linjc16/ctgov huggingface dataset:
Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap

Study Overview
=================
Brief Summary
-----------------
Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap. For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Detailed Description
-----------------
Study conducted on patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap. For each patient, a patient specific PEEK implant was fabricated, the temporalis muscle was exposed, elevated, and transferred to the maxilla, finally PEEK implants were fixed in place to prevent temporal hollowing.

Official Title
-----------------
Patient Specific PEEK Implants for Immediate Restoration of Temporal Fossa After Maxillary Reconstruction With Temporalis Muscle Flap

Conditions
-----------------
Temporal Hollowing

Intervention / Treatment
-----------------
* Procedure: Temporal PEEK implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with major maxillary defects indicating the need of reconstruction with full temporalis muscle flap; or any lesion indicating major maxillary resection and immediate reconstruction with total temporalis muscle flap. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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: PEEK implant<br>Temporal PEEK implant to prevent temporal hollowing after temporalis muscle transfer | Procedure: Temporal PEEK implant<br>* Temporal PEEK implant to reconstruct temporal fossa after temporalis muscle transfer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's satisfaction | patient's satisfaction using five points Likert scale | 3 weeks postoperative |
Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.

Detailed Description
-----------------
Subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study will be recruited. Subjects will be randomized to receive either Dabigatran 150mg daily for three days or standard treatment. Vital signs, CBC, inflammatory markers and BMP, and bleeding complications will be evaluated daily for the next 7 days of until discharge whichever is sooner.

Official Title
-----------------
Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Drug: Dabigatran Etexilate Mesylate
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase >3 times UNL and AP on images) 18-75 years old Willingness to sign the informed consent Symptom onset within 72 hours Exclusion Criteria: Under 18 years of age or over 75 years of age Pregnancy or lactating Presence of pseudo aneurysm on CT Predicted severe acute pancreatitis Unwilling or unable to sign the informed consent Had recent surgery or sphincterotomy Active pathological bleeding Concurrent use of anti-coagulation Known serious hypersensitivity reaction to Dabigatran CrCI <30mL/min or on dialysis Mechanical prosthetic valves Liver disease Cancer On Chemotherapy or immunosuppressant Persistent ALT, AST, Akl Phos >2 x ULN Active hepatitis C, active hepatitis B, and active hepatitis A Anemia (hemoglobin <10g/dL) Thrombocytopenia Concomitant use of P-gp inhibitors

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dabigatran Etexilate Mesylate<br>Dabigatran 150mg BID for 3 days | Drug: Dabigatran Etexilate Mesylate<br>* Dabigatran 150mg BID for 3 days<br>* Other names: Pradaxa;Other: Standard of Care<br>* Daily vital signs, lab work and one outpatient clinic visit<br>|
| Active Comparator: Standard of Care<br>Standard treatment for acute pancreatitis | Other: Standard of Care<br>* Daily vital signs, lab work and one outpatient clinic visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of Reported Adverse Events | One year |
Microbiological Keratitis in a Countryside City of Brazil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the predisposing factors, epidemiological features and clinical and microbiological diagnosis of infectious keratitis in two public referral centers of ophthalmology in a countryside city of Brazil.

Official Title
-----------------
Epidemiologic Characteristics, Predisposing Factors and Microbiological Profile of Infectious Corneal Ulcers in Two Referral Centers in a Countryside City of Brazil

Conditions
-----------------
Keratitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted with clinical suspicious of keratitis from June 2008 to June 2009 (Keratitis group) 37 volunteers without any ophthalmologic claim, recruited in the two ophthalmology centers listed (Control study group) Exclusion Criteria: In the Control Study Group, no infectious ocular disease was accepted
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 |
| --- | --- |
| Keratitis group<br>37 patients with keratitis | |
| Control Study Group<br>37 control volunteers | |

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
-----------------
Keratitis
The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The estimates risks and benefits of the percutaneous kidney biopsy have been reported mainly from retrospective studies. So far no prospective multicentre studies has been designed to identify rates of biopsy related complications. The aim of this prospective multicentre study was to evaluate safety and complication events related to biopsies on native kidney in Italy.

Detailed Description
-----------------
Kidney biopsies performed in 54 italian nephrology centres from 2012 to 2020 were included. Primary outcome of the study was any major complication, such as haemoglobin decrease more than 2 g/dL, macroematuria, gross ematoma, blood transfusion, artero-venous fistula, invasive intervention, pain, symptomatic hypotension, and/or rapid serum creatinine increase. Centre and individual patient risk predictors were analysed using multivariate logistic regression analysis.

Official Title
-----------------
The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: a Prospective Cohort Study

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Procedure: Native kidney biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult or pediatric patients with a kidney disease informed Consent Exclusion Criteria: patient with a transplanted kidney
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Native kidney biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any major post-biopsy complication event | The cecked of major post-biopsy complication events were clinically relevant hematomas, macrohematuria, decrease of haemoglobin levels after 24 hours > 2 g /dL, the need for blood transfusion, a large and persistent AV fistula, a post-biopsy anuria, an increase in serum creatinine greater than 50% in the week following biopsy, the need for invasive post-biopsy procedure related to the procedure including nephrectomy, the death related to biopsy | one week follow-up after native kidney biopsy |
Effect of Soymilk Replacement on Anthropometric and Blood Pressure Value

Study Overview
=================
Brief Summary
-----------------
Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on weight control and blood pressure management. Most studies in this regard have been conducted on postmenopausal or premenopausal women and there are few studies on female youths. Therefore, we are going to determine the effects of soy consumption on the weight, waist circumference and blood pressure in overweight and obese female youths. This was a cross-over randomized clinical trial which was conducted in 2010 in Isfahan on overweight or obese young female youths. After three weeks run-in, females were randomly assigned to consume a diet containing caw's milk or a diet in which only one glass of soy milk was substituted; each one for six weeks. Random sequencing generated in SPSS was used for allocating females in different group randomly. Patients were not blinded because they had to use soy milk in one period of trial and use caw's milk in another period.

Conditions
-----------------
Weight, Waist, Systolic Blood Pressure, Diastolic Blood Pressure

Intervention / Treatment
-----------------
* Dietary Supplement: soy milk, Caw's milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Being in the age range of 18 to 30 and having body mass index more than 30 kg/m2 were the inclusion criteria. - Exclusion Criteria:Having allergy to soy product or caw's milk and not consuming the soy milk or caw's milk, incidence of chronic or acute diseases which make patients not to follow the research protocol or beginning to consume the medications were the exclusion criteria. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 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 |
| --- | --- |
| Experimental: Soy milk<br> | Dietary Supplement: soy milk, Caw's milk<br> <br> |
| Experimental: Caw's milk<br> | Dietary Supplement: soy milk, Caw's milk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth. The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.

Detailed Description
-----------------
Traditional growing rod constructs of spinal instrumentation to treat severe scoliosis in young children require a return to the operating room every six to nine months until skeletal maturity. The Shilla system allows for more spinal growth with fewer surgical procedures necessary for lengthenings. This is a major advantage over existing growth permitting systems and allows surgery to be performed at younger ages with better deformity correction without concerns of repeated surgeries.

Official Title
-----------------
Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine

Conditions
-----------------
Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between the ages of 1 yr and 10 yrs have severe, progressive scoliosis unresponsive to bracing have severe, progressive scoliosis who cannot tolerate bracing Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- | --- |
| 1 Shilla Technique<br>The patients whose data is observed are those who have undergone the shilla surgical technique. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs. |  | 5 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will have continued spinal growth |  | 5 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scoliosis, immature spine
Evaluation of the SCALED (SCaling AcceptabLE cDs)

Study Overview
=================
Brief Summary
-----------------
This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.

Official Title
-----------------
Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable CDS for Venous Thromboembolism Prevention - CDS Data

Conditions
-----------------
Traumatic Brain Injury, Venous Thromboembolism

Intervention / Treatment
-----------------
* Other: Observational
* Other: Observational-control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 and older admitted with a TBI Exclusion Criteria: Patients who die within 24 hours of hospital admission and patients documented as comfort cares during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 4 hospitals using CDS TBI<br>healthcare system leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention. | Other: Observational<br>* There is no intervention, the hospitals will adopt a CDS system which prompts users to follow best practice guidelines.<br>|
| 3 hospitals not using CDS TBI (control)<br>healthcare system not leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention. | Other: Observational-control<br>* There is no intervention, the hospitals will not use the CDS system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary effectiveness outcome | VTE event rate | 2 years and a half | 
| Evaluate implementation strategy guided by the EPIS Implementation | the number of patients that received treatment according to the best practice guideline and the % adherence to the guideline per site | 2 years and a half |
Follow-up of Psychological and Neurocognitive Gulf War Outcome: Relation to Stress

Study Overview
=================
Brief Summary
-----------------
This is the follow-up to an observational epidemiological study of psychological and neuropsychological outcomes of deployed and non-deployed Gulf War-era veterans.

Detailed Description
-----------------
Approximately 800 deployed and 250 nondeployed veterans were originally administered psychological assessment instruments shortly after the cessation of the Gulf War. These veterans are currently being followed to evaluate longer-term psychological outcomes in relation to war-zone stress, intervening life stress, and individual difference factors and personal resources, such as coping and social support. Approximately 75 of these veterans, oversampled for post-traumatic stress disorder, were administered a specialized neuropsychological battery emphasizing attention and memory. This sample will also be followed to evaluate longitudinal neuropsychological outcome in relation to PTSD status. A cross-sectional study will also be conducted examining visual, hierarchical attention in relation to PTSD diagnosis.

Official Title
-----------------
Follow-up of Psychological and Neurocognitive Gulf War Outcome: Relation to Stress

Conditions
-----------------
Gulf War Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Participation in Time 1 data collection

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 |
| --- | --- | --- |
Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

Study Overview
=================
Brief Summary
-----------------
Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat spinal radicular pain. However, inadvertent intravascular injection can lead to severe neurologic complications. Digital subtraction angiography (DSA) during epidural block might increase the detection rate of intravascular penetration, compared to real-time fluoroscopy (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and participants and the high cost of the new and upgraded fluoroscopic equipment. In this study, it was designed to compare DSA and RTF for detection of intravascular penetration in the same participant who underwent cervical TFEB. The investigators prospectively examined the participants who received cervical TFEB. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under DSA.

Official Title
-----------------
Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block: a Comparison of Digital Subtraction Angiography and Real Time Fluoroscopy

Conditions
-----------------
Diagnostic Imaging

Intervention / Treatment
-----------------
* Device: DSA
* Device: RTF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants with radiating pain from spinal stenosis and herniated nucleus pulposus. Exclusion Criteria: pregnancy, allergic to contrast media, participants refusal, and participants with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

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
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cervical TFEB under DSA<br>cervical TFEB was performed under DSA | Device: DSA<br>* DSA was used for detection of intravascular injection<br>|
| Active Comparator: TFEB under RTF<br>cervical TFEB was performed under RTF | Device: RTF<br>* RTF was used for detection of intravascular injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of intravascular injection | The incidence of intravascular injection during cervical transforaminal block | 4 seconds after injection of contrast media |