linjc16/ctgov huggingface dataset:
Comparative Study of Menstrual Blood and Systemic Blood

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate how menstrual blood differs from systemic blood to evaluate if menstrual blood could be utilized as a natural and non-invasive access to blood for regular health monitoring and early diagnostics.

Official Title
-----------------
Comparative Study of Menstrual Blood and Systemic Blood: Quantifying the Difference

Conditions
-----------------
Retention; Menstruation

Intervention / Treatment
-----------------
* Other: Comparative blood analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-45 Exclusion Criteria: weigh less then 110 pounds currently on a birth control method

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

| Intervention/Treatment |
| --- |
|Other: Comparative blood analysis|Collection of menstrual blood and systemic blood|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Markers in Systemic Blood vs. Menstrual Blood | The following biomarkers will be tested for and then compared for systemic blood and menstrual blood: BUN Sodium Potassium Chloride Glucose Calcium HDL LDL Triglycerides CRP Estradiol Ferritin A1c Hemoglobin Hepatic function panel TSH FSH T3 | Up to 2 months |
Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Study Overview
=================
Brief Summary
-----------------
Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.

Detailed Description
-----------------
To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes. The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response.

Official Title
-----------------
Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: chemoembolization ,Radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligibility criteria were: Not indicated for resection, Liver function of Child-Pugh class A or B, 3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter, No portal vein involvement or extrahepatic metastasis, Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct, Platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and No previous HCC treatment. Exclusion Criteria: Exclusion criteria were: Encephalopathy, Refractory ascites, Active gastrointestinal bleeding, Renal failure.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: chemoembolization ,Radiofrequency ablation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response |  | 1-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma,treatment
Reference Values of Circulating Endothelial Progenitor Cells

Study Overview
=================
Brief Summary
-----------------
Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. However reference values have not yet been determined. This study is aimed to determine reference values of CD34+144+CD14- et CD34+VEGF-R2+CD14- in healthy men and women blood donors.

Detailed Description
-----------------
At the time of blood donation, 10mL of blood will be used to calculate the concentration of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- , and the ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells in order to determine reference values.

Official Title
-----------------
Determination of Reference Values of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in a Blood Donnor Population

Conditions
-----------------
Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood donors Exclusion Criteria: age over 65 Arterial hypertension (treated or not) Vascular disease smoker or former smoker who stopped smoking for less than a year

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood donors<br>Blood donors with no exclusion criteria i.e with a very low probability to have an aortic aneurysm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelial progenitor cells, Healthy blood donors
Fenofibrate Bioequivalence Study (0767-031)

Study Overview
=================
Brief Summary
-----------------
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.

Official Title
-----------------
An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: fenofibrate (U.S. formulation)
* Drug: fenofibrate (UK formulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Subject is willing to follow all study guidelines Exclusion Criteria: Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe Female subject is receiving oral contraceptives or hormone replacement therapy

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

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Fenofibrate U.S. Formulation | Drug: fenofibrate (U.S. formulation)<br>* Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.<br>* Other names: Tricor®;|
| Active Comparator: 2<br>Fenofibrate UK Formulation | Drug: fenofibrate (UK formulation)<br>* Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.<br>* Other names: Supralip®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid |  | Predose and up to 168 hours postdose | 
| Maximum Plasma Concentration (Cmax) of Fenofibric Acid |  | Predose and up to 168 hours postdose |
Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.

Official Title
-----------------
Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music

Conditions
-----------------
Pain, Anxiety

Intervention / Treatment
-----------------
* Other: self-selected music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Investigators recruited volunteer patient participants from patients referred to the electrodiagnosis laboratory of Department of Physical Medicine and Rehabilitation in a medical center using convenient sampling. The inclusion criterion is: adult patient with working diagnosis of possible neurological disorder and is referred for both nerve conduction study and needle electromyography Exclusion Criteria: The exclusion criteria are: conscious disturbances, cognitive impairment, or language dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: music<br>Investigators played self-selected background music in the music group | Other: self-selected music<br>* Investigators played self-selected background music in the music group<br>* Other names: self-selected background music;|
| No Intervention: no music (control)<br>Investigators played no music in the music group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Visual Analogue Scale) |  | baseline and after needle electromyography, to measure the change of pain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS) |  | baseline and after electromyography |
Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.

Conditions
-----------------
Pulmonary Embolism, Atrial Fibrillation, Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years of age or older); Willing and able to provide written informed consent and comply with study procedures; Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug. Exclusion Criteria: Hematocrit less than 25 or greater than 55%; Lupus or antiphospholipid syndrome (APS) Vulnerable populations deemed inappropriate for study by the site's principal investigator. Already participated in this study.

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 |
| --- | --- | --- |
| Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System. |  | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with conditions (PE, Afib, DVT) requiring ongoing INR measurements.
Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors

Study Overview
=================
Brief Summary
-----------------
Reconstruction using 3D virtual models has brought about a revolution in diagnostic imaging and its use is increasingly widespread. The objective of this work is to determine the precision of the 3D model when establishing the characteristics of tumors and their relationship with other anatomical structures.

Official Title
-----------------
Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors

Conditions
-----------------
Pancreas Neoplasm

Intervention / Treatment
-----------------
* Diagnostic Test: Virtual modelization.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected pancreatic tumor.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Virtual modelization.|3D-MSP technology is used to make virtual 3D models based on conventional CT.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | To evaluate the correlation between the findings in the virtual model and in the CT. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3D virtual model
Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.

Study Overview
=================
Brief Summary
-----------------
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

Official Title
-----------------
Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)

Conditions
-----------------
Infections, Papillomavirus

Intervention / Treatment
-----------------
* Biological: HPV-16/18 L1/AS04


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A woman between, and including, 10 and 14 years of age at the time of the first vaccination. Written informed consent from the subject prior to enrolment. Subject must be free of obvious health problems. Subject must have negative urine pregnancy test. Exclusion Criteria: Pregnant or breastfeeding. Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality. History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease. Previous vaccination against human papillomavirus (HPV).

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HPV-16/18 L1/AS04|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of HPV vaccine in entire study period. Vaccine immunogenicity. |  |  |
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
Phase 3 Multi-Center, Open Label, Forced Titration Study To Evaluate The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Combination Administered Orally, Once Daily (Qd) In Patients With Homozygous Familial Hypercholesterolaemia

Conditions
-----------------
Hypercholesterolemia, Familial

Intervention / Treatment
-----------------
* Drug: Torcetrapib/atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Homozygous Familial Hypercholesterolemia Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Torcetrapib/atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C and HDL-C |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other lipid variables |  |  |
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise in numerous indications involving tissue ischemia. In the current study, we propose to examine one hundred patients requiring either bypass or angioplasty due to chronic critical limb ischemia resulting from peripheral arterial disease. We intend to challenge patients before and after the intervention, using either an inflated blood pressure cuff or toe raises, to determine if oxygen saturation recovery time in the affected limb is correlated with symptom resolution (i.e. treatment success). Near-infrared spectroscopy will be performed using the ODISsey tissue oximeter developed by ViOptix, Inc. The proposed study will take approximately one year to complete enrolment, and has a follow-up period of 6 months post-intervention. Study Hypothesis: Knowledge of tissue oxygen saturation enhances clinical decision making in patients with chronic critical limb ischemia.

Official Title
-----------------
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia: A Phase Iia, Non-Randomized Study Using the ODISsey Tissue Oximeter to Evaluate the Correlation Between Tissue Oxygen Saturation and Symptom Resolution in Patients With Chronic Critical Limb Ischemia Undergoing Treatment Interventions

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: ODISsey Tissue Oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years old PAD Chronic Critical Limb Ischemia requiring surgical intervention able to give informed consent Exclusion Criteria: emergent/urgent requirement for surgical intervention requiring surgical intervention due to acute traumatic injury

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 |
| --- |
|Device: ODISsey Tissue Oximeter|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
-----------------
Tissue Oxygen Saturation, Peripheral Arterial Disease, Critical Limb Ischemia, Near-infrared Spectroscopy