linjc16/ctgov huggingface dataset:
The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

Study Overview
=================
Brief Summary
-----------------
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

Official Title
-----------------
The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

Conditions
-----------------
Ischemia-Reperfusion

Intervention / Treatment
-----------------
* Drug: Antioxidant
* Other: Placebo
* Drug: Anti-inflammatory drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing breast reconstruction Exclusion Criteria: Diabetes mellitus Kidney or liver disease Use of immunosuppressants

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo tablet and iv | Other: Placebo<br>* Placebo tablet and iv<br>|
| Experimental: 2<br>Placebo tablet and intervention iv | Drug: Antioxidant<br>* Antioxidant iv bolus<br>|
| Experimental: 3<br>Intervention tablet and placebo iv | Drug: Anti-inflammatory drug<br>* Anti-inflammatory tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant concentrations |  | 0,5-24 hours |
Equistasi and Gait in Hemiparesis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of Equistasi device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.

Official Title
-----------------
Efficacy of Equistasi on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident

Conditions
-----------------
Hemiparesis

Intervention / Treatment
-----------------
* Device: equistasi
* Device: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subacute hemiparesis Functional Ambulation Classification <4 Exclusion Criteria: previous neurological deficits Glasgow Coma Scale <13 Complete sensory deficit in the lower limbs Levels of Cognitive Functioning ≤5 polyneuropathy contraindications to mobilization/verticalization

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>3 Equistasi devices will be placed during physiotherapy, 5 times per week, for 4 weeks | Device: equistasi<br>* 3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy<br>|
| Placebo Comparator: controls<br>3 placebo devices will be placed during physiotherapy, 5 times per week, for 4 weeks | Device: placebo<br>* 3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disability change assessed using Functional Independence Measure scale |  | 0. 30. 60. 120 days | 
| balance change assessed using Berg Balance Scale |  | 0. 30. 60. 120 days | 
| gait pattern change assessed using Functional Ambulation Classification scale |  | 0. 30. 60. 120 days | 
| gait speed change assessed using Timed Up and Go scale |  | 0. 30. 60. 120 days | 
| gait pattern change using Tinetti scale for gait |  | 0. 30. 60. 120 days | 
| gait speed change assessed using 10 meter walking test scale |  | 0. 30. 60. 120 days | 
| swaying of the center of gravity change assessed with stabilometric platform indexes |  | 0. 30. 60. 120 days |
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Track (GIT) Symptoms in Thailand

Study Overview
=================
Brief Summary
-----------------
This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed for GERD with GerdQ Thai Version.

Official Title
-----------------
Prevalence of GERD in Patients With upperGITsymptoms in Thailand

Conditions
-----------------
Upper GIT Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Female or male aged at least 18 years Patient must be having symptoms suggestive of upper gastrointestinal tract symptoms such as heart burn/ regurgitation Exclusion Criteria: Involvement in the planning and /or conduct of the study (applies to both AstraZeneca staff and /or staff at study site Participation in a clinical study(excluding non-interventional study or registry) during the last 3 months

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 |
| --- | --- | --- |
| Prevalence of gastroesophageal reflux disease (GERD) in patients presented with upper gastrointestinal tract symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to various treatments for patients who have been diagnosed of GERD |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GerdQ
Trehalose in Subjects With Neuronal Ceroid Lipofuscinoses

Study Overview
=================
Brief Summary
-----------------
Neuronal Ceroid Lipofuscinoses (NCL) or Batten's disease are the most common juvenile neurodegenerative disease, characterized by early blindness, movement disorders, cognitive and behavioral impairment, epilepsy, and retinopathy. This study aims to collect clinical and laboratory data of patients with NCL taking Trehalose.

Detailed Description
-----------------
This study aims to collect clinical and laboratory data of patients with NCL taking Trehalose.

Official Title
-----------------
A Study in Subjects With Neuronal Ceroid Lipofuscinoses Taking Trehalose

Conditions
-----------------
Neuronal Ceroid-Lipofuscinoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NCL genetic diagnosis (mutation in genes CLN3 or CLN6) Signed informed consent Exclusion Criteria: Other concomitant neurodegenerative diseases. Therapeutic and eating changes in the last four months prior to the study Unstable clinical conditions (myoclonus worsening, instability in sleep, parenteral nutrition) Refusal to sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| Change from Baseline clinical status assessed using Annex VII of the Unified Batten Disease Rating Scale (UBDRS) (score 0-5 where 5 is the worst outcome) at 12 and 24 months | Blood samples | month 0, month 12, month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline using Annex VII of Unified Batten Disease Rating Scale (UBDRS) (score 0-5 where 5 is the worst outcome) at 12 and 24 months | Blood samples | month 0, month 12, month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile Neuronal Ceroid-Lipofuscinoses, Unified Batten Disease Rating Scale
Focused Assessment With Sonography in Trauma

Study Overview
=================
Brief Summary
-----------------
The study evaluates the knowledge and attitude about Focused Assessment with Sonography in Trauma examination among medical students and medical staff in Poland.

Official Title
-----------------
Prepared for Focused Assessment With Sonography in Trauma Examination?

Conditions
-----------------
Trauma, Ultrasonography

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Give voluntary consent to participate in the study Exclusion Criteria: not meet the above criteria

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

| Intervention/Treatment |
| --- |
|Other: Survey|Survey about Knowledge and Attitude About Focused Assessment With Sonography in Trauma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of the Medical Knowledge Tool (Questionnaire) | Percentage of healthcare workers and medical students with appropriate knowledge assessed by 10- items questionnaire about basic information about Focused Assessment With Sonography in Trauma. For each correct answer participant receive 1 point (0-1 point scale). | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attitudes, knowledge, examination
Schizotypal Personality Disorder Risperidone

Study Overview
=================
Brief Summary
-----------------
Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperidone and placebo.

Detailed Description
-----------------
The electroencephalogram (EEG) was recorder while participants (SPD participants and controls) performed a behavioral task: the Eriksen Flanker Task. The continuous EEG was segmented, corrected for artifacts and averaged. A component of the event-related brain potential known as the error-related negativity (ERN) was identified and its amplitude quantified in microvolts. This procedure was conducted two hours after the administration of risperidone 1 mg and placebo (lactose) on two different experimental days and for each participant group (SPD patients and controls). The amplitude of the ERN after placebo was compared between groups to test for baseline (non-drug-induced) differences between patients and controls. The impact of risperidone on the amplitude of the ERN was compared between the two participant groups.

Conditions
-----------------
Schizotypal Personality Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizotypal Personality Disorder Exclusion Criteria: Major Psychiatric Disorder Medical condition

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schizotypal Personality Disorder<br>Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose). | Drug: Risperidone<br>* 1 mg Risperidone<br>Drug: Placebo<br>* Lactose Placebo<br>|
| Experimental: Healthy controls<br>Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose). | Drug: Risperidone<br>* 1 mg Risperidone<br>Drug: Placebo<br>* Lactose Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurophysiological indices of self-monitoring (Error Related Negativity) | Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration | During acute effects of pharmacological treatment (up to 2 hours) |
The Comparison of Oxidative Stress Between Inhalation Anesthetics

Study Overview
=================
Brief Summary
-----------------
Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from healthy volunteers(for method quality control) and patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to investigate the effect of different anesthetics on isoprostanes.

Detailed Description
-----------------
Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue. Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.

Official Title
-----------------
The Comparison of Oxidative Stress Between Inhalation Anesthetics

Conditions
-----------------
Oxidative Stress, Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving cardiac valve surgery in ASA II-III physical status Exclusion Criteria: trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| cardiac surgery with CPB<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| isoprostanes isomer as marker of oxidative stress |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isoprostanes, mass spectrometry
Evaluating PVI Using CMR

Study Overview
=================
Brief Summary
-----------------
Using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the ablation scar at 3 months follow up and atrial fibrillation-free survival at 1 year.

Official Title
-----------------
CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (age ≥18 years old) Paroxysmal or persistent AF meeting guideline criteria. Anticipated PVI using index-guided radiofrequency ablation techniques. Availability of LGE-CMR images within 3 months before anticipated PVI. Exclusion Criteria: History of catheter ablation History of cardiac surgery. History of chest radiation therapy Estimated glomerular filtration rate (eGFR) <45 ml/min/kg Known (or suspected) allergic reaction to gadolinium Contraindications for CMR (such as claustrophobia, certain implants, devices, high body mass index). Inability to schedule CMR <48h after PVI Long-term use of anti-inflammatory medication, except for the use of nonsteroidal anti-inflammatory drugs Autoimmune disease or chronic inflammatory illness. Pregnancy of breast feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PVI<br> | Procedure: MRI<br>* MRI prior to PVI, acutely after PVI, and 3 months after PVI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablaton scar | The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrence | The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure | 1 year |
Prevention of Inappropriate ICD Shocks

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.

Conditions
-----------------
Inappropriate ICD Therapy, Appropriate ICD Therapy

Intervention / Treatment
-----------------
* Device: ICD programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Cardiomyopathy (ischemic or not) Current accepted indication for ICD implantation Exclusion Criteria: Previous device implantation Secondary prevention patients Pregnancy, Primary electrical disorders, Patient refusal, <1 year of expected mortality

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional<br>Conventional ICD programming | Device: ICD programming<br> <br> |
| Experimental: High-zone<br>High-zone ICD programming | Device: ICD programming<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First total inappropriate therapy | Occurence of first total inappropriate therapy at 12-month follow-up | 12 months | 
| Occurence of first total appropriate therapy at 12-month follow-up | Occurence of first total appropriate therapy at 12-month follow-up | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Occurence of all-cause mortality at 12-month follow-up | 12 months | 
| Hospitalization for heart failure | Occurence of hospitalization for heart failure at 12-month follow-up | 12 months |