linjc16/ctgov huggingface dataset:
King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children

Study Overview
=================
Brief Summary
-----------------
This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.

Official Title
-----------------
King Vision Video Laryngoscope aBlade System for Use in Children

Conditions
-----------------
Pediatric Anesthesia, King Vision Video Laryngoscope Intubation

Intervention / Treatment
-----------------
* Device: King Vision video Laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children between the ages of 1 month to 10 years with a normal preoperative airway examination Scheduled for a surgical procedure that requires tracheal intubation shall be included. Exclusion Criteria: 1. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Video laryngoscope intubation<br>The King Vision Video Laryngoscope will be used for intubation | Device: King Vision video Laryngoscope<br>* The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.<br>* Other names: Ambu;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Endotracheal Intubation | Ease of endotracheal intubation | During intubation |
Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan

Study Overview
=================
Brief Summary
-----------------
This is a prospective study of up to 250 participants, from birth to 18 months, who have already had a chest x-ray while a patient at the National Institute of Health (NICH) in Karachi, Pakistan. Participants will include both males and females as well as all races and ethnicities. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained radiologists to determine if bacterial pneumonia is present. Results of the thermal image will then be compared to the results of the chest x-ray. If additional images of the chest or other areas of suspected related infection are available, additional thermal images will be taken of the same location within 24 hours of the other image.

Official Title
-----------------
Thermal Images on Smartphones to Diagnose Bacterial Pneumonia in Children in Pakistan

Conditions
-----------------
Infections - Bacterial, Pneumonia - Bacterial

Intervention / Treatment
-----------------
* Device: FLIR ONE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 months or younger; patient at NICH Hospital in Karachi, Pakistan; had chest x-ray within last 24 hours to determine diagnosis of bacterial pneumonia; consent obtained from one parent Exclusion Criteria: thermal image cannot be done within 24 hours of chest x-ray

Ages Eligible for Study
-----------------
Maximum Age: 18 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal Imaging<br>Imaging using a thermal camera | Device: FLIR ONE<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of bacterial pneumonia | Pneumonia is defined as the presence of an airspace opacity, lobar consolidation, or interstitial opacities on a chest x-ray. This determination will be made by two independent radiologists blinded to each other's readings, clinical information and thermal images. If they agree that pneumonia is either present or absent, that will be the final diagnosis. If there is disagreement, a third independent, blinded radiologist will break the tie. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of additional site of infection possibly related to bacterial pneumonia | Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician | up to a maximum of 28 days after original chest x-ray to diagnose pneumonia is taken |
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.

Detailed Description
-----------------
This is a study on volunteers to determine effective dose of dexrazoxane in degrading Topoisomerase 2 b in human blood samples. Each participant will receive one dose of dexrazoxane. Blood samples will be collected to determine the time course and degradation of Topoisomerase 2b and Topoisomerase 2a

Official Title
-----------------
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Dexrazoxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, Age 18-65, Not pregnant, Not currently breast feeding No current illness, Exclusion Criteria: Pregnancy, currently breast feeding Current illness, History of cardiac, or renal disease

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will receive one dose of dexrazoxane.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexrazoxane 100mg/m2<br>one dose of 100mg/m2 dexrazoxane | Drug: Dexrazoxane<br>* One dose of dexrazoxane<br>* Other names: Zinecard;|
| Experimental: Dexrazoxane 200mg/m2<br>one dose of 200mg/m2 dexrazoxane | Drug: Dexrazoxane<br>* One dose of dexrazoxane<br>* Other names: Zinecard;|
| Experimental: Dexrazoxane 300mg/m2<br>one dose of 300mg/m2 dexrazoxane | Drug: Dexrazoxane<br>* One dose of dexrazoxane<br>* Other names: Zinecard;|
| Experimental: Dexrazoxane 400mg/m2<br>one dose of 400mg/m2 dexrazoxane | Drug: Dexrazoxane<br>* One dose of dexrazoxane<br>* Other names: Zinecard;|
| Experimental: Dexrazoxane 500mg/m2<br>one dose of 500 mg/m2 | Drug: Dexrazoxane<br>* One dose of dexrazoxane<br>* Other names: Zinecard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degradation of Topoisomerase 2 b | Topoisomerase 2 b degradation to less than 15 percent of baseline level in human blood of 5 volunteers. | 48 hours after administration |
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.

Detailed Description
-----------------
In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course.

Official Title
-----------------
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy

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

Intervention / Treatment
-----------------
* Radiation: radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed invasive breast carcinoma age >= 18 years exclusive treatment at the Jena University Hospital complete curative-intended adjuvant or definite radiotherapy at least 2 blood collections (before the start of therapy, after the end of the RT) Exclusion Criteria: presence of metastases recurrence DCIS, inflammatory breast cancer second malignancy <10 years before diagnosis of breast cancer radiotherapeutic pretreatment

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| primary non-metastatic breast cancer<br>primary non-metastatic breast cancer | Radiation: radiation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | from the start of Radiotherapy until death / last seen during follow up | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | from the start of Radiotherapy until relapse or metastasis / last seen during follow up | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, CETC, CTC, breast cancer
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients. Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis

Detailed Description
-----------------
Inclusion Criteria: 30 to 75 years old patient Parkinson disease's diagnosed since 5 years Treated by deep brain stimulation Patient with at least 6 degree lateral deviation Without vestibular troubles nor peripheral sensorial trouble. Exclusion Criteria: Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria Camptocormia or incompatible anteflexion with the dispositive of measure device Pregnant woman, nursing mother

Official Title
-----------------
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Behavioral: Subthalamic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 to 75 years old patient Parkinson disease's diagnosed since 5 years Treated by deep brain stimulation Patient with at least 6 degree lateral deviation Without vestibular troubles nor peripheral sensorial trouble. Exclusion Criteria: Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria Camptocormia or incompatible anteflexion with the dispositive of measure device Pregnant woman, nursing mother

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Voluntary subject<br>Patient without parkinson disease, without deep brain stimulation | Behavioral: Subthalamic stimulation<br>* Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus<br>|
| Active Comparator: Patients<br>Subthalamic stimulation | Behavioral: Subthalamic stimulation<br>* Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lateropulsion measured by computerized Posturography | The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007). | 4 days |
Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment

Study Overview
=================
Brief Summary
-----------------
The main aim of the study is to investigate patient satisfaction in the treatment of asthma and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible difficulties in the use of the device under real-life conditions in clinical practice are investigated.

Detailed Description
-----------------
The study detects the instruction expense in the use of the inhaler, reasons for the choice of the medication, or a switch in treatment of asthma or COPD.

Official Title
-----------------
Multicenter, Open-label, Non-interventional Study (NIS) to Evaluate Patient's Satisfaction and Preference, the Usability of DuoResp® SPIROMAX® and the Impact on Clinical Effects, in the Daily Routine of Asthma and COPD Treatment

Conditions
-----------------
Patient Satisfaction

Intervention / Treatment
-----------------
* Drug: Budesonide, Formoterol Fumarate Dihydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination patients who recently changed medication to DuoResp® Spiromax or are about to do so capacitated person with present declaration of consent Exclusion Criteria: diseases contraindicated in accordance with the summary of product characteristic patients who take part in interventional clinical trials parallel or during the last 4 weeks patient shows conditions or diseases that might disturb the monitoring according to the physician patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner patients involved in the planning and construction of the study (Teva staff and employees of the centres) patient is incapable of giving consent

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 |
| --- | --- |
| Single group prospective treatment<br> | Drug: Budesonide, Formoterol Fumarate Dihydrate<br> <br> * Other names: DuoResp® Spiromax®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction and Preference Questionnaire (PASAPQ) | Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ | 12 weeks | 
| Practicability of the device | Investigation of practicability of the device for patients using checklist inhalation errors | 12 weeks |
Does Modified Ultrafiltration Affect Thromboelastography Results?

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the effect of modified ultrafiltration on different components of Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary bypass.

Detailed Description
-----------------
The study will be performed at Advocate Children's Hospital, Oak Lawn. All neonates undergoing cardiac operations with cardiopulmonary bypass and modified ultrafiltration will be enrolled. Parents will be consented before surgery. After weaning from cardiopulmonary bypass and before starting modified ultrafiltration, a TEG sample will be taken. The components studied are Reaction time (R), Coagulation time (K), Angle, Maximum Amplitude (MA) and whole blood clot lysis index at 30 minutes (LY30). Another TEG sample will be taken after finishing modified ultrafiltration and before protamine is given. The different components will be compared pre and after modified ultrafiltration. The Primary end points are the changes of the different TEG components after modified ultrafiltration. The secondary end points are the utilization of different blood products (packed red cells, fresh frozen plasma and platelets transfusion) during and after surgery.

Official Title
-----------------
Does Modified Ultrafiltration Affect Thromboelastography Results?

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - neonates congenital heart disease pediatric cardiac operation with cardiopulmonary bypass modified ultrafiltration done at the end of cardiopulmonary bypass Exclusion Criteria: -patients older than 1 month. Cardiopulmonary bypass is not used Modified ultrafiltration is not performed

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Month

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 |
| --- | --- | --- |
| change in thromboelastography components after modified ultrafiltration | effect of modified ultrafiltration on different components of thromboelastography | 1 hour (time during surgery after doing modified ultrafiltration) to 2 days (postoperative recovery in intensive care unit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood products utilization during and after surgery | use of packed red cells, fresh frozen plasma and platelets during or after surgery | initial phase of recovery (2 days) in the intensive care unit after cardiac surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thromboelastography, modified ultrafiltration
Safety and Efficacy of Immune Therapy for Condyloma

Study Overview
=================
Brief Summary
-----------------
Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata patients only use interferon.

Official Title
-----------------
Safety and Efficacy of Immune Therapy for Condyloma

Conditions
-----------------
Condylomata Acuminata

Intervention / Treatment
-----------------
* Biological: DC-CIK immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:All patients have typical clinical characters of condyloma, positive for HPV-DNA test; All patients have been treated for cryotherapy or laser plus interferon for over half a year without completely recovery. All patients or their family will sign informed consent and approved by Ethics Committee of Shenzhen Second People's Hospital - Exclusion Criteria:pregnant, blood disease, contraindication for immune therapy, allergic to interferon -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC-CIK+interferon Group<br>dendritic cell-activated cytokine-induced killer cells (DC-CIK) immunotherapy plus interferon intervention | Biological: DC-CIK immunotherapy<br>* Cytokine-induced killer (CIK) cells are co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to condylomata acuminata patients<br>|
| Placebo Comparator: Placebo+interferon Group<br>saline as placebo plus interferon intervention | Biological: DC-CIK immunotherapy<br>* Cytokine-induced killer (CIK) cells are co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to condylomata acuminata patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condylomata Acuminata recurrence rate | Condylomata Acuminata recurrence rate in 6 months after treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin tissue HPV gene | use PCR to testify skin tissue HPV gene | 6 months | 
| side effect | evaluate and record side effect of each group | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DC-CIK, interferon