linjc16/ctgov huggingface dataset:
Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow

Study Overview
=================
Brief Summary
-----------------
Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic resonance imaging.

Detailed Description
-----------------
In this study we will systematically investigate the headache-releasing properties of carbon monoxide as well as measure the effect of carbon monoxide on mean blood flow rate in the brain's large vessel with magnetic resonance imaging. These studies are important for understanding and further investigating the carbon monoxide's headache-releasing effect in healthy subjects.

Official Title
-----------------
Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow

Conditions
-----------------
Headache Disorders

Intervention / Treatment
-----------------
* Other: Carbon monoxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Aged 18-50 50-100 kg Exclusion Criteria: Tension type headache more than 5 dage /month Other primary headaches Daily medication except contraceptives Drug taken within 4 times the halflife for the specific drug except contraceptives Pregnant or lactating women Exposure to radiation within the last year Headache within the last 24 hours before start of trial Hypertension Hypotension Respiratory or cardiac disease Smoking Primary relatives with current or previous migraine

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Carbon monoxide<br>Each participant receives CO inhalation | Other: Carbon monoxide<br>* Carbon monoxide inhalation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in brain blood vessels diameters after a short CO inhalation | To investigate changes in the circumference of intra- and extracerebral blood vessels after inhalation of carbon monoxide using magnetic resonance angiography (MRA). | 30 minutes |
Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma

Study Overview
=================
Brief Summary
-----------------
This randomized, controlled trial (RCT) compares the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation alone, with 3 minutes MMC application or with a single layer coverage of amniotic membrane. Outcomes include intraocular eye pressure (IOP), postoperative glaucoma medication and complications. AGV implantation site will be superior or inferior based on indication and these groups will be randomized separately.

Official Title
-----------------
Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma

Conditions
-----------------
Refractory Glaucoma

Intervention / Treatment
-----------------
* Device: Ahmed Glaucoma Valve (AGV)
* Drug: Mitomycin C (MMC)
* Procedure: amniotic membrane coverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with refractory glaucoma Exclusion Criteria: children under 7 years old adults above 75 years old uncooperative patients patients underwent the operation for second time patients with major operation with AGV

Ages Eligible for Study
-----------------
Minimum Age: 7 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ahmed Glaucoma Valve (AGV) alone<br> | Device: Ahmed Glaucoma Valve (AGV)<br>* AGV implantation<br>|
| Experimental: AGV plus MMC<br> | Device: Ahmed Glaucoma Valve (AGV)<br>* AGV implantation<br>Drug: Mitomycin C (MMC)<br>* 3 minute MMC application<br>|
| Experimental: AGV plus amniotic membrane coverage<br> | Device: Ahmed Glaucoma Valve (AGV)<br>* AGV implantation<br>Procedure: amniotic membrane coverage<br>* single layer coverage of amniotic membrane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

Study Overview
=================
Brief Summary
-----------------
The advent of new antiretroviral drugs improved the management of HIV naive patients in terms of efficacy. However, the long term metabolic profile of this drugs has not yet been compared and associations between new antiretrovirals and cardiovascular events remains controversial. Moreover, the better tolerability and easy dosage of this new drugs might hypothetically influence adherence and QOL of HIV patients.

Official Title
-----------------
Metabolic Profile and Cardiovascular Biomarker Pattern Compared in naíve Patients Initiating HAART With TDF-FTC and Raltegravir 400mg BID Vs Darunavir 800 mg Plus Ritonavir 100 mg QD; a One Year Follow-up Observational Study

Conditions
-----------------
Cardiovascular Disease, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VIH-1 Exclusion Criteria: pregnancy previous Antiretroviral exposure

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 |
| --- | --- |
| Raltegravir Cohort<br>Patients taking RAL 400 mg BID with Truvada | |
| Darunavir Cohort<br>Patients taking Darunavir 800 mg QD plus Norvir 100 mg QD with truvada | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile defined as a clinically significant increment (delta) in Total cholesterol LDL, HDL y non-LDL cholesterol. |  | baseline and week 12, 24, 36 and 48 | 
| Insulin resistance defined by HOMA index. |  | baseline and week 12, 24, 36 and 48 | 
| Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs... |  | baseline and week 12, 24, 36 and 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral adherence and quality of life items. |  | baseline and week 12,24,36,48 | 
| Efficacy defined as viral suppression and CD4 count recovery |  | baseline and week 12,24,36,48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular disease, HIV, metabolic disorder, HIV naive patients initiating HAART with Raltegravir or boosted Darunavir
Prognostic Factors of Patients With ADHF

Study Overview
=================
Brief Summary
-----------------
To explore the prognostic indicators for patients with ADHF

Detailed Description
-----------------
According to ESC Guidelines for the diagnosis of acute heart failure 2008, patients with ADHF were diagnosed, and their medical history, laboratory examination and treatment plan were retrospectively analyzed, and the patients were followed up for 1 year. The 1-year outcomes of patients were analyzed to explore the prognostic indicators for patients with ADHF

Official Title
-----------------
Elevated Blood Monocyte Count Predicts 1 Year Poor Outcomes for Patients Admitted With Acute Decompensated Heart Failure

Conditions
-----------------
Acute Decompensated Heart Failure

Intervention / Treatment
-----------------
* Other: elevated monocyte count


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ADHF diagnosed according to ESC Guidelines for the diagnosis of acute heart failure 2008 Exclusion Criteria: disorders of the hematopoietic system, history of cancer and/or previous treatment with chemotherapy, the infection caused by various pathogens, chronic inflammatory conditions, glucocorticoid therapy and/or histories of glucocorticoid use 3 months before the admission and acute myocardial infarction or coronary revascularization within the past 6 months. Also, patients who did not have a differential WBC count or who were lost to follow-up were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 94 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 |
| --- | --- |
| high group<br>high group: monocyte count≥0.445×10*9 cells/L | Other: elevated monocyte count<br>* The monocyte count at admission was higher than 0.445×10*9 cells/L<br>|
| low group<br>low group: monocyte count<0.445×10*9 cells/L; | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death | The primary end point was one-year all-cause death | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF-related rehospitalization | the secondary end point was one-year HF-related rehospitalization. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
monocyte count, heart failure, acute decompensated heart failure, all-cause death
Effect of Donepezil on the Reorganization of Cognitive Neural Network in Patients With Post-Stroke Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the efficacy and safety of donepezil on the recovery of cognitive function in patients with stroke and to delineate the neurophysiologic mechanisms of the therapeutic effect of donepezil on the recovery of cognitive network using functional neuroimaging technique.

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

Intervention / Treatment
-----------------
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic stroke in the territory of right or left middle cerebral artery Post-onset duration of the recent-onset stroke is over 3 months Cognitive deficit ranged from 10 to 26 by minimal mental status examination (MMSE) score Disturbance in activities of daily living (ADL) ranged 0.5   2.0 by clinical dementia rating (CDR) scale Exclusion Criteria: Severe internal carotid artery stenosis on the lesion side Cardiac pacemaker or intracranial metal insertion Post-stroke seizure disorder or any evidence of epileptic spikes on electroencephalography (EEG)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Donepezil|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
-----------------
Donepezil, Stroke, Cognitive function, Cognitive neural network
Retrospective Review of Management of Infective Endocarditis

Study Overview
=================
Brief Summary
-----------------
This is an analysis of the outcomes of patients having undergone surgical intervention for infective endocarditis.

Detailed Description
-----------------
This study will look at the presentations, epidemiology, risk factors, modalities of diagnosis; and the role of specific investigatory tools with surgical intervention and timimg of intervention in patients who underwent surgical treatment for infective endocarditis. Morbidity and Mortality post surgery and prognosis including long term outcome of our patients will be analyzed. Special attention will be made to those patients with pre-operative neurological deficit.

Official Title
-----------------
A Retrospective Review of the Management of Infective Endocarditis in Patients at Virginia Commonwealth University Medical Center From 1996-2006

Conditions
-----------------
Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have undergone surgical treatment for infective endocarditis Exclusion Criteria: Less than 18 years old

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocarditis, neurological deficit
Computer-assisted Diabetes Self-management Interventions

Study Overview
=================
Brief Summary
-----------------
This project evaluates the effectiveness of different aspects of a program to assist type 2 diabetes patients with dietary changes. It evaluates the effectiveness of Personalized Self-Management Training and Community Resources support, using a randomized design. This study will also evaluate what percent of patients are willing to participate in such a program, and what percent of primary care physicians are willing to recommend it to their patients.

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

Intervention / Treatment
-----------------
* Behavioral: Personalized Self-management
* Behavioral: Community Resources


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Diagnosed for at least one year Patient of a primary care provider Exclusion Criteria: No telephone Not speaking English

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Personalized Self-management|nan|
|Behavioral: Community Resources|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
-----------------
diabetes, self-management, randomized trial, RE-AIM evaluation, participation, maintenance, community resources, dietary change
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

Study Overview
=================
Brief Summary
-----------------
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years.

Official Title
-----------------
A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: N1539


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 2 to <17 years of age before dosing on Day 1 Eligible for elective surgery that will be performed according to standard surgical technique under appropriate anesthesia Be premenarche or have confirmed negative urine pregnancy testing before surgery on Day 1, if an adolescent female of childbearing potential Willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent Exclusion Criteria: Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any excipient of N1539 Have a known bleeding disorder that may be worsened with the administration of an NSAID Be undergoing cardiothoracic surgery Has used meloxicam within 7 days before the surgical procedure on Day 1 Has any clinically significant medical history or clinical manifestations of significant disease or any other condition that increases the risk associated with the subject's participation in the study or compromises the scientific objectives of the study.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: N1539<br>N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H | Drug: N1539<br>* Once daily<br>* Other names: Meloxicam IV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Experiencing an AE | Number of study subjects who experienced an AE | Through study completion, approximately 28 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meloxicam, pediatric
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open-label Study of the Tolerability of a Subcutaneous Needle-free Injection Device Used to Administer Fuzeon, Compared With the Standard Needle/Syringe Supplied With Commercial Fuzeon in HIV-1 Infected, ARV Treatment-experienced Adults

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

Intervention / Treatment
-----------------
* Drug: enfuvirtide [Fuzeon]
* Drug: enfuvirtide [Fuzeon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patients, >=18 years of age with HIV-1 infection; previously treated with antiretroviral agents. Exclusion Criteria: prior use of Fuzeon or T-1249; inability to self-inject; active, untreated opportunistic infection.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid by Biojector 2000 NFID for 4 weeks<br>|
| Active Comparator: 2<br> | Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid by 27G1/2 needle/syringe for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint (pain, induration, nodules/cysts). |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state C trough |  | Weekly | 
| Signs and symptoms associated with Fuzeon injections |  | Throughout study |
Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pediatric Pelvic Fracture Urethral Injury

Study Overview
=================
Brief Summary
-----------------
It is prospective randomized comparative clinical trial comparing primary urethral realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture urethral injury regarding: The success rate after initial intervention. The need for urethroplasty in the failed realignment group and cystostomy group. The success rate of urethroplasty in the failed realignment group and cystostomy group.

Official Title
-----------------
Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial

Conditions
-----------------
Urethral Injury

Intervention / Treatment
-----------------
* Procedure: Primary realignment
* Procedure: Suprapubic cystostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male children less than 18 years presenting with pelvic fracture urethral injury Exclusion Criteria: Associated bladder neck injury. Associated rectal injury. Late presentation >2weeks since trauma. History of previous urethral intervention.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary realignment<br> | Procedure: Primary realignment<br>* Endoscopic realignment of rupture urethra over a urethral catheter<br>|
| Active Comparator: Suprapubic cystostomy<br> | Procedure: Suprapubic cystostomy<br>* Percutaneous cystostomy catheter will be inserted under sonographic guidance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate after initial intervention (realignment or suprapubic cystostomy). | The fulfillment of success criteria after initial intervention which includes good stream, no postvoid residual urine, normal Qmax for age and free retrograde urethrogram | 3 months after initial intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of urethroplasty in both groups. | The surgical outcome of urethroplasty in cases of children with posterior urethral stricture after failed realignment or suprapubic cystostomy. | 3 months after urethroplasty. | 
| The need for urethroplasty in both groups. | Comparison of the need for urethroplasty in children with failed realignment or suprapubic cystostomy. | 3 months after initial intervention |