linjc16/ctgov huggingface dataset:
Epilepsy-related Brain Tumors Register

Study Overview
=================
Brief Summary
-----------------
Epilepsy is defined by a cerebral disorder characterized by a lasting predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological and social consequences of this affection. The definition of epilepsy requires the occurrence of at least one epileptic seizure. 1% of the population suffers from epilepsy. The most common causes are genetic and vascular, 10% of epileptic syndromes are caused by a tumor. The incidence of brain tumors in people with epilepsy is approximately 4%. Among patients with brain tumor (s), the frequency of epilepsy is 30% or more depending on type of tumeur. 30-50% of brain tumors are revealed by an epileptic seizure and 10 to 30% of patients with brain tumor (s) will develop seizures during their evolution. The main objective is to evaluate the frequency of epileptic seizures according to the type of brain tumor.

Official Title
-----------------
Epilepsy-related Brain Tumors Register

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient whose age ≥ 18 years Patient hospitalized or seen in consultation in the Department of Neurology within the Hospital Group Paris Saint-Joseph Diagnosis of primary or secondary brain tumor, radiologically and / or histologically Epilepsy revealing or occurring in a patient developing a brain tumor Francophone patient Exclusion Criteria: Pre-existing and known epilepsy before the diagnosis of brain tumors Epilepsy occurring within 2 weeks postoperatively Anteriority of taking antiepileptic treatment Patient under tutorship or curatorship Patient deprived of liberty Patient with comprehension disorders making it impossible to understand the protocol Patient or relative opposing the use of his data

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 |
| --- | --- | --- |
| number of epileptic seizures | number of epileptic seizures at the time of neurology consultation or hospitalization | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of epileptic seizures | number of epileptic seizures at every visit | until 10 years |
PEEP Test and Gas Exchange in ALI/ARDS Patients

Study Overview
=================
Brief Summary
-----------------
The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange.

Detailed Description
-----------------
In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the effect of different levels of PEEP on gas exchange and dead space.

Official Title
-----------------
Positive End Expiratory Pressure (PEEP) Test and Gas Exchange in ALI/ARDS Patients

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Procedure: Mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALI/ARDS patients requiring mechanical ventilation Exclusion Criteria: Hemodynamic instability Barotrauma

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ALI/ARDS patients | Procedure: Mechanical ventilation<br>* measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas exchange, dead space, respiratory mechanics |  | 5, 15, 30, 60 minutes from PEEP change | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gas exchange, dead space, respiratory failure, ALI/ARDS patients
Women's Treatment for Trauma and Substance Use Disorders - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.

Official Title
-----------------
Women's Treatment for Trauma and Substance Use Disorders

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD. Exclusion Criteria: - Women will be excluded from the study who have current psychotic disorders, or a history of active psychosis (past two months); women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD; and women who have current psychotic disorders, or a history of active psychosis (past two months).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug abstinence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavioral intervention
Study of the Hummingbird TTS™ Tympanostomy Tube System

Study Overview
=================
Brief Summary
-----------------
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.

Detailed Description
-----------------
The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.

Official Title
-----------------
Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System

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

Intervention / Treatment
-----------------
* Device: Hummingbird Tympanostomy Tube System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 months through 5 years of age Candidates for ventilation tube placement H-TTS used under moderate sedation and local anesthetic

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hummingbird Tympanostomy Tube System|Insertion of a ventilation tube under sedation and local anesthetic|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Procedures Converted From Sedation to General Anesthesia | Percentage of procedures that require conversion from sedation to general anesthesia | Intra-operative | 
| Rate of Intra-operative Adverse Events | Rate of intra-operative adverse events that occur from the beginning to the end of the procedure | Intra-operative | 
| Rate of Adverse Events Through Discharge | Rate of adverse events that occur between the end of the procedure and discharge | Through discharge, estimated to be approximately 90 minutes post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tympanostomy, myringotomy, otitis media, ear tubes, ear infection
Clinical and Laboratory Characteristics of Sickle Cell Anemia Patients Admitted With Fever

Study Overview
=================
Brief Summary
-----------------
This study will summarized the clinical and laboratory data and the outcome of all the patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to the pediatric ward.

Detailed Description
-----------------
The actual protocol for SCA patients admitted with fever is to obtain blood cultures and start empiric antibiotic treatment. The study cohort included 60 SCA patients actually treated in the Pediatric Hematology Unit.

Official Title
-----------------
Study the Clinical and Laboratory Characteristics and the Outcome of Sickle Cell Anemia Patients Admitted to the Pediatric Ward Because of Fever as the Presenting Symptom

Conditions
-----------------
Sickle Cell Anemia, Sickle Cell Thalassemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted with fever as the only presenting symptom. Exclusion Criteria: Patients admitted with another causes related or unrelated to sickle cell disease and have also fever.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Sickle cell anemia | Other: Observational<br>* Summary of clinical and laboratory data<br>|
| 2<br>Sickle cell thalassemia | Other: Observational<br>* Summary of clinical and laboratory data<br>|

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
-----------------
Fever, Blood cultures
Validation of FDG-PET Segmentation Tools for Tumor Delineation by Correlation of CT- and FDG-PET Volume Measurements With Histopathology of Nodal Metastases of Head and Neck Carcinomas.

Study Overview
=================
Brief Summary
-----------------
Various methods of FDG-PET signal segmentation will be validated by correlation of histopathologically measured tumor dimensions in lymph node dissection specimens of head-and-neck cancer patients.

Official Title
-----------------
Validation of FDG-PET Segmentation Tools for Tumor Delineation by Correlation of CT- and FDG-PET Volume Measurements With Histopathology of Nodal Metastases of Head and Neck Carcinomas.

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: CT-FDG/PET scan of the head-and-neck region


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with N+ squamous cell carcinoma of the head and neck, planned for neck dissection. Age >18 years. Exclusion Criteria: Pregnancy. Women breast feeding

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 |
| --- | --- |
| Head-and-neck cancer patients.<br>Head-and-neck cancer patients eligible for therapeutic lymph node dissection of cervical nodes. | Other: CT-FDG/PET scan of the head-and-neck region<br>* CT-FDG/PET scan of the head-and-neck region<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How accurate are the various FDG-PET segmentation tools? |  | Measurements are performed in conjunction with the clinical pathologist directly postoperatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FDG-PET segmentation tools, Head-and-neck cancer, Histological validation
Correlation Between Serum Anti-Müllerian Hormone & Müllerian Ducts Anomalies in Infertility

Study Overview
=================
Brief Summary
-----------------
Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric glycoprotein that belongs to the transforming growth factor-beta family. It is involved in the regression of the Müllerian ducts during male fetal development. In the female, AMH is solely produced by the granulosa cells of preantral and small antral follicles, and regulates ovarian activity and follicular steroidogenesis

Detailed Description
-----------------
Following approval of the internal review board of Egyptian IVF-ET center, a retrospective analysis will be undertaken where a detailed review of the patients files who underwent intracytoplasmic sperm injection (ICSI) trials starting January 2010 till January 2015 will be done. Patients with diagnosed mullerian anomalies will have their name , age ,duration of infertility, serum FSH, LH ,& AMH levels recorded. The method of diagnosis (HSG, 3D/ultrasonography, hysteroscopy, or laparoscopy) will also be documented.

Official Title
-----------------
Correlation Between Serum Anti-Müllerian Hormone (AMH) Levels & Müllerian Ducts Anomalies in Patients Undergoingintracytoplasmic Sperm Injection (ICSI)

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Anti Mullerian hormone level; Mullerian duct anomaly type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with diagnosed mullerian anomlies whether clinically or through imaging Exclusion Criteria: previous ovarian surgery ovarian drilling polycystic ovarian syndrome (PCOs).

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 |
| --- | --- |
| Mullerian duct anomalies<br>Anti Mullerian hormone level; Mullerian duct anomaly type | Other: Anti Mullerian hormone level; Mullerian duct anomaly type<br>* Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-Müllerian hormone (AMH), Mullerian anomalies, ICSI
Lichen Sclerosus - the Influence on Quality of Life

Study Overview
=================
Brief Summary
-----------------
A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.

Detailed Description
-----------------
The patients are randomized to an intervention Group and a control Group. The intervention gets 6-8 visits with clinical sexologist and the control Group is having the usual care.

Official Title
-----------------
Lichen Sclerosus - the Influence on Quality of Life

Conditions
-----------------
Lichen Sclerosus

Intervention / Treatment
-----------------
* Other: Standard care and sexological counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Lichen Sclerosus Age over 18 years Exclusion Criteria: Patients who does not understand or speak Danish Patients with a psychiatric diagnosis and can not follow the course

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard care and sexological counseling<br>Standard care including gynecological examination and 6-8 sexological consultations. | Other: Standard care and sexological counseling<br>* 6-8 sexological consultants in a period of six months<br>|
| No Intervention: Standard care<br>Standard care including gynecological examination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in women with Lichen Sclerosus | Change in EuroQol five dimension (EQ-5D) score. The descriptive system comprises 5 dimensions (mobili-ty, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment, Quality of Life, Sexology, Women
Noninvasive Positive Pressure Ventilation in Overlap Syndrome

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary diseases (COPD) coexisting with obstructive sleep apnea is called overlap syndrome (OS). Patients with OS seem to have worse prognosis than patients with only one disorder. Noninvasive positive pressure ventilation is an efficient treatment in obstructive sleep apnea, but the effectiveness in improving outcomes of OS patients is still not fully investigated. The aim of this non-randomized concurrent control trial is to evaluate noninvasive positive pressure ventilation's effectiveness in OS patients.

Official Title
-----------------
The Effectiveness of Noninvasive Positive Pressure Ventilation Treatment in Overlap Syndrome

Conditions
-----------------
COPD, Sleep Apnea Syndromes, Non-invasive Positive Pressure Ventilation

Intervention / Treatment
-----------------
* Device: NIPPV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with COPD and sleep apnea dyspnea syndrome Exclusion Criteria: patients with non-stable hemodynamics; patients with limited life expectancy; patients with other severe respiratory diseases; patients with motor neuron diseases; patients with contraindications for NIPPV

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-invasive positive pressure ventilation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Interventional group<br>NIPPV as treatment of OS | Device: NIPPV<br>* BiPAP treatment for 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD acute exacerbations | total times of COPD acute exacerbations | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD assessment test (CAT) score | symptom score of COPD | 3 years | 
| modified British medical research council (mMRC) score | dyspnea score | 3 years | 
| all-cause mortality | survival rate in % | 3 years |
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged survival of beta cell allografts in type 1 diabetic patients with early chronic complications of diabetes.

Official Title
-----------------
Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Procedure: islet cell grafts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 insulin-dependent diabetic patients in relatively good general condition non-smoker body weight < 80 kg C-peptide < 0.03 nmol/l (<0.09 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl) EBV antibody positive cooperative and reliable patient giving informed consent by signature; the patient should be informed in sufficient detail on the content and procedure of the protocol, indicating potential risks of intervention and of immunosuppressive therapy; the patient should also be informed that withdrawal of immunosuppressive therapy in patients with persistent plasma C-peptide positivity may result in subsequent loss of ß-cell graft function; the ß cell implant should be identified as a clinical trial Exclusion Criteria: history of thrombosis or pulmonary embolism abnormal liver function HLA antibodies

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: islet cell grafts|Intraportal injection of an islet cell graft into the liver.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically relevant beta cell function. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, type 1, pancreatic beta cell, transplantation