linjc16/ctgov huggingface dataset:
Immune Responses to BCG Vaccination in Malawi and the UK

Study Overview
=================
Brief Summary
-----------------
BCG vaccination has been found to provide greater protection against TB in the UK than in Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and young adults in Malawi and in the UK.

Conditions
-----------------
Immunity, Cellular, Hypersensitivity, Delayed Type

Intervention / Treatment
-----------------
* Biological: BCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BCG unvaccinated HIV negative Not pregnant Informed Consent Exclusion Criteria: HIV positive Pregnant Seriously ill

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: BCG|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed-type hypersensitivity |  |  | 
| cytokine responses (eg IFNg) to mycobacterial antigens |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar size |  |  |
Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

Study Overview
=================
Brief Summary
-----------------
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.

Official Title
-----------------
Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women

Conditions
-----------------
Menstrual Problem, Hirsutism, Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Myo-inositol+L-tyrosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ° PCOS patients Exclusion Criteria: thyroid dysfunction hyperprolactinemia adrenal hyperplasia patients taking oral contraceptive any other endocrinological pathologies

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 38 Years

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

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: Myo-inositol+L-tyrosine<br>One sachet per day containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid for improving PCOS symptoms. | Dietary Supplement: Myo-inositol+L-tyrosine<br>* PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restore of regular menstrual period | Self report | 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving hirsutism | Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism, | 6 months of treatment | 
| Restore ovulation | Progesterone value in luteal phase | 6 months of treatment |
Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol

Study Overview
=================
Brief Summary
-----------------
Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL

Official Title
-----------------
Effect of Ezetimibe on Oxidized LDL Cholesterol

Conditions
-----------------
Coronary Artery Disease, Diabetes

Intervention / Treatment
-----------------
* Drug: ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CAD or CAD equivalent Exclusion Criteria: Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage >2 Creatinin clearance < 30 ml/min

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ezetimibe<br>will receive the active treatment with ezetimibe and statin | Drug: ezetimibe<br>* Patients will receive 10 mg/day of ezetimibe for 8 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: ezetimibe<br>* Patients will receive 10 mg/day of ezetimibe for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of oxidized LDL cholesterol at end of study |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| small dense LDL level |  | 8 weeks of treatment |
Lymph Node Yield in Colon Cancer Resection Specimens

Study Overview
=================
Brief Summary
-----------------
In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.

Detailed Description
-----------------
Lymph node yield in colon resection specimens has been associated with the accuracy of staging and cancer outcomes. It has been proposed that the more central the mesenteric vascular ligation, the greater the nodal yield. However, the optimal number of harvested nodes is still a matter of debate. We prospectively evaluated the relation between specimen properties such as lenght, area, tumor location and pedicle length to the number of harvested nodes and rate of node positivity.

Official Title
-----------------
Macroscopic Evaluation of Colon Cancer Resection Specimens to Predict Metastatic Lymph Node Yield

Conditions
-----------------
Colon Cancer, Lymph Node Metastases

Intervention / Treatment
-----------------
* Procedure: Calculation of metric variables on the colectomy specimens.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The surgical patients with a histologic diagnosis of colonic neoplasm, Colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection Exclusion Criteria: rectal or rectosigmoid cancer colectomy beyond the inclusion criteria for colectomies patients younger than 18 previous colon resection emergency colon resection familial adenomatous polyposis or ulcerative colitis

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: Calculation of metric variables on the colectomy specimens.|Calculation of metric variables on the colectomy specimens including Lengths as mm Proximal colon, Ileum in cases with right hemicolectomy only, Proximal border, Tumor, Distal border, Total specimen, Vascular pedicle, the longitudinal distance between the nearest bowel wall and the end of ligated major vascular pedicle depending on the tumor's localization, 2. Colonic mesenteric area as mm2.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph Node Yield in Colon Cancer Resection Specimens | Count of lymph node | September 2019- November 2020 | 
| Lymph Node Yield in Colon Cancer Resection Specimens | Involvement of lymph node | September 2019-November 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ileocolic pedicle, colon cancer, Staging
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema

Official Title
-----------------
An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Fluocinolone Acetonide
* Drug: Fluocinolone Acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years with diabetic macular edema Diagnosis of diabetes mellitus types 1 or 2 Best corrected visual acuity of ≥ 19 letters Retinal thickness > 250 microns by OCT Investigator is comfortable deferring macular laser treatment for 6 weeks Exclusion Criteria: Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months Any ocular surgery within the last 3 months Retinal laser treatment within the last 3 months History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy Any lens opacity which impairs visualization of the posterior pole

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Fluocinolone Acetonide<br>* 0.5 mg fluocinolone acetonide intravitreal insert<br>|
| Experimental: 2<br> | Drug: Fluocinolone Acetonide<br>* 0.2 mg fluocinolone acetonide intravitreal insert<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data. | over 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Thickness |  | over 36 months |
Bevacizumab and Retinal Vascular Occlusions

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of Intravitreal Bevacizumab in macular edema in retinal vascular occlusion.

Conditions
-----------------
Edema Macular, Vascular Occlusion

Intervention / Treatment
-----------------
* Drug: Intravitreal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vascular occlusion and edema macular diagnosticated by fluorescein angiography and coherent optic tomography Exclusion Criteria: Previous surgery Uveitis Glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravitreal injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data in Koreans

Study Overview
=================
Brief Summary
-----------------
64 channel multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures depending on different status of metabolic diseases. The investigators also aimed to analyze the risk factors associated with number and severity of stenosis as well as plaque characteristics using logistic regression models.

Official Title
-----------------
Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data of Over 15,000 Individuals in Korea

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or older Exclusion Criteria: pregnant women patients with chronic kidney disease (Cr>2.0)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NGT/IFG/DM, MeS/no-MeS<br>NGT: normal glucose tolerance IFG: impaired glucose tolerance DM : diabetes mellitus MeS: metabolic syndrome no-MeS: no metabolic syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular event |  | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary heart disease, Multidetector row cardiac computed tomography, type 2 diabetes, metabolic syndrome
Prospective Evaluation of the Predictive Criteria of Severity for Respiratory Infection Due to COVID-19 Virus

Study Overview
=================
Brief Summary
-----------------
Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.

Official Title
-----------------
Prospective Evaluation of the Predictive Criteria of Severity Related to Patient Calling Emergency Centre for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID-19.

Conditions
-----------------
SARS-CoV2

Intervention / Treatment
-----------------
* Other: Follow-up phone call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID Exclusion Criteria: unknown contact facility call not regulated by a practitioner from the medical emergency help team

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Follow-up phone call|Follow-up phone call after month to detect which patient have been hospitalized|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | Hospitalization declared by the patient 1 month after his call to the emergency call center | Month 1 |
PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod

Study Overview
=================
Brief Summary
-----------------
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months.

Detailed Description
-----------------
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients assessing the change in QoL and PRO outcome measures from baseline to 12 months after starting fingolimod. Patients will complete 4 questionnaires at baseline (prior to first fingolimod dose), then repeat them at 3, 6 and 12 month intervals via post.

Official Title
-----------------
Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)

Conditions
-----------------
Relapsing Remitting Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prescribed Gilenya within the EU licence No previous exposure to Gilenya Patient's HCP considers patient able to complete study questionnaires Patient is between 18-55 years of age - Exclusion Criteria: There are no exclusion criteria for this study. -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them |  | 12 months | 
| Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment |  | 12 months | 
| Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya |  | 12 months | 
| Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29 |  | 12 months | 
| Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L |  | 12 months |
Genetic of Response to Acute Saline Load Test in Hypertension (Naload)

Study Overview
=================
Brief Summary
-----------------
NHP referred to our outpatient clinic will be enrolled (150 newly recruited) in acute saline test for phenotype characterisation of PNat relationship(7). For each patient we will collect urine and blood samples for standard clinical biochemistry, including electrolytes, creatinine, EO, aldosterone, plasma renin activity, urinary uromodulin (ELISA), urinary and serum uric acid and blood samples for genetic test.

Detailed Description
-----------------
Acute salt load test: after the equilibration period and achievement of a steady state, a constant-rate i.v. infusion of 2 L of 0.9% NaCl was carried out in 2 hours. BP (mean of 3 measurements taken 3 minutes apart) was measured every 30 minutes during the 2 hours of loading and 3 times at 3-min intervals at the end of the infusion. These last 3 BP values were averaged and used in the analysis. The results of these tests will be added to an already collected database of salt load test collected in the previous studies (already published)

Official Title
-----------------
Role of Genetic Determinants in the Response to Acute Saline Load Testing in Patients With Essential Hypertension (Naload)

Conditions
-----------------
Hypertension,Essential, Salt; Excess, Genetic Hypertension, Genetic Predisposition to Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 65years; body mass index (BMI) <30 kg/m2; Na intake, evaluated as urinary Na excretion of <300 mEq/24 hours; .office systolic BP (SBP) >140 mm Hg and diastolic BP (DBP) >90 mm Hg in 3 consecutive visits to their family doctors. Exclusion criteria: Female patients history of myocardial infarction, stroke, congestive heart failure, liver disease, secondary cause of hypertension, diabetes, severe hypertension (>160/110 mm Hg), abuse of drugs or alcohol, .creatinine clearance < 80 mL/m. Secondary forms of hypertension (e.g. primary aldosteronism) were ruled out with specific investigations when deemed appropriate

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| DMBP120 | Blood pressure variation at the end of infusion | 120 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, salt sensitivity, genetic