linjc16/ctgov huggingface dataset:
Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the efficacy and safety of prehospital administration of bivalirudin, as a substitute for heparin, in patients with acute myocardial infarction redirected for primary angioplasty bypassing local hospitals, immediately after the diagnosis is confirmed via tele-transmission of a 12-lead electrocardiogram.

Detailed Description
-----------------
Primary angioplasty (pPCI) is the therapy of choice in patients with ST elevation acute myocardial infarction (STEMI) in Denmark. However, time is lost transferring patients from a local hospital to an invasive treatment centre. Time can be saved by redirecting STEMI patients to pPCI based on wireless prehospital 12-lead electrocardiogram (ECG) transmission directly to a cardiologist's handheld device. To prevent complications during the transportation of STEMI patients to the invasive hospital, patients are treated with oxygen, aspirin, clopidogrel, heparin, and nitro-glycerine in the ambulance. However, heparin use is cumbersome for the ambulance personnel since it must be kept at 5 degrees Celsius. An alternative to heparin may be bivalirudin, since it can be kept at room temperature and thus is easily administered in the prehospital setting. Comparison: Heparin versus bivalirudin treatment. Efficacy is determined by thrombolysis in myocardial infarction (TIMI) flow in the first and final coronary angiogram. Safety is determined by the rate of bleeding complication.

Official Title
-----------------
Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients Redirected for Primary PCI Based on Tele-Transmitted 12-Lead ECGs

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ST elevation acute myocardial infarction patients redirected for primary angioplasty Symptoms less than 12 hours Exclusion Criteria: Contraindications against primary angioplasty
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bivalirudin, Heparin, Bleeding, TIMI flow, STEMI
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.

Official Title
-----------------
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System

Conditions
-----------------
First Metatarsophalangeal Joint Arthritis

Intervention / Treatment
-----------------
* Device: Flower Cube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful Hallux Limitus or Rigidus Painful Geriatric Hallux Valgus Failed prior 1st MTP joint arthroplasty (hemi-total) Arthritis of any etiology other than degenerative causes Exclusion Criteria: Age less than 18 years Pregnant Females Active or prior infection at the target joint Immunocompromised patients Patients unwilling to sign informed consent Patient's unwilling to participate the in study protocol Subject with known sensitivity to titanium implants

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

| Intervention/Treatment |
| --- |
|Device: Flower Cube|single use, sterile disposable fixation construct|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union Rates | Confirm union rates comparable to existing outcomes complications with our proposed construct. | 12 months | 
| Hardware Failures | Evaluate hardware failures with our proposed construct. | 12 months | 
| Complications | Evaluate complications with the procedure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Data | Review cost data using the Flower Orthopedics single use, sterile disposable fixation construct performed in an outpatient surgical setting compared to in patient hospital setting. | 12 months |
Non-invasive Haemodynamic Monitoring to Predict Spinal Hypotension During Caesarian Section

Study Overview
=================
Brief Summary
-----------------
Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases. Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.

Official Title
-----------------
Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study

Conditions
-----------------
Hypotension, Pregnancy Related, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Intervention / Treatment
-----------------
* Device: Clearsight monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia Exclusion Criteria: emergent ceasarean section eclampsia or pre-eclampsia undergoing anti-hypertensive treatment arythmia

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Third trimester pregnant women undergoing ceasarean section<br> | Device: Clearsight monitoring<br>* Non invasive hemodynamic monitoring using a finger cuff Cardiac ultrasound performed to calculate Velocity - Time - integral (VTI) Both intervention are performed before and after a passive leg raising challenge.<br>* Other names: Cardiac ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Ejection volume (mL) | Systolic ejection volume is measured using Clearsight (non invasive monitoring device) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity - Time - Integral (cm) | Velocity - Time - Integral is measured using transthoracic cardiac ultrasound | 30 minutes |
A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

Study Overview
=================
Brief Summary
-----------------
This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.

Official Title
-----------------
A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

Conditions
-----------------
Glucosephosphate Dehydrogenase Deficiency, Favism

Intervention / Treatment
-----------------
* Drug: Primaquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Normal clinical evaluation Willing and able to make all scheduled visits Exclusion: pregnant or planning pregnancy Have taken any anti-malarial medication in past month Positive blood tests for HIV and specific types of hepatitis Allergic to primaquine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
G6PD, Favism, G6PD Deficiency, hemolysis, drug reaction, drug-induced hemolysis
Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND.

Official Title
-----------------
Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer:a Retrospective Cohort Study

Conditions
-----------------
Surgery-Complications

Intervention / Treatment
-----------------
* Other: Whether lymph node dissection is qualified or not


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing laparoscopic surgery Laparoscopic system is 2D and has complete D2 lymph node dissection. Exclusion Criteria: patients undergoing laparotomy incomplete video or clinicopathological information
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| qualified of D2 Lymph node dissection group<br> | Other: Whether lymph node dissection is qualified or not<br>* Klass-02-QC LND scale and general error score tool were used to quantitatively evaluate the intraoperative performance of D2 LND<br>|
| not-qualified D2 Lymph node dissection group<br> | Other: Whether lymph node dissection is qualified or not<br>* Klass-02-QC LND scale and general error score tool were used to quantitatively evaluate the intraoperative performance of D2 LND<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery complicated | Incidence of operative complications between qualified group and unqualified group | 30 days after operation |
Sleep Disorders of Patients With Diseases of the Nervous System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assist training doctors about different diseases of the nervous system affecting sleep. Patients selected to participate in this study will have any of a variety of sleep disorders. They will undergo several tests including an overnight recording of brain activity, eye movement, leg movement, breathing, heart rate, and other measures. Results of these tests will be used to better understand diseases causing sleep disorders and may be used to develop better treatments for them.

Detailed Description
-----------------
The objective of this protocol is to provide training in a broad range of neurological sleep disorders to clinical associates who are eligible for sitting in the Board examination of the Added Qualification of Clinical Neurophysiology administered by the American Board of Psychiatry and Neurology. This protocol is to supplement small accrual of research patients who are referred from within the NIH.

Official Title
-----------------
Training Protocol for Various Sleep Disorders in Patients With Neurological Disorders

Conditions
-----------------
Hypersomnia, Narcolepsy, Nervous System Disease, Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
IINCLUSION CRITERIA: Patients 5 years of age and older, with the following referring diagnoses: Narcolepsy Hypersomnia REM behavior disorder Frontal nocturnal dystonia Restless legs syndrome Insomnia Parasomnia Nocturnal epileptic seizure Nocturnal movement disorder Sleep-related diagnostic dilemma Sleep apnea associated with neurological disorders Patients who are ambulatory and who are able to comply with the study procedures. Patients who are able to understand and sign the informed consent. (Parent or guardian for minors). EXCLUSION CRITERIA: Patients who have been diagnosed with acute and progressive neurological disorders. Patients who are unable to comply with the study procedures and require other than standard care.

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narcolepsy, Polysomnography, Multiple Sleep Latency Test, Sleep Disorders, Hypersomnia, Periodic Leg Movements
Anecortave Acetate in Patients With Open-angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.

Official Title
-----------------
A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
* Other: Anecortave Acetate Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older with open-angle glaucoma. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component. Other protocol-defined exclusion criteria may apply.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anecortave Acetate 3 mg Depot<br>Single injection, anterior juxtascleral depot (AJD) | Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL<br>* Single injection, anterior juxtascleral depot (AJD)<br>|
| Experimental: Anecortave Acetate 15 mg Depot<br>Single injection, anterior juxtascleral depot (AJD) | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL<br>* Single injection, anterior juxtascleral depot (AJD)<br>|
| Experimental: Anecortave Acetate 30 mg Depot<br>Single injection, anterior juxtascleral depot (AJD) | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL<br>* Single injection, anterior juxtascleral depot (AJD)<br>|
| Other: Anecortave Acetate Vehicle<br>Single injection, anterior juxtascleral depot (AJD) | Other: Anecortave Acetate Vehicle<br>* Single injection, anterior juxtascleral depot (AJD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in intraocular pressure at 9 am from baseline |  | Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure |  | At time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open-angle, glaucoma
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

Study Overview
=================
Brief Summary
-----------------
Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.

Detailed Description
-----------------
Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after macular hole surgery. The correlation between the mean length of COST defect and the BCVA was determined. Prognostic factors might have influenced for COST repair was also evaluated by multivariable analysis.

Official Title
-----------------
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Procedure: Vitreous surgery for macular hole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: macular hole patients with surgically-closed hole Exclusion Criteria: macular hole patients failed to close hole presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length >27.0mm or refractive error > -8.0 diopters(D). patients who were not followed at least 6 months

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eyes with macular hole<br> | Procedure: Vitreous surgery for macular hole<br>* Vitreous surgery for macular hole<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Preoperative, postoperative 1, 3, 6, 9, 12 months | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrity of cone outer segment tips line | The mean length of cone outer segment tips defect on preoperative and postoperative 1, 3, 6, 9, and 12 months with spectral domain optical coherence tomography | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spectral-domain optical coherence tomography, idiopathic macular hole, cone outer segment tips line, vitrectomy
Teach-Back Method on Quality of Life in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
This study determines effect of education with Teach-Back method in patients with Heart failure. In this randomized clinical trial, 70 patients with Heart failure hospitalized in year 2016-17 were selected and they were randomly divided into control group and test group.Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the case group, and control group received routine treatment. Information have collected whit Demographic questionnaire and SF36 questionnaire before and after training. Data were analyzed by Spss version18 And there were analyzed by descriptive statistics and Chi-square, Independent T-test, Paired T-test and Co-variance tests.

Official Title
-----------------
Effect of Self-care Education With Teach-Back Method on Quality of Life in Heart Failure Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Education with Teach-Back method
* Other: Received routine treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 45 to 85 Heart failure diagnosed six months ago The Ejection Fraction less than 45 Have reading and writing skills Have perfect consciousness Fluency in Persian Exclusion Criteria: Patient do not cooperate with researchers The inability of each sample to continue cooperation during the study because of the problem or acute disease.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the Test group | Behavioral: Education with Teach-Back method<br> <br> |
| Active Comparator: Control group<br>The control group received routine treatment | Other: Received routine treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF 36 questionnaire | SF36 questionnaire was used to measuring the quality of life | Up to 48 hours | 
| Demographic questionnaire | Demographic questionnaire was used to collect information | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self Care, Heart Failure, Quality of Life, Teach-Back