linjc16/ctgov huggingface dataset:
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An association was shown between AGE measured by biopsy (invasive) and DE patients with diabetes (increase of AGE level in the corpora cavernosa). To date no studies have explored the link between DE and the measure of AGE by a non-invasive method of Auto-fluorescence (AF) Skin (AGEReaderTM). If the hypothesis of an association between DE and AGE measured by AF was checked, screening for erectile dysfunction and measurement of AGEs could help to improve the overall management of diabetic patient (including cardiovascular) and their quality of life.

Official Title
-----------------
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients

Conditions
-----------------
Diabetes Mellitus, Non-Insulin-Dependent, Erectile Dysfunction

Intervention / Treatment
-----------------
* Other: DE assessment
* Other: AGE measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Type 2 Exclusion Criteria: skin hyperpigmentation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE assessment and AGE measurements<br>To evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients | Other: DE assessment<br>* by a validated self-administered questionnaire: Index International erectile function (IIEF-15)<br>Other: AGE measurement<br>* By AGE-ReaderTM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erectile dysfunction and AGE levels | To evaluate the association between erectile dysfunction and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients | 2 hours |
Alere Triage fs B-type Natriuretic Peptide (BNP) Method Comparison Evaluation

Study Overview
=================
Brief Summary
-----------------
This study will evaluate method correlation and mean bias between six B-type natriuretic peptide (BNP) platforms.

Official Title
-----------------
Alere Triage fs BNP Method Comparison Evaluation

Conditions
-----------------
Specimens With BNP Values of 5 to 5000 pg/ml, Triage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples with BNP range of 5-5000 pg/ml Samples with sufficient volume for testing Exclusion Criteria: BNP <5 pg/ml

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 |
| --- | --- | --- |
| bias |  | Sept 2011 |
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy

Study Overview
=================
Brief Summary
-----------------
This study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. Clinical parameters as well as health economy will be assessed. The study hypothesis is that the endoscopic approach is equivalent or superior to microdiscectomy.

Official Title
-----------------
Transforaminal Endoscopic Surgery Cost Outcome Research Trial

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Procedure: joimax TESSYS
* Procedure: Microdiscectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic lumbar disc herniation clinical and radiological evidence of nerve root compression failure of conservative treatment for at least 6 weeks Exclusion Criteria: previous lumbar spine surgery severe or progressive motor deficit BMI > 40 cauda equina syndrome

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endscopy<br> | Procedure: joimax TESSYS<br>* Transforaminal Endoscopic Surgery System<br>* Other names: TESS;|
| Active Comparator: Microsurgery<br> | Procedure: Microdiscectomy<br>* Standard procedure for disc surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Oswestry Disability Index at 4 years |  | total follow-up period of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Quality of Life (SF-12) |  | total follow-up period of 4 years | 
| Health resources consumption |  | total follow-up period of 4 years | 
| Complication rate |  | 2 years | 
| Patient satisfaction |  | Total follow-up period of 4 years | 
| Change from baseline in back and leg pain (NRS) |  | total follow-up period of 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar spine, herniated disc, slipped disc, disc herniation, discectomy, nucleotomy, disc surgery, endoscopy, spine
Health2006 - an Observational Study of Cardiovascular Disease, Diabetes, Asthma and Allergy

Study Overview
=================
Brief Summary
-----------------
The aim is to assess the population prevalence of risk factors for different chronic diseases such as cardiovascular disease, type 2 diabetes, osteoporosis, asthma, and allergy. Risk factors include genetic and serologic biomarkers, questionnaire data on health and lifestyle. There are many hypotheses under study for each research field.

Detailed Description
-----------------
A population-based random sample of persons living in Copenhagen is drawn from the Danish Civil Registration System and invited for a health examination including blood sample drawing, measurement of lung function, serologic and genetic biomarkers, questionnaires on lifestyle and health. The study will form the basis for research within many different areas such as cardiovascular disease, type 2 diabetes, asthma, and allergy.

Official Title
-----------------
Health2006 - an Observational Population-based Study of Cardiovascular Disease, Type 2 Diabetes, Asthma and Allergy

Conditions
-----------------
Type 2 Diabetes, Cardiovascular Disease, Asthma, Hypersensitivity, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons living in 11 municipalities in Copenhagen Exclusion Criteria: Pregnancy Non-Danish citizenship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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
-----------------
epidemiology, risk factors
Populational Program of Physical Activity and Healthy Eating Promotion: the Life of Health Study

Study Overview
=================
Brief Summary
-----------------
This is a population-based natural experiment study aimed to examine the effect of a multi-approach intervention focused on physical activity and healthy eating promotion to individuals living in Jaguariuna city (São Paulo, Brazil).

Conditions
-----------------
Health Behavior

Intervention / Treatment
-----------------
* Behavioral: Healthy lifestyle promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: citizens from Jaguariuna city (Sao Paulo, Brazil) Exclusion Criteria: citizens not from Jaguariuna city (Sao Paulo, Brazil) children below 8 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity and healthy eating promotion<br> | Behavioral: Healthy lifestyle promotion<br>* Healthy lifestyle changes (i.e., increase in physical activity levels and improvement in eating habits) will be promoted via population-based counselling through media (i.e., radio, newspapers, magazines, television, banners), cell phone applicative, workshops, specific programs at schools and companies, and community physical activity programs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting glycemia |  | 7 months | 
| fasting insulinemia |  | 7 months | 
| total cholesterol |  | 7 months | 
| LDL-cholesterol |  | 7 months | 
| HDL-cholesterol |  | 7 months | 
| triglycerides |  | 7 months | 
| VLDL-cholesterol |  | 7 months | 
| C-reactive protein |  | 7 months | 
| objectively measured physical activity levels | assessed by accelerometers in a sub-sample | 7 months | 
| subjectively measured physical activity levels | assessed by International Physical Activity Questionnaires (IPAQ) | 7 months | 
| subjectively measured physical activity levels | assessed by phone interview | 7 months | 
| food intake | food frequency questionnaire | 7 months | 
| blood pressure |  | 7 months | 
| body mass index |  | 7 months | 
| self-perceived health status | assessed by phone interview | 7 months |
Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Official Title
-----------------
Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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

Intervention / Treatment
-----------------
* Drug: placebo for adalimumab
* Drug: adalimumab
* Drug: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe chronic plaque psoriasis Active psoriasis, despite topical therapies Exclusion Criteria: Other active skin diseases or skin infections Prior exposure to any anti-TNF therapy Subject has other active skin diseases Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) Poorly controlled medical conditions History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease. History of cancer or lymphoproliferative disease History of active TB or listeriosis, or persistent chronic or active infections Known to have immune deficiency or is immunocompromised Clinically significant abnormal laboratory test results Erythrodermic psoriasis or generalized pustular psoriasis

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: placebo for adalimumab<br>* 80 mg at Week 0 and 40 mg eow through Week 11<br>* Other names: placebo;|
| Active Comparator: B<br> | Drug: adalimumab<br>* 80 mg at Week 0 and 40 mg eow through Week 11<br>* Other names: Humira;|
| Active Comparator: C<br> | Drug: adalimumab<br>* 80 mg at Week 0 and 40 mg weekly through Week 11<br>* Other names: Humira;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 12 | 
| Adverse Events |  | Throughout Study Participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 1, 2, 4, 8, 12 | 
| DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D |  | Week 12 |
EEG Slow Wave Activity in Hypoxic Brain Injury

Study Overview
=================
Brief Summary
-----------------
BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome.

Detailed Description
-----------------
BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome. Comatose adult patients admitted to intensive care unit (ICU) after cardiac arrest are included. Patients with previous neurological disease expected to affect substantially the EEG are excluded. The patients' relatives are asked for an informed written consent to participate. In the intensive care, the patients are sedated using continuous infusion of propofol while receiving temperature management/hypothermia treatment following the ICUs' common practice. EEG is recorded within the first 24h after ICU admission. If possible, the recording is repeated on the second and third day i.e. 48h and 72h after ICU admission, respectively. To induce the maximum effect of propofol on EEG, additional boluses of propofol during the EEG recording may be given until the burst suppression level is reached. Slow wave activity is calculated offline from the EEG recordings. The neurological recovery of the patients is defined 6 months after cardiac arrest from patient documents and/or by phone call to the patient/ relative using Cerebral Performance Category. After the follow-up period patient or the relative is also asked to fill a survey (SF-36) to estimate the health and quality of life.

Official Title
-----------------
Assessment of EEG Slow Wave Activity in Comatose Cardiac Arrest Survivors Under Propofol Anesthesia

Conditions
-----------------
Hypoxic-Ischemic Encephalopathy, Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Comatose patients admitted to intensive care after cardiac arrest Exclusion Criteria: Previous neurological disease expected to affect EEG substantially

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 |
| --- | --- | --- |
| EEG slow wave activity | EEG slow-wave activity determined from the low-frequency (<1 Hz) signal component calculated from the EEG recordings made within 24 hours from ICU admission and repeated, if possible, at 48 hours and 72 hours. | 0-72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, Intensive Care, Propofol
Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease and Hepatocellular Cancer

Study Overview
=================
Brief Summary
-----------------
To identify risk factors for the development and diagnosis of hepatocellular CA in patients with chronic hepatitis C and to use the data to ultimately develop an effective screening program.

Official Title
-----------------
Risk Factors and Molecular Genomics for Hepatocellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study

Conditions
-----------------
Carcinoma, Hepatocellular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For both experimental subjects and controls: Patients between older than 18 years of age of all ethnic backgrounds and genders. Patients with chronic liver disease For Experimental Subjects Only: Patients with HCC with a hepatic mass larger or equal to 5cm Patients with HCC with a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection Patients with HCC with a hepatic mass lesion with characteristic CT or MRI or angiographic appearance. For Controls Only: Patients with chronic liver disease without evidence of HCC confirmed by either : 1. A normal AFP level 2. a negative imaging study (ultrasound, CT, or MR imaging). 3. Negative liver cancer on explants. *Exclusion Criteria: Patients who declined to participate in the study Patients with a history of HIV infection Patients with concurrent advanced malignancy of non-hepatic origin. Patients with significant use of androgenic steroid. Patients with exposure to vinyl chloride.

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 |
| --- | --- |
| HCC PTS<br>Patients with HCC with either: (i) a hepatic mass larger or equal to 5cm, or; (ii) a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection, or; (iii) a hepatic mass lesion with characteristic CT or MRI or angiographic appearance. | |
| LD<br>Patients with chronic liver disease without evidence of HCC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phage Safety Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.

Official Title
-----------------
Phage Safety Retrospective Cohort Study

Conditions
-----------------
Bone and Joint Infection, Prosthetic Joint Infection

Intervention / Treatment
-----------------
* Other: patients having had avderse event after phagotherapy for bone or joint or implant infection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients having had avderse event after phagotherapy for bone or joint infection<br> | Other: patients having had avderse event after phagotherapy for bone or joint or implant infection<br>* to determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients having had an adverse event | number of patients having had an adverse event | 1 year | 
| rate of adverse event attributable to the surgery | number of patients having had an adverse event because of the surgery | 1 year | 
| type of adverse event attributable to the surgery | classification according to Clavien's Clasification | 1 year | 
| rate of adverse event attributable to the antibiotic treatment | number of patients having had an adverse event because of the antibiotic treatment | 1 year | 
| rate of adverse event attributable to the phagotherapy | number of patients having had an adverse event because of phagotherapy | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone and joint infection, phagotherapy, adverse event, Prosthetic Joint Infection