linjc16/ctgov huggingface dataset:
Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

Study Overview
=================
Brief Summary
-----------------
The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming. Currently, there is no device which measures either oxygen consumption, or another variable that depends on oxygen consumption - resting energy expenditure - in neonates or infants. Our group has developed a new device which can attach to any ventilator and measures these two variables with accuracy in the preclinical setting, including in rodents as small as severely preterm infants. The purpose of this study is to compare measurements of oxygen consumption and energy expenditure in neonates using this device and comparing it with a gold standard which is rarely used, a Douglas bag method in which expired gas is collected and later analyzed.

Official Title
-----------------
Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

Conditions
-----------------
Neonatal Respiratory Failure, Congenital Heart Defect

Intervention / Treatment
-----------------
* Device: Measurement of oxygen consumption and caloric expenditure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria. Mechanically ventilated neonates and infants (<1 year of age). Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital. Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes. Written parental informed consent. Exclusion criteria. Hemodynamic or respiratory instability. Patients on extracorporeal membrane oxygenation support. Clinically significant tracheo-esophageal fistula Measured endotracheal tube leak >20% (i.e. difference between inspiratory and expiratory tidal volumes)

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Measurement of oxygen consumption and caloric expenditure|This study will involve an  1 hour, single point in time measurement of oxygen consumption, carbon dioxide production, resting energy expenditure, and respiratory quotient using two methods while patients are breathing an FiO2 of 40%. These measurements will be measured using the novel, responsive device and compared with gas collected simultaneously collected from a Douglas bag.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen consumption |  | 1 hour | 
| Carbon dioxide production |  | 1 hour | 
| Respiratory quotient |  | 1 hour | 
| Resting energy expenditure |  | 1 hour |
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.

Official Title
-----------------
A Randomized, Open-Label, Crossover, Drug Interaction Study to Evaluate the Effects of DVS SR And Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Conditions
-----------------
Depression, Depressive Disorder, Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: desvenlafaxine SR
* Drug: desipramine
* Drug: duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy men and women between 18 to 55 years of age. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs and a 12-lead electrocardiogram. History of being a nonsmoker for a least 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: desvenlafaxine SR|nan|
|Drug: desipramine|nan|
|Drug: duloxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

Study Overview
=================
Brief Summary
-----------------
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.

Official Title
-----------------
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years of age or older Signed informed consent form Women who have been histologically diagnosed with carcinoma of the breast prior to surgery Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure Exclusion Criteria: Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) Neoadjuvant systemic therapy All T4 tumors Previous radiation in the operated breast Prior surgical procedure in the same quadrant Implants in the operated breast Pregnancy Lactation Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Optical coherence tomography|Optical coherence tomography was used to image ex vivo breast tissue specimens.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With All Positive Margins Correctly Identified With the Device | In this study, a patient had positive margins if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, tumor on ink). | one week after surgery | 
| Number of Margins With False Positive Device Readings |  | one week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumpectomy, breast cancer, optical coherence tomography, tumor margin, imaging
Thyroid Function in Late Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been found to be related to severity of illness. T4 levels in very low birth weight infants born prematurely has been found to be inversely correlated to severity of illness. In very low birth weight infants, TH has been associated with poor outcomes. Little is known about thyroid function in late preterm infants. Hypotheses: Ill late preterm infants will have lower total T4 levels than healthy late preterm infants. Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes. Late Preterm infants born by cesarean section will have lower T4 levels compared to those born by vaginal birth.

Official Title
-----------------
Thyroid Function in Late Preterm Infants in Relation to Severity of Illness

Conditions
-----------------
Transient Hypothyroxinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any infant born between 34 0/7 weeks and 36 6/7 weeks gestation born at Christiana Hospital Exclusion Criteria: outborn infants infants with major congenital anomalies

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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 |
| --- | --- |
| Late preterm<br>Late preterm infants admitted to the NICU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery. |  | First week of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transient Hypothyroxinemia, Late Preterm Infants, Total T4, TSH, Illness severity, NICU
Comparison of PHVP of Different VTH Methods

Study Overview
=================
Brief Summary
-----------------
To evaluate the post-hysterectomy vault prolapse (PHVP) rates performed using different methods of vaginal total hysterectomy (VTH).

Detailed Description
-----------------
Objective: To evaluate the post-hysterectomy vault prolapse (PHVP) rates performed using different methods of vaginal total hysterectomy (VTH). Methods: A computer search identified a total of 251 women who underwent VTH with/without concomitant surgeries between January 1986 and December 2001 in a single center. Thirty-eight women were excluded due to not only a vaginal approach. Of the remaining 213 women, 129 and 84 underwent VTH via the Tsuzi method with residual uterine ligament ligation (ligations group) and traditional VTH (without ligations group), respectively. The χ2 and Mann-Whitney U tests were applied to compare the data. The cumulative percentages of women without PHVP were calculated over time and compared using Kaplan-Meier curves and log-rank tests. A p value of less than 0.05 was considered statistically significant.

Official Title
-----------------
Comparison of the Vault Prolapse Rate After Vaginal Hysterectomy With or Without Residual Uterine Ligament Ligation

Conditions
-----------------
Vault Prolapse, Vaginal

Intervention / Treatment
-----------------
* Procedure: VTH via the Tsuzi method with residual uterine ligament ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Received VTH with or without other combined operations. Exclusion Criteria: Laparoscopic-assisted vaginal hysterectomy (LAVH) Conversion to an abdominal approach Unsatisfactory medical record

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ligations group<br>VTH via the Tsuzi method with residual uterine ligament ligation (ligations group) | Procedure: VTH via the Tsuzi method with residual uterine ligament ligation<br>* VTH via the Tsuzi method with residual uterine ligament ligation<br>|
| Without ligations group<br>Traditional VTH without residual uterine ligament ligation (without ligations group) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-hysterectomy vault prolapse | PHVP was defined as more than or equal to the second stage of descent of the vaginal vault was noted during the follow-up visits. | Between January 1986 and December 2001 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vault prolapse, Vaginal total hysterectomy
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.

Official Title
-----------------
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study

Conditions
-----------------
Osteoporosis, Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Zoledronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary liver transplantation retransplantation within two weeks written informed consent Age ≥ 18 years Exclusion Criteria: chronic kidney disease: Creatinine Clearance < 35 ml/min or Serum Creatinine > 2,5 mg/dl known hypersensitivity to Zoledronate, or any of the recipients of the drug bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first bone fracture or death within 24 months after liver transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density (pre-transplant, 6 and 12 months post-transplant) |  |  | 
| serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone) |  |  | 
| histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant) |  |  |
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.

Official Title
-----------------
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

Conditions
-----------------
Glucose Intolerance

Intervention / Treatment
-----------------
* Dietary Supplement: low feeding frequency (3x)
* Dietary Supplement: High feeding frequency (14x)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI: 20-35 kg/m2 Gender: Male Age: subjects has to be older than 18 and younger than 70 years old Impaired Glucose Tolerant (IGT) = plasma glucose, two hours after consuming 75g glucose, appears to be superior to 7.8mmol/l (normal level) but remains inferior to 11.1mmol/l (diabetes level) and fasting plasma glucose is less than 7.0mmol/l. Caucasian Exclusion Criteria: Lactose intolerant Diabetes Mellitus Cardiovascular diseases Stomach and intestinal diseases Normal glucose levels after 2 hours Anticoagulants Medication that has a effect on energy and glucose homeostasis and absorption of foods Conditions or situations when subjects can't lose 500 ml blood

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High feeding frequency (14x)<br> | Dietary Supplement: High feeding frequency (14x)<br>* 14 meals a day<br>|
| Experimental: low feeding frequency (3x)<br> | Dietary Supplement: low feeding frequency (3x)<br>* 3 meals a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism |  | 24 hour profile | 
| Insulin metabolism |  | 24 hour profile | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets |  | 24 hour profiles | 
| Metabolic markers (FFA and TG metabolism) |  | 24 hour profile | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin, Insulin Metabolism, Glucose Metabolism, Substrate Partitioning, Muscle Biopsies, Feeding Frequency
Effect of Cardiac Preconditioning Upon the Inotrope Score

Study Overview
=================
Brief Summary
-----------------
preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support

Detailed Description
-----------------
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ;pharmacologic or Physical) Pharmacological pc may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc ) Ischemic pc includes local ;remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs The liberated mediators have favorable effects not only upon the myocardium But ;it extend to protect other organs against inflammatory activation ;ischemia reperfusion injury Inotropic score IS is already an evident predictor of postoperative cardiac mobidity and mortality

Official Title
-----------------
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery

Conditions
-----------------
Open Heart Surgery, Preconditioning

Intervention / Treatment
-----------------
* Procedure: ischemic preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient valve replacement surgery ASA grade 2 or 3 Exclusion Criteria: emergency surgery - poor general conditions impaired hepatic or renal function peripheral vascular disease patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ischemic preconditioning<br>ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles | Procedure: ischemic preconditioning<br>* ) ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles<br>|
| No Intervention: control<br>no intervention will be done | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inotropic score |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function | serum creatinine | 2 dyas |
Nutritional Intakes in Burn Patients Treated as Outpatients

Study Overview
=================
Brief Summary
-----------------
Nutrition is a key component of burn care. The primary goal of nutrition is to provide adequate supply in macro and micronutrients that are necessary to maintain organ function but also to wound healing, infection control and muscle preservation. Studies about nutrition and burn care are mainly focused on severe burn patients. There is a few or no data regarding nutrition in minor burns. Those patients rarely receive a multidisciplinary approach, at least in Belgium. The present study aimed to describe the nutritional condition of less severe burn patients treated as outpatients in a Belgian burn center. The ultimate goal was to determine whether this population needs specific dietetics follow-up or not.

Official Title
-----------------
Evaluation of Macronutrients and Micronutrients Intakes in Burn Patients Treated as Outpatients

Conditions
-----------------
Burns, Nutritional Deficiency

Intervention / Treatment
-----------------
* Other: Burn injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn treated exclusively in an outpatient clinic Exclusion Criteria: Not french speaking Psychiatric disorders Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Burn injury|minor burn injury|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional intakes | Using a standardized food questionnaire, mean daily nutritional intakes were calculated for each patient (macronutrients and micronutrients). Food questionnaire is a questionnaire created by our dietetics unit, aiming to quantify the amount of food eaten at each meal. Quantities of macronutrients and micronutrients at each meal were then calculated using tables of food content (Nubel for all nutrients, excepting vitamin E calculated according Ciqual table). | During the first week following injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body composition measured using bio impedance | During the first week following injury | 
| Handgrip strength | Strength measured an handheld dynamometer | During the first week following injury |