linjc16/ctgov huggingface dataset:
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

Study Overview
=================
Brief Summary
-----------------
To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on cognitive function, quality of life, and activities of daily living.

Detailed Description
-----------------
Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.

Official Title
-----------------
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

Conditions
-----------------
Cognitive Disorders, HIV Infections

Intervention / Treatment
-----------------
* Drug: OPC 14117


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV seropositivity. Cognitive impairment. Prior Medication: Allowed: Prior OPC-14117 other than on the current study. Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis). Severe pre-morbid psychiatric illness including schizophrenia and major depression that would interfere with protocol compliance. CNS neoplasms. Any other clinically significant condition or laboratory abnormality that would interfere with ability to participate on study. Current participation in other drug studies. Patients with the following prior conditions are excluded: Past history of opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis). History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease. History of adverse reaction / allergy to OPC-14117. Prior participation on this study. Prior Medication: Excluded: Other investigational drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OPC 14117|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
-----------------
Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Free Radical Scavengers, Antioxidants, OPC 14117
Comparing the Ultrasound Appearance of the Sciatic Nerve With Its Appearance Under a Microscope

Study Overview
=================
Brief Summary
-----------------
The investigators are proposing to conduct this study to compare the ultrasonographic appearance of the sciatic nerve with their corresponding histologic architecture. Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled. We intend to do an ultrasound examination of the sciatic nerve at its bifurcation (about 4 inches above the knee). The investigators would mark the area on the skin where the image is obtained. Following surgery we will conduct a histologic examination of the nerve at the same site. Ultrasound examination is not standard of care, but is a fairly noninvasive procedure and does not add any risk to the subject. Histologic examination of the nerve is also not standard of care, but is conducted on a pathology specimen

Official Title
-----------------
Correlation of the Ultrasound Appearance of the Sciatic Nerve With Its Histologic Appearance in Pathology Specimens Obtained From Patients Undergoing Above Knee Amputation

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes Exclusion Criteria: Minors

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee Amputation<br>Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasonographic appearance | There is outcome measure pe se. This is an observational study. We intend to study the ultrasonographic appearance of the sciatic nerve and compare this ultrasonographic appearance with the histologic appearance of the nerve. We know the nerve in diabetic neuropathy appears ultrasonographically different than a normal nerve. We just want to study the changed appearance of the nerve under ultrasound examination with the corresponding appearance of the nerve under the microscope. | at examination before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
above knee amputation, sciatic nerve, ultrasonography, histology
Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether positron emission tomography (PET) using the tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of hematological toxicity

Official Title
-----------------
Value of FLT PET/CT in Radium-223 Therapy of Patients With Metastatic Castration-resistant Prostate Cancer

Conditions
-----------------
Metastatic Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: FLT PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic castration resistant prostate cancer Eligible for Radium-223 therapy Informed consent Exclusion Criteria: Inability to understand study protocol Extensive metastatic involvement of the axial skeleton (superscan on bone scintigraphy)
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: FLT PET/CT<br>FLT PET/CT | Other: FLT PET/CT<br>* FLT PET/CT before first series of Radium-223 and after 2 series<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of FLT in hematological bone marrow |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hematological toxicity |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radium-223 therapy
Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors

Study Overview
=================
Brief Summary
-----------------
Blood donors are a precious community resource. Each month at Blood Center of Wisconsin (BCW), 200 men and 600 women over age 50 are turned away (deferred) because of anemia. In those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC). CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet with proper testing CRC outcomes can be improved by early diagnosis. This project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. This project has the potential to lead to better CRC outcomes in Wisconsin blood donors.

Official Title
-----------------
Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors

Conditions
-----------------
Anemia, Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Educational brochure
* Behavioral: Standard pamphlet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult blood donors who have been deferred (not allowed to donate) due to low blood count, specifically all male donors found to have hematocrit < 38% and to all female donors over 50 years old found to have hematocrit < 36% Exclusion Criteria: deferred donors who have previously donated more than 3 times in the past year, as their anemia is more likely due to frequent donation women less than 50 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Educational brochure<br>* This brochure will educate anemic blood donors regarding the possible causes of their anemia, and based on age will make recommendations for who should seek consultation with a physician.<br>|
| Active Comparator: 2<br>standard approach currently being used | Behavioral: Standard pamphlet<br>* The BloodCenter of Wisconsin's default action when a potential donor has been found to be anemic is to provide a standard pamphlet with very basic nutritional information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported seeking of medical care for diagnosis of anemia found at time of blood donation |  | 3 months |
Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?

Study Overview
=================
Brief Summary
-----------------
Working hypothesis and aims: To investigate the association between cervical length in non-pregnant women, and the risk of premature birth. The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The investigators will invite them 3 month or more after delivery to ultrasound examination of the cervical length. The participants in the control group will be the women whom term delivery follows by chronological manner to those in study group. Data of the cervucal length will be collected at the time of the examination.

Detailed Description
-----------------
Women will be invited to undergo an examination in Ultrasound Unit of Department of Obstetrics and Gynecology, HaEmek Medical Center. Ultrasound examination will be performed using the Voluson E8 device, General Electric. The cervical length,between the external and internal orifice will be measured using conventional technologies available including: Doppler, three dimensional and two dimensional ultrasound.

Official Title
-----------------
Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?

Conditions
-----------------
Preterm Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nonpregnant women aged 18-40 years. Singelton last pregnancy. Last birth, spontaneous premature (24-37 week) Last birth at least 3 months ago. Exclusion Criteria: Presence of uterine malformations. Sonographic pathologic findings. Technical failure (failed appropiate sonographic visualisation) Presence of fetal malformations ( in preterm delivery ) Presence of comorbidities including diabetes, hypertension, collagen disease, thrombophilia Presence of risk factors for premature delivery (amniotic fluid infection, cervical surgical treatments - conization, polyhydramnios, etc.).

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group: previous preterm labor<br> | |
| control group:previous term delivery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of the cervix in mm. | External orifice location is well-defined anatomically and easy for identification .Internal orifice location will be determined by the level of the uterine arteries at both sides of the cervix. | up to 20 month |
Intima Media Thickness Regression in Dyslipidemic Teenagers

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.

Detailed Description
-----------------
Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.

Official Title
-----------------
Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque

Conditions
-----------------
Obesity, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity Abnormal Triglyceride levels (>1.7mmol/L). Abnormal HDL-C levels (1.0mmol/L) Exclusion Criteria: Abnormal thyroid unfction (not treated) Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin<br>Atorvastatin 10 mg every day for one year | Drug: Atorvastatin<br>* 10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year<br>* Other names: Lipitor;|
| Placebo Comparator: Sugar pill<br>Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year. | Drug: sugar pill<br>* placebo controlled arm receives similarly looking placebo.<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intima media thickness | Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | weight, height and BMI recorded before and after intervention | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Dyslipidemia, Cholesterol, Intima media thickness
Estrogen and Gender Biased Autoimmunity

Study Overview
=================
Brief Summary
-----------------
This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

Detailed Description
-----------------
This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.

Official Title
-----------------
Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus

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

Intervention / Treatment
-----------------
* Other: Peripheral lab draws


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant. Exclusion Criteria: Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female Lupus patients<br>Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling. | Other: Peripheral lab draws<br>* 100ml blood for analysis, taken no more than 4 times in one year.<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
-----------------
Systemic Lupus Erythematosus, Estrogen receptors, T cells, Hormones, Female adult SLE
Corneal Barrier Function With Multi-Purpose Solutions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Detailed Description
-----------------
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Official Title
-----------------
Comparison of Human Corneal Barrier Function With Three Marketed Multi-Purpose Solutions

Conditions
-----------------
Contact Lens Care

Intervention / Treatment
-----------------
* Device: Multi-purpose solutions (polyquaternium-1 and PHMB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40 Exclusion Criteria: Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Multi-purpose solutions (polyquaternium-1 and PHMB)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of fluorescein dye penetration rate of test eye vs. control |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal fluorescein staining |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
barrier function, multi-purpose solutions, silicone hydrogel contact lenses
Bivalirudin as a Procedural Anticoagulant in Pediatrics

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics and safety of weight based bivalirudin in children

Official Title
-----------------
Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease

Conditions
-----------------
Cardiology

Intervention / Treatment
-----------------
* Drug: bivalirudin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and non-pregnant females, with an age range of birth to 16 years of age. Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease. Written informed consent from a legal guardian/parent. Life expectancy of at least 15 days at study entry. Assent of the patient if older than 8 years, whenever possible. Exclusion Criteria: History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit. Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles. Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit. Known congenital or acquired bleeding or clotting disorder. Patients undergoing renal dialysis.* Weight < 2.5 kg. Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential). Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®). Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements. Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study. Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is > 1.5. Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus. Patients who have received a dose of LMWH within 8 hours prior to study drug bolus. Patients previously enrolled in the study.

Ages Eligible for Study
-----------------
Maximum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bivalirudin|anticoagulation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK/PD and safety |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, bivalirudin