linjc16/ctgov huggingface dataset:
Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.

Detailed Description
-----------------
Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on androgen precursors and androgens in women is yet unknown. Therefore the effect of increased FFAs on adrenal androgens and androgen precursors should be investigated in a randomized controlled cross-over trial.

Official Title
-----------------
Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women

Conditions
-----------------
Hyperandrogenism, Glucocorticoid Metabolism

Intervention / Treatment
-----------------
* Drug: lipid/heparin infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and women Exclusion Criteria: diabetes mellitus or impaired glucose tolerance clinical signs of hyperandrogenism polycystic ovary hormonal therapy BMI > 30 kg/m2 dysmenorrhoea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LHI<br>to perform an i.v. lipid heparin infusion for 4 h | Drug: lipid/heparin infusion<br>* to perform an i.v. lipid heparin infusion infusion for 4 h<br>|
| Sham Comparator: SHI<br>to perform an i.v. saline heparin infusion for 4 h | Drug: lipid/heparin infusion<br>* to perform an i.v. lipid heparin infusion infusion for 4 h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of DHEA | Measurement of serum DHEA | 1 day | 
| change of DHEAS | Measurement of serum DHEAS | 1 day | 
| change of testosterone | Measurement of serum testosterone | 1 day | 
| change of androstenedione | Measurement of serum androstenedione | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary androgen excretion |  | 1 day | 
| urinary cortisol excretion | measurement of urinary cortisol, aTHF and THF | 1 day | 
| urinary cortisone excretion | measurement of urinary cortisone and THE | 1 day | 
| changes in metabolic parameters (e.g. FGF-21) |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgens, fatty acids
Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164 in healthy male volunteers.

Official Title
-----------------
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of DWJ1392 and DWC20164 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: DWJ1392
* Drug: DWC20164


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant findings Age 19-50 years at screening Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test drug<br>DWJ1392 | Drug: DWJ1392<br> <br> |
| Experimental: Reference drug<br>DWC20164 | Drug: DWC20164<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | 0-72 hours | 
| Area under the plasma concentration versus time curve (AUC) |  | 0-72 hours |
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Study Overview
=================
Brief Summary
-----------------
Post Marketing study, Interventional, Prospective, non randomised Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).

Official Title
-----------------
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: ICM Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AF thermoablation indication Informed Consent signed, Age between 18 & 75 Exclusion Criteria: Participation to other clinical trial Non compliant patient Pregnant women Left Atrial thrombus Endocarditis, infection

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

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AF monitoring by ICM<br>Only one arm | Device: ICM Implantation<br>* Sub cutaneous implantation of the ICM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical exam and ECG record |  | one month, 3 months, 6 months , 12 months |
Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.

Official Title
-----------------
A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator Body mass index (BMI) between 18 and 27 kg/m^2, inclusive Non-smoker Fasting plasma glucose maximum 6 mmol/L Exclusion Criteria: Known or suspected allergy to trial products or related products Previous participation in this trial Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant) The receipt of any investigational drug within the last 3 months prior to this trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycerol<br> | Drug: insulin detemir<br>* Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)<br>|
| Active Comparator: Mannitol<br> | Drug: insulin detemir<br>* Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin detemir concentration curve |  |  | 
| Maximum serum insulin concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  |  | 
| Time to maximum serum insulin concentration |  |  | 
| Terminal serum insulin half life |  |  | 
| Area under the serum insulin detemir concentration curve |  |  | 
| Maximum glucose infusion rate |  |  | 
| Time to maximum glucose infusion rate |  |  | 
| Adverse events |  |  |
Vascular Reparative Mechanism in Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to study blood stem cells in diabetic patients and normal patients. We would like to better understand if these cells, called endothelial precursor cells (EPCs), are not working as expected in people with diabetes. We would like to see if the function of these cells can predict the development of diabetic retinopathy. Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding in the retina. Even with current treatments, the quality of life for people with diabetic retinopathy is much reduced.

Official Title
-----------------
Vascular Reparative Mechanism by ACE2/Ang-(1-7) in Diabetes

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Other: Diabetic Patients
* Other: Healthy Controls


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women 18 years or older 39 type 1 or type 2 diabetic patients 13 with mild retinopathy 13 with moderate retinopathy 13 with severe, nonproliferative retinopathy 39 age and sex matched healthy controls Exclusion Criteria: Current pregnancy as evidence by a urine pregnancy test as the blood from a pregnant female will influence the results of the laboratory tests

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic Patients<br>Mild, Moderate and Severe Retinopathy | Other: Diabetic Patients<br>* measuring CD34 cell function in relation to diabetic retinopathy status<br>|
| Healthy Controls<br>Age and sex matched Healthy Controls | Other: Healthy Controls<br>* measuring CD34 cell function<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ACE/ACE2 ratio within EPC's | Peripheral blood of 150cc, approximately 8-10 tablespoons will be collected from a vein in the arm of both diabetic and healthy control patients. | up to 216 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The balance of the RAS (renin-angiotensin system) within EPCs | The Endo-PAT2000 will be used to obtain this measurement. This is a 15-minute office-based test where a blood-pressure cuff is placed around the arm, inflated and measurements are obtained from a small fingertip monitor | up to 216 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Retinopathy
Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression

Study Overview
=================
Brief Summary
-----------------
To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.

Detailed Description
-----------------
WB-MRA is an examination that can evaluate the arteries from head to feet. Timing of the injected bolus of contrast medium can be difficult, especially in the legs. As the result of the WB-MRA depends on the contrast medium only being in the arteries at the time of examination, the use of venous compression is a possible way of overcoming the problem of early venous filling, that can hamper the diagnostic value of the examination. Venous compression is performed with a blod pressure cuff around the thighs. It is inflated to subsystolic pressure (45 mm Hg). This elevated pressure leads to filling of the lower leg arteries and late venous filling.

Official Title
-----------------
Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia. Experience With Venous Compression.

Conditions
-----------------
Atherosclerosis, Intermittent Claudication

Intervention / Treatment
-----------------
* Procedure: Whole body magnetic resonance angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic lower extremity ischemia (claudication, ischemic wounds) Referred to digital subtraction angiography (DSA) Exclusion Criteria: Renal insufficiency (GFR < 30 ml/min) Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker) Dementia Pregnancy/lactation Allergy to gadolinium based MRI contrast agents Acute disease

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

| Intervention/Treatment |
| --- |
|Procedure: Whole body magnetic resonance angiography|Magnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Magnetic resonance, whole body, angiography, venous compression
Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. Consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. The aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.

Detailed Description
-----------------
Method: Monocentric prospective study with diagnostic and prognostic expectations. Primary objective: Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. Secondary objective: Research of clinical and biological prognostic factors.

Official Title
-----------------
Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

Conditions
-----------------
Sepsis, Septic Shock, Cancer

Intervention / Treatment
-----------------
* Other: SELDI-TOF MS for plasmatic proteic profile


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient from oncology or hematology with a septic shock Patient aged 18 years and older Inclusion within the 24 hours of the septic shock in the intensive care unit Signed consent according to the emergency reglementation Exclusion Criteria: Pregnancy, breast feeding Patient with decision of care limitation Patient with legal protection

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SELDI-TOF MS<br>The proteic profiling is performed by SELDI-TOF mass spectroscopy. | Other: SELDI-TOF MS for plasmatic proteic profile<br>* An extra blood sample is required to determine the plasmatic proteic profile used to identify one or several signatures which are correlated to the clinical evolution (mortality at D30).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research of clinical and biological prognostic factors. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, septic shock
Diagnostic Approach of Deep Vein Thrombosis in Primary Care

Study Overview
=================
Brief Summary
-----------------
To asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care. To describe the differential diagnosis and the strength of association between each outcome variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional, multicentric study.

Detailed Description
-----------------
The participants are the patients referred from the 15 primary care centers (400.000 inhabitants) to the Hospital de la Santa Creu i Sant Pau emergency department with suspected DVT. We will enter physical examination and anamnesis variables, Wells and Oudega's rules variables, D-Dimer value and ultrasonography result. The outcome variables are the cost (€) of each possible way of diagnostic approach and the effectiveness will be measured by the ultrasonography result, which confirms or excludes the diagnosis. The sample will include 437 patients. A decision tree will be developed to analyze the different diagnostic options in DVT cases, using standard notation.

Official Title
-----------------
Orientación Diagnóstica de la Trombosis Venosa Profunda en la Atención Primaria. Estudio de Coste Efectividad

Conditions
-----------------
Thrombosis

Intervention / Treatment
-----------------
* Other: D Dimer and ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau Exclusion Criteria: anticoagulant treatment patients who will not be able to follow control visit patients with oncologic treatment

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 |
| --- | --- |
| Deep Vein Thromobosis signs or symptoms<br> | Other: D Dimer and ultrasonography<br>* clinical history, Dimer D, ultrasonography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep vein thrombosis, Primary care, Diagnosis, Clinical model
Healthy Kids I-PAL

Study Overview
=================
Brief Summary
-----------------
Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.

Official Title
-----------------
Healthy Kids at I-PAL (Interactive Physical Activity Lab)

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: m-health approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Child: Have at least one participating parent Be physically capable of exercise Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer Inclusion Criteria for Parent: Have a smart phone Be willing to use the smartphone for the mHealth intervention Exclusion Criteria for Child: Significant cardiovascular disease or disorders via self-report from parent Other significant medical problems that would prevent them from engaging in regular physical activity.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: m-health approach<br>All dyads will receive the m-health approach. | Behavioral: m-health approach<br>* Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability/feasibility of the mHealth approach | Acceptability/feasibility of the mHealth approach will be evaluated by a survey. | Week 0 to Week 14-16 |