linjc16/ctgov huggingface dataset:
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

Official Title
-----------------
A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab

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

Intervention / Treatment
-----------------
* Biological: Evolocumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed week 80 of study 20120153 (NCT01813422). Exclusion Criteria: Did not complete investigational product in the 20120153 parent study Have an unstable medical condition, in the judgment of the investigator Known sensitivity to any of the products to be administered during dosing Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Evolocumab<br>Participants received 420 mg evolocumab once a month for up to 2 years. | Biological: Evolocumab<br>* Administered by subcutaneous injection once a month<br>* Other names: Repatha;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device. | From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) |  | Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128 |
The Effect of Magnesium Oxide on Plasma Phosphate in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients.

Conditions
-----------------
Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: Mg Oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis with duration>3 months serum P level >5.5 mg/dl serum Ca>8 mg/dl. Exclusion Criteria: Mg level >3 mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mg Oxide<br>Mg Oxide (Mg®, 21st Century®) 250 mg orally for 4 weeks | Drug: Mg Oxide<br>* 250 mg orally for 4 weeks<br>* Other names: (Mg®, 21st Century®);|
| placebo<br>placebo 1 tab TDS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma phosphate level |  | 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mg oxide, hyperphosphatemia, plasma phosphor level
An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The real-world observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

Detailed Description
-----------------
The trial is a multi-centre, real-world non-interventional observational study. In the study, the patients with T1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

Official Title
-----------------
A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of the Chinese Patients With T1 Non-small Cell Lung Cancer Complicated With Lymph Metastases

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Surgeries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received surgeries from 2015 to 2017; Pathologically diagnosed patients with T1 non-small cell lung cancer; Exclusion Criteria: - Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC patients with lymph metastases<br>Pathologically diagnosed patients with T1 non-small cell lung cancer complicated with lymph metastases after surgeries | Procedure: Surgeries<br>* Surgeries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the patients with lymph metastases | Percentages of the patients with lymph metastases categorised by patient demographic and tumor biological characteristics | 2015 - 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of N0/N1/N2/N3 patients | Percentages of N0/N1/N2/N3 patients in the target population | 2015 - 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese, T1 non-small cell lung cancer, Lymph metastases
Measuring Upper Extremity Functional Movement With Accelerometry: FitBit® vs Actigraph®

Study Overview
=================
Brief Summary
-----------------
To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility of accelerometry measurement of UE movement.

Detailed Description
-----------------
Participants will wear two different accelerometers (FitBit and Actigraph) to record normal, everyday movement. Data from each accelerometer will be compared to determine similarity.

Official Title
-----------------
Measuring Upper Extremity Functional Movement With Accelerometry: FitBit vs Actigraph

Conditions
-----------------
Motor Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults with no upper extremity limitations Exclusion Criteria: Upper extremity limitations

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy adults<br>Healthy adults without any limitations in upper extremity movement or function. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steps | Number of steps | 24 hours |
Venous Thromboembolism Taskforce Audit Program

Study Overview
=================
Brief Summary
-----------------
To determine the effect of an interventional campaign run by a dedicated VTE Nurse Educator over a 6-month period and the effect on prophylaxis rates. To determine the proportion of medically admitted patients with risk factors for VTE. To assess and compare the use of venous thromboembolism (VTE) prophylaxis in hospitalized medical patients versus recommendations and current guidelines. To determine the patient characteristics of those deemed to be at risk of VTE. To determine the proportion of patients receiving appropriate thromboprophylaxis for their risk. To determine the type and duration (where possible) of prophylaxis used.

Official Title
-----------------
Venous Thromboembolism Taskforce Audit Program

Conditions
-----------------
Venous Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital admission for an acute illness with an in-patient hospital stay of 3 days or more. Exclusion Criteria: Patients who have undergone any type of surgery during current admission Patients who are admitted to a ward or department that is excluded from this study e.g psychiatric, paediatric, maternity, intensive care unit, coronary care unit. Prior enrollment in this protocol during current admission Prior enrollment in a VTE study involving pharmaceutical or mechanical treatment within last 90 days. Admission for suspected or diagnosed deep vein thrombosis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30

Study Overview
=================
Brief Summary
-----------------
To evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in view of their use in future multicenter, multinational clinical efficacy trials testing a putative cognitive enhancer for individuals with Down syndrome aged 6-30.

Official Title
-----------------
A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Japanese Individuals With Down Syndrome Aged 6-30

Conditions
-----------------
Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects may have standard trisomy 21, Robertsonian translocation, isochromosome21,Down syndrome with reciprocal translocation or mosaicism. Availability of parent or other reliable caregiver who agrees to accompany the subject to clinic visits, provide information about the subject's behavior and symptoms. Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate to the study provided they are on stable medication for at least 8 weeks prior to screening. Exclusion Criteria: Individuals who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 30 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suitability for individuals with Down syndrome assessed by number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values. |  | 26 weeks |
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether an ultrathin endoscope will improve a patient's tolerance during the procedure. In addition, this study will look at whether local pharyngeal anaesthesia is necessary during ultrathin endoscopy.

Official Title
-----------------
Comparison of Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patients With or Without Local Pharyngeal Anaesthesia: A Randomized Controlled Trial

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Procedure: Local pharyngeal anaesthesia
* Device: Ultrathin endoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18-70 Exclusion Criteria: Previous experience of upper endoscopy Allergy to local pharyngeal anaesthesia Patient requesting sedation during endoscopy

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Local pharyngeal anaesthesia|nan|
|Device: Ultrathin endoscope|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's tolerance and anxiety in visual analog scale (VAS) score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's satisfaction; procedure time; complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper endoscopy, local pharyngeal anaesthesia, ultrathin endoscope
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

Study Overview
=================
Brief Summary
-----------------
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia

Official Title
-----------------
Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia

Conditions
-----------------
Chronic Insomnia

Intervention / Treatment
-----------------
* Device: Lacrima Medical Device and sham comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Adult subjects, 18 years of age and older at screening Diagnosis of primary insomnia based on International Classification of Sleep Disorders, revision no 2 Total score of Pittsburgh Sleep Quality questionnaire is > 5 Latency to persistent sleep is > 30 minutes based on Pittsburgh questionnaire Able to understand and provide written informed consent Main Exclusion Criteria: Patients using any pharmacological treatments for insomnia for 14 days Patients currently using stimulants drugs 7 days Patients currently using antidepressants causing sleepiness Patients who are unable to commit to avoid consumption alcohol during the study Patients who are unable to commit to avoid consumption caffeine after 12 pm Patients who have a clinical significant or unstable medical or surgical condition

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacrima medical active device<br> | Device: Lacrima Medical Device and sham comparator<br> <br> |
| Sham Comparator: Lacrima medical sham device<br> | Device: Lacrima Medical Device and sham comparator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events |  | Up to 37 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep latency time based on sleep actigraph |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, medical device, sleep latency
Effect of Intravenous Patient-controlled Analgesia (IV-PCA) With Fentanyl in Adults for Acute Postoperative Pain Control

Study Overview
=================
Brief Summary
-----------------
In this retrospective study, the investigators examined incidence and risk factors of postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA).

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between 20 to 60 years old Date from 1st, May 2011 to 31st, October 2011 Patients with fentanyl based intravenous patient-controlled analgesia for postoperative pain control Exclusion Criteria: Reoperation within 48 hours Patients who cannot express numerical rating scale for pain due to sedation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fentanyl|intravenous patient-controlled analgesia|

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
-----------------
intravenous patient-controlled analgesia, IV PCA
Predicting Intubation of Patients Hospitalised for Acutely Attacked Asthma

Study Overview
=================
Brief Summary
-----------------
Although the asthmatic treatments currently be effective in term of efficacy of inhaled medications and good clinical outcome including symptom controlled and asthma exacerbation number, the large number of worse event still have been reported. Few cases eventually have been intubated and died even though using optimal medication. In this study, we will search to identify factors that may influence intubation in hospitalised patient with asthmatic attack.

Official Title
-----------------
Predicting Factors of Intubation in Hospitalised Patients With Acutely Attacked Asthma

Conditions
-----------------
Intubation Complication, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had been admitted and diagnosed as asthmatic attack between year 2016-2018. Patients who have age > 15 year old. Exclusion Criteria: Non

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Intubated asthma attack<br>Patients who had been hospitalised with asthma attack, then intubated during hospitalisation. | |
| Non-Intubated asthma attack<br>Patients who had been hospitalised with asthma attack without intubation during hospitalisation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number case of intubated patient | Number case of hospitalized asthmatic attack patients during 2-year review. | Retropectively review 2 years backard between 2017-2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of previous asthma attack before this admission | Number of previous asthma attack with 12 months before this hospitalization. | 1 year before admission | 
| Blood eosinophil count at admission time | Blood eosinophil may help predict outcome and risk for intubation. | Retropectively review 2 years backard between 2017-2018 | 
| Number patients dead | Number patient dead during hospitalization | Retropectively review 2 years backard between 2017-2018 |