linjc16/ctgov huggingface dataset:
The Clinical Feature of Ulcer Base Over Time After Prophylactic Argon Plasma Coagulation in Colonic EMR

Study Overview
=================
Brief Summary
-----------------
The prophylactic APC right after colonic EMR doesn't mean the complete coagulation of visible vessel because of injection material. The aim of this study was to evaluate the clinical feature of the visible vessels in ulcer base over time after prophylactic APC in colonic EMR.

Detailed Description
-----------------
The prophylactic Argon plasma coagulation (APC) of non-bleeding visible vessels seems not to have an additional advantage in the prevention of delayed post polypectomy bleeding in recently studies. However, immediate APC after endoscopic mucosal resection (EMR) may not mean the complete coagulation of exposed vessels because of injection material. The aim of this study was to evaluate the clinical feature of the exposed vessels in ulcer base over time after prophylactic APC in colonic EMR. Methods: This study was designed as a prospective study. Investigators excluded diminutive polyp, large polyp (> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR. Between August 2013 and May 2014, patients who were enrolled underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection. After checking the complete coagulation of visible vessels, the numbers of visible vessel group were counted by lap of time such as 1, 3, 5, and 7 min in ulcer base.

Official Title
-----------------
The Clinical Feature of the Exposed Vessels in Ulcer Base Over Time After Prophylactic Argon Plasma Coagulation in Colonic Endoscopic Mucosal Resection

Conditions
-----------------
Gastrointestinal Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection. Exclusion Criteria: Diminutive polyp, large polyp (> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR.
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 |
| --- | --- | --- |
| underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection. After checking the complete coagulation of visible vessels, the numbers of visible vessel group were counted in ulcer base. |  | 4 months |
Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ARDS patient survival rate and better post-ICU life quality.

Detailed Description
-----------------
The investigators will first identify acute respiratory distress syndrome (ARDS) patients receiving ECMO support in ICU at National Taiwan University Hospital, and then collect blood, urine and bronchioalveolar lavage fluid (BALF) samples at different time points: before setting up ECMO, 2, 6, 12, 24, 72 hours,5 and 14 days after ECMO installment, time to wean ECMO and the day removing ECMO and leaving ICU. From the samples, the free radicals, cytokines (IL-1, IL-6, IL-8, IL-18,tumor necrosis factor-α, transforming growth factor-β), and inflammasome- related markers, immune cell responses and other biochemical markers would be measured. The novel biomarkers to predict the outcome of the patient will be identified.

Official Title
-----------------
Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support

Conditions
-----------------
ARDS, Multi-organ Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old ARDS, needing ECMO support Exclusion Criteria: pre-existing sepsis pre-existing chronic renal failure (dialysis dependent), liver failure other diseases precluding chance of survival.

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 |
| --- | --- | --- |
| Mortality or multi-organ failure | Patients who survived for more than 7 days after ECMO treatment were defined as survival, and non-survival patients were defined as expired or multiple organ failure incompatible with life within 7 days after ECMO installation. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute respiratory distress syndrome (ARDS), Extracorporeal membrane oxygenation (ECMO), biomarker
Effect of Rapeseed Oil and Sunflower Oil

Study Overview
=================
Brief Summary
-----------------
Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). The purpose of this study is to compare the effect of a diet low in saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children and adolescents with FH on serum lipoproteins.

Official Title
-----------------
Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia

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

Intervention / Treatment
-----------------
* Dietary Supplement: rapeseed oil
* Dietary Supplement: sunflower oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chilren and adolescents between 6 and 18 years of age LDLc > 130 mg/dl and TC > 200 mg/dl 7 day nutrition record written informed consent Exclusion Criteria: overweight underweight mental disability drug therapy

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br> | Dietary Supplement: rapeseed oil<br>* rapeseed oil in amounts between 14 and 27 g<br>|
| Active Comparator: sunflower oil<br> | Dietary Supplement: sunflower oil<br>* sunflower oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids. |  | done in Week 1, Week 7, Week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation, compliance, increase of quality of life. |  | done in Week 1 and Week 13 | 
| Acceptance and approach to the disease. |  | done in Week 1 and Week 13 | 
| Improvement of knowledge and understanding about the disease by the patients. |  | done in Week 1 and Week 13 |
Feasibility of Ambulatory Surgery for Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only.

Detailed Description
-----------------
The patients with small breast tumours (<2 cm)and clinically node negative disease, were randomized to receive breast conserving surgery and sentinel node biopsy as ambulatory surgery or inpatient-surgery.Complication rate, patient satisfaction and psychosocial outcomes were compared. The psychosocial effects of the treatment mode on their spouses were recorded as well.

Official Title
-----------------
Same Day Discharge After Surgery for Early Breast Cancer - a Feasible Option

Conditions
-----------------
Early Breast Cancer, Psychosocial Wellbeing, Ambulatory Surgery

Intervention / Treatment
-----------------
* Other: Ambulatory surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer < 2cm Clinically node negative ASA I-II Exclusion Criteria: Axillary clearance performed ASA III-IV No adult companion at home

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day surgery group<br>Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group. | Other: Ambulatory surgery<br>* Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.<br>|
| Active Comparator: In-Patient group<br>Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group. | Other: Ambulatory surgery<br>* Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial wellfare | Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare | First postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications and return to hospital rate | The difference in the number of complications or return to the hospital rate between the groups | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early breast cancer surgery, Psychosocial wellbeing, Ambulatory surgery
Study of the Treatment of Articular Repair (STAR)

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.

Official Title
-----------------
A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.

Conditions
-----------------
Articular Cartilage

Intervention / Treatment
-----------------
* Biological: Carticel (autologous cultured chondrocyte) implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provided written informed consent Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure Exclusion Criteria: see above

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 |
| --- |
|Biological: Carticel (autologous cultured chondrocyte) implantation|Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in the KOOS |  | Baseline, 6 month, 12 months, 24 months, 36 months, 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Modified Cincinnati Score |  | 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo | 
| Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport |  | 12mo, 24mo, 36mo, 48mo | 
| Change from Baseline in the SF-36 Health Status Survey |  | 12mo, 24mo, 36mo, 48mo |
Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Study Overview
=================
Brief Summary
-----------------
Trial of effects of minocycline as add-on therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.

Detailed Description
-----------------
This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).

Official Title
-----------------
Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: minocycline
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult asthmatics History of or current use of oral steroids to control symptoms Exclusion Criteria: Pregnant women

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: Crossover Assignment
Interventional Model Description: Double blind, placebo-controlled. crossover study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline<br>Addition of minocycline 150 mg po twice daily to current asthma treatment regimen. | Drug: minocycline<br>* addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.<br>* Other names: Minocin;|
| Placebo Comparator: Placebos<br>Addition of placebo capsules po twice daily to current asthma treatment regimen | Drug: Placebos<br>* Addition of oral placebo capsule in addition to standard of care regimen<br>* Other names: oral placebo capsules;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in oral steroid therapy requirements. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in symptoms scores | Asthma Quality of Lifes Scores (AQLQ) | 8 weeks | 
| improvement in spriometric parameters | improvement in spirometric parameters including FEV1, FVC, FEV1/FVC, FEF25-75 | 8 weeks | 
| improvement in morning and evening peak flow |  | 8 weeks | 
| decrease in rescue inhaler usage |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minocycline, asthma, oral corticosteroids
Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets

Study Overview
=================
Brief Summary
-----------------
We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator. We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.

Official Title
-----------------
Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study Investigating Changes in Immunological Parameters and Cutaneous Reactivity Induced by a Short Course Immunotherapy With ALK Grass Tablets

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: ALK Grass tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of grass pollen allergy Positive skin prick test to grass Positive specific IgE to grass Exclusion Criteria: Treatment with anti-IgE

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Biological: ALK Grass tablet<br> <br> |
| Placebo Comparator: 2<br> | Biological: ALK Grass tablet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in serum leves of IgG4 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in IgE level |  | 6 months | 
| Changes in cutaneous response |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinitis, Oral tablets, Ig G4, grass pollen, inmunotherapy
Evaluation of LB in THA

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of practice local injection containing plain bupivacaine.

Detailed Description
-----------------
Investigation of liposomal bupivacaine to determine if this drug is a valid alternative to standard of care local anesthesia based on evaluation in total hip arthroplasty This is a retrospective cohort study of consecutive patients undergoing THA at 3 hospitals within a U.S. healthcare system from January 2013 to July 2016. The control group received the standard of care undergoing THA (plain bupivacaine or ropivacaine), while the LB group received a mixture containing this drug as the alternative to the standard care. The outcome variables include hospital length of stay, readmissions, total hospital costs, patient pain scores, discharge disposition, morphine equivalent opioid consumption, and postoperative patient ambulation. Generalized linear models were employed to examine aforementioned outcomes controlling for age, gender, race, BMI, alcohol use, tobacco use, and surgeons..

Official Title
-----------------
Evaluation of Intraoperative, Local Site Injections of Liposomal Bupivacaine as an Alternative to Standard Local Anesthetics in Patients Undergoing Total Hip Arthroplasty

Conditions
-----------------
Hip Disease

Intervention / Treatment
-----------------
* Drug: Bupivacaine liposome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females over the age of 18 have undergone a THA surgery during the period of interest January 2013 to July 2016). Exclusion Criteria: excluded from the study based on the following criteria: Concurrent, painful, physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical treatment; Uncontrolled anxiety, schizophrenia, or other psychiatric disorder; and Significant renal or hepatic insufficiency.

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 |
| --- |
|Drug: Bupivacaine liposome|Replace bupivacaine with bupivacaine liposome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing physical function of the control group with the experimental group | distance in feet walked | 43 months | 
| Comparing length of stay in acute care facility of the control group with the experimental group | number of days | 43 months | 
| Comparing total hospital costs of the control group with the experimental group | Number of dollars | 43 months |