linjc16/ctgov huggingface dataset:
A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.

Official Title
-----------------
A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation

Conditions
-----------------
Chronic Subdural Hematoma

Intervention / Treatment
-----------------
* Device: Minimally Invasive Cortical Access System (MICAS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 55 years of age or greater. Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation. Exclusion Criteria: Failure to obtain consent. Vulnerable study population. Any need for chronic anticoagulation. Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma. Glasgow Coma Scale (GCS) less than 8.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>During clinically indicated surgery for subdural hematoma, the patient will undergo a single burr hole evacuation with the MICAS device with endoscopic assistance. | Device: Minimally Invasive Cortical Access System (MICAS)<br>* Temporary surgical tool that provides access to the sub-dural space through the cranium.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all serious adverse events | Number of adverse events including unanticipated adverse device effects | 3 years |
Intra-Atrial vs. Extra-Cardiac Technique During Fontan Operation

Study Overview
=================
Brief Summary
-----------------
Our aim is a retrospective chart review seeking to determine any differences in the main clinical and outcome variables as well as general outcome data such as functional recovery, readmission rates, somatic growth and mortality. An n size of 150 to 200 for each of the 2 groups will give us excellent power to detect potential differences.

Detailed Description
-----------------
The Fontan procedure is indicated as final-stage treatment for pediatric cardiac patients with single ventricle physiology. This procedure, whose aim is to provide for total cavopulmonary disconnect and perfusion of the pulmonary arteries via systemic veins, is performed via two differing techniques: intra-atrial, so-called lateral tunnel technique, employing PTFE graft material and internal atrial baffle, versus the extracardiac technique, using larger PTFE tubing and externally constructed baffle. There is persistent debate regarding the optimal technique to use, centered around the following main issues: 1) need for use of cardiopulmonary bypass and attendant consequences, 2) rates of thrombosis and embolism, 3) incidence of postoperative protein-losing enteropathy (PLE), 4) incidence of arrhythmias, and 5) baffle patency rates. A handful of small- to medium-sized studies has addressed the above issues, but, importantly, has not used patient data from the same institution. Here at CHOA, there are an estimated 200+ lateral tunnel, and have been up to 125 to 150 extracardiac Fontan procedures, performed in the last 15 years (1.1.1980-3.31.2005). Data from these cases would be potentially very helpful in answering all of these questions.

Official Title
-----------------
The Determination of Differences Between Intr-Atrial vs. Extra-Cardiac Technique During the Fontan Operation: A Retrospective Review

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children's Healthcare of Atlanta patients lateral tunnel procedure during 1.1.1990-3.31.2005 extracardiac Fontan procedures during 1.1.1990 - 3.31.2005 Exclusion Criteria: those who do not meet inclusion criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fontan procedure, single ventricle physiology, intra-atrial, extracardiac technique
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2 crossover method.

Official Title
-----------------
ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -

Conditions
-----------------
Healthy, Pharmacokinetics of Atorvastatin

Intervention / Treatment
-----------------
* Drug: ASP1585
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight: =<50.0kg, <80.0kg Body mass index: =<17.6, <26.4 Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data Exclusion Criteria: Attending another clinical trial within 120 days before the study Blood donation within 90 days (400ml) or 30 days (200ml) before the study Receiving any drugs within 7 days before the study History of allergy to drugs Having GI disorders History or complication of liver diseases History or complication of heart disease History or complication of respiratory diseases History or complication of renal diseases History or complication of cerebrovascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-add first group<br>single administration first, then concomitant administration | Drug: ASP1585<br>* oral<br>Drug: atorvastatin<br>* oral<br>* Other names: Lipitor;|
| Experimental: combi-add first group<br>concomitant administration first, then single administration | Drug: ASP1585<br>* oral<br>Drug: atorvastatin<br>* oral<br>* Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of atorvastatin |  | 48 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by AE, vital signs 12-lead ECG and lab tests |  | 7 days after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1585, Drug-drug interaction, Atorvastatin, Healthy volunteer
Recurrence in High-grade Lesions After Conization

Study Overview
=================
Brief Summary
-----------------
Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ). Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.

Official Title
-----------------
Presence of Positive Resection Margins, Hypooestrogenism and Specimen Volume May Influence Risk of Disease Recurrence in Patients With High-grade Cervical Intra-epithelial Neoplasia Undergoing Large Loop Excision of the Transformation Zone

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. history of surgery for conization Exclusion Criteria: under 18 years of age, immunosuppressed, Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Recurrent lesions | |
| Control<br>Absence of lesions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rates after conization | Number of patients who are regarded as recurrence based on the following criteria: - relapse occurred when cytology and/or biopsy showed that CIN had returned after 12 months | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical intraepithelial neoplasia, human papillomavirus, conization
The Use of Exhaled Nitric Oxide in Conjunction With the Asthma Control Test to Determine Asthma Control in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control Test (ACT). During the study the investigators will also examine if the combination of eNO and ACT will better predict asthma control that either tool alone when compared to a medical provider's assessment of the patient's asthma control.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of asthma by pediatric pulmonologist Age 6-18 years Exclusion Criteria: Age <6 years or >18 years history of bronchopulmonary dysplasia history of cystic fibrosis history of primary ciliary dyskinesia current acute asthma exacerbation current acute viral upper respiratory infection recent ingestion of nitrate-rich foods

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| 1<br>Pediatric patients with previously diagnosed asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled nitric oxide level |  | One office visit |
Invasive Group A Streptococcal Infection

Study Overview
=================
Brief Summary
-----------------
This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection

Detailed Description
-----------------
The main of this study is to identify and record cases of invasive and severe infections due to Streptococcus pyogenes. In order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management. Admitted patients to intensive care or critical care units in reported via Santé Publique France may also be included in this study. Secondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group A Streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.

Official Title
-----------------
French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)

Conditions
-----------------
Sepsis Due to Streptococcus, Group A, Risk Factors, Severe Infection, Medical Care, Medical Complications, Outcome, Fatal, Therapy, Strain, Virulence Factors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age<18 years Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis) Exclusion Criteria: Opposition of the patient or his/her legal representative

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Hospitalisation | How long patient was hospitalised during this infection | 1 year | 
| Treatments provided in intensive care unit | what treatments are used in intensive care unit to treat infection | 1 year | 
| Complications | what are the complications due to severe infection | 1 year | 
| Treatments used in routine care unit | which treatments are used in routine care unit to treat the infection | 1 year | 
| Risk factors | description of underlying conditions | 1 year | 
| Characterization of Group A Streptococcus strains | Characterization of Group A Streptococcus strains by the CNR | 1 year | 
| Death | Death Outcome during hospitalisation | 1 year |
Assessment of Needs of Moisturizers After Various Laser Treatments

Study Overview
=================
Brief Summary
-----------------
Assessment of needs of moisturizers after various laser treatments

Detailed Description
-----------------
The investigators would like to assess of needs of moisturizers after various laser treatment : by investigating the changes in the skin barrier function after fractional carbon dioxide laser and fractional Er:Glass laser in mice and human skin

Official Title
-----------------
Phase 4 Study of Assessment of Needs of Moisturizers After Various Laser Treatment

Conditions
-----------------
Dermatologic Disorders, Injury Due to Laser

Intervention / Treatment
-----------------
* Other: Physiogel
* Other: Moisturizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age without any dermatologic diseases Exclusion Criteria: Taking other known dermatologic disease Others who are shown pigmented lesion on treated-area Who have allergy or history of hypersensitivity reaction to moisturizers Who have other definitive cutaneous findings

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiogel, Laser therapy, Moisturizer<br>Experimental: Physiogel treated & Non-treated 1 Palmitoylethanolamide, Physiogel 3 times a day for 2 weeks | Other: Physiogel<br>* Application of moisturizer on laser-treated area<br>* Other names: Other Names:Physiogel;Other: Moisturizer<br>* Application of moisturizer on laser-treated area<br>* Other names: Other Names:Physiogel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of erythema, transepidermal water loss | The clinical assessment of erythema, pigmentation, transepidermal water loss will be evaluated by using apparatus. | 2weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moisturizer, laser
A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

Study Overview
=================
Brief Summary
-----------------
This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.

Official Title
-----------------
Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study

Conditions
-----------------
Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive Patients who will not require dialysis within 12 months after the start of Mircera therapy Patients whose life expectancy is greater than 12 months after Mircera initiation Patients >/= 18 years and </= 75 years of age Patients who are female and of childbearing potential must be using effective contraception methods Patients with no contra-indications to ESA treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local SmPC) Patients who have given written informed consent where local regulations allow or require it Exclusion Criteria: Patients with stage I-II or stage V CKD Poorly controlled hypertension Active malignant disease

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mircera<br>Patients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator. | Other: No intervention<br>* No intervention was administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb Levels At Start And End Of Treatment |  | 12 months | 
| Mircera Dose At Start And End Of Treatment |  | 12 months | 
| Time To Achieve Response To Mircera |  | 12 months | 
| Percent Of Participants Treated With Iron Supplements |  | 12 months | 
| Percent of Participants Who Required Transfusion At Start And End Of Treatment |  | 12 months |
Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery

Study Overview
=================
Brief Summary
-----------------
Serratus plane block (SPB) was first described in 2013 by Blanco and designed to primarily block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. It was first described by Forero et al. in 2016, effectiveness being reported in four cases. The aim of this study is to compare Serratus plane block and erector spinae plane block on postoperative pain in patients undergoing modified radical mastectomy and axillary lymph node dissection

Official Title
-----------------
Erector Spinae Plane Block Versus Serratus Plane Block on Postoperative Opioid Consumption for Modified Radical Mastectomy and Axillary Lymph Node Dissection

Conditions
-----------------
Postoperative Pain, Breast Cancer

Intervention / Treatment
-----------------
* Drug: Bupivacaine Hcl 0.25% Inj
* Drug: Bupivacaine HCl Inj 0.25%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients undergoing breast cancer surgery 18-65 years Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases coagulopathy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound guided serratus plane block<br>Ultrasound Guided Serratus Plane Block 30 ml %0.25 Bupivacaine | Drug: Bupivacaine Hcl 0.25% Inj<br>* 30 ml %0,25 bupivacaine<br>|
| Active Comparator: ultrasound guided erector spinae plane block<br>Ultrasound Guided Erector Spinae Plane Block 20 ml %0.25 Bupivacaine | Drug: Bupivacaine HCl Inj 0.25%<br>* 20 ml %0,25 bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | First 24 hours total fentanyl consumption with patient controlled analgesia | First 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively | postoperative first24 hours | 
| Block Performing Time | The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration | First hour |