linjc16/ctgov huggingface dataset:
Effect of Vitamin E+Selenium on Kidney Function in Controlled Hypotension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Kidney injury happens in controlled hypotension during brain operations by using Neutrophil Gelatinase Associated Lipocalin ELISA Kit and if so, does VitaminE+Selenium prevent it

Detailed Description
-----------------
NGAL(Neutrophil Gelatinase Associated Lipocalin) is a 25KD protein which bounds with Gelatinase in Neutrophil granules.It is also expressed in epithelial cells of kidney tubules.NGAL increases in ischemic and toxic injuries of kidney. During controlled hypotension in brain operations injury to the kidneys might occur . This study is designed to assess this possibility and evaluate the effect of VitaminE+Selenium on prevention of this problem

Official Title
-----------------
Assessment of Preventive Effect of Vitamin E +Selenium on Acute Kidney Injury Through NGAL in Patients Undergoing Controlled Hypotension During Neurosurgery Operations

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: vitamin E +Selenium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are candidate for brain surgery under controlled hypotension Exclusion Criteria: Positive history of renal disease Positive history of diabetes mellitus, CHF, HTN, Breast cancer, fever, leukocytosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vitamin E +Selenium|vitamin E 400 IU once 8 hrs before operation selenium 150 mic once 8 hrs before operation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increased amount of urinary or serum NGAL after controlled hypotension |  | from 2 hours to 24 hours after controlled hypotension |
A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of KPS-0373 in patients with SCD.

Official Title
-----------------
A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD

Conditions
-----------------
Spinocerebellar Degeneration

Intervention / Treatment
-----------------
* Drug: KPS-0373
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese SCD patients with mild to moderate ataxia Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: KPS-0373<br> | Drug: KPS-0373<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for Assessment and Rating of Ataxia (SARA) |  | 4 weeks + 12 weeks | 
| Upper and lower extremity function |  | 4 weeks + 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinocerebellar degeneration, Thyrotropin-Releasing Hormone (TRH), SCD
ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.

Detailed Description
-----------------
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri. Flow may be limited due to slit ventricles

Official Title
-----------------
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri

Conditions
-----------------
Pseudotumor Cerebri

Intervention / Treatment
-----------------
* Diagnostic Test: ShuntCheck


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older Adult men or women who possess a VP shunt placed for PTC; Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as surrogates in this protocol) capable of providing valid, signed informed consent; Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op Exclusion Criteria: Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction; ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated; Presence of an interfering open wound or edema over any portion of the VP shunt.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ShuntCheck<br>Participants will be administered the ShuntCheck diagnostic test. | Diagnostic Test: ShuntCheck<br>* The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of ShuntCheck test |  | 15 minutes | 
| Negative Predictive Value of ShuntCheck test |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of performing ShuntCheck test twice |  | 60 minutes | 
| Negative Predictive Value of performing ShuntCheck test twice |  | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudotumor Cerebri, Ventriculoperitoneal Shunt
Medical Abortion Self-Confirmation (MASC)

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the ability of participants to perform and accurately interpret the multi-level pregnancy test and the low sensitivity pregnancy test following medication abortion, without routine provider contact.

Official Title
-----------------
Medication Abortion Self-Confirmation (MASC): Comparison of Two Home Pregnancy Tests as an Alternative to Office Follow-up

Conditions
-----------------
Medical Abortion

Intervention / Treatment
-----------------
* Behavioral: Self-assessment: MLPT
* Behavioral: Self-assessment: LSPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age of less than or equal to 63 days English speaking Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form Exclusion Criteria: Allergy to mifepristone and/or misoprostol Non-english speaking Inability to access internet

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-level pregnancy test (MLPT)<br>Patients randomized to multi-level pregnancy test (MLPT) arm will receive MLPTs to perform at home one and two weeks after taking mifepristone. They will be asked to interpret the results of the MLPT as it relates to their pregnancy termination status. | Behavioral: Self-assessment: MLPT<br>* Patients enrolled in the study will self-assess the outcomes of their medical abortion using the multi-level pregnancy test.<br>|
| Experimental: Low sensitivity pregnancy test (LSPT)<br>Patients randomized to low sensitivity pregnancy test (LSPT) arm will receive LSPTs to perform at home at one and two weeks after taking mifepristone. They will be asked to interpret the results of the LSPT as it relates to their pregnancy termination status. | Behavioral: Self-assessment: LSPT<br>* Patients enrolled in the study will self-assess the outcomes of their medical abortion using the low sensitivity pregnancy test.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct interpretation of pregnancy test |  | 4 weeks after taking medication abortion medication, mifepristone | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abortion, medical abortion, mifepristone, pregnancy test
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.

Official Title
-----------------
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: simvastatin
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Patients Over 18 Years Old Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR) Signed Informed Consent Form (ICF) Exclusion Criteria: Patients With LDL-C Below 90 mg/dL Pregnant Or Breast Feeding Diabetes Mellitus Or Any Clinically Relevant Organ Disfunction

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: Drug | Drug: simvastatin<br>* simvastatin 20mg daily at nights for 12 weeks. Tablets<br>* Other names: MK0733;|
| Placebo Comparator: 2<br>Arm 2: Placebo | Drug: Comparator: Placebo<br>* placebo daily at nights for 12 weeks. Tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. | The study was terminated; no outcome measure data analyses were conducted. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Cholesterol From Baseline at Week 12 | The study was terminated; no outcome measure data analyses were conducted. | Baseline and 12 weeks | 
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment | The study was terminated; no outcome measure data analyses were conducted. | Baseline and 12 weeks | 
| Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment | The study was terminated; no outcome measure data analyses were conducted. | Baseline and 12 weeks |
Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries

Study Overview
=================
Brief Summary
-----------------
Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Detailed Description
-----------------
Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries involve risks that require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. Therefore, the investigators analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Official Title
-----------------
Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries

Conditions
-----------------
Deep Wound, Wrist Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deep wrist injury from 2008-2018 Treated in University Hospital Schleswig-Holstein Agreed to retrospective analysis, questionnaires and hand function assessment Exclusion Criteria: Non-compliance

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 |
| --- | --- |
| Self-inflicted wrist injury<br>Wrist injury by self-infliction | |
| Traumatic wrist injury<br>Wrist injury by not self-inflicted trauma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand function | Assessment of hand function by measuring sensibility (2-point-discrimination) and motoric (degree joints) | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric history | Assessment of quality of life | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep wrist injury, Self inflicted, Traumatic wrist injury
Creation of a Pressure Reducing Areas in Socks

Study Overview
=================
Brief Summary
-----------------
Evaluation of the ability of socks weaved with pressure relieving areas to reduce the pressure on the foot when weight bearing.

Detailed Description
-----------------
Increased pressure in weight bearing areas of the foot, especially in insensate feet may lead to the development of pressure sore. The creation of socks with pressure relieving areas by special weaving technique may prevent the development of these complications. Three (3) volunteers will be examined walking on a Tekscan pressure mat, barefoot and then wearing socks weaved in a new technique, from cotton, nylon and acrilan.

Official Title
-----------------
Evaluation of Foot Pressure in Volunteers Wearing Socks Weaved With Pressure Reducing Soles

Conditions
-----------------
Pressure Ulcers

Intervention / Treatment
-----------------
* Device: special socks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: foot deformity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: special socks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure measurement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pressure ulcers, socks, foot pressure
French One Day Survey in 2011 - Knowing Our Population of Labile Blood Products Recipients

Study Overview
=================
Brief Summary
-----------------
Describe the epidemiologic profile and clinical context of transfusion recipients in France. Describe the clinical context of transfusion. Describe the characteristics of the transfusion prescriptions, the use of blood products and the main indications for transfusion. Describe transfusion practice according the type of hospital stay.

Official Title
-----------------
French Transfusion Recipients Cross Sectional Study : Get to Know the Transfusion Recipients Population

Conditions
-----------------
Blood Product Transfusion for All Conditions, Trauma, Surgical Blood Loss, Hematologic Diseases

Intervention / Treatment
-----------------
* Procedure: Transfusion of blood products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Transfusion with at least one blood product on the day of the study. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood product recipients<br>All patients who received at least one blood product on the day of the study | Procedure: Transfusion of blood products<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of red blood cell concentrates received | transversal study | 1 day (cross sectional) | 
| Number of platelet concentrates recevied | transversal study | 1 day (cross sectional) | 
| Number of plasma units received | transversal study | 1 day (cross sectional) |
Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined. This study aims to compare the effects of ESP block administered in two different volumes on poststernotomy pain.

Official Title
-----------------
Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study

Conditions
-----------------
Sternotomy Pain

Intervention / Treatment
-----------------
* Procedure: Ultrasound-guided erector spinae plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESP 20 ml<br>Ultrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine | Procedure: Ultrasound-guided erector spinae plane block<br>* Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine<br>|
| Active Comparator: ESP 30 ml<br>Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine | Procedure: Ultrasound-guided erector spinae plane block<br>* Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue analgesia | Total amount of rescue analgesic | Post-extubation 24 hours |