linjc16/ctgov huggingface dataset:
What Should be the Anesthesia Method in Endobronchial Coil Treatment

Study Overview
=================
Brief Summary
-----------------
This prospective, randomize study was conducted in a university hospital. Bronchoscopic lung volume reduction (BLVR) coil treatment has recently been introduced into clinical practice as an alternative for patients chronic obstructive pulmonary disease (COPD) with severe refractory heterorogenous emphysema to conventional medical treatment. Thirty two patients diagnosed with (COPD) with severe refractory heterorogenous emphysema undergoing BLVR coil treatment were included in the study. Seventeen procedure were performed under general anesthesia and fifteen procedure were performed under deep sedation-analgesia. in the general anesthesia group peak pressure, air leakage and end-tidal carbon dioxide were recorded. In the both groups pulse oximeter, transcutaneous carbondioxide, recovery time, bronchospasm, laryngospasm, pneumothorax, massive bleeding were recorded.

Official Title
-----------------
Comparison of General Anesthesia and Deep Sedation in Enbronchial Coil Treatment

Conditions
-----------------
Coil Treatment, Deep Sedation

Intervention / Treatment
-----------------
* Other: method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with COPD with undergoing BLVR coil treatment. Exclusion Criteria: patients who refuse to participate in the study
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 |
| --- | --- |
| Other: randomized<br> | Other: method<br>* to compare the use of general anesthesia and deep sedation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time measurement | to compare the recovery time in both groups | 2 hours | 
| complication rate | to compare the complication rate in both groups | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coil treatment, general anesthesia, deep sedation
Post-Operative Treatment With Ketorolac After Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if ketorolac, given after abdominal myomectomy, will decrease the frequency of post-oerative fevers as well as improve post-operative pain management.

Official Title
-----------------
Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients

Conditions
-----------------
Febrile Morbidity, Pain

Intervention / Treatment
-----------------
* Drug: ketorolac
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ant patient undregoing abdominal myomectomy Exclusion Criteria: Patients with contraindication to NSAIDs including history of peptic ulcer disease, renal disease, bleeding diathesis, or hypersensitivity to NSAIDS

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: saline<br>* 15mg IV every 6hrs for 4 doses<br>|
| Active Comparator: 2<br>Ketorolac | Drug: ketorolac<br>* 15mg IV every6 hours for 4doses<br>* Other names: Toradol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative febrile morbidity |  | Inital 24hrs post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain management |  | Initial 24hrs post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-operative febrile morbidity, Post-operative pain management
Genetics of Middle Ear Disease

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify the genes that contribute to susceptibility to recurrent/persistent middle ear disease. Five hundred families with at least 2 children who have undergone tympanostomy tube insertion will be enrolled. A blood sample will be obtained from the children who had tubes and any available parent (at least 1), as well as any siblings without significant histories of middle ear disease.

Detailed Description
-----------------
Using the twin study approach, the investigators demonstrated that time with middle ear effusion (MEE), number of episodes of MEE and numbers of episodes of acute otitis media (AOM) have a strong genetic component. The point estimate of heritability of time with MEE was 0.73. While there is significant evidence that susceptibility to recurrent/persistent OM is largely genetically determined, the specific genes which confer susceptibility are unknown. The overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow the investigators to balance cost efficiency with statistical power. Five hundred evaluable pairs of siblings with a history of tympanostomy tube insertion (affected), their parent(s) and available non-affected full siblings will be recruited. A blood sample will be obtained from each subject for genotyping.

Official Title
-----------------
Genetic Epidemiology of Otitis Media

Conditions
-----------------
Otitis Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: families: 2 or more full sibs who had tympanostomy tubes inserted Exclusion Criteria: major congenital malformations medical conditions with a predisposition for OM (e.g. cleft palate, Down syndrome, or other craniofacial malformations cared for in the Intensive Care Unit as neonate been on assisted ventilation known sensorineural hearing loss
Sexes Eligible for Study
-----------------
All

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
middle ear, otitis, genetics
A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine

Study Overview
=================
Brief Summary
-----------------
This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.

Official Title
-----------------
A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotypes Ib and III Antibodies in Women Previously Immunized With a GBS Ib and III Crm-Glycoconjugate Vaccine

Conditions
-----------------
Group B Streptococcus (GBS) Disease

Intervention / Treatment
-----------------
* Biological: Group B streptococcus (GBS) vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who have given written consent. Individuals who participated in V98P2 and received the complete schedule of vaccinations. Exclusion Criteria: Individuals who have not given written consent. Subjects who did not receive the complete schedule of vaccination in V98P2.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1<br>This is a phlebotomy study. | Biological: Group B streptococcus (GBS) vaccine<br>* No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P2 study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody (Ab) response data at 24-months after the last injection given in study V98P2 GMCs, GMRs and associated 95% confidence intervals will also be determined. |  | 24- months post last injection from V98P2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GBS, Group B streptococcus, Vaccine
Lipid-lowering Effect of Plant Stanol Drink

Study Overview
=================
Brief Summary
-----------------
To determine the effect of investigational products on serum LDL cholesterol.

Official Title
-----------------
The Effect of Plant Stanol Drink on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Dietary Supplement: Drink that contains plant stanols
* Dietary Supplement: Placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults signed written informed consent Exclusion Criteria: participation in a clinical study within 30 days prior to screening visit and throughout the study severe obesity consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study consumption of plant stanol or plant sterol containing food products such as Benecol or Becel pro active 1 month prior to visit 2

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drink that contains plant stanols<br>Dietary supplement: Plant stanol | Dietary Supplement: Drink that contains plant stanols<br> <br> |
| Placebo Comparator: Placebo drink<br>Dietary supplement: Placebo | Dietary Supplement: Placebo drink<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum LDL cholesterol |  | 0 vs 4 weeks |
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

Study Overview
=================
Brief Summary
-----------------
A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.

Detailed Description
-----------------
To test the ability of a daily 3-month treatment with triheptanoin to prevent migraine attacks in 10 migraine patients. This is an open, non-randomized pilot trial that might justify a placebo-controlled trial, if there are at least 50% of patients with ≥50% reduction in attack frequency.

Official Title
-----------------
A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Triheptanoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females aged 18-65 years old having an effective contraception or being menopaused Diagnosis of migraine without aura (ICHD3beta 1.1) since at least 2 years 4-10 migraine days per month during the last 3 months No preventive anti-migraine therapy during the last month Exclusion Criteria: > 4 tension-type headache episodes per month Medication overuse headache or other headache types Resistance to >3 previous preventive anti-migraine drug treatments Any serious medical or psychiatric condition On-going or previous bowel disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| Other: treatment arm<br>pilot-study with single arm of 10 migraine patients treated for 3 months with triheptanoin 1mg/kg/day | Drug: Triheptanoin<br>* Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months<br>* Other names: UX007;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in monthly migraine days |  | Between the 1-month baseline and the 3rd month of triheptanoin treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean attack severity |  | Between the 1-month baseline and the 3rd month of triheptanoin treatment | 
| Change in mean attack duration |  | Between the 1-month baseline and the 3rd month of triheptanoin treatment | 
| Number of patients who have at least a 50% reduction in monthly migraine days |  | Between the 1-month baseline and the 3rd month of triheptanoin treatment |
Treatment of Impaired Glucose Tolerance in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc <7.0 mmol/l and 2 h P-gluc >10.0 and <12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.

Official Title
-----------------
Randomized Controlled, Multicenter Study Evaluating Treatment of Glucose Intolerance in Pregnancy

Conditions
-----------------
Impaired Glucose Tolerance, Fetal Macrosomia

Intervention / Treatment
-----------------
* Drug: Insulin aspart and Insulin human (isophane)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with 75g OGTT result : fasting capillary plasma <=7.0 mmol/l and/or 2 h value >= 12.2 mmol/l Exclusion Criteria: Multiple pregnancy Pregestational Diabetes

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B2<br>IGT randomized to treatment | Drug: Insulin aspart and Insulin human (isophane)<br>* Insulin treatment if fasting p-glucose >5.0 mmol/l or post meal value >6.5 mmol/l according to study protocol.<br>* Other names: Insulatard FlexPen, A10AC01;|
| No Intervention: B1<br>IGT randomized to no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal morbidity and intrauterine growth |  | 1 year post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children´s future health |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational diabetes mellitus, Impaired glucose Tolerance, Pregnancy, Fetal macrosomia, Treatment, Perinatal morbidity
EEG Monitoring in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This study seeks to investigate whether drug effects in suspected overdose patients could be identified using the electroencephalogram (EEG). From previous work it is known that different classes of anesthetic drugs have specific EEG signatures related to the drug mechanisms. Many of the drugs of abuse that are frequently encountered in overdose patients are similar or identical to anesthetic drugs. The hypothesis for this study is that the EEG could be used to characterize the brain effects of intoxicants using EEG in the ED setting. Such monitoring could one day help clinicians and first responders at the point-of-care make more informed decisions to improve the care of overdose patients.

Official Title
-----------------
Observational Study of EEG Monitoring of Patients in the Emergency Department

Conditions
-----------------
Drug Overdose, Substance Abuse, Alcohol Abuse

Intervention / Treatment
-----------------
* Other: Observational EEG Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse Exclusion Criteria: Hemodynamic instability or other acute medical condition for which the primary treating team does not thing it would be appropriate or safe for the study staff to approach the patient The patient has an overt head trauma or deformity of the face which would preclude application of the forehead EEG monitoring lead The patient has dermatological issues or skin conditions on the forehead The patient has known dementia and/or mental impairment The patient is a prisoner The patient is an employee or student at one of the study sites.

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 |
| --- | --- |
| Observational EEG Monitoring<br> | Other: Observational EEG Monitoring<br>* Subjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalogram (EEG) | Subject EEG activity following arrival to Emergency Department with suspected overdose, including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroencephalogram, Opioids, Alcohol, Benzodiazepines, Alpha-2 agonists, Propofol, Ketamine, Marijuana, Neuromechanisms of intoxicants
Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

Study Overview
=================
Brief Summary
-----------------
A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis

Detailed Description
-----------------
Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.

Official Title
-----------------
A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis

Conditions
-----------------
Acute Bronchitis

Intervention / Treatment
-----------------
* Drug: N02RS1 1200mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 19, under 75 of age Patients acute bronchitis, sputum symptoms, BSS over 7 points. Patients acute bronchitis within 7days. Non-pregnant, patients who agree to contraception. Patients who can write diary and available to communicate. Patients voluntarily agreed Exclusion Criteria: Patients with hypersensitivity to the drug. Patients who have gotten systemic steroid treatment within 4 weeks. Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days. Patients who have gotten treatment of mucus solvents or antitussives within 3 days. Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease. Patients heart disease, severe kidney, liver disease. The bleeding tendency or immunosuppressed patients. Patients with clinically significant abnormal values. Pregnant women or nursing mothers. Patients alcoholics or drug abuse. Patients taking other clinical trail's medicines within 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N02RS1 1200mg<br>Combination of Broussonetia spp and Lonicera spp | Drug: N02RS1 1200mg<br>* 1200mg/day, Three times a day orally, 2 tablets once, 7 days<br>|
| Placebo Comparator: Placebo<br>sugar pill | Drug: Placebo<br>* 1200mg/day, Three times a day orally, 2 tablets once, 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days |  | Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days) |