linjc16/ctgov huggingface dataset:
OPALS Critical Care Sub-Studies

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the incremental benefit of a full advanced life support EMS program on the outcomes of chest pain, respiratory and major trauma patients.

Official Title
-----------------
Ontario Prehospital Advanced Life Support (OPALS) Study Phase III Cardiac Arrest and Critical Care Sub-Studies - Chest Pain Sub-Study, Respiratory Sub-Study, and Major Trauma Sub-Study

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Procedure: Advanced Life Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chest Pain Sub-Study: Adult patients with a complaint of chest pain of an acute nature transported to hospital by ambulance. Patients with a complaint of pain in arms, neck or jaw if consistent with myocardial ischemia. Patients must have an ambulance return code of prompt, urgent, or no patient carried. Respiratory Sub-Study: Adult patients with a chief complaint of shortness of breath defined as ACR codes of Respiratory Failure, Shortness of Breath NYD, Pulmonary Edema (CHF), Asthma and had either prehospital assisted ventilation or abnormal respiratory rates (&gt;=24 or &lt;=10) Major Trauma Sub-Study: Adult patients who have suffered an injury from any mechanism with an Injury Severity Score of &gt;12 who have been transported to hospital by land ambulance, and who have been entered into the Ontario Trauma Registry (OTR) Comprehensive Data Set. Exclusion Criteria: All Sub-Studies: Patients under the age of 16 Patients who are vital signs absent prior to EMS arrival. Chest Pain Sub-Study: Patients suffering primarily from respiratory distress, respiratory failure, pulmonary edema, asthma, palpitations or epigastric pain. pain

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

| Intervention/Treatment |
| --- |
|Procedure: Advanced Life Support|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to discharge |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generic Quality of Life |  |  | 
| Disease Specific Quality of Life CPC Score and FIM Score |  |  | 
| Performance of ALS Procedures |  |  | 
| Response Time Intervals |  |  | 
| Length of Stay in Hospital |  |  | 
| Length of Stay in Critical Care Units |  |  | 
| Ventilator time |  |  | 
| Disease Specific Quality of Life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest Pain,, Shortness of breath,, Injury,, Trauma
The Prediction and Prevention of Disease by Using Big Data in Motion Analysis

Study Overview
=================
Brief Summary
-----------------
Variable patterns of gait disturbance can be found in patients with spine disease including the problems of gait initiation, freezing of gait, reduced balance and postural control, reduced step lengths, increased step times, and slow walking speed.

Official Title
-----------------
The Prediction and Prevention of Disease by Using Big Data in Motion Analysis

Conditions
-----------------
Ankylosing Spondylitis, Adolescent Idiopathic Scoliosis, Gait Analysis

Intervention / Treatment
-----------------
* Device: Inertial measurement unit sensor-based gait analysis system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pusan National University Hospital orthopedics, otorhinolaryngology, neurology outpatient or inpatient who agreed to the study. For adult men and women 18 years of age or older. Exclusion Criteria: Patients unable to walk independently.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait analysis<br>Gait analysis of patients with ankylosing spondylitis, patients with adoldescent idiopathic scoliosis and control group. | Device: Inertial measurement unit sensor-based gait analysis system<br>* Gait analysis was performed on 20-m long corridor to collect gait data on more than 23 strides. The gait protocol was performed with an IMU sensor-based gait analysis system (DynaStab™, JEIOS, South Korea) consisting of a shoe-type data logger (Smart Balance1 SB-1, JEIOS, South Korea) and a data acquisition system (DynaStab-Spotfire1, Tibco Spotfire 7.10). The shoe-type data logger included an IMU sensor (IMU-3000™, InvenSense, USA) that measured tri-axial acceleration (up to ± 6 g) and tri-axial angular 136 velocity (up to ± 500˚ s-1) along three orthogonal axes.12,16 The IMU sensors were installed in both shoe outsoles, and the data were transmitted wirelessly to a data acquisition system via Bluetooth®. Shoe sizes were adapted to each participant, with available sizes ranging from 225 mm to 280 mm. The local coordinate system for the IMU sensors included the 140 anteroposterior, mediolateral, and vertical directions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait asymmetry | comparing the swing times performed by one leg with respect to the swing times performed by the other, according to the following formula: GA = 100 x ln(SSWT/LSWT) | for 1minute walking | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait analysis, Spine
18F-FES PET/CT's Additional Clinical Value in ER+ BC

Study Overview
=================
Brief Summary
-----------------
To figure out whethetr 18F-FES PET/CT could influence the staging and management of newly diagnosed Oestrogen Receptor-positive Breast Cancer Patients.

Official Title
-----------------
18F-FES PET/CT Influences the Staging and Management of Newly Diagnosed Oestrogen Receptor-Positive Breast Cancer Patients: A Retrospective Comparative Study With 18F-FDG PET/CT

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed immunohistochemical confirmed oestrogen receptor (ER)-positive breast cancer Patients underwent both 18F-FES PET/CT and 18F-FDG PET/CT in Fudan University Shanghai Cancer Center within 1 week after diagnosis Patients with available medical history Exclusion Criteria: Patients with incomplete medical history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| PET group<br>the staging and management of newly diagnosed ER+ Breast Cancer Patients based on 18F-FDG PET/CT | |
| FES group<br>the staging and management of newly diagnosed ER+ Breast Cancer Patients based on 18F-FDG PET/CT and 18F-FES PET/CT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staging of breast cancer | Deliver questionnaire to phycians to investigate the staging of BC according to AJCC 8 (TNM staging). | 6 weeks |
Carotid Artery Analysis During an LPEC Manoeuvre

Study Overview
=================
Brief Summary
-----------------
Verify in ultrasound the impact of a Sellick and LPEC manoeuvre in terms of compression of the carotid artery and decrease in vascular flow.

Official Title
-----------------
Effect of the Left Paratracheal Compression of the Cervical Esophagus and the Sellick Manoeuvre on the Compressibility of the Carotid Artery and Its Possible Effects on the Vascular Flow

Conditions
-----------------
Carotid Occlusion

Intervention / Treatment
-----------------
* Procedure: Ultrasound LPEC/Sellick


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Volunteers Exclusion Criteria: pregnant women people with carotid artery defects people with an anomaly in the oropharyngeal massif

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LPEC/Sellick ultrasound<br> | Procedure: Ultrasound LPEC/Sellick<br>* We will perform an ultrasound of the carotid artery and then apply a Sellick manoeuvre and a left paratracheal compression of the cervical esophagus respectively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compression of the carotid artery during an esophageal compression manoeuvre | Measurement of the diameter of the carotid artery in cross-section and longitudinal section | through study completion, an average of 1 month | 
| Vascular flow of the carotid artery during an esophageal compression manoeuvre | Measurement of systolic velocities in pulsed Doppler in the carotid artery | through study completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the force to be applied to compress the esophagus without compressing the carotid artery | use of a dynamometer to measure the force required to exert at the left paratracheal level | through study completion, an average of 1 month |
A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects

Official Title
-----------------
A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Nelfinavir and Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects between the ages of 18 and 55 years. Exclusion Criteria: Subjects with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir and Omeprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole |  |  |
Personalized Radiation Therapy for GBM

Study Overview
=================
Brief Summary
-----------------
The study is a pilot study to estimate the efficacy of personalized dose-escalation radiation therapy in patients with glioblastoma, as measured by estimating the median of progression-free survival. Toxicity, patterns of recurrence, and overall median survival will be measured as secondary endpoints. Adverse events will be monitored.

Official Title
-----------------
Personalized Treatment of Glioblastoma Via Image-Guided Predictive Modeling of Recurrence: A Single-Arm, Single Institutional Pilot Prospective Study of Dose-Escalated Radiation Therapy

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Radiation: Radation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy-proven WHO Grade IV glioblastoma, after gross-total or near-total resection, who are undergoing definitive chemoradiation as part of their treatment regimen Age 18 or older Ability to give signed informed consent Karnofsky Performance Status (KPS) at least 70 Exclusion Criteria: Placement of Gliadel wafers Participation in another investigational trial Active treatment of another malignancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Dose-escalated radiation therapy | Radiation: Radation Therapy<br>* Personalized Radiation Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 2 years |
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, ages 18-65 Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.<br>* Other names: Abilify;|
| Placebo Comparator: A2<br> | Drug: Placebo<br>* Tablets, Oral, 0 mg, Once daily, 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to endpoint on the MADRS total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Bipolar Version |  |  | 
| Severity of illness score depression |  |  | 
| Mean change from baseline to endpoint |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depressed
Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.

Conditions
-----------------
Pyloric Stenosis

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Drug: Acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who presented for pyloromyotomy Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IV Acetaminophen<br>Acetaminophen administered by intravenous infusion. | Drug: Acetaminophen<br>* Acetaminophen given by IV<br>* Other names: Ofirmev;|
| Rectal Acetaminophen<br>Acetaminophen administered by rectal suppository. | Drug: Acetaminophen<br>* Acetaminophen suppository given rectally<br>* Other names: Acephen, Feverall;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetaminophen Dosage | One time in the OR prior to the start of surgery | Baseline | 
| Average FLACC Pain Score in the PACU | The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. | 0-60 minutes post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU Time | Time spent in the post-anesthesia care unit post-operatively. | 45-60 minutes post-operatively |
Comparison Between Single Shot Ultrasonographic Guided Fascia Iliaca Block and Quadratus Lumborum Block in Hip Arthralgia. Comparative Double Blind Study

Study Overview
=================
Brief Summary
-----------------
hip arthralgia is a painful condition specially geriatric patients. Trail to alleviate pain using locoregional procedures

Detailed Description
-----------------
hip arthralgia is a common presentation in many conditions as rheumatoid arthritis, systemic lupus . Pain is agonizing and disabling patinet to have normal life. we are considering fascial plane block versus quadratus lumborum block to dampen pain score.

Official Title
-----------------
Comparison Between Single Shot Ultrasonographic Guided Fascia Iliaca Block and Quadratus Lumborum Block in Hip Arthralgia. Comparative Double Blind Study

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: Sonar guided fascia iliaca
* Procedure: Sonar guided quadratus lumborum block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All candidates with hip arthalgia (primary or secondery) Exclusion Criteria: History of warfarin or clopidogrel adminstration . patient on chemotherapy Cognitive disrder

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fascia iliaca group<br> | Procedure: Sonar guided fascia iliaca<br>* Sonar guided fascia iliaca<br>|
| Active Comparator: quadratus lumborum<br> | Procedure: Sonar guided quadratus lumborum block<br>* Sonar guided quadratus lumborum block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Visual analogue scale | one week and 3 months |
Use of Apheretic Technologies in Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of H.E.L.P. apheresis on lipid profile, Lp(a) level, and some inflammatory adypocytokines in patients with high cardiovascular risk.

Official Title
-----------------
Use of H.E.L.P. Apheresis in Patients With High Cardiovascular Disease Lp(a)-Related

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Procedure: H.E.L.P. apheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high Lp(a) not responsive to diet and pharmacological treatment Exclusion Criteria: heart failure hepatic failure renal failure

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: active procedure<br>High cardiovascular risk patients will undergo H.E.L.P. apheresis. | Procedure: H.E.L.P. apheresis<br>* High cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lp(a) reduction | We will evaluate the efficacy of apheretic technique through the reduction of Lp(a) in the plasma sample expressed by mg/dL. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory adypocytokines | We will evaluate the efficacy of apheretic technique through the improvement of inflammatory adypocytokines in the plasma sample. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High level of Lp(a)