linjc16/ctgov huggingface dataset:
The Role of Fat Emboli in the Trauma Inflammatory Response

Study Overview
=================
Brief Summary
-----------------
This is an observational study designed to investigate the role of fat emboli in patients who are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of this study is to obtain samples of bone marrow and blood during tibial or femoral fracture procedures to understand the inflammatory response.

Detailed Description
-----------------
Bone marrow is routinely removed during a tibial or femoral fracture procedure; researchers will take samples for this study from bone marrow that has already been removed as part of this procedure. No additional marrow samples will be taken as part of this research study. Also, researchers will collect blood (about 4 teaspoons) for testing inflammatory response and coagulation. Researchers may need to insert an additional line to collect your blood.

Official Title
-----------------
The Role of Fat Emboli in the Trauma Inflammatory Response

Conditions
-----------------
Femoral Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a tibial or femoral fracture procedure in the operating room. Exclusion Criteria: n/a
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 |
| --- | --- | --- |
| Inflammatory Response | Samples will be tested using proteomic and metabolomic assays from samples of bone marrow reamed during intramedullary (IM) femoral nailing. Blood samples drawn at the time of IM nailing will be tested to determine if clinically relevant amounts of marrow containing these inflammatory mediators are released into the bloodstream. | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femur, MCR, anaphlylatoxin, TEG, Fat, Emboli, Bone, Marrow, proteomic, proteomics, metabolomics, metabolomic, inflammatory, cytokine, chemokine, Thromboelastography, Medical Center of the Rockies, Fat Embolism Syndrome, Injury, Fracture, Metabolite, FES
Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and procedural success during commercial use of ZES. The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm) with 1st generation ZES (Endeavor Sprint, retrospective arm).

Official Title
-----------------
RESOLUTE-KOREA Registry - Registry to Evaluate the Efficacy of Zotarolimus-eluting Stent

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Endeavor Resolute stents
* Device: Endeavor Sprint stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. Exclusion Criteria: There are no exclusion criteria for this registry.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resolute<br>Prospective recruitment of Resolute arm will start in March 2009 | Device: Endeavor Resolute stents<br>* 2nd generation ZES<br>* Other names: Endeavor Resolute;|
| Endeavor<br>The retrospective recruiting period of Endeavor arm comprises a fixed 2-year time between January 2006 and December 2008. The patients, who were treated with Endeavor in that period, will be enrolled if they agree to participate in this study. | Device: Endeavor Sprint stent<br>* 1st generation ZES<br>* Other names: Endeavor Sprint;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent & In-segment Late Loss |  | 9 months | 
| Stent Thrombosis |  | 1 year | 
| Target Vessel Failure (composite of cardiac death, MI, and TVR) |  | 12 months | 
| Any death, cardiac death, MI, TLR, TVR |  | 1 year | 
| Composite rate of cardiac death and any MI |  | 1 year | 
| Composite rate of all death and any MI |  | 1 year | 
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization |  | 1 year | 
| Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy |  | 1 year | 
| Clinical device and procedural success |  | During the health care facility stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zotarolimus, Drug eluting stent, Endeavor Resolute
Genetic Analysis of Pediatric Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study will ascertain approximately 150 subjects, which will include pediatric psoriasis patients diagnosed before age 12, parents not affected by psoriasis, and if a family history is indicated, up to third-degree family members. Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.

Official Title
-----------------
Genetic Analysis of Pediatric Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: Saliva or buccal sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent. Parents of patients who developed psoriasis before 12 years of age Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated. Exclusion Criteria: Patients, parents, and other family member unable to give a saliva or buccal swab sample. Patients, parents, and other family member unable to give written informed consent.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis patients<br>Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent. | Other: Saliva or buccal sample<br>* Saliva or buccal sample<br>|
| Parents of psoriasis patients<br>Parents of patients who developed psoriasis before 12 years of age | Other: Saliva or buccal sample<br>* Saliva or buccal sample<br>|
| Up to third-degree family members with or without psoriasis<br>Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated. | Other: Saliva or buccal sample<br>* Saliva or buccal sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CARD14 mutations | The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| De novo mutations | The number of candidate psoriasis genes through the identification of de novo mutations in moderate-to-severe pediatric cases who require systemic intervention. | one year |
TREAT (Telemedicine for Reach, Education, Access, and Treatment)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.

Detailed Description
-----------------
This study will assess whether a new care delivery model combining telemedicine videoconference diabetes consultations with diabetes self-management teaching is efficacious in reducing HbA1c in patients with type 2 diabetes in rural areas. The control group will consist of patients with type 2 diabetes receiving usual care, i.e., who have not received a referral to the endocrinologist telemedicine team. Secondary outcomes include patient satisfaction, level of understanding of self-management skills, and hypoglycemia

Official Title
-----------------
TREAT (Telemedicine for Reach, Education, Access, and Treatment)

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Telemedicine diabetes intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older with type 2 diabetes Referral by a primary care provider. HbA1c equal or greater than 7.0%. Exclusion Criteria: Type 1 diabetes Gestational Diabetes

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine Diabetes Intervention<br> | Other: Telemedicine diabetes intervention<br>* 3 month duration telemedicine consultation and diabetes education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c % from baseline |  | 3 and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes
The TOGETHER Project - Kidney

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to develop a way to customize immunosuppression treatment, based on the results of a blood test that measures the risk of rejection.

Official Title
-----------------
The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients With Realtime Assay Monitoring

Conditions
-----------------
Kidney Transplant Rejection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conventional solitary kidney transplant (ABO compatible, crossmatch negative, not a kidney transplant simultaneously transplanted with another non-renal organ including heart, liver, lung or pancreas) Patients who have given informed consent and are willing to comply with the protocol, including the use of their specimens and data for subsequent research. Exclusion Criteria: EBV -seronegative recipient ABO incompatible kidney transplants. Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, bone marrow transplantation, etc or prior recipient of non-renal transplant. Subjects who had previous extra renal transplants may be included in the study. Positive crossmatch kidney transplants (T cell crossmatch >100, B flow cytometric crossmatch >150). Participating in other clinical trials Any kidney transplant recipient < 18 years of age.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney Transplant Recipients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the findings of TruGraf (a peripheral blood RNA signature that has been shown to correlate with rejection in renal allografts) with rejection episodes in renal transplant patients . | The study will validate the ability of a peripheral blood assay to assess the risk of rejection and determine the role this assay will have in immunosuppression monitoring in our patients at Mayo Clinic (3 sites). | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant
Scheduled Intranasal Ketamine

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine if scheduled intranasal ketamine effects opioid requirements in adult trauma patients with moderate to severe pain in the inpatient setting.

Official Title
-----------------
Effects of Opioid Requirements With Scheduled Intranasal Ketamine During Admission for Traumatic Pain

Conditions
-----------------
Pain, Trauma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient between aged 18-80 years, present following a traumatic incident, rate pain > 5 on the numeric rating scale (NSR), and require admission to the hospital. Exclusion Criteria: - Patients that arrive at facility intubated Patients that received Ketamine in the field Patients less than 18 years old or greater than 80 years Pregnant or breast-feeding females Hemodynamic instability defined as need for vasoactive drugs or Systolic blood pressure >180 Weight less than 80 pounds or greater than 300 pounds Glasgow Coma Scale less than 15 Current acute head injury resulting in unconsciousness Current or history of eye injury Current or history of seizures Facial or nasal fractures that require nasal precautions Current or history of intracranial hypertension History of Schizophrenia BAC (Blood Alcohol Content) greater than 0.08 Current alcohol abuse Current drug abuse or positive drug screen Chronic pain or patients on pain contracts Inability to assess pain intensity Contraindications or allergies to the treatment Patients with hepatic insufficiency Prisoners Nursing home residents Urine drug screen positive for illicit drugs or medications not on their home medication list. BAC > 0.08 Positive pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Intranasal Ketamine | Drug: Ketamine<br>* Treatment arm<br>|
| Placebo Comparator: Control<br>Normal Saline | Drug: Placebo<br>* Control arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Morphine Equivalents (TME) throughout hospitalization | Total Morphine Equivalents is a standardized way of measuring opioids that patients receive over time. This will be calculated by a member of the research study team utilizing a standardized formula under pharmacies direction. The Medication Administration Record (MAR) will be reviewed to gather administered doses of opioids throughout the participants hospital stay. | 72 hours |
Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the characteristics of subjects with hypertension at onset among a cohort of apparently healthy subjects, with overweight or obesity (BMI ≥ 25 Kg / m2), and free of any drug treatment at the baseline. The evaluation includes anthropometric (weight, height, BMI, waist circumference), haematochemical (hormones, metabolic and routine) parameters and the screening for hypertension with ABPM. The diagnosis of hypertension is made in accordance with the 2017 guidelines of the American College of Cardiology / American Heart Association ACC / AHA.

Official Title
-----------------
Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension

Conditions
-----------------
Hypertension, Obesity

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight or obesity (BMI> 25 Kg/m2) Exclusion Criteria: Any kind of drug Hypertension Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), Chronic inflammatory diseases Renal failure Liver failure Angina pectoris Myocardial infarction and heart failure Genetic heart diseases Thrombocytopenias

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|Observational and prospective study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin | Insulin (mIU/L) concentration in serum | At baseline | 
| Potassium | Potassium (mmol/L) concentration in serum | At baseline | 
| Sodium | Sodium (mEq/L) concentration in serum | At baseline | 
| eGFR (estimated glomerular filtration rate) | eGFR (ml/min/1.73 mq) | At baseline | 
| Creatinin | Creatinin (mg/dl) concentration in serum | At baseline | 
| Uric acid | Uric acid (mg/dL) concentration in serum | At baseline | 
| Total cholesterol | Total cholesterol (mg/dL) concentrations in serum | At baseline | 
| Thyroid hormones (FT3, FT4) | FT3 (pg/mL), FT4 (pg/mL) concentration in serum | At baseline | 
| HDL cholesterol | HDL cholesterol (mg/dL) concentrations in serum | At baseline | 
| LDL cholesterol | LDL cholesterol (mg/dL) concentrations in serum | At baseline | 
| Triglycerides | Triglycerides (mg/dL) concentrations in serum | At baseline | 
| TSH | TSH (mU/L) concentration in serum | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | BMI (kg/m^2) | At baseline | 
| Height | Height in meters | At baseline | 
| Weight | Weight in kilograms | At baseline |
Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia

Study Overview
=================
Brief Summary
-----------------
This project, a small-scale pilot study, will attempt to determine if involvement in a group-based creative expression program may correlate with a reduction in use of psychotropic drugs for persons with dementia.

Detailed Description
-----------------
The study site has two skilled-nursing dementia Special Care Units. One unit will serve as a control with residents receiving the standard care activity program. The other unit will receive the standard care activity program as well as the TimeSlips storytelling program (two hour-long sessions per week for six weeks). The behavioral symptoms and psychotropic drug usage for both cohorts will be studied for eight months, the first four months with no intervention and the last four months with or without the six-week TimeSlips intervention.

Official Title
-----------------
Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia in Long-term Care: a Cluster-randomized Pilot Study

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Behavioral: TimeSlips
* Behavioral: Standard care activity program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residence in one of two dementia special-care skilled nursing units at the study site clinical diagnosis of dementia

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TimeSlips group storytelling program<br> | Behavioral: TimeSlips<br>* TimeSlips is a group-based creative storytelling program for people with dementia. The intervention will be held twice a week for six weeks, in hour-long sessions.<br>* Other names: storytelling program;|
| Active Comparator: Standard care activity program<br> | Behavioral: Standard care activity program<br>* Standard-of-care activities for the study site's skilled-nursing dementia Special Care Units.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of psychotropic drug prescriptions for study participants. |  | eight months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and behavior patterns |  | eight months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavioral symptoms, Long-term care