challenge across the world, and is linked to the recent introduction and globalization of an ultra-processed food supply largely based on refined carbohydrates. However, more high-quality studies are needed to directly assess the role of carbohydrate quality in abdominal adiposity. We also need studies with greater long-term adherence to prescribed food profiles, which may be achievied with the help of new electronic tools such as meal planning applications. The participants select (...) links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Acellular carbohydrate diet Prescribed dietary pattern. Carbohydrates from acellular sources, e.g., refined flour/bakery products, at least 500 grams of fruits/vegetables per day, and a macronutrient composition within typical nutritional recommendations for the general population. Behavioral: Acellular carbohydrate diet Participants will be asked to consume

2017 Clinical Trials

4423. Steroid Eyedrop Adherence After Trabeculectomy

of patients in the USA yearly. There is reasonable evidence that steroid drops benefit success, but there is essentially no data on how successfully patients remember to take the drops. In previous research, investigators have shown that glaucoma patients take only half to two-thirds of prescribed drops. An electronic monitoring device is now available that can fit the eye drop bottle used in steroid drops, accurately measuring the time and date of each drop taken. The investigators can further assess (...) Party): Johns Hopkins University Study Details Study Description Go to Brief Summary: The study will monitor how often persons use eye drops that are prescribed after glaucoma surgery and will compare the adherence with drop use to the success rate of the surgery. Condition or disease Intervention/treatment Glaucoma Adherence, Patient Drug: monitoring of adherence with medication Detailed Description: Trabeculectomy is the most common operation performed for all forms of glaucoma. The procedure

2017 Clinical Trials

4424. Dapagliflozin in Type 2 Diabetes Patients, a Retrospective Cohort Study From Turkey

for prescribing dapagliflozin will be described. Limitations: Variation in timing and completeness of clinical measures. The patient medical records are not collected for research purposes and the diagnostic and procedure coding on such data may be recorded incorrectly or not recorded at all, thereby potentially introducing measurement error with respect to code-based variables. The centres participating in the study, record that a prescription was issued, but not whether it was dispensed from the pharmacy (...) in dapagliflozin treated T2D patient management. The National Coordinator will also provide insight on the national situation regarding dapagliflozin medication prescription (reimbursement, public or private insurance). All this information will be used to select sites and investigators for the study, resembling as closely as possible, the real-world situation. Sites will also be evaluated for existence and use of electronic medical records as part of feasibility. Data quality of sites will be assessed before

2017 Clinical Trials

4425. Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort: The 4F Study

Institute on Alcohol Abuse and Alcoholism (NIAAA) Information provided by (Responsible Party): Richard Saitz, Boston University Study Details Study Description Go to Brief Summary: The purpose of this study is to follow a cohort of HIV-infected adults who have alcohol and/or drug use to: 1) test the associations between alcohol (and illicit drugs and polypharmacy (multiple prescribed medications)) and falls (fractures secondarily), and whether frailty mediates these associations; and 2) test (...) . Healthcare utilization [ Time Frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years ] We will use self-report to measure recent emergency department use and hospitalization for falls and fractures. Secondary Outcome Measures : Falls from electronic medical record review [Time Frame: 6 months prior to study entry and prior to each annual visit] Electronic records will identify falls that receive medical attention. Falls from electronic record review

2017 Clinical Trials

4426. Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening; Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator; Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated; History of substance-related disorders within 1 year of Screening; History of smoking or the use of nicotine containing products or electronic cigarettes (...) within 3 months of Screening by self-reporting; A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period; Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening Positive for Syphilis Antibody Subjects with any flu

2017 Clinical Trials

4427. Comparison of the Microbial Composition in Lean and Obese Subjects

) during the three (3) months prior to study start; Use of temporary or irregular medication for diabetes, dyslipidemia or hypertension; Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, H2 receptor antagonists, proton pump inhibitors, analgesics, herbal remedies or anti-inflammatory drugs (e.g. NSAIDs) during the three (3) weeks prior to study start; Use of probiotics or prebiotics during the three (3) months prior to study start; Mental status (...) that is incompatible with the proper conduct of the study; Presence of swallowing or passage disorder; Carrying a pacemaker or any other (implanted) medical electronic device; Scheduled for an MRI scan during the study period; Not willing to have an X-ray if the capsule is not recovered from the faeces; Alcohol consumption > 15 units/week and >3/day. In case of less alcohol consumption: not willing to stop during the study; Drug abuse, and not willing/able to stop this during the study; Heavy exercise or sports

2017 Clinical Trials

4428. Real World Data on Management of Male LUTS

Time Perspective: Retrospective Official Title: Real World Data Exploring the Practices of Primary Care Providers in the Managment of Male Lower Urinary Tract Symptoms Study Start Date : May 2016 Actual Primary Completion Date : December 2016 Actual Study Completion Date : December 2016 Resource links provided by the National Library of Medicine related topics: Groups and Cohorts Go to Outcome Measures Go to Primary Outcome Measures : The percentage of men given a drug prescription (...) to the date of the phone interview. Able to read, speak and understand English. Willing to provide informed consent for study participation, authorize the release of their previous 12-month medical records from their PCP for review and de-identified data entry by Mapi into an electronic study database. Exclusion criteria: Reported during screening that they had had their first-ever discussion of urinary symptoms with PCP within the 14 days prior to the date of the phone interview. Participation

2017 Clinical Trials

4429. Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy

in the avoidance of surgical intervention. The investigators plan to evaluate this using an electronic outcomes data collection system. The hypothesis is that the majority of patients will not see a significant enough improvement with physical therapy to avoid surgery, especially in a subset of patients such as those with sub spine impingement. The investigators plan to prospectively collect data for three years and monitor the outcome of each hip patient, especially those treated with physical therapy (...) Completion Date : February 2019 Resource links provided by the National Library of Medicine related topics: Groups and Cohorts Go to Group/Cohort Femoracetabular impingent (FAI) Subjects will be given a prescription for physical therapy specifically for Femoracetabular impingent (FAI). They will then be followed clinically per the investigator's normal routine and the gold standard. Outcome Measures Go to Primary Outcome Measures : Change in sub spine impingement associated with physical therapy [ Time

2017 Clinical Trials

4430. 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

4431. 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

4432. 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

4433. 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

4434. Effect of Galantamine on Inflammation and Cognition

and at the beginning of each treatment period. If CO sample does not reflect self-report, the PI will be consulted to determine eligibility. Exclusion Criteria: Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study. Smoking Behavior Current enrollment or plans to enroll in another smoking cessation program in the next 7 months. Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes. Current use or plans (...) . Those who screen positive for amphetamines, benzodiazepines, methadone, oxycodone, and/or opiates (low level cut-off 300 ng/mL) and who are prescribed these medications will be reviewed on a case-by-case basis by the study physician and PIs (see Measures and Table 1 for details). Participants believed to have a false-positive result on the drug screen may continue in the study, with investigator approval. Medical/Psychiatric Conditions Women who are pregnant, planning a pregnancy or lactating

2017 Clinical Trials

4435. Assessing Differential Adherence to Medications and Quality of Life Among People Living With HIV and Comorbidities

and laboratory testing. TEAMH provides a constant dialog between provider and patient through ongoing text messaging, allowing providers to regularly monitor patients' adherence to their medication regimen (data is transmitted directly to the providers) and to their medical appointments. Any number of medications can be included, making it ideal for HIV patients with comorbidities. In addition, TEAMH has the potential to interface with the Northwell Health (NH) electronic medical record (EMR) system allowing (...) application intervention for a period of 6 months. Enrolled patients will be grouped into two mutually exclusive cohorts according to the number of daily prescribed chronic medications (both ART and non-ART). Patients will be assigned to the Lower Medications (LM) cohort group (N=85) if they received a drug regimen of less than five different medications/day during the study period. Whereas, patients will be assigned to the Higher Medications (HM) cohort group (N=85) if they received a drug regimen

2017 Clinical Trials

4436. Internet-Based Exercise and Diet Support in Prostate Cancer Survivors

: Prescription Participants receive tailored exercise prescription and tailored diet recommendations Experimental: Group III Written Information Prescription Technology Behavioral: Written Information Receive written information on diet and exercise relevant to older men with prostate cancer Behavioral: Prescription Participants receive tailored exercise prescription and tailored diet recommendations Behavioral: Technology Participants receive motivational text messages and can electronically log and track (...) their exercise and diet habits Experimental: Group IV Written Information Prescription Technology Coaching Behavioral: Written Information Receive written information on diet and exercise relevant to older men with prostate cancer Behavioral: Prescription Participants receive tailored exercise prescription and tailored diet recommendations Behavioral: Technology Participants receive motivational text messages and can electronically log and track their exercise and diet habits Behavioral: Coaching

2017 Clinical Trials

4437. Investigation of the Role of Pictorial Asthma Action Plans to Promote Self-management in Rural Youth With Asthma

Asthma Action Plan Not Applicable Detailed Description: Asthma is the most common chronic health condition of childhood, and continues to be associated with morbidity and mortality. Many children with persistent asthma follow a treatment plan including a prescription to take a daily inhaled corticosteroid (controller), often in conjunction with a daily oral controller medication, and a dose of an albuterol (rescue) inhaler before activity or exercise. Young people with asthma must add (...) Action Plan (AAP) to all people diagnosed with asthma, summarizing their treatment plan using a traffic light format; Green Zone for daily, symptom-free management, Yellow Zone for symptom flare, and Red Zone for extreme symptom flare. Despite evidence for the effectiveness of AAPs, they are often not prescribed for reasons including readability and accessibility for families and young people, and asthma provider perceptions of their utility and suitability. In this study, young people

2017 Clinical Trials

4438. Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects

-containing products in any form (e.g., gum, patch, electronic cigarettes) within 3 months prior to the planned first day of dosing. Use of prescription medications within 14 days or 10 half-lives (whichever is longer) prior to Day 1 of the dosing period, or any over-the-counter (OTC) medication (including multivitamin, herbal, or homeopathic preparations, excluding hormonal contraception, hormone-replacement therapy, and/or an occasional dose of acetaminophen) within 7 days prior to Day 1 of the dosing

2017 Clinical Trials

4439. A Mobile Application for Post-op Analgesic Consumption

will receive standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions.For the mobile group, the Medable Axon Software developed by Stanford University will be used to customize a mobile application that will be used one week post surgery to monitor postoperative analgesic consumption and disposal practices, pain control, and patient satisfaction, In the control group, case report forms will be used to gather data from the electronic (...) by (Responsible Party): Boston University Study Details Study Description Go to Brief Summary: Surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. The majority of these patients do not return for follow up unless they experience a problem. There is limited data on whether

2017 Clinical Trials

4440. Researching Emotions And Cardiac Health: Phase III

the patients, care providers, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of prior acute coronary syndrome, coronary artery disease, coronary artery bypass graft, congestive HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (renal function, left ventricular ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, race (...) by examining the rates of use of the Actigraph. SRMA [ Time Frame: Baseline, 12 weeks and 24 weeks ] The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks. Acceptability of the exercises [ Time Frame: Weekly, up to 12 weeks ] Participants will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale. Immediate impact of the exercises

2017 Clinical Trials

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