linjc16/ctgov huggingface dataset:
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy

Study Overview
=================
Brief Summary
-----------------
It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far

Official Title
-----------------
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy

Conditions
-----------------
Otitis Media With Effusion

Intervention / Treatment
-----------------
* Procedure: adenoidectomy, myringotomy, tubes insertion
* Procedure: A-M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age Exclusion Criteria: other health problems especially related with the condition eg cleft palate

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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: A-T<br> | Procedure: adenoidectomy, myringotomy, tubes insertion<br>* adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)<br>|
| Experimental: A-M<br> | Procedure: A-M<br>* adenoidectomy and myringotomy alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OM-6 |  | one year post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tympanogram type B |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
New Type of a Pancreaticojejunostomy

Study Overview
=================
Brief Summary
-----------------
Previously we have demonstrated in animal experiments,that pancreas is extremely vulnerable to handling, reacting with the development of pancreatitis. In human pancreatic surgery, post-operative pancreatitis mediates many other post-operative complications. A new anastomosis was developed to diminish the injury, as being without any stitches going through the pancreas. The aims were to study up to 30 patients as phase one study, with an interim analysis in this open uncontrolled trial after the first few patients.

Official Title
-----------------
New Type of a Pancreaticojejunostomy - a Pilot Study

Conditions
-----------------
Pancreaticojejunostomy After Pancreatic Head Resection

Intervention / Treatment
-----------------
* Procedure: Pancreaticojejunostomy without stiches through the pancreas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo peancreatic head resection Exclusion Criteria: Those who refuse from the 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

| Intervention/Treatment |
| --- |
|Procedure: Pancreaticojejunostomy without stiches through the pancreas|The pancreas is cut with knife, without electric cautery and without stay sutures. Bleeding is controlled with 2-3 exactly placed stiches. The pancreatic stump is sunk inside the jejunum, which is tightened around the pancreas with a purse string. A biodegradable stent is left into the pancreatic duct to prevent its occlusion when tightning the purse string.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistula, other complications |  | One year from operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of the pancreaticojejunostomy |  | One year |
Plasma Glucagon-like Peptide-1 Levels and Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release, vasodilatation and coronary flow in AMI mouse model, one may speculate that total GLP-1 level may associate with adverse cardiovascular events in AMI patients, the hypothesis is therefore tested in this study.

Official Title
-----------------
Prognostic Value of Plasma Glucagon-like Peptide-1 Levels in Acute Myocardial Infarction

Conditions
-----------------
Coronary Angiography, Glucagon-like Peptide-1

Intervention / Treatment
-----------------
* Diagnostic Test: plasma glucagon-like peptide-1 levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutive patients of acute AMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment. Exclusion Criteria: patients with cancer, and patients who were taking a DPP4 inhibitor or a glucagon-like peptide-1 (GLP-1) analogue

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: plasma glucagon-like peptide-1 levels|The plasma GLP-1 levels was determined by enzymatic assays.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | The median follow-up was 29 months | 
| cardiovascular mortality |  | The median follow-up was 29 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-cardiovascular mortality |  | The median follow-up was 29 months | 
| Myocardial infarction |  | The median follow-up was 29 months | 
| heart failure readmission | readmission to any hospital due to diagnosed heart failure | The median follow-up was 29 months | 
| Stroke | defined using the World Health Organization criteria | The median follow-up was 29 months | 
| repeated revascularization | defined as repeated PCI or bypass grafting of not only infarct related artery | The median follow-up was 29 months |
Bacterial Growth in Vascular Surgery Wounds

Study Overview
=================
Brief Summary
-----------------
The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. The aim of the present study is to investigate the prevalence of bacteria in vascular surgery wounds perioperatively, and determine whether is correlates with the incidence of wound infections postoperatively.

Official Title
-----------------
The Effect of Bacterial Growth in Vascular Surgery Wounds to the Incidence of Postoperative Wound Infections

Conditions
-----------------
Lower Limb Ischaemia, Aneurysm

Intervention / Treatment
-----------------
* Other: bacterial samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: need for lower limb vascular by-pass surgery Exclusion Criteria: allergic to cefuroxime patients refusal to participate

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 |
| --- | --- |
| bacterial cultures<br>Bacterial samples are collected preoperatively from urine, nose and possible lower limb ischaemic wounds, perioperatively from inguinal area and wound edges, and twice postoperatively. In addition, in case of a wound infection, bacterial samples are taken for diagnosis as usual. | Other: bacterial samples<br>* bacterial samples taken<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection | incidence of wound infection after lower limb vascular surgery | 3 months |
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Official Title
-----------------
A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

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

Intervention / Treatment
-----------------
* Drug: Liprotamase Powder for Oral Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Part A: males or females ≥7 years of age For Part B: males or females 28 days to <7 years Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride Low fecal elastase Fair-to-good nutritional status Exclusion Criteria: History or diagnosis of fibrosing colonopathy Distal intestinal obstruction syndrome in 6 months prior to screening Receiving enteral tube feedings Chronic diarrheal illness unrelated to pancreatic insufficiency Liver abnormalities, or liver or lung transplant, or significant bowel resection

Ages Eligible for Study
-----------------
Minimum Age: 28 Days

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age | Drug: Liprotamase Powder for Oral Solution<br>* Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy<br>* Other names: Liprotamase;|
| Experimental: Part B<br>Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years | Drug: Liprotamase Powder for Oral Solution<br>* Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy<br>* Other names: Liprotamase;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of subjects reporting 1 or more adverse events | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Liprotamase, Pancreatic Enzyme Replacement Therapy (PERT)
ABC Science Collaborative Registry Study

Study Overview
=================
Brief Summary
-----------------
The ABC Registry is associated with Pro00107943 and provides a resource for collecting information on members of school communities both regionally in North and South Carolina, as well as nationally in the United States (U.S.) through the National Program, including children, parents, teachers, superintendents, and other staff; and children identified through clinical practice. The overall goals of the Registry are to collect data relevant to public health during the coronavirus 2019 (COVID-19) pandemic and to establish and engage school communities that may be eligible for participation in future research studies, including observational studies, as well as prospective COVID-19 trials.

Official Title
-----------------
ABC Science Collaborative Registry Study

Conditions
-----------------
COVID19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant currently attends, is the parent of a student, works in, or works with a school that is participating in the ABC Science Collaborative, or participant is an adult or child who learned of the registry through clinical practice and is interested in participating in COVID-19 related research, Participant or their parent/guardian has provided informed consent or assent, as applicable Participant or their parent/guardian has downloaded the ABC Science App from the App store as a part of the ABC Science Collaborative and has agreed to the App's Terms of Use Participant or their parent/guardian is able to speak and read English or Spanish Exclusion Criteria: There are no specific exclusion criteria for this registry. Participants must meet inclusion criteria.
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 |
| --- | --- |
| Participants enrolled in the registry<br>Participants enrolled in the registry will include school community members including students, parents, staff, etc. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants who enroll in the ABC Registry | Number of participants who enroll in the ABC Registry (e.g. are interested in participating in upcoming research studies, including those related to COVID-19). | Up to 5 years |
Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot study in the Department of the Alpes-Maritimes.

Official Title
-----------------
Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Procedure: bone densitometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient member of Caisse Primaire d'Assurance Maladie Exclusion Criteria: Patient incapable of understanding the questionary

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bone densitometry|All patients do a bone densitometry after the inclusion.|

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
-----------------
osteoporosis
Antiangiogenic Effects of BCG on Urinary Concentration of Angiogenic Factors

Study Overview
=================
Brief Summary
-----------------
To determine if there is an association between basic fibroblast growth factor,vascular endothelial growth factor, and interleukin levels and a patients response to BCG treatment ( as standard treatment)in the urine of patients with superficial TCC. To determine if the levels of these angiogenic factors can predict response to BCG, disease recurrence, progression risk factors.

Detailed Description
-----------------
200 patients that are candidates for intravesical BCG therapy and 20 control patients with no history of malignancy will be enrolled. The study group wol;; be asked to provide a urine sample just prior to receiving their first BCG treatment(week # 1) and just prior to receiving their last (week # 6) BCG treatment. The control patients will provide one urine sample only. Samples will be analysed by enzyme-linked immunosorbant assay(ELISA). clinical data will be reviewed on tumor stage and grade prior to BCG, timme to recurrence, tumor stage and grade of recurrence, time to disease progression and death, cause of death and total follow-up time.

Official Title
-----------------
Intravesically Administered BCG May Have Antiangiogenic Effects on Urinary Concentrations of Basic Fibroblast Growth Factor ( bFGF), Vascular Endothelial Growth Factor (VEGF) and Interleukin (IL-8)

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 200 study group 1. Must be a candidate for BCG therapy. 20 control group 1. No history of malignancy. Exclusion Criteria: N/A
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antiangiogenic effects of bcg treatment and prognosis
Prediction of Neonatal Respiratory Distress Syndrome in Preterm Fetuses by Assessment of Fetal Lung Volume by Vocal and Pulmonary Artery Resistance Index a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance index in preterm fetuses and correlating the results with postnatal respiratory distress of the preterm neonates.

Conditions
-----------------
Fetal Lung Volume of Preterm Fetuses Measured by VOCAL, PA-RI Measured by Pulsed Doppler

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm labour Exclusion Criteria: twins

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| Neonatal respiratory distress | Apgar score at birth, need for NICU admission after delivery, need for neonate with RDS for continuous positive airway pressure ventilation | at time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal mortality rate | Follow up for early neonatal mortality rate after NICU admission , | One week after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FLV, VOCAL, PA-RI, preterm fetuses, RDS
Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.

Official Title
-----------------
Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

Conditions
-----------------
Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Drug: Acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life. Exclusion Criteria: Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST> 150 U/L, ALT>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 30 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acetaminophen to close PDA<br>Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen | Drug: Acetaminophen<br>* Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of PDA closure | PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete. | 3 days | 
| Change in PDA size | Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete. | 3 days |