linjc16/ctgov huggingface dataset:
A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers

Study Overview
=================
Brief Summary
-----------------
This study aims to establish a novel approach assisting the rational development of analgesic and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether proteins mediating inflammation and pain can be detected in an experimentally induced inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected from the inflamed skin site via small porous catheters. We wish to establish the expression pattern of different proteins and correlate it with various tests assessing pain.

Official Title
-----------------
Proof-of-concept Study for Bio-marker Assay Validation in Humans

Conditions
-----------------
Skin Diseases

Intervention / Treatment
-----------------
* Procedure: Micro-plasmapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Age between 21-60. 2. Skin type II or III according to the classification of Fitzpatrick (II: fair skin, always burns, sometimes tans, III: medium skin, sometimes burns, always tans).&#xA; Exclusion Criteria:1. History of a significant systemic disease, a dermatological disease, bleeding disorder, or chronic pain. 2. Consumption of analgesic drugs. 3. Hypersensitivity to sunlight.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Micro-plasmapheresis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor |  |  |
Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia

Study Overview
=================
Brief Summary
-----------------
The study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. It is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial.

Official Title
-----------------
Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Dietary Supplement: Beetroot shot then placebo shot
* Dietary Supplement: Placebo shot then beetroot shot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Trained athletes with personal best performances for a 10km run of sub 40 minutes Exclusion Criteria: - Unable to give informed consent Unstable medical condition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beetroot shot then placebo shot<br>Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice ( 7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK). Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot ( 0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK) | Dietary Supplement: Beetroot shot then placebo shot<br>* Beetroot shot, four day wash out, then placebo shot<br>|
| Placebo Comparator: Placebo shot then beetroot shot<br>Intervention: Participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot ( 0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK). Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice ( 7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK). | Dietary Supplement: Placebo shot then beetroot shot<br>* Placebo shot, four day wash out, then beetroot shot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete a 10 km Run | Time taken following consumption of beetroot shot or consumption of placebo shot | Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention) |
A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring

Study Overview
=================
Brief Summary
-----------------
This study includes a behavioral educational intervention that focuses on healthy eating, physical activity and glucose management during pregnancy and post partum among women newly diagnosed with gestational diabetes mellitus (GDM).

Detailed Description
-----------------
This is a pilot trial in which 50 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2)Usual Care (Self-directed) educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.

Official Title
-----------------
A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring: A Pilot Trial

Conditions
-----------------
Pregnancy, Gestational Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with gestational diabetes Confirmed singleton pregnancy 24-32 weeks gestation age Planning to deliver within the study area Exclusion Criteria: Pre-existing diabetes (type 1 or 2) Non-english speaking Not planning to deliver in the study area

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Counseling<br>Participants will obtain access to an internet-based educational intervention. | Behavioral: Lifestyle Counseling<br>* Participants receive lifestyle counseling on healthy eating and physical activity through an internet based program or self-directed educational program.<br>* Other names: Glucose Control;|
| No Intervention: Usual Care (Self-Directed)<br>Participants receive information via email on health related topics that surround pregnancy, physical activity, nutrition, and gestational diabetes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated hemoglobin |  | Baseline and 36 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight after pregnancy |  | 6 weeks postpartum to 30 weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational diabetes
Trachoma Elimination Follow-up

Study Overview
=================
Brief Summary
-----------------
The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large part by mass oral azithromycin distributions. It is not clear how frequently or for how long these treatments are necessary. Here we assess the frequency and duration of treatment.

Detailed Description
-----------------
40 villages in the Gurage Zone of Ethiopia were randomly assigned to biannual treatment, annual treatment, and a single treatment. Each treatment consisted of a single dose of oral azithromycin to the entire population over the age of 1 year (when the study was started, azithromycin had not yet been approved for ages below 1 year). We assess the prevalence the ocular chlamydia that causes trachoma in the peak prevalence age of 1-5 years at baseline, and 2, 6, 12, 18, and 24 months post treatment. An extension of the study monitors infection at 30 and 36 months post treatment. Untreated villages from the same area are enrolled in a step-wedge design to assess the presence of a secular trend. A random sample of those not within the 1-5 year old age group are examined to assess the prevalence of infection in the entire community.

Official Title
-----------------
Trachoma Elimination With Repeated Mass Azithromycin Treatments

Conditions
-----------------
Trachoma, Chlamydia

Intervention / Treatment
-----------------
* Drug: Mass treatment with oral azithromycin to an entire village


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1 to 5 years old in a village in the Gurage zone with endemic trachoma Exclusion Criteria: Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mass treatment with oral azithromycin to an entire village|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of ocular chlamydia infection in a village as determined by PCR |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical active trachoma, as determined by the WHO simplified grading system, by village |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trachoma, Chlamydia, Azithromycin
Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to investigate the safety and effectiveness of EYLEA.

Detailed Description
-----------------
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study. The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice) .

Official Title
-----------------
Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

Conditions
-----------------
Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who start EYLEA treatment for mCNV(myopic choroidal neovascularization). Exclusion Criteria: Patients who have already received EYLEA treatment.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Decision of treatment is made by attending investigator according to the Japanese Package Insert | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Administration by intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of Adverse drug reaction (ADR's) |  | Up to 12 months | 
| Number of episodes of Infections |  | Up to 12 months | 
| Number of episodes of Serious Adverse Events(SAE's) |  | Up to 12 months | 
| Number of episodes of Ocular Adverse events |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes in visual acuity |  | Baseline up to 12 months | 
| Mean changes in retina thickness |  | Baseline up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aflibercept, Anti-VEGF
Body Composition Analysis in Cirrhotic Undergoing Paracentesis

Study Overview
=================
Brief Summary
-----------------
Ascites is a frequent complication of liver cirrhosis, initial treatment consists on diuretics intake, however, as the disease progresses this complication becomes more severe, consequently other therapeutic options are used. Paracentesis is indicated when severe ascites is present and it should be accompanied by albumin infusion. Nutritional status is generally affected in patients with liver cirrhosis, even more patients with severe ascites show decreased energy intake due to gastric compression.

Official Title
-----------------
Body Composition Analysis in Cirrhotic Patients With Ascites Undergoing Paracentesis

Conditions
-----------------
Liver Cirrhosis, Ascites

Intervention / Treatment
-----------------
* Behavioral: Body composition in paracentesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any genre. Age 18-70 years old. Diagnosis of liver cirrhosis of any etiology (documented by clinical, biochemical, radiological and / or biopsy. Presence of high volume ascites The signing of informed consent will be required for the inclusion of any patient. Exclusion Criteria: Hepatic encephalopathy grade III or IV. 2) liver transplantation. Congestive heart failure. Hemodialysis. Acute or chronic renal failure. Nephrotic syndrome with protein loss. Alcoholism active in the last 6 months. Pregnancy. upper gastrointestinal bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Body composition in paracentesis<br>Taking blood samples and bioelectrical impedance, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF) before and after paracentesis. | Behavioral: Body composition in paracentesis<br>* Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | bioelectrical impedance vector analysis | Baseline and 8 days post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paracentesis, Liver Cirrhosis, ascites, body composition
Monitoring Key Activity and Physiology of Neonates in Intensive Care

Study Overview
=================
Brief Summary
-----------------
To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

Detailed Description
-----------------
To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

Official Title
-----------------
Monitoring Key Activity and Physiology of Neonates in Intensive Care

Conditions
-----------------
Neonatal Seizure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed parental consent Exclusion Criteria: -
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 |
| --- | --- | --- |
| Joint position | Joint position | First week of life |
Intraductal Papillary Mucinous Neoplasm With Malignant Change

Study Overview
=================
Brief Summary
-----------------
Purpose: To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012. Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

Detailed Description
-----------------
Purpose To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012 Enroll criteria Patient who is suspected to have pancreas IPMN on imaging Interval between imaging study and surgery is less than 2 months Who is scheduled for surgery due to IPMN

Official Title
-----------------
Intraductal Papillary Mucinous Neoplasm (IPMN) With Malignant Change: Prospective Study to Assess Diagnostic Performance of CT and Magnetic Resonance Imaging (MR) According to International Consensus Guidelines 2012

Conditions
-----------------
IPMN

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who is suspected to have IPMN by imaging study or clinician Time interval between imaging study and surgery less than 2 months Exclusion Criteria: Patients who have pathology results not by surgery Who is less than 20 years old Who cannot voluntarily agree study design

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Imaging predictor of malignant IPMN of the pancreas | We will assess baseline CT and MRI findings of patients within one month after surgery. | one month |
Ultrasound Guided Arthrocentesis

Study Overview
=================
Brief Summary
-----------------
Does ultrasound guidance improve success rate and decrease aspiration attempts for peripheral arthrocentesis?

Official Title
-----------------
Randomized Control Trial of Ultrasound-Guided Peripheral Arthrocentesis

Conditions
-----------------
Arthritis, Joint Pain

Intervention / Treatment
-----------------
* Procedure: Ultrasound guided arthrocentesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at or over 18 Indication for peripheral arthrocentesis Exclusion Criteria: Hemodynamic instability Previous arthroplasty of the joint Known intraarticular fracture Hip arthrocentesis

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound guided arthrocentesis|Guidance of joint aspiration by ultrasound guidance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate for arthrocentesis |  | within ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in aspiration attempts |  | within ED visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthrocentesis, ultrasound, emergency
Comparison of On-line and Off-line Measurements of Exhaled Nitric Oxide (NO)

Study Overview
=================
Brief Summary
-----------------
Asthma is a major health problem worldwide. The measurement of fractional exhaled nitric oxide (FENO) has been established as a valuable non invasive and simple tool in the diagnosis of asthma and may also act as a useful surrogate inflammatory marker on which to base treatment decisions in asthma management algorithms. The measurement is useful also in other respiratory diseases. Current methods of measuring FENO include on line measurements by heavy duty expensive analyzers which are not widely and easily available. Off line measurements of breath samples which can be analysed later may be a simple solution. We hypothesize tha toff line measurements of NO will be as reliable and valid as those measured on-line

Official Title
-----------------
Comparison of On-line and Off-line Measurements of Exhaled NO

Conditions
-----------------
Asthma, Primary Ciliary Dyskinesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteer to participate Filed a short health questionnaire Exclusion Criteria: None
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 |
| --- | --- | --- |
| Off line measurement of exhaled NO |  | Two types of breathing in the same day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exhaled NO, off line, on line, comparison, Bland altman method