linjc16/ctgov huggingface dataset:
Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications

Study Overview
=================
Brief Summary
-----------------
Radiation dose reduction has been a primary driver of technology development in multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and task specific computed tomography (CT) applications continues to be an ongoing challenge, especially in pediatric patients where the desire to reduce radiation dose to lowest possible levels leads to both positive and negative effects. A novel research tool on the Siemens dual source (Flash® and Force ®) CT scanners allows one to assess multiple tube current levels from a single CT acquisition without incurring additional dose to the patient. Tube current is a primary contributor to radiation dose and image noise, which are inversely related. This is achieved by independently adjusting the current of each tube, while maintaining same kV in each x-ray tube. Moreover, Duke's medical physics team has developed a method based on mathematical expressions that allows the creation of incremental dose levels from the acquired image data sets. This innovative and powerful tool can be used to compare diagnostic accuracy, detectability, and many more relevant clinical features amongst multiple tube current levels with the attainment of a single CT acquisition.

Official Title
-----------------
Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications

Conditions
-----------------
Split Dose CT

Intervention / Treatment
-----------------
* Device: Dual-source multi-detector computed tomography (DSSE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Pregnant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Split CT<br> | Device: Dual-source multi-detector computed tomography (DSSE)<br>* Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Noise |  | Up to 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT Scan
Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls. II. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients and healthy controls receive an oral dose of doubly labeled water following initial urine collection on day 1. Patients undergo additional urine collection at 4-6 hours following doubly labeled water consumption and then daily for 7 days. Additionally, at the beginning of the study, patients and healthy controls undergo respiratory calorimetry over approximately 45 minutes at rest, starting approximately 2-3 hours after the last meal consumption and last use of aerosol bronchodilators (if required).

Official Title
-----------------
Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of cystic fibrosis (CF) by two positive sweat tests No exacerbations of present condition within past 2 months FEV1 less than 50% of predicted No other uncorrected lung disease No requirement for supplemental oxygen OR Healthy (control group) Age matched to CF patients No preexisting lung disease Clinically well No hospitalizations within past 6 months --Prior/Concurrent Therapy-- Concurrent pancreatic enzyme supplementation for CF required Clinically stable on current medications (CF patients) --Patient Characteristics-- Age: Birth to 12 months 6 to 10 years Cardiovascular: No major cardiovascular problems (CF patients) No preexisting heart disease (control group) Pulmonary: See Disease Characteristics Other: No chromosomal abnormalities (CF patients) No acute infection (CF patients) No diabetes mellitus (both groups)

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 10 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
Psychology of Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether emotional processing and somatic dissociation influence IBS-like symptoms in Crohn's Disease patients.

Official Title
-----------------
Will The Real Psychology Of Crohn's Disease Please Stand Up?

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 19 or greater Outpatient with diagnosis of Crohn's disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Crohn's disease patient<br>Outpatients who carry a diagnosis of Crohn's disease made by a gastroenterologist. | Behavioral: Questionnaire<br>* Questionnaire consisting of the following validated surveys: Rome II criteria - Scale of Body Connection (SBC), Private Body Consciousness Sub-Scale (PBCS), Body Vigilance Scale (BVS), Emotional Processing Scale (EPS25)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of functional gastrointestinal disorder |  | within previous 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in ability to process emotions |  | within previous 6 months | 
| difference in body awareness and degree of bodily-dissociation |  | within previous 6 months | 
| difference in sensitivity to internal bodily sensations |  | within previous 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, IBS, Dissociation, Emotional processing
A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients Undergoing Major Surgery

Study Overview
=================
Brief Summary
-----------------
Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

Detailed Description
-----------------
The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb

Official Title
-----------------
Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin

Conditions
-----------------
Child

Intervention / Treatment
-----------------
* Device: blood measurement
* Device: pulse co-oxymeter (SpHb)
* Device: hemoCue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric patients scheduled for major orthopaedi or neurosurgical process under general anesthesia Arterial catheter necessary in the anesthetic protocol. BMI<30 No opposition holders of parental authority and children. Exclusion Criteria: Hemoglobin disease Pretreatment with erytropoietin or iron

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hemoglobine monitoring<br>3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement | Device: blood measurement<br>* Hemoglobin measurement<br>Device: pulse co-oxymeter (SpHb)<br>* non invasive method of hemoglobin measurement<br>Device: hemoCue<br>* non invasive method of hemoglobin measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decision | comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb | within the day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
major pediatric surgery, hemoglobin measurement
Effects of N-acetylcysteine on Diabetic Foot Oxygenation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether N-acetylcysteine is effective in the treatment or prevention of the foot ulcers in diabetic patients.

Official Title
-----------------
Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients

Conditions
-----------------
Foot Ulcer, Diabetic

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 45 and 70 years. Type 1 or 2 diabetes mellitus with foot ulcer (grade 0 stage C according to Texas University Classification). Written informed consent. Exclusion Criteria: N-acetylcysteine assumption in the 6 months previous to the study. Hypersensibility to acetylcysteine. Neoplasms, severe systemic, hepatic, pulmonary, cardiovascular or renal diseases. Psychiatric diseases or drug abuse problems.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine<br>50 patients that receive 600 mg of acetylcysteine for 3 times a day. | Drug: N-acetylcysteine<br>* 600 mg, 1 tablet 3 times a day for 3 months<br>* Other names: Fluimucil (R) 600 mg, tablets;|
| Placebo Comparator: Placebo<br>50 subjects taking placebo pills 3 times a day | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue oxygenation improvement |  | Basal (time 0) and after 3 months of treatment/observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the endothelial function | nitrites/nitrates - ICAM - VCAM - PAI-1 | Basal (time 0) and after 3 months of treatment/observation | 
| Oxidation status reduction | 8-iso PGF-2alpha assessment | Basal (time 0) and after 3 months of treatment/observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage C, grade 0 (Texas University)
The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures

Study Overview
=================
Brief Summary
-----------------
Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low back pain. But there are only part of patients with acute OVFs, because some patients do not have low back pain although OVFs occurred.

Detailed Description
-----------------
Many patients of acute OVFs present with low back pain. While there are also many patients without low back pain even if acute OVFs occurred. The mechanism of low back pain after acute OVFs is well unknown. We set up a hypothesis that low back pain results from vertebral body mobility, which refers to a change of vertebral height or configuration with changes in body positioning. The main objective of this study is to reveal the relationship between vertebral body mobility and low back pain.

Official Title
-----------------
The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures

Conditions
-----------------
Osteoporotic Vertebral Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute osteoporosis fractures Exclusion Criteria: Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Relationship between dynamic mobility of acute vertebral fracture body and low back pain | The investigators plan to analyze 300 patients who presented with acute back pain and were diagnosed as having acute OVFs on MRI. All radiographs were taken at the initial visit. Fracture mobility was determined by comparing cross-table supine lateral radiographs with sitting lateral radiographs (dynamic radiography). Mobility was considered present when a measurable change in vertebral body height occurred between supine and sitting radiographs.We also evaluate low back pain using visual analog scale (VAS) score. Then the patients undergo external fixation using Gips. After Gips fixation, dynamic radiography was performed again to evaluate reduction of dynamic mobility of the OVF body. VAS score was also evaluated after external fixation. We investigate patients' background such as age, sex, bone mineral density, etc. We performed statical analyses to determine the factors which related to low back pain after acute OVFs, especially fracture mobility. | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vertebral fracture, low back pain, gips, mobility
Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns

Study Overview
=================
Brief Summary
-----------------
To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients

Detailed Description
-----------------
Anterior segment optical coherence tomography OCT will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study

Official Title
-----------------
Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns

Conditions
-----------------
Progressive Keratoconus

Intervention / Treatment
-----------------
* Procedure: corneal cross-linking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: progressive keratoconus stage 1-2 Exclusion Criteria: any concomitant ocular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transepithelial accelerated cross-linking<br>Paracel is instilled 1 drop every 1.5 minutes for 4.5 minutes then vibex-xtra is instilled 4 drops at 5.5 minutes followed by 1 drop at 6.5 minutes for a total soak time of 11 minutes followed by ultraviolet-A UVA irradiation with intended irradiance of 45mW/cm2 for 2.4 minutes | Procedure: corneal cross-linking<br>* Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation<br>|
| Active Comparator: Epithelium-off accelerated cross-linking<br>Vibex-rapid is instilled every 2 minutes for 10 minutes followed by ultraviolet-A UVA irradiation of 30 mW/cm2 for 4 minutes | Procedure: corneal cross-linking<br>* Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of depth of demarcation line | Anterior segment optical coherence tomography AS-OCT is used to measure depth of demarcation line | 1 month postoperative |
Bias Source of Signal in SCOUT DS

Study Overview
=================
Brief Summary
-----------------
The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.

Detailed Description
-----------------
In the process of calibrating multiple SCOUT DS units, consistent inter-device score differences were found. These differences could create a bias in the measurement of Diabetes Risk scores (DRS) in human subjects. This study is intended to examine two of the various subsystems of the SCOUT DS to determine whether either of them might be capable of introducing bias into the measurements, with the ultimate aim of eliminating inter-device measurement variation. The testing of human subjects in this trial is necessary to determine whether variability in the performance of these device subsystems actually affect DRS scores in a real world setting. The trial will be a prospective, single site, investigational trial. The trial will utilize four SCOUT DS devices. Subjects will report to the investigative site for multiple visits. The number of visits will vary between three to seven visits.

Official Title
-----------------
Bias Source of Signal in SCOUT DS

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and/ or females greater than or equal to 18 years of age Exclusion Criteria: Have received investigational treatments in the past 14 days Have psychosocial issues that interfere with an ability to follow study procedures Are known to be pregnant Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. Have been treated in the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H) Are known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Device Bias | The primary objective of this study is to identify device characteristics, components, or subsystems that manifest as screening score bias in SCOUT DS. The study will switch subsystems between devices and if the bias differs by more than 3.5 Diabetes Risk Score units compared to the baseline score, we would conclude that the bias was contained within that particular subsystem | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Screening for Type 2 diabetes