linjc16/ctgov huggingface dataset:
Tolerability of Grazax in Patients With Hayfever in Real Life Settings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.

Detailed Description
-----------------
To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment

Official Title
-----------------
Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings

Conditions
-----------------
Allergic Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Grazax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of grass pollen allergy Positive skin prick-test and/or positive specific IgE to grass Exclusion Criteria: Severe, unstable or uncontrolled asthma (FEV1<70% of predicted value)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grazax Tablets 75000 SQT<br>Timothy Extract | Drug: Grazax<br>* 1 tablet/day - pre and co-seasonal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events related to Grazax | All adverse events were reported according to the MedDRA dictionary | From November 2007 to October 2010 (3 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic, Rhinoconjunctivitis, Immunotherapy
Change of Gut Microbiome in the Treatment of Graves' Disease

Study Overview
=================
Brief Summary
-----------------
Graves' disease is the main cause of hyperthyroidism. Graves' disease has a prevalence of 0.5% in the general population. As a non-surgical treatment, antithyroid drug (ATD) and radioactive iodine treatment have been proposed and ATD is the first-line treatment in Korea. However, ATD has a rare but fatal side effect of agranulocytosis. Furthermore only half of its users maintain long-term remission and frequent recurrence is a problem to this disease. Therefore it is essential to distinguish between patients who respond well to ATD and those who resist it. The aim of this study is to verify the changes in gut microbiome in Graves' disease patients before and after six-month treatment with ATD. Patients first diagnosed with Graves' disease will participate in the study. The study design is a prospective longitudinal trial. The patients are asked to have their gut microbiome analyzed before and after the treatment of Graves' disease with ATD. Primary endpoint is the changes of analyzed gut microbiome before and after ATD treatment. Secondary outcome is to find species that can be used as a biomarker to differentiate the patients refractory to ATD.

Official Title
-----------------
A Prospective Study Analyzing the Change of Gut Microbiome With Antithyroid Drug Treatment of Graves' Disease

Conditions
-----------------
Graves' Disease

Intervention / Treatment
-----------------
* Drug: Antithyroid Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 19 years and lesser than 70 years First diagnosed as Graves' disease and planned to have antithyroid drug Exclusion Criteria: Pregnancy and lactating women Inflammatory bowel disease Active malignancy Autoimmune disease Immune-deficiency patients

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 69 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 |
| --- | --- |
| Graves' disease patients<br>First diagnosed Graves' disease patients volunteered for stool collection | Drug: Antithyroid Drug<br>* Administration of antithyroid Drug for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gut microbiome in the treatment of Graves' disease | Analysis of gut microbiome before and after treatment of Graves' disease with antithyroid drug | 6 months after treatment |
Thyroid Disease Serum Repository

Study Overview
=================
Brief Summary
-----------------
Thyroid disease is more common among females and is increasing in incidence. Otolaryngology faculty members and residents will perform head and neck examinations as part of the subject's routine care. If the participant is noted to have thyroid disease, they will be asked if they would like to participate in the research portion by having approximately 10cc's of blood drawn. Faculty and staff will complete a data collection sheet that will contain demographic and clinical data.

Official Title
-----------------
Thyroid Disease Serum Repository

Conditions
-----------------
Thyroid Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with benign or malignant thyroid disease.

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 |
| --- | --- | --- |
| To gather demographic and cultural information on approximately 1000 men and women with thyroid disease between the years 2007 and 2012 at the University of Arkansas for Medical Sciences. |  | 2007-2012 |
Plant-Based Dietary Intervention in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.

Detailed Description
-----------------
Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. We therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.

Official Title
-----------------
Plant-Based Dietary Intervention in Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Behavioral: Low-fat, low-Glycemic Index, vegan diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus Exclusion Criteria: hemoglobin A1c values <6.5% or >10.5% use of insulin for > 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.

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>Low-fat, low-Glycemic Index, vegan diet | Behavioral: Low-fat, low-Glycemic Index, vegan diet<br> <br> |
| Active Comparator: 2<br>ADA diet | Behavioral: Low-fat, low-Glycemic Index, vegan diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 22 weeks | 
| Plasma lipid concentrations |  | 22 weeks | 
| Urinary albumin |  | 22 weeks | 
| Dietary Acceptability |  | 22 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

Study Overview
=================
Brief Summary
-----------------
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

Detailed Description
-----------------
A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.

Official Title
-----------------
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma

Conditions
-----------------
Glaucoma, Glaucoma, Open Angle

Intervention / Treatment
-----------------
* Device: AqueSys XEN 45 Glaucoma Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Refractory Glaucoma Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg Visual field mean deviation score of -3 dB or worse Shaffer Angle Grade ≥ 3 Area of free, healthy and mobile conjunctiva in the targeted quadrant Exclusion Criteria: Active Neovascular Glaucoma Previous glaucoma shunt/valve in the targeted quadrant History of corneal surgery, opacities or disease/pathology Anticipated need for ocular surgery Non-study eye with BCVA of 20/200 or worse

Ages Eligible for Study
-----------------
Minimum Age: 45 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: AqueSys XEN 45 Glaucoma Implant<br> | Device: AqueSys XEN 45 Glaucoma Implant<br>* Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications | Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis. | 12 Months | 
| Mean Change in IOP From Baseline | Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention. | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma Implant, Trabeculectomy, POAG, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma
Results of Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.

Detailed Description
-----------------
There is a higher risk of rotator cuff tears following dislocation when the individual is greater than 40 years old. Rotator cuff tears after dislocation of the shoulder are more of a challenge to repair particularly if there is a delay in diagnosis. Clinical experience would suggest that rotator cuff repair within the first month of injury allows for better results in acute rotator cuff tears without shoulder dislocation. There are no reported results for rotator cuff repairs following shoulder dislocation and timing of repair. If we find that early repair provides better results this will be important for Primary Care Providers and Emergency Department physicians to refer these patients early for evaluation and subsequently earlier treatment.

Official Title
-----------------
Results of Rotator Cuff Repair Following Acute Shoulder Dislocation

Conditions
-----------------
Shoulder Dislocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 35 years or older with acute rotator cuff tear following documented shoulder dislocation requiring reduction, subjects sustained acute rotator cuff tear following shoulder dislocation that was treated surgically with open and/or arthroscopic technique between January 1, 2001 and June 1, 2011, surgical intervention within 6 months of dislocation, minimum follow up time of one year from surgery. Exclusion Criteria: rotator cuff tears without shoulder dislocation, known previous rotator cuff disease, history of other trauma to the shoulder, inability to provide informed consent, other suspect pathology (ie: tumor, infection).

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotator cuff tear<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of pain, range of motion and strength | Patient are asked to complete ASES, SST, SF-12 questionaires. Clinical evaluation of bilateral range of motion and strength measurements. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotator Cuff Tears, Dislocation, Shoulder Dislocation
Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial

Study Overview
=================
Brief Summary
-----------------
Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint. The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.

Conditions
-----------------
ST Segment Elevation Myocardial Infarction, Myocardial Oedema

Intervention / Treatment
-----------------
* Other: Cardiac magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STEMI providing written informed consent Exclusion Criteria: contraindication to CMR, atrial fibrillation, claustrophobia, eGFR < 30

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CMR following ST segment myocardial infarction<br> | Other: Cardiac magnetic resonance imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mass of myocardial oedema measured by CMR |  | Day 2 following STEMI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extra cellular volume |  | Day 2 following STEMI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, Myocardial edema, Cardiovascular magnetic resonance
Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the risk of fetal loss in women with unprovoked venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared with women who have the diagnosis of venous thromboembolism (VTE) excluded.

Official Title
-----------------
Determining the Risk of Fetal Loss in Women With Unprovoked Venous Thromboembolism (VTE) Who Do NOT Have Identifiable Inherited Thrombophilia Compared With Women Who Have the Diagnosis of VTE Excluded

Conditions
-----------------
Venous Thromboembolism, Fetal Death

Intervention / Treatment
-----------------
* Other: Thrombophilia Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female At least 18 years of age Symptomatic for unprovoked venous thromboembolism (deep vein thrombosis [DVT] or pulmonary embolism [PE]) At least one pregnancy not terminated intentionally Exclusion Criteria: Previous VTE in patients with current VTE excluded

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1, 2 ,3<br>Group 1 Women with unprovoked VTE and No Known Thrombophilia Group 2 Women who are investigated for VTE and are negative (Control) Group 3 Women with unprovoked VTE who have Thrombophilia | Other: Thrombophilia Testing<br>* TP testing in Group 1 and 3 only<br>|

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
-----------------
venous thromboembolism, VTE, thrombophilia, fetal loss
Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy

Study Overview
=================
Brief Summary
-----------------
There is some evidence to suggest that obesity is a risk factor for the development of cognitive dysfunction, although this is not a universal finding. This discordance might be ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of metabolic risk factors. We examined whether the association of obesity with cognitive dysfunction is dependent on the individual's metabolic health. 60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol, triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as 'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic abnormalities). Cognitive dysfunction will be assessed by moca and minimental score. Results: Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was categorized as metabolically healthy. Relative to non-obese healthy participants, after adjustment for baseline covariates, the metabolically unhealthy obese participants had elevated risk of cognitive dysfunction although the metabolically healthy obese did not. The association between obesity and risk of cognitive dysfunction appears to be partly dependent on metabolic health, although further work is required to confirm these findings. In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese patients suffer from higher incidences of cardiovascular complications such as atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are three different types of Hp which differ in their antioxidant ability. Several clinical studies have shown that Hp 2-2 genotype is associated with higher incidence of cardiovascular diseases.

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Freely given written informed consent BMI>=30 Exclusion Criteria: Evidence of Chronic Liver Diseases Pregnant Women

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 |
| --- | --- |
| metabolically healthy<br> | |
| Unhealthy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transient elastography |  | Baseline |