linjc16/ctgov huggingface dataset:
Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).

Conditions
-----------------
Benign Prostate Hyperplasia

Intervention / Treatment
-----------------
* Procedure: Prostate artery embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living) Urinary retention (related to BPH) leading to catheterization. Refractory to medical treatment or patient is not willing to consider medical treatment Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery. Exclusion Criteria: Mild symptoms (IPSS <8) Moderate to severe lower urinary tract symptoms (i.e. IPSS>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living). Suspected malignancy. Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency. Advanced atherosclerosis and unsuitable vascular access. Allergy to intravenous contra
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Other: Embolization<br>Prostate artery embolization | Procedure: Prostate artery embolization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS). |  | 1, 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPH
A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus

Study Overview
=================
Brief Summary
-----------------
It is thought that Edratide may be able to reduce the symptoms of SLE.

Official Title
-----------------
A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)

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

Intervention / Treatment
-----------------
* Drug: edratide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give written informed consent Between the ages of 18 and 65 years (inclusive) Fulfilled at least 4 ACR classification criteria SLE patients with moderate, active disease Subjects on stable dose of SLE medications for at least 4 weeks before randomization. Women of child-bearing potential must practice a medically acceptable method of contraception.. Must understand the requirements of the study and agree to comply with the study protocol. Exclusion Criteria: Any condition which the investigator feels may interfere with participation in the study. Subjects having a history of chronic infection Subjects with a history of immunodeficiency syndrome or malignancy, Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization, Subjects treated with any cytotoxic agents in the 3 months prior to randomization.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: edratide<br>* 0.5 mg, 1.0 mg, 2.5 mg injection once weekly<br>|
| Placebo Comparator: 2<br> | Drug: edratide<br>* 0.5 mg, 1.0 mg, 2.5 mg injection once weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Disease Activity Score |  | 30 weeks |
Ultrasound Measurement of RIJV in Patients Between 0-2 Years

Study Overview
=================
Brief Summary
-----------------
After obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. The success rates and outcomes of catheterization will be recorded.

Official Title
-----------------
The Evaluation of Anatomical Variations and Dimensions of RIJV With Ultrasound in Pediatric Patients Between 0-2 Years

Conditions
-----------------
Anatomic Abnormality, Internal Jugular Vein, Neonates, Infants, Premature, Children

Intervention / Treatment
-----------------
* Procedure: Ultrasonographic evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0-2 years Elective surgery Requirement for central venous cannulation Exclusion Criteria: Congenital cardiovascular anomalies Emergency surgeries Previous cannulation or any intervention on the neck

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- |
| Group I<br>0-1 month old newborns | Procedure: Ultrasonographic evaluation<br>* Right internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions<br>|
| Group II<br>1 month-2 year-old pediatric patients | Procedure: Ultrasonographic evaluation<br>* Right internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical variations and dimensions of right internal jugular vein | The central vein will be evaluated by ultrasound | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central venous catheter, pediatrics, ultrasound imaging
Th17 Inducing Cytokines Pregnancy and After Postpartum

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.

Detailed Description
-----------------
IL-17 have a synergytic effect with IL-6 and IL-23. IL-17A levels elevated with periodontal diseases. Many systemical chronic conditions such as atherosclerosis and cardiovascular disease, pregnancy may contribute increasing of IL-17 family cytokine.

Official Title
-----------------
Interleukin-17 and Th17 Inducing Cytokines Exacerbate Periodontal Disease During Pregnancy and Postpartum

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: Saliva collection
* Other: GCF collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 2 and 3 trimester of their pregnancy Exclusion Criteria: any known systemic disease, periodontal treatment within the last six months, patients having less than 10 teeth, smokers, individuals with a BMI > 30 kg/m2, gestational diabetes and preeclampsia during pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Pregnancy group<br>Women, who were in their second trimester (weeks 16-24) or third trimester (weeks 25-34)selected for the study. Saliva and GCF samples were collected and clinical periodontal measurements were made gently | Other: Saliva collection<br> <br> Other: GCF collection<br> <br> |
| Postpartum group<br>Postpartum women 6 months after giving birth recalled. Saliva and GCF samples were collected and clinical periodontal measurements were made. | Other: Saliva collection<br> <br> Other: GCF collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing Il-17A levels | Salivary and GCF level measured by ELISA | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing IL-6 levels | Salivary and GCF level measured by ELISA | 6 month | 
| Changing IL-23 levels | Salivary and GCF level measured by ELISA | 6 month | 
| Changing IL-17E levels | Salivary and GCF level measured by ELISA | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, postpartum
Awareness & Use of Emergency Contraception

Study Overview
=================
Brief Summary
-----------------
General objective: To decrease the percentage of unwanted and/or unplanned pregnancies and their consequences on women's reproductive health. Specific objectives: To assess awareness of the study participants about emergency contraception. Determine the percentage of ever use among the participants. To identify factors that affect the awareness and use of emergency contraception among the study participants

Official Title
-----------------
Awareness & Use of Emergency Contraception Among Women Attending Kidwany MCH Center , Assiut City

Conditions
-----------------
Emergency Contraception

Intervention / Treatment
-----------------
* Behavioral: correct use of the contraceptions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Married women in reproductive age (15 - 49 years) Exclusion Criteria: Infertile and postmenopausal women.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: correct use of the contraceptions|know the emergency contraception and how to use|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of awareness and use of emergency contraception | when to use emergency contraception to prevent the unwanted pregnancy | baseline |
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide. Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A further objective is the description of the PK of teduglutide following SC administration of 10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy subjects.

Detailed Description
-----------------
Pharmacokinetic study.

Official Title
-----------------
Open Label Pharmacokinetic (PK) Study, Conducted at One Investigational Site in Germany, to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Teduglutide Following Subcutaneous Administration of 10 mg Teduglutide and to Evaluate Safety and Tolerability of 10 mg Teduglutide

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: Teduglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with moderate, severe and end stage renal failure and matched healthy controls.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Teduglutide<br> | Drug: Teduglutide<br>* 10 mg, one-time subcutaneous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of teduglutide |  | 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of 10 mg teduglutide (assessed by physical examination, vital signs, clinical laboratory, electrocardiogram [ECG] and adverse events [AE]) |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal impairment, Renal impairment study
COVID-19 RELATED KIDNEY DAMAGE

Study Overview
=================
Brief Summary
-----------------
In this study, we investigate whether the early detection of risk factors in Covid-19 associated acute kidney injury contributes to us in the early initiation of treatment. We predict that if acute kidney damage is detected early in patients with early risk factors, permanent kidney damage will be seen less. In addition, we think that covid-19 patients may have positive contributions to shortening treatment time and reducing treatment costs. In addition, we are investigating whether it has a positive effect on patients' survival. In other words, we are investigating the contribution of risk factors to early diagnosis and treatment, the effect on health expenditures and mortality in patients with COVID-19 with acute kidney damage.

Official Title
-----------------
INVESTIGATION OF RISK FACTORS RELATED TO COVID-19 RELATED KIDNEY DAMAGE: A PROSPECTIVE OBSERVATIONAL STUDY

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

Intervention / Treatment
-----------------
* Other: ACUTE KIDNEY INJURY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 aged patients in ICU Exclusion Criteria: Patients with known Chronic Renal Failure who have received dialysis treatment before who are under 18 years of age

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE<br>COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE | Other: ACUTE KIDNEY INJURY<br>* KDIGO LEVELS<br>|
| COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE<br>COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE | Other: ACUTE KIDNEY INJURY<br>* KDIGO LEVELS<br>|
| COVİD19 PCR (Polymerase Chain Reaction) AND CT will be evaluated as NEGATIVE.<br>COVİD19 PCR (Polymerase Chain Reaction) AND CT will be evaluated as NEGATIVE. | Other: ACUTE KIDNEY INJURY<br>* KDIGO LEVELS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KDIGO | Kidney Disease: Improving Global Outcomes | 4 MONTHS |
Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the risk factor, molecular character and susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia

Detailed Description
-----------------
To characterize the genotypes of the pathogens isolated from recurrent ESBL-EK bacteremia versus non-recurrent ESBL-EK bacteremia to differentiate relapse from reinfection recurrent versus non-recurrent relapse versus reinfection To correlate the patient characteristics, clinical manifestations, severity of illness (the modified Pitt bacteremia score), diagnosis of deep-site infection, co-morbid conditions (including diabetes mellitus, hepatic and renal dysfunction), length of stay in ICU/hospitalization, the presence of invasive procedures, source of pathogen (community acquired or nosocomial infection), antimicrobial regimen (i.e carbapenems versus non-carbapenems(flomoxef or quinolones), microbiological characteristics (E coli and Kleb. pneumoniae) and outcome endpoints (clinical outcome and mortality) with ESBL recurrence and genotypes

Official Title
-----------------
Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change

Conditions
-----------------
Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (age>=18 years) with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010 Exclusion Criteria: Patients who died within 48h after first episode of ESBL-EK bloodstream infection

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 |
| --- | --- | --- |
Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
MRI has been shown to be helpful in identifying patients who present with undifferentiated inflammatory arthritis who will develop RA within a one year follow up period. The absence of other clinically apparent symptoms often causes delays in diagnosis of RA. The use of the MRI in conjunction with the physical examination has the potential to reduce diagnostic delay. Earlier diagnosis would allow for earlier treatment implementation for better patient outcomes.

Official Title
-----------------
Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Undifferentiated inflammatory arthritis suspected to be early RA (≥1 joint with synovitis and ≥1 other tender joint) Symptom duration ≤1 year Exclusion Criteria: Unwillingness or inability to return to Mayo Clinic Rochester for research follow-up visits Current or previous use of DMARDS Taking ≥10 mg of prednisone a day Contraindications to contract enhanced MRI History of another definite autoimmune or inflammatory rheumatic disease History of psoriasis History of inflammatory bowel disease Unsuitably as deemed by the principal investigator

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 |
| --- |
|Diagnostic Test: MRI|Magnetic resonance imaging (MRI) produces detailed images of the body's internal structures without relying on radiation. It is used to diagnose and also gauge efficacy of treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Earlier Diagnosis of RA if MRI is utilized | To determine if MRI is predictive of later development of RA in patients with undifferentiated inflammatory arthritis; patients with inflammatory arthritis who receive an MRI will have earlier initiation of treatment | 1 year |
A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.

Official Title
-----------------
Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions

Conditions
-----------------
Carcinoma, Renal Cell, Carcinoma, Renal Cell (Advanced)

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study Exclusion Criteria: Exclusion criteria must be read in conjunction with the Belgian product information

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated |  | At 1, 3, 6 and 9 months and after one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Renal Cell Carcinoma ( RCC)