linjc16/ctgov huggingface dataset:
General Practice Quality Assurance Project. Chronic Obstructive Pulmonary Disease (COPD) Diagnosis and Treatment

Study Overview
=================
Brief Summary
-----------------
A Cross sectional observational Quality Assurance Project in General Practice to COPD Diagnosis and Treatment

Official Title
-----------------
General Practice Quality Assurance Project. COPD Diagnosis and Treatment

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients over 35 years of age More than two annual renewals with the following group of inhalation preparations: Anticholinergic, beta-2 antagonists, steroids or a combination of these Exclusion Criteria: Asthma

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To optimise the diagnosis and treatment of COPD via a quality assurance project |  | Up to 1.2 years | 
| Increase the knowledge and use of diagnostic tools and treatment amongst PCPs |  | Up to 1.2 years | 
| To focus on implementation of national guidelines for diagnosis and treatment of COPD |  | Up to 1.2 years |
IR, Inflammatory and Cardiovascular Markers in PCOS Among Obese and Non-obese Women

Study Overview
=================
Brief Summary
-----------------
FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity is per se associated with increased adipose expression and plasma levels of leptin, lower expression of adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory markers and cardiovascular risk in women with PCOS, body weight status should be considered. Investigator therefore conduct this retrospective study to evaluate the insulin resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.

Conditions
-----------------
Polycystic Ovary Syndrome,, Insulin Resistance,

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers. Exclusion Criteria: women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, ovarian failure, hyperprolactinemia, and chromosomal anomalies; women who had had menarche less than 1 years before evaluation or who were older than 49; women who received hormones or drugs for major medical diseases within three months.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 48 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 |
| --- | --- | --- |
| Studying the insulin resistance, inflammatory and cardiovascular markers in polycystic ovary syndrome among obese and non-obese women. |  | A retrospective study in 800 Taiwanese women medical records reviewed from 2009 to 2012, up to 4 years in Wan Fang Hospital. |
Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

Detailed Description
-----------------
In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be made by collecting stool during the last three days of each period.

Official Title
-----------------
An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency

Conditions
-----------------
Cystic Fibrosis, Exocrine Pancreatic Insufficiency

Intervention / Treatment
-----------------
* Drug: rhBSSL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cystic fibrosis and pancreatic insufficiency who are able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days and are able to produce stools >= 5 times per week

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhBSSL<br>170 mg rhBSSL three times daily for 5 to 6 consecutive days | Drug: rhBSSL<br>* oral suspension, 170 mg BSSL, 3 times daily for 5-6 days<br>* Other names: BSSL, Bucelipase alfa, rhBSSL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA) | The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level. CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed). Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period. Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method. The unit of CFA is % | Final 3 days of baseline and treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, pancreatic insufficiency, bucelipase alfa, bile salt stimulating lipase, BSSL, coefficient of fat absorption
Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy

Study Overview
=================
Brief Summary
-----------------
Utility of image fusion system for the fracture and fracture malunion management will be evaluated.

Detailed Description
-----------------
The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.

Official Title
-----------------
Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy

Conditions
-----------------
Fractures, Bone, Fracture Malunion, Bone

Intervention / Treatment
-----------------
* Device: Image fusion system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fracture paitents need osteosynthesis Exclusion Criteria: Fracture patients under 18 years old

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Image fusion group (Image fusion)<br>Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.) | Device: Image fusion system<br>* Image fusion system for the 3D preoperative planning<br>|
| No Intervention: Control group (ZedTrauma)<br>only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction accuracy | Reproducibility of the reduction shape will be measured. | 1month after the surgery | 
| Implant placement | Reproducibility of the implant placement will be evaluated. | 1month after the surgery | 
| Implant choices | Reproducibility of the implant choices will be evaluated. | 1month after the surgery |
Validation of a Smartphone-based Assessment of Movement Health

Study Overview
=================
Brief Summary
-----------------
To correlate a smartphone-based assessment of mobility, stability, and posture with those derived from standard clinical tests among a heterogeneous cohort.

Detailed Description
-----------------
Smartphone movement health assessment introduces a new measure of health that helps users analyze and improve their mobility, stability and posture through performance of movements and physical exercises. To verify the accuracy of this measure, the goal is to provide data-driven evidence regarding its accuracy in comparison to gold standard tests for measuring movement health. To address this challenge, the assessment scores will be benchmarked to a set of gold standard tests and sensor metrics for measuring movement health recommended by professional associations such as the American Physical Therapy Association (APTA) or American College of Sport Medicine (ACSM) and found valid in clinical studies , .

Official Title
-----------------
Validation of a Smartphone-based Assessment of Movement Health Compared to a Battery of Standardized Clinical Tests for Mobility, Stability, and Posture

Conditions
-----------------
Mobility Limitation

Intervention / Treatment
-----------------
* Other: Smartphone Movement Health Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants should be able to perform the Smartphone movement health assessment and receive a score for their movement health. This will be evaluated by the research team members during the recruitment process. Ages 18-85 years old Able and willing to give written consent and comply with study procedures Exclusion Criteria: Pregnant or nursing Skin allergies or irritation that would prevent safe use of sensors described in protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental<br>Each participant will perform a Smartphone movement health assessment and a series of 12 gold standard tests under the supervision of a licensed physical therapist or other research study staff | Other: Smartphone Movement Health Assessment<br>* Participants will perform the assessment using an App installed on a smartphone device. Following the smartphone assessment, gold standard clinical assessments will be performed and scored for comparison<br>* Other names: Gold Standard Movement Assessments;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation | Positive correlation between Smartphone's movement health assessment scores and the scores of standardized tests and sensors metrics for mobility, stability and posture | Baseline |
Effects of the Use of Platelet-rich Fibrin on Bone Regeneration After Impacted Third Molar Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the bone regeneration after impacted third molar surgery on split mouth design using platelet-rich fibrin.

Official Title
-----------------
Randomized Double Blind Clinical Trial Evaluation of Bone Regeneration After Impacted Third Molar Surgery With the of Platelet-rich Fibrin: Pilot Study

Conditions
-----------------
Fibrin/Therapeutic Use, Blood Platelets, Molar, Third, Bone Regeneration

Intervention / Treatment
-----------------
* Procedure: Platelet-rich fibrin
* Procedure: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients Preoperative platelet count higher than 150,00/ mm3 Patient who required bilateral mandibular third molar extractions Exclusion Criteria: Smokers patients Alcoholics patients Patients whom the inferior second molar was missing Patients who had acute pericoronitis on the inferior third molar Severe periodontal disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 29 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-rich fibrin group<br>Use platelet-rich fibrin after mandibular third molar extraction | Procedure: Platelet-rich fibrin<br> <br> |
| Placebo Comparator: Control group<br>mandibular third molar extraction | Procedure: Control group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone density through tomography evaluation |  | Change from Baseline bone measurement at three months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation |  | Change from baseline at 3 months after surgery | 
| Pain through Visual Analogue Scale |  | 1st day after surgery | 
| Pain through Visual Analogue Scale |  | 3rd day after surgery | 
| Pain through Visual Analogue Scale |  | 7th day after surgery | 
| Soft tissue healing through Clinical evaluation numeric scale |  | 7th day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet-rich fibrin, third molar, bone regeneration
Ellipsys Fistula for Hemodialysis Access

Study Overview
=================
Brief Summary
-----------------
To report the outcomes of patients having percutaneous proximal radial artery fistula creation.

Detailed Description
-----------------
The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent previous Ellipsys® patients with appropriate medical records so that the Investigator may capture participants data for outcomes reporting.

Official Title
-----------------
Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access

Conditions
-----------------
ESRD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age > 18 years or older Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start of dialysis Adjacent vein diameter of > 2.0 mm at target anastomosis site and confirmed clinically significant outflow Arterial lumen diameter of > 2.0 mm at target anastomosis site Adequate collateral arterial perfusion: Barbeau test grade A through C Radial artery -adjacent vein proximity < 1.5 mm measured lumen edge-to-lumen edge via ultrasound Exclusion Criteria: Target vessel that are < 2mm is diameter Distance between the target artery and vein > 1.5 mm Edema of the upper extremity on the ipsilateral side Barbeau test grade D

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow Volume | Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex | 90 days |
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

Study Overview
=================
Brief Summary
-----------------
A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Fimasartan/Amlodipine/Rosuvastatin
* Drug: Fimasartan/Amlodipine
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a Healthy male subject, aged 19- 50 years Exclusion Criteria: History of clinically significant hypersensitivity to study drug, any other drug Hypotension or hypertension Active liver disease History of gastrointestinal disease History of excessive alcohol abuse Participation in any other study within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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 |
| --- | --- |
| Other: Group 1<br>Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day. | Drug: Fimasartan/Amlodipine/Rosuvastatin<br> <br> Drug: Fimasartan/Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |
| Other: Group 2<br>Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day. | Drug: Fimasartan/Amlodipine/Rosuvastatin<br> <br> Drug: Fimasartan/Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Fimasartan, Amlodipine and Rosuvastatin |  | 0 144 hour after medication | 
| AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin |  | 0 144 hour after medication |
Study of Effects of L-Arginine in Colitis and Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell. The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.

Detailed Description
-----------------
Amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (HPLC). Cytokines and chemokines are being measured in colon tissues and in serum by Luminex assay. Cytokines and chemokines are also being measured in colon tissues by real-time polymerase chain reaction (PCR) analysis of mRNA expression.

Official Title
-----------------
Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer

Conditions
-----------------
Ulcerative Colitis, Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis) Screening for cancer Exclusion Criteria: refusal to participate age less than 18 years at time of colonoscopy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonoscopy<br>Healthy volunteer who is having a screening colonoscopy | |
| Ulcerative Colitis<br>Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L-Arg intake in the diet of UC patients and control subjects |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulcerative colitis, colon cancer, endoscopy, screening