linjc16/ctgov huggingface dataset:
Cardiovascular Health Effects of Flavanol Rich Chocolate

Study Overview
=================
Brief Summary
-----------------
In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.

Official Title
-----------------
Cardiovascular Health Effects of Flavanol Rich Chocolate

Conditions
-----------------
Endothelial Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: High flavanol chocolate
* Dietary Supplement: Low flavanol chocolate
* Dietary Supplement: High fat challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 45-70 years old BMI between 25 and 32 kg/m2 Exclusion Criteria: Urine glucose concentrations outside normal ranges (> 0,25 g/l) Fasting blood glucose < 7.0 mmol/L) Systolic Bp > 160 mmHg or diastolic Bp > 100 mmHg Blood Hb values below 8.4 mmol/L Allergic to cow milk, dairy products or chocolate Vegetarian Tobacco smoker Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High flavaonol chocolate<br> | Dietary Supplement: High flavanol chocolate<br>* chocolate high in flavanols<br>Dietary Supplement: High fat challenge<br>* Milkshake with 95g fat<br>|
| Placebo Comparator: Low flavanol chocolate<br> | Dietary Supplement: Low flavanol chocolate<br>* chocolate low in flavanols<br>Dietary Supplement: High fat challenge<br>* Milkshake with 95g fat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 0, 4wk | 
| FMD |  | 0, 4wk | 
| PWA |  | 0, 4wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leukocyte count and activation |  | 0, 4wk | 
| PBMC gene expression |  | 0, 4wk | 
| Markers of inflammation and ED |  | 0, 4wk | 
| Blood pressure | acute study part | 0 and 2h | 
| FMD | acute study part | 0 and 2hrs | 
| PWA | acute study part | 0 and 2 hrs | 
| Leukocyte count and activation | acute study part | 0 and 2 hrs | 
| PBMC gene expression | acute study part | 0 and 2 hrs | 
| markers of inflammation and ED | acute study part | 0 and 2hrs |
Open-Label Lesinurad Monotherapy Extension Study in Gout

Study Overview
=================
Brief Summary
-----------------
This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

Detailed Description
-----------------
This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

Official Title
-----------------
A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Drug: lesinurad


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. Subject completed the double-blind treatment period in Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit. Subject is willing to adhere to the visit/protocol schedules. Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication. Exclusion Criteria: Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study. Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis. Subject developed kidney stones during Study RDEA594-303

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lesinurad 400 mg<br> | Drug: lesinurad<br>* Tablets, 400 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL |  | Month 1 | 
| Incidence of Treatment-emergent Adverse Events (TEAEs) |  | Up to approximately 2 years |
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation

Study Overview
=================
Brief Summary
-----------------
The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain during the laser photocoagulation, for diabetic retinopathy.

Detailed Description
-----------------
To do so we compare two group of patients, randomized 1:1, one use the medication(etoricoxib) and other use placebo and they quantify the pain using the Pain visual analogue scale

Official Title
-----------------
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation

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

Intervention / Treatment
-----------------
* Drug: placebo (Control Group)
* Drug: Etoricoxib (Treatment Group)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetic retinopathy that needs laser photocoagulation for the first time Exclusion Criteria: Younger than 17 Signs and symptoms of liver dysfunction or abnormal liver function tests Gastrointestinal diseases Pregnant women Edema Pre-existing cardiac insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Patients who received placebo | Drug: placebo (Control Group)<br>* Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation<br>|
| Active Comparator: Treatment Group<br>Patients who received etoricoxib 120 mg | Drug: Etoricoxib (Treatment Group)<br>* Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation<br>* Other names: Etoricoxib 120mg is Arcoxia 120mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The group taking the etoricoxib feel less pain then the group taking placebo |  | After each laser session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laser Photocoagulation, Pain relief
Med-alert Bracelet in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This is a pilot observational study to evaluate subjects with chronic kidney disease acceptance of an alert device linked to an informational website intended to increase recognition of chronic kidney disease, and to guide patients and providers to the safe delivery of care required for this disease. Primary device was a bracelet with the alternative of a key fob with same information supplied when requested. Patients usage of the device was evaluated by survey with Likert scale as to whether the device is 0 = not useful, 1 = somewhat useful, 2 = extremely useful

Detailed Description
-----------------
No need for more extensive description

Official Title
-----------------
Safe Kidney Care Med-Alert Bracelet/Keytag

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Device: Medical Alert Bracelet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with chronic kidney disease defined as estimated glomerular filtration rate of < 60 ml/min/1.73m2. Exclusion Criteria: Persons expected to be on dialysis within 6 months. Less than 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 |
| --- | --- |
| Safe Kidney Care<br>Patients with Chronic Kidney Disease (eGFR < 60 ml/min/1.732)and not expected to need dialysis within 6 months of enrollment | Device: Medical Alert Bracelet<br>* Medical Alert Bracelet alerting health care providers to consider the patient's chronic kidney disease condition when planning care. It also provides a link to a website about safe kidney care (safekidneycare.org)<br>* Other names: Safe Kidney Care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device. | Qualitative questionnaire with primary assessment: How useful do you think the Med-alert device will be for future healthcare. Response recorded based on a Likert scale with response of 0 = not useful, 1 = somewhat useful, 2 = extremely useful | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient safety, chronic kidney disease, med-alert
Multimodal Imaging Analysis of Spinal Tumors

Study Overview
=================
Brief Summary
-----------------
In this study, we retrospectively analyzed the imaging data of spinal tumors to find out more imaging features of spinal tumors, in order to provide more accurate reference for the diagnosis of spinal tumors.

Detailed Description
-----------------
Bone tumors account for 1-2% of total body tumors, and spinal tumors only account for 6.5% of total body tumors. Because of the low incidence rate, the number of patients and the attention in this field are far lower than other tumors, so far, all the researches on spinal tumors are relatively lacking. Because the diagnosis of bone tumor needs the combination of clinical, imaging and pathological to make a more accurate diagnosis, so the imaging diagnosis of spinal tumor is very important. In this study, through retrospective analysis of a variety of imaging data of patients with spinal tumor, measurement and recording of spinal tumor image related parameters, and statistical analysis, in order to find out more imaging characteristics of patients with spinal tumor, more accurate diagnosis of lesions, and provide more help for clinical decision-making.

Official Title
-----------------
Multimodal Imaging Analysis of Spinal Tumors

Conditions
-----------------
Bone Tumor

Intervention / Treatment
-----------------
* Diagnostic Test: radiomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete and accurate clinical and pathological data are available；Imaging examination was performed in our hospital Exclusion Criteria: Patients with missing image data and unclear image
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metastases<br>patients with spinal metastases | Diagnostic Test: radiomics<br>* Differential diagnosis of spinal myeloma and metastases by radiomics<br>|
| multiple myeloma<br>patients with spinal multiple myeloma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiomics features | 1409 radiomics features can be extracted from the images. Objective to search for the radiomics index which is helpful to the diagnosis of tumor. | 2020.12.1-2020.12.25 |
Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients.

Official Title
-----------------
Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients

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

Intervention / Treatment
-----------------
* Behavioral: Lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 25 or older, type 2 diabetes mellitus, HbA1c 6.5-10% BMI 23 or higher. Exclusion Criteria: type 1 diabetes, recent (within 3 months) cardiovascular event, severe hepatic or renal dysfunction, insulin use, glucocorticoid use.

Ages Eligible for Study
-----------------
Minimum Age: 25 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle modification<br>supervised exercise with diet education | Behavioral: Lifestyle modification<br>* Exercise and diet education<br>|
| No Intervention: Control<br>Control (ordinary care with usual education) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, serum adipokine levels |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 3 months | 
| Pulse wave velocity |  | 3 months | 
| Insulin secretion and sensitivity |  | 3 months | 
| VO2max |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes mellitus, lifestyle modification
Evaluation of Multidisciplinary Palliative Care on Terminal Cancer Patients in Taiwan

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the quality of dying and death of terminal cancer patients from the perspectives of medical staff and main care giver (family). The hypothesis is that their view points will be different.

Official Title
-----------------
Evaluation of Multidisciplinary Palliative Care on Terminal Cancer Patients in Taiwan

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitively intact. Contact with the patient in the last month. Exclusion Criteria: Cognitively not intact. No contact with the patient in the last month.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of dying and death of terminal cancer patients
A Crossover Study Assessing the Pharmacokinetics, Pharmacodynamics, and Safety of Recombinant Human Insulin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of recombinant human insulin. The study will consist of 2 phases.

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

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male Subjects Age between 18 and 40 years of age Exclusion Criteria: History of Diabetes Subjects with clinically significant active disease Known allergy to insulin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Insulin|nan|

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
-----------------
Human Volunteers
Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?

Study Overview
=================
Brief Summary
-----------------
Acetaminophen is the first drug involved in voluntary drug poisoning. According to the studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver failure, and this poisoning is responsible of 10 percent of liver transplants each year in these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly correlated with factors predisposing socio-economic field are an important issue, including the speed and appropriateness of care are key factors both in terms of reducing morbidity mortality in socio-economic terms for the community.A nomogram defines a statistical threshold from which the blood concentration of paracetamol has a significant risk of liver toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a toxic dose, but there is no consensus on whether or not to repeat this dosage during the treatment, as the first result is beyond the threshold or not.The administration of the antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a protocol that can vary in different services.In the absence of clear guidelines, the question of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the curve, and thus enable the return home of the patient's somatic point of view (excluding psychiatric care when is voluntary drug intoxication), with consequences in terms of costs (hospital days) and duration of treatment?

Official Title
-----------------
Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?

Conditions
-----------------
Acetaminophen Overdose

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Having taken a single dose of acetaminophen With a supposed ingested dose over 4 grams Exclusion Criteria: Patients treated with N-Acetyl Cysteine before their admissions in the participating units With repeted ingested doses Pregnant and nursing wifes Patients unable to give their consent to the study

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 |
| --- | --- | --- |
Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.

Detailed Description
-----------------
We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 30 - 40 serum calcium < 2.55 mmol/L Exclusion Criteria: serious diseases reduced kidney function renal stone disease using psychopharmaca using drugs for weight reduction

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cholecalciferol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight |  |  | 
| Body composition |  |  | 
| Measures of calcium metabolism |  |  | 
| Insulin sensitivity |  |  | 
| Muscle strength |  |  | 
| Depression score |  |  | 
| Blood pressure |  |  |