linjc16/ctgov huggingface dataset:
Premature Birth and Its Sequelae in Women

Study Overview
=================
Brief Summary
-----------------
To establish in children born prematurely a set of links between lung function in late infancy and lung function at school age, between lung function at school age and that in adolescence, and between lung function in adolescence and that in adulthood in order to evaluate pulmonary outcomes of neonatal therapeutic strategies and to relate these strategies to lung health in adult life.

Detailed Description
-----------------
BACKGROUND: Effective perinatal treatment strategies during the past 20 years have increased the survival of low birth weight infants. Accompanying this increased survival has been a 4-6 fold increase in the number of children surviving with bronchopulmonary dysplasia, although the birthweight specific incidence has remained constant or declined. Limited data currently available indicate that individuals who had BPD as infants have, as childrearing adults, impaired lung growth as well as both fixed and reversible airways obstruction. The study was part of an Institute-initiated program on Collaborative Projects in Women's Health. The concept was developed by the NHLBI staff and given concept clearance at the February 1992 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in April 1992. DESIGN NARRATIVE: The study was part of a four-grant collaborative project on women's health. Based on available data, Dr. Mary Ellen Wohl hypothesized that bronchopulmonary dysplasia (BPD) morbidity was related to impaired lung growth in the first year of life, did not improve during adolescence and was accentuated in females because of their intrinsically smaller lungs. To test this hypothesis, she measured lung size and airway function in teenagers and young adults, previously studied at school age, who were born, 1) at term, 2) prematurely, 3) developed respiratory distress syndrome of the newborn (RDS) or 4) developed BPD. Children born from 1987-89 previously studied at 10 months of age by novel lung function function methods developed in this laboratory were restudied at school age. Techniques of measuring total respiratory system compliance and resistance and of obtaining forced expiratory flow at functional residual capacity were applied to cohorts of born premature infants at 10-18 months of age to assess outcome of current perinatal strategies. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Bronchopulmonary Dysplasia, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)

Study Overview
=================
Brief Summary
-----------------
Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF) to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective study to test the efficacy of NGF for CRN.

Conditions
-----------------
Cerebral Necrosis, Nashopharyngeal Cancer, Nerve Growth Factor

Intervention / Treatment
-----------------
* Drug: NGF group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months. Exclusion Criteria: CRN combined with local or regional relapse, or with distant metastasis. CRN combined with other cerebrovascular disease. CRN combined with the second primary malignancy. CRN without neurologic symptoms or signs. CRN combined with diabetes. CRN patients that were supposed to live less than 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| NGF group<br>This group will be treated with NGF 18u daily for 60 days. | Drug: NGF group<br>* This group will be treated with NGF 18u per day im for 60 days<br>|
| control group<br>this group will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or wait and see policy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of using NGF for treating CRN |  | 6-8 months |
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.

Official Title
-----------------
A Randomized, Prospective Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

Conditions
-----------------
Burn Surgery

Intervention / Treatment
-----------------
* Device: AWBAT™-D and Mepilex® Ag dressings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn wounds requiring skin grafting Matched donor sites available 1-30% TBSA Exclusion Criteria: Severe inhalation injury Pregnancy Co-morbidity which may compromise healing Known allergy to pork or pork products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AWBAT™-D and Mepilex® Ag dressings|Comparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare rate of healing of donor sites |  | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare complication rates |  | 6 month follow-up | 
| Compare patient reported perception of pain |  | 6 month follow-up | 
| Compare clinical outcome (scarring) |  | 6 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burn, donor site, treatment of burns, Treatment of Donor Sites
Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the preoxygenation efficacy of tidal volume breathing and vital capacity breathing.

Official Title
-----------------
Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen

Conditions
-----------------
Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia

Intervention / Treatment
-----------------
* Procedure: Tidal volume breathing technique
* Procedure: Vital capacity breathing technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Adult patients 20 years of age or older who are planning to undergo surgery under general anesthesia Exclusion Criteria: -basal skull fracture, 2번 - facial anomaly, 3번 - consciousness disorder, 4번 - Risk of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: Tidal volume breathing technique<br>High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Tidal volume breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously. | Procedure: Tidal volume breathing technique<br>* High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Tidal volume breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously.<br>|
| Active Comparator: Vital capacity breathing technique<br>High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Vital capacity breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously. | Procedure: Vital capacity breathing technique<br>* High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Vital capacity breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen reserve index | End-tidal O2 will be monitored continuously before anesthetic induction. | for 10 minutes before anesthetic induction. At Day 0. |
A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate

Study Overview
=================
Brief Summary
-----------------
This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The TAP20-C device collects small amounts of blood from the forearm which can then be used for blood testing. The study will also involve collecting blood by fingerstick which is a common way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods. Additional information will be collected about how the TAP20-C device performs.

Official Title
-----------------
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick Using the SAFE-T-FILL Capillary Blood Collection System

Conditions
-----------------
Diabetes, Anemia

Intervention / Treatment
-----------------
* Device: TAP20-C
* Device: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subject Group 1. Male and female volunteers 18 years of age or older Diabetic Subject Group Male and female volunteers 18 years of age or older Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report Exclusion Criteria: 1.Subjects who are pregnant or nursing mothers by self report 2.Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins 3.Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested 4.Subjects with a missing index or middle finger on either hand or a missing forearm 5.Subjects who have known allergies to titanium -

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP20-C<br>Single Use Integrated Capillary Blood Collection System | Device: TAP20-C<br> <br> |
| Active Comparator: SAFE-T-FILL CAPILLARY SYSTEM<br>Single Use Capillary Blood Collection System | Device: SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Inferiority of Analyte Levels | The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods in a single two hour session. | Day 1 |
Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.

Study Overview
=================
Brief Summary
-----------------
The aims of the presented study are as follows: To evaluate the endothelial function and arterial stiffness in a large cohort of prevalent CKD patients by means of non-invasive applantion tonometry. To evaluate the association between the serum levels of the representatives of the various classes of uremic toxins and markers of endothelial function and arterial stiffness. To evaluate the association between markers of inflammation and oxidative stress and markers of endothelial function and arterial stiffness. To evaluate the association between echocardiographic parameters and markers of arterial stiffness

Official Title
-----------------
Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.

Conditions
-----------------
Arterial Stiffness, CHRONIC RENAL FAILURE, Left Ventricular Hypertrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-60 Chronic kidney disease: according to the K-DOQI guidelines ( kidney damage ≥ three months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either: pathological abnormalities; or markers of kidney damage, including damage in the composition of blood or urine test, or abnormalities in imaging tests; GFR< 60 ml/min/1.73m² for ≥ three months, with or without kidney damage) Written informed consent Exclusion Criteria: major illnesses( life expectancy of < 1 year) history of atrial fibrillation history of myocardial infarction, unstable angina, congestive heart failure, peripheral vascular diasease ,cerebrovascular disease, diabetes (nonechogenic)

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 |
| --- | --- |
| CKD patients<br> | |

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
-----------------
CKD,
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of creatine monohydrate or vitamin D supplementation on strength gains following a traditional resistance training program for adults with spinal cord injury.

Official Title
-----------------
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Dietary Supplement: Creatine
* Dietary Supplement: Placebo
* Dietary Supplement: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal cord injury Minimum time since injury: 3 months Exclusion Criteria: Participation in resistance training programmes in the previous 6 months Creatine or vitamin D supplementation in the previous 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Daily supplementation with 3g of dextrose during eight weeks and placebo ampoules each two weeks. | Dietary Supplement: Placebo<br> <br> |
| Experimental: Creatine<br>Daily supplementation with 3g of monohydrate creatine during eight weeks. Placebo ampoules each two weeks. | Dietary Supplement: Creatine<br>* Daily supplementation with 3g of monohydrate creatine during 8 weeks<br>|
| Active Comparator: Vitamin D<br>Daily supplementation with 3g of dextrose during eight weeks. Vitamin D supplementation, 25000 IU each two weeks. | Dietary Supplement: Vitamin D<br>* Vitamin D supplementation with 25000 IU each two weeks during eight weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | 8 weeks | 
| Sum of 4 skinfold | Triceps, Biceps, Subscapular and Iliac crest | 8 weeks | 
| Corrected Arm Muscle Area |  | 8 weeks | 
| Seated Medicinal Ball Throw |  | 8 weeks | 
| Handgrip Strength with Hand Dynamometer |  | 8 weeks | 
| Manual Wheelchair Slalom Test |  | 8 weeks |
Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution

Study Overview
=================
Brief Summary
-----------------
Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose of sterofundin solution given to healthy volunteer in the resuscitation manner compared with normal saline solution.

Detailed Description
-----------------
10 healthy volunteers were randomly assigned to receive either normal saline or sterofundin for the first solution in dose of 30 mL/kg (max 2 L) over 1 hour. Blood was collected at baseline (T0), at 60 minutes (T1), 120 minutes (T2), and 240 minutes (T4) from baseline. Time to fist void after initiation of fluid and urine volume were also recorded. After wash-out period of at least 1 week, crossover studies were performed with another fluid.

Official Title
-----------------
Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution

Conditions
-----------------
Change in Serum Chloride Level

Intervention / Treatment
-----------------
* Drug: Sterofundin
* Drug: NSS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No underlying disease LVEF > 0.5 No current medication usage Exclusion Criteria: Pregnancy or lactation BMI <18 or >25 Fever presented in the past 2 weeks

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSS<br>NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour | Drug: Sterofundin<br>* Fluid loading<br>Drug: NSS<br>* Fluid loading<br>|
| Experimental: Sterofundin<br>Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour | Drug: Sterofundin<br>* Fluid loading<br>Drug: NSS<br>* Fluid loading<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum chloride | At 0, 1, 2, and 4 hours from initiation | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum pH | At 0, 1, 2, and 4 hours from initiation | 4 hours | 
| Change in serum osmolality | At 0, 1, 2, and 4 hours from initiation | 4 hours | 
| Change in serum SID | At 0, 1, 2, and 4 hours from initiation | 4 hours | 
| Time to first void | Time in minutes from initiation of fluid to first urination | Within 24 hours | 
| Urine volume | Volume of first urination in ml | Within 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sterofundin, resuscitation, normal saline, chloride, fluid, SID, pH, osmolality, urine