linjc16/ctgov huggingface dataset:
DXR Stent(Previous Cilotax) Implantation Registry

Study Overview
=================
Brief Summary
-----------------
Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients

Official Title
-----------------
Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)

Conditions
-----------------
Coronary Artery Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with significant coronary artery disease and receiving Cilotax (dual drug eluting stent) The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site Exclusion Criteria: Patients with a mixture of other DESs Terminal illness with life expectancy <1 year Patients presented with cardiogenic shock

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) |  | at 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (all cause and cardiac) |  | one month | 
| Death (all cause and cardiac) |  | 6 months | 
| Death (all cause and cardiac) |  | 12 months and yearly up to 5 years | 
| Myocardial Infarction |  | 12 months and yearly up to 5 years | 
| Myocardial Infarction |  | one month | 
| Myocardial Infarction |  | 6 months | 
| Composite of death or MI |  | 6 months | 
| Composite of death or MI |  | one month | 
| Composite of death or MI |  | 12 months and yearly upto 5 years | 
| Composite of cardiac death or MI |  | one month | 
| Composite of cardiac death or MI |  | 6 months | 
| Composite of cardiac death or MI |  | 12 months and yearly up to 5 years | 
| Target Vessel Revascularization |  | 12 months and yearly up to 5 years | 
| Target Vessel Revascularization |  | one month | 
| Target Vessel Revascularization |  | 6 months | 
| Target-lesion revascularization |  | one month | 
| Target-lesion revascularization |  | 6 months | 
| Target-lesion revascularization |  | 12 months and yearly up to 5 years | 
| Stent thrombosis |  | 12 months and yearly up to 5 years | 
| Stent thrombosis |  | one month | 
| Stent thrombosis |  | 6 months | 
| Procedural success | It is defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization. | at day 1 |
CTHRC1 Abiomarker in Rheumatoid Arthritis Diagnosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity.

Detailed Description
-----------------
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Of interest, CTHRC1 is a secreted modulator of Wnt signaling, which is a key regulator of joint remodeling, and promotes cell proliferation and migration. Therefore, CTHRC1 may contribute to multiple aspects of the pathogenic FLS behavior in RA and modulate processes that promote synovial hyperplasia and invasion.The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients

Official Title
-----------------
CTHRC1 Apromising Biomarker in Rheumatoid Arthritis Diagnosis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Diagnostic Test: CTHRC1 biomarker level in rheumatoid arthritis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients diagnosed as RA. Patients ( >18)who are age and sex matched with the controls Exclusion Criteria: . Other Rheumatologic diseases. .Patients with malignancy . .Patients with hepatic disease .

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CTHRC1 biomarker level in rheumatoid arthritis|measurment of levels of CTHRC1 in patients diagnosed as RA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTHRC1 Apromising biomarker in rheumatoid arthritis diagnosis | measurement of levels of CTHRC1 in rheumatoid arthritis patients | one year |
Study of Carrageenan's Effect on Insulin Resistance in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the ingestion of the common food additive carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes in humans.

Official Title
-----------------
Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans

Conditions
-----------------
Diabetes Mellitus, Type 2, Insulin Resistance

Intervention / Treatment
-----------------
* Dietary Supplement: Carrageenan
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index (BMI) 18.5 - 29.9 kg/m² Exclusion Criteria: any chronic illness any ongoing medication known infections known liver disease known renal insufficiency alcohol consumption over 30 g/d shift work

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Placebo intervention Assessment block (3 days) Washout-phase of 21-35 days Carrageenan intervention Assessment block (3 days) | Dietary Supplement: Carrageenan<br>* Carrageenan 250 mg bid supplemented to a standard food<br>* Other names: E407;Dietary Supplement: Placebo<br>* Placebo (Mannitol/Aerosil) bid supplemented to a standard food<br>|
| Other: Group B<br>Carrageenan intervention Assessment block (3 days) Washout-phase of 21-35 days Placebo intervention Assessment block (3 days) | Dietary Supplement: Carrageenan<br>* Carrageenan 250 mg bid supplemented to a standard food<br>* Other names: E407;Dietary Supplement: Placebo<br>* Placebo (Mannitol/Aerosil) bid supplemented to a standard food<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index |  | 2 weeks | 
| Insulin sensitivity assessed by hyperinsulinemic clamp: M-value |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endogenous glucose production measured by tracer-method |  | 2 weeks | 
| Cerebral insulin sensitivity measured by MRI |  | 2 weeks | 
| Intrahepatic triglyceride content |  | 2 weeks | 
| Glycemia during OGTT |  | 2 weeks |
Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?

Study Overview
=================
Brief Summary
-----------------
Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most likely to occur when the mother experiences a primary infection during pregnancy, and it is much less common in cases of reactivation of the disease or infection by a different CMV strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between 0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004). It is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a major risk factor for perceptual deficits. However, its influence on children's future neuropsychological functioning is less well established. Symptomatic congenital CMV infection is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard 2007), but the available data regarding neuropsychological outcome for asymptomatic children is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007). We evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV) infection and normal consecutive fetal neurosonographic examinations and determined whether Magnetic Resonance Imaging (MRI) provided additional information in these cases.

Official Title
-----------------
Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?

Conditions
-----------------
CMV, Prenatal Diagnosis, Ultrasound, MRI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CMV PCR positive in the amniotic fluid Exclusion Criteria: US abnormal findings during fetal life

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropsychological outcome |  | 1-7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CMV, Prenatal Diagnosis, Ultrasound, MRI
Safety of Epidural Fentanyl and Adrenalin During Childbirth

Study Overview
=================
Brief Summary
-----------------
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

Detailed Description
-----------------
Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet University Hospital, may be included. A randomized, placebocontrolled, double blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of pain relief, total amount of epidural solution injected, and plasma concentration of fentanyl.

Official Title
-----------------
Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth

Conditions
-----------------
Pregnancy, Pain

Intervention / Treatment
-----------------
* Drug: adrenalin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women at term in active labor Exclusion Criteria: age below 18 years BMI > 40 drug hypersensitivity

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>adrenalin | Drug: adrenalin<br>* adrenalin 2 microgram pr ml placebo<br>|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* Saline instead of adrenaline in the epidural mixture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of fentanyl |  | hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of active labor |  | hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor analgesia, fentanyl, epinephrine
ASSESSING THE GAY MALE EXPERIENCE WITH ANAL CANCER PREVENTION STRATEGIES

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.

Official Title
-----------------
SAVE THE BOTTOMS!!!: ASSESSING THE GAY MALE EXPERIENCE WITH ANAL CANCER PREVENTION STRATEGIES

Conditions
-----------------
Anal Cancer

Intervention / Treatment
-----------------
* Other: Observational/Survery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Current resident of the U.S. Engage in anoreceptive intercourse with male partners Fluent in English or Spanish Exclusion Criteria: Under the age of 18 years old Not living in the United States Not born with sex assigned at birth as male Does not engage in sex with male partners

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Men who have sex with men (MSM)<br> | Other: Observational/Survery<br>* MSM participants will complete a one-time survey, delivered in an e-format. Survey will be accessible via Meta-based social media platforms (Facebook, Instagram).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSM awareness of anal cancer risk | Survey with question items on participants' awareness of anal cancer risk | 2 months | 
| MSM awareness of strategies to decrease anal cancer risk | Survey with question items of strategies to decrease anal cancer risk | 2 months |
The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Detailed Description
-----------------
The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure. Patients in this study will be treated with standard hormonal treatment. Patients will remain on treatment regardless of rising PSA. PSA, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist. The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years. The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together, the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together, and to determine the association of these markers with overall survival.

Official Title
-----------------
The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T3a + PSA > 20 Gleason 8 or higher Karnofsky performance status ≥ 70. Signed study-specific informed consent Exclusion Criteria: -

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

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

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 |
| --- | --- | --- |
| Number of patients with biochemical failure showing coexistence of PTEN and TMPRSS2-ERG gene fusion. | Biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy (LHRH) who have either clinical progression or 3-year hormonal refractory free survival will be tested to evaluate the predictive value of the coexistence of TMPRSS2-ERG gene fusion and the PTEN deletion. The results between the two groups will be compared to see if either DNA changes are an indicator of LHRH refractoriness | recruitment over 4 years |
Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment

Study Overview
=================
Brief Summary
-----------------
Our aim is to evaluate the potential of a new laboratory method that measure sperm capacitation to predict fertilization of oocytes in patients that undergo IVF treatments

Detailed Description
-----------------
Capacitation is a physiologic process in which the sperm acquire the potential to fertilize oocytes. Capacitation can be measured, but the available technics are expensive, inaccurate and complex. A new method to evaluate sperm capacitation was developed in Bar Ilan University, Israel. We intend to measure the capacitation of semen that is used for fertilizing human oocytes in patients treated at the IVF unit at Assaf Harofeh Medical Center.By this, to evaluate the potential of the new method to predict human oocyte fertilization.If the method will be found valuable, it will enable to develop new drugs/methods that may improve sperm capacitation and by this to improve oocyte fertilization leading to more embryos, pregnancies and deliveries.

Official Title
-----------------
Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment

Conditions
-----------------
Sperm Capacitation

Intervention / Treatment
-----------------
* Biological: sperm capacitation
* Other: biologic
* Other: sperm capacitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring IVF within the routine work of an IVF Unit normo-responding woman non ICSI cycles Exclusion Criteria: Patients undergoing ICSI only cycle Low responders-less than 8 oocytes Male patients with low semen volume

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| A<br>Sperm capacitation: Sperm capacitation is measured in a sample of the same ejaculated sperm unit given for fertilizing human oocytes in an IVF treatment cycle | Biological: sperm capacitation<br>* sperm capacitation measured at Bar Ilan University<br>Other: biologic<br>* sperm synthesis of G-actine to F-actine<br>* Other names: sperm capacitation;Other: sperm capacitation<br>* sperm synthesis of G-actine to F-actine<br>* Other names: sperm synthesis of G-actine to F-actine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate of human oocytes in thr routine IVF Laboratory work |  | One year |
Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms

Study Overview
=================
Brief Summary
-----------------
Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( < 15% in best clinical care institutions ). Ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. STAT was the first RCT of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.

Official Title
-----------------
Multicenter Parallel Randomized Double-Blind Placebo Controlled Study of Efficacy and Safety of Intravenous Ancrod ( Arvin ) Given Within 6 Hours After the Onset of Acute Ischemic Stroke: European Stroke Treatment With Ancrod Trial ESTAT

Conditions
-----------------
Brain Infarction, Cerebral Ischemia, Acute Stroke

Intervention / Treatment
-----------------
* Drug: Ancrod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and above, both sexes Acute ischemic stroke with first symptoms within 6 hours of beginning Treatment after onset of symptoms SSS < 40 at baseline ( consciousness necessary ) Exclusion Criteria: Clinical or CT evidence of brain hemorrhage or hemorrhagic transformation CT evidence of major signs of developing infarction Coma Prior strokes within 6 weeks Severe hypertension (> 220 systolic > 120 mm Hg diastolic) Baseline fibrinogen < 100 mg/dL Recent use of thrombolytic agents Recent or anticipated surgery

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ancrod|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
-----------------
stroke, vascular diseases