linjc16/ctgov huggingface dataset:
Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals

Study Overview
=================
Brief Summary
-----------------
Familial combined hyperlipidemia (FCHL) is an inherited disorder characterized by elevated levels of cholesterol and triglycerides; it often occurs in Mexican individuals with coronary heart disease (CHD). The purpose of this study is to identify the specific genes that predispose Mexican individuals to FCHL.

Detailed Description
-----------------
CHD is the leading cause of death in Mexico. Dyslipidemia that is characterized by high total cholesterol, high triglycerides, and low good high-density lipoprotein (HDL) cholesterol is a risk factor for developing CHD. Research has shown that the Mexican population has an increased tendency towards dyslipidemia, but it is not known what genetic factors contribute to this predisposition. This study will examine the genetic basis of FCHL, which is an inherited form of dyslipidemia characterized by elevated levels of total cholesterol and triglycerides. FCHL is a major contributing factor in CHD; 20% of individuals with CHD under the age of 60 have FCHL. The purpose of this study is to identify and characterize the specific DNA sequence variations that predispose Mexican individuals to FCHL. Results of this study may aid in the development of appropriate prevention and screening techniques. This study will enroll individuals in Mexico who have FCHL. Participants will attend one study visit for blood collection and DNA sampling. Family members of participants will be contacted and asked to provide a DNA sample also. A select group of participants will return for a second study visit for RNA sampling. Study researchers will analyze participants' DNA and RNA samples, as well as two FCHL genes identified in previous research studies.

Official Title
-----------------
Genetic Susceptibility to Common Lipid Disorders in Mexico

Conditions
-----------------
Coronary Disease, Hyperlipidemia, Familial Combined

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated levels of serum total cholesterol, triglycerides, or both Elevated levels of serum apolipoprotein B (using the Mexican population percentiles) Exclusion Criteria: Tendon xanthomas Kidney disease Thyroid disorder

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying the specific genes that predispose Mexican individuals to FCHL |  | Measured through the use of genetic samples |
Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).

Official Title
-----------------
Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic

Conditions
-----------------
Diabetes Mellitus, Type 2, Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus, Type 2 Age above 18 years Exclusion Criteria: Atrial fibrillation or other cardiac arrhythmia known stenosis of aorta or arteria subclavia/brachialis

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calibration, Validation, Transfer function, SphygmoCor, Arteriograph
Use of Fibrin Glue in Vitreoretinalsurgery

Study Overview
=================
Brief Summary
-----------------
To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery

Official Title
-----------------
Safety and Efficacy in the Use of Fibrin Glue in Vitreoretinal Surgery

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Procedure: fibrin glue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vitreorretinal procedures that require suture Exclusion Criteria: None

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fibrin glue<br> | Procedure: fibrin glue<br> <br> * Other names: Beriplast;|

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
-----------------
fibrin glue, vitrectomy, safety and efficacy of fibrin glue
Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. It is used to treat or prevent excessive blood loss during surgery and in various medical conditions such as excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from growing and causing problems. When this process becomes overactive it can result in excessive bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.

Official Title
-----------------
Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty

Conditions
-----------------
Status Post Total Hip and Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Effects of IV TXA on TEG in patients undergoing THA or TKA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total hip and knee arthroplasty patients presenting to WVU Center for Joint Replacement 40-90 years old Exclusion Criteria: Known coagulopathy History of venothrombotic event Unstable angina Recent Myocardial infarction (MI) History of bleeding events History of chronic anemia Preoperative anemia Current use of blood thinners including aspirin

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Effects of IV TXA on TEG in patients undergoing THA or TKA|Subjects will undergo surgery per standard of care. All subjects will have 3 additional vials of blood drawn to evaluate TEG.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All time measurements which indicate various aspects of clotting cascade | Data derived from the TEG which includes R, MA, LY30 (R = clotting factors, MA clot strength and platelet function and LY30 is fibrinolysis). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss and transfusions | Estimated and Calculated blood loss and transfusion requirements | 3 months |
A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

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

Intervention / Treatment
-----------------
* Drug: IDP-110
* Drug: Clindamycin
* Drug: Benzoyl peroxide
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: Dermatological conditions of the face other than acne that could interfere with clinical evaluations Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: IDP-110<br>* Topical application for 12 weeks<br>|
| Active Comparator: 2<br> | Drug: Clindamycin<br>* Topical application for 12 weeks<br>|
| Active Comparator: 3<br> | Drug: Benzoyl peroxide<br>* Topical application for 12 weeks<br>|
| Placebo Comparator: 4<br> | Drug: Vehicle<br>* Topical application for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in number of lesions |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in global severity |  | 12 weeks |
The Role of Zamzam Water in Idiopathic Oligohydramnios

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of drinking zamzam water versus tap water in increasing the AF index in women with oligohydramnios.

Detailed Description
-----------------
Oligohydramnios refers to decrease in amniotic fluid and it is defined as a deepest fluid pocket of less than 2 cm or an amniotic fluid index of 5 cm or less. Oligohydramnios complicates 0.5% to 8% of pregnancies, and 12 % if postdates When it occurs in first half of pregnancy it is associated with birth defects while in second half it causes poor fetal growth, malpresentations , FHR decelerations , MAS , Fetal suicidal syndrome and increases cesarean section and management and prognosis depend on gestational age

Official Title
-----------------
Effect of Zamzam Water on Amniotic Fluid Index, in Oligohydramnios : a Randomized Controlled Trial

Conditions
-----------------
Oligohydramnios

Intervention / Treatment
-----------------
* Dietary Supplement: zamzam water
* Dietary Supplement: tap water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant female with idiopathic oligohydramnios Exclusion Criteria: patients with medical disorder congenital anomalies premature rupture of membrane Patient refuse to participate

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open label randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zamzam water<br>patient will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term | Dietary Supplement: zamzam water<br>* will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term<br>* Other names: study group;|
| Active Comparator: tap water<br>will receive the normal need of daily requirement of water (2.5 liter) in form of tap water | Dietary Supplement: tap water<br>* will receive the normal need of daily requirement of water (2.5 liter) in form of tap water<br>* Other names: Active Comparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amniotic fluid index | the change of the amniotic fluid volume | 10 weeks |
p450 Mediated Lung Toxicity

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to do cross species comparisons of the metabolism and toxicity of a number of toxicants which require metabolism for toxicity. All of the toxicants in question are encountered by humans in the workplace, through lifestyle choices (cigarette smoking) and as a result of environmental contamination. The high incidence of pulmonary diseases in the human population means that it will be difficult if not impossible to determine whether humans are at risk from exposure to these chemicals without solid mechanistic data. Recent rodent bioassays suggest that these compounds have oncogenic potential further supporting the need to test the potential for injury in primates. As part of this testing, we intend to establish in vitro methods for assessing critical steps in the metabolism of these agents and their interaction with cellular macromolecules. Once this is done, similar studies can be conducted in Rhesus or in human lung tissue that is available because it cannot be used for transplant purposes.

Conditions
-----------------
Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
All available organ donors in the Sacramento area

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung function, smoking, metabolism
Study of the Cleavage of the Egg in Relation to the Stimulation Treatment

Study Overview
=================
Brief Summary
-----------------
This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.

Official Title
-----------------
Kinetics in Time-lapse Culture of Human Preembryos

Conditions
-----------------
Female Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF/ICSI treatment Regular cycles of 25-35 days Follicle stimulation with Bravelle and/or Menopur Women aged 38-35 years Long agonist or short antagonist treatment Willing and able to understand a Danish, English or German patient information form Willing and able to provide written Informed Consent Exclusion Criteria: BMI more than 35 Presence of hydrosalpinx on ultrasound FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation Known allergic reactions to the planned medications Use of testicular sperm

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 45 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 |
| --- | --- |
| Group 1<br>Women treated with Menopur | |
| Group 2<br>Women treated with Menopur and Bravelle | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection) |  | Week 1 after oocyte retrieval | 
| Time for disappearance of pronuclei in transferred embryos |  | Week 1 after oocyte retrieval | 
| Time for first cleavage in transferred embryos |  | Week 1 after oocyte retrieval | 
| Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos |  | Week 1 after oocyte retrieval | 
| Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage |  | Week 1 after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of gonadotrophin used |  | 1 month | 
| Gonadotrophin dose per oocyte retrieved |  | 1 month | 
| Number of oocytes retrieved |  | 1 month | 
| Number of fertilized and cleaved oocytes |  | 1 month | 
| Number of preembryos with top quality |  | 1 month | 
| Implantation rate |  | 2 months | 
| Ongoing pregnancy rate week 7 |  | 3 months | 
| Live birth rate |  | 9 months |
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Tourette Syndrome

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Tourette Syndrome

Detailed Description
-----------------
This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Tourette Syndrome. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Tourette Syndrome

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Tourette Syndrome Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group (AlloRx)<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourette Syndrome, stem cell treatment
Analysis of the Vascular Pattern of the Superficial Temporal Artery

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis to the course and branching pattern as well as surgically relevant inner diameters and lengths of the superficial temporal artery (STA) by digital subtraction angiographies (DSA).

Official Title
-----------------
In Vivo Analysis of the Vascular Pattern of the Superficial Temporal Artery Based on Digital Subtraction Angiography

Conditions
-----------------
Arteria Temporalis Superficialis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good quality digital subtractions angiographies of the STA Exclusion Criteria: bad quality digital subtractions angiographies of the STA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Vascular pattern 1<br> | |
| Vascular pattern 2<br> | |
| Vascular pattern 3<br> | |
| Vascular pattern 4<br> | |
| Vascular pattern 5<br> | |
| Vascular pattern 6<br> | |
| Vascular pattern 7<br> | |
| Vascular pattern 8<br> | |
| Vascular pattern 9<br> | |
| Vascular pattern 10<br> | |
| Vascular pattern 11<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vessel diameters |  | up to 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vessel length |  | up to 36 months |