linjc16/ctgov huggingface dataset:
Activity Levels and Rehabilitation Outcomes of Patients Post-stroke

Study Overview
=================
Brief Summary
-----------------
Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be recruited into the study. The participants will wear two activity monitors (one commercial grade and one research grade) for the duration of their rehab stay. Data from the monitors will be correlated with rehab outcomes, therapy units billed, and length of stay.

Official Title
-----------------
The Correlation Between Activity Levels and Rehabilitation Outcomes of Patients Post-stroke in an In-patient Rehabilitation Center

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: activity monitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of stroke patient at the Brookdale Center for Healthy Aging & Rehabilitation not greater than maximum assistance to walk 10 feet walking re-training included in the therapy plan of care Exclusion Criteria: primary diagnosis other than stroke allergy or reaction to the wrist bands of the activity monitors

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: activity monitors|activity monitors are worn on the wrist, much like a watch. Data from the activity monitors will be downloaded once a week and at discharge. Normal hospital and therapy activities will not be altered.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Level | Amount of physical activity each day and throughout rehab stay as measured by 2 activity monitors beginning at admission and ending at discharge from the facility | from the date of recruitment to the date of discharge or up to 45 days whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapy units billed | therapy units are billed 15 minute time blocks; the number of each type of unit will be assessed at discharge from the facility | from the date of recruitment to the date of discharge or up to 45 days whichever comes first | 
| Functional Independence Measure (FIM) | FIM is a standard rehabilitation outcome used in all rehabilitation hospitals; measured at admission and discharge from the facility | from the date of recruitment to the date of discharge or up to 45 days whichever comes first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation outcomes, activity level
Impact of Anti-static Chamber/Mask

Study Overview
=================
Brief Summary
-----------------
To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children. Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold.

Detailed Description
-----------------
Objective -- to determine whether an anti-static chamber increases the one-hour steady-state fluticasone plasma concentration, which is an indirect measure of airway delivery and direct measure of systemic exposure. Twelve children 1-6 yrs with well-controlled persistent asthma were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily. The drug was administered by conventional polycarbonate or anti-static valved-holding chambers with masks in an unblinded, randomized, crossover manner each for at least three days. A blood sample was collected one hour after the last dose when adherence documented by electronic monitor was 100%. FP plasma concentrations were measured by liquid chromatography mass spectrometry assay. Results evaluated using regression analysis.

Official Title
-----------------
The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: HFA FP MDI
* Device: conventional chamber/mask; anti-static chamber/mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children 1-6 years old; adequately controlled persistent asthma; currently receiving FP delivered by CFC MDI attached to valved-holding chamber/mask; ability to use chamber with mask effectively Exclusion Criteria: inadequately controlled asthma: nocturnal awakening > 2 nights/month, prn albuterol use > 2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HFA FP MDI|nan|
|Device: conventional chamber/mask; anti-static chamber/mask|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-hour steady-state plasma concentration of fluticasone after each device |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluticasone, asthma therapy, spacer inhaler, HFA-134a
Nutritional Deficiencies in the Bariatric Patients

Study Overview
=================
Brief Summary
-----------------
Although morbidly obese subjects have larger than regular caloric intake, there is evidence that they suffer from nutritional deficiencies at a higher rate than the general population, probably because they eat mostly unhealthy food.

Official Title
-----------------
Preoperative Nutritional Deficiencies in the Bariatric Surgery Patients

Conditions
-----------------
Morbid Obesity, Nutritional Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All morbidly obese subjects who are surgery candidates Exclusion Criteria: Previous bariatric operations
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia

Official Title
-----------------
An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia

Conditions
-----------------
Diabetes Mellitus, Type 2, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged from 20 to 80 years (at inclusion visit). Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin. And having signed a written informed consent.- Exclusion Criteria: Known Type 1 Diabetes, uncontrolled type 2 diabetes [HbA1c > 9.5 %, Fasting plasma glucose (FPG) > 240 mg/dL (> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)]. TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months). Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (> 1 year since their last menstrual period). Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)|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
-----------------
Type II diabetes, dyslipidemia, metformin, fenofibrate, synordia
Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical

Study Overview
=================
Brief Summary
-----------------
To asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.

Detailed Description
-----------------
Management of diabetes in patients admitted to non-intensive unit of a cardiology hospital in order to reduce the number of episodes of hypo-and hyperglycemia, improve glucose control and reducing the number of hospital days. Eligibility criteria: Patients with previous history of diabetes mellitus type 2, or are in use of oral antidiabetics or insulin or having fasting glucose or less 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, aged greater 18 years.

Official Title
-----------------
Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical Trial

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Behavioral: Intensive education of the doctor/nursing team on the protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, age greater than or equal 18 years Exclusion Criteria: Patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in the study

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

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

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: Intensive education of the doctor/nursing team on the protocol<br> | Behavioral: Intensive education of the doctor/nursing team on the protocol<br> <br> |
| No Intervention: Without intervention in the team<br> | Behavioral: Intensive education of the doctor/nursing team on the protocol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in hypo/hyperglycemia episodes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower mean glycemia, reduced time of stay in hospital |  |  |
Cerebrospinal Fluid (CSF) Raltegravir Substudy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid. The hypotheses are: Raltegravir concentrations in CSF will be measurable Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios. Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.

Official Title
-----------------
MK: Raltegravir Concentrations in Cerebrospinal Fluid

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in a raltegravir parent protocol at UCSD. Willing to undergo lumbar puncture. Able to give informed consent. If cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure. Exclusion Criteria: Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets<50,000/µL), hemophilia, or use of anticoagulant medication. Psychiatric disease that would interfere with study participation, in the opinion of the investigator. No major opportunistic infections within 30 days. Moderate or severe cognitive impairment. The proposed study does not have a neuropsychological objective.
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
-----------------
Human Immunodeficiency Virus, Cerebrospinal Fluid, Raltegravir, Drug Concentrations
KTP Green Light Prostatectomy Compared With Open Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).

Official Title
-----------------
The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (180W) Compared With Open Prostatectomy When Treating Benign Prostatic Hyperplasia, a Prospective Randomized Study

Conditions
-----------------
BPH (Benign Prostatic Hyperplasia)

Intervention / Treatment
-----------------
* Procedure: KTP Green Light Prostatectomy
* Device: Green Light
* Procedure: Open prostatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men undergoing surgery for BPH with prostate size more than 100cc Exclusion Criteria: Previous prostate surgery Carcinoma of the prostate Neurogenic bladder Bladder carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 95 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KTP Green Light Prostatectomy<br>Device | Procedure: KTP Green Light Prostatectomy<br> <br> Device: Green Light<br> <br> |
| Active Comparator: Open prostatectomy<br>Surgical procedure | Procedure: Open prostatectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS (International Prostate Symptom Score) | symptom score | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAN-PSS (Danish Prostate Symptom Score) | symptom score | 0, 3, 6 and 12 months | 
| Maximum flow rate (Qmax) |  | 0, 3, 6 and 12 months | 
| Residual urine |  | 0, 3, 6 and 12 months | 
| Length of catheterization |  | Participants will be followed for the duration of hospital stay, an expected maximum of two weeks | 
| Length of hospital stay |  | Participants will be followed for the duration of hospital stay, an expected maximum of two weeks | 
| Perioperative bleeding |  | Time of operation | 
| IIEF (International Index of Erectile Function questionnaire) |  | 0,12 months | 
| Prostate volume measured with TRUS (transrectal ultrasound) |  | 0, 12 moths | 
| Rate of unscheduled hospital contacts |  | 12 months | 
| IPSS (International Prostate Symptom Score) |  | 0, 3 and 6 months |
The Effect of a Real-time Audiovisual Feedback System on CPR Quality

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the effect of a real-time audiovisual feedback system on CPR quality during in-hospital cardiac arrest.

Official Title
-----------------
The Effect of a Real-time Audiovisual Feedback System on CPR Quality During In-hospital Cardiac Arrest: A Prospective Observational Study

Conditions
-----------------
Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Other: Real-time audiovisual feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 17 years old who require cardiopulmonary resuscitation in a medical or surgical intensive care units Exclusion Criteria: Patients less than 18 years Patients with Do Not Resuscitate order Patients who require cardiopulmonary resuscitation outside a medical or surgical intensive care unit

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: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual compression<br>A group who get no real-time audiovisual feedback from the R Series® Monitor/Defibrillator (Zoll medical). | |
| Active Comparator: real-time audiovisual feedback<br>A group who get the real-time audiovisual feedback from the R Series® Monitor/Defibrillator (Zoll medical). | Other: Real-time audiovisual feedback<br>* During the chest compressions, doctors receive audiovisual feedback on the depth and speed of the appropriate chest compressions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chest compression fraction | the percentage of time in which chest compression are done by rescuers during a cardiopulmonary resuscitation | 2 min |
Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:- Differences between ethnic subgroups Differences between immigrant and native-born populations Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

Detailed Description
-----------------
Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:- Differences between ethnic subgroups Differences between immigrant and native-born populations Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors. The clinical features will include pattern of onset, details of full clinical exam ( including ALSFRS-R score, power, reflexes, and other signs of upper or lower-motor neuron dysfunction. Correlations between different clinical parameters themselves will be made, as well as correlation between clinical parameters and other epidemiological factors.

Official Title
-----------------
Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)

Conditions
-----------------
ALS

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Suspected, possible, probable ,definite ALS Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 120 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALS patients<br>ALS patients ( suspected, possible, probable or definite per El-Escorial criteria). Observation | Other: Observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression rate | Progression of ALSFRS-R score over time | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of clinical features of UMN or LMN dysfunction | Appearance of clinical features of UMN or LMN dysfunction over time | 10 years |