linjc16/ctgov huggingface dataset:
A Prospective Pharmacodynamic Study of Rivaroxaban

Study Overview
=================
Brief Summary
-----------------
The ability to explain bleeding or clotting complications in patients treated with rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding abnormal responses to rivaroxaban. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of rivaroxaban and to determine which tests may be most clinically useful for monitoring rivaroxaban.

Official Title
-----------------
A Prospective Pharmacodynamic Study of Rivaroxaban Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Rivaroxaban

Conditions
-----------------
Blood Clot

Intervention / Treatment
-----------------
* Drug: Rivaroxaban
* Other: no anticoagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person taking therapeutic dose of Rivaroxaban Exclusion Criteria: CrCl < 15 mL/min Non-FDA approved dose based on calculated CrCl with most recent SCr Age < 18 years Inability to communicate in the English language Decisionally-impaired individuals Incarcerated Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Experimental<br>Patient taking FDA approved dose of rivaroxaban | Drug: Rivaroxaban<br>* Patients will continue on their Rivaroxaban dose as previously prescribed by their individual physician. No dose adjustments will be made for the purpose of this study.<br>* Other names: Xarelto;|
| Control Group<br>Patient not taking any form of anticoagulation | Other: no anticoagulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sexual Dimorphism Analysis in Egyptian Population by Locating the Mandibular Canal Using CBCT

Study Overview
=================
Brief Summary
-----------------
Sexual dimorphism analysis in Egyptian population by locating the mandibular canal using cone-beam computed tomography: an observational cross sectional study

Detailed Description
-----------------
Many studies from different countries such as United States, China, Japan, and Europe were done to observe the distinct morphologic and morphometric manifestations of sexual dimorphism. Accordingly, it is mandatory to target a specific population with their unique skeletal features.

Official Title
-----------------
Sexual Dimorphism Analysis in Egyptian Population by Locating the Mandibular Canal Using Cone-beam Computed Tomography: an Observational Cross Sectional Study

Conditions
-----------------
Gender Identity

Intervention / Treatment
-----------------
* Other: CBCT scan by planmeca promax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and above. Absence of large pathological lesions in mandible. Dentulous patients Exclusion Criteria: Patients younger than 18 years old Presence of large pathological lesions in mandible Completely edentulous patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- |
| mandible CBCT scans in males<br>74 males CBCT scan by planmeca promax 3D Mid machine using 90 kVp, 10 mA, 14 seconds and 200×60 mm FOV with a 0.2 mm voxel size. | Other: CBCT scan by planmeca promax<br>* software measurement tool of CBCT<br>|
| mandible CBCT scans in female<br>74 females CBCT scan by planmeca promax 3D Mid machine using 90 kVp, 10 mA, 14 seconds and 200×60 mm FOV with a 0.2 mm voxel size | Other: CBCT scan by planmeca promax<br>* software measurement tool of CBCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior ramus width , posterior ramus width | distance from mandibular foramen to most anterior and posterior points of ramus respectively | 2 years |
Prediction of Coronary Artery Disease Severity by Epicardial Adipose Tissue Thickness

Study Overview
=================
Brief Summary
-----------------
is to test the hypotheses that epicardial adipose tissue can be a marker of severity of coronary artery disease in myocardial infarction patients

Detailed Description
-----------------
epicardial adipose tissue is defined as the adipose tissue between the visceral pericardium and the outer margin of the myocardium which can be considered an endocrine organ that secretes pro-inflammatory and anti-inflammatory cytokines and chemokines including adiponectin.as investigators know, inflammatory response is an important factor in the coronary atherogenesis. Therefore,epicardial adipose tissue is likely to be connected with the severity of coronary artery disease.Recent studies showed that the thickness of the epicardial adipose tissue in patients with coronary artery disease was greater than that with normal coronary arteries. epicardial adipose tissue will be assessed using transthoracic echocardiography and cardiac magnetic resonance which allows for an accurate volumetric quantification of epicardial fat.

Official Title
-----------------
Predictive Value of Epicardial Fat Thickness for Disease Severity in Coronary Artery Disease Patients

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

Intervention / Treatment
-----------------
* Radiation: echocardiography and cardiac magnetic resonance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Normal thoracic shape Sinus rhythm without severe respiratory diseases Exclusion Criteria: contraindication for cardiac magnetic resonance. Patients who previously underwent coronary artery bypass grafting or percutaneous coronary angiography prior to admission history of chronic kidney disease with glomerular filtration rate <30 mL/min pericardial and/or pleural effusion.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| myocardial infarction patients<br>transthoracic echocardiography and cardiac magnetic resonance | Radiation: echocardiography and cardiac magnetic resonance<br>* transthoracic echocardiography and magnetic resonance imaging of the heart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of epicardial adipose tissue as marker of severity of coronary artery disease in myocardial infarction patients. | epicardial adipose tissue measurement using transthoracic echocardiography and cardiac magnetic resonance | one year |
Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
A comparison of oral prednisolone administration with intravenous methylprednisolone infusion in the treatment of acute asthma exacerbation in hospitalized patients. Oral glucocorticosteroids administration may be effective as intravenous high-dose methylprednisolone infusion.

Official Title
-----------------
Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: methylprednisolone sodium succinate (mPSL)
* Drug: prednisolone (PSL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma patients, who need hospitalized treatment, who do not respond with initial treatment including bronchodilator and IV methylprednisolone therapy Exclusion Criteria: Need for incubation With severe complications Received systemic glucocorticosteroid therapy in the previous 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>mPSL 240 mg per day for 5 days | Drug: methylprednisolone sodium succinate (mPSL)<br>* mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days<br>* Other names: methlyprednisolone sodium succinate;|
| Experimental: 2<br>PSL 40mg per day for 10 days | Drug: prednisolone (PSL)<br>* PSL 40 mg per day for 10 days<br>* Other names: prednisolone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of oral prednisolone for the treatment of acute asthma |  | three-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of oral prednisolone for the treatment of acute asthma |  | three-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma Patients
Ear Drops for Children With Otitis Media

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.

Official Title
-----------------
Ear Drops for Children With Otitis Media

Conditions
-----------------
Acute Otitis Media

Intervention / Treatment
-----------------
* Drug: Hyland's earache drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting to participating clinic with otitis media Diagnosed with acute otitis media Parents rate symptoms as a moderate problem or more Exclusion Criteria: Diagnosis of otitis media within preceding 30 days Receipt of antibiotics within 2 days Perforated ear drum or bullous lesion Receipt of homeopathic treatment within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>homeopathic ear drops in addition to standard care for otitis media | Drug: Hyland's earache drops<br>* 3-4 drops in affected ear 3 times a day as needed for up to 5 days<br>|
| No Intervention: 2<br>No ear drops, standard care for otitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Otitis Media Symptoms | Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects of Therapy |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
otitis media, children
Tonsillectomy and Primitive IgA Nephropathy in Children: Strasbourg Cohort and Assessment Practices in Inter North East Region

Study Overview
=================
Brief Summary
-----------------
Primitive kidney disease IgA, represented by Berger's disease and rheumatoid purpura nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes in 20 years to end-stage renal failure is described in 10 to 30 % of cases in Berger's disease and in 15 to 20% of cases in nephropathy HSP. These two pathological entities share biological and histological characteristics, as well as common pathophysiological mechanisms, particularly the production of abnormally glycosylated IgA1 promoting their proliferation in the mesangium. Tonsils part of Iga abnormal production sites that would be associated with an infectious stimulus, tonsillectomy has been studied as a possible treatment in primitive IgA nephropathy. The benefit of tonsillectomy is controversial: many Japanese studies demonstrate its effectiveness in terms of reduction of proteinuria, improved renal function in the long term regression of histological lesions and reduced risk of relapse following clinical remission whereas European studies do not suggest its effectiveness in treating IgA nephropathy. In this context, the aim of our study is to describe the scope of practice of tonsillectomy in the treatment of primary renal disease in IgA child in the inter East region and describe the short renal become Strasbourg end of the cohort that received this treatment.

Official Title
-----------------
Tonsillectomy and Primitive IgA Nephropathy in Children: Strasbourg Cohort and Assessment Practices in Inter North East Region

Conditions
-----------------
Tonsillectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Children with a clinical diagnosis and / or histological evidence of primary IgA nephropathy Follow the University Hospital of Strasbourg since 2009 Having received a tonsillectomy in their care Children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes Exclusion criteria: Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Evaluation of the management of the tonsillectomy at the CHU of Strasbourg by a standardized questionnaire |  | since January 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgA, Tonsillectomy, primary IgA nephropathy, primary nephropathy, Berger's disease, Purpura rheumatoid, kidney failure
Evaluation of Esthetic Outcomes of M-shaped Flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the PES after implant uncovering using M flap versus I-shaped incision.The primary objective is evaluation of esthetic outcomes around implant using PES. Hypothesis: The use of I-shaped incision exposure technique will result in better esthetic outcomes.

Official Title
-----------------
Evaluation of Esthetic Outcomes of M-flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score (PES) (RCT)

Conditions
-----------------
Dental Implant Failed

Intervention / Treatment
-----------------
* Procedure: I-incision, M-flap and conventional implant exposure techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with osseointegrated dental implant in the anterior maxilla. Patients of 20 - 50 years Periodontally healthy patients. No intraoral soft and hard tissue pathology. No systemic condition that contraindicate surgical intervention. Exclusion Criteria: Intraoral soft and hard tissue pathology. Heavy smokers more than 20 cigarettes per day. Patients with systemic disease that may affect normal healing. Psychiatric problems. Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br> | Procedure: I-incision, M-flap and conventional implant exposure techniques<br>* Implant uncovering in the second stage using 3 different exposure techniques<br>|
| Active Comparator: I-incision<br> | Procedure: I-incision, M-flap and conventional implant exposure techniques<br>* Implant uncovering in the second stage using 3 different exposure techniques<br>|
| Active Comparator: M-flap<br> | Procedure: I-incision, M-flap and conventional implant exposure techniques<br>* Implant uncovering in the second stage using 3 different exposure techniques<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PES | Esthetic outcomes around implant | 3 months |
Prostate Delineation: High Quality Volume CT

Study Overview
=================
Brief Summary
-----------------
This study will look at how feasible it is to use a certain type of Computed Tomography (CT) to scan prostate cancer, called a high quality volume CT scan. It is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. Using this type of CT scan will also lessen the amount of time patients spend in the scanner. This study will not offer patients a different treatment for their prostate cancer. Patients will receive the most appropriate standard treatment whether or not they are in this study.

Official Title
-----------------
Prostate Delineation During Radiation Treatment Planning for Prostate Cancer: Comparison of High Quality Volume Computerized Tomography With Conventional Tomography and Magnetic Resonance Imaging

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

Intervention / Treatment
-----------------
* Other: High Quality Volume CT Scan; MRI Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Subjects undergoing radical external beam radiotherapy for prostate cancer Ability to provide written informed consent Exclusion Criteria: Age ≤ 18 years Subjects not suitable for MRI scanning 3 usable image sets not obtained during treatment planning scans.

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Quality Volume CT Scan; MRI Scan<br>Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI Scan. | Other: High Quality Volume CT Scan; MRI Scan<br>* Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI scan. --------------------------------------------------------------------------------<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using different scanning methods for patients undergoing radical external beam radiotherapy for prostate cancer to determine inter-observer variability in prostate gland delineation on the images. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the concordance between delineators in identifying the prostate apex on the 2 CT image sets. MRI will be considered the gold-standard for identifying the prostate apex. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, MRI scan, External beam radiotherapy