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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2343 | Lifestyle intervention Wiki | 0.30 |
| drug1321 | Dietary program Wiki | 0.30 |
| drug3158 | Phentermine 37.5 Mg Wiki | 0.30 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2016 | Hypocaloric, moderate low fat diet Wiki | 0.30 |
| drug2015 | Hypocaloric, low carbohydrate diet Wiki | 0.30 |
| drug742 | CCTP Wiki | 0.30 |
| drug3398 | Project Health Wiki | 0.30 |
| drug5097 | nonfood-specific go/no-go computerized training Wiki | 0.30 |
| drug1586 | Exposure to the Dutch measures due to the Covid-19 pandemic. Wiki | 0.30 |
| drug2896 | Nutritional counseling Wiki | 0.30 |
| drug2555 | Mediterranean diet, no caloric restriction Wiki | 0.30 |
| drug5251 | suspected of COVID-19 infection Wiki | 0.30 |
| drug4955 | food-specific go/no-go computerized training Wiki | 0.30 |
| drug5094 | non-interventional Wiki | 0.30 |
| drug4750 | Whole Health Program Wiki | 0.30 |
| drug3676 | Response and Attention Training Wiki | 0.30 |
| drug175 | AZD2693 Wiki | 0.21 |
| drug1569 | Exercise program Wiki | 0.17 |
| drug1224 | DAS181 Wiki | 0.12 |
| drug1150 | Convalescent plasma Wiki | 0.06 |
| drug3195 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009765 | Obesity NIH | 0.27 |
| D063766 | Pediatric Obesity NIH | 0.25 |
| D000073296 | Noncommunicable Diseases NIH | 0.21 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D015431 | Weight Loss NIH | 0.20 |
| D065626 | Non-alcoholic Fatty Liver Disease NIH | 0.17 |
| D005234 | Fatty Liver NIH | 0.17 |
| D008659 | Metabolic Diseases NIH | 0.13 |
| D003327 | Coronary Disease NIH | 0.11 |
| D003922 | Diabetes Mellitus, Type 1 NIH | 0.08 |
| D006331 | Heart Diseases NIH | 0.08 |
| D002908 | Chronic Disease NIH | 0.08 |
| D002318 | Cardiovascular Diseases NIH | 0.05 |
| D003920 | Diabetes Mellitus, NIH | 0.05 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D007239 | Infection NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001513 | Obesity HPO | 0.27 |
| HP:0001824 | Weight loss HPO | 0.20 |
| HP:0001397 | Hepatic steatosis HPO | 0.17 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100651 | Type I diabetes mellitus HPO | 0.08 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.05 |
| HP:0000819 | Diabetes mellitus HPO | 0.05 |
Navigate: Correlations HPO
There are 11 clinical trials
Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults. The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.
Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults. The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches. COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.
Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in HbA1C - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in HbA1C - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in HbA1C - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: Change in the percent of time spent in hypoglycemia during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 1 Time: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) VisitDescription: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 2 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 3 Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.
Measure: Difference in time spent within target blood glucose range - Randomization 1 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.
Measure: Difference in time spent within target blood glucose range - Randomization 2 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.
Measure: Difference in time spent within target blood glucose range - Randomization 3 Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) VisitThis project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.
Description: Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)
Measure: Body Fat Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in BMI (Not collected during COVID-19 shelter-at-home order)
Measure: Body Mass Index (BMI) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in weight concerns. Scale scores range from 0 to 42 with higher scores being indicative of higher weight concerns.
Measure: Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in depressive symptoms
Measure: Beck Depression Index (BDI) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in eating disorder symptoms
Measure: Eating Disorder Interview (EDDI) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsIntroduction: Obesity is a major public health problem and adopting healthy lifestyle habits, while effective, is challenging in real-world settings. Culinary coaching is a behavioral intervention that aims to improve nutrition and overall health by facilitating home cooking through an active learning process that combines culinary training and health coaching. Our goal is to evaluate whether a culinary coaching telemedicine program (twelve 30-minute sessions) will significantly improve outcomes among subjects with overweight or obesity. General hypothesis: A culinary coaching telemedicine program will result in significant weight loss, and improvement in culinary attitude and self-efficacy, nutritional intake, and metabolic outcomes. Methods: This is a two-site, 36-month randomized controlled trial in which study participants between the ages of 25 to 70, with 27.5 ≤ BMI ≤ 35 Kg/m2 will be randomly assigned to nutritional counseling combined with a structured culinary coaching program or to nutritional counseling group (18 intervention, 18 control at each site). Intervention will include a 3-month culinary coaching telemedicine program with outcome data collected periodically for 12 months. The pre-defined primary outcome is body weight loss at 6 months, and secondary outcomes include change in body weight and composition at 1 year, as well as culinary attitudes and self-efficacy through a validated questionnaire, nutritional intake, lipid profile, blood pressure, and HgA1c (glycated hemoglobin); and participants' perception of the program. Potential impact: The investigators believe that this program has a potential to be a viable tool in promoting effective and scalable home cooking interventions aimed at improved nutrition and health outcomes in overweight and obesity.
Description: 5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.
Measure: Body weight at 6 months Time: Six monthsDescription: Body weight (kg), measured by a registered dietitian
Measure: Body weight Time: Body weight will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Culinary attitudes and self-efficacy will be evaluated by the Cooking With a Chef (CWC) Instrument. This is a 22-item self-administered Likert scale questionnaire that generates three subscales: 1) the cooking techniques and meal preparation self-efficacy subscale (14 items; 1 - not al all confident; 5- extremely confident; sub-scale range 14-70), 2) the negative cooking attitudes subscale (4 items; 1 - strongly disagree; 5 - strongly agree; sub-scale range 4-20), and, 3) the self-efficacy to consume fruit and vegetables subscale (5 items; 1 - not al all confident; 5- extremely confident; sub-scale range 5-25).
Measure: Culinary attitude & self-efficacy Time: Culinary attitude & self-efficacy will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Nutritional intake will be evaluated by a 4-day food record. Intake will be analyzed for its caloric content (kcal), saturated fats(g), trans fats(g), legumes (g), fruits (g), red and processed meat (g), sugars(g), processed food(g), vegetables(g), soft drinks(g), fish(g), whole grain(g), refined grain(g), and monounsaturated fat-saturated fat ratio. Vegetables, legumes, fruits, nuts, whole grains, fish, monounsaturated fat-saturated fat ratio, alcohol, and meat will be aggregate to report Mediterranean index in points (1-9))
Measure: Nutritional intake Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Adherence to Mediterranean Diet will be evaluated by the validated 14 items Questionnaire of Mediterranean Diet Adherence, extracted by a dietitian from a 4-day food record (0 - low adherence; 14 - high adherence)
Measure: Adherence to Mediterranean Diet Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Consumption of ultra-processed food will be evaluated by the NOVE food classification, extracted by a dietitian from a 4-day food record (unprocessed or minimally processed foods (g), processed culinary ingredients (g), processed foods (g), ultra processed foods (g))
Measure: Consumption of ultra-processed Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: blood pressure (both systolic and diastolic), measured in a seated position by a nurse using a sphygmometer
Measure: Blood pressure Time: Blood pressure will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides), measured from a blood sample drawn
Measure: Lipid profile Time: Lipid profile will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: HbA1c, measured from a blood sample drawn
Measure: HbA1c Time: HbA1c will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Lean body mass (g) will measured using Bone Densitometry
Measure: Lean body mass Time: Lean body mass will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Total fat mass (g, %fat) will measured using Bone Densitometry
Measure: Total fat mass Time: Total fat mass will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Trunk fat mass (g, %fat) will measured using Bone Densitometry
Measure: Trunk fat mass Time: Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Fat distribution will measured using Bone Densitometry. Measurements includes: android fat mass (g, %fat) and gynoid fat mass (g, %fat). Fat distribution will be extracted from Android/ Gynoid
Measure: Fat distribution Time: Body composition will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Stages of change in relation to home cooking as assessed by the validated University of Rod Island Change Assessment (URICA) Scale. This is a 32-item self-administered Likert scale questionnaire (1 - strongly disagree; 5 - strongly agree). Minimum score - 32, maximum score - 160
Measure: Stages of change in relation to home cooking Time: Stages of change will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Perceived Stress, evaluated by the validated Perceived Stress Scale. This is a 10-item self-administered Likert scale questionnaire (0 - never; 4 - very often). Minimum score - 0, maximum score - 10.
Measure: Perceived Stress Time: Perceived stress will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using a structured open-ended questionnaire.
Measure: Subject perceptions of the program Time: subjects perception of the program will be obtained using open ended questionnaires at baseline, 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using In-depth semi-structured interview.
Measure: Subject perceptions of the program Time: Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).Description: Overall resiliency to cope with the COVID-19 epidemic with be obtained through the Brief Resilient Coping Scale and copying strategies through the Brief Cope scale
Measure: Coping with Stress Time: Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemicThis Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in male and female subjects of non-childbearing potential in overweight but otherwise healthy subjects, and healthy Chinese and Japanese subjects.
Description: To investigate the safety and tolerability of SC administration of SAD of AZD2693
Measure: Number of subjects experiencing adverse events and serious adverse events Time: From baseline (Day 1) until Day 112 (Week 16, Final follow-up)Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC) Time: At Day 1 pre-dose, 0.25 hours [h], 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48h)] Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Maximum observed plasma drug concentration (Cmax) of AZD2693 Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time to reach maximum observed concentration following drug administration (tmax) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693.
Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing CL/F by λz (Vz/F) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Mean residence time (MRT) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time delay between drug administration and the first observed concentration in plasma (tlag) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time of the last quantifiable concentration (tlast) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Cumulative amount of analyte excreted into the urine from time zero through the last sampling interval [Ae(0-last)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC [CLR] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseThis study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.
Description: Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.
Measure: Change in weight child Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.
Measure: Change in weight parents Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs, hereafter: "coronacrisis-period"). Three months after the "measures"-period, 1 follow-up moment.Description: eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.
Measure: Eating behaviour Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.
Measure: Symptoms Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Daystructure of children during the coronacrisis, measured with an online questionnaire.
Measure: Day structure Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.
Measure: Physical activity Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Screentime during the the coronacrisis, measured with an online questionnaire.
Measure: Screentime Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.
Measure: Online possibilities Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Quality of life during the coronacrisis, measured with the Kidscreen-27.
Measure: Quality of life in children Time: Once in first month of the study and once within three months after COVID-19 measures are scaled down.Description: Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.
Measure: Parenting practices Time: Once in first month of the study and once within three months after COVID-19 measures are scaled down.Description: Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.
Measure: Qualitative data on lifestyle in children Time: Up to approximately 1 yearNon-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults.
Description: percentage of patients with non-infectious diseases relating to overall number of patients registered in study
Measure: rate of non-infectious diseases Time: 12 month since a moment of request of medical helpDescription: correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups
Measure: severity of COVID-19 depending on pre-existing diseases Time: 12 month since a moment of request of medical helpDescription: Registration of disability or change of disability status
Measure: disability registration / change of disability status Time: 12 month since a moment of request of medical helpDescription: rate of deaths among registered participants
Measure: rate of letal outcomes Time: 12 month since a moment of request of medical helpDescription: correlation between number of deaths and pre-existing diseases
Measure: rate of letal outcomes depending on pre-existing disease Time: 12 month since a moment of request of medical helpThis study will study the effects associated with the prescription of phentermine in a virtual setting, comparing with prescription of phentermine via a standard face-to-face visit for patients with obesity or overweight.
Description: The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight.
Measure: Change in body weight (percentage) Time: 12 weeksDescription: Assessed as number of missed visits
Measure: Adherence to weight management program Time: 12 weeksDescription: Assessment of medication compliance
Measure: Adherence to medication use Time: 12 weeksDescription: Mean change in BMI from baseline to week 12
Measure: Change in BMI Time: 12 weeksThe purpose of this study is to assess the effect of a food-specific Go/No-Go (GNG) computerized training task on weight loss, food evaluation, and disinhibition in a population of overweight and obese individuals.
Description: Body weight will be measured by participant using personal or university scale. Participants will take a picture of their weight send it to the research team (Due to COVID-19 precautions, in person weighing is not possible).
Measure: Change in body weight from baseline to post 4-week intervention, to 6-month follow-up Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using the Disinhibition subscale of the Three Factor Eating Questionnaire; minimum value = 0; maximum value = 16; higher scores for this measure means worse outcomes
Measure: Change in disinhibition scores from baseline to post 4-week intervention, to 6-month follow-up. Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using a food frequency questionnaire assessing food intake over the previous month.
Measure: Change in frequency of food consumption from baseline to post 4-week intervention, to 6-month follow-up. Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using the binge eating questions of the Eating Disorder Examination Questionnaire; minimum value = 0; maximum value = unlimited; higher scores for this measure means worse outcomes
Measure: Change in binge eating behaviors from baseline to post 4-week intervention, to 6-month follow-up. Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using a visual analog scale; minimum value = -100; maximum value = 100; higher scores for this measure on healthy foods means better outcomes, higher scores on this measure for unhealthy foods means worse outcomes
Measure: Change in liking of foods from baseline to post 4-week intervention, to 6-month Time: baseline, post 4-week intervention, 6-month follow-upDescription: This will be measured using an impulsive food choice test.
Measure: Change in automatic responses to healthy and unhealthy foods from baseline to post 4-week intervention, to 6-month Time: baseline, post 4-week intervention, 6-month follow-upWholehearted living touches every aspect of life, from eating nourishing foods, to enjoying enough physical activity, to cultivating relationships that support healthy choices, to joining with neighbors to stand up for positive changes, and more. Unfortunately, for many low-income Californians, the idea of wholehearted living is an aspiration and not a reality. Koa Family: Strong, Healthy, Whole is an approach designed to make wholehearted living available for all. The Approach Koa Family is a 4-month journey to establish "micro-communities" of women supporting one another- mind, body, and spirit. The foundation of this approach is a new, custom-designed, online Whole Health Program (WHP) that addresses healthy eating, physical activity, and weight management within the context of wholehearted living. Low-income women and a lifestyle coach will meet weekly in a virtual platform to learn, experience, grow, and thrive as they reach their diet, physical activity, and weight management goals. Participants in the WHP will receive additional encouragement and access to local resources through a private and secure Facebook group. The group will provide a place for women to continue their wholehearted health journeys beyond the weekly meetings. Koa Family participants also will be invited to take part in a neighborhood tree planting campaign to create real, long-lasting, healthy changes to the environment in which they live. The Study Koa Family, with WHP at its core, is the product of extensive formative research both nationally and within low-income California communities. Koa Family will be introduced in Sacramento County in February 2021. It will be evaluated for effectiveness among 120 low-income, Supplemental Nutrition Assistance Program (SNAP)-Ed eligible women using a randomized controlled trial study design, the gold standard for assessing effectiveness of an intervention. Outcomes include changes in Body Mass Index, diet, and physical activity measured at 4 and 6 months from baseline. An economic analysis will assess the cost-effectiveness of Koa Family, while qualitative methods will identify mediating factors related to the study outcomes. Funding Koa Family is a project of the Population Health Group at the University of California, Davis, Center for Healthcare Policy and Research. Funding is provided by the United States Department of Agriculture Supplemental Nutrition Assistance Program-Education and the California Department of Forestry and Fire Protection (CalFIRE).
Description: Weight (kg) measured with an electronic scale
Measure: Change from Baseline Weight at 4 Months Time: Difference in weight between baseline and 4 monthsDescription: Weight (kg) measured with an electronic scale
Measure: Change from Baseline Weight at 6 Months Time: Difference in weight between baseline and 6 monthsDescription: weight (kg)/height (m) x height (m)
Measure: Change from Baseline Body Mass Index (BMI) at 4 Months Time: Difference in BMI between baseline and 4 monthsDescription: weight (kg)/height (m) x height (m)
Measure: Change from Baseline Body Mass Index (BMI) at 6 Months Time: Difference in BMI between baseline and 6 monthsDescription: Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Measure: Change from Baseline Diet at 4 Months Time: Difference in diet between baseline and 4 monthsDescription: Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet
Measure: Change from Baseline Diet at 6 Months Time: Difference in diet between baseline and 6 monthsDescription: Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Measure: Change from Baseline Physical Activity (PA) at 4 Months Time: Difference in PA between baseline and 4 monthsDescription: Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module
Measure: Change from Baseline Physical Activity (PA) at 6 Months Time: Difference in PA between baseline and 6 monthsDescription: Well-being and general health measured with Short Form-36v2; There are 8 sections each scored 0-100 with a high score indicating less disability
Measure: Change from Baseline Health-Related Well-being at 4 Months Time: Difference in health-related well-being between baseline and 4 monthsDescription: Well-being and general health measured with Short Form-36v2
Measure: Change from Baseline Health-Related Well-being at 6 Months Time: Difference in health-related well-being between baseline and 6 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports