linjc16/ctgov huggingface dataset:
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.

Detailed Description
-----------------
It is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. The purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.Patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. During the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. These blood samples will be sent for analysis of biomarkers. The patient will then have an echocardiogram done 1 year from their heart catheterization.

Official Title
-----------------
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

Conditions
-----------------
Diastolic Heart Failure, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Ability to provide informed consent. Presenting for cardiac catheterization for evaluation of heart disease Ejection Fraction > 50% Exclusion Criteria: Unable to provide informed consent. Unable or unwilling to comply with the protocol and follow up. Infiltrative cardiomyopathy Constrictive pericarditis Severe valvular disease Comorbid status with life expectancy <3 years Right ventricular dysplasia Congenital heart disease On immunosuppressive drugs. Patients who has heart transplant. Ejection Fraction < 50% Mean Pulmonary Artery Pressure <25 Wedge pressure <15

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 |
| --- | --- |
| high PH and normal PVR<br>Group I, diastolic heart failure with high PH and normal PVR | |
| high PH and high PVR<br>Group II, diastolic heart failure with high PH and High PVR | |
| normal PH and normal PVR<br>Group III, no heart failure, normal PH and normal PVR | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Checking vital statistics on each patient at one year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Checking vital statistics on each patient at one year | 1 year |
Accurate Controlled Dental Sedation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.

Detailed Description
-----------------
The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.

Official Title
-----------------
The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation

Conditions
-----------------
Mental Retardation

Intervention / Treatment
-----------------
* Device: Target controlled infusion(TCI), Bispectral index(BIS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged 16 or over, American Society of Anesthesiologists (ASA) physical status 1 or 2 The treatments of dental caries, endodontics, periodontics and prosthesis were planed Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment Exclusion Criteria: Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons, Patients needed premedication Patients had uncontrolled or sever medical condition

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mental Retardation<br> | Device: Target controlled infusion(TCI), Bispectral index(BIS)<br>* Using TCI and BIS or not<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose of anesthesia agent |  | 1 day | 
| The recovery times of eyelash reflex and eye opening |  | 1 day | 
| The time to going home |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravenous sedation, Target controlled infusion, Bispectral index, Dental treatment, Mental Retardation, Deep sedation
EQUIC-CC: Enhancing Quality of Informed Consent - Customized Consent

Study Overview
=================
Brief Summary
-----------------
Patients in 'parent' cooperative study projects are interviewed about their experiences in the informed consent process.

Detailed Description
-----------------
Intervention: (1) Cognitive stratification (obtained by a test of cognitive ability, followed by a tailored IC process); (2) Pre-recruitment video (a patient-activation video designed to prevent several common misconceptions; (3) Provide prospective research volunteers with a sense of the purpose and methods of controlled research); and (4) Evaluation of the informed consent process using the Brief Informed Consent Evaluation Protocol (BICEP) developed in EQUIC-DP. Primary Hypothesis: The validity of informed consent can be improved, as measured by an independent interview of patients (BICEP), by at least one of three interventions described above. Primary Outcomes: The quality of the informed consent process, as measured by the BICEP (Brief Informed Consent Evaluation Protocol). The BICEP also offers a method to certify informed consent in routine use. Study Abstract: Customized Consent will develop and test an innovative, supplemental method of disclosing information to patients in the informed consent process. This disclosure strategy is intended to increase patients' understanding and satisfaction with the consent process. This study has two goals: to evaluate the effectiveness of an intervention to improve comprehension during informed consent; and to identify those patients for whom this intervention is most effective. The primary goal of EQUIC-CC is to determine whether an intervention, added to usual procedures for obtaining informed consent, is able to improve comprehension. The second goal of EQUIC-CC is to identify those patients for whom an augmented consent intervention is most effective, as well as to determine which subgroups of patients, if any, are most likely to benefit from visual information added to the usual disclosure phase of obtaining informed consent.

Official Title
-----------------
CSP #476CC - Enhancing Quality of Informed Consent (EQUIC-CC) Customized Consent

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Depends on 'parent' study Exclusion Criteria: Exclusion Criteria: Depends on 'parent' study
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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve method of disclosing information to patients in the informed consent process |  | post-randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Informed Consent
Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

Study Overview
=================
Brief Summary
-----------------
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

Official Title
-----------------
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Device: LASIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age at the time of pre-operative exam Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better Demonstration of refractive stability Anticipated post-operative stromal bed thickness of at lest 250 microns Willing and capable of returning for follow-up examinations for the duration of the study Exclusion Criteria: Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study Concurrent use of topical or systemic medications that may impair healing History of any medical conditions that could affect wound healing History of prior intraocular or corneal surgery, active ophthalmic disease,or other ocular abnormality Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wave-front guided LASIK<br> | Device: LASIK<br>* Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | < 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity (UCVA) of 20/40 or Better | 85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Astigmatism, refractive, error, LASIK
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.

Official Title
-----------------
Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Triiodothyronine
* Drug: triiodothyronine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring CABG or valve repair/replacement surgery. Patient must be able to provide informed consent. Exclusion Criteria: Patients less than 18 or over 85 years of age. Patients less than 50kg or greater than 120kg. Patients currently with endocrine disorders, excluding diabetes. Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated. Patients currently receiving thyroid replacement therapy. Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation. Patients who have received any investigational drugs within the previous one month or five half-lives of the drug. Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential. Patients currently in atrial fibrillation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triiodothyronine|0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.|
|Drug: triiodothyronine|IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of atrial fibrillation |  | during hospitalization |
Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.

Official Title
-----------------
Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin lispro
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin lispro|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | After 16 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Type 1
Conventional Double-lumen Tube vs VivaSight DL

Study Overview
=================
Brief Summary
-----------------
The investigators sought to compare the time to intubation and success rate of the endotracheal intubation using standard double-lumen tube and video tube ETView DL in an adult cadaver model in normal and difficult airway conditions.

Official Title
-----------------
Ability of Anesthesiologist to Placid a Double-lumen Tube. A Randomized Crossover Cadaver Study Comparing VivaSight DL and Conventional Double-lumen Tube

Conditions
-----------------
Endotracheal Intubation

Intervention / Treatment
-----------------
* Device: VivaSight DL
* Device: conventional double-lumen tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fresh adult cadavers Exclusion Criteria: cadavers with face injures

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal airway<br>intubation with normal airway Cormack-Lehane classivication I | Device: VivaSight DL<br>* intubation using VivaSight DL tube<br>Device: conventional double-lumen tube<br>* intubation using conventional double-lumen tube<br>|
| Experimental: difficult airway<br>intubation with difficult airway Cormack-Lehane classivication III | Device: VivaSight DL<br>* intubation using VivaSight DL tube<br>Device: conventional double-lumen tube<br>* intubation using conventional double-lumen tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for endotracheal intubation | time from pick up the tube to first ventilation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for visual confirmation of double lumen tube position position | Time required for visual confirmation of double lumen tube position position | 1 day | 
| success rate of intubation attempt | success rate of first intubation attempt | 1 day | 
| Ease of intubation | To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult). | 1 day |
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate dependence treatment.

Official Title
-----------------
Efficacy/Safety Trial of Buprenorphine/Nx for Opiate Dependence

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine/naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 57 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

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine/naloxone|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
-----------------
opiate dependence
Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi

Study Overview
=================
Brief Summary
-----------------
Women with HIV infection in Mississippi who are pregnant or who have had their baby in the past year can agree to fill out a questionnaire about what helps or hurts return to care for HIV infection after having a baby. The combined results should show the most common things that keep women from getting care for HIV infection after having a baby. This will help design another study in order to help more women get into care for HIV infection after having a baby.

Detailed Description
-----------------
Following recruitment and completion of informed consent, a participant will be given a questionnaire to look at factors that help or hinder access to HIV care after delivery. After finishing the initial questionnaire the participant will get a Wal-Mart gift card for $15. The participant may then be asked to complete a longer interview for which she would receive an additional gift card for $25. The combined results will be used to design an interventional study to improve entry into HIV care after delivery.

Official Title
-----------------
Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older women with HIV infection who are pregnant or up to 2 months postpartum English speaking able to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| linked to long-term HIV care | retrospective chart review for documentation of visit attendance | within six months of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment for depression | use of Edinburgh depression screening tool | cross-sectional at time of study visit | 
| assessment of intimate partner violence | use of WEB (Women's Experience with Battering) screening tool | cross-sectional at time of study visit | 
| assessment of stigma | use of HIV Related Experiences screening tool | cross-sectional at time of study visit | 
| attended a postpartum visit | retrospective chart review for documentation of visit attendance | within six months of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, postpartum, postpartum entry into HIV care