linjc16/ctgov huggingface dataset:
Quetiapine vs Haloperidol Decanoate for the Long Term Treatment of Schizophrenia and Schizoaffective Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.

Official Title
-----------------
Predicting the Optimal Pharmacotherapy for Outpatients With Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: quetiapine
* Drug: haloperidol decanoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Schizophrenia or Schizoaffective Disorder diagnosed by DSM-IV Between the ages 18-60. A candidate for maintenance antipsychotic therapy. This means that patients will have had at least two documented episodes of acute schizophrenic illness or at least two years of continuing psychotic symptoms. Exclusion Criteria Organic brain disease. Mental Retardation Chronic medical illness which would make antipsychotic medication inappropriate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine|nan|
|Drug: haloperidol decanoate|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
-----------------
quetiapine, haloperidol decanoate
The Incidence and Risk Factors of Postoperative Delirium

Study Overview
=================
Brief Summary
-----------------
Delirium is known to be one of the most common postoperative complications in elderly patients undergoing surgery. Because postoperative delirium can affect the length of hospital stay and prognosis significantly, it is important to identify the risk factors for postoperative delirium in advance. However, there have been few reports concerning intraoperative modifiable risk factors, such as postoperative pain, for postoperative delirium.

Detailed Description
-----------------
In this observational study, we will review the electronic medical records of elderly patients underwent spine surgery and assess the incidence and risk factors for postoperative delirium.

Official Title
-----------------
The Incidence and Risk Factors of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery

Conditions
-----------------
Delirium in Old Age

Intervention / Treatment
-----------------
* Procedure: spine surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital Exclusion Criteria: Patients who had no information on postoperative care and managements.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: spine surgery|Risk factors for postoperative delirium in elderly patients underwent spine surgery will be evaluated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium | Incidence of delirium after spine surgery | through study completion, postoperative period up to 2 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative delirium, elderly, spine surgery
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

Detailed Description
-----------------
Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the Prosigna test.

Official Title
-----------------
Prospective Observational Study to Evaluate the Impact of the Determination of the Intrinsic Subtypes of Breast Cancer by PAM50 NanoString Technology in the Use of Adjuvant Chemotherapy in Women With Breast Cancer, HR+ and Node -.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0) Estrogen receptor status will be evaluated by Immunohistochemistry (IHC)and more than 1% of stained tumor cells will be considered positive. HER2 status will be evaluated by (IHC; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization. Postmenopausal females, which is defined as: Natural Amenorrhea > 12 months, regardless of age Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) Radiological castration with amenorrhea > 3 months, regardless of age Hysterectomy and postmenopausal blood levels Able to give consent Eligible for treatment of breast cancer with adjuvant chemotherapy ECOG performance status of 0 or 1 Exclusion Criteria: Tumor size T3-T4 Non-invasive breast cancer (e.g., Paget's disease, DCIS) Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+) Tumors that are estrogen-receptor negative or HER2 positive Have metastatic disease Unable to give informed consent Unable to complete patient reported outcome surveys Have contraindications for adjuvant chemotherapy Age, performance status, significant comorbidities ECOG performance status > 1
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Prosigna, FFPE, node negative, estrogen receptor positive, HER2 negative
Predicting Success of HFNC: The Utility of the ROX Index

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation in pneumonia patients with acute respiratory failure treated with High Flow nasal cannula.

Detailed Description
-----------------
Purpose The purpose of the study is to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation (MV) in pneumonia patients with hypoxemic acute respiratory failure (ARF) treated with high-flow nasal cannula (HFNC). Materials and methods This is a 4-year prospective observational 2-center cohort study including patients with severe pneumonia treated with HFNC. High-flow nasal cannula failure was defined as need for MV. ROX index was defined as the ratio of pulse oximetry/fraction of inspired oxygen to respiratory rate.

Official Title
-----------------
Predicting Failure of High Flow Nasal Cannula in Pneumonia Patients With Hypoxemic Respiratory Failure: The Utility of ROX Index

Conditions
-----------------
Acute Respiratory Failure, Pneumonia

Intervention / Treatment
-----------------
* Procedure: mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of acute respiratory failure secondary to pneumonia receiving HFNC therapy Exclusion Criteria: younger than 18 years old indication for mechanical ventilation at ICU admission limitation of therapeutic effort

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exit<br>HFNC with no need for mechanical ventilation | |
| failure<br>HFNC with need for mechanical ventilation | Procedure: mechanical ventilation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction of need for mechanical ventilation using ROX index | participants will be followed during their stay in the ICU registering the days with HFNC treatment and their need or not for mechanical ventilation. | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high flow nasal cannula, success, failure, ROX index
Intraoperative NIRS of Transplanted Kidney for Prediction of Acute and Sub-acute Injury

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational cohort study, designed to explore the use of NIRS in kidney transplants. This study will investigate an association between measurements of intra- operative NIRS and post - operative graft dysfunction as manifested in initiation of renal replacement therapy.

Official Title
-----------------
Intraoperative Near Infrared Spectroscopy of Transplanted Kidney for Prediction of Acute and Sub-acute Kidney Injury in Transplanted Patients

Conditions
-----------------
Graft Failure

Intervention / Treatment
-----------------
* Device: Invos Model 5100C Cerebral/Somatic Oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant candidates (living/ cadaver donor) at TLVMC who will consent to participate. Exclusion Criteria: Patients unable to give consent, patients whose surgeries were aborted before transplant, patients who were lost to follow up during the first 7 post-transplant days, patients who suffered from surgical graft failure (vascular problems or need for re exploration due to bleeding etc.) No pregnant patients will participate in this study. No minors will participate in this study.

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

| Intervention/Treatment |
| --- |
|Device: Invos Model 5100C Cerebral/Somatic Oximeter|To measure the correlation between post arterial and venous anastomoses (reperfusion) NIRS values of transplanted kidney and post-transplant graft failure as manifested in initiation of renal replacement therapy post transplant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Failure | Initiation of renal replacement therapy | 7 days post operative | 
| Graft Failure | Initiation of renal replacement therapy | 6 months post operative |
The Role of Microsurgery in Surgical Treatment of Varicocele.

Study Overview
=================
Brief Summary
-----------------
This study is to set the place of microsurgery in surgical treatment od varicocele in infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.

Official Title
-----------------
The Role of Microsurgery in Surgical Treatment of Varicocele.

Conditions
-----------------
Varicocele, Infertility

Intervention / Treatment
-----------------
* Procedure: subinguinal microscopic varicocelectomy
* Procedure: laparoscopic varicocelectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical varicocele infertility duration of min one year poor semen quality otherwise unexplained infertility in the couple Exclusion Criteria: female infertility

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microsurgery<br>40 patients will undergo subinguinal microscopic varicocelectomy | Procedure: subinguinal microscopic varicocelectomy<br> <br> |
| Active Comparator: laparoscopy<br>20 patients will undergo laparoscopic varicocelectomy | Procedure: laparoscopic varicocelectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate after the intervention |  | one yaer after the intervention |
Effects of Alcohol on Simulated Driving

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. The present study will investigate the effects of five different dosages of ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering performance and brain activity will be recorded in both single- and dual-task conditions.

Official Title
-----------------
The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: He/she is aged between 21-50 Written informed consent Right-handed Normal static binocular acuity, corrected or uncorrected Normal hearing Social Drinker (average of 7 to 21 alcoholic drinks per week) Possession of a drivers license Be considered as reliable and mentally capable of adhering to the protocol. Exclusion Criteria: Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) Positive urine pregnancy drug screen in women Use of psychoactive medication Positive alcohol breath test Prior enrolment in the same study Physical or mental illness Excessive alcohol use (>21 alcoholic drinks per week) Excessive smoking (more than 10 cigarettes per day) Intake of caffeine-containing beverages over 5 glasses per day

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>alcohol and placebo | Drug: alcohol<br>* alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo<br>* Other names: alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error). |  | 5 testdays | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction speed after hearing the deviant target tone. Brain activity: ERPs of interest are the mismatch negativity (MMN), P3a, P3b, and reorienting negativity (RON) |  | 5 testdays | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, Driving, Multitasking, ERP, social drinkers
Pediatric Behavioral Informatics to Prevent Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.

Official Title
-----------------
Pediatric Behavioral Informatics to Prevent Cancer

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary care givers or legal guardians of children 4-10 years of age who has attended the last two well-child visits with their child Exclusion Criteria: parent cares for a child who is on a special diet prescribed by pediatrician

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Survey<br>A lifestyle survey was administered to primary-care givers or legal guardians who take their children 4-10 y/o to the pediatric well-child visits. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sugar-sweetened beverages | Behavioral outcome measure of the amount of sugar-sweetened beverages consumed. | one time point (baseline only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | weight status as defined by body mass index (BMI) | one time point (baseline only) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, obesity, prevention, health behaviors, guidelines
Interactionality of Music Preference and Individual Variables in Pain Perception and Management

Study Overview
=================
Brief Summary
-----------------
The purposes of this study were 1) to delineate any differences in general musical taste (trait) and context-specific music preference (state), as well as preferred music characteristics in cancer patients, 2) to investigate the contributions of individual variabilities, personality, behavioral coping styles, and pain levels in predicting changes from trait to state preferences and preferred music characteristics under various pain conditions. Cancer patients were recruited to fill in questionnaires pertaining to their demographic information (age, gender, religious preference, ethnicity, music background and experience), personality traits, music preferences, preferences for music characteristics, coping styles, and pain experiences.

Official Title
-----------------
Interactionality of State-Trait Music Preference, Individual Variability, and Music Characteristics as a Multi-Axis Paradigm for Context-Specific Pain Perception and Management

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IV cancer diagnosis Between 40 - 70 years old Normal or corrected hearing Able to communicate (speak, comprehend, read, write) in English Signed informed consent form Exclusion Criteria: Under 40 or over 70 years old Not able to communicate in English Uncorrected hearing loss/impairment Dementia, psychosis (hallucinations, delusions) that interferes with cognitive processing (verbal and music)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| cancer patients<br> | Other: Questionnaires<br>* Questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on the McGill Pain Questionnaire |  | one year |