linjc16/ctgov huggingface dataset:
A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial

Study Overview
=================
Brief Summary
-----------------
Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU.

Detailed Description
-----------------
Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography.

Official Title
-----------------
A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial

Conditions
-----------------
Weaning of Mechanical Ventilation, Critical Care, Trans-thoracic Echocardiography, Mitral Doppler, Diastolic Function

Intervention / Treatment
-----------------
* Other: trans thoracic echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ventilated requiring first weaning trial of mechanical ventilation Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line Ventilated patients Exclusion Criteria: -

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 |
| --- | --- |
| ZEEP and tubing-spontaneous ventilation<br>Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography. | Other: trans thoracic echocardiography<br> <br> |
| trans-thoracic echocardiography<br>Prospective clinical study in ICU with ventilated patients eligible to weaning trials of mechanical ventilation (ZEEP and tubing-spontaneous ventilation) comparing hemodynamic and cardiac effects evaluated by trans-thoracic echocardiography. | Other: trans thoracic echocardiography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular filling pressure | Echo-cardiographic evaluation is realized at the end of the weaning trial (1 hour) or less if failed | after 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of other echocardiographic parameters of left ventricular filling pressures | Comparison of other echocardiographic parameters of left ventricular filling pressures (E, Ea, deceleration time) at the end of weaning trial | after 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weaning, Cardiac, Echocardiography, Mechanical Ventilation
Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for additional three years.

Official Title
-----------------
Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Opicapone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis with PD subjects who are willing to participate in the trial. subjects who participated in the BIA 9-1067-302 clinical trial. Exclusion Criteria: subjects who didn't take part at the BIA 9-1067-302 clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br> | Drug: Opicapone<br>* 25mg or 50mg once per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| off periods | number of off periods during the day without worsening dyskinesia. | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PD, Off periods, quality of life, dyskinesia, end-off-dose motor fluctuations
Multislice Computed Tomography in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma

Study Overview
=================
Brief Summary
-----------------
Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures. The onset of paralysis may be immediate, delayed or undetermined, the latter of which often occurs in unconscious patients with accompanying life-threatening complications.About one fourth has complete paralysis.

Detailed Description
-----------------
Facial nerve paralysis might have variable etiologies apart from idiopathic Bell's palsy, Congenital, infectious, inflammatory, neoplastic, neurological, toxic, iatrogenic and atraumatic causes. Surgical intervention is indicated if 90-95% loss of function is seen at the very early period on Electroneuronography or if there is axonal degeneration on Electromyography lately with no sign of recovery. High-resolution multislice computed tomography of the temporal bone is routinely required for evaluation of traumatic facial paralysis. High-resolution multislice computed tomography is known to be the best method for evaluating the intratemporal course of the facial nerve, but it has some limitations as well. Occasionally, the surgeon may encounter facial nerve injuries which have not been revealed in the preoperative computed tomography. There are limited data in recent medical publications evaluating the diagnostic value of temporal bone High-resolution multislice computed tomography in the evaluation of traumatic facial paralysis. Therefore, in this study,the investigators will compare the findings of preoperative high-resolution multislice computed tomography with surgical findings to determine the diagnostic value of computed tomography.

Official Title
-----------------
Reliability of Multislice Computed Tomography Scan in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma

Conditions
-----------------
Facial Nerve Paralysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with temporal bone fracture presented with facial nerve paralysis of immediate onset and meet the criteria of facial nerve exploration regardless of age and sex. Exclusion Criteria: Pregnant women. Unfit patients for surgery. Patients refuse surgical intervention.
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 |
| --- | --- | --- |
| Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography | Evaluation the reliability of multislice computed tomography in the assessment of facial nerve paralysis due to temporal bone trauma | up to 2 years |
The Use of Visual Feedback in Airway Clearance

Study Overview
=================
Brief Summary
-----------------
Cystic Fibrosis (CF) patients perform airway clearance incorporating various breathing strategies, to clear secretions from their lungs. Hand held devices may aid mucus expectoration, and also motivate the patient to manage by themselves. Our aims was to study if resistive expiration through volumetric incentive spirometer (VISex) can improve lung function in the short term in Cystic Fibrosis (CF) patients.

Official Title
-----------------
The Immediate Effect of Resistive Expiration Via Volumetric Incentive Spirometer on Lung Function in Patients With Cystic Fibrosis.

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

Intervention / Treatment
-----------------
* Device: Tri-Gym


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cystic fibrosis patients Exclusion Criteria: i.v. antibiotic therapy during the experiment day

Ages Eligible for Study
-----------------
Minimum Age: 5 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lung function<br> | Device: Tri-Gym<br>* 40 CF patients performed airway clearance using the VISex, by exhaling against chosen resistance being motivated by visual feedback of raising colored balls. The level of resistance was set to cause longest expiration/volume, until mucus was transported from the peripheral to the central airways, to be expectorated by the subsequent cough.<br>* Other names: incentive spirometer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function | Forced expiratory maneuvers were measured before and 15 minutes after intervention. | fifteen minutes after intervention |
CDIAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the therapeutic efficacy and side effect of chidamide, decitabine combined with priming IAG regimen for relapsed or refractroy acute myeloid leukemia

Official Title
-----------------
Chidamide, Decitabine Combined With Priming IAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia, Relapsed, Adult

Intervention / Treatment
-----------------
* Drug: CDIAG regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory acute myeloid leukemia patients without severe complications such as active infections and bleedings; ECOG score less than 3. Exclusion Criteria: Inablity to tolerate inducton chemotherapy; life expectancy less than 1 month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: CDIAG<br>Relapsed or refractroy acute myeloid leukemia patients reveive chidamide, decitabine combined with priming IAG regimen treatment. | Drug: CDIAG regimen<br>* Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, decitabine 20mg/m2 intravenously daily for 5 days (d1-d5) and IAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 4-17; idarubicin, 5mg intravenously every other day on days 4, 6, 8, 10, 12, 14; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily on days 3-17.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission Rate | Remission rate achieved after one-two couses induction therapy by CDIAG regimen | 1 month | 
| Overall survial | It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events in hematological system | Record of adverse events in hematological system during and after CDIAG regimen induction | 1 month | 
| Adverse events in other organs or systems | Record of adverse events in other organs or systmes during and after CDIAG regimen induction | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chidamide, decitabine, priming regimen
Evaluation of Consistency of StaphVAX Manufacturing Lots

Study Overview
=================
Brief Summary
-----------------
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.

Official Title
-----------------
A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers

Conditions
-----------------
Staphylococcal Infections

Intervention / Treatment
-----------------
* Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, written informed consent, negative serum pregnancy test if appropriate, expect to comply with protocol procedures and schedule Exclusion Criteria: known HIV, immunomodulatory drugs, malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer), active infection in the 2 weeks prior to study injection, serious S. aureus infection within the last 3 months prior to injection, use of investigational drugs, vaccines or devices within the prior 30 days, hypersensitivity to components of StaphVAX

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type-specific antibody concentrations 6 weeks after vaccine dose. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody concentrations at other time points. |  |  | 
| Elicited health events. |  |  |
Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65

Study Overview
=================
Brief Summary
-----------------
Half of the people over the age of 65 are not functioning at their optimal level because of interference from pain. > 50% of older adults had taken prescriptions of pain medication beyond a 6-month period. In Emergency Department 80% of visits involving conditions with painful component. The study aims to observe and check side effects of most frequently pain killers prescribing at home to patients over 65 years old after a visit in emergency department.

Detailed Description
-----------------
- observe side effects of pain medications prescribed in emergency department to patient over 65 yo

Official Title
-----------------
Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65. The MOSE65 Study

Conditions
-----------------
Acute Pain, Analgesics, Elderly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years or older new analgesic treatment po following emergency department visits easily reachable by phone Exclusion Criteria: age under 65 pt may not able to hear, or answer the phone pt with a history of dementia pt who already takes pain killer, or neuroleptics

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Acetam, acetam + codeine, Ibuprofen, Oxycodone<br>monitoring side effects of pain medication prescribed in patients over 65 acetaminophen 1000 mg tabs po q6h acetaminophen + codeine 500 mg tabs po q6h ibuprofen 200 mg tabs po q8h oxycodone 5 mg tabs po bid | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure side effects of pain medication prescribed by emergency department to patients older 65 years | To Measure the rate of mayor and minor complications and the number of hospitalization during the therapy | up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To ascertain the number of patients pain free | July 1, 2014 | 1 month | 
| Measure the number of patients that follow the therapy prescribed | July 1 2014 | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication Adherence, Medication Compliance, Medication Therapy Management, Side effects, Analgesics, Emergency Medicine, Home care, Aged, Acetaminophen, codeine, ibuprofen, Oxycodone
Determination of Safety and Efficacy of a Laser With Cooling for Treatment of Skin

Study Overview
=================
Brief Summary
-----------------
The appearance of aged skin is a common cosmetic complaint of middle aged and older individuals. This study evaluates the safety and efficacy of a new laser with cooling to improve the appearance of aged skin. The laser being used will heat various depths of the skin while protecting the outer layer.

Conditions
-----------------
Aged Skin

Intervention / Treatment
-----------------
* Device: dermatological infrared laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Aged skin, light to medium skin types. Exclusion: Known photosensitivity Any of the following pre-existing skin conditions: eczema, psoriasis, allergic dermatitis or other conditions that may affect treatment. Other treatments within the past year for aged facial skin

Ages Eligible for Study
-----------------
Minimum 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: Basic Science
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: dermatological infrared laser|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score on a grading scale at post treatment visits |  |  |
Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify if postprandial walks are effective in obese pregnant women, as regards to gestational weight gain and typical diseases of that period, as gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as macrosomia, shoulder dystocia and fetal death.

Official Title
-----------------
Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial

Conditions
-----------------
Obesity, Gestational Diabetes, Preeclampsia

Intervention / Treatment
-----------------
* Behavioral: Postprandial walks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 40 years; Gestational age ≤ 20 weeks, calculated from the last menstrual period and confirmed by the first ultrasound scan; Obesity - body mass index ( BMI ) ≥ 30 kg/m2, based on the weight before pregnancy, reported by pregnant women no more than 5 kg below measured at admission to the study; Physically inactive - according to the International Physical Activity Questionnaire (IPAC); Single pregnancy. Exclusion Criteria: Kidney disease or collagen; Previous history of GDM; Diabetes type 1 or type 2; Hypertensive disorders related to pregnancy; Hemodynamic instability; Vaginal bleeding; Visual, auditory or cognitive impairment.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postprandial walk<br> | Behavioral: Postprandial walks<br>* Obese pregnant women will be target to carry out walks lasting 10' after the main meals (breakfast, lunch and dinner), Monday to Friday, during 8 weeks. Adherence to the program will be determined by daily readings of pedometers previously provided to pregnant women; minimum of 1500 steps per day from Monday to Friday.<br>|
| No Intervention: sedentary pregnant women<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain after postprandial walks in obese pregnant women. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perinatal outcomes