linjc16/ctgov huggingface dataset:
Comparison of Effect of Equi-MAC Anesthetics on PSI

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.

Detailed Description
-----------------
There have been several studies comparing electroencephalogram-derived indices produced by sevoflurane and desflurane. However, to the best of our knowledge, there has been no study which compared the two inhaled anesthetics using patient state index. Therefore, the aim of this study is to compare the patient state index values produced by sevoflurane and desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.

Official Title
-----------------
Comparison of the Effect of Sevoflurane and Desflurane on Patient State Index: A Randomized Controlled Trial

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged between 19 and 65 yr patients with American Society of Anesthesiologists physical status classification I or II patients scheduled for elective surgery under volatile anesthesia patients obtaining written informed consent Exclusion Criteria: patients with a history of any psychiatric or neurological disease patients receiving any medication affecting the autonomic or central nervous system patients with a history of alcohol or drug abuse pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>Anesthesia is maintained with sevoflurane. | Drug: Sevoflurane<br>* Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.<br>* Other names: Sevorane;|
| Experimental: Desflurane<br>Anesthesia is maintained with desflurane. | Drug: Desflurane<br>* Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.<br>* Other names: Suprane;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient state index | patient state index value at a steady-state anesthesia of equi-MAC | After a 30-min waiting period from the induction of anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient state index, sevoflurane, desflurane, minimum alveolar concentration
Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone

Study Overview
=================
Brief Summary
-----------------
Hypotheses: Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only will demonstrate significantly better outcomes compared to an age and severity matched control group without ABA treatment. Preschool children with ASDs who undergo ABA in combination with risperidone will demonstrate significantly better outcomes compared to age and severity matched children who are receiving ABA alone. Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment. At baseline, children with ASDs will show significantly lower performances on measures of cognitive, neuropsychological, and socio-emotional functioning than age-matched typically developing controls.

Official Title
-----------------
Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone

Conditions
-----------------
Autistic Disorder

Intervention / Treatment
-----------------
* Drug: Risperidone
* Behavioral: ABA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of autism or severe pervasive developmental disorder (PDD) not otherwise specified (NOS) according to the Autism Diagnosis Interview-Revised (ADI-R) Aged 2.6 to 5.0. Exclusion Criteria: Fragile X or metabolic etiology of PDD symptoms Diagnosis of other central nervous system (CNS) disorders Chronic serious medical problems

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 5 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone|nan|
|Behavioral: ABA|nan|

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
-----------------
Autism, Applied Behavioral Analysis, Risperidone
Development of Population Norms of the Computerized Neuropsychological Assessment for Effectiveness of the Antipsychotic Treatment in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Schizophrenia affects cognition, emotion, and behavior. Neuropsychological assessment enables a better understanding of antipsychotic effectiveness and the brain processes, underlying cognitive functioning in schizophrenia. Neurocognitive deficits in schizophrenia patients appears to explain up to 61% of the variance of functional outcome and is an important predictor of social reintegration (Peuskens et al, 2005) and independent living activitiy (Green et al, 2004). Impaired social functioning within schizophrenia population has been associated with increased health-care costs. Since social and occupational disability may generate the largest indirect costs of the illness, treatment of cognitive deficits has an enormous impact on the cost and disability associated with schizophrenia (McGurk and Mueser, 2004). However, the gap between cognitive science and clinical practice limits the implementation of cognitive assessment in the routine evaluation of schizophrenia patients. Pharmaceutical industry initiated numerous large scale, multisite studies on the impact of novel antipsychotics on cognitive deficits in schizophrenia patients. The aim of this research is to develop population norms of the computerized neuropsychological assessment for effectiveness of the antipsychotic treatment in schizophrenia.

Official Title
-----------------
Development of Population Norms of the Computerized Neuropsychological Assessment for Effectiveness of the Antipsychotic Treatment in Schizophrenia

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An IQ, which is within normal range. Exclusion Criteria: Psychiatric co-morbidity. Physical disability or illness. A history of severe head injury.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| 1<br>350 healthy women , aged from 18 to 89 | |
| 2<br>350 healthy men, aged from 18 to 89 | |

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
-----------------
Computerized Neuropsychological Assessment, Development of Population Norms of the Computerized Neuropsychological Assessment
Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps

Study Overview
=================
Brief Summary
-----------------
The relationship between otitis media with effusion (OME) and chronic rhinosinusitis with nasal polyposis (CRSwNP) remains unclear. A cross-sectional study of 80 consecutively presenting patients who were diagnosed with CRSwNP was conducted. The aim was to ascertain the prevalence of OME in CRSwNP patients, to determine whether the severity of CRSwNP affected OME, and to identify risk factors for OME in CRSwNP patients.

Official Title
-----------------
Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps

Conditions
-----------------
Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Intervention / Treatment
-----------------
* Other: Sinonasal and otologic evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 15 years of age Presence of chronic rhinosinusitis with nasal polyposis (CRSwNP) previously diagnosed or diagnosed at study's onset by endoscopic nasal examination Exclusion Criteria: Presence of a mucopurulent discharge or granuloma during endoscopic nasal examination

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Sinonasal and otologic evaluation|At onset, each participant had: sinonasal evaluation (several nasal signs and symptoms were evaluated, bilateral endoscopic nasal examination, computed tomography (CT) of the sinuses when sinus surgery became necessary). otologic evaluation (evaluation of middle ear status, documentations of personal history of otologic disease, otoscopic examination, pure-tone audiometry and tympanometry)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of OME in CRSwNP patients. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
otitis media with effusion (OME), prevalence, risk factor, endoscopic nasal examination, otoscopic examination, pure-tone audiometry, tympanometry
Hospital Orientation Since SAMU Regulation Centre Call

Study Overview
=================
Brief Summary
-----------------
Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit

Detailed Description
-----------------
Anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call for patients with suspected sepsis and their subsequent hospital orientation

Official Title
-----------------
Study of Association Between Clinical Criteria Collected at the SAMU Regulation Centre Call and the Hospital Orientation of Patients With Suspected Sepsis State

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults (age>18years) patients with suspected sepsis state at the regulation SAMU centre call Exclusion Criteria: minor (age<18years)

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 |
| --- |
|Other: observational study|observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admission Service | Emergency department or intensive care unit | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Adults, Pre hospital settings, Triage, Hospital orientation, Outcome
Pemoline in the Treatment of Stimulant Dependence - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder (ADHD).

Official Title
-----------------
Pemoline in the Treatment of Stimulant Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Pemoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  |  | 
| Depression |  |  | 
| Incidence of stimulant use |  |  | 
| Severity of stimulant withdrawal symptoms |  |  | 
| ADHD symptom severity |  |  | 
| Degree of drug craving |  |  | 
| Frequency of IV drug use and sexual risk behaviors |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
A Study of DER 45-EV Gel to Treat Rosacea

Study Overview
=================
Brief Summary
-----------------
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: DER 45 EV
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 18 years of age or older Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules) Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study Exclusion Criteria: Subjects who are pregnant, breast feeding, or planning a pregnancy during the study Allergy or sensitivity to ingredients in test product Any dermatological conditions of the face that may interfere with study evaluations Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DER 45 EV Gel, 1%<br>DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks | Drug: DER 45 EV<br>* Topical application to face for 12 weeks<br>|
| Placebo Comparator: Vehicle<br>Placebo Gel applied topically once a day for 12 weeks | Drug: Vehicle<br>* Topical application to face for 12 weeks<br>|
| Experimental: DER 45 EV Gel, 5%<br>DER 45 EV Gel, 5% applied topically once a day for 12 weeks | Drug: DER 45 EV<br>* Topical application to face for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) Improvement From Baseline | The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe). | Baseline to Week 12 / end of treatment | 
| Change in Inflammatory Lesion Counts From Baseline | The LS mean changes from Baseline in inflammatory lesion count at Week 12. | Baseline to Week 12 / end of treatment |
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Official Title
-----------------
ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia Not on Dialysis

Conditions
-----------------
Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: ASP1585
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2) Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl Written informed consent Exclusion Criteria: Patients with gastrointestinal surgery or enterectomy Patients with severe cardiac diseases Patients with severe constipation or diarrhea Patients with a history or complication of malignant tumors Patients with uncontrolled hypertension Patients treated with parathyroid intervention within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1585 group<br> | Drug: ASP1585<br>* oral<br>* Other names: bixalomer;|
| Placebo Comparator: placebo group<br> | Drug: placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum phosphorus level at the end of treatment |  | Baseline and Week 12 or treatment discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement rate of the target range of serum phosphorus level |  | During 12 week treatment | 
| Time to achieve the target range of serum phosphorus level |  | During 12 week treatment | 
| Time-course changes in serum phosphorus levels |  | During 12 week treatment | 
| Time-course changes in serum calcium levels |  | During 12 week treatment | 
| Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs |  | During 12 week treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, Not on dialysis, ASP1585, Bixalomer
Coagulopathy in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Coagulopathy in cardiac surgery; a quaternary-care academic center experience Objectives: Primary: To determine incidence of coagulopathy after cardiac surgery in Thai people To determine incidence of resternotomy for stop bleeding, morbidity and mortality Secondary: To identify risk factors which associated with non-red cell transfusion and coagulopathy study decide: Retrospective chart review

Detailed Description
-----------------
Data to be collected: Age*, gender* Body weight, height, body mass index* Underlying disease: DM, renal disease*, liver disease* Pre-op. Antiplatelet or anticoagulant* Pre-op coagulogram and platelet count* Emergency or elective surgery Resternotomy or not* Intraoperative blood component Intraoperative factor concentration Dose and timing of antifibrinolytic administration* CPB time* Postoperative body temperature* *Possible risk factors for non-red cell transfusion statistic: To assess the relationship between risk factors and non-red cell transfusion a univariate analysis was performed using an unpaired t-test and a Chi-square test. For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.

Official Title
-----------------
Coagulopathy in Cardiac Surgery; a Quaternary-care Academic Center Experience

Conditions
-----------------
Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Schedule to cardiac surgery under cardiopulmonary bypass Exclusion Criteria: Schedule for aortic surgery or complex congenital cardiac surgery Using ECMO before surgery Incomplete anesthetic record

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of coagulopathy after cardiac surgery in Thai people | coagulopathy and throbocytopenia | 1 year |