linjc16/ctgov huggingface dataset:
Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions

Study Overview
=================
Brief Summary
-----------------
Randomized control trial studying the effect of medical assistant health coaching for patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care community clinics, Mission Neighborhood Health Center and Southeast Health Center

Conditions
-----------------
Diabetes, Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Behavioral: Health coaching by medical assistants in primary care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active patients at Mission Neighborhood Health Center, SF, USA or Southeast Health Center, SF, USA age 18-75 years Uncontrolled diabetes II, hypertension or hyperlipidemia Spanish or English speaking Exclusion Criteria: Cognitive dysfunction, mental health or physical condition that prevents participation in health coaching.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Coaching<br> | Behavioral: Health coaching by medical assistants in primary care<br>* Patients with uncontrolled diabetes, hypertension, hyperlipidemia will receive health coaching by medical assistants working with primary care providers in the Teamlet Model [Bodenheimer 2007] for 12 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL | This second measurement of clinical outcomes will occurs one year after the end of the intervention. | 24 months |
The Effect of Vitamin K Supplementation on Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether vitamin K supplementation has an effect on glucose metabolism in terms of acute beta cell response.

Detailed Description
-----------------
Recently, many studies have reported that vitamin K metabolism is related to glucose metabolism. The suggested mechanisms connecting vitamin K metabolism and glucose metabolism, are inflammation responses and osteocalcin effect on glucose metabolism. Most of the studies have investigated fasting glucose and insulin sensitive index, few have assessed glucose-intake-stimulated responses in regard to vitamin K supplementation. The purpose of this study is to test whether vitamin K supplementation has an effect on glucose metabolism in terms of acute beta cell response using intravenous glucose tolerance test.

Official Title
-----------------
The Effect of Vitamin K Supplementation on Glucose Metabolism

Conditions
-----------------
Diabetes, Prediabetic State

Intervention / Treatment
-----------------
* Drug: Menatetrenone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteer older than 20 years Exclusion Criteria: Subjects with (a history of) diabetes Subjects receiving medication related to diabetes or obesity Subjects receiving warfarin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin K<br>Vitamin K supplementation (menatetrenone 30 mg, 3 times a day for 4 weeks) | Drug: Menatetrenone<br>* Menatetrenone 30 mg, 3 times a day for 4 weeks<br>|
| Placebo Comparator: Placebo control<br>Placebo control | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test) |  | 4 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beta-cell function (FSIGT) |  | 4 weeks later | 
| disposition index (FSIGT) |  | 4 weeks later | 
| insulin sensitivity (FSIGT) |  | 4 weeks later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin K, beta cell, glucose metabolism, insulin resistance
Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.

Official Title
-----------------
Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Warfarin
* Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
* Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive Subject has a body mass index of 18 to 32 kg/m2, inclusive Subject is able and willing to abstain from alcohol, grapefruit, caffeine Subject has no clinically relevant abnormalities on the basis of medical history, physical examination, and vital signs Exclusion Criteria: Subject has clinically relevant out-of-range prothrombin time (PT), activated partial thromboplastin time, fibrinogen, protein C, or protein S Subject has abnormal prolongation of bleeding time at Screening Subject has hematuria on urinalysis Subject has personal or family history of coagulation or bleeding disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin/Rosuvastatin<br> | Drug: Warfarin<br>* Warfarin 5 mg once daily<br>Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)<br>* Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)<br>Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)<br>* Warfarin 5 mg + Pitavastatin 4mg<br>|
| Experimental: Rosuvastatin/Pitavastatin<br> | Drug: Warfarin<br>* Warfarin 5 mg once daily<br>Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)<br>* Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)<br>Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)<br>* Warfarin 5 mg + Pitavastatin 4mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Mean Change From Baseline of International Normalized Ratio (INR) | INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI) | 22 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Screening in Trauma for Opioid Misuse Prevention

Study Overview
=================
Brief Summary
-----------------
The current study seeks to begin the crucial work of creating effective protocols to prevent opioid misuse, addiction, and related complications by developing and pilot testing an opioid risk screening protocol at Wisconsin trauma centers.

Official Title
-----------------
Screening in Trauma for Opioid Misuse Prevention (STOMP): Screen Development and Pilot Implementation Study

Conditions
-----------------
Opioid Use Disorder

Intervention / Treatment
-----------------
* Other: Opioid risk screen development & implementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient victim of traumatic injury Expected need for post-discharge outpatient opioid analgesia English speaking Disposition to short-term rehabilitation facility is allowed Exclusion Criteria: Disposition to a skilled nursing or long-term acute care facility Current active opioid use disorder or current active participation in a program of recovery for another substance use disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Opioid risk screen development & implementation|Development of a screening tool for the risk of opioid misuse in patients with traumatic injury.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use disorder (CIDI-SAM) or opioid misuse (COMM) Opioid Use Disorder in 6 Months Post Traumatic Injury | This data will be analyzed in tandem with patient demographics, physical and mental health, and hypothesized risk factors for opioid misuse. | 6 months subject participation |
Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients

Study Overview
=================
Brief Summary
-----------------
Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.

Official Title
-----------------
An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: SLV-313 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, aged 18-50 years old Women, aged 18-50 years old Exclusion Criteria: Non-lactating women, aged 18-50 years old Non-pregnant women, aged 18-50 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2 mg SLV-313 SR (fixed dose) | Drug: SLV-313 SR<br>* sustained relase tablets taken once daily for 14 days<br>|
| Experimental: 2<br>5 mg SLV-313 SR (fixed dose) | Drug: SLV-313 SR<br>* sustained relase tablets taken once daily for 14 days<br>|
| Experimental: 3<br>10 mg SLV-313 SR (fixed dose) | Drug: SLV-313 SR<br>* sustained relase tablets taken once daily for 14 days<br>|
| Experimental: 4<br>xx mg SLV-313 SR (titration) | Drug: SLV-313 SR<br>* sustained relase tablets taken once daily for 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe safety and tolerability |  | 25 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK and PD profile |  | 25 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety,Tolerability, Schizophrenia
Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines.

Official Title
-----------------
Prevalence of Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Embolism, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known or suspected COPD COPD-exacerbation Exclusion Criteria: other causes of dyspnea unable to perform CT pulmonary angio (contrast allergy, pregnancy) already included in the study (each patient included only once) use of anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pulmonary embolism in exacerbations of COPD |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary embolism, Pulmonary Disease, Chronic Obstructive
Dietary Fatty Acids, PPAR Activated Genes, and CHD

Study Overview
=================
Brief Summary
-----------------
To examine the relationship between genetic and dietary factors that modify the risk of coronary heart disease (CHD).

Detailed Description
-----------------
BACKGROUND: Coronary heart disease (CHD) is the major cause of death in most industrialized and developing countries. Links between genetic and dietary factors that modify the risk of CHD should give fundamental insight into its causes and improve population-based CHD prevention strategies. DESIGN NARRATIVE: The study will identify genes that modulate the association between dietary fatty acids (FAs) and myocardial infarction (MI). The study uses DNA samples obtained during a population-based, case-control study in Costa Rica of 2,150 subjects who experienced myocardial infarctions and 2,150 matched controls. Biochemical measurements, dietary data, and general information are available for this population. One unique aspect of the study is that adipose tissue biomarkers of polyunsaturated FAs will be used to evaluate dietary exposure variables. Adipose tissue biomarkers (i.e., alpha-linolenic and linoleic acid) are very good indicators of intake in this population. Furthermore, this study showed that increased levels of these biomarkers in adipose tissue are strongly associated with decreased risk of MI, whereas an increase in 18:2 trans FAs increase the risk of MI. Gene-diet association studies and a candidate pathway approach will be used to elucidate genetic mechanisms that link risk of MI with exposure to polyunsaturated FAs [including cis and trans isomers of linoleic acid (n-6), and alpha-linolenic acid (n-3)]. The focus will be on peroxisome proliferator-activated receptor (PPAR) genes, and PPAR-regulated genes, that are involved in vascular inflammation. Among controls, the investigators will examine whether genetic and dietary factors independently affect biochemical markers (phenotypes) of the proposed genes. They will also test whether these phenotypes are more clearly identified when genetic and dietary factors are examined together. Because polyunsaturated FAs are important as activators of PPARs and their capacity to regulate gene expression at the level of transcription, this metabolic system is a suitable candidate for the study.

Official Title
-----------------
Dietary Fatty Acids, PPAR Activated Genes, and CHD

Conditions
-----------------
Coronary Disease, Cardiovascular Diseases, Heart Diseases, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
First acute MI Living in catchment area Randomly selected controls Matched for age sex and area of residence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Work Place Health Promotion: a Change Project

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if intelligent physical exercise training can increase the productivity of office workers in Denmark. Effects of intervention is measured after 1 and 2 years. The project is driven as a change project. The investigators measure productivity as: Individual health Sick leave Retention at the workplace

Official Title
-----------------
Work Place Health Promotion as a Change Project

Conditions
-----------------
Health Prevention

Intervention / Treatment
-----------------
* Behavioral: Intelligent physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Office workers Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Excercise group<br> | Behavioral: Intelligent physical activity<br>* 30 minutes of moderate activity 6 days a week and 45 minutes of high intensity training 1 day a week. Moderate activity is monitored in diaries and high intensity training is monitored by a trainer.<br>* Other names: Productivity;|
| No Intervention: Reference<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aerobic capacity |  | After 1 and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sick leave |  | After 1 and 2 years | 
| Individual productivity |  | After 1 and 2 years | 
| Retention |  | After 1 and 2 years |
Regional Activation of Leukocytes in Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the role of leukocyte activation in coronary artery disease

Detailed Description
-----------------
The primary aim of REAL CAD is to determine regional differences of leukocyte activation in different vascular beds in vivo. The secondary aim is to investigate differences in leukocyte activation between diabetic and CAD subjects and patients suffering from both. The third aim is to investigate the relationship between complement components, triglycerides and leukocyte activation markers in order to gain more insight into the causative processes leading to activation of leukocytes. The fourth aim is to get more insight in the MBL genotypes and serum levels of CAD and/or diabetic patients and the 'healthy' groups included in our study.

Official Title
-----------------
Regional Activation of Leukocytes in Coronary Artery Disease

Conditions
-----------------
Inflammation, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects scheduled to undergo a coronary catheterization Provide written informed consent Aged >18 and <75 years BMI < 35 kg/m2 Exclusion Criteria: Emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. Subjects who are not able to understand the patient information CRP > 20 mg/l Unstable angina pectoris CABG or PTCA during the last 6 months Alcohol use > 2 units/day Aberrations in kidney, liver and thyroid function Use of any experimental medication within 6 months of the catheterization The use of immunosuppressive drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the level of leukocyte activation in different vascular beds, by measuring monocyte CD11b and neutrophil CD11b and CD66b in blood obtained from the left and right coronary artery, the abdominal aorta, the femoral artery and a peripheral vein |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate differences in leukocyte activation between patients with and without diabetes mellitus or coronary artery disease by comparing the level of monocyte CD11b and neutrophil CD11b and CD66b |  | Baseline | 
| To investigate the predictive value of leukocyte activation markers CD11b and CD66b in different vascular regions in the prediction of future coronary events, by measuring these markers at baseline |  | 6 years follow-up |