linjc16/ctgov huggingface dataset:
Long-term Study of TAK-875

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with TAK-875 in diabetic patients.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: TAK-875
* Drug: TAK-875


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is an outpatient. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-875 25 mg<br>(long-term monotherapy or long-term combination therapy with anti-diabetic drugs) | Drug: TAK-875<br> <br> |
| Experimental: TAK-875 50 mg<br>(long-term monotherapy or long-term combination therapy with anti-diabetic drugs) | Drug: TAK-875<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | From Baseline to Week 53 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy
Hesperidin and Bone Health in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.

Detailed Description
-----------------
Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study. Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).

Official Title
-----------------
Hesperidin and Bone Health in Postmenopausal Women

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Dietary Supplement: Hesperidin and Calcilock
* Dietary Supplement: Hesperidin
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women at least 4 years postmenopausal Exclusion Criteria: Medications affecting bone resorption
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hesperidin and Calcilock<br>Subjects will consume 4 cookies containing Hesperidin and Calcilock. | Dietary Supplement: Hesperidin and Calcilock<br>* Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).<br>|
| Experimental: Hesperidin<br>Subjects will consume 4 cookies containing Hesperidin, 552mg, daily | Dietary Supplement: Hesperidin<br>* Hesperidin (552mg) will be administered in the form of cookies (biscuit).<br>|
| Placebo Comparator: Control<br>Subjects will consume 4 cookies daily without Hesperidin or Calcilock. | Dietary Supplement: Control<br>* Cookies without Hesperidin or Calcilock added.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination of 41Calcium in Urine. | Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton. | 50 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hesperidin, Osteoporosis, Bone Loss
Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)

Study Overview
=================
Brief Summary
-----------------
Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants of Israel are known to use carob extract to ease sores in the mouth, due to the tannins which create a complex with various proteins and polysaccharides, thus creating an impenetrable layer covering the sores, allowing spontaneous healing.

Official Title
-----------------
Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)

Conditions
-----------------
Aphtostomatitis, Mucositis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Herpetic aphtomatitis Bacterial aphtostomatitis Viral aphtostomatitis Fungal aphtostomatitis Exclusion Criteria: Oncology patients Systematic diseases (Colitis, Crohn, diabetes, Behcet) Pregnancy Arthritis

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 |
| --- | --- |
| Sorend<br>Group no. 1 shall receive Sorend following diagnosis of aphtostomatitis or mucositis. | |
| Sorend placebo<br>Group no. 2 shall receive Sorend placebo following diagnosis of aphtostomatitis or mucositis. | |

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
-----------------
Aphtostomatitis, Mucositis, Mouth sores, Natural, Herbal
ST Elevation in Acute Chest Pain; Could Measurement of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) be Helpful to the Clinician?

Study Overview
=================
Brief Summary
-----------------
A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs mimicking infarction. A test of clinical potential if proven to be able to support either origin of acute chest pain etiology.

Detailed Description
-----------------
Too many times young patients presenting with acute chest pain are referred to invasive angiography or treated with anticoagulation therapy a measure of detrimental effect in those inflicted with acute pericarditis. A simple blood test (the PLAC test) may have some value in aiding rapid diagnosis saving need for cath.

Official Title
-----------------
ST Elevation (Acute Coronary Syndrome Versus Pericarditis;Could Measurement of Lp-associated PLA2 -a Vascular Specific Marker of Inflammation- be Helpful to the Clinician?

Conditions
-----------------
Acute Chest Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute chest pain acute ST elevation elevated troponin I Exclusion Criteria: patients with recent (> 24 hour chest pain) myocardial infarction refusing to provide blood samples

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| acute chest pain ST elevation<br>patients admitted with acute chest pain sharing ST elevation in ER-ECG and elevated troponin | |
| controls<br>asymptomatic patients | |

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
-----------------
LpPLA2, ST elevation, acute pericarditis
Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.

Detailed Description
-----------------
Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8. The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.

Official Title
-----------------
Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Other: Withdraw cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year Exclusion Criteria: history of acute rejection, or subclinical rejection

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus with Prednisolone<br>Sirolimus with Prednisolone, and withdraw cyclosporine | Other: Withdraw cyclosporine<br> <br> |
| No Intervention: Sirolimus with Cyclosporine with Prednisolone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| longterm glomerular filtration rate defined by eGFR CKD-EPI |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection rate |  | 5 years |
Correlation Between Headaches and Septum and Nasal Mucosa Contact

Study Overview
=================
Brief Summary
-----------------
Headache is the most common complaint to neurologists. In the 80´s and 90's few papers, with limited number of patients, have proposed the association between nasal septum contact and headache. The International Classification of Headaches Disorders proposed specific diagnostic criteria for this entity. With the major use of CT scans, the contact between nasal mucosa and septum is daily observed in many patients without complaint of headache. The purpose of this study is to determine if there is any correlation between nasal and septum mucosa contact and the prevalence of headache. The investigators hypothesized that no correlation will be found using CT scans in a large series of patients.

Detailed Description
-----------------
Every patient older than 18 years old whom underwent sinuses or facial computed tomography will be asked to answer a questionnaire, where he will be able to describe his headache features (if present) . This information will be correlated with patient images findings, which are going to be evaluated by head and neck radiologists blinded for clinical information. Logistic regression model will be used to verify this association; the presence of sinusitis and fever will used be as covariates.

Official Title
-----------------
Correlation Between Headaches and Septum and Nasal Mucosa Contact

Conditions
-----------------
Nasal Septum Deviation, Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients older than 18 years whom underwent sinuses or facial tomography. Exclusion Criteria: Patients with clinical history of trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Complain of Headache during last 3 months (binary response - question answered by the patient at the moment of CT scan) | In order to analyze the effect of nasal mucosal contact points explaining the presence of headache we are going to perform a logistic regression model with the following explanatory variables: grade and location of the contact between nasal septum and nasal mucosa (8 dummy variables) and history of previous nasal surgery. Our hypothesis is that the presence of headache will not be explained by any of these variables. In addition we will also include in this model the following variables: fever, tomographic signs of sinusitis, obliteration of nasal sinus pathways, gender. | within less than a day from the date that CT scan is performed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal septum, Headache, Mucosa contact point headache
Tracheobronchitis in Respiratory Involvement on the Lung SPECT/CT Images of COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
Tracheobronchitis signs may be observed on ventilation lung scintigraphy during COVID-19 infection. This case report study aimed to analyze the rates and associated factors of such tracheobronchitis in COVID-19 patients referred to ventilation/perfusion lung scintigraphy with shortness of breath, suspected of pulmonary embolism.

Official Title
-----------------
Tracheobronchitis May Constitute the Main Sign of Respiratory Involvement on the Lung SPECT/CT Images of COVID-19 Patients

Conditions
-----------------
Ventilation Lung Scintigraphy During COVID-19 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with Tracheobronchitis signs patient with lung scintigraphy exam Exclusion Criteria: none
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 |
| --- | --- | --- |
| Tracheobronchitis signs may be observed on ventilation lung scintigraphy during COVID-19 infection. | analyze the rates and associated factors of such tracheobronchitis in COVID-19 patients referred to ventilation/perfusion lung scintigraphy with shortness of breath, suspected of pulmonary embolism. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID19, lung ventilation, perfusion scintigraphy, Tracheobronchitis, Shortness of breath, CZT-SPECT, CT
Physical Activity in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.

Official Title
-----------------
Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women

Conditions
-----------------
Postmenopausal Disorder

Intervention / Treatment
-----------------
* Other: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women aged 40 to 80 years and age matched men without major diseases Exclusion Criteria: Known cardiac disease, excessive weight change during last year, cancer and mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moderate exercise training<br> | Other: Exercise training<br>* Different dose of exercise training<br>|
| Experimental: intensive exercise training<br> | Other: Exercise training<br>* Different dose of exercise training<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) |  | 3 months | 
| Waist circumference |  | 3 months | 
| Lab data (lipid profile, CRP, insulin resistance) |  | 3 months | 
| QT interval and corrected QT interval (QTc) |  | 3 months | 
| Cardiovascular fitness |  | 3 months | 
| Heart rate recovery after exercise test |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial perfusion |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopausal women, Physical activity, Cardiovascular risks, Cardiac function, Dose-response
Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases

Study Overview
=================
Brief Summary
-----------------
To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.

Detailed Description
-----------------
Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.

Official Title
-----------------
Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders

Conditions
-----------------
Lipid Metabolism, Inborn Errors

Intervention / Treatment
-----------------
* Biological: Anti-oxLDL IgM antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology) Familial hypercholesterolemia, NPB, NPC Partial lipodystrophy (PPARg mutations and laminin A/C mutations) Intention to be treated and participate to the treatment - Written informed consent Exclusion Criteria: Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome Alcohol abuse (quantitative limit >20g/day for men and >10g for women) Illiteracy Patients younger than 10 years. Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 64 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: Anti-oxLDL IgM antibodies<br>administration Anti-oxLDL IgM antibodies | Biological: Anti-oxLDL IgM antibody<br>* Immunization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of inflammation |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of lysosomal enzymes |  | 4 weeks | 
| the level of cholesterol metabolism |  | 4 weeks |