linjc16/ctgov huggingface dataset:
Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum

Study Overview
=================
Brief Summary
-----------------
The main goal of this study the possible involvement of netrin-1 into the pathophysiology of placenta accrete spectrum. To delineate the role of netrin-1, neogenin - zeb1 signaling pathway in mechanism of morbidly adherent placenta.

Detailed Description
-----------------
The main goal of this study is: To shed light on the possible involvement of netrin-1 into the pathophysiology of placenta accrete spectrum. To study the role of netrin-1 in Epithelial to mesenchymal transition as a possible pathophysiological mechanism of placenta accrete spectrum. To delineate the role of netrin-1, neogenin - zeb1 signaling pathway in the progression of invasion of placenta accrete spectrum.

Official Title
-----------------
Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum

Conditions
-----------------
Pathophysiology of Placenta Accreta

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages between 20 to 40 years will be included. Gestational age: between 34 to 38 weeks. History of previous cesarean sections. Ultrasonographic findings suggestive PAS according to Jauniaux et al. (2018) : Loss of the retro-placental clear zone. Thinning of myometrium. Abnormal placental lacunae. Bladder wall interruption. Placental bulge. Exophytic placental mass. Doppler findings suggestive PAS according to Jauniaux et al. (2018): Subplacental hypervascularity. Uterovesical hypervascularity/bridging vessels. Vascular lacunae with turbulent flow/feeder vessels. Exclusion Criteria: Fundal and middle anterior or posterior placenta. • Pregnancy associated with morbid conditions as: hypertension, diabetes mellitus, autoimmune disease, cardiac disease, renal disease, and endocrinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group A<br>group A : placental tissue of 30 patients with placenta accreta | |
| group B<br>group B : placental tissue of 30 normal pregnancy as a control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of netrin-1 in the pathophysiology of placenta accreta spectrum | Estimation of local placental netrin-1 protein expression by immunohistochemistry , Estimation of local placental expression of neognin by immunohistochemistry. Estimation of local placental expression of Zeb-1 by immunohistochemistry | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Netrin-1, neogenin,PAS, zeb-1
To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets and one HGP1206 125 mg tablet in healthy male volunteers.

Detailed Description
-----------------
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and safety of Traclear 62.5 mg Tablets and HGP1206 125mg Tablet in Healthy Male Volunteers.

Official Title
-----------------
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Traclear 62.5 mg 2 Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: HGP1206
* Drug: Traclear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Age between 20 and 55 Signed informed consent Exclusion Criteria: Has a history of Primary pulmonary hypertension to investigational product ingredients Hypotension or hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test→Reference<br>HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets | Drug: HGP1206<br>* One Bosentan 125 mg tablet<br>* Other names: Bosentan 125 mg;Drug: Traclear<br>* Two Bosentan 62.5 mg tablets<br>* Other names: Traclear 62.5 mg;|
| Experimental: Reference→Test<br>Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet | Drug: HGP1206<br>* One Bosentan 125 mg tablet<br>* Other names: Bosentan 125 mg;Drug: Traclear<br>* Two Bosentan 62.5 mg tablets<br>* Other names: Traclear 62.5 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0-24h | 
| Cmax |  | 0-24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | 0 24h | 
| AUCinf |  | 0 24h | 
| t1/2 |  | 0 24h |
Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

Study Overview
=================
Brief Summary
-----------------
Fatty liver is known to be one of the most frequent liver pathologies in IBD patients (35-40%). Despite this fact, there are only few publications that evaluated the prevalence of fatty liver in IBD patients. Moreover, the pathogenesis of this phenomenon in IBD has not been widely investigated. The paradox of lean patients and fatty liver can be explained by high use of steroids, by rapid weight loss, and by the abundance of TNFα cytokine in IBD patients that causes insulin resistance. The aim of the study: To evaluate the frequency of fatty liver in a cohort of IBD patients and to learn its risk factors. Methods: One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited. Patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome. Each patient will undergo blood examinations in order to assess inflammation, and metabolic status. Fatty liver will be assessed by liver ultra-sonography.

Official Title
-----------------
Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver

Conditions
-----------------
Inflammatory Bowel Disease, Fatty Liver

Intervention / Treatment
-----------------
* Other: clinical evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBD patients above the age of 18 years old, suffering from the disease for at least one year. Exclusion Criteria: Pregnant women, Patients suffering from ulcerative colitis after total colectomy, HIV patients, Patients suffering from other chronic liver disease, Patients suffering from cancer currently or in the past, OR Patients suffering from any other chronic severe diseases.

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 |
| --- | --- |
| cases<br>IBD patients above the age of 18 years old, suffering from the disease for at least one year. | Other: clinical evaluation<br>* Patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome. Each patient will undergo blood examinations in order to assess inflammation, and metabolic status. Fatty liver will be assessed by liver ultra-sonography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation and metabolic status |  | first visit | 
| Assessment of Fatty liver |  | first visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, inflammatory bowel disease, fatty liver
Screening for Glaucoma in Namil Area, South Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the prevalence of glaucoma in Korea, the investigators selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma.

Detailed Description
-----------------
Screening includes following examinations; Questionaire and Consent form, Visual acuity test, Auto-refraction, IOL Master measurement, Pachymetry, FDT Perimetry, Fundus Photography, Slit lamp examination, Goldmann applanation Tonometry, Gonioscopy, and Binocular optic disc evaluation. For the cases showing any abnormality in FDT perimetry, optic disc morphology, or intraocular pressure, Humphrey automated visual field test is to be performed as an extended examination. Finally, optic nerve head evaluation by OCT or GDx analyzer is to be used as a confirmation test, as well as additional Humphrey visual field test.

Official Title
-----------------
Epidemiologic Study for the Prevalence of Glaucoma in Namil Area, Geumsan City, South Korea

Conditions
-----------------
Glaucoma, Intraocular Pressure, Optic Nerve Head, Visual Field

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents aged over 40 in Namil area Exclusion Criteria: Individuals registered but not actually living in this area

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Prevalence of glaucoma in Namil area |  | cross-sectional | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical factors associated with the glaucoma |  | cross-sectional | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevalence study, glaucoma
Alveolar Ridge Preservation Using Amniotic Chorion Membrane

Study Overview
=================
Brief Summary
-----------------
the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).

Official Title
-----------------
Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)

Conditions
-----------------
Alveolar Ridge Preservation

Intervention / Treatment
-----------------
* Other: Amniotic Chorion Membrane and Bio-Oss xenograft
* Other: Amniotic Chorion Membrane only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration. Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT) Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index Male and female within age range of 20-45 years. Exclusion Criteria: Smokers. Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures. Pregnant and breast-feeding females. Patients with acute peri-apical infection or sinus tract. Vulnerable group of patients as handicapped patients, orphans,prisoners,etc

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Amnoitic Chorion Membrane and xenograft<br>extraction sockets where ridge preservation will be performed using Chorion Membrane with Xenograft | Other: Amniotic Chorion Membrane and Bio-Oss xenograft<br>* Bioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation<br>|
| Active Comparator: Amnoitic Chorion Membrane only<br>extraction sockets where ridge preservation will be performed using Chorion Membrane Alone | Other: Amniotic Chorion Membrane only<br>* Bioxclude Amniotic Chorion Membrane only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bucco-lingual bone width | Bone width will be measured using bone caliper and radiographically | at baseline, 1 months and 4 months | 
| Change in Corono-apical bone height | Bone height using a pre-fabricated stent. | at baseline, 1 months and 4 months | 
| total bone volume change | It will be evaluated by the use of 3D scans of patient dental models | at baseline, and 4 months |
Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
A magnetomotive ultrasound combines standard diagnostic ultrasound equipment with the application of an external time-varying magnetic field. The investigators aim to use this equipment to improve preoperative diagnostics in rectal cancer.

Detailed Description
-----------------
The investigators will compare magnetomotive ultrasound with MRI and pathology report on specimens extracted during surgery.

Official Title
-----------------
Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer

Conditions
-----------------
Rectal Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal cancer Surgery with abdominoperineal resection Exclusion Criteria: No informed consent Not fulfilling inclusion criteria No rectal cancer

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with rectal cancer<br>Patients with rectal cancer will be included and asked to participate in the study where a MMUS will be used after resection to test diagnostic accuracy. | Diagnostic Test: MMUS<br>* MMUS will be used to perform diagnostics, we will compare with MRI and histology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of lymph node diagnosis compared to pathology report | Accuracy of lymph node diagnosis - a comparison between the findings with the device and the pathology report | 1 hour postoperatively | 
| Accuracy of lymph node diagnosis compared to MRI | Accuracy of lymph node diagnosis compared to MRI | 1 hour postoperatively |
Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome map for those who receive HSCT for their primary disease.

Official Title
-----------------
Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).

Conditions
-----------------
Busulfan Pharmacokinetic Analysis, GST Genetic Polymorphism

Intervention / Treatment
-----------------
* Drug: Hematological Stem Cell Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment Busulfan should be part of the preparative protocol Exclusion Criteria: Known sensitivity or allergy to Busulfan

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hematological Stem Cell Transplantation|Oral or Intravenous Busulfan as part of the preparative protocol for transplantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic Veno-Occlusive Disease, Graft versus host disease |  | every week after HSCT up to 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Busulfan, Glutathione S-transferase, Genetic polymorphism, HVOD, GVHD
Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy

Study Overview
=================
Brief Summary
-----------------
Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.

Official Title
-----------------
Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study

Conditions
-----------------
Pain Due to Certain Specified Procedures, Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: BOTOX
* Other: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary) Exclusion Criteria: contraindications for botulinum toxin

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX<br>Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area | Drug: BOTOX<br>* A syringe of 1 ml contain 25 Allergan units.<br>|
| Placebo Comparator: PLACEBO<br>Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area | Other: PLACEBO<br>* The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in average pain intensity as measured by the Brief Pain Inventory (BPI) |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS in the last 24 hours |  | 24 hours | 
| Neuropathic Pain Inventory |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathic pain due to thoracotomy, Neuropathic Pain Due to Thoracoscopy