linjc16/ctgov huggingface dataset:
Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.

Conditions
-----------------
Intravascular Ultrasound (IVUS) Angiography Co-registration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing routine coronary angioplasty Exclusion Criteria: Cardiogenic shock Acute myocardial infarction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Accuracy of Co-Registration of IVUS and Coronary Angiography | For determination of the accuracy of the co-registration feature, and the accuracy and precision of the length measurements, a flexible phantom was used in order to simulate an artery and enable simulation of the cardiac motion. The sample size for testing the co-registration algorithm was 108 samples (each sample was defined as a landmark). The resultant mean of the absolute distance accuracy was 0.995 mm with a standard deviation of 0.809 mm. The statistical validation in phantoms, resulted in an accuracy of 1.12 mm, meeting the original specification. | One month |
Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients

Study Overview
=================
Brief Summary
-----------------
Gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. This association is through elevated anti-Tissue transglutaminase (Anti-tTG) levels both in Celiac disease and thyroiditis. In our study we tried to find if there is any correlation in between Anti-tTG and degree of fibrosis in thyroid tissue (Post-operative specimen).

Detailed Description
-----------------
Most common auto-immune disease associated with Celiac disease is autoimmune thyroiditis. This association in between Celiac disease and aout-immune thyroiditis is related with asymptomatic rise in anti-tTG levels. In our study, we planned to show that if there is any correlation of thyroiditis related fibrosis in thyroid tissue with anti-tTG IgA ( immune-globulin A) and IgG (immune-globulin G).

Official Title
-----------------
Does Gluten Sensitivity Play a Role in Development of Thyroiditis

Conditions
-----------------
Thyroid Fibrosis

Intervention / Treatment
-----------------
* Other: Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thyroiditis patients operated for any indication Exclusion Criteria: Patients with known IgA deficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operated Patients<br>Measurement of fibrosis degree and Anti-tTG levels | Other: Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples<br>* Examination of pathology specimen and laboratory measuring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of fibrosis in thyroid tissue and measured level of anti-tTG levels in serum | Degree of fibrosis was defined after painting of slides with masson trichrome as absent, mild, moderate semi-quantitatively. | one day after operation | 
| Measurement of Anti-tTG levels in serum | Amount of serum Anti-TG in IU/mL | one day after operation |
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.

Official Title
-----------------
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Antidepressant + Placebo
* Drug: Antidepressant + Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18-65 years old Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration. Treatment history of an inadequate response to at least one and no more than three antidepressants.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A1<br> | Drug: Antidepressant + Placebo<br>* Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.<br>|
| Active Comparator: A2<br> | Drug: Antidepressant + Aripiprazole<br>* Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in a depression rating scale at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in a disability scale and Clinical Global Impression scale at endpoint |  |  |
Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

Study Overview
=================
Brief Summary
-----------------
The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia

Official Title
-----------------
Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina.

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Drug: Amlodipine
* Drug: iso- 5 - mononitrate
* Procedure: Blood tests
* Procedure: Exercise Stress Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients > =18 years of age with diagnosed clinically stable angina pectoris Exclusion Criteria: Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amlodipine|nan|
|Drug: iso- 5 - mononitrate|nan|
|Procedure: Blood tests|nan|
|Procedure: Exercise Stress Test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the time to 1mm ST depression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety |  |  |
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome. Subjects completing the 12 week treatment period of SP583 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be followed on an annual basis. Two primary efficacy variables will be assessed, which are observation and assessment of adverse events and duration on therapy. Secondary efficacy parameters included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF). The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.

Official Title
-----------------
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Drug: SPM 907


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in SP583 Exclusion Criteria: Failure to complete 12 week treatment with SPM 907

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 907|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women

Study Overview
=================
Brief Summary
-----------------
Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.

Official Title
-----------------
Effectiveness of Transversus Abdominis Plane Block in Reducing Immediate Postoperative Pain in Obese Women After Laparoscopic or Robotic Gynecologic Procedures

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.5% 20cc injectate bilaterally
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures Exclusion Criteria: Conversions, non-obese women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP<br>Patients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe | Drug: Ropivacaine 0.5% 20cc injectate bilaterally<br> <br> |
| Placebo Comparator: Saline<br>Patients will receive Normal saline 20cc injectate from a study labeled syringe | Drug: Placebo<br> <br> * Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable | 0, 1, and 2 hours | 
| Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable | 4hrs, 8hrs, 12hrs, and 24hrs. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transversis Abdominis Plane Block, obese, robotic surgery, laparoscopic surgery
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma

Study Overview
=================
Brief Summary
-----------------
the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial

Detailed Description
-----------------
the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.

Official Title
-----------------
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial

Conditions
-----------------
Periampullary Carcinoma

Intervention / Treatment
-----------------
* Procedure: pancreaticoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both the sex aged between >18 years. Patients with a diagnosis of resectable periampullary carcinoma on imaging. Patients with ASA grade 1 or 2 Exclusion Criteria: 1) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open pancreaticoduedenectomy<br>will include all the patients who will undergo open pancreaticoduodenectomy | Procedure: pancreaticoduodenectomy<br>* pancreaticoduodenectomy either laparoscopically or open will be done<br>|
| Active Comparator: Laparoscopic pancreaticoduodenectomy<br>will include all the patients undergoing laparoscopic pancreaticoduodenectomy | Procedure: pancreaticoduodenectomy<br>* pancreaticoduodenectomy either laparoscopically or open will be done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss in ml, quantitative | blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV | 24 hours |
Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case

Study Overview
=================
Brief Summary
-----------------
To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable: a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages, a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure

Official Title
-----------------
Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case

Conditions
-----------------
Liver Biopsy

Intervention / Treatment
-----------------
* Device: Planning@IFE and Standard@IFE Software
* Device: MR Syngo (Numaris/4) software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years old Affiliated to a social security scheme Informed consent Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI Exclusion Criteria: Patient with a contraindication for MRI exam Patient with a contraindication for performing a biopsy Pregnancy Exclusion period Patient unable to receive and understand information about the study Patients under guardianship Patients under judicial protection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group: with IFE<br>Patients treated with IFE software | Device: Planning@IFE and Standard@IFE Software<br> <br> |
| Active Comparator: Test group: without IFE<br>Patients treated with Numaris 4 software | Device: MR Syngo (Numaris/4) software<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of the intervention (planning and implementation) |  | up to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver
Macrophage Migration Inhibitory Factor for Diagnosing Endometriosis and Its Severity

Study Overview
=================
Brief Summary
-----------------
Endometriosis is a chronic disease affecting women of reproductive age. Macrophage migration inhibitory factor (MIF) is one of non-invasive blood biomarker that was detected in sera of endometriotic patients.The aim of this study was to evaluate the value of serum macrophage migration inhibitory factor in diagnosing endometriosis in women with infertility and chronic pelvic pain and correlate its level with the stage of the disease. Three hundred patient candidate for diagnostic laparoscopy were included in a case-control observational study

Detailed Description
-----------------
observational case-control study conducted in Fayoum University hospital from March 2016 till September 2018. Three hundred women candidate for diagnostic laparoscopy for either infertility or gynecologic chronic pelvic pain were included. The study group included patients with diagnostic criteria of endometriosis. The control group included other causes of infertility or pelvic pain.

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Diagnostic Test: serum Eliza assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenstrual women in childbearing period, presenting with either gynecologic chronic pelvic pain (CPP) or infertility indicated and fit for diagnostic laparoscopy. All women must have no hormonal treatment for the last 3 months and. Exclusion Criteria: Women with bleeding tendency, suspicious of gynecologic malignancy or active infection

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 |
| --- | --- |
| endometriosis<br>laparoscopy and directed biopsy of lesions serum macrophage migration inhibitory factor ELIZA assay | Diagnostic Test: serum Eliza assay<br>* laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor<br>* Other names: laparoscopy;|
| control<br>diagnostic laparoscopy serum macrophage migration inhibitory factor ELIZA assay | Diagnostic Test: serum Eliza assay<br>* laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor<br>* Other names: laparoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of serum macrophage migration inhibitory factor and stage of the disease | serum MIF is a promising marker for noninvasive diagnosis of severity of endometriosis | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macrophage migration inhibitory factor, Endometriosis, Laparoscopy