linjc16/ctgov huggingface dataset:
A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients

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 surgery under general anesthesia Arterial catheter necessary in the anesthetic protocol BMI<30 Written consent of holders of parental authority No opposition of children Exclusion Criteria: - Hemoglobine disease

Ages Eligible for Study
-----------------
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
Interventional Model Description: Blood measurement
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemoglobin 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 |
| --- | --- | --- |
| level of hemoglobin 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
Effect of Sleep Restriction on Decision Making and Inflammation

Study Overview
=================
Brief Summary
-----------------
hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes inclusion criterias: healthy subjects, men, under 35 years, BMI<26, no sleep troubles, intermediate chronotype design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights). parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure control of sleep restriction: continuous polysomnographic survey

Official Title
-----------------
Effect of Sleep Restriction on Decision Making and Inflammation

Conditions
-----------------
Sleep Deprivation

Intervention / Treatment
-----------------
* Other: Sleep restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men, < 35 yr old, BMI<26, intermediate chronotype Exclusion Criteria: sleep trouble, acute or chronique disease (cardiological, neurological...), women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sleep restriction<br>Longitudinal study of response to sleep restriction. Comparison between baseline values and sleep restriction values | Other: Sleep restriction<br>* 4 hours sleep by night during one week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| London tower test score (décision making) | % of good score and mean response time resulting from London Tower test, assessed during baseline, sleep restriction (day 1 to day 5) and recovery (day 1 to day 3) at 10 AM | up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wakefulness |  | maintenance of wakefulness test (MWT) score observed every day during baselline, sleep restriction and recovery at 09 AM, 12 AM, 4 PM and 7 PM | 
| cognitive function |  | up to 3 days | 
| Inflammation |  | biological marker of inflammation levels assessed every day during baseline, sleep restriction and recovery at 08 AM | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep restriction, decision making, wakefullness
Hepatocellular Carcinoma and Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk of developing malignancies, while studies examining the association between hepatocellular carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of HCC between participants with and without RA.

Detailed Description
-----------------
The investigators did a retrospective, observational, nested case-control study in a cohort that was previously recruited from a population-based RA survey. All participants were enrolled prospectively in Taiwan's national health insurance between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009. RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria. The investigators matched RA and non-RA subjects by propensity score in a 1:1 ratio. The primary outcome was the risk of developing HCC. Cox proportional hazards regression was applied to estimate the hazard ratio (HR) and 95% confidence interval (CI) of HCC for RA and non-RA cohort.

Official Title
-----------------
Hepatocellular Carcinoma and Rheumatoid Arthritis

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Other: RA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects were required to have ≥2 RA diagnosis (International Classification of Diseases, Ninth Revision [ICD-9-CM]-codes 714.0x), and to be ≥18 years of age on the date of first diagnosis. And inclusion in the Registry for Catastrophic Illness Patient Database (RCIPD) Exclusion Criteria: who were diagnosed with RA only once during the study interval, <18 years of age when first diagnosed with RA, first diagnosed with RA after July 1, 2009, or not registered in the RCIPD were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| RA cohort<br>RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria. | Other: RA<br>* RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria<br>|
| Non-RA cohort<br>Participants who were ≥18 years of age, without a RA diagnosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the risk of developing hepatocellular carcinoma |  | between Jan 1, 1999 and Dec 31, 2009 |
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.

Detailed Description
-----------------
Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10^6 cells/kg once or at weekly intervals dependent on clinical effect.

Conditions
-----------------
Hemorrhagic Cystitis

Intervention / Treatment
-----------------
* Biological: Decidual Stromal Cell therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemorrhagic cystitis grade 2-4 Exclusion Criteria: Urinary urge without macroscopic hematuria or clots
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decidual Stromal Cell therapy for Hemorrhagic Cystitis<br> | Biological: Decidual Stromal Cell therapy<br>* Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response at day 28 after onset of hemorrhagic cystitis | Disappearance of macroscopic hematuria. | 28 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actuarial survival at one year after onset of hemorrhagic cystitis |  | One year after inclusion | 
| Time to disappearance of pain or urges |  | Up to 6 months after inclusion | 
| Time to disappearance of microscopic hematuria |  | Up to 84 days after inclusion | 
| Transplant related mortality | All mortality except for relapse | Up to one year after inclusion | 
| Incidence of severe infections | Incidence of severe bacterial, viral or fungal infections. | Up to one year after inclusion | 
| Incidence of graft versus host disease |  | Up to one year after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem Cell Transplantation, Decidual Stromal Cells
Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive training
* Device: Noninvasive brain stimulation (active)
* Device: Noninvasive brain stimulation (sham)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-60 years old Smoking > 15 cigarettes per day Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria Exclusion Criteria: Contraindications to noninvasive brain stimulation Psychiatric or neurologic condition

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active noninvasive brain stimulation and cognitive training<br>In active condition, subject will receive stimulation during all the 30-minute stimulation period combined with cognitive training. | Behavioral: Cognitive training<br> <br> Device: Noninvasive brain stimulation (active)<br>* Neuroconn DC-STIMULATOR PLUS<br>|
| Sham Comparator: Sham noninvasive brain stimulation<br>In sham condition, subject will receive stimulation only during the first 30 seconds of the 30-minute stimulation period combined with cognitive training. | Behavioral: Cognitive training<br> <br> Device: Noninvasive brain stimulation (sham)<br>* Neuroconn DC-STIMULATOR PLUS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tobacco craving assessed by the Questionnaire of Smoking Urge |  | immediately before and immediately after the end of the noninvasive brain stimulation |
A Study to Measure Needle Bending and Changes in Prostate Shape During a Prostate Seed Implant

Study Overview
=================
Brief Summary
-----------------
Prostate brachytherapy is an effective treatment option for men with localized prostate cancer, with excellent cure rates and a favorable toxicity profile. With the current needle insertion technique, seed placement inaccuracy is primarily caused by needle deflection and soft tissue deformation, which both occur during the brachytherapy operation. This study will accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of ultrasound images, video clips and one CT scan.

Official Title
-----------------
Quantifying Needle Deflection and Tissue Deformation in Transperineal Interstitial Permanent Prostate Brachytherapy: A Basis for Development of Next-Generation Implant Technique

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer Treated with prostate brachytherapy at the Cross Cancer Institute Low and intermediate risk prostate cancer ambulatory patients stable medical condition Over 18 years of age Capable of giving informed consent Exclusion Criteria: Any hormonal therapy

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Needle deflection, Prostate Deformation, Prostate Brachytherapy, Needles
Is NIRS Able to Detect Ischemia Following Brain Insult

Study Overview
=================
Brief Summary
-----------------
We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.

Official Title
-----------------
The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2

Conditions
-----------------
Brain Trauma, SAH, ICH

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Necessity of monitoring by PtiO2 and ICP Exclusion Criteria: Inability to apply NIRS sensor

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PtiO2, NIRS
Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determinate the utility of staple-line reinforcement on lineal gastrointestinal anastomoses. Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive lineal stapled anastomoses.

Official Title
-----------------
Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial

Conditions
-----------------
Leak on Lineal Stapled Anastomoses, Bleeding on Lineal Stapled Anastomoses

Intervention / Treatment
-----------------
* Device: Seamguard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example) Exclusion Criteria: circular anastomoses bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>without seamguard | |
| Experimental: 2<br>with seamguard | Device: Seamguard<br>* GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.<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
-----------------
Seamguard, staple-line reinforcement, leak, bleeding
Hyperthermia With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate immunogenic effect of hyperthermia applied with flexible electrode-typed 2-MHz device during radiotherapy for solid tumors.

Official Title
-----------------
Exploratory, Open-labelled, Control Group-included, Single Institution Clinical Trial for Evaluating Immunogenic Effect of Hyperthermia Applied With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Other: Hyperthermia
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid tumor (primary, metastatic) Eastern Cooperative Oncology Group (ECOG) score 0-3 Ability to understand and the willingness to sign a written informed consent documents Exclusion Criteria: Myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia within 6 months Active infectious disease Pregnant or probability of pregnancy during treatment Obesity (BMI ≥35) Immunosuppressive drug after organ transplantation Autoimmune disease Skin injury on treatment area

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperthermia group<br>Hyperthermia Radiotherapy | Other: Hyperthermia<br>* Patients will be treated with hyperthermia 2 or 3 times a week. Treatment will be performed for 1 hours per each visit. Patients will be treated with radiotherapy 5 times a week.<br>Radiation: Radiotherapy<br>* Patients will be treated with radiotherapy 5 times a week.<br>|
| Active Comparator: Control<br>Radiotherapy | Radiation: Radiotherapy<br>* Patients will be treated with radiotherapy 5 times a week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenic effect | NK cell, CD4+ T cell, CD8+ T cell | 1 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Hyperthermia