linjc16/ctgov huggingface dataset:
Immune-cell Membrane Trafficking

Study Overview
=================
Brief Summary
-----------------
Organ failure following trauma is a leading cause of morbidity and mortality. It appears that the development of organ failure is a direct result of an altered immune response. This altered response results in the production of circulating factors in the blood that causes direct injury to the injured patients' organs. The mechanism in which this altered immune response occurs is unknown. Based on work we have performed in our laboratory, we believe that this response is initiated on the cell membrane of particular immune cells known as macrophages. Although the cell membrane may appear uniform, it is not. The membrane is composed of specific segments that allow proteins to associate with each other forming receptors that are required for immune cell activation. These specific membrane components are composed of various lipids and cholesterol, and have been termed lipid rafts. Based on our laboratory work it appears that these lipid rafts can be altered following injury. In particular both the lipid and protein content within these raft segments may be altered allowing immune cells to become active leading to the production of factors that directly injure normal cells and organs. Thus, we plan to examine if these laboratory findings can be seen in patients suffering from trauma who develop clinical organ failure at Harborview Medical Center. If this is accomplished, this data will lead to the development of both prognostic and therapeutic interventions for the optimal care of injured patient

Official Title
-----------------
Trauma and Sepsis Induced Changes in Immune-cell Membrane Receptor Trafficking

Conditions
-----------------
Severe Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older, blunt or penetrating trauma and one or more of the following: systolic blood pressure less than 90 mmHg at the scene or within one hour of arrival to the Emergency Department, 2) base deficit ≥ -6 within one hour of admission, 3) ISS greater than 25, or 4) more than 6 units of blood transfused in the first 12 hours.- Exclusion Criteria:

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 |
| --- | --- | --- |
| Assessment of protein and lipid changes in immune cells following severe injury |  | 5/08 to 8/12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of severe injury effect on plasma and cellular lipid content |  | 5/08 to 8/12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lipids, proteins, membrane, lipid raft
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. 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 of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2329 are eligible Written informed consent HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from study CLAF237A2329 Other protocol-defined exclusion criteria may apply

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: vildagliptin|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Change from baseline in fasting lipids at 52 weeks |  |  | 
| Change from baseline in body weight at 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
Low-Dose Endotoxemia and the Acute Phase Response

Study Overview
=================
Brief Summary
-----------------
The purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters.

Conditions
-----------------
Endotoxemia, Sepsis

Intervention / Treatment
-----------------
* Drug: E. Coli endotoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healty volunteers - Exclusion Criteria: Infection 14 days prior to the trial Regular medication Present and /or former heart disease -

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: E. Coli endotoxin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women

Study Overview
=================
Brief Summary
-----------------
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled.

Detailed Description
-----------------
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled. They will take the evaluation of spine X-ray and answer to a few questions. Their medical record will be reviewed and relevant clinical findings will be collected.

Official Title
-----------------
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Other: Fracture evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were diagnosed post menopausal state Subjects over 50 years old The Definition of Post Menopause Women : Women whose last menstruation was over 12months ago Subjects who visit orthopedic surgery Subjects who have informed consents Exclusion Criteria: Subjects who are not confirmed as post menopause state Subjects who do not understand the contents of questionnaire Subjects over 80 years old Subjects experienced any high energy fracture (including trash and fall) within 3 months. Subjects experienced a fracture except vertebral fracture within 6 months Unable to evaluate L-spine BMD over 2 levels because of spinal fracture or instrumentation for L-spine 1-4. Unable to evaluate BMD at both femur because of hip fracture or instrumentation.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 79 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post menopausal women<br>Post menopausal women between 50 to 80 | Other: Fracture evaluation<br>* DEXA(Dual-energy X-ray absorptiometry), X-ray<br>* Other names: X-ray;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of OVCFs confirmed by history and X-ray |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of asymptomatic (or missed) fractures |  | 1 day |
Effect of Sofosbuvir-daclatasuvir on Angiogenesis

Study Overview
=================
Brief Summary
-----------------
The study aimed at study of the Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection

Detailed Description
-----------------
The study primary aim was at evaluation of the Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection

Official Title
-----------------
Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection

Conditions
-----------------
HCV Coinfection

Intervention / Treatment
-----------------
* Drug: Sofosbuvir-daclatasvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic HCV patients Exclusion Criteria: HCC. HIV or HBV. Malignancy. Pregnancy.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Drug sof-Dakla
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sofosbuvir-daclatasvir<br>Sofosbuvir-daclatasvir for 3 months | Drug: Sofosbuvir-daclatasvir<br>* Sofosbuvir-daclatasvir for 3 months<br>* Other names: sof-dakla;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with change in VEGF, TGFB1 | Number of patients with change in VEGF, TGFB1 | 6 months |
Rapid Analysis of Infections by Spectrometry of Exhaled Breath

Study Overview
=================
Brief Summary
-----------------
To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.

Official Title
-----------------
Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients

Conditions
-----------------
Respiratory Tract Infections, Hematologic Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Breath analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18y at start of study One of the following diagnoses: De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy Aplastic anemia requiring ATG therapy Any patient admitted for either autologous hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment. Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission. Written informed consent obtained from the patient Exclusion Criteria: Hematological disease beyond the specified inclusion criteria Signs of active respiratory infection If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).

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 |
| --- |
|Diagnostic Test: Breath analysis|Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy | Through study completion (i.e. 6 weeks after diagnosis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT |  | 2 weeks after diagnosis | 
| Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT |  | 6 weeks after diagnosis |
LXRs, Cholesterol Metabolism and Uterine Dystocia

Study Overview
=================
Brief Summary
-----------------
Despite the fact that a link between cholesterol and the myometrium has been clearly established, no study investigating aspects of cholesterol metabolism and uterine dystocia currently exists. This study is a pilot study whose aim is to test the hypothesis that an association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes coding for the LXRs.

Official Title
-----------------
The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta

Conditions
-----------------
Uterine Inertia, Dystocia

Intervention / Treatment
-----------------
* Biological: Whole blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing C-section for a dystocia: 2 to 3 hours of stagnation in labor progress are observed (ie no increasing dilation, and uterine contractions less that 3-5 per 10 minutes) in spite of measures taken to overcome dystocia (oxytocin injection and artificial breaking of waters) the child is alive the child does not have apriori known malformations that could interfere with a vaginal birth foetus in cephalic position full term pregnancy (>= 37 weeks of amenorrhea) single birth patient has signed consent patient is affiliated with a social security system Exclusion Criteria: vaginal birth programmed C-section C-section is chosen because the fetus has a cardia rhythm problem, and there is no stagnation in the labor process multiple pregnancy the child is in a breech position premature birth (<37 weeks amenorrhea) in utero fetal death fetal malformation known before birth that could interfere with a vaginal birth non french-speaking patient (impossible to correctly inform the patient) patient under guardianship

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Control group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved. | Biological: Whole blood sampling<br>* Whole blood sampling for SNP polymorphism analysis<br>|
| Group 2<br>These patients have uterine dystocia | Biological: Whole blood sampling<br>* Whole blood sampling for SNP polymorphism analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The multi-loci genotype of the target DNA sequence. | The polymorphisms of interest are the following SNPs: rs3758673, rs3758674, rs12221497, rs11039155, rs2279238, rs7120118, rs35463555, rs1052533, rs2248949, rs41432149, rs1405655, rs4802703. | Day 1 |
Effectivity and Safety Study of Trans-artificial-urethral Resection of Female Urethral Caruncle

Study Overview
=================
Brief Summary
-----------------
To explore the minimally invasive and exhaustive treatment of female urethral canruncle by using trans-artificial-urethral resection of the canruncle. The investigators plant to recruit patients using this surgical method and study the effectivity of this method.

Conditions
-----------------
Urethral Caruncle

Intervention / Treatment
-----------------
* Procedure: TAURFUC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patient with urethral caruncle Exclusion Criteria: - recurrence urethral caruncle
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Other: surgical group<br>transurethral resection of urethral caruncle | Procedure: TAURFUC<br>* female patients with urethral caruncle will receive transurethral resection combine with extension tube.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | Up to 6 months | 
| Length of hospital stay |  | Up to 6 months | 
| Estimated blood loss |  | Up to 6 months | 
| pathological type |  | Up to 6 months | 
| Complication incidence rate |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence-free survival |  | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
female, minimally invasive surgery
Follow-up of Immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers After 6 Months

Study Overview
=================
Brief Summary
-----------------
In the spring of 2009, a recently emerged novel influenza A (H1N1) virus was first identified in Mexico and USA and it has continued to spread globally. The rapid global spread of a novel influenza A (H1N1) 2009 virus prompted the World Health Organization (WHO), on 11 June 2009, to declare the first influenza pandemic in 41 years. In Taiwan, a clinical study to assess the immunogenicity and safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in healthy volunteers has already been completed. In the previous study, we found that a single 15 mcg HA dose of the AdimFlu-S (A/H1N1) vaccine induces a protective immune response in most adults, including those > 60 years of age (>70%). Our current study aims to follow-up subjects who received Influenza Virus Vaccine, AdimFlu-S (A/H1N1), six months ago. These subjects' serum samples were tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI). The seroconversion is defined as the post-vaccination serum HAI titer had at least 1:40 for subjects who had seronegative pre-vaccination or a four-fold or greater increase in HAI titers for subjects who had seropositive pre-vaccination serum. The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after half a year will be analyzed and discussed among the subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection.

Official Title
-----------------
Follow-up of Immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers After 6 Months

Conditions
-----------------
Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after half a year will be analyzed and discussed.