linjc16/ctgov huggingface dataset:
One Year Glargine Treatment in CFRD Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements

Detailed Description
-----------------
To evaluate the effect of glargine treatment on BMI, lung function, acute pulmonary infections and HbA1c in cystic fibrosis (CF) patients with different glucose derangements, eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or abnormalities at the oral glucose tolerance test. They were classified on the basis of a gluco-score ranging 0-5. Patients with gluco-score > 1 were treated with glargine. We report on the results of the first 20 patients who completed 12 months of treatment. BMI z-score, forced expiratory volume in the first second (FEV1), number of acute lung infections in the previous year and HbA1c were the study outcomes.

Official Title
-----------------
One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements

Conditions
-----------------
Cystic Fibrosis, Glucose Metabolism Disorders

Intervention / Treatment
-----------------
* Drug: Glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by Cystic Fibrosis who had shown glucose derangements. Exclusion Criteria: Patients with/without Cystic Fibrosis without glucose derangements.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 20 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of decline in pulmonary function measured as FEV1 |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of: Body Mass Index, Number of Lung Infections, HbA1c |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystis Fibrosis, Glucose intolerance, Glargine, FEV1%
Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs

Study Overview
=================
Brief Summary
-----------------
The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

Conditions
-----------------
Viral Respiratory Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The specimen is a nasopharyngeal swab. The specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility. The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia. Exclusion Criteria: The specimen is not a nasopharyngeal swab. The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Respiratory Symptoms<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample collection study only |  | prospective sample collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Virus
Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA. The polyethylene to be used is E-Poly (Biomet). The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.

Detailed Description
-----------------
Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.

Official Title
-----------------
Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics

Conditions
-----------------
Primary Arthrosis, Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Total hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50-65 years old Primary or secondary osteoarthritis Exclusion Criteria: Significant anatomical divergence are excluded Rheumatoid arthritis Fracture sequelae Dysplasia Immune suppression or grave systemic illness

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: 1<br>Uncemented total hip replacement, 32 mm caput | Procedure: Total hip arthroplasty<br>* 32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene<br>* Other names: E-poly, Vitamine E, Hip, degenerative joint disease;|
| Active Comparator: 2<br>Uncemented total hip replacement, 36 mm caput | Procedure: Total hip arthroplasty<br>* 32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene<br>* Other names: E-poly, Vitamine E, Hip, degenerative joint disease;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure polyethylene wear and bone mineral density between the two groups |  | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamine E, E-poly, Hip, Degenerative joint disease
MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation

Official Title
-----------------
A Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK0633 in Japanese Asthmatic Children Aged 12 to Less Than 16 Years

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: MK0633


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Is Judged To Be In Good Health, Other Than Having Mild To Moderate Asthma, Based On Medical History, Physical Examination, Vital Signs, And Laboratory Safety Tests Patient Has No Clinically Significant Abnormality On Electrocardiogram (Ecg) Performed At The Prestudy (Screening) Visit And/Or Prior To Administration Of The Initial Dose Of Study Drug Patient Has At Least 1 Year Of Mild-To-Moderate Asthma Patient Has Been A Nonsmoker For At Least 6 Months Patients Of Childbearing Potential Must Agree To Use A Medically Acceptable Method Of Contraception During The Study Patients Must Be Able To Swallow Tablets Exclusion Criteria: Patient Has A History Of Clinically Significant Endocrine, Gastrointestinal, Cardiovascular, Hematological, Hepatic, Immunological, Renal, Respiratory, Other Than Asthma, Or Genitourinary Abnormalities Or Diseases Patient Has Required A Visit To A Hospital Or Emergency Room Due To An Asthma Exacerbation Within 3 Months Of The Prestudy Visit Patient Has Unresolved Signs And Symptoms Of An Upper Respiratory Tract Infection (Uri) Or Has Had Had An Upper Respiratory Tract Infection Within 3 Weeks Prior To The Prestudy Visit Patient Has A History Of Stroke, Chronic Seizures, Or Major Neurological Disorder Patient Has A History Of Neoplastic Disease Use Of Theophylline, Anti-Allergic Compounds (Except For Nasal Drop And Eye-Drop Omalizumab, Zileuton, Oral Corticosteroid, And Oral Beta Agonists (Including Patch) Are Excluded   2 Weeks Prior To Administration Of Study Drug And Throughout The Study 7)Patient Consumes Alcoholic Beverages

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0633 | Drug: MK0633<br>* MK0633 (50 mg) Oral, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences |  | 1 day |
Development Study Using Vaginal Tactile Imager

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.

Detailed Description
-----------------
Pelvic organ prolapse affects 40-50% of women in US. This study aims to establish a reliable examination procedure, collect data necessary for assessing the performance of Vaginal Tactile Imaging sensors, assess clinical suitability of interface software and correlate elasticity measurements with clinical examination findings for normal versus prolapse conditions of the female pelvis.

Official Title
-----------------
A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no evidence of pelvic organ prolapse and no prior pelvic surgery stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments no evidence of pelvic organ prolapse with prior pelvic surgery (with or without the use of graft material) Exclusion Criteria: patients with active skin infection, tissue breakdown or ulceration patients with abnormal vaginal anatomy, including vaginal septum, history of vaginal/pelvic radiation, presence of a vaginal tumor or lesion recent pelvic surgery with less than 3-month interval from surgery

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether there is a detectable difference in 3-D elasticity images provided by Vaginal Tactile Imager for the patients with presence or absence of prolapse. |  | 1 Year |
Evaluation of Laparoscopic Internal Retractor Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.

Official Title
-----------------
Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Device: Gallbladder retraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic cholelithiasis Age 18-60 ASA 1-2 Able to sign an informed consent Exclusion Criteria: ASA 3 or more Acute cholecystitis Choledocholithiasis Coagulation disorders Patients on blood thinners Use of Steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subjects will undergo a laparoscopic cholecystectomy. The gallbladder will be retracted using the Endograb retractor. | Device: Gallbladder retraction<br>* The gallbladder will be retracted using the Endograb retractor<br>* Other names: Endograb;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome will be either success or failure. Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No adverse effects related directly to the use of the Endograb retractor. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystectomy, Cholecystectomy, Laparoscopic, Laparoscopy
The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy

Study Overview
=================
Brief Summary
-----------------
A prospective trail. Pregnant women in the first trimester with positive BHCG and no visualization of gestational sac will be recruited. The correlation between endometrial pattern and ectopic pregnancy will be assessed.

Official Title
-----------------
The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy

Conditions
-----------------
Ectopic Pregnancy

Intervention / Treatment
-----------------
* Other: ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First trimester of pregnancy No visualization of gestational sac Exclusion Criteria: Hemodynamic instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ultrasound examination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the corellation between presence and width of trilaminar endometrium as evaluated by transvaginal ultrasound and the diagnosis of ectopic pregnancy |  | first trimester of pregnancy |
A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Chiropractic Adjustive Technique

Study Overview
=================
Brief Summary
-----------------
There are a variety of treatment approaches used by the chiropractic profession. Some of these require forceful joint manipulation and some do not. This study is designed to compare outcomes of two such techniques that are common to chiropractic practice. The hypothesis is that there is no difference between forceful and non-forceful approaches to treatment.

Detailed Description
-----------------
The comparison will permit a one month treatment period for both techniques and a three week follow-up. Patients will be assessed at baseline (intake), and at specified intervals and at three weeks following the termination of care.

Official Title
-----------------
A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Adjustive Technique

Conditions
-----------------
Low Back Pain, Headache, Shoulder Pain

Intervention / Treatment
-----------------
* Procedure: spinal manipulation & patient education/nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic musculoskeletal pain ability to communicate in English Exclusion Criteria: pregnancy contraindications to manipulation pending litigation chiropractic care within the last month

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: spinal manipulation & patient education/nutrition|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Disability Index (PDI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  |  | 
| Patient Expectation |  |  | 
| Evaluation of Clinic Services |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chiropractic, spinal manipulation, low back pain
AirSonea Wheeze Detection Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.

Official Title
-----------------
AirSonea Wheeze Detection Study - Multipart Clinical Performance Assessment to Determine Agreement on Wheeze Detection Between AirSonea™ Versus Physician Auscultation and an Expert Panel.

Conditions
-----------------
COPD, Asthma

Intervention / Treatment
-----------------
* Device: AirSonea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part I: Participants presenting to an Acute Care Setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms Part II: Volunteer participants without asthma Part III: Participants with asthma For all parts of study Age: 18 years or older Participant has signed an Informed Consent after having the Study explained to them. Exclusion Criteria: Any medical finding by the physician that would exclude the patient from participating. < than 18 years of age

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AirSonea<br>Use of AirSonea to detect wheeze sounds. | Device: AirSonea<br> <br> * Other names: No intervention, AirSonea is an adjuct to physician/clinician auscultation.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Efficacy | Device wheeze detection as compared to physician wheeze detection via auscultation. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheeze Rate break points | Wheeze Rate break points for the user of rescue inhalers | Up to 1 week |
Head Elevation in Prone Position

Study Overview
=================
Brief Summary
-----------------
Semi-recumbent position leads to improvement of gas exchange and lung mechanics in patients suffering from ALI or ARDS. Prone positioning leads to similar effects. To date, no data on the combination of these two positioning measures exist. The investigators hypothesize that head elevation in prone position leads to improvement in gas exchange and lung mechanics.

Official Title
-----------------
Influence of Head Elevation in Prone Position on Gas Exchange and Lung Mechanics in Patients With ALI/ARDS

Conditions
-----------------
Gas Exchange, Lung Mechanics

Intervention / Treatment
-----------------
* Procedure: Prone position with head elevation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated ALI or ARDS No contraindications for prone position Exclusion Criteria: Patient < 18 or > 89 years old Pregnancy Elevated intracranial pressure PaO2/FiO2 - ratio < 60 ECMO Open abdomen Instable spine Malignant arrhythmias Severe hemodynamic instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Start with turning to prone position without head elevation, after 2 hours 30° head elevation, after 2 hours back to PP without head elevation. | Procedure: Prone position with head elevation<br>* Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)<br>|
| Active Comparator: 2<br>Start with turning to prone position with 30° head elevation, after 2 hours PP without head elevation, after 2 hours back to 0° PP. | Procedure: Prone position with head elevation<br>* Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio |  | Study period (5 hours on 2 consecutive days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaCO2, Compliance (Chest wall, lung, respiratory system) |  | Study period (5 hours on 2 consecutive days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prone position, ALI/ARDS, Head elevation