linjc16/ctgov huggingface dataset:
S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Evaluate efficacy and safety of Indobufen v. Aspirin in preventing thromboembolic events in patients at high risk of CV events such as patients suffering from nonrheumatic atrial fibrillation.

Official Title
-----------------
II Italian Study on Atrial Fibrillation (S.I.F.A. II): Prevention of Thromboembolic Events in Patients With Non Valvular Atrial Fibrillation.

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

Intervention / Treatment
-----------------
* Drug: indobufen
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus Exclusion Criteria: Clinically relevant organ disease creatinine clearance < 30 ml/min gastric or duodenal ulcer severe anaemia or poliglobulia

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: indobufen<br>* Indobufen capsules 100 and 200mg<br>|
| Active Comparator: 2<br> | Drug: aspirin<br>* Acetylsalicylic acid capsules 300mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combined endpoints: cerebral ictus (ischemic or haemorragic), cardiovascular death, nonfatal acute myocardial infarction (AMI) or peripheral embolism. The first event occurring during the study will be considered. |  | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms. |  | 3.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of thromboembolic events in patients with non valvular atrial fibrillation
Predictive Value Of Admission Blood Glucose Level In Patients With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Coronary atherosclerosis is the leading cause of death worldwide. Diabetes mellitus is associated with increased prevalence of coronary artery disease Increased plasma glucose is a common feature in the acute phase of myocardial infarction, even in patients without diabetes. Patients with stress hyperglycemia, but without previous diagnosis of diabetes, were at increased risk of congestive heart failure, arrhythmia and cardiogenic shock as well as increased both in-hospital and long-term mortality . Previous studies have demonstrated larger infarct size and poorer prognosis inpatients with hyperglycemia upon hospital admission compared with patients without hyperglycemia It has been reported that stress hyperglycemia impairs microvascular circulation and may lead to no-reflow phenomenon. No reflow phenomenon was significantly more frequent among patients with hyperglycemia and increased progressively with increasing admission blood glucose in patients with Acute Myocardial Infarction . Furthermore, patients with high admission glucose are more likely to develop restenosis and require repeat revascularization procedures compared with those with normal admission glucose and are also at increased risk for repeated Myocardial Infarction, stent thrombosis and death.

Official Title
-----------------
Predictive ValueOf Admission Blood Glucose Level In Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Angioplasty

Conditions
-----------------
Predictive Value of Admission Blood Glucose Level in Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Diagnostic Test: Blood Glucose Level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute ST Segment Elevation Myocardial Infarction patients not known to have Diabetes Mellitus undergoing primary PCI. Exclusion Criteria: patients known to have Diabetes mellitus (known diabetes mellitus on admission, which was treated with diet, oral glucose-lowering medication, and/or insulin). Patients with prior Primary Percutaneous Intervention and/or Coronary Artery Bypass Graft (altering disease state). Patients with severe liver or renal disease (altering disease state). Patients with anemia, kidney disease or certain blood disorders (thalassemia).
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Blood Glucose Level|ON Admission Blood Glucose Level Fasting Blood Glucose Level|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of level of blood glucose on admission in patients with ST Segment Elevation Myocardial Infarction and Hospital Outcome |  | 1 month |
Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody

Study Overview
=================
Brief Summary
-----------------
This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.

Official Title
-----------------
An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: CP-675,206
* Drug: CP-675,206


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III or Stage IV melanoma No evidence of disease following resection of melanoma lesions Recovered from all prior surgical or adjuvant treatment-related toxicities Exclusion Criteria: History of chronic inflammatory or autoimmune disease History of inflammatory bowel disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercial Formulation<br>Commercial Formulation | Drug: CP-675,206<br>* CP-675,206 15 mg/kg iv single dose on Day 1<br>* Other names: anti-CTLA4 human monoclonal antibody;|
| Experimental: Current Formulation<br>Current Formulation | Drug: CP-675,206<br>* CP-675,206 15 mg/kg iv single dose on Day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: maximum plasma concentration of CP-675,206 |  | 1 hour | 
| Pharmacokinetics: AUC, defined as the area under the concentration -time curve |  | Time 0 to Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human-anti-human antibodies |  | 1 year | 
| Adverse events |  | 1 year | 
| Safety laboratory tests |  | 1 year | 
| Proportion of patients alive and free of disease at 1 year |  | 1 year |
ICG Fluorescence Imaging in Lower Extremity Amputation Patients

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.

Detailed Description
-----------------
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.

Official Title
-----------------
Indocyanine Green Fluorescence Guided Imaging in Lower Extremity Amputation Patients

Conditions
-----------------
Trauma Injury

Intervention / Treatment
-----------------
* Procedure: Lower Extremity Amputation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Scheduled for a lower extremity amputation (either below knee, through knee or above knee) Provision of informed consent Exclusion Criteria: Iodine allergy Pregnant women

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 |
| --- |
|Procedure: Lower Extremity Amputation|patients 18 years of age or older who will have a planned lower leg (either below knee, through knee, or above knee) amputation surgery are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee), performed by a participating surgeon or delegate. Provision of informed consent.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Bone Blood Flow (TBBF) | Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging. | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Amputation, Orthopaedic, Lower Extremity
Evaluation of CYP2C9 Activity

Study Overview
=================
Brief Summary
-----------------
The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9. The purpose of the present study is: To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity To correlate phenytoin metabolic ratio with CYP2C9 genotype To study the frequency distribution of CYP2C9 activity in-vivo

Official Title
-----------------
The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity In-vivo

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Phenytoin single dose (300 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range of 20-50 years old Absence of significant disease states Exclusion Criteria: The presence of significant disease states The use of drugs (including birth control pills)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenytoin<br> | Drug: Phenytoin single dose (300 mg)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between phenytoin metabolic ratio and CYP2C9 genotype |  | 24 hours | 
| Frequency distribution of phenytoin metabolic ratio in the population |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol A1281074).

Official Title
-----------------
An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone

Conditions
-----------------
Pyschotic Disorders

Intervention / Treatment
-----------------
* Drug: Ziprasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychotic disorder Completion of previous study of intramuscular ziprasidone Ability to continue with oral ziprasidone Exclusion Criteria: Concomitant treatment with other anti-psychotic agents within 12 hours prior to the enrollment; for depot agents, a period of two weeks or a cycle, whichever is longer, should occur between the last administration and the patient's enrollment. Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for MAOIs (monoamine oxidase inhibitors) and moclobemide, this period should be of two weeks; for fluoxetine, five weeks. Resistance to conventional psychotic agents. (Resistance is defined as a failure to present a therapeutic response during the acute exacerbation after proper attempts of treatment with marketed antipsychotic agents in two or more occasions during the two years prior to the enrollment in the study.)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Ziprasidone<br>* Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.<br>* Other names: Geodon, Zeldox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Clinical Global Impression-Severity (CGI-S) score |  | Until Final Visit (within 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Baseline and Months 1, 2, and 3 |
Surgery and Convergence Insufficiency Intermittent Exotropia

Study Overview
=================
Brief Summary
-----------------
This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.

Detailed Description
-----------------
Surgery can give better results,

Official Title
-----------------
Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial

Conditions
-----------------
Complications

Intervention / Treatment
-----------------
* Procedure: Post exercise Surgery
* Procedure: Orthoptics
* Procedure: Postop orthoptics
* Procedure: Post exercises surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia No stereopsis Good visual acuity Exclusion Criteria: Amblyopia Anisometropia > 2.5D Vertical deviations
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical arm<br>UNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES | Procedure: Post exercise Surgery<br>* ORTHOPTICS/MINUS LENS THERAPY<br>* Other names: Accomodative therapy;|
| Active Comparator: Exercises<br>ORTHOPTICS/MINUS LENS THERAPY | Procedure: Orthoptics<br>* MINUS LENS THERAPY/ ORTHOPTICS<br>* Other names: MINUS LENS THERAPY/ORTHOPTICS;|
| Active Comparator: Postoperative Exercises<br>POST SURGICAL ORTHOPTICS/MINUS LENS | Procedure: Postop orthoptics<br>* ORTHOPTICS/MINUS LENS THERAPY<br>* Other names: Minus Lens Therapy;|
| Active Comparator: Surgical<br> | Procedure: Post exercises surgery<br>* UNIOCULAR/BINOCULAR RECESSION/RESECTION<br>* Other names: Minus Lens Therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative gain of stereopsis |  | 1month-1 year |
Effect of Ramosetron on Post-discharge Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.

Official Title
-----------------
Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center

Conditions
-----------------
Hysteroscopy

Intervention / Treatment
-----------------
* Drug: Ramosetron
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo hysteroscopic surgery and are discharged on the day of surgery. Exclusion Criteria: American Society of Anesthesiologists physical statue 3 or more Planned admission after surgery Intravenous anesthesia During chemotherapy Pregnancy or breastfeeding Abnormal liver or kidney function

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Ramosetron<br> | Drug: Ramosetron<br>* Ramosetron 0.3 mg is administered after induction of general anesthesia.<br>|
| Placebo Comparator: Control<br> | Drug: Normal saline<br>* Normal saline 2 ml is administered after induction of general anesthesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the occurrence of postoperative nausea |  | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour | 
| The change in the occurrence of postoperative vomiting |  | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of postoperative pain score | Score range is from 0 to 10. | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour | 
| The change in the number of postoperative administration of rescue analgesic drug |  | Postoperative 30 minute and 3 hour | 
| The change in the number of postoperative administration of rescue antiemetic drug |  | Postoperative 30 minute and 3 hour | 
| The change of patient's satisfaction score | Score range is from 0 to 10. | Postoperative 30 minute, 3 hour, 24 hour, and 48 hour |
Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia

Study Overview
=================
Brief Summary
-----------------
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if Multi-Target Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS.

Official Title
-----------------
Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia

Conditions
-----------------
Dystonia, Dystonia, Secondary

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with hemi-dystonia secondary to stroke Candidate for GPi DBS Able to provide informed consent Exclusion Criteria: History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor. History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease). Incompetent adults or those unable to communicate.

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pallidal (GPi) Deep Brain Stimulation<br>GPi is the standard target for treating most dystonia. This setting will be the active comparator | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation Electrode<br>|
| Experimental: Thalamic (Vim) Deep Brain Stimulation<br>Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation Electrode<br>|
| Experimental: GPi + Vim (Multi-Target) Deep Brain Stimulation<br>Combined stimulation of GPi and Vim stimulation (both electrodes ON) | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation Electrode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burke Fahn Marsden Disability Rating Scale (BFMDRS) |  | 3 months | 
| SF-36 Quality of Life Scale |  | 3 months | 
| Adverse effects of Vim or Vim + GPi Neuromodulation |  | 3 months |