linjc16/ctgov huggingface dataset:
Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Study Overview
=================
Brief Summary
-----------------
Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems. There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia. This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.

Official Title
-----------------
Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Conditions
-----------------
Hyperglycaemia

Intervention / Treatment
-----------------
* Drug: Actrapid Human Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birthweight <1500g Blood sugar >/= 10mmol/L Clinician decision to start an insulin infusion Exclusion Criteria: Infants who were moribund and not expected to survive
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Actrapid Human Insulin|Actrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemia whilst receiving insulin | Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU. | Length of hospital stay in NICU which will be from birth to 5 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperglycaemia, Very low birthweight infants, Insulin
Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis transmembrane conductance regulator gene to nasal epithelium in patients with cystic fibrosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: Cystic fibrosis transmembrane conductance regulator (CFTR) gene complexed with lipid is administered intranasally to the right inferior turbinate. Lipid without CFTR is administered to the left nostril as a control. Cohorts of 3 patients are given successively lower doses of CFTR, each dose complexed with 500 micrograms of lipid. Patients are followed at days 2-12, 15, and 21, then every 3-4 days for 3 weeks, every 2-3 weeks for 10 weeks, and every 3 months thereafter.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Genetic: Cystic fibrosis transmembrane conductance regulator


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Cystic fibrosis (CF), i.e.: Sweat chloride greater than 60 mEq/L Clinical manifestations of CF Homozygous delta F508 mutation preferred Compound heterozygotes for F508 mutation with pancreatic insufficiency eligible FEV1 greater than 40% of predicted PO2 at least 60 mm Hg on room air No acute or recurrent sinusitis No obstructive nasal polyposis No pneumothorax or hemoptysis, e.g., more than 250 mL blood within 24-hour period, within past year No unstable lung disease with worsening pulmonary symptoms, arterial blood gas, or pulmonary function tests within 2 weeks prior to entry No pulmonary exacerbation within 4 weeks prior to entry --Prior/Concurrent Therapy-- At least 2 months since participation in any other clinical study At least 2 months since DNase At least 4 months since corticosteroids --Patient Characteristics-- Cardiac: No severe cardiac disease Other: No other severe organ system disease, e.g., juvenile-type diabetes mellitus No pregnant women

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Cystic fibrosis transmembrane conductance regulator|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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
Safety and Efficacy of Recombinant Human Acid Alpha-Glucosidase in the Treatment of Classical Infantile Pompe Disease

Study Overview
=================
Brief Summary
-----------------
Pompe disease is caused by a deficiency of a critical enzyme in the body called acid alpha glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In infants with severe cases of Pompe disease (called Classical Infantile Pompe disease), an excessive amount of glycogen accumulates and is stored in various tissues, especially heart, skeletal muscle, and liver, which prevents their normal function. This study being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for Pompe disease. Patients diagnosed with Classical Infantile Pompe disease who have a small, but inactive, amount of natural GAA enzyme present in their bodies (called Cross-Reacting Immunologic Material-Positive or CRIM (+) patients), will be studied.

Official Title
-----------------
A Prospective Multinational, Multicenter, Clinical Trial of the Safety and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) in Cross-Reacting Immunologic Material-Positive Patients With Classical Infantile Pompe Disease

Conditions
-----------------
Pompe Disease, Glycogen Storage Disease Type II, Acid Maltase Deficiency Disease, Glycogenosis 2

Intervention / Treatment
-----------------
* Drug: recombinant human acid alpha-glucosidase (rhGAA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Classical Infantile Pompe Disease endogenous GAA activity < 1.0% cardiomegaly cardiomyopathy CRIM (+) ability to comply with the clinical protocol which will require extensive clinical evaluations Exclusion Criteria: respiratory insufficiency cardiac failure major congenital abnormality any other medical condition that could potentially decrease survival CRIM (-)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: recombinant human acid alpha-glucosidase (rhGAA)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Connected Electronic Wrist Strap for Patient Follow-up After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
After cardiac surgery, patients' follow-up after discharge is a major public health issue. Since the main complications occur mostly during the first extra-hospital month, a follow-up period becomes necessary as the average duration of hospitalization tends to decrease. The resumption of normal physical activity is rarely transmitted and when complications arise, the healthcare team is most often informed late. An electronic wristband is worn by the patient during the day, between the day of discharge from the hospital (D0) and the end of the second extra-hospital month (D60). The data recorded by the wristband include : bracelet ID, date, time and number of steps per day. The primary objective of the study is to measure the resumption of physical activity after elective cardiac surgery. This objective will be quantified by the number of daily footsteps. A secondary objective is to determine perioperative predictors of the physical resumption.

Official Title
-----------------
Connected Electronic Wrist Strap for Patient Follow-up After Cardiac Surgery

Conditions
-----------------
Cardiac Surgery, Surgery--Complications, Cardiac Disease, Physical Disability

Intervention / Treatment
-----------------
* Behavioral: Count daily number of footsteps.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention. Exclusion Criteria: Refuse of the patient, Misunderstanding of the system (electronic wristband, application) or the principle of the study (language problem, cerebral vascular sequelae), Pre-existing handicap that does not allow walking (not related to the cardiac pathology leading to the planned cardiac surgery). Patients who are unable to understand the content of the information delivered Pregnant women can not be included in the study.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Count daily number of footsteps.|Using a connected electronic wristband to mainly quantify daily number of footsteps.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the resumption of physical activity after cardiac surgery by counting the number of daily footsteps. | Count the number of daily footsteps | 2 months |
New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Detailed Description
-----------------
Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Official Title
-----------------
New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy

Conditions
-----------------
Gastric Cancer, Intestinal Metaplasia, Atrophic Gastritis, Inflammation

Intervention / Treatment
-----------------
* Device: probe-based confocal laser endomicroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for pCLE examination aged between 18 and 80 years old Exclusion Criteria: Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium Pregnant or breast-feeding (for females) Impaired renal function

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pCLE examination<br>patients will be prospectively recruited and examined first with high-definition endoscopy (EG-2990i, Pentax, Japan) followed by probe-based confocal laser endomicroscopy | Device: probe-based confocal laser endomicroscopy<br>* all patients will receive pCLE examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of the new classification system | Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of the new classification of gastric pit patterns and vessel architecture using probe-based confocal laser endomicroscopy | 3 month |
Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)

Study Overview
=================
Brief Summary
-----------------
Despite its known prevalence, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In patients with Chronic Kidney Disease but Non-Dialysis, the determination of Ferritinemia and Transferrin Saturation Factoris performed in only 30% and 10% of cases whereas they should be performed routinely in inflammatory situations and in case of anemia (HAS 2011, KDIGO 2012). The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients with CKD-ND, applying the international recommendations and those of the French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).

Official Title
-----------------
Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Iron status testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, over 18 years of age; Patient present at the hospital on the day of the study (traditional hospitalization, week hospital, day hospital, or in consultation with CKD-ND); Diagnosis of CKD-ND (glomerular filtration rate (GFR) > 15 mL/min/1.73 m²) Patient with signed consent Exclusion Criteria: Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision; Pregnant or breastfeeding woman; Patient with dialysis

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDK-ND<br> | Diagnostic Test: Iron status testing<br>* Iron status testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood iron status | ferritin | One day | 
| Complete blood iron status | Transferrin Saturation Factor | One day |
Wheelchair Use in Patients With Amputation

Study Overview
=================
Brief Summary
-----------------
There are no specific criteria for wheelchair use in patients with lower extremity amputations. The main purpose of this study is to determine the characteristics of wheelchair use in lower extremity amputee patients. In addition, it is aimed to determine the reasons for using and not using a wheelchair, and what type of wheelchair is needed.

Detailed Description
-----------------
There are no specific criteria for chair use in patients with lower extremity amputations. The main purpose of this study is to determine the characteristics of wheelchair use in lower extremity amputee patients. In addition, it is aimed to determine the reasons for using and not using a wheelchair, and what type of wheelchair is needed. Thus, it is thought that the main points to be considered while prescribing a wheelchair in patients with amputation can be determined. Patients with traumatic unilateral or bilateral lower extremity amputation who are hospitalized or applied to outpatient clinics will be included in the study. Demographic and clinical characteristics of the patients will be recorded. Current age, time since the injury (in months), occupation, etiology (mine,rocket launcher, rifle, shrapnel, etc.), amputation level, amputation side, accompanying upper extremity problem, last operation reason, and activity level, knee joint type (hydraulic, simple microprocessor, other microprocessor), foot type (carbon, hydraulic, microprocessor controlled), socket-suspension type, daily use of prosthesis (hour/day), use of assistive device or AFO, how long he/she has been using a wheelchair, the type of wheelchair (light manual, active, battery powered), the reason for using a wheelchair, the reason for not using, the frequency of using a wheelchair, the upper extremity problem/pain while using the chair will be recorded.

Official Title
-----------------
Wheelchair Use in Patients With Lower Limb Amputation

Conditions
-----------------
Amputation, Wheelchair

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 65 years, time since amputation ≥ 6 months, unilateral or bilateral LLA above the ankle level Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Wheelchair type | Active, light, powered | through study completion, an average of one and a half months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for wheelchair use | Mobility, upper extremity pain, transfer | through study completion, an average of one and a half months |
Jaw-thrust on Postoperative Sore Throat

Study Overview
=================
Brief Summary
-----------------
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing endotracheal intubation for general anesthesia.

Official Title
-----------------
Influence of Two-handed Jaw Thrust on Postoperative Sore Throat

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Procedure: Two-handed jaw thrust
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Patients scheduled for general anesthesia with endotracheal intubation Exclusion Criteria: Difficult airway Mallampatti scores greater than 2 Recent sore throat Cervical spine disease Recent upper respiratory infection Recent analgesics History of head and neck surgery Friable teeth Multiple intubation attempts

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The attending anesthesiologist provided intubation without two-handed jaw thrust. | Procedure: Control<br>* The intubation was done without two-handed jaw thrust.<br>|
| Experimental: Two-hand<br>The attending anesthesiologist provided intubation with two-handed jaw thrust. | Procedure: Two-handed jaw thrust<br>* The assistant applied two-handed jaw thrust for intubation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative sore throat for postoperative 24 hour |  | At postoperative 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative sore throat |  | At postoperative 2, 4, and 24 hour | 
| Postoperative sore throat scores | Visual analogue scales will be used (10: most imaginable pain, 0: no pain). | At postoperative 2, 4, and 24 hour | 
| Number of participants with postoperative hoarseness |  | At postoperative 2, 4, and 24 hour | 
| Number of participants with postoperative shivering |  | At postoperative 2, 4, and 24 hour | 
| Wound pain scores | Visual analogue scales will be used (10: most imaginable pain, 0: no pain). | At postoperative 2, 4, and 24 hour | 
| Number of participants with jaw discomfort |  | At postoperative 2, 4, and 24 hour |