linjc16/ctgov huggingface dataset:
Cardiac Output Monitoring in Aortic Aneurysm Surgery

Study Overview
=================
Brief Summary
-----------------
To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required.

Conditions
-----------------
Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair Exclusion Criteria: Patients not giving informed consent. Patients under the age of 18 years. Patients who may be pregnant Patients with learning disabilities. Rhythm other than sinus rhythm. Patients on oral lithium therapy. Patients less than 40kg Patients with severe mitral regurgitation

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 |
| --- | --- |
| Repair<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic aneurysm repair
Fast Magnetic Resonance Imaging as Compared to Computed Tomography Scan in Pediatric Orbital Cellulitis Imaging

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare orbital and central nervous system (CNS) imaging with Computed Tomography (CT) scan to that of Fast Magnetic Resonance Imaging (Fast MRI) in children with mild, moderate or severe orbital cellulitis with medical indications for imaging.

Conditions
-----------------
Orbital Cellulitis

Intervention / Treatment
-----------------
* Device: Computed Tomography Scan
* Device: Fast Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with orbital cellulitis with indications for imaging Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Computed Tomography Scan<br>To determine the presence of periosteal or orbital abscess, intracranial abscess and dural venous sinus thrombosis that are imaged properly with Computed Tomography scan. | Device: Computed Tomography Scan<br> <br> |
| Active Comparator: Fast Magnetic Resonance Imaging<br>To determine the presence of periosteal or orbital abscess, intracranial abscess and dural venous sinus thrombosis that are imaged properly with T1/T2-weighted MRI. | Device: Fast Magnetic Resonance Imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI sensitivity for the detection of orbital cellulitis compared to CT | MRI results will be compared to CT results | One year |
Sentinel Lymph Node Technique in Multifocal Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

Detailed Description
-----------------
The sentinel lymph node is located preferentially by: association of subareolar injection of technecium and blue dye or, in case of blue dye allergy, by the subareolar injection of technecium only or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery This procedure is immediately follows by complete axillary dissection during breast surgery The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.

Official Title
-----------------
Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Sentinel Lymph Node Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multifocal invasive breast cancer At least 2 focuses (clinically and/or by mammography or ultrasound) Proven by pre-surgical histology (on 1 focus at least) Age > 18 years old Clinically negative axillary lymph nodes No treatment before surgery Signature of written informed consent Exclusion Criteria: Multifocality proven after surgery Non invasive breast cancer Inflammatory breast cancer Axillary lymph node Metastatic disease Previous homolateral breast cancer Dementia or alterated mental status Pregnant or lactating woman

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Sentinel Lymph Node Technique|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate of sentinel nodes |  | surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of sentinel nodes removed |  | surgery | 
| localisation of the sentinel nodes |  | surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma, breast, multifocal lesions, surgery
Amplatzer PFO Occluder Post-marketing Surveillance Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

Detailed Description
-----------------
Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as PFO occluder).

Official Title
-----------------
Amplatzer PFO Occluder Post-marketing Surveillance Study

Conditions
-----------------
PFO - Patent Foramen Ovale

Intervention / Treatment
-----------------
* Device: Amplatzer PFO Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refer to Amplatzer PFO occluder IFU Exclusion Criteria: Refer to Amplatzer PFO occluder IFU
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amplatzer PFO Occluder<br>Percutaneous PFO Closure using Amplatzer PFO occluder | Device: Amplatzer PFO Occluder<br>* Percutaneous PFO closure using Amplatzer PFO Occluder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device- or procedure related SAE rate | device- or procedure related serious adverse events (SAEs) through 30 days | up to 30 Days | 
| PE, DVT and ischemic stroke and atrial fibrillation rate | rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years | beyond 30 days through 3 years | 
| Effective PFO closure | Effective closure of the PFO at 1 year | At 1 year |
Cognitive Behavioral Treatment of Pediatric Trichotillomania

Study Overview
=================
Brief Summary
-----------------
This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM).

Detailed Description
-----------------
TTM is a persistent impulse control disorder in which the individual acts on urges to pull out his or her own hair. Onset typically occurs by adolescence, and TTM is often associated with significant functional impairment and distress. CBT is a type of psychotherapy designed to change problematic behaviors and thinking. It includes self-monitoring of hair-pulling urges and homework assignments to practice the use of cognitive and behavioral strategies. Participants are assigned randomly to receive either CBT or AC for 8 weeks. Participants assigned to CBT receive weekly 1-hour sessions of CBT for 8 weeks; participants assigned to AC receive 6 telephone contacts and 2 in-person sessions for 8 weeks. After 8 weeks, CBT participants who respond to treatment enter Phase II, which lasts an additional 8 weeks and includes 4 in-person maintenance sessions. AC participants who are still symptomatic after 8 weeks are offered CBT.

Official Title
-----------------
Cognitive Behavioral Treatment of Pediatric Trichotillomania

Conditions
-----------------
Trichotillomania

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Trichotillomania Minimum symptom duration of 6 months Presence of a stable parent or guardian Exclusion Criteria: Other primary psychiatric diagnosis Bipolar illness, pervasive developmental disorder, thought disorder, current major depression, ADD/ADHD Concurrent psychotherapy Currently receiving psychotropic medications

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Mental Health (NIMH) Trichotillomania Severity Scale | Semi-structured interview about hair-pulling and related symptoms | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive-behavior Therapy, Minimal Attention Control
Symbicort Turbuhaler 30/60 Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs, unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on bronchial asthma and Patient satisfaction

Official Title
-----------------
Symbicort Turbuhaler 30/60 Clinical Experience Investigation

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Symbicort for the first time due to bronchial asthma Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symbicort<br>Those with an exposure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | Range of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of asthma control |  | Range of 12 weeks | 
| The level of patient satisfaction with Symbicort |  | Range of 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial asthma, Symbicort
A Complicated Skin and Soft-tissue Infection Patient Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.

Detailed Description
-----------------
A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.

Official Title
-----------------
A Prospective, Multi-center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy

Conditions
-----------------
Staphylococcal Skin Infections, Diabetic Foot Infections, Surgical Wound Infection, Abscess, Cellulitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of complicated skin and soft-tissue infection Patients who require IV antibiotic therapy as a primary treatment regimen Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information. Exclusion Criteria: Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis Patients for whom amputation or a complete resection of the infection site is a planned component of treatment Patients who are pregnant Patients simultaneously participating in any interventional clinical trial Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements Patients who are employees of the investigator or study hospital

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complicated Skin and Soft-Tissue Infection, Skin Infection, Skin Infection Registry, cSSTI Registry
Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate levels of circulating cell free DNA (cfDNA), circulating tumor DNA (ctDNA), circulating tumor cells (CTC) and immunological changes after self-expanding metal stent (SEMS) placement for malignant obstruction in the colon, and interpret these levels in relation to overall- and disease-free survival. Furthermore, we intend to study the opportunity to identify patients with a higher risk of recurrence due to the SEMS placement by monitoring cfDNA and ctDNA-levels, as it may be a potential biomarker to initiate or optimize chemotherapy and thereby ensure a better prognosis for the patients.

Detailed Description
-----------------
Study design This prospective study will include 20 patients undergoing SEMS placement as a bridge to elective surgery at Koege- and Slagelse Hospital. Baseline blood samples will be collected before the procedure. After the procedure blood samples will be collected 1, 4, 12 and 24 hours after SEMS placement. After elective surgery a tumor sample will be collected. Prior to SEMS placement: When potential candidates are admitted to the hospital they will be presented to the study by the relevant surgeon. The investigators will be contacted, when the patient is admitted to hospital.

Official Title
-----------------
Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction

Conditions
-----------------
Cancer of Colon

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages of 18 to 95 years Patients with acute malignant obstruction in the colon. ASA class I-III (Classification of the American Society of Anesthesiology) Signed informed consent Exclusion Criteria: Known immune-defects Withdrawal of informed consent Bloodtransfusion 24 hours prior to stent-placement until 24 hours after stent-placement. Surgery within 24 hours after stent-placement Known inflammatory bowel disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| ctDNA/cfDNA levels in relation to colorectal stent placement | Blood samples will be collected before the treatment and again 1, 4, 12 and 24 hours after stent placement. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological response | Flow cytometry will be performed and additionally multiplex cytokine analyses will be performed | 2 years | 
| Metastatic ability of the cancer cells | Cell adhesion assay, proliferation and migration will be performed on serum. | 2 years |
Open-label Study of ASP2151 in Herpes Simplex Patients

Study Overview
=================
Brief Summary
-----------------
A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).

Official Title
-----------------
Open-label Study of ASP2151 in Herpes Simplex Patients

Conditions
-----------------
Herpes Simplex

Intervention / Treatment
-----------------
* Drug: ASP2151


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region Kaposi varicelliform eruption: Patients with major skin symptoms of papulae or vesicles Patients who can start receiving the study drug within 48 hours after onset of rash Age: 16 years or older, but younger than 80 years Exclusion Criteria: Patients who are not expected to have an adequate response to oral antiviral medication. Patients with two or more types of herpes simplex. An extreme decline in immune function Presence of serious complications Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent: AST or ALT ≥ 2.5 x upper limit of normal Platelet count < lower limit of normal Serum creatinine ≥ 1.5 mg/dL Creatinine clearance < 30 mL/min Current or previous history of malignant tumor within 5 years before informed consent Diagnosis of autoimmune disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 79 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP2151<br> | Drug: ASP2151<br> <br> * Other names: 200 mg once daily;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects achieving lesion healing by Day 8 of study treatment |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing |  | 29 days | 
| Time to complete crusting |  | 29 days | 
| Time to virus disappearance |  | 29 days |