linjc16/ctgov huggingface dataset:
IV Acetaminophen and Patent Ductus Arteriosus

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.

Official Title
-----------------
The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants 23-30 weeks gestation, PDA requiring treatment Exclusion Criteria: infection, congenital heart disease, genetic syndrome, NEC, pulmonary hypertension, hydrops, intestinal perforation, grade 3 or 4 IVH, serum creatinine >1.5, previous treatment with a COX inhibitor.

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 2 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acetaminophen<br>Group of patients randomized to receive acetaminophen to treat their PDA | Drug: Acetaminophen<br>* infants receive acetaminophen for treatment of their PDA<br>* Other names: tylenol;|
| Active Comparator: ibuprofen<br>Group of patients randomized to receive ibuprofen to treat their PDA | Drug: Ibuprofen<br>* infants receive ibuprofen, standard of care in our unit, for treatment of a PDA<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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonate, acetaminophen
Effect of the Adjusted Vocal Expression Method on the Satisfaction of Parturients About Their Childbirth

Study Overview
=================
Brief Summary
-----------------
To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted. The emission of a sound vibration conjugated to a positive intention managed during the childbirth was experimented with around thirty mothers. In the term of this pilot study, most of the women expressed one felt very positive towards the new method, in particular when they compared it with a previous childbirth where this method was not used. During these childbirths, the midwives also indicated a shortening of the working time. The present study aim essentially is to confirm the positive effect of the method on the felt of the childbirth.

Official Title
-----------------
Effect of the Adjusted Vocal Expression Method on the Satisfaction of Parturients About Their Childbirth (NaîtreEnchanté)

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: Antenatal classes
* Other: Physical and psychic preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women of more than 18 years old Primipara Patients joining the antenatal classes dispensed by the midwives. Patients affiliated to a national insurance scheme or benefiting from such a diet Patients having given a written consent form Exclusion Criteria: None

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Antenatal classes | Other: Antenatal classes<br> <br> |
| Experimental: Group B<br>Physical and psychic preparation | Other: Physical and psychic preparation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Childbirth Perception Questionnaire (CPQ) score | French adaptation of CPQ score | 5 months |
Diagnostic Performance of Exome Sequencing in Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
Evaluation of the diagnostic performance of exome sequencing in a prospective series of patients with autism spectrum disorders (ASD).

Official Title
-----------------
Diagnostic Performance of Exome Sequencing in Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with ASD who has been previously diagnosed by an expert center according to the DSM5 criteria using standardized instruments (ADOS, ADI-R), referred to genetic consultation by the psychiatrist who performed the clinical diagnosis, according to the recommendations of the HAS, and requesting a genetic analysis for medical purposes in this context. Patient over 3 years old Patient affiliated to a social security scheme For minor patients: Holders of the exercise of parental authority who have read and understood the newsletter and signed the consent form For a major patient: Major patient who has read and understood the newsletter and signed the consent form Supervised minor / minor patient: Legal representative who has read and understood the newsletter and signed the consent form Major patient under guardianship: Major patient assisted by his curator or by the judge having read and understood the newsletter and signed the consent form DNA of the patient and parents available Exclusion Criteria: Patient who has already benefited from exome sequencing Person deprived of liberty by an administrative or judicial decision Pregnant or lactating woman
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 |
| --- | --- | --- |
| Proportion of unrelated index cases | at least one definite or probable risk factor or causal variant of a monogenic form of autism | through study completion, an average of 4 years |
Characteristics and Consequences of Coronary Angiograms Performed in Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
Coronary angiography is a key examination in the management of many patients hospitalized in intensive care units. The most frequent indication remains the performance of a gesture of unblocking of part of the coronary network in the context of an acute coronary syndrome (ACS) complicated by cardiogenic shock (CS) and/or cardiac arrest. cardio-respiratory (ACR). However, there are other indications in intensive care, in particular for diagnostic purposes. Given the lack of harmlessness of this procedure in itself and the consequences of intra-hospital transport outside intensive care units for patients who are sometimes very unstable, the risk-benefit balance before performing a coronary angiography requires always be properly assessed by the resuscitating physician.

Official Title
-----------------
Characteristics and Consequences of Coronary Angiograms Performed in Intensive Care Patients

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) Patients hospitalized in Intensive Medicine - Resuscitation between January 1, 2015 and January 1, 2020 in whom a coronary angiography was performed. Patient not objecting to the reuse of their data for scientific research purposes. Exclusion criteria: • Patient who has expressed his opposition to the reuse of his data for scientific research purposes.

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

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 |
| --- | --- | --- |
| Number of complications occurring in the 3 days following the performance of a coronary angiography during their stay in the intensive care unit |  | 3 days following the performance of a coronary angiography during their stay in the intensive care unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndrome, Coronary angiography, Cardiogenic shock, Cardio-respiratory arrest
The Relationship Between Patients' Head Position and ETT Intracuff Pressure

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population.

Detailed Description
-----------------
There are currently no data in the literature as to the effect of changes in head position on CP. As the cuff is located in the patients' trachea, the shape of the patents' trachea may be change depending on the position of the patient's head and therefore, the CP may also change. If the intracuff pressure will increase as the patient's head is moved into a flexed or extended position, these patients may be at risk for tracheal damage. The investigators will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery.

Official Title
-----------------
The Relationship Between Patients' Position and Endotracheal Tube Intracuff Pressure in Pediatric Population

Conditions
-----------------
Patients Undergoing ENT Surgery With Cuffed ETT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age less than 18 years Undergoing otolaryngological surgery with endotracheal intubation Exclusion Criteria: Patient who is intubated with an uncuffed endotracheal tube Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Intracuff pressure<br>Procedure/Surgery: Cuffed endotracheal tube | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal tube intracuff pressure | An intracuff pressure ≥ 30 cmH2O may compromise the tracheal mucosal perfusion and result in tracheal damage. | 1 day |
A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction

Study Overview
=================
Brief Summary
-----------------
This study is a randomized controlled trial on the effect of retrograde partial bladder fill on time to discharge in patients who have had urological surgery for BPH, and whether it affects overall medical staff satisfaction.

Official Title
-----------------
A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction

Conditions
-----------------
Retrograde Bladder Fill

Intervention / Treatment
-----------------
* Procedure: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any male patient between ages 20-80 with foley catheter indwelled after urological surgery performed at our institution Exclusion Criteria: Any patient that does not remove foley catheter at discharge

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder fill<br>Retrograde bladder filling of 250cc of 0.9% normal saline for irrigation prior to removal of foley catheter | Procedure: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter<br>* 0.9% NS 250cc was introduced before foley catheter removed for discharge<br>|
| No Intervention: No bladder Fill<br>no filling prior to removal of foley catheter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to void | time from foley catheter removal to actual initial voiding | 1day | 
| Time to discharge | time from foley catheter removal to actual discharge | 1day | 
| Medical staff satisfaction | Medical staff satisfaction discomfort/satisfaction with overall process based on a Likert scale (5) | 1year | 
| Patient satisfaction | patient discomfort/satisfaction with overall process based on a Likert scale (5) | 1day |
The Short Form-36: Pre- Versus Post-Surgical Administration in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical perspective.

Detailed Description
-----------------
The purpose of this study, is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical perspective.

Official Title
-----------------
The Short Form-36: Pre-vs. Post-Surgical Administration in Cardiac Surgery Patients

Conditions
-----------------
Coronary Artery Bypass Grafting, Heart Diseases, Heart Valve Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery patients who are between the ages of 18 and 100 Are English speaking Able to give consent Undergoing cardiac surgery including (but not limited to): Aortic valve replacement (AVR) Mitral valve replacement (MVR) Tricuspid valve replacement (TVR) Coronary artery bypass graft (CABG). Exclusion Criteria: Non-cardiac surgery patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recall bias, Cardiac surgery patients, Quality of Life, Aortic valve replacement, Mitral valve replacement, Tricuspid valve replacement, Coronary artery bypass graft surgery
Securing the Immediate Perioperative Walk: Creating and Validating a Score.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to set up a pre and postoperative ambulation score on a population of adult patients and undergoing outpatient surgery operated under locoregional anesthesia and sedation.

Official Title
-----------------
Securing the Immediate Perioperative Walk: Creating and Validating a Score.

Conditions
-----------------
Wandering Behavior, Anesthesia

Intervention / Treatment
-----------------
* Behavioral: Perioperative score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years-old Patient undergoing sedation with or without associated local anesthesia Patient having giver their consent Patient are benefiting from a social protection insurance Patient hospitalized as part of the outpatient for ophthalmologic surgery or upper limb surgery, plastic surgery or surgery for implantation of a vascular access device Exclusion Criteria: Patient whose surgery is performed on the lower limbs Patient with psychiatric disorders Patient with dementia Patient who has already participated in this same study (ex: cataract the second eye is made a few weeks after the first) Patient's refusal to participate in the study Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult patients undergoing sedation with or without associated local anesthesia<br> | Behavioral: Perioperative score<br>* Creation and validation of a perioperative walk score. The patient has to answer different items.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The validity of the perioperative walk score | The validity of the score will be assessed using the theory of item response (TRI). This theory is based on the correlations between the items of the score. | 1 day |
Omega-3 Hydrogel and Prevention of Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.

Official Title
-----------------
Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial

Conditions
-----------------
Mucositis Oral

Intervention / Treatment
-----------------
* Drug: topical oral Omega-3 hydrogel
* Drug: conventional preventive treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy. Patients whose radiotherapy treatment planned dose is 50 Gy or above Males and females with an age not less than 18 years Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy. Exclusion Criteria: Patients under Anticoagulants such as warfarin, heparin, or aspirin. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical oral Omega-3 hydrogel group<br>Patients will be given topical oral Omega-3 hydrogel | Drug: topical oral Omega-3 hydrogel<br>* Topical oral Omega-3 hydrogel prepared from fish oil<br>|
| Active Comparator: Conventional preventive treatment group<br>Patients will be given conventional preventive treatment | Drug: conventional preventive treatment<br>* topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash. Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Mucositis Severity | Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | up to 6 weeks |