linjc16/ctgov huggingface dataset:
Prognostic Value of Plasma Biomarkers Among Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Hypertension is the most important risk factor for cardiovascular and cerebrovascular diseases，and also a substantial public health problem. The purpose of the study is to investigate the association between plasma biomarkers and adverse outcomes in patients with hypertension.

Official Title
-----------------
Prognostic Value of Plasma Biomarkers Among Patients With Hypertension

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old In accordance with the diagnosis of hypertension (BP≥140/90mmHg) Exclusion Criteria: The exclusion Criteria for the study program were as follows: Pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (eGFR less than 30 mL/min/1.73 m2) in the past three months.

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 |
| --- | --- | --- |
| Primary mortality of hypertension | The incidence rate of primary mortality of hypertension | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes of heart | The incidence rate of left ventricular hypertrophy, myocardial infarction, congestive heart failure, and arrhythmia | Through study completion, an average of 2 years | 
| Secondary outcomes of brain | The incidence rate of stroke (include cerebral hemorrhage and cerebral ischemia | Through study completion, an average of 2 years | 
| Secondary outcomes of kidney | The incidence rate of hypertensive renal injure and end-stage renal disease | Through study completion, an average of 2 years | 
| Secondary outcomes of eyes | The incidence rate of hypertensive eye injure | Through study completion, an average of 2 years |
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.

Official Title
-----------------
To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Biological: HRV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g. Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B. Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b. History of allergic disease Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator. Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination) Previous confirmed occurrence of RV GE. Household contact with an immunosuppressed individual or pregnant women. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HRV vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of RV GE |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE |  |  |
Immune Mechanisms of Rejection in Human Lung Allografts

Study Overview
=================
Brief Summary
-----------------
The investigators have obtained compelling evidence that the development of anti-human leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag period between the development of anti-HLA antibodies and the onset of BOS gives us an opportunity to intervene to delay and/or prevent the development of BOS.

Official Title
-----------------
Immune Mechanisms of Rejection in Human Lung Allografts

Conditions
-----------------
Bronchiolitis Obliterans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung transplant recipient. Exclusion Criteria: Pregnant women, Prisoners, AND Anyone who is unable or unwilling to consent to this study.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy event is the change in pulmonary function testing values (FEV1). |  | Lung function is monitored at regular intervals. Patients will be followed for five years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy measurements include allograft and patient survival, incidence of BOS and Obliterative bronchiolitis. |  | The subjects are monitored at regular intervals. Patients will be followed for five years. |
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Official Title
-----------------
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2305 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from study CLAF237A2305 Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vildagliptin in combination with glimepiride during 52 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between 24 weeks and 52 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Change in fasting plasma glucose between 24 weeks and 52 weeks |  |  | 
| Change from baseline in HOMA B at 52 weeks |  |  | 
| Change from baseline in HOMA IR at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Male

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine.

Detailed Description
-----------------
Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Official Title
-----------------
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Conditions
-----------------
Gallbladder Diseases

Intervention / Treatment
-----------------
* Drug: Sugammadex Injectable Product
* Drug: Neostigmine Injectable Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic cholecystectomy under general anesthesia Exclusion Criteria: BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sugammadex group<br>Sugammadex group receives the intravenous sugammadex of 3 mg/kg. | Drug: Sugammadex Injectable Product<br>* Sugammadex of 3 mg/kg is injected.<br>|
| Placebo Comparator: neostigmine group<br>Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg. | Drug: Neostigmine Injectable Product<br>* Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal Ce of remifentanil | Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia | from the ene of surgery until endotracheal extubation |
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug

Study Overview
=================
Brief Summary
-----------------
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.

Official Title
-----------------
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>40 undergoing bariatric surgery Exclusion Criteria: use of drug inducing or inhibiting CYP3A4 activity pregnancy, breastfeeding renl insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Morbidly obese patients<br> | Drug: Midazolam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery |  | 0.5-2 years |
Accuracy of Endometrial Volume Measured by VOCAL Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps

Study Overview
=================
Brief Summary
-----------------
Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women complaining of abnormal uterine bleeding. The safety of both procedures will be compared .

Official Title
-----------------
Accuracy of Endometrial Volume Measured by Virtual Organ Computer-aided AnaLysis (VOCAL)Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps

Conditions
-----------------
Premenopausal; Metrorrhagia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 20 years Patients with irregular vaginal bleeding Exclusion Criteria: Age less than 20 years Postmenopausal women presence of uterine fibroids Causes of vaginal bleeding due to systemic pathology , anticoagulant use , patients on hormonal contraception or using Intra Uterine Contraceptive Device ( IUCD ) .

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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 measure the Safety and Tolerability and Efficacy of 3DUS versus office Hysteroscopy for diagnosis of endometrial polyps in premenopausal women | A prospective Observational Study | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the best cut off value for endometrial volume (CC ) using Three Dimensional Sonography ( 3DUS and (VOCAL ) to diagnose endometrial polyps in women with premenopausal bleeding |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial volume , VOCAL , Endometrial , Metrorrhagia
Cerebral Oxymetry at Elective Coronary and Valve Surgery.

Study Overview
=================
Brief Summary
-----------------
Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.

Official Title
-----------------
Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.

Conditions
-----------------
Coronary Artery Disease., Aortic Valve Stenosis., Aortic Valve Regurgitation.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age under 80. Patients should undergo elective coronary artery bypass grafting surgery (ACB) or heart valve surgery (AVR or MVR). The patient must be admitted at least 18 years of years. Exclusion Criteria: Damage to the frontal lobes corresponding to the area where SCO2 monitored. Patients in pharmacological studies. Patients with known intracranial vascular anomalies or cerebral aneurysms. Patients with known neurological disease. Patients with known undergone cerebral insult, TIA or carotid stenosis.

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 |
| --- | --- |
| Cerebral oximetry<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxymetry values |  | March 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Oximetry., Aortic valve stenosis., Aortic valve regurgitation., Coronary artery disease.
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.

Official Title
-----------------
Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.

Conditions
-----------------
Trigger Finger

Intervention / Treatment
-----------------
* Procedure: Corticosteroid injections
* Procedure: Open surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trigger finger Quinell grade IIb-V in digit I-V Exclusion Criteria: Former treatment of Trigger finger in affected digit Dupuytrens contracture in affected digit Allergies or intolerance to used medications Rheumatoid Arthritis Insulin dependent Diabetes Mellitus Amyloidosis Mucopolysaccharidosis Already included in study with another digit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Active Comparator: Open surgery<br> | Procedure: Open surgery<br>* Open A1-pulley release<br>|
| Active Comparator: Corticosteroid Injection<br> | Procedure: Corticosteroid injections<br>* Corticosteroid injections in and around A1-pulley.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quinell grade | Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb. Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) score | Pain following either procedure measured by NRS (score 0-10, 10 is severe pain) | 12 weeks | 
| infection | Infection occurence following either procedure | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quinell grade, Open surgery, corticosteroid injections, randomized controlled trial, Trigger finger
A Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized open-label pilot study to compare mycophenolate mofetil in combination with corticosteroid treatment and tacrolimus in combination with corticosteroid treatment in membranous lupus nephritis. The change in urine protein excretion will be the primary outcome studied. The study duration will be 24 months for each patient.

Official Title
-----------------
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membranous Nephritis

Conditions
-----------------
Lupus Nephritis, Glomerulonephritis, Membranous

Intervention / Treatment
-----------------
* Drug: prednisolone and mycophenolate mofetil
* Drug: prednisolone and tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abnormal urine protein excretion and biopsy-proven membranous lupus nephritis

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

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

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

| Intervention/Treatment |
| --- |
|Drug: prednisolone and mycophenolate mofetil|nan|
|Drug: prednisolone and tacrolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteinuria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
membranous lupus nephritis