linjc16/ctgov huggingface dataset:
TMAO and Atherosclerosis in HIV

Study Overview
=================
Brief Summary
-----------------
In the present study, the investigators sought to prospectively examine the associations of plasma levels of TMAO (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a 7-year period, in women and men with and without HIV infection from the WIHS (Women Interagency HIV Study) and MACS (Multicenter Aids Cohort Study).

Official Title
-----------------
Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection

Conditions
-----------------
Carotid Artery Plaque

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013). Exclusion Criteria: a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WIHS<br>Women's Interagency HIV Study | Other: No intervention<br> <br> |
| MACS<br>Multicenter AIDS Cohort Study | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incident carotid artery plaque | assessed by repeated B-mode carotid artery ultrasound imaging | 2011-2013 |
Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.

Official Title
-----------------
A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: RX-10045
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age; Have provided written informed consent; Have a history of dry eye for at least 6 months prior to enrollment; Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months; Demonstrate a response when exposed to the CAE. Exclusion Criteria: Have an on-going ocular infection, or active ocular inflammation Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study; Have contact lens-induced dry eye; Have previously had laser in situ keratomileusis (LASIK) surgery; Be using or have anticipated use of temporary punctual plugs during the study; Have best corrected visual acuity > +0.7 in both eyes; Be a woman who is pregnant, nursing or planning a pregnancy; Have a known allergy and/or sensitivity to the test article or its components; Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo eye drop<br>|
| Experimental: RX-10045<br> | Drug: RX-10045<br>* RX-10045 eye drop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal fluorescein staining and integrated subject diary data |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dry eye signs and symptoms |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratoconjunctivitis Sicca, Dry eye, Resolvin
Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

Study Overview
=================
Brief Summary
-----------------
Is there any difference in the intensity of postoperative pain, nausea, urinary retention and legth of hospital stay in patients undergoing robotic assisted laparoscopic surgery if they receive intrathecal morphine or peroral and intravenous opiates during the surgery and is there a significant difference in the need of opiates after the surgery.

Official Title
-----------------
Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy- a Prospective Randomized Controlled Study.

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Procedure: Robotic-assisted hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Patients accepted for robotic-assisted laparoscopic surgery Exclusion Criteria: Coagulopathy, Prior spine surgery, Chronic pain problems, Drug abuse, Pregnancy < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intrathecal morphine<br>Spinal injection of 15mg Bupivakain and 0,25mg morphine before surgery. | Procedure: Robotic-assisted hysterectomy<br>* Robotic-assisted surgery<br>|
| Active Comparator: opiate po/iv<br>Patient given 10mg Oxycodone orally before surgery. | Procedure: Robotic-assisted hysterectomy<br>* Robotic-assisted surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postop morphine consumption | Amount of opiates given postop | First 48 hours after surgery | 
| Postop grade of nausea & vomiting | Amount of antemetics given | First 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay. | Time from surgery (day 0) until Fit For Discharge FFD, defined as: 1) is taking oral pain medication only; 2) is able to walk around independently; 3) is tolerating full oral diet and have bowel movements; 4) is hemodynamically an respiratory stable; 5) has no drains or urinary catheter. | Up to 7 days | 
| Patient overall satisfaction score. | 1-10, where 1 is unsatisfied and 10 is very satisfied. | Up to 7 days. |
The Time Delay Correlated With LV Functions and Heart Failure Incidence in STEMI?!

Study Overview
=================
Brief Summary
-----------------
To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI

Official Title
-----------------
In Non-diabetic Patients With STEMI Treated With Primary PCI: is the Time Delay Correlated With LV Functions and Heart Failure Incidence?!

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with anterior STEMI according to ESC guidelines 2017. Subjects undergoing PPCI for the first time . Non diabetic patients. Exclusion Criteria: • Patients with previous PCI. Patients with previous CABG. Patients with TIMI flow II or less . Cardiogenic shock.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to what extent could the time be relevant to the incidence of Heart failure | is the time delay correlated with LV functions and heart failure incidence?! | baseline |
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae

Study Overview
=================
Brief Summary
-----------------
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.

Official Title
-----------------
Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

Conditions
-----------------
End Stage Renal Disease, AV Fistula, Kidney Failure

Intervention / Treatment
-----------------
* Device: Venous Window Needle Guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deep, uncannulatable, upper extremity arteriovenous fistula Minimum arteriovenous fistula flow 400 ml/min One year life expectancy Exclusion Criteria: Non-transposed basilic or brachial vein arteriovenous fistula History of peripheral vascular disease History of cardiovascular disease History of cerebral vascular disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venous Window Needle Guide<br>Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula | Device: Venous Window Needle Guide<br>* Subcutaneous, extravascular needle guide made of medical-grade titanium<br>* Other names: VWNG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis | Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide | Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End Stage Renal Disease, Hemodialysis, AV fistula, Kidney failure
Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.

Official Title
-----------------
A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase

Conditions
-----------------
Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance World Health Organization (WHO) performance status ≤ 2 Exclusion Criteria: Cytopathologically confirmed central nervous system (CNS) infiltration Impaired cardiac function Use of therapeutic coumarin derivatives Acute chronic liver or renal disease unrelated to tumor Other uncontrolled medical conditions Treatment with hematopoeitic colony stimulating factors Treatment with medications that have potential to prolong the QT interval Another malignancy currently clinically significant or requires active intervention Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nilotinib|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
-----------------
Imatinib resistant,, Imatinib intolerant,, CML- blast crisis,, CML- Accelerated phase,, CML- chronic phase,, nilotinib,, Chronic myelogenous leukemia,, blast crisis,, accelerated phase,, chronic phase
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if 4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these processes, individuals with Stargardt disease may have better chances of saving their remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by shutting down the body's ability to process alcohols. This medication has an excellent safety profile and has been reported to have no short-term or long-term side effects, as long as patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment to save Stargardt patients' vision, and may also have similar effects in other macular degenerative diseases.

Official Title
-----------------
Clinical Interventions Against Stargardt Macular Dystrophy: Phase 1 Pilot Study of 4-MP as an Inhibitor of Dark Adaptation

Conditions
-----------------
Macular Dystrophy, Corneal

Intervention / Treatment
-----------------
* Drug: 4-Methylpyrazole
* Other: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All nonpregnant, nonlactating adults with normal vision in both eyes Exclusion Criteria: Previous ocular pathologies

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 4-Methylpyrazole<br>* 15 mg/kg dose<br>|
| Placebo Comparator: 2<br>saline | Other: saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dark adaptation inhibition, Stargardt macular dystrophy, 4-Methylpyrazole (4-MP), Antizol, Fomepizole
Differential Plasma MicroRNA Profiles in ED and Normal Erectile Function in Older Males

Study Overview
=================
Brief Summary
-----------------
Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging population and the increase in life expectancy, an increase in the prevalence of ED is expected in the years to come. Currently, the mechanism of ED is not fully understood. MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression post-transcriptionally. It has been included in many in vitro physiology and pathophysiology processes, which also involved in the process of ED. This research was designed to investigate the differential plasma MiRNA profiles in ED and normal erectile function in older males. The results might tell us which MiRNA and how did it involved in the process of ED in aging.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Other: Take blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older males with erectile dysfunction Exclusion Criteria: have some other general diseases, e.g. hypertension, vascular diseases, depression, chronic kidney disease, diabetes.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Older males with ED | Other: Take blood<br> <br> |
| Group II<br>Older males with normal erectile function | Other: Take blood<br> <br> |
| Gourp III<br>Young males with normal rectile function | Other: Take blood<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene chips |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RT-PCR |  | 15 days |
Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia

Study Overview
=================
Brief Summary
-----------------
Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't develope significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpouse of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and cardiac T2*MRI in order to determine the cardiac and liver iron.

Official Title
-----------------
Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Using T2* Cardiac MRI.

Conditions
-----------------
MRI, Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload

Intervention / Treatment
-----------------
* Other: Cardiac and Liver T2* MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients with Sickle cell anemia and Sickle cell Thalasemia that are currently in follow up at the Pediatric Hematology Unit Exclusion Criteria: Age below 18 years.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cardiac and Liver T2* MRI|Laboratory examinations that are routinely used in follow up of those patients and T2* MRI analysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Iron overload. |  | December 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Institute the criteria for iron chelator treatment |  | December 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, MRI