linjc16/ctgov huggingface dataset:
Vasopressor Preload Modulation During General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Is is debated whether administration of pure vasopressor may augment cardiac output (CO) by means of preload modulation. We wish to test this in 20 patients under general anesthesia, with preload dependency induced by head-up-tilt and preload modulation with infusion of phenylephrine. To document any changes in CO the patients will be monitored by Lithium dilution method. Furthermore we will monitor changes in peripheral perfusion index and test the ability of this non-invasive modality to track changes in CO.

Official Title
-----------------
Vasopressor Preload Modulation During General Anaesthesia

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned surgery under general anesthesia Exclusion Criteria: atrial fibrillation refusal to participate

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac output |  | 30 minutes | 
| Changes in peripheral perfusion index |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
monitoring, cardiac output, perfusion index
The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.

Conditions
-----------------
Ischemic Heart Disease, Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: aerobic training
* Other: aerobic and strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: s/p acute myocardial infarction 14-30 days ability to perform exercise Exclusion Criteria: unstable angina chronic atrial fibrillation severely reduced LV function NYHA 4 severe valvular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard of care<br> | |
| Active Comparator: aerobic training only<br> | Other: aerobic training<br> <br> |
| Active Comparator: Aerobic and strength training<br> | Other: aerobic and strength training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventrcular dyssynchrony | Assessed by 2-D strain imaging | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic function | Assessed by Holter | 3 months |
Predictors of Drug Hypersensitivity in HIV Infected Subjects

Study Overview
=================
Brief Summary
-----------------
A case-control study to look at hypersensitive and tolerant individuals matched for HLA genetic predisposition, when considering predictors of drug hypersensitivity.The study aims to identify the immunological factors increasing the risk of drug reactions in HIV positive individuals.

Detailed Description
-----------------
To determine in a case control study clinical parameters associated with drug HSR to abacavir, nevirapine and efavirenz in HIV infected subjects. To measure functional and numerical differences in DC populations and responses to TLR ligands in patients with HSR and tolerant subjects sharing genetic markers for susceptibility to HSR. Identify the role of different DC populations in the development of abacavir reaction by mixing and depletion studies in sensitized subjects and in in vitro assays for abacavir hypersensitivity. To measure T cell parameters including T cell viability in culture, and expression of fas and fasL on blood mononuclear cells in HIV infected controls and HSR patients. To measure blood T cell populations including drug reactive T cells and T regulatory cells in tolerant and reactive subjects with genetic susceptibility to Abacavir and Nevirapine HSR.

Official Title
-----------------
Predictors of Drug Hypersensitivity in HIV Infected Subjects

Conditions
-----------------
HIV Infections, Hypersensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected patients on treatment with the drugs Efavirenz, Nevirapine, or Abacavir. Age over 18 Cases are those who have had a hypersensitivity reaction, and controls are those who have had no reaction

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 |
| --- | --- |
| Drug hypersensitive group<br>HIV positive patients with a history of a Hypersensitivity Reaction to the antiretroviral medications Nevirapine, Abacavir or Efavirenz | |
| Drug tolerant group<br>HIV positive patients selected based on drug exposure greater than 2 weeks and tolerance to to Abacavir or Nevirapine. | |

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
-----------------
Treatment Experienced, HIV
Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers

Study Overview
=================
Brief Summary
-----------------
To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice to healthy female volunteers.

Official Title
-----------------
Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers

Conditions
-----------------
Urogynecology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent urodynamics at the urogynecology clinic during the past 12 months Voids larger than 50 mls. Exclusion Criteria: History of pelvic organ prolapse, incomplete bladder emptying, and voids less than 50cc.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urodynamic patients<br>Uroflow studies of patients who underwent urodynamics as part of an incontinence work-up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voiding variables of patients will be compared to those of healthy female volunteers collected from another study. |  |  |
Theracal Pulpotomy in Primary Molars

Study Overview
=================
Brief Summary
-----------------
Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

Detailed Description
-----------------
sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.

Official Title
-----------------
Theracal Versus Formocresol Pulpotomy in Primary Molars

Conditions
-----------------
Deep Caries

Intervention / Treatment
-----------------
* Drug: Theracal LC
* Drug: Formocresol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, cooperative children mandibular primary molars with vital pulp exposures Exclusion Criteria: clinical or radiographic evidence of irreversible pulpitis physiological root resorption

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theracal LC<br>Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. | Drug: Theracal LC<br>* pulpotomy<br>|
| Active Comparator: Formocresol<br>Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. | Drug: Formocresol<br>* Pulpotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Examination | Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Examination | Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Theracal, formocresol, pulpotomy
Hydrogen Sulfide Production by Oral Microflora

Study Overview
=================
Brief Summary
-----------------
Oral malodor is a common condition. In most cases this condition results from the proteolytic activity of anaerobic oral bacteria. These bacteria produce volatile sulfide compounds which are fowl smelling and are felt during exhalation and speech. the aim of the present study is to examine a simple method of detecting these bacteria in samples taken from the oral cavity of oral malodor patients.

Official Title
-----------------
Detection of Hydrogen Sulfide Production by Oral Microflora Samples

Conditions
-----------------
Oral Malodor (Halitosis)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oral malodor patients Exclusion Criteria: smokers, users of antibiotic one month prior to study

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Evaluation of the Ethmoid Sinus Spacer

Study Overview
=================
Brief Summary
-----------------
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system

Official Title
-----------------
Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)

Conditions
-----------------
Sinusitis, Chronic Rhinosinusitis

Intervention / Treatment
-----------------
* Device: Ethmoid Sinus Spacer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 21 years old Both male and female Ethmoid disease on CT scan At least one non-ethmoid sinus requiring treatment Failed medical management and symptomatic Exclusion Criteria: Previous ethmoid surgery Not sufficient room for placement of Spacer Patient requires septoplasty Has received steroid treatment with in 2 weeks Extensive sinonasal osteoneogenesis preventing device placement Sinonasal tumors or obstructive lesions History of facial trauma that distorts sinus anatomy Asthmatic patients with aspirin sensitivity Pregnant or lactating females

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Ethmoid Sinus Spacer placement<br>Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 | Device: Ethmoid Sinus Spacer<br>* Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40<br>* Other names: Acclarent Ethmoid Sinus Spacer and Access System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant |  | Procedural and 6 weeks post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures |  | 1 wk, 2wk, 4wk, 6wk |
Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)

Study Overview
=================
Brief Summary
-----------------
Consultations in general medical practice concerning the follow-up of the patients receiving opiate substitution treatments are not exceptional. It is nowadays agreed that addictive pathology goes far beyond the issue of product dependence, in favor of a pathology in itself. Centered on problems of attachment, of framework, of trust. The implementation of the opiate substitution treatments and the lifting of the product dependence appears only as a preliminary to the background work with the patient ex-user of opiate. Finally, the literature provides little information on the experience of general practitioners and their patients under opiate substitution treatments regarding follow-up consultations in the stability phase. The objective of this work is therefore to study the feelings on follow-up consultations, general practitioners and their patients under opiate substitution treatments considered stabilized.

Official Title
-----------------
Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)

Conditions
-----------------
Opioid Substitution Treatment

Intervention / Treatment
-----------------
* Other: semi-directed interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major people patients receiving opiate substitution treatments Exclusion Criteria: considered unstabilized with opiate substitution treatments

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br> | Other: semi-directed interviews<br>* semi-directed interviews<br>|
| Doctors<br> | Other: semi-directed interviews<br>* semi-directed interviews<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of feelings on follow-up consultations with standardized questionnaire |  | 1 hour |
Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation

Study Overview
=================
Brief Summary
-----------------
Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.

Detailed Description
-----------------
27 patients are examined before and after microsurgical fibula flap performed at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.

Official Title
-----------------
Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation in 27 Consecutive Cases: a Clinical Cohort Study.

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: Fibula Explantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned continuity interrupting mandible resection Planned mandible reconstruction with free fibula flap Informed consent Procedure performed at University Medical Center Hamburg Eppendorf Exclusion Criteria: Preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic) Musculosceletal pain at the time of study enrollment

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fibula Explantation|surgical harvest of an osteomyocutaenous transplant consisting of a part of the fibula and surrounding soft tissues|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Esslinger Fitness Index | Jumping Mechanography, Functional Assessment on Leonardo Mechanograph GFRP | 1 day before fibula transplantation and 8.3 months postoperatively on average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS Score | Objective and Subjective Score for functionality and pathology of the ankle region | 1 day before fibula transplantation and 8.3 months postoperatively on average | 
| Balance Test | Functional Assessment on Leonardo Mechanograph GFRP, measures the patients' stability | 1 day before fibula transplantation and 8.3 months postoperatively on average | 
| Range of Motion | Measuring Ankle Motion before and after surgery with a goniometer | 1 day before fibula transplantation and 8.3 months postoperatively on average |
Continuous Glucose Monitoring in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.

Detailed Description
-----------------
We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.

Official Title
-----------------
Continuous Glucose Monitoring in Infants

Conditions
-----------------
Neonatal Hypoglycemia

Intervention / Treatment
-----------------
* Device: Dexcom continuous glucose monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother at least 18 years of age Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA) Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers Exclusion Criteria: Infants born small for gestational age (SGA) Infant birth weight <2.5 kg Infant BMI <10th percentile on Olsen chart Infants born <38 weeks gestation Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound Mother is non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 2 Hours

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 |
| --- | --- |
| No increased risk of hypoglycemia<br>Infants born with no obvious risk factors for hypoglycemia in the neonatal period. | Device: Dexcom continuous glucose monitor<br>* Measurement of interstitial glucose<br>|
| Increased risk of hypoglycemia<br>Infants considered at increased risk for hypoglycemia after birth including the following criteria: Infant born to a diabetic mother Very large for gestational age (VLGA) infant with weight >97% | Device: Dexcom continuous glucose monitor<br>* Measurement of interstitial glucose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent with glucose <40 mg/dL | The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as <40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of <40 mg/dL. | The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal. |