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4141. 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

4142. 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

4143. The Smart Hypertension Control Study

readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians. Outcome Measures Go to Primary Outcome Measures : Systolic blood pressure (mmHg) at 6 months [ Time Frame: 6 months ] Secondary Outcome Measures : Diastolic blood pressure (mmHg) at 6 months [ Time Frame: 6 months (...) ) Standardized mean blood pressure measurement ≥180 mmHg systolic or ≥110 mmHg diastolic Persistent atrial fibrillation as indicated in the electronic health record (EHR) Pregnant or planning to become pregnant during the study period Severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis) Hearing impaired and unable to respond to phone calls Lack of fluency in English History

2017 Clinical Trials

4144. FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study

been undertaking up to enrolling in the study, but not to increase exercise or begin weight-lifting over the period of study participation. Outcome Measures Go to Primary Outcome Measures : Dose reductions [ Time Frame: 3-6 months ] At the initiation of adjuvant chemotherapy, the investigators will ascertain planned cumulative dose for participants.The investigators will examine electronic medical records for reductions in chemotherapy doses throughout treatment. Dose delays [ Time Frame: 3-6 (...) months ] At the initiation of adjuvant chemotherapy, the investigators will ascertain planned treatment duration for participants.The investigators will then examine electronic medical records for changes in chemotherapy timing such as dose delays. Early discontinuation of treatment [ Time Frame: 3-6 months ] At the initiation of adjuvant chemotherapy, the investigators will ascertain planned treatment duration for participants.The investigators will then examine electronic medical records for early

2017 Clinical Trials

4145. Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

to measure the possible effect of this intervention. Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery. Study participants will undergo four types of assessments: Functional/Cognitive testing; Blood/cerebrospinal fluid (CSF) samples and Muscle biopsies; Brain Imaging; and Brain Activity Recording. Clinical Outcomes will also be obtained from the Duke electronic medical record system (...) of and estimate the efficacy of a preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e. age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the possible effect of this intervention. Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior

2017 Clinical Trials

4146. Stepped Care aiTBS 2 Depression Study (Ghent)

) ten days later. This CCT consists of 20 sessions, spread over 4 weeks. Patients will be randomized to receive either real CCT or a control training. During this follow-up treatment, all patients will be prescribed antidepressant medication (SSRI) again. As iTBS treatment effects are known to decline over time, the investigators expect that combining aiTBS with a follow-up CCT therapy will stabilize the clinical effects over time compared to receiving the iTBS treatment alone. For baseline (...) regions as being stimulated previously by aiTBS, namely the DLPFC. thereby possibly stabilizing clinical effects of aiTBS over time. In total 20 sessions of CCT vs. control training (of approximately 25 minutes per session), will be spread over a period of 4 weeks. Other Name: cognitive control training Drug: SSRI All patients will be prescribed antidepressant medication (SSRI) again when starting the CCT (vs. control training). Other Name: selective serotonin reuptake inhibitor Experimental: Active

2017 Clinical Trials

4147. Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints

Eligible for Study: 40 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Probability Sample Study Population The study will be conducted in patients aged 40 years or older diagnosed with COPD initiating treatment with aclidinium bromide or other inhaled COPD treatments. Patients must have at least 1 year of enrolment in the electronic database and to have not been prescribed the study medication of interest during the 6-months before (...) the date of the first prescription for that specific study medication. Patients with life-threatening non-cardiovascular comorbidity (e.g., malignancy, HIV infection, other) will be excluded Criteria Inclusion Criteria: Have at least 1 year of enrolment in the electronic database. In the CPRD, only patients with permanent registration status in "up to standard" participant general practices will be included in the cohort. Be aged 40 years or older. Have a recorded diagnosis of COPD. Have not been

2017 Clinical Trials

4148. OUTREACH: Urine Analysis and Antihypertensive Treatment

mass spectrometry (HPLC-MS/MS)-based assay screens spot urine samples for the presence of 40 commonly prescribed blood pressure lowering medications. The results of the test provide a clinician with information on the presence/absence of prescribed antihypertensive drugs or/and their metabolites in urine - a direct confirmation of therapeutic adherence/non-adherence. The study is a prospective multi-centre randomised controlled trial to examine if HPLC-MS/MS-guided intervention is superior (...) analysis combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment Active Comparator: Arm B Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care. Other: Standard care Standard care for hypertensive patients Outcome Measures Go to Primary Outcome Measures : Change in Clinic systolic blood pressure [ Time Frame: visit 4 (short term follow-up; 3 months post intervention) ] Blood pressure

2017 Clinical Trials

4149. Triggered Escalating Real-time Adherence (TERA) Intervention

(HIV-1 RNA ≥200 copies/ml) within 45 days of enrollment despite having been on ART for at least 24 weeks. They may be continuing the same ART regimen or starting a new once daily regimen. Participants will be stratified by age (<18 vs. ≥18 years of age) and randomized in equal proportions to receive the study intervention (TERA) or standard of care (SOC), with no enrollment limits in each stratum. TERA is a time-limited (12 weeks) intervention approach that (a) uses wireless electronic dose (...) -1 quantitative ribonucleic acid (RNA) assay >1,000 copies/mL; Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay; or Positive plasma HIV-1 RNA qualitative assay Participant aware of his or her HIV infection, as determined by site staff Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL

2017 Clinical Trials

4150. Social Norms and Antihypertensive Medication Adherence

using two different methods. The first method is through the use of eCaps (electronic caps). The second method is through a monthly randomized phone call during which the participant will be asked to perform a pill count of their medication. The secondary outcome of the study is blood pressure which will be measured using two different instruments . The first instrument will be the ambulatory blood pressure monitor (ABPM). The second instrument will be a home blood pressure monitor (HBPM) which (...) of it on the Data Collection form.The participant will provide the project nursing student with his/her antihypertension prescription records so that the dosage amount and number of pills can be recorded on the Data Collection form. Other Name: eCap Active Comparator: Individual Contingency Management During the intervention phase, those in the Individual Contingency Management (ICM) arm will also continue to take their hypertensive medication for the four-month period but will receive a payment after each

2017 Clinical Trials

4151. Anticoagulation Length of ThErapy and Risk of New Adverse evenTs In Venous thromboEmbolism Study

Permanente Northern California and Kaiser Permanente Southern California) and followed until December, 2019. Data will be obtained from administrative and electronic health records, supplemented with a cross-sectional patient survey. The first two aims of this study are to compare the rates of recurrent VTE and hemorrhage between (1) extended anticoagulation vs. no extended anticoagulation after VTE; and (2) DOAC vs. warfarin treatment of VTE. The third specific aim is to describe patient-defined (...) Southern California Index VTE event, defined as an incident clinical encounter (inpatient, emergency department, or outpatient) with a primary or secondary diagnosis of VTE during the time period January 1, 2010 to December 31, 2018 Anticoagulant prescription (oral or parenteral) filled after index VTE discharge/encounter date Continuous outpatient anticoagulant therapy for ≥ 3 months from fill date of prescription Continuous pharmacy benefits and health plan membership for at least 12 months before

2017 Clinical Trials

4152. Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain

Comparator: Usual care The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes. Drug (...) : Conventional medication Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Other Names: Conventional medicine Conventional drugs Procedure: Physical therapy Physical therapy will be prescribed in an individually

2017 Clinical Trials

4153. Resistance Training and Sarcopenic Obesity Elderly Women

, horizontal leg press, knee extension, leg curl, , and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise. Other: resistance training Participants from TG performed program, executed in 3 sets of 10-15RM, 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was composed of 8 exercises comprising one exercise (...) : baseline and 12 weeks ] Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale (Balmak, Laboratory Equipment Labstore, Curitiba, Paraná, Brazil), with the participants wearing light workout clothing and no shoes. Height was measured with a stadiometer attached to the scale to the nearest 0.1 cm, with subjects standing without shoes. Body mass index was calculated as body mass in kilograms divided by the square of height in meters. Eligibility Criteria Go to Information from

2017 Clinical Trials

4154. Ketamine in Borderline Personality Disorder

: Change in bias scores on the Implicit Association Tests (IAT) of death, escape and self harm imagery. [ Time Frame: Timepoints: at baseline and 1, 3, 7, 28 days after infusion. ] The Implicit Association Test measures implicit automatic associations by tracking the speed at which participants associate different groups of words. The scale is delivered electronically using an open-source software. Three distinct IATs will be administered to assess participant's implicit associations with death, escape (...) : All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Age 21-60 Clinical diagnosis of Borderline Personality Disorder Has suicidal ideation. Fluent in English Has a current mental health treater, and agrees for study to communicate with treater Exclusion Criteria: Current suicidal intent Med changes in last 4 weeks Any ketamine in any context in the last one year. Current prescription for topiramate, lamotrigine, or lithium. Psychotic disorder in self or first-degree relative Current

2017 Clinical Trials

4155. Use of a self-rating scale to monitor depression severity in recurrent GP consultations in primary care - does it really make a difference? A randomised controlled study. Full Text available with Trip Pro

' and patients' joint assessments of care need in each case. Depression severity was measured with Beck Depression Inventory-II (BDI-II), quality of life with EQ-5D, and psychological well-being with the General Health Questionnaire-12 (GHQ-12). Data on sick leave, antidepressant and sedatives use, and care contacts were collected from electronic patient records. All variables were measured at baseline and 3, 6, and 12 months. Mean intra-individual changes were compared between the intervention and TAU (...) group.There were no significant differences between the intervention and control group in depression severity reduction or remission rate, change in quality of life, psychological well-being, sedative prescriptions, or sick leave during the whole 12-month follow-up. However, significantly more patients in the intervention group continued antidepressants until the 6 month follow-up (86/125 vs 78/133, p < 0.05).When GPs used a depression self-rating scale in recurrent consultations, patients more often

2017 BMC family practice Controlled trial quality: uncertain

4156. Assessing adherence to multiple medications and in daily life among patients with multimorbidity. (Abstract)

regimens completed three monthly panel questionnaires. A randomly assigned subsample additionally completed a 30-day daily diary.The Non-Adherence Report; a brief self-report measure of adherence to each prescribed medication (NAR-M), and in daily life. We further assessed the Medication Adherence Report Scale (MARS), and a subsample of participants were randomised to electronic adherence monitoring.The NAR-M indicated M = 94.7% adherence at Time 1 (SD = 9.3%). The NAR-M was significantly correlated (...) with the MARS (rt1 = .52, rt2 = .57, and rt3 = .65; p < .001), and in tendency with electronically assessed adherence (rt2 = .45, rt3 = .46, p < .10). Variance components analysis indicated that between-person differences accounted for 10.2% of the variance in NAR-M adherence rates, whereas 22.9% were attributable to medication by person interactions.This study highlights the importance and feasibility of studying adherence to multiple medications differentially, and in daily life. Future studies may use

2017 Psychology & health Controlled trial quality: uncertain

4157. Prenatal Lactation-Focused Motivational Interviewing

, the age and reason for non-qualification or declination to participate will be recorded; any other data will be destroyed by shredding or electronic shredding. For those who do qualify, name and contact information will be kept confidential and maintained in a locked room. Participants will be asked to rate on a scale of -10 to +10 about their certainty that they will provide exclusive breastmilk to their babies for first six months. Responses from this item will be used as the covariate (...) (AIDS) Human T-cell lymphotropic virus type I or type II History of lumpectomy or radiation to breast Uses or is dependent upon any of the following substances (Moretti, Lee, & Ito, 2000): Heroin Cocaine Methamphetamines Marijuana Phencyclidine (PCP) Non-prescription opioids (e.g., morphine, oxycodone, hydrocodone) Undergoing any of the following medications/treatments (American Academy of Pediatrics, 2001): Antiretrovirals Cancer chemotherapy (e.g., antimetabolites) Radiation therapy Acebutolol

2017 Clinical Trials

4158. Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence

) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Patient has a primary care physician at University of Pennsylvania Health System Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin prescription in the electronic health record Exclusion Criteria: Patient has an allergy or adverse reaction to statins documented in the electronic health record Patient has glomerular filtration rate less than 30 mL/min Physicians (...) remove one or more studies before adding more. Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence (PRESCRIBE) 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. Read our for details. Identifier: NCT03021759 Recruitment Status : Completed First Posted : January 16, 2017 Last Update Posted

2017 Clinical Trials

4159. Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

, which is placed vaginally twice per week. Each participant will be informed of her assigned medication, and will receive a medication coupon to help offset the cost of the medication. Each medication is FDA-approved for long-term use of at least 52 weeks. For this study, a 12-week prescription for the medication will be sent electronically to the pharmacy of the participant's choice. The improvements in sexual health and VVA symptom severity will be compared in each group. Study Design Go to Layout

2017 Clinical Trials

4160. Olfactory Training in Chronic Rhinosinusitis

, for 12 weeks. One smell training group will be given odors made of fragrance oils to use for smell training. The other smell training group will be given odors made of essential oils to use. Participants in all groups will continue taking all medications and nasal rinses for sinusitis as prescribed by their doctor. Condition or disease Intervention/treatment Phase Olfactory Dysfunction Other: Olfactory Training with Essential Oils Other: Olfactory Training with Pure Fragrance Oils Not Applicable (...) regardless of group will be sent an electronic version of the mQOD via email after the first and second month. Regardless of which group subjects are assigned, they will continue taking all medications and treatments for CRS as if they were not enrolled in this study. After three months, all subjects will again complete this survey as well as a second BSIT test. This study will determine if a) OT is an effective treatment for OD due to CRS, b) essential oils are as effective as pure fragrance oils for OT

2017 Clinical Trials

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