linjc16/ctgov huggingface dataset:
Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.

Official Title
-----------------
Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.

Conditions
-----------------
Cardiovascular Complications, Hemorrhagic Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or more patient requiring a non cardiac surgery patient with a coronary stent patient agree for personal health data collection and analysis Exclusion Criteria: patient less than 18 years patient unable to understand

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 |
| --- | --- | --- |
| Composite cardiovascular and hemorrhagic postoperative complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative death |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary stents, non cardiac surgery, cardiovascular complications, hemorrhagic complications, antiplatelet agents, bare metal stent, drug eluting stent, surgery
Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

Study Overview
=================
Brief Summary
-----------------
Estimating the risk of future cardiovascular events such as death, stroke and myocardial infarction using traditional risk factors (such as age, gender, smoking, diabetes, hyperlipidaemia and hypertension) is well accepted in patients with and without existing cardiovascular disease. These estimates are based on a number of robust observational studies, including the original Framingham study. While these methods apply reasonably well on a population level their application to the individual patients is not always straightforward. In addition, risk charts, such as those published by the Joint British Societies and American Heart Association, may underestimate risk in certain groups, notably diabetics and patients of Indo-Asian background, whilst overestimating risk in others (by as much as 50% in some studies).

Detailed Description
-----------------
A number of variables including clinical, biochemical, and enzymatic have been evaluated to see if they add to conventional risk-reduction models such as Framingham and if so, to understand if they may be used in routine clinical practice. The aim of this study is to assess several known and a few novel risk-factors (heart rate variability, pulse wave analysis, high-sensitivity CRP and BNP) prior to planned elective coronary angiography (cross-sectional analysis) and in a prospective cohort of high and low-risk patients.

Official Title
-----------------
Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years or older) Male or Female Exclusion Criteria: Acute coronary syndrome Urgent angiography Assessment would constitute harm to patient Informed consent not obtained

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 |
| --- | --- |
| ARM-CAD 1<br>Cross-sectional analysis using coronary angiogram results | |
| ARM-CAD 2<br>Prospective cohort for incident cardiovascular events and mortality | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent and severity of angiographic coronary artery disease |  | cross-sectional | 
| All-cause death or myocardial infarction |  | 1, 2, 5 years | 
| All-cause death, MI or need for cardiac surgery |  | 1, 2, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 1, 2, 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BNP, Risk, Coronary artery disease, Heart Rate variability, Pulse wave analysis, CRP
Creatine Metabolism in Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The pathological mechanism is barely understood. Although feeding difficulties may play a role in this, other constitutional factors as altered metabolic processes are suspected. Preliminary research showed elevated plasma creatine concentrations and increased urinary creatine/creatinine ratios in half of the RTT girls. The aim of this study is to confirm previous findings and examine the functionality of the creatine transporter in RTT girls. The investigators assume that previous findings will be confirmed, and are due to an altered functionality of the creatine transporter.

Official Title
-----------------
Metabolic Evaluation of Nutrition in Rett Syndrome: Creatine Metabolism

Conditions
-----------------
Rett Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of RTT (meeting consensus diagnostic criteria (Hagberg et al, 2002)); MECP2-mutation; Complete neurophysiological work-up; Participant preliminary research (research protocol NL25356.068.08). Exclusion Criteria: Male gender

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rett syndrome girls<br>The study population (identical to the population in the preliminary research project) consists of a well-defined group of thirteen Dutch RTT girls with complete clinical, molecular, neurophysiological and metabolic work-up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm previous findings and examine the functionality of the creatine transporter in RTT girls | Blood as well as urine samples will be collected to confirm previous findings concerning plasma and urine creatine concentrations. Furthermore, blood samples will be used to perform mutation analysis of the SCL6A8 gene. Secondary, a skin biopsy will be collected for functional studies regarding the creatine transporter in RTT girls. By comparing intracellular and extracellular creatine concentrations, one can assess the functionality of the creatine transporter. | One hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rett syndrome, Nutritional status, Creatine metabolism
This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep

Study Overview
=================
Brief Summary
-----------------
Thermal comfort and subsequent sleep quality will improve with the use of bedding that incorporates thermoregulation technology, in comparison to standard bedding products.

Detailed Description
-----------------
Participants will spend nights sleeping in the residential module of the Well Living Lab. Participants will cross over from normal sheets to hygro cotton sheets to assess impact of different sheet types on microclimate (e.g. temperature) and the impact on sleep quality.

Official Title
-----------------
Sleep Quality and Microclimate Study

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Other: hygro cotton sheets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria. Premenopausal women Age 21-45 Exclusion Criteria History of sleep disorders

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional Model Description: Participants will be randomly assigned to sleep in the residential module of the Well Living Lab. One week will be with standard sheets, followed by one week of hygro cotton sheets.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sleep participants<br>Crossover from standard sheets to hygro cotton sheets | Other: hygro cotton sheets<br>* hygro cotton sheets will be utilized to impact microclimate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body temperature | body temperature collected via body sensors | 1 night |
Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).

Detailed Description
-----------------
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency

Official Title
-----------------
The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV

Conditions
-----------------
Human Immunodeficiency Virus (HIV), Vitamin D Deficiency, HIV Infections

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior 25-hydroxyvitamin D level <20 On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry Exclusion Criteria: Pregnancy or Breast Feeding Diabetes Creatinine Clearance <50 Any active infectious or inflammatory condition aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months prior to study entry

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants that have been randomized into this arm will receive placebo pills. | Other: Placebo<br>* Placebo pills will be administered to enrollees in this arm<br>|
| Active Comparator: Vitamin D 4000 IU<br>Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily. | Drug: Vitamin D<br>* Vitamin D 4000 IU will be administered to enrollees on the active comparator arm<br>* Other names: Calciferol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Endothelial Function | Endothelial function measured by flow mediated brachial artery dilation | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum 25-hydroxyvitamin D Concentration in Both Groups |  | Baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Human Immunodeficiency Virus (HIV), Complementary Therapies
Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)

Detailed Description
-----------------
Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.

Official Title
-----------------
Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: DA-8159 (Udenafil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged 20 years or more diagnosed with erectile dysfunction(ED) Exclusion Criteria: Had uncontrolled blood pressure Had hepatic or renal dysfunction Had significant psychiatric disorders or drug abuses Was currently under anticancer chemotherapy Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors

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

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

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

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: DA-8159<br>Udenafil(The study had one arm.) | Drug: DA-8159 (Udenafil)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients. | 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal | The efficacy measures(Unit of Measure) IIEF EF domain score(Change from baseline) IIEF other domain scores(Change from baseline) GAQ & Shift to normal(percentage of subject) | 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study) |
Optimal Low B-value in Intravoxel Incoherent Motion Diffusion-weighted MR Imaging of the Brain

Study Overview
=================
Brief Summary
-----------------
Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain.

Detailed Description
-----------------
As an improved MRI technique, diffusion-weighted imaging (DWI) is considered the most sensitive for early pathological changes. Perfusion measurement has been shown to improve sensitivity and predictive value for tumor grading and prognosis, also as a predicator of recovery with reperfusion in patients of acute ischemic stroke.Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain.

Official Title
-----------------
Can the Distribution of Low B-value and the NEX Influence the Pseudodiffusion Parameter Derived From IVIM in Brain?

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: different low b-values distribution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no hypertension or cerebral vascular diseases, no systemic metabolic disease; no infection or fever; no use of corticosteroid drugs; no MRI contraindication. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Low b=(0,50,150,200)，NEX=(1,3,2,2) | Other: different low b-values distribution<br> <br> |
| Group 2<br>Low b=(0,30,50,100,200)，NEX=(1,3,3,2,2) | Other: different low b-values distribution<br> <br> |
| Group 3<br>Low b=(0,30,60,90,120,150,180,200)，NEX=(1,3,3,3,2,2,2,2) | Other: different low b-values distribution<br> <br> |
| Group 4<br>Low b=(0,30,60,90,120,150,180,200)，NEX=(1,1,1,1,1,1,1,1) | |
| Group 5<br>Low b=(0,20,40,60,80,100,120,140,160,180,200)NEX=(1,3,3,3,3,2,2 | Other: different low b-values distribution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters D* and f in healthy white matter or gray mater |  | 2-3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain, IVIM, diffusion-weighted imaging
Translation and Verification of English Lysholm Knee Scoring Scale

Study Overview
=================
Brief Summary
-----------------
Through the translation and verification of the Lysholm Knee Score Scale, a Chinese version of the Lysholm Knee Score Scale supported by experimental data was obtained. And on this basis, explore the knee joint score scale that fits the Chinese situation

Detailed Description
-----------------
Lysholm Knee Scoring Scale needs to be translated and back translated into Chinese version of Lysholm Knee Scoring Scale. Through data collection and analysis, the reliability, validity and sensitivity of the Chinese version of the Lysholm Knee Score Scale were studied, and on this basis, the advantages and disadvantages of the scale were analyzed, and a new knee score scale was developed based on the domestic situation.

Official Title
-----------------
Translation and Verification of English Lysholm Knee Scoring Scale

Conditions
-----------------
Evaluations, Diagnostic Self

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ruptured ligaments, dislocation of the patella, meniscus injury or total knee replacement before and after surgery, and have the ability to read or communicate with others normally. Exclusion Criteria: Patients with other injuries to the joints of the lower limbs, or patients who do not have the ability to read or communicate with others normally.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pre-operation<br>Within one month before operation of diagnoses with a ligament rupture, patella dislocation, meniscus injury, or total knee replacement surgery | Other: no intervention<br>* no intervention<br>|
| early after operation<br>Within three months after operation of ligament rupture, patella dislocation, meniscus injury, or total knee replacement surgery | Other: no intervention<br>* no intervention<br>|
| lately after operation<br>within three months to one year after operation of ligament rupture, patella dislocation, meniscus injury, or total knee replacement | Other: no intervention<br>* no intervention<br>|
| healthy volunteers<br>Healthy people without abnormalities | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese version of Lysholm Knee Score Scale | Chinese version of Lysholm Knee Score Scale | 1 year after operation | 
| IKDC Knee Joint Score Scale | IKDC Knee Joint Score Scale | 1 year after operation |