linjc16/ctgov huggingface dataset:
Ciclosporin A and Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.

Official Title
-----------------
Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: ciclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients, aged more than 18, with suspected first acute myocardial infarction Within 12 hours of the onset of chest pain With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty. Exclusion Criteria: Hypersensibility to ciclosporine A Cardiac arrest or cardiogenic shock Immunosuppressive disease (< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc. Known renal failure or serum creatinine > 120 µmole/l at admission Liver failure Uncontrolled hypertension Current pregnancy or women without contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ciclosporine A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial contractile reserve assessed by dobutamine echocardiography at day 5. |  |  | 
| No reflow evaluated by MRI at day 5 |  |  | 
| Recovery of myocardial contraction assessed by echocardiography and MRI at month 3 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemia, Reperfusion, Myocardial infarction, ciclosporin A, acute myocardial infarction
Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities

Study Overview
=================
Brief Summary
-----------------
The present study assesses the health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis.

Detailed Description
-----------------
A cross sectional study based on a retrospective review of prosthetic using major traumatic lower limb amputees' demographic and clinical details together with HRQoL and locomotor capabilities patient-reported outcome measures.

Official Title
-----------------
Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities

Conditions
-----------------
Amputees

Intervention / Treatment
-----------------
* Procedure: Below-knee amputation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Below-knee prosthesis users with amputation due to trauma age >18 Exclusion Criteria: 1. Patients with no prosthesis

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: Below-knee amputation|Patients with traumatic below-knee amputation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The health-related quality of life measured by HRQoL score |  | 2-5 years | 
| Locomotor capabilities of traumatic below-knee amputees with prothesis |  | 2-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15D health-related quality of life instrument |  | 2-5 years | 
| Prothesis Evaluation Questionnaire |  | 2-5 yeats |
A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers

Study Overview
=================
Brief Summary
-----------------
An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.

Official Title
-----------------
An Open-label, Single Dosing Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram After Oral Administration in Elderly Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subject aged 65 or older at screening A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0 subjects who decide to participate voluntarily and write a informed consent form Exclusion Criteria: subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor Subject judged not eligible for study participation by investigator

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br> | Drug: Escitalopram<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F |  | pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval |  | pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose |
Predictive Values for the Outcome of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to assess a predictive value or correlation between patient and procedural characteristics and outcome measures results after genicular nerve radiofrequency ablation.

Detailed Description
-----------------
Genicular nerve radiofrequency stimulation procedure is an effective treatment for patients with chronic pain due to knee osteoarthritis; however, little is known about factors that predict procedure success. This study evaluated correlation between patient characteristics and procedural characteristics and pain improvement after ultrasound guided genicular nerve radiofrequency stimulation procedure.

Official Title
-----------------
Predictive Values for the Outcome of Ultrasound Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain

Conditions
-----------------
Osteoarthritis, Knee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's 18 years or older Patients who recently underwent ultrasound guided genicular nerve radiofrequency (RF) procedure Exclusion Criteria: lack of documentation of predictive factors to assess outcome Patients in whom adequate follow-up data was not available Patients who were prescribed a new analgesic drug or received concurrent treatments for different pain sources during the follow-up period, that could affect interpretation of genicular RF treatment results.

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 |
| --- | --- | --- |
| Pain assessed by NRS | A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain. | Change from baseline pain score at 6 months |
The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to : Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate. Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.

Official Title
-----------------
The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

Conditions
-----------------
Ectopic Pregnancy

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: Letrozole
* Drug: cetrotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undisturbed ectopic pregnancy .Who are: have no significant pain have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm with no visible heartbeat have a serum human chorionic gonadotropins level less than 1,500 IU/litre do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) . Exclusion Criteria: An undisturbed ectopic pregnancy and significant pain An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 IU/litre or more intrauterine pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methotrexate group<br> | Drug: Methotrexate<br>* Drugs to treat undisturbed ectopic pregnancies<br>|
| Active Comparator: Letrozole group<br> | Drug: Letrozole<br>* Drugs to treat undisturbed ectopic pregnancies<br>|
| Active Comparator: Gonadotropins releasing hormone antagonist group<br> | Drug: cetrotide<br>* Drugs to treat undisturbed ectopic pregnancies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated . |  | 3 months |
Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes.

Official Title
-----------------
Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: human insulin
* Drug: inhaled human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Treatment for at least 12 months HbA1c lesser or equal to 11.0% Body weight between 25 and 80 Kg Capable to use the device Exclusion Criteria: Any diseases other than diabetes requiring prescriptive medication Known or suspected allergy to trial product or related products Active proliferative retinopathy as judged by the Investigator Recurrent severe hypoglycaemia as judged by the Investigator The receipt of any investigational drug within 4 weeks prior to this trial

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: human insulin|nan|
|Drug: inhaled human insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin curve |  | from 0 to 5 hours post-dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum insulin concentration |  | in the interval from 0 to 5 hours post-dosing | 
| Time to maximum serum insulin concentration |  | in the interval from 0 to 5 hours post-dosing |
Predictive Equations for Resting Energy Expenditure

Study Overview
=================
Brief Summary
-----------------
Predictive equations are the main clinical tool for determining resting energy expenditure (REE). Thus, it is important to investigate the accuracy and agreement of these equations in different populations and context of diseases. The purpose of this study is to investigate the accuracy and agreement of predictive equations of REE in overweight women with polycystic ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means of indirect calorimetry and predicted (pREE) through ten equations basing on the anthropometric parameters (Harris & Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU including weight and height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones, Müeller, De Luis and Lazzer).

Official Title
-----------------
Accuracy and Agreement of Predictive Equations for Resting Energy Expenditure Among Overweight Patients With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women treated in an endocrinology centre specialising in hyperandrogenism at the university hospital of University Federal of Minas Gerais (Belo Horizonte, Minas Gerais, Brazil) The patients were of reproductive age (range: 18-45 years) were overweight or obese (Body mass index ≥ 25.0 kg/m2) and signed an informed consent statement Exclusion Criteria: Women who were pregnant, were lactating, had a diagnosis of hypothyroidism or hyperthyroidism or had high physical activity levels were excluded from the sample.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polycystic ovary syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy and agreement of predictive equations of resting energy expenditure |  | Six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison and correlation between the resting energy expenditure measured by means of indirect calorimetry and predicted through equations. |  | Six month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resting energy expenditure, Predictive equations, Overweight
A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy

Study Overview
=================
Brief Summary
-----------------
A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.

Conditions
-----------------
Prostate Cancer, Cancer of Prostate, Prostatic Cancer, Cancer of the Prostate

Intervention / Treatment
-----------------
* Drug: YM155


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed prostate cancer. Prior chemotherapy regimen for prostate cancer Exclusion Criteria: History of other malignancy in the last 5 years Major surgery within the past 21 days

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: YM155|nan|

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
-----------------
Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety
Mortality Due to COVID-19 in the COVID-AGEBRU Study

Study Overview
=================
Brief Summary
-----------------
The COVID-Age Brugmann study aims to identify the clinical predictors of mortality risk in older patients admitted to an acute care unit due to COVID-19

Detailed Description
-----------------
The COVID-19 disease has been shown to be associated to higher mortality risk and health adverse consequences. Despite of the fact that the SAR-COV2 virus has been shown that affects every populations, the negative impact is higher in older people, pointing this population as the most severely affected. The COVID-Age Brugmann study aims to identify if comorbidity, geriatric syndromes, and health issues at admission are associated to mortality risk in older patients admitted to an acute care unit due to COVID-19

Official Title
-----------------
Predictors of Intrahospital Mortality in Older Patients Admitted Due to COVID-19 in the COVID-19 AGEBRU Study

Conditions
-----------------
Covid19, Old Age; Debility, Morbidity, Multiple

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 70 and older Patients admitted to an acute care geriatric unit due to COVID-19 Patients with COVID-19 by PCR, serology or CT scan suggestive of this disease Exclusion Criteria: No other demographic or clinical exclusion criteria will be applied

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| All-cause mortality during hospital admission (admission up to discharge time) | Vital status was obtained from medical records | Through study completion, an average of one month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of medical diseases and geriatric syndromes | Clinical and demographical conditions, and geriatric syndromes | Through study completion, an average of one month. |
The Effect of Obesity on Oral Peri-implant Health - A Cross-Sectional Study

Study Overview
=================
Brief Summary
-----------------
In recent years, greater emphasis has been placed on the link between oral and systemic health. Obesity, a growing medical problem worldwide, has been associated with multiple chronic inflammatory diseases such as diabetes mellitus and cardiovascular disease. With respect to the effect of obesity on periodontal health, it has been shown that obese subjects exhibit higher inflammation around natural teeth and are at increased risk of tooth loss than individuals with normal weight. Peri-implantitis, an inflammatory condition of bacterial origin that occurs around oral implants and resembles periodontal disease, has become a serious concern for the dental profession given its increasing prevalence and challenging treatment. There is also strong evidence that individuals with a history of periodontitis are also at risk for peri-implantitis. However, knowledge about the pathogenesis and treatment of peri-implantitis is scarce. Hence, it is extremely important to understand the implications of excessive body fat on peri-implant health. Based on the current understanding on the effect of obesity on systemic and local inflammation around natural teeth, the investigators hypothesize that obesity will have a significant impact on peri-implant health by inducing an increased inflammatory response as measured by clinical as well as molecular markers of inflammation.

Official Title
-----------------
The Effect of Obesity on Oral Peri-implant Health - A Cross-Sectional Study

Conditions
-----------------
Obesity, Peri-implant Inflammation, Peri-implantitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years or older) Currently non-smokers Subjects in maintenance care with adequate dental plaque control (<20% plaque index according to O'Leary et al. 1972) Subjects with at least one rough surface titanium oral implant in function for at least 6 months. Exclusion Criteria: Edentulous subjects or subjects presenting with blade-type implants and/or implants with smooth surface. Pregnant or nursing women Subjects who have taken medications that are known to alter the oral inflammatory status, such as antibiotics and anti-inflammatory agents, for 3 months prior to the study. Subjects with a history of aggressive periodontitis (As defined by the American Academy of Periodontology).

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group cross sectional<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of peri-implant inflammation |  | Single time point - during their single visit (day one) |