linjc16/ctgov huggingface dataset:
Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners

Study Overview
=================
Brief Summary
-----------------
This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements

Official Title
-----------------
Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners Versus Gold Standard Plaster Model (Diagnostic Accuracy Study)

Conditions
-----------------
Orthodontics

Intervention / Treatment
-----------------
* Device: intra-oral digital scanner and extra-oral digital scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients seeking orthodontic treatment permanent dentition Exclusion Criteria: deciduous or mixed dentition cleft lip and palate patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-oral scanning<br> | Device: intra-oral digital scanner and extra-oral digital scanner<br>* intra-oral and extra-oral digital scanners used to obtain digital models<br>|
| Experimental: extra-oral scanning of the plaster model obtained via alginate<br> | Device: intra-oral digital scanner and extra-oral digital scanner<br>* intra-oral and extra-oral digital scanners used to obtain digital models<br>|
| Experimental: extra-oral scanning of plaster model obtained via rubber base<br> | Device: intra-oral digital scanner and extra-oral digital scanner<br>* intra-oral and extra-oral digital scanners used to obtain digital models<br>|
| Experimental: extra-oral scanning of the rubber base impression<br> | Device: intra-oral digital scanner and extra-oral digital scanner<br>* intra-oral and extra-oral digital scanners used to obtain digital models<br>|
| Experimental: extra-oral scanning of the alginate impression<br> | Device: intra-oral digital scanner and extra-oral digital scanner<br>* intra-oral and extra-oral digital scanners used to obtain digital models<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy | evaluation of the accuracy of digital models obtained using scanners | 6 months |
Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

Study Overview
=================
Brief Summary
-----------------
Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.

Official Title
-----------------
Risk of Bacterial Infection in Cirrhotic Patients With Acute Severe Liver Injury: a Multicenter,Prospective, Observational Study

Conditions
-----------------
Cirrhosis, Liver, Bacterial Infections, Acute Liver Injury

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation; Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin >=85mmol/L and international normalized ratio (INR)>=1.5 with a definite hepatic insult. Exclusion Criteria: (1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LC with SALI<br>cirrhosis patients with severe acute liver injury | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of bacterial infection | Site,source, pathogen and severity | Within 3 months from admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day Mortality | Disease-associated mortality | Within 28 days after enrollment | 
| 90-day Mortality | Disease-associated mortality | Within 90 days after enrollment |
Study of Recombinant Human N-Acetylgalactosamine 4-Sulfatase in Patients With MPS VI

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose levels of weekly intravenous infusions of recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.

Official Title
-----------------
Double-Blind,2 Dose Group Study of Recombinant Human N-Acetylgalactosamine 4-Sulfatase in Patients With MPS VI

Conditions
-----------------
Mucopolysaccharidosis VI

Intervention / Treatment
-----------------
* Drug: N-acetylgalactosamine 4-sulfatase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient consent Patient must be five years of age or older Patient must have documented diagnosis of MPS VI, confirmed at screening by measurable clinical signs and symptoms of MPS VI Leukocyte ASB enzyme activity level less than 20% of the normal range Clinical evidence of significant MPS VI disease that provides adequate opportunity to achieve quantitative, short-term therapeutic benefit in three or more of the following parameters: endurance (as measured by a six-minute walk test), forced vital capacity (as measured by spirometry), joint range of motion, urinary glycosaminoglycans, and hepatomegaly. Ability to perform all protocol tests Ability to stand independently for six minutes Sexually active subjects must agree to use an adequate form of contraception Exclusion Criteria: History of bone marrow transplantation Pregnant or lactating patient Use of an investigational drug or device within 30 days prior to study participation. A medical condition, serious intercurrent illness, or other extenuating circumstances that may significantly decrease study compliance including prescribed follow-up Known hypersensitivity to rhASB or to components of the study drug History of cancer (except low grade and fully resolved skin malignancy)
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

| Intervention/Treatment |
| --- |
|Drug: N-acetylgalactosamine 4-sulfatase|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysosomal storage disease |  |  |
TGFB1 And LAMA1 Gene Polymorphisms in High Myopia

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate TGFB1 and LAMA1 gene polymorphisms in children with high myopia in order to determine the genetic basis of large myopic shifts causing severe visual impairment and complications. Seventy-four children with high myopia (≥6 diopters [D]; study group) and 77 emmetropic children (±0.5D; control group) were included. Genetic and polymorphism analyses were performed in the Medical Genetics Laboratory using DNA purified from the patients' blood samples.

Official Title
-----------------
TGFB1 and LAMA1 Gene Polymorphisms in Turkish Children With High Myopia

Conditions
-----------------
High Myopia, Gene Mutations

Intervention / Treatment
-----------------
* Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under the age of 13 Patients with cycloplegic refraction values ≥6 D (for study group) Emmetropic patients (for control group) Exclusion Criteria: Patients who had additional ocular pathology that may affect refraction (such as glaucoma, cataracts, corneal disease) Patients with history of ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Children with cycloplegia refractive error more than -6 D TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined | Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS<br>* we evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia in an attempt to further elucidate the genetic basis of high myopia.<br>|
| Other: Control group<br>Emmetropic children TGFB1 AND LAMA1 GENE POLYMORPHISMS were examined | Genetic: TGFB1 AND LAMA1 GENE POLYMORPHISMS<br>* we evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia in an attempt to further elucidate the genetic basis of high myopia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic basis of high myopia | evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High myopia, TGFB1Gene Polymorphisms, LAMA1 Gene Polymorphisms
Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

Official Title
-----------------
Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Adalimumab
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history Subject has a diagnosis of rheumatoid arthritis as defined by the 1987 ACR criteria Subjects with treatment failure criteria to Mtx or Mtx + another DMARD Exclusion Criteria: Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast-feeding or considering becoming pregnant Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months

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: Adalimumab|nan|
|Drug: Methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes |  |  | 
| Clinical response indicators |  |  | 
| Safety parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, adalimumab, quality of life
Glu298Asp Polymorphism and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events, proposed to be due to reduced nitric oxide production by eNOS reported in some but not all studies. We hypothesise that beetroot-enriched bread interacts with the Glu298Asp polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite, particularly in carriers of the T allele, which have been associated with lower eNOS activity and increased risk of hypertension.

Official Title
-----------------
The Effects of Beetroot Bread on Postprandial Blood Pressure According to Glu298Asp Polymorphism in the eNOS Gene

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male A signed consent form Age 18-64 years Body mass index - 18.5-30 kg/m2 Non-smoking, healthy individuals Normal blood pressure at screening (< 150/90) Exclusion Criteria: Subjects with anaemia Sufferers of chronic illnesses Individuals with food allergies People with diabetes People with coeliac disease Women Vegetarians

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control white bread<br> | Dietary Supplement: Bread<br> <br> |
| Experimental: Beetroot bread<br> | Dietary Supplement: Bread<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial blood pressure |  | 30 minute intervals for a period of 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial plasma NOx |  | 30 minute intervals for a total period of 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glu298Asp polymorphism, Blood pressure, Plasma NOx, Beetroot
Determinants of the Success of Flap Reconstruction: Outcome Analysis of 484 Surgeries for Pressure Injury

Study Overview
=================
Brief Summary
-----------------
Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Here, we aimed to determine the appropriate timing to conduct flap reconstruction in patients with PIs and identify factors affecting surgical outcomes. Materials and Methods: We retrospectively reviewed the data of all patients who received debridement or flap reconstruction surgery for PIs in our hospital from January 2016 to December 2021. The extracted data included patient demographics, surgical records, blood test results, vital signs, and flap outcomes. Next, these characteristics including the flap outcomes of our patients with PIs were analyzed, along with the risk factors for poor wound healing and complications.

Official Title
-----------------
b Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Conditions
-----------------
Pressure Injury

Intervention / Treatment
-----------------
* Procedure: flap reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021 Exclusion Criteria: the patients who did not received debridement or flap reconstruction surgery for Pressure injury

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 |
| --- | --- |
| debridements group<br>During study peroid, the patient who received debridement surgery for pressure injury | Procedure: flap reconstruction<br>* received flap reconstruction over sacrum, back, trochanter, ischium, elbow, and lower extremities<br>|
| flap reconstructions group<br>During study peroid, the patient who received flap reconstruction surgery for pressure injury | Procedure: flap reconstruction<br>* received flap reconstruction over sacrum, back, trochanter, ischium, elbow, and lower extremities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete wound healing | no presentation of wound drainage or wound dehiscence at the surgical site 14 days after drainage tube removal. | from January 2016 to December 2021 |
QuickFlex Micro Left Ventricular Lead Post Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.

Detailed Description
-----------------
The primary endpoints of the study are: Freedom from LV lead-related complications at 5 years LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years

Official Title
-----------------
QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Implantation of a QuickFlex® μ Model 1258T LV Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin Have a life expectancy of less than 5 years due to any condition Be less than 18 years of age

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 |
| --- |
|Device: Implantation of a QuickFlex® μ Model 1258T LV Lead|Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants Alive and Without a Left Ventricular Lead-related Complication | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol). | 5 years | 
| Left Ventricular Bipolar Pacing Capture Threshold | Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure