linjc16/ctgov huggingface dataset:
A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.

Official Title
-----------------
Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: Aleglitazar
* Drug: Microgynon®
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volunteer, 18 to 45 years of age Body mass index (BMI) between 18.0 and 29.9 kg/m2 Body weight at least 55.0 kg Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment Non-smoker for at least 3 months Exclusion Criteria: Currently active gynecological disorder History of amenorrhea within the previous 3 years Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening. History of clinically significant disease that could jeopardize the volunteer safety in the study

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Microgynon®<br>* Multiple oral doses<br>Drug: Placebo<br>* Multiple oral doses<br>|
| Experimental: Treatment<br> | Drug: Aleglitazar<br>* Multiple oral doses<br>Drug: Microgynon®<br>* Multiple oral doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of Levonorgestrel: area under the concentration time curve |  | pre-dose and up to 24 hours post-dose | 
| Pharmacokinetics of ethinyl estradiol: area under the concentration time curve |  | pre-dose and up to 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: luteinizing/follicular stimulation hormone concentration |  | Days 1, 7, 13, 14, 15, 21 | 
| Safety: incidence of adverse events |  | 16 weeks |
A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that renal clearance of metformin is affected in Caucasian with the known single nucleotide polymorphisms A270S in OCT2.

Official Title
-----------------
A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers.

Conditions
-----------------
Metformin, Organic Cation Transporter 2, Polymorphism,Single Nucleotide

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Written consent rs316019 genotyped Age 18-65 years old Exclusion Criteria: Daily medication Alcohol abuse Pregnancy Breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Homozygote for the A270S wildetype<br> | Drug: Metformin<br>* A single dose study with one tablet of metformin 500 mg, time frame 24 hours<br>* Other names: Orabet;|
| Active Comparator: Homo- or heterozygote for A270S minor alleles<br> | Drug: Metformin<br>* A single dose study with one tablet of metformin 500 mg, time frame 24 hours<br>* Other names: Orabet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal clearance of metformin |  | 24 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type 2, Metabolic Clearance Rate, Pharmacokinetics, Pharmacogenetics
Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.

Official Title
-----------------
A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy

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

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: isophane human insulin
* Drug: insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c between 7.5 % and 13.0% (both inclusive) Fasting C-peptide above or equal to 0.33 nmol/l BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive) Exclusion Criteria: Medical history of treatment with insulin within the last 6 months Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rep + NPH<br> | Drug: repaglinide<br>* 2 mg (tablets) before each main meal<br>Drug: isophane human insulin<br>* Injection s.c. (under the skin) at bedtime<br>|
| Active Comparator: Premixed insulin/NPH<br> | Drug: insulin<br>* Injection s.c. (under the skin) twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FBG (Fasting Blood Glucose) |  |  | 
| Change in body weight |  |  |
Circulating Fibrocytes in Non-small Cell Lung Cancer.

Study Overview
=================
Brief Summary
-----------------
The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in NSCLC patients.

Detailed Description
-----------------
Fibrocytes have been described in both mice and humans, where they bear a hematopoietic progenitor phenotype (CD45+Col-1+). Fibrocytes have previously been described in murine cancer, implicated as mediators of tumor immune escape. In this study, the investigators will collect fibrocytes including CD45+Col-1+ expression. The cells express indoleamine oxidase, which is primarily responsible for their immunosuppressive properties. The investigators hypothesize that patients with non-small cell lung cancer experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in non-small cell lung cancer patients.

Conditions
-----------------
NSCLC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Exclusion Criteria: Combination of other malignancy. Age less than 20 years (not include 20 years). Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Non-small cell lung cancer<br>The cohort data of patients with NSCLC will follow up from diagnosis, treatment response and final survival. Fibrocytes will be checked on the date of diagnsis (before treatment), re-staing (3months after treatment) and disease progression. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment response of participants by RECIST. | Correlation of circulating fibrocytes and treatment (chemotherapy, surgery, target treatment) response of patients with NSCLC. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of participants. | Correlation of circulating fibrocytes and survival (progression free survival, disease free survival and overall survival) of patients with NSCLC. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circulating fibrocytes, fibrocyte, NSCLC, treatment response, survival, stage
Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This study will compare the two methods 5 days holtermonitoring and 30 days thumb electrocardiogram for detection of atrial fibrillation in stroke patients

Detailed Description
-----------------
Patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days thumb ECG at the same time. The detection rates of the two methods will be compared

Official Title
-----------------
Detection of Atrial Fibrillation, -Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients

Conditions
-----------------
Atrial Fibrillation, Stroke

Intervention / Treatment
-----------------
* Device: Holter monitoring and Thumb ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke or TIA within the last 3 months verified by a CT or a MR scan or unequivocal symptoms and old infarcts visualised on CT or MR age 65 or above patients able to handle the thumb-ECG written informed consent Exclusion Criteria: earlier diagnose of atrial fibrillation pacemaker or ICD device stroke induced by trauma, infection or surgery procedure carotid stenosis of more than 60%

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Holter monitoring and Thumb ECG|5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation detection rate on Thumb-ECG |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation detection rate on holtermonitoring |  | 5 days | 
| Time to detection of atrial fibrillation on holter |  | 5 days | 
| Time to detection af atrial fibrillation on thumb-ECG |  | 30 days |
Vascular No-React Graft Against Infection

Study Overview
=================
Brief Summary
-----------------
This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.

Official Title
-----------------
Vascular No-React Graft Against Infection

Conditions
-----------------
Vascular Infections

Intervention / Treatment
-----------------
* Device: No-React Non-valved Conduit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infected prosthetic graft and/or bifurcation High risk of infection at graft implantation Mycotic aneurysm No alternative available Exclusion Criteria: Below-knee procedure AV access
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: No-React Non-valved Conduit|Operative replacement of infected graft or implantation in infected area.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of graft infection 3 months after implantation | Percentage of graft infection 3 months after implantation as assessed with different infection parameters: CRP value, leukocytes, Samson classification of infection, temperature, wound healing, wound infection, purulence | 3 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patency 12 months after implantation | Percentage of patency 12 months after implantation as assessed with duplex ultrasound or CT imaging. <50% stenosis are defined as patent | 12 months after implantation |
Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases---Shanghai Baoshan Study

Study Overview
=================
Brief Summary
-----------------
Objective: Recruit 3 cohorts with 1000-1200 subjects each: people with normal glucose metabolism, impaired glucose regulation (IGR), and with Type 2 diabetes. To study the risk factors in development of type 2 diabetes.

Detailed Description
-----------------
Methods: We aim to perform a two-step blood glucose survey in 2008-2009 in a population selected from a single urban community of Shanghai. The Institutional Review Board of the Rui-Jin Hospital approved the study protocol. Informed consent will be obtained from each participant. In the first step, we first invited all registered permanent residents aged 40 or above by local poster advertisement and by mail to participate in a screening examination, during which we collected information on lifestyle, medical history and the use of medications using a questionnaire, and performed anthropometrical measurements and fasting glucose measurement. The first step of diabetes screening finished in June, 2008. In the second step, after exclusion of subjects with self-reported diabetes, we classified the screened subjects into 3 groups according to their fasting plasma glucose concentration of 7.0 mmol/L or above, 5.0 to 6.9 mmol/L or below 5.0 mmol/L. We selected randomly a sample from these 3 subgroups for further investigation including a 75-g oral glucose tolerance test (OGTT) and blood and urine sampling and other vascular functional measurements. Our selection was based on a ratio of 1:1.2:1.44, because of the concern that by knowing the results of fasting plasma glucose test, subjects with lower glucose levels might have a lower participation rate than those with higher glucose concentrations. Nevertheless, this ratio was arbitrarily chosen. Finally, 1000 Type 2 diabetic patients, 1200 subjects with IGR and 1440 subjects with normal glucose metabolism were selected as target population of this study by random sampling for further blood and urine sampling. Biomarkers and genetic risk factors will be evaluated in the study subjects.

Official Title
-----------------
Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases

Conditions
-----------------
Type 2 Diabetes, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged above 40 years Exclusion Criteria:

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?
-----------------
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
-----------------
genetic
Citrate Anticoagulation for Postdilution Hemofiltration

Study Overview
=================
Brief Summary
-----------------
This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.

Detailed Description
-----------------
Acute kidney injury (AKI) requiring continuous renal replacement therapy (CCRT occurs in approx. 15 % of all intensive care patients. A sustained and prolonged filter running time is required to deliver an effective dialysis dose. This requires effective anticoagulation. Today, regional citrate anticoagulation (RCA) is preferred over systemic anticoagulation because of prolonged filter lifetimes and less adverse effects. We here study prospectively patients with AKI who are treated with continuous veno-venous haemofiltration using an RCA protocol. We will evaluate all parameters of CRRT including filter running times, delivered dialysis dose, causes for treatment interruption and control of pH and electrolytes.

Official Title
-----------------
Citrate Anticoagulation for Postdilution Hemofiltration

Conditions
-----------------
Acute Kidney Injury, Critical Illness

Intervention / Treatment
-----------------
* Other: renal replacement therapy as clinically indicated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute kidney injury critical illness and treatment at ICU Exclusion Criteria: age < 18 years pregnancy or breast feeding severe lactate acidosis ( > 10 mmol/l) for longer than 6 hours and pH < 7.2

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: renal replacement therapy as clinically indicated|Continuous renal replacement therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filter running time | Filterlifetime with regional citrate anticoagulation for haemofiltration | 72 hours |
Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses

Detailed Description
-----------------
The purpose of the study is to evaluate the concentrations of antibiotics (daptomycin, vancomycin, cefotaxime, ceftriaxone, cefepime) in serum and periprosthetic tissues(bone and synovial joint) used as empirical treatment during reimplantation of infected hip and knee prostheses (1-stage or 2-stage management).

Official Title
-----------------
Dosing of Antibiotics (Serum and Periprosthetic Tissues) During Reimplantation of Infected Knee and Hip Prostheses

Conditions
-----------------
Prosthesis-Related Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (aged of 18 years or more) who undergo reimplantation surgery for infected hip or knee prosthesis (performed in 1 or 2-stage(s)), and for whom referral physicians plans to use an empirical antibiotic therapy including cefotaxime, ceftriaxone, cefepime, daptomycin, or vancomycin. Exclusion Criteria: Patients with multiple prosthetic joint infections, or with curative antibiotic therapy ongoing within two weeks or less prior to surgery, or for whom an antibiotic prophylaxis is decided by referral for the reimplantation surgery, or for whom an antibiotic-loaded cement containing the same antibiotic chosen for empirical therapy after reimplantation was used in case of 2-stage exchange

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 |
| --- | --- | --- |
| Primary outcome measure was the evaluation of concentrations in serum and periprosthetic tissues of antibiotic agents used as empirical therapy during reimplantation of the infected prosthesis |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome will analyze the ratio of antibiotic concentration in serum and prosthetic tissues to minimum inhibitory concentration of the concerned antibiotic for the pathogen(s) identified in intraoperative samples |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prosthesis-Related Infections, Antibiotic dosing, Reimplantation, Knee-prothesis, Hip-prothesis