linjc16/ctgov huggingface dataset:
The Clinical Efficacy of Laryngeal Mask Airway in Elderly Patients: Comparison With Young Adults

Study Overview
=================
Brief Summary
-----------------
There are some differences between elderly and young adult patients regarding the anatomy of upper airways. Elderly patients have larger upper airways than young adult patients at all pharyngeal levels as revealed by CT. Another study explained that there is a progressive descent of the larynx and epiglottis with aging, which lengthens the upper airway and possibly makes it more likely to collapse. The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in elderly patients with young adults. In this study, the investigators will measure the ease of insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure, gastric leak pressure, fiberoptic position and intraoperative complications of the classic LMA.

Conditions
-----------------
Minor Urologic Surgery, Lower Extremity Surgery

Intervention / Treatment
-----------------
* Procedure: classic LMA insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 20-40 and 65-85years ASA status 1-2 Undergoing minor urologic surgery or lower extremity surgery Undergoing general anesthesia using classic LMA Exclusion Criteria: Predicted difficult airway Increased risk of aspiration Gastroesophageal reflux Neuromuscular disease Significant acute or chronic lung disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: young adult group<br>young adult patients undergoing minor urologic surgery or lower extremity surgery | Procedure: classic LMA insertion<br> <br> |
| Active Comparator: elderly group<br>elderly patients undergoing minor urologic surgery or lower extremity surgery | Procedure: classic LMA insertion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oropharyngeal leak pressure | After successful placement of LMA, airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O(fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
classic laryngeal mask airway, elderly patients
Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections

Study Overview
=================
Brief Summary
-----------------
Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, manual manipulation, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be scheduled for a piriformis muscle (PM) corticosteroid injection.

Official Title
-----------------
Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections: Does Accuracy Improve Efficacy?

Conditions
-----------------
Subjects Will Have Failed Conservative Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject Scheduled to receive piriformis injection for buttock pain Baseline pain visual analogue scale (VAS) value of at least 4 on a scale of 0-10 points Subjective complaint of pain in the buttocks with radiation down the thigh and/or leg Objective clinical diagnosis of piriformis syndrome Reproduction of pain with maneuvers that stretch or contract the piriformis muscle over the sciatic nerve Exclusion Criteria: Litigation Those receiving long-term (>6 months) remuneration for their pain or seeking new or increased long-term remuneration Those unable to read English and complete the assessment instruments Diagnosis of systemic inflammatory arthritis (e.g. rheumatoid, lupus) Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study Possible pregnancy or other reason that precludes the use of fluoroscopy. Fluoroscopy is the current standard of care for piriformis injections. Its use in this study is no different than the standard of care and will be no different if the subjects are enrolling in the study or not Contra-indication to corticosteroid, including known allergies or sensitivities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Ultrasound evaluation of fluoroscopically guided needle placement in the piriformis muscle. | Following the fluoroscopically guided needle placement, the non-invasive ultrasound probe will then be placed on the skin with gel and will be used to visualize the needle tip and evaluate the accuracy of the fluoroscopically guided needle placement. Needle placement will be recorded as either inside or outside the piriformis muscle. | Following fluoroscopic guidance of the needle placement and prior to the injection, the needle position will be evaluated by ultrasound. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
piriformis muscle
Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations

Study Overview
=================
Brief Summary
-----------------
compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?).

Detailed Description
-----------------
Group A One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation. Group B One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation. For each patient, intubation time, number of intubation attempts, hypoxia (recognized when oxygen saturation decreases below 94%), pharyngeal trauma, and need for corkscrewing will be recorded.

Official Title
-----------------
Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations

Conditions
-----------------
Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Intervention / Treatment
-----------------
* Device: modified Magill forceps
* Device: Magill forceps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the American Society of Anesthesiology physical status of 1 or 2 Age 4 to 8 years old. Elective dental surgeries. Exclusion Criteria: Parental refusal to consent (absolute contraindication), Patients with aspiration risk. Known upper airway abnormalities. Those having difficult airway.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified Magill forceps group<br>One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation | Device: modified Magill forceps<br>* modified pediatric Magill forceps was used to assist nasotracheal intubation.<br>|
| Active Comparator: Magill forceps group<br>One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation. | Device: Magill forceps<br>* Magill forceps was used to assist nasotracheal intubation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time |  | just after anesthesia induction for 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of intubation attempts |  | after anesthesia induction for 30 minutes | 
| hypoxia |  | after anesthesia induction for 30 minutes | 
| pharyngeal trauma |  | after intubation for 30 minutes | 
| need for corkscrewing |  | after anesthesia induction for 30 minutes |
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class

Study Overview
=================
Brief Summary
-----------------
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be documented.

Official Title
-----------------
Preserve Registry: Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class

Conditions
-----------------
Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome

Intervention / Treatment
-----------------
* Device: Any pacemaker with right ventricular pacing option


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted pacemaker for more than 6 months, VVI/DDD, written consent Exclusion Criteria: Pacemaker implanted for less than 6 months, no right ventricular pacing possibility (AAI), no consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Any pacemaker with right ventricular pacing option|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
-----------------
Pacemaker, NYHA class, Ejection fraction, Heart Failure
A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine

Study Overview
=================
Brief Summary
-----------------
This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.

Detailed Description
-----------------
Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.

Official Title
-----------------
Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection

Conditions
-----------------
Anaphylaxis

Intervention / Treatment
-----------------
* Drug: Epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects 18-30 years-old Exclusion Criteria: Pregnancy Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epinephrine IN, epinephrine IM, saline IN<br>Intranasal saline Intramuscular epinephrine Intranasal epinephrine | Drug: Epinephrine<br>* Intranasal epinephrine 5 mg /spray Intramuscular epinephrine 0.3 mg Intranasal saline spray<br>* Other names: adrenaline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Pharmacokinetics of epinephrine | Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route | predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with adverse events as a measure of safety and tolerability | Any side effects from such administration such as bad smelling, sorethroat. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intranasal epinephrine, Plasma epinephrine level
Assessing Free Immunoglobulin Light Chains in Patients With Myeloma

Study Overview
=================
Brief Summary
-----------------
Multiple myeloma is a disorder in which malignant plasma cells accumulate in the bone marrow. These plasma cells produce an abnormal protein called paraprotein / M spike in the serum which can be serially monitored to assess the response of tumour on therapy. The paraprotein has a heavy chain which can be either IgG, IgA, IgM or IgD and a light chain which can be either kappa or lambda. At present, these can be assessed by serum and urine electrophoresis (SPE and UPE). These techniques are relatively insensitive and poorly quantitative compared with other immunoassays for tumour markers. The potential of serum free light chain (flc) measurement as a marker for myeloma has been recognised for some time. However, development of such assays has proved elusive, primarily due to the difficulty in developing assays that are both convenient to use and have the required specificity to measure flc in serum. Recently , the assay has been standardised and is in use. Its likely that the assessment of flc might be a sensitive marker of documenting complete remission in patients with myeloma. The aim of this study is to study the flc in patients with myeloma in complete remission (CR) to see if patients have CR documented by standard criteria- are the free light chains still positive and if so are they better markers of remission. The samples will be collected and tested in batches of 60 each.

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple Myeloma patients in CR Exclusion Criteria: not being able to give consent

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function. The investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients.

Official Title
-----------------
CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Bi Ventricular Pacing
* Device: Right Ventricular Pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Left ventricular systolic dysfunction. Atrio-ventricular node disease. Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation). Ability to walk independently (walking aid permitted). Exclusion Criteria: Patients meeting criteria for CRT by current guidelines will be excluded. Life expectancy less than12 months. Inability to walk independently. Patients not likely to be compliant with follow-up. Bradyarrhythmia due with sino-atrial disease only.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Biventricular Pacing | Device: Bi Ventricular Pacing<br> <br> |
| Active Comparator: 2<br>Right Ventricular Pacing | Device: Right Ventricular Pacing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute hall walk test |  | Baseline, 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Function |  | Baseline, 3, 6, 9 and 12 months | 
| Cardiac Output |  | Baseline, 3, 6, 9 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resynchronization, Device, Bradycardia, atrioventricular block, Cardiac Resynchronization
Diabetes Mellitus and Pregnancy : Knowledge Assessment

Study Overview
=================
Brief Summary
-----------------
Diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as preeclampsia, congenital malformations and macrosomia. Preconception care is all methods to assess the best prognostic for a diabetic pregnancy. Among these methods, contraception is very important to plan the pregnancy on a chosen moment. The content of the preconception care is well established. However, information of diabetic women concerning contraception and giabetic pregnancy has been little studied.

Detailed Description
-----------------
The aim of the study is to describe the knowledge of the patients with diabetes concerning contraception and pregnancy planning.

Official Title
-----------------
Evaluation of Knowledge About Contraception and Pregnancy Planning Among Type 1 and Type 2 Diabetes Women

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Data record


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria : Patients Aged between 18 and 40 years old With type 1 or type 2 diabetes mellitus Consulting in the department of diabetology in Reims and Charleville Mezieres hospitals Accepting to participate in the study exclusion criteria : Patients With secondary diabetes (endocrine, pancreatic or genetical origin) With postmenopausal status Without capacity to have a pregnancy (uterine aplasia, hysterectomy)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients<br>Women between 18 and 40 years old with type 1 and type 2 diabetes | Other: Data record<br>* Data record<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of unplanned pregnancy | Knowledge concerning the risk of unplanned pregnancy in diabete women | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contraception, Diabetes mellitus, pregnancy
Persistent Weight Maintenance for 6 Months After 3 Months of Active Weight Loss

Study Overview
=================
Brief Summary
-----------------
This study is intended to report changes in the weight and metabolic indicators of the subjects six months after the end of the study for adults with a risk factor of 27 kg/m2 or higher (formerly the research task name[clinicaltrial.gov;NCT03675191]).

Detailed Description
-----------------
There was no special intervention after the previous research intervention. After the previous research was completed, we will check the changes in the body composition and metabolic indicators over six months.

Official Title
-----------------
An Observation Study on Maintaining Weight for 6 Months After 3 Months of Weight Loss Program

Conditions
-----------------
Weight Reduction

Intervention / Treatment
-----------------
* Other: observation of weight after 6months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who have participated in the previous trial (NCT03675191) and have completed the three-month study Those who agreed the trial. Exclusion Criteria: Those who have withdrawn the previous trial (NCT03675191)

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| overweight or obese adults<br>overweight or obese adults who participate the trial (NCT03675191) | Other: observation of weight after 6months<br>* This study is an observational study for 96 people who have completed the previous weight loss program. We will check the body composition and lipid profile of the participants who voluntarily visit after 6months after the end of the study. .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | weight changes | after 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile | total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride | after 6months |