linjc16/ctgov huggingface dataset:
Amnion Chorion Membrane and Oroantral Communication

Study Overview
=================
Brief Summary
-----------------
An oroantral communication is a relatively common yet, serious complication following the extraction of posterior maxillary teeth because of their close relationship to the maxillary sinus. Several surgical techniques exist for the repair of oroantral communication, including local and free flaps, tissue expansion, allogenic tissue, and biomaterials. The present study aims to evaluate the use of the BioXclude amnion chorion membrane in the repair of oroantral communication.

Detailed Description
-----------------
This study will be performed on ten patients who have oroantral communication after extracting posterior maxillary teeth. The oroantral communication will be repaired by using the BioXclude amnion chorion membrane.

Official Title
-----------------
Evaluation of Amnion Chorion Membrane in the Repair of Oro Antral Communication

Conditions
-----------------
Oroantral Communication

Intervention / Treatment
-----------------
* Procedure: BioXclude amnion chorion membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be free of any relevant systemic diseases. Patients with recent oroantral communication (O.A.C) (24:72) hours . Good oral hygiene Exclusion Criteria: An immune compromised state. Previous sinus disease. History of sinus surgery. Presence of intra-antral foreign bodies and need for cold well-luc procedure. Presence of intra-sinus pathology

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioXclude amnion chorion membrane<br> | Procedure: BioXclude amnion chorion membrane<br>* The OAC will be closed by the Bioxclude ACM Amnion chorion membrane which is applied over the extraction socket then supported with a buccal advanced flap.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of surgery | Surgery will be considered successful in case of negative nose-blowing 1-month postoperatively, absence of infection, absence of dehiscence or other healing complication | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | Post-operative pain measure by patients rating 12 h after surgery using visual analogue scale (VAS) of 100 unit on three-point scale with: 0-34 as mild pain, 35 - 64 as moderate pain and 65 - 100 as severe pain | 12 hours | 
| Change in bone formation | Evaluation of bone formation at the communication site by computed tomography will be measured at 3 months and 6 months post operatively | at 3rd, 6th months |
Treatment of Extended Spectrum Betalactamase Producing Bacteria Causing Urinary Tract Infections in General Practice

Study Overview
=================
Brief Summary
-----------------
The prevalence of extended spectrum beta-lactamase (ESBL) producing bacteria found in urine sample cultures has been increasing over the past decades. The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam treatment of ESBL producing E. coli and K. Pneumoni, as well as to observe the clinical and microbiological outcome of the same group of bacteria treated with other antiinfectious agents. Samples are gathered in primary care setting.

Official Title
-----------------
What is the Outcome of Treatment of Urinary Tract Infections Caused by Bacteria Producing Extended Spectrum Betalactamase in a Primary Care Setting?

Conditions
-----------------
Urinary Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients were urinary sample taken in a primary care setting shows significant growth of ESBL producing E. coli. Above age 16. Exclusion Criteria: - Sample from patients in hospital care or living in nursing home facilities. Inability to understand and sign information leaflet.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| ESBL producing E. coli bacteria<br>Group of patients with identified ESBL producing E.coli in a urine sample taken in a primary care setting. | |
| Non-ESBL E.coli urinary tract infection<br>E.coli bacteria found in the setting of a urinary tract infection in a primary care setting where ESBL producing bacteria are not found. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days until symptomatic resolution | Number of days from the start of treatment that the patient feels completely free of urinary tract symptoms Number of days after start of antibiotic treatment with mecillinam when the patient feels free of symptoms from the urinary tract | Two weeks after finishing the primary antibiotic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with ESBL producing bacteria detected in a urine sample taken two weeks after finishing initial treatment |  | Two weeks after end of initial treatment | 
| Number of patients who received a second treatment regime in the follow-up period | Number of patients who received a secondary antibiotic treatment to obtain clinical cure. | 2 weeks after end of initial treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extended-Spectrum Beta-lactamase Producing Bacteria
Asphyxia at Birth : Causes and Neonatal Outcome

Study Overview
=================
Brief Summary
-----------------
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas cord blood were introduced in our maternity ward. The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main factors including second line strategy introduction, systematic umbilical cord acid-base implementation and improvement in antenatal risk factor screening for asphyxia. The investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was improved with systematic early after birth EEG evaluation, allowing early treatment and surveillance.

Official Title
-----------------
Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016

Conditions
-----------------
Neonatal Asphyxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016 Exclusion Criteria: Infants born after medical pregnancy termination and born out of the hospital and secondarily hospitalized in our department will be excluded

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Neonatal asphyxia | Neonatal asphyxia define as fetal death, neonatal death, NICU transfer, neonatal seizure, umbilical-artery blood pH ≤ 7.05 with a base deficit ≥ 12 mmol per liter, intubation for ventilation at delivery or neonatal encephalopathy | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
umbilical cord acid-base status, Neonatal asphyxia, neonatal acidosis, fetal ECG
Airflow Perturbation Device (APD) for the Evaluation of Pulmonary and Sleep Disorders

Study Overview
=================
Brief Summary
-----------------
In a prospective, observational study the investigators compared resistance values measured using the airway perturbation device (APD) to impulse oscillometry and spirometry. The investigators also created reference equations for normal APD resistance ranges using the data from clinically normal volunteers.

Official Title
-----------------
Airflow Perturbation Device (APD) for the Evaluation of Pulmonary and Sleep Disorders

Conditions
-----------------
Airway Obstruction

Intervention / Treatment
-----------------
* Diagnostic Test: Airflow pertubation device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects > 18 years Referred for PFTs and/or PSG at WRNMMC All races and ethnicities will be included Pregnant women will be included Exclusion Criteria: < 18 years of age If mental status is questionable, the patient will be excluded at the discretion of the consenting provider Unable/unwilling to follow the directions necessary for APD use

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Airflow pertubation device|Participants have airway resistance measured at the mouth by tidal breathing into a mouth-piece connected to the airflow perturbation device.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with APD correlation > 0.5 with spirometry | Respiratory resistance ( cm H20/L/s) measured with APD correlated with volumes (in liters) measured by spirometry. | At enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with APD correlation > 0.5 with impulse oscillometry | Respiratory resistance (cm H20/L/s) measured with APD correlated with resistance (cm H20/L/s) measured using impulse oscillometry | At enrollment |
Physiological Role of KiSS-1/GPR54 System in the Human Ovary

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to study the physiological role of the KiSS-1/GPR54 system in the granulosa cells of the human ovary.

Official Title
-----------------
Physiological Role of KiSS-1/GPR54 System in the Human Ovary

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting oocyte donors Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Donors<br>Oocyte donor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients

Study Overview
=================
Brief Summary
-----------------
Adequate sleep is an important aspect of any healing process, and because it is known that children recovering from burns suffer long term sleep disruptions, the investigators believe that Healing Touch may improve the quality and quantity of sleep in the pediatric burn population.

Detailed Description
-----------------
This study examines the impact of Healing Touch on the quality and quantity of sleep in pediatric burn survivors. Polysomnography recordings are obtained in order to assess nocturnal sleep in conjunction with Healing Touch; which is done on 1 of 2 nights during Polysomnography. Soft background music is played on both nights. Healing Touch is performed by one of 2 Healing Touch Certified Practitioners.

Official Title
-----------------
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients: A Prospective Cross Over Trial

Conditions
-----------------
Burn

Intervention / Treatment
-----------------
* Other: Healing Touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients (from 5 to 21 years of age) admitted for treatment (following an acute burn injury) to Shriners Hospitals for Children - Cincinnati Burns Hospital will be screened. Include electrical, flame, scald and chemical burns. Signed informed consent Exclusion Criteria: Patients admitted for treatment unrelated to a burn injury. Patients admitted for less than 2 nights. Patients with face and head grafting if they interfere with the lead placements Neurological disorder

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healing Touch<br> | Other: Healing Touch<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sleep | Comparison of sleep with and without Healing Touch at bedtime. Polysomnography measures whether the patient enters into all the different stages of sleep, particularly Rapid Eye Movement sleep. | It takes 1 month for the PSG results to be completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of sleep | Polysomnography measures percentages of sleep stages and the overall duration of the combined stages. | It takes 1 month for the polysomnography results to be completed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polysomnography, sleep, healing touch, pediatric burn
Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa of IBS patients and also clarify sex differences in the pathophysiology of IBS.

Official Title
-----------------
Expression of Neurotrophic Factors, Tight Junction Proteins, and Cytokines According to the Irritable Bowel Syndrome Subtype and Sex

Conditions
-----------------
Irritable Bowel Syndrome, Tight Junction Alteration, Pathophysiology

Intervention / Treatment
-----------------
* Procedure: colonoscopic mucosal biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Control group Those who were between 18 and 80 years old and did not have any abnormalities in colonoscopy Irritable bowel syndrome group Patients who diagnosed as irritable bowel syndrome according to the ROME III criteria Exclusion Criteria: history of IBD abdominal operation severe systemic disease malignancy,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Sham Comparator: IBS group<br>Patients who were diagnosed with IBS according to the ROME III criteria. Colonoscopic mucosal biopsy was undertaken for every subject. | Procedure: colonoscopic mucosal biopsy<br>* colonoscopic mucosal biopsy was undertaken for every participant<br>|
| Active Comparator: Control group<br>Healthy participants who have no gastrointestinal symptoms and no colonoscopic abnormality. Colonoscopic mucosal biopsy was undertaken for every subject. | Procedure: colonoscopic mucosal biopsy<br>* colonoscopic mucosal biopsy was undertaken for every participant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa | real-time qPCR | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa | real-time qPCR and Western blot | up to 24 weeks | 
| IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa | real-time qPCR | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable bowel syndrome, Subtype, Tight junction, Sex
Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
Bronchiolitis is the leading cause of pediatric intensive care unit admission in infants. Seizures during bronchiolitis may be a neurological complication of respiratory viruses but also of the treatments. The investigating team's hypothesis is that the incidence of seizures is not so so uncommon in infants hospitalized in the pediatric intensive care unit for severe bronchiolitis.

Official Title
-----------------
Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis : Description and Risk Factors

Conditions
-----------------
Bronchiolitis, Seizures, Hyponatremia

Intervention / Treatment
-----------------
* Other: Incidence, management and risk factors of seizure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 90 days hospitalization from January 1st, 2010 to April 30th, 2018 in the Pediatric Intensive Care Unit (PICU) of pediatric hospital in Lyon with bronchiolitis (clinical diagnosis according to American Academy of Pediatrics) Exclusion Criteria: neurological history that may explain the occurrence of seizures significant congenital heart disease

Ages Eligible for Study
-----------------
Maximum Age: 90 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children admitted in the PICU for severe bronchiolitis<br>Children admitted in the Pediatric Intensive Care Unit (PICU) for severe bronchiolitis between January 1st, 2010 and April 30th, 2018 | Other: Incidence, management and risk factors of seizure<br>* Incidence of seizure, management (treatment, paraclinical examinations) and risk factors of seizure in children admitted for severe bronchiolitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| : Incidence of seizure during bronchiolitis (before or during hospitalization in the pediatric intensive care unit) | Clinical or infra-clinical (diagnosed on Electroencephalography, EEG) seizure, simple or status epilepticus | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant
Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.

Study Overview
=================
Brief Summary
-----------------
At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. The role of the premature refeeding remains discussed. Up to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative. The main objective of this study is to estimate the POV in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice). The secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)

Conditions
-----------------
Post-operative Vomiting Incidence, Pediatric Day Case Surgery

Intervention / Treatment
-----------------
* Other: early refeeding
* Other: refeeding only in the recovery room (usual practice).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of less than 4 years old A pediatric day case surgery scheduled Exclusion Criteria: Child lower age or 3 month old equal Premature child of conceptional age lower than 60 weeks Anesthetic or surgical constraint dissuading day case surgery or early refeeding Digestive pathology predisposing to the VPO (Hernia hiatal, gastro-oesophageal reflux) treatment interfering with emesis (imidazoles, neuroleptic) Period of exclusion defined by another study

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 4 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberal group<br>Early refeeding | Other: early refeeding<br> <br> |
| Sham Comparator: Control group<br>Refeeding in the day case ward (usual practice) | Other: refeeding only in the recovery room (usual practice).<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between withdrawal of orotracheal tube and POV |  | The participant are followed for 3 days. |