linjc16/ctgov huggingface dataset:
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.

Official Title
-----------------
Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Conditions
-----------------
Biliary Strictures

Intervention / Treatment
-----------------
* Device: GORE® VIABIL® Biliary Endoprosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis Subject is ≥18 years of age Subject is able to comply with study protocol and follow-up requirements Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form Exclusion Criteria: Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region) Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent The subject has malignant biliary disease Subject has known pregnancy Participated in protocol involving investigational drug or device within 90 days prior to entry into this study

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 |
| --- | --- |
| Other: GORE VIABIL® Biliary Endoprosthesis<br>Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency | Device: GORE® VIABIL® Biliary Endoprosthesis<br>* Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe Stent Removal | The stent removal is considered safe when the Study Device is removed successfully and without SAEs. | Upon Removal |
Endoscopic Drainage of Collections After Pancreatic Surgery

Study Overview
=================
Brief Summary
-----------------
The pancreatic surgery causing some pancreatic collections. And in a number of case, this surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage. The endoscopic care of the treatment of pancreatic collections post-surgery is not yet standardized. After failure of the medical treatment, the drainage of collections by echo-endoscopy was described. There are not much series on this specific subject. Only 2 series contain more than 20 patients with 31 patients for the most important. The timing and the technical choice of the endoscopic treatment as well as the long-term follow-up are not clear. The purpose of this study is to estimate the success and the complications of the endoscopic drainage by echo-endoscopy according to the techniques of drainage and the timing of the endoscopic treatment. The not estimated long-term follow-up will be also considered.

Official Title
-----------------
Endoscopic Drainage of Collections After Pancreatic Surgery

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Endoscopic drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically Exclusion Criteria: Contraindication surgery

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 |
| --- |
|Procedure: Endoscopic drainage|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term evaluation of the risk of relapse |  | Up to 6 month | 
| Timing of endoscopic drainage |  | Up to 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate efficiency |  | Immediate post operative intervention |
G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
This study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1) Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic factors/anti-inflammatory cytokines.

Official Title
-----------------
Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: G-CSF (Leucostim)
* Biological: CB (autologous cord blood)
* Drug: Placebo (Normal saline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages from 2 years to 10 years at the time of enrollment Non-severe type of cerebral palsy Willing to comply with all study procedures Exclusion Criteria: Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin Presence of chromosomal abnormalities Unwillingness to participate clinical trial Presence of hypersensitivity reaction to G-CSF Evidence of hepatic, renal, cardiac dysfunctions

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CB + G-CSF<br> | Drug: G-CSF (Leucostim)<br> <br> Biological: CB (autologous cord blood)<br> <br> |
| Placebo Comparator: CB + placebo<br> | Biological: CB (autologous cord blood)<br> <br> Drug: Placebo (Normal saline)<br> <br> |
| Experimental: G-CSF<br> | Drug: G-CSF (Leucostim)<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo (Normal saline)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm the safety of autologous cord blood infusion and repeated injection of G-CSF in children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations |  | For 18 months from date of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm the efficacy of autologous cord blood infusion and/or G-CSF in children with cerebral palsy using standardized Gross Motor Function Measure evaluation. |  | Every 6 months from date of randomization up to 18 months |
Biomarkers in Idiopathic Juvenile Arthritis

Study Overview
=================
Brief Summary
-----------------
Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular JIA with antinuclear antibodies affects about half of all children. There 's no specific markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human Protein Microarray allows rapid and efficient detection of protein interaction using a suitable protein or small molecule probe. The investigators hope so detect novel potential autoantigen biomarkers specific in JIA.

Detailed Description
-----------------
We select 10 patients with inclusion criteria and 10 controls. We analyse their blood sample (5ml). The ProtoArray® Microarray allows to detect novel protein-protein interactions, to rapidly perform serum profiling using a sensitive method to detect potential autoantigen biomarkers. The ProtoArray® Human Protein Microarray is a high-density protein microarray containing thousands of purified human proteins for protein interaction screening.

Official Title
-----------------
Usefulness of Protoarray®Microarray for Identifying Biomarkers in Idiopathic Juvenile Arthritis Antinuclear Antibodies Positive.

Conditions
-----------------
Idiopathic Juvenile Arthritis

Intervention / Treatment
-----------------
* Other: blood sample for identifying biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for experimental group : child age from 2 to 16 years Oligoarticular JIA with antinuclear antibodies with or without uveitis Exclusion criteria for experimental group : immunosuppressive and biological therapy Inclusion Criteria for control group : child age from 2 to 16 years

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: idiopathic juvenile arthritis<br>blood sample | Other: blood sample for identifying biomarkers<br> <br> |
| Other: control<br>blood sample | Other: blood sample for identifying biomarkers<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of specific autoantigen biomarkers | Identify blood sampling biomarkers of juvenile idiopathic arthritis | 1 day |
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

Study Overview
=================
Brief Summary
-----------------
A non-interventional study to explore actual asthma control status in real-life environment and to observe the efficacy after stepped-up to Symbicort SMART or various identical regimens. The study will be implemented by screening asthmatic patients from respiratory clinics to identify those not optimally controlled and required stepping up the controllers to initiate, or to titrate dose of, ICS/LABA including Symbicort.

Official Title
-----------------
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma patient who was partly controlled or uncontrolled by previous controllers of ICS only, or low dose ICS plus either LABA, leukotriene modifier or theophylline; or ICS- naïve with severe and persist symptom based on physician's judgment According to GINA guideline, who need to step up the controller medications, and ICS/LABA to be prescribed based on physician's discretion Exclusion Criteria: Patients aged not within limitation refer to label information of various product prescribed Patients who have taken oral corticosteroids within 4 weeks prior to enrollment Patients with contraindications to prescribed medication
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<br>Asthma patients who were partly controlled or uncontrolled, need to step up, or adjust dose of the controller medications to ICS/LABA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ACQ score from baseline to the mean of all available data from the follow up visits |  | wk 4±1; wk 12 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the individual asthma control status & pulmonary function from enrollment |  | wk 4±1; wk 12 16 | 
| Dose/usage of ICS/LABA and relievers & Patient compliance |  | wk 4±1; wk 12 16 | 
| Medical resource utilization |  | wk 4±1; wk 12 16; 6 month; 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symbicort SMART, budesonide, formoterol, ICS/LABA, Asthma Control Questionnaire, Not optimally controlled asthma
The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU

Study Overview
=================
Brief Summary
-----------------
Postoperative pain is a major concern in routine management of children admitted to pediatric intensive care treatment. There are significant negative physiological and psychological ramifications of postoperative pain such as impairment of cardiac function due to tachycardia, restlessness in an intubated patient requiring increase dosage of sedative and paralytic drugs and reduced patient cooperation in the healing process. The main body of evidence dealing with gender differences in pain perception and treatment stems from studies in the adult and adolescent population as the gonadal hormones have a central role in the way one experiences pain The hypothesis of this study is that there is a difference in the perception of pain, the amount of analgesia used and the response to pain medication between male and female infants undergoing craniosynostosis repair or untethering of cord.

Official Title
-----------------
The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU

Conditions
-----------------
Craniosynostosis Repair, Untethering of Cord

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants 0-1 year old, admitted to PICU after craniosynostosis repair or untethering of cord. Exclusion Criteria: Contraindication to analgesic medication Infants with neurologic deficits that may hinder the assessment of pain severity such as facial nerve palsy and limb paralysis. Ventilated infants.

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male<br> | |
| Female<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average amount per kg of analgesic medications in male and female infants 0-1 year old. |  | The first 24h after surgery | 
| The average reduction in pain severity score after receiving analgesics in male and female infants. |  | 24h after surgery |
Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine what effect, if any, do different dental materials used to seal the prosthetic screw channels of implant supported restorations have on dental implant health parameters and microbiology.

Official Title
-----------------
An In Vivo Assessment of the Effects of Using Different Implant Abutment Occluding Materials on Implant Microleakage and the Peri-Implant Microbiome

Conditions
-----------------
Peri-Implantitis, Dental Implant Failed, Dental Implant Failure Nos

Intervention / Treatment
-----------------
* Device: Cotton Pellet
* Device: Polytetrafluoroethylene Tape
* Device: Synthetic Foam
* Device: Polyvinylsiloxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fully edentulous patient Patient has at least one arch restored with a full-arch dental supported prosthesis Exclusion Criteria: poor oral hygiene and motivation (as determined with prosthesis in place) uncontrolled diabetes pregnant or lactating substance abusers current smokers psychiatric problems or unrealistic expectations acute infection in the area intended for implant sealing positive to HIV and hepatitis B and C affected by autoimmune diseases under chronic treatment with steroids or non-steroidal anti-inflammatory drugs.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dental Materials<br> | Device: Cotton Pellet<br> <br> * Other names: Richmond Dental Bleached Cotton;Device: Polytetrafluoroethylene Tape<br> <br> * Other names: Merco M55 Thread Seal Tape;Device: Synthetic Foam<br> <br> * Other names: Jordco Endoring Foam Inserts;Device: Polyvinylsiloxane<br> <br> * Other names: Dentsply Aquasil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Index |  | 6 Months | 
| Plaque Index |  | 6 Months | 
| Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols |  | 6 Months | 
| Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols |  | 6 Months |
Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral block with bupivacaine on both perioperative anesthetic agent consumption and postoperative analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.

Detailed Description
-----------------
This study was performed after approval of Ethics Committee and parents written consent. Between the ages 1-5, planned percutaneous nephrolithotomy due to kidney stones 40 patients were enrolled in this study, and patients were randomly divided into two group. All patients were performed general anaesthesia. The Group I patients was given ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5 after giving prone position and the Group II patients was given 15 mg/kg of paracetamol as postoperative analgesia. In the period of postoperative, if the FLACC > 4; it was planned to dose 1 mg/kg of tramadol. Patients' hemodynamic parameters, oxygen saturation, sevoflurane concentration were recorded 10, 15, 30 and 60 minutes intraoperatively. Patients' hemodynamic parameters, oxygen saturation, pain scores (FLACC), satisfaction of parents, the number of patients who additional analgesic requirements and side effects (nausea,vomiting, hypotension, bradycardia, respiration problems etc) were recorded in the postoperative period. Primary outcome measures was pain scores using FLACC scale.

Official Title
-----------------
Ultrasound Guided Thoracic Paravertebral Block

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: paravertebral blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-II Between the ages of 1-5 years Forty children Exclusion Criteria: Refusals by parents Children with spine deformities Cutaneous infection Bleeding diathesis Allergy to drugs used ASA physical status III-IV

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral blockade<br>Paravertebral blockade | Procedure: paravertebral blockade<br>* ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5<br>|
| No Intervention: Paracetamol<br>The patients was given 15 mg/kg of paracetamol. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | 12 hours |
Endosonographic Shear Wave Elastography for Liver Stiffness

Study Overview
=================
Brief Summary
-----------------
This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.

Official Title
-----------------
Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Diagnostic Test: Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for EUS guided liver biopsy Elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or NASH requiring histological confirmation Ability to provide informed consent and willing to participate Exclusion Criteria: Clinical evidence of cirrhosis which obviates need for liver biopsy Noninvasive lab testing which confirms presence of cirrhosis Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy Thrombocytopenia with platelet count less than 50,000/mL Pregnancy (positive urine pregnancy test in females of childbearing age) Lack of consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elastography<br> | Diagnostic Test: Elastography<br>* Endosonographic shear wave elastography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of fibrosis | Degree of fibrosis based on histological assessment | through study completion, an average of 1 year |