linjc16/ctgov huggingface dataset:
Preventing Aggressive Behavior in Demented Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and pilot test and non-pharmacological intervention designed to prevent the occurence of aggression in persons with dementia.

Detailed Description
-----------------
An expert panel has met to review the investigators' prior work and literature to help create a non-pharmacological intervention designed to prevent the incidence of aggression. The investigators have created a manual based on prior work and expert input. Recruitment for pilot patients is now ready to begin. The purpose of the pilot will be to further adapt the intervention, assess feasibility, and examine recruitment options.

Official Title
-----------------
Preventing Aggressive Behavior in Demented Patients

Conditions
-----------------
Dementia, Aggression

Intervention / Treatment
-----------------
* Behavioral: Preventing Aggressive Behavior in Demented Patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of dementia, caregiver Exclusion Criteria: history of aggression, residence of nursing homes
Sexes Eligible for Study
-----------------
All

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pilot study. Developing intervention | Behavioral: Preventing Aggressive Behavior in Demented Patients<br>* Preventing Aggressive Behavior in Demented Patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggression prevention |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavioral Research, Dementia, Aggression
The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The pathophysiological characteristics of COPD is irreversible airflow restriction which may influence the gas exchange and cause the abnormal PaO2 and PaCO2. Assessment of the partial arterial pressure of carbon dioxide (PaCO2 ) is the 'gold standard' for the evaluation of the adequacy of alveolar ventilation.Method used mostly nowadays : arterial puncture which is accurate but is invasive 、painful、 non-dynamic and there is risk of infection and tissue、nerve damage. Noninvasive measurement methods (Most commonly used)： end-tidal CO2（ ETCO2）、 transcutaneous CO2(TcCO2). They all can monitor the PaCO2 dynamically、 noninvasively, but is existence of controversy of the accuracy. So the investigators want to compare the accuracy of these two noninvasive methods for assessment of PaCO2.

Official Title
-----------------
The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients Exclusion Criteria: hemodynamics is unstable; any other lung disease despite COPD； other diseases influencing experiments: Cognitive impairment disease、 mouth and nose trauma.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| stable COPD group<br>include COPD patients with stable state | |
| AECOPD group<br>include COPD patients with acute exacerbation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance between the values of PetCO2 and PaCO2 measured at the same time | concordance between the values of PetCO2 and PaCO2 measured at the same time | 1 hour | 
| concordance between the values of PtcO2 and PaCO2 measured at the same time | concordance between the values of PtcO2 and PaCO2 measured at the same time | 1 hour |
Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)

Study Overview
=================
Brief Summary
-----------------
The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup

Official Title
-----------------
Relative Bioavailability of Bromhexine for Oral Administration of 16 mg of Bromhexine Hydrochloride Granules Compared to 16 mg of Bromhexine Hydrochloride Syrup in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Replicate Design Phase I Study With Two Treatments in Four Crossover Periods)

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

Intervention / Treatment
-----------------
* Drug: Bromihexine hydrochloride syrup
* Drug: Bromihexine hydrochloride granules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Healthy male and female volunteers Exclusion criteria: - Any relevant deviation from healthy conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromihexine hydrochloride granules<br>16 mg granules | Drug: Bromihexine hydrochloride granules<br>* granules<br>|
| Experimental: Bromihexine hydrochloride syrup<br>16 mg syrup | Drug: Bromihexine hydrochloride syrup<br>* syrup<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-tz (area under the plasma concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) |  | 48 h | 
| Cmax (maximum measured concentration of the analyte in plasma) |  | 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) |  | 48 h |
Effect of Constraining Joint Motions on Postural Control

Study Overview
=================
Brief Summary
-----------------
A major advantage of understanding a neural control scheme is able to simultaneously perform multiple tasks based on the Uncontrolled Manifold (UCM) hypothesis by taking advantage of motor redundancy. The present study aims to investigate this hypothesis further by examining the effect of artificially eliminating knee and lumbar-thoracic joint motions on postural control when the arms performing targeting task simultaneously in standing. Subjects (Younger group: 20 35 years old; Elder group: 60 85 years old) will execute a targeting task with and without an additional ball-balancing task in standing with free joint motions and with restricted joint motions. The investigators expect to recruit 50 subjects for each group. Analyses of joint configuration variance on the stability of the center of mass (COM) position and the hand path will be performed using the UCM method of variance analysis. This method partitions joint configuration variance into one component consistent with the use of motor abundance and a component that leads to COM position or hand path variability. Furthermore, the differences between the younger group and the elder group will be evaluated.

Official Title
-----------------
Effect of Constraining Joint Motions on Postural Control

Conditions
-----------------
Healthy Adults

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are healthy with no self-reported neurological deficits, musculoskeletal conditions or motion sickness that affected their ability to maintain stable upright posture. Exclusion Criteria: Participants are healthy with self-reported neurological deficits, musculoskeletal conditions or motion sickness that affected their ability to maintain stable upright posture.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Variability of Fluconazole Concentration in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing and ineffective fluconazole trough serum concentrations were found in a recent retrospective study. Variability in fluconazole exposure can be easily measured with therapeutic drug monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug monitoring can be valuable regards decreasing mortality.

Official Title
-----------------
Fluconazole Exposure in Critically Ill Patients and the Value of Therapeutic Drug Monitoring

Conditions
-----------------
Invasive Candidiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years or older. Treatment with fluconazole. Written informed consent obtained from patient. Written informed consent obtained from representative of patient. Exclusion Criteria: Blood sampling not possible

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 |
| --- | --- | --- |
| Plasma concentrations of fluconazole in critically ill patients | Plasma concentrations of fluconazole will be determined using a validated method involving LC-MS/MS | Up to one month |
Retrospective Evaluation of Carvedilol Versus Captopril in CHF Patients

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children's Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study. We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

Detailed Description
-----------------
This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children's Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study. We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

Official Title
-----------------
The Retrospective Evaluation of Carvedilol Versus Captopril and Digoxin/Lasix Therapy in Congestive Heart Failure Due to Left-to-Right Shunt Lesions

Conditions
-----------------
Heart Failure, Heart Murmurs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 0-18 years with a cardiac defect resulting in a left-to-right shunt (i.e. ventricular septal defect) who develop congestive heart failure. Patient must have been treated with one of the study medications: carvedilol, digoxin, or furosemide. - Exclusion Criteria: Patients who are not between 0-18, who do not have a defect resulting in left-to-right shunt, who do not have congestive heart failure and who have not been treated with one of the study medications: carvedilol, digoxin, or furosemide. -

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, Left-to-Right Shunt
From ACute To Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy

Study Overview
=================
Brief Summary
-----------------
Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1 year after surgery, but it is unknown if it is related to acute postoperative shoulder pain. The purpose of the study is to systematically describe postoperative shoulder pain after lobectomy and examine the time progress up to 1 year after surgery.

Detailed Description
-----------------
Further study details are provided by Departement V, Odense University Hospital

Official Title
-----------------
From Acute to Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for elective lobectomy 18 years or older at the day of the operation Satisfactory abilities to speak and read danish Exclusion Criteria: Previous Thoracical Surgery. Patients with diseases in the nervous system. Patients with preoperative shoulder pain, neuropathies or sensory disturbances in the arm or shoulder. Patients who are reoperated in the thorax in the study period or any other body-region within the first 4 postoperative days.

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 |
| --- | --- | --- |
| Shoulder Pain |  | 12 months | 
| Shoulder range of motion | Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoracical Pain |  | 12 months | 
| Presence of allodynia and hyperalgesia on the shoulder on the operated side. | Presence of allodynia and hyperalgesia on the shoulder on the operated side, compared to the contralateral shoulder. | 1. postoperative day | 
| Quantitative sensory testing values on the shoulder | Quantitative sensory testing values in referred pain area compared to contralateral side and preoperative values. The following quantitative sensory tests are performed: Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshold, Mechanical detection Threshold, Mechanical Pain Threshold, Mechanical Pain Sensitivity, Allodynia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold | 12 months | 
| Hospital Anxiety and Depression Score |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative shoulder pain, Persisting postoperative pain
Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the accuracy of continuous SpHb measurement ( Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood sampling), both during phases of hemoconcentration and hemodilution.

Official Title
-----------------
Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry

Conditions
-----------------
Elective Hepatic Resection

Intervention / Treatment
-----------------
* Biological: Hemoglobin determination + NaCl 0.9% bolus
* Biological: hemoglobin determination + Venofundin bolus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients: Age > 18 years ASA class I and II patient requiring hepatic resection Exclusion Criteria: Patient refusal Patients with a perioperative blood loss exceeding 5ml/kg

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 |
| --- | --- |
| Group 1: 15 patients<br>for elective hepatic resection | Biological: Hemoglobin determination + NaCl 0.9% bolus<br> <br> |
| Group 2: 15<br>for elective hepatic resection | Biological: hemoglobin determination + Venofundin bolus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement |  | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of a bolus of crystalloid on SpHb level will be compared to the effect of a bolus of colloid on the SpHb level. |  | during operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemoglobin, Coagulation variables, blood chemistry, Blood gas analysis
Sonazoid Enhanced Liver Cancer Trial for Early Detection

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.

Official Title
-----------------
Sonazoid Enhanced Liver Cancer Trial for Early Detection

Conditions
-----------------
Hepatocellular Carcinoma, Liver Cirrhosis, Hepatitis B, Hepatitis C

Intervention / Treatment
-----------------
* Device: CE-US (Sonazoid™)
* Device: B-mode US


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 20 HBV or HCV related liver cirrhosis No history of HCC Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet<130,000 Inpatient or outpatient Patients who signed a written informed consent form Exclusion Criteria: History of hypersensitivity to egg yolk Pregnant or lactating women and women who may be pregnant Severe liver dysfunction(AST, ALT,or BIL level >10ULN Associated with HCC Patients receiving interferon Age under 20 Judged by investigator not to be appropriate for inclusion in this study

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group of CE-US<br>screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months | Device: CE-US (Sonazoid™)<br>* screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months<br>* Other names: Sonazoid Group;|
| Active Comparator: Group of B-mode US<br>screening by conventional B-mode US every 3-5 months | Device: B-mode US<br>* screening by conventional B-mode US every 3-5 months<br>* Other names: B-mode Group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of HCC which is detected first |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to detection of HCC |  | 10 years | 
| The improvement of prognosis of patients who are diagnosed in this study |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sonazoid, Early detection, Hepatocellular carcinoma, Liver cirrhosis