linjc16/ctgov huggingface dataset:
Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children

Study Overview
=================
Brief Summary
-----------------
Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Furthermore, they were developed when using a polyvinylchloride cuff and not the thinner polyurethane cuff which is in common clinical use today. Hence, the purpose of this current study is to evaluate which of the currently available formulas most closely predicts the appropriate size of cuffed ETT to be used based not only on the fit within the trachea, but more importantly the intracuff pressure after the cuff is inflated to seal the airway.

Official Title
-----------------
Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children

Conditions
-----------------
Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Device: Cuffed ETT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are less than 8 years of age and are scheduled for surgical procedures requiring endotracheal intubation with a cuffed ETT. Exclusion Criteria: Children with airway anomalies or other factors that may impact tracheal size will be excluded from the study.

Ages Eligible for Study
-----------------
Maximum Age: 8 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 |
| --- | --- |
| Group C<br>Size of the cuffed ETT based on the Cole formula = (Age/4) + 4. | Device: Cuffed ETT<br>* Cuffed endotracheal tube.<br>|
| Group D<br>size of the cuffed ETT based on the Duracher formula = (Age/4) + 3 + 0.5 mm. | Device: Cuffed ETT<br>* Cuffed endotracheal tube.<br>|
| Group K<br>size of the cuffed ETT based on the Khine formula = (Age/4) + 3. | Device: Cuffed ETT<br>* Cuffed endotracheal tube.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that needed their ETT exchanged | Having to remove the original ETT and replacing it with a smaller or larger size due to excessive air leak or excessive pressure in the cuff. | Immediately following intubation |
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.

Official Title
-----------------
Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed GHLiquid-1518. If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded. Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies. Exclusion Criteria: Subject with a history of acromegaly. Subject with diabetes mellitus. Subject suffering from malignancy. Several medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in truncal fat (kg) |  | from the baseline to the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment |  |  | 
| Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) |  |  | 
| FPG, insulin, and HbA1C |  |  | 
| IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio |  |  | 
| Clinical laboratory tests |  |  |
Construction of Computerized Intraoperative Keratometer and Experimental Study

Study Overview
=================
Brief Summary
-----------------
To construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

Detailed Description
-----------------
The study is designed to construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

Official Title
-----------------
Construction of Computerized Intraoperative Keratometer and Experimental Study

Conditions
-----------------
Orientation, Corneal Astigmatism

Intervention / Treatment
-----------------
* Device: computerized intraoperative keratomer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cornea astigmatism from -1.0 D to -4.0D; Exclusion Criteria: any significant corneal disease Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on; Previous corneal or intraocular surgery; Refuse surgery;

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: computerized intraoperative keratomer|computerized intraoperative keratomer can analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axis of astigmatism |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axis of implantation |  | day 1 |
Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne. The purpose of this study is to determine cognitive functioning in treatment naive acne patients, without a history of any psychiatric disorder.

Official Title
-----------------
Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: The participants that had a symptom or a history of mental retardation (IQ < 70), serious head trauma, seizures or any other mental disorder, and participants on any medical treatment will be excluded. Participants with a family history (first degree relatives) of schizophrenia, bipolar disorder or schizoaffective disorder will also be excluded to avoid the negative effect of these disorders on cognitive functions. The same exclusion criteria will also be applied to the control group.

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 |
| --- | --- |
| Acne Patients<br> | |
| Control Subjects<br>From General Population | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functions |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne vulgaris cognitive functions
Yoga as a Therapy for Traumatic Experiences

Study Overview
=================
Brief Summary
-----------------
The purpose of the proposed research is to conduct a feasibility study of yoga as an adjunctive therapy for the treatment of posttraumatic stress disorder (PTSD) in 15 military personnel at the Walter Reed Army Medical Center (WRAMC) in Washington, DC. Participants will complete 10 weeks of yoga training, in addition to the continuing their usual and customary care for PTSD at WRAMC. The style of yoga chosen for this study, Yoga Nidra, uses deep relaxation, deep breathing and meditation to systematically reduce physical, emotional, mental, and even subconscious tension. After a diagnostic mental health assessment at baseline, participants will attend a total of 18 classes taught over a 10-week period and will practice daily at home using a compact disk provided by the instructor. Baseline measures will include the Patient Health Questionnaire, PD-HAT Trauma Questions, PTSD Symptom Scale - Interview, Fear of Loss of Vigilance Scale, and expectation of efficacy. The primary outcome measure will be the PTSD Checklist. Changes in health status, locus of control, and pain will be assessed over the course of the study. An additional goal of this study is to gather preliminary data on the anticipated effect size and feasibility of conducting a larger clinical study of the adjunctive use of yoga for the treatment of PTSD symptoms in enlisted military personnel.

Official Title
-----------------
Yoga as an Adjunctive Therapy for Post-Traumatic Stress Disorder: A Feasibility Study

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Yoga Nidra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active Duty military personnel Aged 18 and over A minimum score of 40 on the Posttraumatic Stress Disorder Checklist (PCL-M), a brief, self-report instrument used to assess PTSD severity. Exclusion Criteria: Active suicidal or homicidal ideation Severe cognitive impairment or history of cognitive disorder Serious surgical procedures within the last two months or planned Treatment for refractory pain New or dose adjusted psychotropic medication (i.e. SSRIs and anxiolytics) in last month Unwilling or unable to practice Yoga Nidra at home Amputation of any body part

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

| Intervention/Treatment |
| --- |
|Behavioral: Yoga Nidra|nan|

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
-----------------
Post-Traumatic Stress Disorder, Yoga Nidra
Metabolic Aspects of Citrate Anticoagulation in Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
Citrate anticoagulation is associated with metabolic side effects which are linked to a portion of citrate reaching systemic circulation. Data on significance of systemic gain of citrate and its relationship to method configuration are missing. Patient might also receive certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution is used. The authors test variable methods of indirect estimate of systemic dose of citrate which would allow to quantify the metabolic input without mostly unavailable measurements of citrate levels.

Official Title
-----------------
Metabolic Aspects of Citrate Anticoagulation in Renal Replacement Therapy

Conditions
-----------------
Acute Renal Failure, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute renal failure on continuous renal replacement therapy for more than 24 hours (CVVH or CVVHDF). Exclusion Criteria: Absence of consent.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| ACD (acid-citrate-dextrose)<br> | |
| 4% trisodium citrate<br> | |
| unfractionated heparin (UFH)<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
-----------------
Acute renal failure, Anticoagulation, Citrate, Haemodiafiltration, Haemofiltration, Renal replacement therapy
Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity

Study Overview
=================
Brief Summary
-----------------
This study will test the potential of two techniques using light properties of adipose tissue to diagnose crown-like structures and inflammation to be compared with pathologic examination of adipose tissue biopsies from ongoing clinical studies.

Detailed Description
-----------------
Adipose tissue (fat) inflammation is emerging as an important harbinger of disease development including Type 2 diabetes, heart disease and potentially cancer. The hallmark feature of adipose tissue inflammation is the crown-like structure, a dying fat cell surrounded by immune cells attempting to clear the damage. Current methods for detecting adipose tissue inflammation rely on invasive procedures such as fat biopsies. We propose developing methods that use the light reflection properties of inflamed adipose tissue as a potential non-invasive method to detect adipose tissue inflammation.

Official Title
-----------------
Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Fat Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol Exclusion Criteria: -History of any skin disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese subjects for fat biopsy<br>10 patients recruited during fat biopsies for sample collection | Procedure: Fat Biopsy<br>* Fat biopsy<br>|
| Lean controls for fat biopsy<br>5 Lean controls will be recruited | Procedure: Fat Biopsy<br>* Fat biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy | Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy | Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Healthy Volunteers
Food Effect Study For Apixaban Commercial Image Tablets

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.

Official Title
-----------------
An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Apixaban
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: History or evidence of abnormal bleeding or coagulation disorder (eg, easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery) and/or having a first degree relative under 50 years of age with a history of abnormal bleeding or coagulation disorder

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Period I: fasting state, Period II: fed state | Drug: Apixaban<br>* Period I: 1 x 5 mg Commercial Image Tablet in fasting state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fed state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period)<br>|
| Experimental: 2<br>Period I: fed state, Period II: fasting state | Drug: Apixaban<br>* Period I: 1 x 5 mg Commercial Image Tablet in fed state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fasting state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | dosing to 3 days | 
| AUC(INF) |  | dosing to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(tlqc) |  | dosing to 3 days | 
| Tmax |  | dosing to 3 days | 
| t1/2 |  | dosing to 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apixaban, Food effect study, Pharmacokinetics
Unicentric Form of Castleman Disease - Surgery Therapy Benefit

Study Overview
=================
Brief Summary
-----------------
Observation study on patients with unicentric form of Castleman disease, evaluation of surgical treatment benefit. Observation of surgical treatment strategy.

Official Title
-----------------
Castleman Disease - Diagnosis and Surgery

Conditions
-----------------
Castleman Disease, Unicentric Castleman Disease, Surgery

Intervention / Treatment
-----------------
* Procedure: surgery type/exstirpation/debulking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with unicentric form of Castleman disease underwent surgery resection Exclusion Criteria: multilocalised Castleman disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgery type/exstirpation/debulking|Evaluation of benefit according to surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 year survival | surgery treatment success | each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression | 
| recurence rate | surgery treatment success | each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unicentric form of Castleman disease, Surgical resection