linjc16/ctgov huggingface dataset:
Impact of Heparin on the Need for Mechanical Ventilation in Neonates

Study Overview
=================
Brief Summary
-----------------
This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.

Detailed Description
-----------------
Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies

Official Title
-----------------
Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation

Conditions
-----------------
Respiration, Artificial, Hemorrhage

Intervention / Treatment
-----------------
* Drug: heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns < day 28 of life Necessity for intensive care treatment Necessity for parenteral drug or fluid application for at least five days Informed consent of parents Exclusion Criteria: Body weight < 500g Mechanical ventilation directly after birth Major malformations Absolute indication for heparin Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease) Cerebral bleeding or other major bleeding Platelet count < 50,000/µl

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of neonates requiring mechanical ventilation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of dependency on mechanical ventilation |  |  | 
| major bleeding |  |  | 
| heparin induced thrombocytopenia |  |  | 
| anti PF4/heparin antibodies |  |  |
An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: memantine HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI Stable dose of donepezil for 3 months Exclusion Criteria: Other evidence of psychiatric disorders Oncologic diagnosis Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: memantine HCl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Inventory |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen Mansfield Agitation Inventory |  |  | 
| Clinical Global Impression Scale |  |  | 
| ADCS-ADL |  |  | 
| Agitation/aggression domain of Neuropsychiatric Inventory (NPI) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
memantine HCl, Dementia, Agitation, Alzheimer Disease
A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

Official Title
-----------------
An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Conditions
-----------------
Ocular Hypertension, Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Latanoprost Punctal Plug Delivery System
* Drug: Xalatan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension Currently on prostaglandin therapy Exclusion Criteria: Uncontrolled medical conditions Subjects who wear contact lenses Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Latanoprost Punctal Plug Delivery System followed by Xalatan<br>Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study. | Drug: Latanoprost Punctal Plug Delivery System<br>* To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.<br>Drug: Xalatan<br>* Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in IOP measurements |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular Hypertension, Open-Angle Glaucoma, Xalatan, IOP
Length of Small Bowel. How Can Standardise Measurement and Why?

Study Overview
=================
Brief Summary
-----------------
Measurement of the small bowel length studied by anatomists, surgeons and radiologists. Results were highly different among these series. Technical and mechanical factors have major effects on measures. Investigators decided to reach a standardization for the measurement of small bowel length.

Detailed Description
-----------------
Small bowel length will be measure in patients undergoing intraabdominal surgery. This will be establish by two surgeon from Treitz ligament to ileocecal valve two, consecutively. For measurement, a tape will place to antimesenteric, mesenteric border and the midline between these two sides. Exclusion criteria include patients with inflammatory bowel disease, peritonitis, prior abdominal surgery. Demographic data, patients clinical details and small bowel length will be recorded.

Official Title
-----------------
Length of Small Bowel. How Can Standardise Measurement and Why?

Conditions
-----------------
Small/Large Bowel

Intervention / Treatment
-----------------
* Procedure: Laparotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for abdominal surgery Exclusion Criteria: Inflammatory bowel disease History of intraabdominal surgery peritonitis
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 |
| --- | --- |
| laparotomy and small bowel length<br>measurement of small bowel length in laparotomies | Procedure: Laparotomy<br>* Small bowel length will measure in laparotomy, regardless of indication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Small Bowel. How Can Standardise Measurement and Why? |  | postop 1 months |
The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions

Study Overview
=================
Brief Summary
-----------------
Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy normals and may be sufficiently different to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals.

Detailed Description
-----------------
Resting state fMRI scans of chronic pain sufferers may be sufficiently different from scans of normal subjects to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals. The analysis will use pattern recognition methods in a leave N out cross validation design. The success of the classifications will be the mean of all the validation runs.

Official Title
-----------------
The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Daily Pain lasting for more than 6 months. Ages eligible for study are between 20 and 70 years. Exclusion Criteria: Adults unable to consent Children, teenagers Pregnant women Prisoners Subjects who do not know English MRI exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Chronic Pain<br>Adults, > 6 months duration, daily pain | |
| Healthy Normals<br>Age and gender matched controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional brain connectivity | Assessed by fMRI | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pain, fMRI, DTI
Effect of Laser Puncture on Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
Studying the effect of laser puncture on rheumatoid arthritis patients

Official Title
-----------------
Effect of Laser Puncture on Rheumatoid Arthritis Patients

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: Laser
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meeting the criteria of ACR classification for rheumatoid arthritis Meeting the criteria of EULAR classification for rheumatoid arthritis Exclusion Criteria: Having malignancy Having connective tissue disease Smokers

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Group<br> | Device: Laser<br>* Laser puncture and exercise<br>|
| Active Comparator: Control Group<br> | Procedure: Control<br>* Exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAQ (Change) | Health Assessment questionnaire | Pre-intervention, 4 weeks | 
| RAQoL (Change) | Rheumatoid Arthritis Quality of Life | Pre-intervention, 4 weeks | 
| CRP (Change) | Analysis of serum C-reactive protein | Pre-intervention, 4 weeks | 
| IL-6 (Change) | Plasma interleukin-6 inflammatory markers | Pre-intervention, 4 weeks | 
| ATP (Change) | Plasma ATP concentration anti-oxidant marker | Pre-intervention, 4 weeks | 
| MDA (Change) | plasma malondialdehyde oxidative marker | Pre-intervention, 4 weeks |
Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.

Official Title
-----------------
A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: VBP-245
* Drug: Placebo Gel (no Povidone-Iodine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study. Male or female ≥ 8 years old. Subject has a clinical diagnosis of verruca vulgaris (common warts). Subject has up to 6 warts located on the trunk or extremities Exclusion Criteria: Subject has clinically atypical warts on the trunk or extremities. Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.) Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.

Ages Eligible for Study
-----------------
Minimum Age: 8 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: VBP-245<br>Topical 2% Povidone-Iodine Gel | Drug: VBP-245<br>* 2% Povidone-Iodine Gel<br>|
| Placebo Comparator: Control<br>Placebo Gel (no Povidone-Iodine) | Drug: Placebo Gel (no Povidone-Iodine)<br>* Placebo Gel (no Povidone-Iodine)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in wart diameter (mm) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of wart | Wart diameter = 0 mm | 12 weeks | 
| Application Site Reaction Adverse Events |  | 12 weeks |
Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
=================
Brief Summary
-----------------
The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.

Conditions
-----------------
Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
-----------------
* Drug: Conventional sedation
* Drug: Experimental sedation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who scheduled for ERCP Exclusion Criteria: The patients with ASA physical classification V The patients with history of sulfite, egg or soy bean allergy The patients during pregnancy or latency period The patients who informed consent could not be obtained The patients who were under 20 years old

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol based group<br> | Drug: Conventional sedation<br>* Propofol Meperidine : 25 mg IV just before procedure IV bolus of 1 mg/kg for sedation induction, Infusion of 60 mcg/min/kg for maintenance of sedation Additional bolus dose of 10mg as needed for adequate sedation<br>|
| Active Comparator: Fentanyl based group<br> | Drug: Experimental sedation<br>* Fentanyl IV bolus of 1 µg/kg for sedation induction Additional bolus dose of 0.5 µg/kg as needed for adequate pain control Propofol IV bolus of 0.4 mg/kg for sedation induction Infusion of 30 µg/min/kg for maintenance of sedation Additional bolus dose of 10mg as needed for adequate depth of sedation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time | Recovery time (time from scope withdrawal to full recovery) | time from scope withdrawal to full recovery at averange 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event during and after procedure | Adverse event during and after procedure i. Desaturation rate ii. Apnea | measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, Sedation, Fentanyl, Propofol
Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic shock would decrease their functional disability and cognitive impairment. We plan to enroll patients with severe sepsis and septic shock who admitted an urban teaching hospital in Seoul, South Korea via ER. We will randomize those subjects into the intervention group which will take a standardized rehabilitation with routine clinical care for sepsis and the control group which will take routine clinical care for sepsis. And, we plan to assess their functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time of enrollment, 28 days, and 6 months later.

Conditions
-----------------
Severe Sepsis or Septic Shock

Intervention / Treatment
-----------------
* Other: exercise rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥20; confirmed or suspected infection; two or more among 1)-4) 1) body temperature >38˚C or <36˚C 2) heart rate >90/min 3) respiratory rate >20/min or PaCO2<32 mmHg 4) WBC >12000/mm3, <4000/mm3, or band forms >10%; within 48 hours after arriving ER Exclusion Criteria: severe functional disability before admission; central nervous system infection; contraindication for exercise rehabilitation according to the investigators' decision; severe medical illness or mental problem or laboratory abnormality which can confound the results; pregnancy

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rehabilitation arm<br>daily standardized exercise rehabilitation during the admission period, and daily standardized self exercise after discharge | Other: exercise rehabilitation<br> <br> |
| No Intervention: control arm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe functional disability | We will assess the functional activity with 0-11 score of 6 ADL(walking, dressing, bathing, eating, getting into and out of bed, toileting) and 5 IADL(preparing a hot meal, shopping for groceries, making telephone calls, taking medicines, managing money). If the patient has a score 4 or more, the patient will be considered to have a severe functional disability. | 6 months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, septic shock, rehabilitation, exercise