linjc16/ctgov huggingface dataset:
Study of Telaprevir in Subjects With Hepatic Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.

Conditions
-----------------
Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: telaprevir (VX-950)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed with Child Pugh score of 7-9 or greater than 10 Women of non-childbearing age Exclusion Criteria: Tested positive for HIV, Hepatitis C, Hepatitis B

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

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

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

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

| Intervention/Treatment |
| --- |
|Drug: telaprevir (VX-950)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Disease
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer

Detailed Description
-----------------
evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

Official Title
-----------------
Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer

Conditions
-----------------
Colorectal Cancer Metastatic

Intervention / Treatment
-----------------
* Drug: Raltitrexed
* Drug: Oxaliplatin
* Drug: lipiodol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed colorectal adenocarcinoma Disease limited to the liver Unresectable disease by surgery or other local therapies Age >18 years ECOG performance status 0-2,Child pugh A or B Expected survival ≥ 3 months Adequate hematological, hepatic, and renal function Exclusion Criteria: Pregnant or lactating women Patients with severe organ dysfunction or failure With severe cardiovascular disease, or mental Extraliver metastases

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltitrexed and Oxaliplatin<br>Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle. | Drug: Raltitrexed<br>* 4mg, every 4 weeks,transhepatic arterial infusion<br>Drug: Oxaliplatin<br>* 100 150mg, every 4 weeks, transhepatic arterial infusion<br>Drug: lipiodol<br>* 5-20ml, every 4 weeks, hepatic artery embolization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survivial | From date of randomization until date of first documented PD, date of death | 8 months after last patient randomized | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced colorectal cancer of liver metastatic
Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine

Study Overview
=================
Brief Summary
-----------------
This is a randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine.

Detailed Description
-----------------
Randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine

Official Title
-----------------
Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 yrs scheduled surgery General anesthesia ASA I to III Able to use a VAS No psychological disorders, able to speak french Exclusion Criteria: Age < 18 yrs Locoregional anesthesia or analgesia Allergia to morphine or ketamine Morphine or ketamine contraindication Pregnancy or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>intravenous morphine titration combined to ketamine | Drug: Ketamine<br>* intravenous morphine titration combined to ketamine<br>* Other names: or intravenous morphine titration combined to ketamine;|
| Placebo Comparator: placebo<br>morphine titration alone | Drug: Ketamine<br>* intravenous morphine titration combined to ketamine<br>* Other names: or intravenous morphine titration combined to ketamine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic efficacy | the analgesic efficacy, in two groups of patients recevieving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine | 24 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative, pain, analgesia, morphine, titration, ketamine
A Morbidity-Mortality and Remodeling Study With Valsartan

Study Overview
=================
Brief Summary
-----------------
The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.

Detailed Description
-----------------
Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. However, it is a problem that the number of Asian patients is very little in these trials. The researchers examine the treatment meaning by ARB about the prognosis of the patient who amalgamates either among high blood pressure, the ischemic heart disease, and congestive heart failures.

Official Title
-----------------
A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease

Conditions
-----------------
Hypertension, Ischemic Heart Disease, Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure Exclusion Criteria: Pregnancy Severe renal damage Severe liver damage Acute myocardial infarction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke |  |  | 
| new or recurrent transient ischemic attack |  |  | 
| new or recurrent acute myocardial infarction |  |  | 
| new occurrence or exacerbation of heart failure |  |  | 
| new occurrence or exacerbation angina pectoris |  |  | 
| dissecting aneurysm of the aorta |  |  | 
| lower limb arterial obstruction |  |  | 
| transition to dialysis |  |  | 
| doubling of plasma creatinine (Cr) levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death from any cause |  |  | 
| left ventricular hypertrophy |  |  | 
| changes in ECG |  |  | 
| proteinuria |  |  | 
| B-type natriuretic peptide (BNP) |  |  | 
| heart failure symptoms |  |  | 
| heart failure syndrome (edema, rales on auscultation) |  |  | 
| blood pressure and heart rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, myocardial infarction, angina, renal damage
Comparative Study of Calculating the X-ray Dose to the Skin of the Patient Exposed

Study Overview
=================
Brief Summary
-----------------
The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.

Detailed Description
-----------------
The procedures of Interventional Cardiology are realized under exposure in the X-rays which can be sometimes important for the patient according to the nature of the procedure. The estimation of the dose in the skin following a procedure of interventional cardiology is difficult. The knowledge of this dose allows to anticipate the appearance of determinist effects, and so to activate a dermatological follow-up of the exposed patient in case of overtaking of a dose threshold. Unfortunately, it is impossible to measure it directly and the thresholds of exposures are fixed from the measure of the kerma in the air accumulated at the exit of the tube with X-ray, what remains very indistinct. Since a few years the manufacturers propose tools allowing an estimation of the dose the skin of the patient. The DoseMap software ® allows to consider this dose from the data of exposure supplied by the system. To do it, it uses a modelling simplified of the patient to feign the deposit of dose in the latter. It seems to us interesting to verify the precision of this simulation by comparing it with a measure of the in vivo dose.

Official Title
-----------------
Comparative Study of Calculating the Dose to the Skin by the Dosemap® Software and Its Measurement in Vivo by Gafchromic Movie

Conditions
-----------------
Measure of the X-ray Dose

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Procedure of Interventional Cardiology potentially more irradiant (angioplasty of the circumflex artery , or of several vessels) Body mass index > 25 Collection of the Non-opposition of the patient Exclusion Criteria: Diagnostic coronarography, Emergency procedures, Minor patients

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 |
| --- | --- | --- |
| Difference between the calculation by the software and the measurement by the dosimetry film |  | 6 months |
Evaluation of Yoga for the Treatment of Pediatric Headaches

Study Overview
=================
Brief Summary
-----------------
This study will examine the feasibility and acceptability of yoga for adolescents seen by a medical practitioner for their headaches. The study will also examine whether yoga decreases anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and improve quality of life.

Official Title
-----------------
Evaluation of Yoga for the Treatment of Pediatric Headaches

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Other: 8 weeks of Iyengar Yoga
* Other: 8 weeks of Iyengar Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13-17 years patient seen in the headache clinic at Children's Hospital of Wisconsin Exclusion Criteria: neck, spinal, or back injuries

Ages Eligible for Study
-----------------
Minimum Age: 13 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>8 weeks of Yoga, followed by 8 weeks of follow-up | Other: 8 weeks of Iyengar Yoga<br>* Participants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity)<br>|
| Active Comparator: 2<br>8 weeks of follow-up, followed by 8 weeks of yoga | Other: 8 weeks of Iyengar Yoga<br>* Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Pain |  | Pre; Post; Weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yoga Attendance |  | weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, Complementary and Alternative Medicine, Pediatric, Yoga
Imaging Characteristics of Breast Cancer in Women Under 40 Years of Age

Study Overview
=================
Brief Summary
-----------------
To evaluate if there is any imaging characteristic of breast cancers in women younger than 40 years of age.

Detailed Description
-----------------
In Western countries, breast cancer is the most commonly diagnosed cancer in women and breast cancer screening using mammography has reduced breast cancer mortality by 18-29%. In Taiwan, breast cancer is the second most common cancer in women and the Bureau of Health Promotion, Department of Health has started breast cancer screening using mammography in women between 50 and 69 years old since 2002, between 40 and 49 years old since early 2004. However, young women at 20 to 39 years of age have never been enrolled in the mass screening mammography program because of their relatively young age and mammographic findings of breast cancer in young women were seldom reported.Some authors found out that breast cancer in young women is more advanced and more often presents with a mass, has higher grade, more extensively proliferating and vessel invading disease when compared with those in older age groups. Most intraductal carcinomas (>80%) present as clustered microcalcifications on mammograms, and the sensitivity of mammography can be reduced in younger, denser breasts. Given these, mammography seems not to be a proper diagnostic tool for breast cancer women at a younger age. However, this presumption needs to be clarified since there are neither definite documented facts regarding breast cancer manifestation of young women on mammograms, nor documented sensitivity and false-negative rate of mammography in detecting of breast cancer among young women, at whom mammography is seldom used to be a diagnostic imaging tool. Our study is conducted to analyze the mammographic findings of breast cancers in young women between 20 and 39 years of age, regarding tumor size, location, major finding type, pathology type and grade. We will compare all of the above issues between younger age group and older age groups (40 to 49 and 50 to 69 years old).The breast ultrasound findings of the breast cancer among young women will be also compared with their corresponding mammographic findings, regarding the sensitivity, specificity, false-negative rate and accuracy.

Conditions
-----------------
Breast Cancer, Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-39 years women with breast cancers Exclusion Criteria: pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast neoplasms, breast radiography, young women.
The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia

Study Overview
=================
Brief Summary
-----------------
The spleen in Sickle Cell Anemia and Sickle Cell Thalassemia is usually enlarged in the first years of life but the immune protection provided is considered insufficient. In homozygous Sickle cell patients the spleen usually developed recurrent infarcts and after the first decade of age become fibrotic. Acute splenic sequestration is also frequent in those patients and this is considered as an indication for splenectomy. In comparison in Sickle cell thalassemia patients, hypersplenism is more frequent. The purpose of this study is to compare the clinical and laboratory issues related to the spleen in two groups of Sickle cell patients.

Detailed Description
-----------------
Clinical and laboratory characteristics related to the spleen in SCA patients will be studied. Two groups of patient will be compared, a group of Sickle cell patients (Homozygous) and a second group of patients with Sickle cell beta thalassemia. In those patients that splenectomy was performed the incidence of infections will be recorded besides the indications for splenectomy and the incidence of thrombotic events or thrombocytosis.

Official Title
-----------------
The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia. Clinical Presentation and Follow up. Splenectomy, Indications and Complications.

Conditions
-----------------
Sickle Cell Anemia, Thalassemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients followed up at the Pediatric Hematology Unit Exclusion Criteria: Patients lost from follow up of with insufficient data

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 35 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 |
| --- | --- |
| Sickle Cell Patients<br>Patients with homozygous Sickle Cell Anemia | |
| Sickle Cell Thalassemia<br>Patients with Sickle Cell Thalassemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical events and abnormal laboratory results |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Splenectomy, Thrombocytosis, Infections, Spleen, Sickle Cell Thalassemia
Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock

Study Overview
=================
Brief Summary
-----------------
Although few cases reported successful treatment of septic shock using extracorporeal membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a randomized study to allocate patients in such critical condition, we aimed to conduct a retrospective observational study using propensity score matched analysis to compare the survival of adults with septic shock treated by ECMO or conventional treatment.

Official Title
-----------------
Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock

Conditions
-----------------
Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >20 admitted at ICU septic shock Exclusion Criteria: nil

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Conventional Group<br>Patients who developed refractory shock, but didn't received ECMO as salvage treatment | |
| ECMO group<br>Patient who have septic shock, and progreseed to have ECMO as salvage therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In hospital mortality | inhospital mortality as primary outcome, mean length of hospital stay around 30 days | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adults, ECMO