linjc16/ctgov huggingface dataset:
MPS II Immunophenotyping

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how participant's body's immune system responds to idursulfase, an enzyme replacement therapy (ERT) and find out which types of immune cells are involved in causing untoward responses to the ERT so that the investigators can relate the level of immune response to the treatment.

Official Title
-----------------
Immunophenotyping of Patients With MPS II Treated With Enzyme Replacement Therapy

Conditions
-----------------
MPS II, Mucopolysaccharidosis II, Hunter Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a confirmed diagnosis of Mucopolysaccharidosis type II (MPS II) or Hunter Syndrome based on enzyme activity and variant analysis. Subject who plan to receive or have received enzyme replacement therapy with idursulfase. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Naive<br>subjects who are naïve to ERT and start treatment with idursulfase | |
| Treatment less than 3 years<br>Subjects who have received ERT for <3 years | |
| Treatment over 3 years<br>Subjects who have received ERT for 3 or more years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the frequency of natural killer cells measured by flow cytometry |  | baseline, 1, 3, 6 months | 
| Changes in level of circulation memory B cells measured by flow cytometry |  | baseline, 1, 3, 6 months | 
| Changes in level of T follicular helper cells measured by flow cytometry |  | baseline, 1, 3, 6 months | 
| Changes in distribution of helper T cells measured by flow cytometry |  | baseline, 1, 3, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MPS II, Mucopolysaccharidosis II, Hunter Syndrome
Autonomic Dysfunction in Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
The contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response.

Detailed Description
-----------------
All patients were submitted to office blood pressure measurement, Ambulatory blood pressure monitoring and 24-hour Holter monitoring. Baseline blood samples for the measurement of glycemia (mg/dL), total cholesterol (mg/dL), LDL cholesterol (mg/dL), triglycerides (mg/dL), creatinine (mg/dL), serum uric acid, serum sodium, serum potassium, plasma aldosterone concentration (PAC) and plasma renin activity (PRA) were collected at 08:00 after overnight fasting.

Official Title
-----------------
Circadian Autonomic Disturbances in Resistant Hypertension With and Without White-coat Phenomenon

Conditions
-----------------
Hypertension, Resistant to Conventional Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resistant hypertensive patients Exclusion Criteria: White-coat hypertension obstructive sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| Resistant Hypertension<br>The current definition of resistant hypertension (RH) includes both patients whose blood pressure (BP) is uncontrolled on three or more medications and those whose BP is controlled when using four or more antihypertensive medications | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the autonomic function in resistant hypertensive patients | The autonomic nervous system can be assessed by the heart rate variability. Variations in heart rate variability are normally observed in association with diurnal rhythms and blood pressure changes. The heart rate variability parameters are different in many studies, although the consensus is that lower values of the indices of vagal as well as high indices of sympathetic functions are associated prospectively with death and disability. In humans, the disturbances of the circadian rhythms of heart rate variability and blood pressure have been intensively studied, mainly due to the increased cardiovascular death reported during the morning hours | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistant hypertension, White-coat phenomenon, Heart rate variability, autonomic activity
Multi-frequency Bioelectrical Impedance for Estimating Total Body Water by Deuterium Dilution

Study Overview
=================
Brief Summary
-----------------
SPECIFIC AIM: Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium water (D2O) measurements. HYPOTHESIS: The Biospace Body Composition Analyzers are valid tools for measuring total body water and body composition.

Official Title
-----------------
Utility of Multi-frequency Bioelectrical Impedance Compared to Deuterium Dilution for Assessment of Total Body Water

Conditions
-----------------
Total Body Water Assessment

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women between 18-59 years of age Exclusion Criteria: Acute illness (infection, recent surgery, trauma). pregnancy pacemaker or defibrillator We would like to standardize the procedures and measurements in the adult population first. Older adults are excluded because by including older adults at this time, we would need to increase the sample size because we believe older adults have greater fluctuations in hydration due to medications, diet, and co-morbidities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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 |
| --- | --- |
| otherwise healthy with various BMI<br> | Other: observation<br>* no intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Body Water differences between criterion and test devices | from BIA and from D2O | Baseline only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total lean body mass differences between criterion and test devices | From BIA and from DXA | Baseline only | 
| Appendicular lean mass differences between criterion and test devices | from BIA and from DXA | Baseline only | 
| Trunk lean mass differences between criterion and test devices | from BIA and from DXA | Baseline only | 
| Total fat mass differences between criterion and test devices | from BIA and from DXA | Baseline only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multi-frequency, bioelectrical impedance, body composition, hydration
Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap

Study Overview
=================
Brief Summary
-----------------
Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap

Official Title
-----------------
Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap

Conditions
-----------------
Surgery--Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be over 18 years old to be operated on for pituitary surgery to have express no objection to the study Exclusion Criteria: refusal to participate in the study pregnant women to be Under the age of 18 not being able to understand and accept participation in the study to have a life expectancy of less than a year

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with nasoseptal flap<br>patient who undergo a pituitary gland surgery with nasoseptal flap | |
| without nasoseptal flap<br>patient who undergo a pituitary gland surgery without nasoseptal flap | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative epistaxis | no epistaxis - begnin epistaxis - severe epistaxis. | during two month after surgery | 
| post operative rhinoliquorrhea | physical examination and symptomatic rhinorrhea | during two month after surgery |
PCOS, Therapy and Markers of Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS) is also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead to the development of diabetes, hypertension, atherosclerosis and coronary heart disease. Serum markers of inflammation are being increasingly recognized as predictors of atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes mellitus. Therefore, the aim of the present study is to evaluate the effects of commonly used non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives, metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular risk markers in women with PCOS. The study hypothesis is that some of the commonly used therapies of women with PCOS may have more favorable effects on classical and surrogate markers of cardiovascular risk then others or some of them may even confer a higher risk of cardiovascular events

Official Title
-----------------
Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Drug: oral metformin
* Drug: oral contraceptive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS Exclusion Criteria: diabetes pregnancy contraindications to oral contraceptives

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

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

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 |
| --- | --- |
| Active Comparator: Metformin<br>oral metformin at a dose of 850mg twice daily | Drug: oral metformin<br> <br> |
| Active Comparator: Oral contraceptive<br>oral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen) | Drug: oral contraceptive<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum C-reactive protein (CRP) levels |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pcos, metformin, oral contraception, cyproterone acetate
Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.

Official Title
-----------------
Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire

Conditions
-----------------
Difficult Peripheral IV Access

Intervention / Treatment
-----------------
* Device: Ultrasound guided peripheral IV placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Difficult peripheral IV access (2 failed attempts by nursing staff) Prior history of difficult IV access and patient request for ultrasound guided IV Exclusion Criteria: Need for emergent access or central venous access Inability to provide informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Standard of care ultrasound guided peripheral IV placement | |
| Experimental: Experimental<br>Ultrasound guided peripheral IV placement with the use of a guidewire | Device: Ultrasound guided peripheral IV placement<br>* Accucath™ 20 Gax 5.7cm catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt success rate | First attempt success is defined as ability to place and use the catheter after only one attempt and will be reported by study staff. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success rate | Overall success is defined as ability to place and use the catheter (after 2 or fewer attempts) and will be reported by study staff. | 60 minutes | 
| Number of skin punctures | Number of skin punctures will be recorded by study staff. | 60 minutes | 
| Complications including hematoma, IV infiltration, catheter dislodge | Patients will be monitored for complications of IV placement by study staff | 3 days |
Use of Hair to Diagnose the Presence of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with breast cancer exhibits a difference in its molecular structure compared to that of an individual without breast cancer. This difference is visible in the X-ray diffraction pattern as a ring superimposed on the pattern for normal hair. The hypothesis of this study is that synchrotron x-ray diffraction can be used to differentiate hairs from women with medically diagnosed breast cancer from women not known to have the disease. To test this hypothesis, hair from 2000 women attending radiology clinics for mammography will be collected, analysed by x-ray diffraction and then analysed using Fermiscan proprietary image analysis software. The mammogram status of the subjects will be blinded from the diffraction analysts. Results will then be compared with mammography results to allow a direct comparison between the Fermiscan test and mammography in terms of specificity and sensitivity.

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

Intervention / Treatment
-----------------
* Procedure: diagnosis of breast cancer by x-ray diffraction of hair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult women (aged >20) who are undergoing mammography, and Who are willing and able to provide informed consent; and Who have usable scalp and/or pubic hair Exclusion Criteria: Women who have dyed or permed their scalp hair within the previous 6 weeks and whose pubic hair is unavailable; Women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and CIN [cervical intra-epithelial neoplasia]) within 5 years.

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: diagnosis of breast cancer by x-ray diffraction of hair|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (sensitivity and specificity) of the breast cancer test based on detection of an abnormal pattern of hair x-ray diffraction compared to the gold standard of mammography plus biopsy where indicated |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of a positive hair x-ray diffraction pattern and a negative mammogram; and the prevalence of a negative hair x-ray diffraction pattern and a positive mammogram; |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, diagnosis, x-ray diffraction, synchrotron, hair
Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors

Study Overview
=================
Brief Summary
-----------------
Reliable data on stent thrombosis (ST) in comatose out of hospital cardiac arrest (OHCA) survivors is lacking. In comatose OHCA survivors suspicion of ST can be made with precise clinical monitoring of the patient with definite confirmation being possible only by coronary angiography or autopsy of deceased patients. However in addition to definite ST which can be confirmed using current protocols, additional ST which are clinically silent are plausible. These could be identified only by systematic coronary angiography of all OHCA survivors or by autopsy of deceased patients. Collectively with definite ST confirmed by coronary angiography upon clinical suspicion the incidence of all forms of ST in survivors of OHCA treated with PCI and hypothermia could be obtained. Consecutive comatose survivors of OHCA treated with percutaneous coronary intervention (PCI) and hypothermia will be included. All study participants will receive treatment per our established clinical protocol and will be followed for 10 days. In all patients in whom clinical suspicion of ST will be made immediate coronary angiography and if necessary PCI will be carried out. In all patients that will die in the observed period of 10 days autopsy will be performed. Survivors however will have an additional control coronary angiography on 10th day after admission, to assess presence of clinically silent ST. We expect that the incidence of true definitive ST in comatose OHCA survivors treated with urgent PCI with stenting and hypothermia is greater than one, which is confirmed on the basis of clinical suspicion by angiography or later with autopsy.

Official Title
-----------------
Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors Treated With Percutaneous Coronary Intervention and Hypothermia

Conditions
-----------------
Out of Hospital Cardiac Arrest, Stent Thrombosis, Drug Eluting Stent, Therapeutic Hypothermia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Comatose out-of-hospital cardiac arrest survivors admitted to University Medical Centre Ljubljana Treated with primary PCI with stenting Treated with therapeutic hypothermia. Exclusion Criteria: Younger than 18 years old.

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 |
| --- | --- | --- |
| Incidence of definite early ST until day 10 |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stent Thrombosis
Postoperative Troponin in Renal Dysfunction After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Elevated level of troponin is frequently observed among patients with renal dysfunction. Increase in troponin after cardiac surgery may predict postoperative outcome in cardiac surgery patients. However, the relationship between the increased troponin and outcome after cardiac surgery has not been fully elucidated in patients with renal dysfunction.

Detailed Description
-----------------
This is a retrospective observational study to evaluate the prognostic value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery. Electrical medical records of patients who underwent cardiac surgery between 2004 and 2015 will be assessed. Perioperative laboratory data including troponin and glomerular filtration rate, type of surgery, and outcome variables including mortality will be analysed to determine the prognostic value of postoperative value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery.

Official Title
-----------------
Prognostic Value of Postoperative Troponin in Patients With Renal Dysfunction Undergoing Cardiac Surgery

Conditions
-----------------
Renal Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: postoperative troponin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital Exclusion Criteria: Patients without laboratory information on glomerular filtration rate or troponin levels

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: postoperative troponin|assess postoperative troponin levels after cardiac surgery in patients with renal dysfunction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality after cardiac surgery | through study completion, average 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, troponin, mortality