linjc16/ctgov huggingface dataset:
Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether heated humidified high flow nasal cannula (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to continues positive airway pressure (CPAP) treatments in children and to compare their adherence and compliance.

Official Title
-----------------
Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Device: HHHFNC
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criterias: Age: 0-16 years old. Refered for treatment with non invasive ventilation. Diagnosed with OSAS and AHI>=5 There are no exclusion criteria

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| CPAP<br>CPAP, as a first line treatment to OSAS. | Device: CPAP<br>* CPAP, as a first line treatment in OSAS.<br>|
| HHHFNC<br>Treatment with HHHFNC after CPAP treatment fails. | Device: HHHFNC<br>* After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average hours per night and per week using HHHFNC . |  | One year | 
| Average hours per night and per week using CPAP. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea hypopnea index (AHI) | Severity of sleep apnea using AHI. | One year | 
| Pediatric sleep questionnaire (PSQ) score | Obstructive sleep-related breathing disorders using PSQ score | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Obstructive Sleep Apnea Syndrome (OSAS), Heated Humidified High Flow Nasal Cannula (HHHNC), Continues positive airway pressure (CPAP), Non invasive ventilation, Treatment
Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.

Study Overview
=================
Brief Summary
-----------------
A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.

Detailed Description
-----------------
This is an open-label, adaptive-design, single-dose, non randomized PET occupancy study.The primary aim of this study is to describe the relationship between plasma concentrations and brain occupancy of GSK1018921 over time. Up to 22 healthy volunteers will be administered single doses of GSK1018921 in order to obtain 12 evaluable complete data sets of occupancy estimates.

Official Title
-----------------
An Adaptive PET Study in Healthy Volunteers Using [11C]GSK931145 to Establish the Relationship of Glycine Transporter 1 Occupancy by GSK1018921 to Plasma Concentrations Over Time.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: GSK1018921


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male subjects Age: 18-55 years No history of physical, neurological or mental illness Exclusion criteria History of claustrophobia or inability to lie still in the PET camera for at least 2 hours Cardiac pacemakers or metal implants in the body that contraindicate MRI scan. History of regular alcohol consumption (weekly intake >21 units) within the previous six months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK1018921<br>All subjects will received a dose of GSK1018921 and will peforme three PET scans using the ligand [11C]GSK931145, but in order to obtain adequate sampling of the exposure-time-occupancy curves, a range of doses will be evaluated, and the timing of the post-dose scans will differ between subjects. | Drug: GSK1018921<br>* GSK1018921 is a GT1 recepor antagonist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET occupancy with GSK1018921 |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests. |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycine Tranporter, MRI, PET
Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion

Study Overview
=================
Brief Summary
-----------------
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.

Official Title
-----------------
A Retrospective Review of Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion With Four Years Followup

Conditions
-----------------
Atherosclerosis, Lower Extremity Ischemia, Claudication, Rest Pain

Intervention / Treatment
-----------------
* Procedure: Femoral-popliteal bypass
* Procedure: Stent-graft placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic lower extremity ischemia patients treated by femoral-popliteal bypass or percutaneous covered stent graft in previous prospective study Exclusion Criteria: NA

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 |
| --- | --- |
| Surgical Bypass Group<br>Those patients that underwent bypass of blockage in the thigh with surgery. | Procedure: Femoral-popliteal bypass<br>* Surgical bypass of blockage in the thigh<br>|
| Stent-graft group<br>Patients that underwent treatment of blockage in the thigh with balloon angioplasty and stent placement. | Procedure: Stent-graft placement<br>* Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary artery/graft patency |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary artery/graft patency |  | 48 months | 
| Limb salvage |  | 48 months | 
| Improvement of lower extremity ischemic symptoms |  | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, covered stent, percutaneous intervention, stent, angioplasty
Predictors of Difficult Videolaryngoscopy

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study was to identify parameters affecting the failure of videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and the most frequently used patient groups.

Detailed Description
-----------------
Videolaryngoscopy is widely used in the management of patients with presumed difficult airway. It offers an improved laryngeal view compared with direct laryngoscopy and increases the likelihood of successful intubation in patients for whom direct laryngoscopy is anticipated to be difficult. It is among the most frequently preferred difficult airway devices due to its ease of use, portability and direct laryngoscopy resemblance. The use of videolaryngoscopy has been shown to improve intubation success in many cases associated with difficult intubation, such as morbid obesity, pregnancy, limitation of cervical motility, and poor mouth opening.

Official Title
-----------------
Determination of Factors Leading to Failure of Videolaryngoscopy

Conditions
-----------------
Videolaryngoscopy

Intervention / Treatment
-----------------
* Device: Videolaryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who used videolaryngoscopy for intubation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 95 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Videolaryngoscopy patients<br>The patients who were attempted to be intubated with videolaryngoscopy | Device: Videolaryngoscopy<br>* Videolaryngoscopy device type<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation success | The success of intubation attempt with videolaryngoscopy (yes/no) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reason of videolaryngoscopy | Why videolaryngoscopy is preferred instead of standard direct laryngoscopy | 15 minutes | 
| The type of videolaryngoscopy blade | acute angled/macintosh/miller blade | 15 minutes | 
| The rescue technique | The rescue technique used for patients who could not be intubated with videolaryngoscopy | 30 minutes | 
| Factors affecting success of videolaryngoscopy | Mallampati score, thyromental distance, neck movements, upper lip bite test, mouth opening | 30 minutes |
Norepinephrine Weaning in Septic Patients

Study Overview
=================
Brief Summary
-----------------
The weaning rate of vasopressors drugs is usually chosen empirically by the clinician in critically patients. The investigators applied fuzzy logic principles to modify intravenous norepinephrine infusion rates during norepinephrine infusion in septic patients in order to reduce the duration of shock. The investigators goal was to reduce the duration of poorly controlled hemodynamic status.

Official Title
-----------------
Continuous Administration of Norepinephrine Assisted by Fuzzy Logic Assisted Control in Septic Shock Patients

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Device: norepinephrine infused at the clinician's discretion
* Device: norepinephrine infused under computerized fuzzy logic control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Septic shock Exclusion Criteria: Less than 18 years Pregnancy Weight above 135 kg Requirement for continuous epinephrine infusion Severe head injury, stroke, a comatose state following cardiac arrest

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Patients were assigned to norepinephrine infused at the clinician's discretion. | Device: norepinephrine infused at the clinician's discretion<br> <br> |
| Active Comparator: 2<br>Patients were assigned to norepinephrine infused under computerized fuzzy logic control. | Device: norepinephrine infused under computerized fuzzy logic control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to shock resolution defined as cessation of vasopressor support |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock, fuzzy logic, norepinephrine weaning
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea

Study Overview
=================
Brief Summary
-----------------
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

Detailed Description
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: Azelaic acid foam 15%
* Drug: Finacea® (Azelaic acid Foam) 15%
* Drug: Vehicle of the test product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea. Subjects must have provided IRB approved written informed consent. Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azelaic acid foam 15%<br>Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). | Drug: Azelaic acid foam 15%<br>* Azelaic acid foam 15%<br>* Other names: AZAF 1703;|
| Active Comparator: Finacea® (azelaic acid) Foam, 15%<br>Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). | Drug: Finacea® (Azelaic acid Foam) 15%<br>* Azelaic acid foam 15%<br>|
| Placebo Comparator: Vehicle of the test product<br>Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). | Drug: Vehicle of the test product<br>* Vehicle of the test product<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the inflammatory lesion counts | Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts | 12 weeks |
Dual Time Point PET Imaging in Lymphoma

Study Overview
=================
Brief Summary
-----------------
Comparison of single time point with dual time point PET imaging in the accuracy of diagnosing active lymphoma. Biopsy results or clinical/radiological progression will be used in conjunction with the PET data.

Conditions
-----------------
Hodgkin's or Non-Hodgkin's Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age 16 and above Diagnosis of Hodgkin's or Non-Hodgkin's lymphoma PET scan scheduled as part of management Exclusion Criteria: Pregnant or lactating Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
Effect of Diet on Men and Women With Genetic Alterations Associated With Abnormal Blood Tests

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate different diets and the effects of blood measures or inflammation and endothelial function in association with genetics tending to abnormal blood test levels.

Official Title
-----------------
Clinical Implications of Genetic Alterations in TG Rich Lipoproteins

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Behavioral: Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polymorphism in Apo C3 promoter and normal controls.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Diet|nan|

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
-----------------
Diet, triglyceride, inflammation, Genetic polymorphism
An Explanatory Factors Analysis of Inflammatory Bowel Diseases(IBD's) Management Costs for Adults Patients Treated by Biotherapy and Followed at Nancy University Hospital

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative colitis

Official Title
-----------------
Etude Des Facteurs Explicatifs Des Coûts de la Prise En Charge Des Patients Adultes Atteints d'Une MICI Suivis au CHRU de Nancy et traités Par biothérapie

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients consulted at the Gastroenterology services of Nancy University Hospital during the period of inclusion Patients over 18 of age the day of consultation Patients treated at least one time by biotherapy during the last 12 months preceeding inclusion Patients with crohn's disease or ulcerative colitis. Patients accepting to respond to the questionnary Exclusion Criteria: Age under 18 years , the day of consultation Patient that not accept or unable to complete the retrospective questionnary

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 |
| --- | --- | --- |
| Retrospective health care consumption | Desease treatment cost individual level data | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Disease, Ulcerative Colitis
Antibiotics for Prevention of SSI in Obese Women Undergoing CS

Study Overview
=================
Brief Summary
-----------------
Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS

Detailed Description
-----------------
Comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing CS and follow up of any signs of wound infection

Official Title
-----------------
Combination Vs Single Antibiotics for Prevention of SSI in Obese Women Undergoing CS

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Cephalexin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese women under elective CS Exclusion Criteria: immunodeficient women
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 Groups of obese women under elective cesarean section
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cephalexin<br>Group a will receive cephalexin 1gm before skin incision intravenous | Drug: Cephalexin<br>* Giving cephalexin and metronidazole in one group &cephalexin alone in another group<br>* Other names: Metronidazole;|
| Experimental: Cephalexin &metronidazole<br>Group b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision | Drug: Cephalexin<br>* Giving cephalexin and metronidazole in one group &cephalexin alone in another group<br>* Other names: Metronidazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection | Fever, redness, ecchymosis and tenderness | One week |