linjc16/ctgov huggingface dataset:
Safety and Feasibility Study of the Chartis System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments during bronchoscopy.

Official Title
-----------------
A Safety and Feasibility Study of the Chartis System During Diagnostic Bronchoscopy

Conditions
-----------------
Bronchoscopy

Intervention / Treatment
-----------------
* Device: Chartis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo clinically indicated routine diagnostic bronchoscopy Exclusion Criteria: Hyperexcretive chronic bronchitis or excessive sputum secretion Active pulmonary infection FEV1 <20% predicted FVC <50% predicted

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Chartis System<br>* Assessment of airway flow and pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Until discharge or 24 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | During procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchoscopy, Clinically indicated for routine diagnostic bronchoscopy
Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Study Overview
=================
Brief Summary
-----------------
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

Official Title
-----------------
A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: Lamivudine
* Drug: Entecavir
* Drug: Adefovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I Naïve to nucleoside/nucleotide analogues except for LVD HBV DNA > 17,200 IU/mL Compensated liver function Serum ALT <10 × ULN Exclusion Criteria: Women who are pregnant or breastfeeding Evidence of decompensated cirrhosis Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lamivudine plus Adefovir<br> | Drug: Lamivudine<br>* Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response<br>* Other names: Heptotin;Drug: Adefovir<br>* Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response<br>* Other names: Hepsera;|
| Active Comparator: Entecavir<br> | Drug: Entecavir<br>* Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response<br>* Other names: Baraclude;|
| Experimental: Entecavir plus Adefovir<br> | Drug: Entecavir<br>* Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response<br>* Other names: Baraclude;Drug: Adefovir<br>* Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response<br>* Other names: Hepsera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with HBV DNA < 50 IU/mL at W48 |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patient with HBV DNA < 50 IU/mL at W 96 |  | Week 96 | 
| Mean reduction of HBV DNA at W 48 & 96 |  | Week 48 and 96 | 
| The proportion of subjects with ALT normalization at W 48 & 96 |  | Week 48 & Week 96 | 
| The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96 |  | Week 48 & 96 | 
| Safety |  | Week 48 and Week 96 | 
| Resistance |  | Week 48 & Week 96 |
Topical Antimicrobial Effectiveness Testing

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.

Official Title
-----------------
Test for Preinjection Skin Preparation

Conditions
-----------------
Antimicrobial Effectiveness

Intervention / Treatment
-----------------
* Drug: ChloraPrep One-Step
* Drug: 70% isopropyl alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in good general health have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders. Exclusion Criteria: - topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ChloraPrep One-Step|1.5 ml applicator patient preoperative skin preparation|
|Drug: 70% isopropyl alcohol|Curity Alcohol Prep Pads|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial Efficacy | Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count. | 30 seconds after treatment | 
| Antimicrobial Efficacy | Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count. | 10 minutes after treatment |
Urine Testing to Detect Kidney Transplant Rejection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if analysis of urine samples for specific markers can predict transplant rejection in people who have received kidney transplants.

Detailed Description
-----------------
Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. An increase in the serum creatinine level is often the first clinical indicator of kidney transplant rejection; however, this marker lacks sensitivity and specificity. Rejection is currently diagnosed using an invasive transplant biopsy procedure; in addition to being expensive, transplant biopsies can result in bleeding from the transplant and even graft loss. In early studies, it has been observed that significant increases in the levels of perforin, granzyme B, and CD3 messenger RNA (mRNA) in urinary cells signal the development of acute transplant rejection. The purpose of this study is to evaluate whether the noninvasive procedure of measuring perforin, granzyme B, and CD3 mRNA levels in urine samples can accurately diagnose and predict kidney transplant rejection, make transplant biopsy unnecessary, and provide an opportunity to initiate treatment for early rejection with the aim to minimize damage to the kidney. This study will last 3 years post-transplant. There will be a total of 14 study visits. Blood and urine collection will occur at all visits. Additional visits may be necessary for those participants who develop abnormal kidney function.

Official Title
-----------------
Noninvasive Diagnosis of Renal Allograft Rejection by Urinary Cell mRNA Profiling

Conditions
-----------------
Kidney Transplantation, Kidney Disease, Kidney Failure, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo primary or redo deceased- or living-donor kidney transplantation Ability to provide informed consent Exclusion Criteria: Requires combined organ transplantation Previously received a solid organ transplant (other than kidney transplant) or islet cell transplant HCV infected HIV infected

Ages Eligible for Study
-----------------
Maximum Age: 80 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
-----------------
allograft, graft
Stevens-Johnson Syndrome Antimicrobial

Study Overview
=================
Brief Summary
-----------------
Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance, with skin involvement and mucous membranes, related to several factors, such as, viral or bacterial infections and mainly the administration of medicines, in general painkillers and antibiotics. The objective of this work is report the emergence of ulcerative vesicle -bubble chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old patient, leucoderma and masculine gender, in treatment of breathing infection with sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.

Detailed Description
-----------------
Among the serious medicaments reactions, there are as great representative the Mucocutaneous Disorders immunological mediated. Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance, with skin involvement and mucous membranes, related to several factors, such as, viral or bacterial infections and mainly the administration of medicines, in general painkillers and antibiotics. The objective of this work is report the emergence of ulcerative vesicle -bubble chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old patient, leucoderma and masculine gender, in treatment of breathing infection with sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.

Official Title
-----------------
Stevens-Johnson Syndrome Associated With Antimicrobial

Conditions
-----------------
Stevens-Johnson Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stevens-Johnson syndrome associated with antimicrobial Exclusion Criteria: Not sick

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Sick | |

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
-----------------
Steven-Johnson syndrome, erythema multiform, autoimmune disease
The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study was to evaluate, based on the intraoperative anesthetic that is routinely carried out at the Department of Day Surgery, the difference in timing of the patient's discharge from the hospital (ie when the patient has autonomous demabulation and urination spontaneous) in patients undergoing correction of varicocele according Marmar.

Official Title
-----------------
The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis

Conditions
-----------------
Varicocele

Intervention / Treatment
-----------------
* Procedure: Anaesthesiological procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male ASA I-II No mental alteration Exclusion Criteria: Chronic pain Allergies to local anaesthetics, acetaminophen,oppioids ASA III - IV Postoperative discharge to ICU Epatic or renal failure Mental status alteration Coagulopathy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Anaesthesiological procedure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discharge time | check the elapsed time between the induction of anesthesia and obtaining discharge criteria, urination and deambulation, from the Department of Day Surgery. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the onset of acute post-operative pain |  | four days | 
| Check the occurence of any side effects |  | three months | 
| Clinical evaluation of patients at 1 and 3 months after surgery (possibility of chronic pain) |  | three months |
Cell Surface Marker Expression in Autoimmune Diseases

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the expression of cell-surface markers in the following seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g) inflammatory myositis.

Official Title
-----------------
A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases

Conditions
-----------------
Sjogren's Syndrome, Systemic Lupus Erythematosus, Multiple Sclerosis, Systemic Sclerosis, Crohn's Disease, Ulcerative Colitis, Inflammatory Myositis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female participants 19 years of age or older. Participant or legal surrogate able and willing to provide written, informed consent. Participant is, or has been undergoing care for one of the specified diseases in a participating centre with a confirmed clinical diagnosis of the specified disease. Participant has or will provide the relevant peripheral blood (required) and normal practice tissue specimens (if available). Participant has one of the following target auto-immune or inflammatory diseases diagnosed according to local clinical practice guidelines: Crohn's Disease Inflammatory myositis Multiple sclerosis Sjogren's syndrome Systemic lupus erythematosus Systemic sclerosis Ulcerative colitis Exclusion Criteria: Participants receiving investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to enrolment. Participants suffering from any additional disease that may interfere with the biomarker signals as per the investigator's discretion.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Systemic Lupus Erythematosus<br> | |
| Sjogren's Syndrome<br> | |
| Multiple Sclerosis<br> | |
| Systemic Sclerosis<br> | |
| Crohn's Disease<br> | |
| Ulcerative Colitis<br> | |
| Inflammatory Myositis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD28 Expression | Percentage of CD28+ T cells in peripheral blood | At enrollment | 
| ICOS Expression | Percentage of ICOS+ T cells in peripheral blood | At enrollment |
Eeva System Imaging Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Detailed Description
-----------------
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System. Primary Objectives Include: To collect imaging data on embryos followed to blastocyst stage (Day 5-6) Secondary Objectives Include: To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)

Official Title
-----------------
Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: Eeva™ Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Women undergoing in vitro fertilization treatment using their own eggs Fresh or Frozen Blastocyst (Day 5-6) transfer At least 5 diploid (2PN) embryos at fertilization check Willing to have all 2PN embryos imaged by Eeva Willing to comply with study protocol and procedures Willing to provide written informed consent Exclusion Criteria: Freeze-all due to ovarian hyperstimulation syndrome (OHSS) Use of donor egg / gestational carrier Fertilization using surgically removed sperm History of cancer Assisted Hatching (AH) on Day 3

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Eeva™ Test|The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit. |  | 36 months |
Risk Factors of Ascending Aortic Atheromatous

Study Overview
=================
Brief Summary
-----------------
Background Incidence of perioperative stroke In cardiac surgery is 2.6-5.2%. Ascending aortic atheromatous plaque and stroke are strongly associated. Propose of study To determine incidence of ascending aortic atheroma in Thai people To identify risk factors which associated with ascending aortic atheroma Methodology After received standard general anesthesia and start sternotomy. Epiaortic scan will be performed by surgeon use L15-7i Phillips® ultrasound probe cover with sterile cover. Five standard epiaortic views will be collected. Epiaortic clips will be review and determine about atheroma by two qualified echocardiographers. Atheroma more than third grade will defined to significant. Potential risk factors of atheroma will be gather from medical record To assess the relationship between risk factors and atheroma a univariate analysis was performed using an unpaired t-test and a Chi-square test. For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.

Official Title
-----------------
Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient

Conditions
-----------------
Ascending Aortic Atheromatous Plaque

Intervention / Treatment
-----------------
* Diagnostic Test: epiaoryic scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Schedule to cardiac surgery with sternotomy Exclusion Criteria: Abnormal ascending aortic anatomy such as: dissection, aneurysm
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: epiaoryic scan|Epiaortic scan will be performed by use L15-7i Phillips®. Ultrasound probe cover with sterile cover. Five standard epiaortic views will be collected|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ascending aortic atheromatous plaque in Thai population | incidence of ascending aortic atheromatous plaque | 1 year |