linjc16/ctgov huggingface dataset:
Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique

Study Overview
=================
Brief Summary
-----------------
Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.

Detailed Description
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The investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation and Implantation of an external ventricle drain or a subdural ICP Monitoring devise. The second ICP probe is fixed epicutaneously on the skin over the frontal fontanel. The hourly measured ICPs within 24 hours postoperatively were compared with the Bland-Altman two methods analysis.

Official Title
-----------------
Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique

Conditions
-----------------
Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child with open fontanel Need of ICP monitoring Exclusion Criteria: closed fontanel No Need of ICP monitoring

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 15 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intracranial ICP monitoring<br>invasive intracranial ICP monitoring | |
| tranfontanel ICP monitoring<br>Noninvasive transfontanel ICP monitoring | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe. | ICP values in mmHg will be collected in both arms | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noninvasive ICP monitoring
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)

Study Overview
=================
Brief Summary
-----------------
CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of CMV development after bone marrow transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the development of CMV infection after transplantation.

Detailed Description
-----------------
We will evaluate whether CMV-specific cell-mediated immune response before transplant, 1 month, 3 months, and 6 months after transplantation will predict CMV infection after bone marrow transplantation.

Official Title
-----------------
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)

Conditions
-----------------
Bone Marrow Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 16 or more agree with written informed consent Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 99 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 |
| --- | --- |
| high CMV ELISPOT results<br>high spot counts in ELISPOT | |
| low CMV ELISPOT results<br>low spot counts in ELISPOT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV infection | CMV infection is defined as follows. CMV viremia: CMV antigenemia or CMV quantitative PCR (+) CMV disease: CMV syndrome or tissue-invasive CMV disease i) CMV syndrome: ① CMV viremia ② temperature > 38 without other cause ③ WBC < 4000, atypical lymphocyte > 3%, transaminase elevation, platelet < 100,000/mm ii) tissue-invasive CMV disease: evidence of CMV in histopathologic specimen (inclusion body or viral antigen in biopsy or bronchoalveolar lavage fluid) | 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 6 months after transplantation |
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are: Evaluation of the safety profile of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone, hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion protein. Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome Analysis of patient's blood samples for the detection of activated kinases.

Official Title
-----------------
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

Conditions
-----------------
Hypereosinophilic Syndrome

Intervention / Treatment
-----------------
* Drug: imatinib mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic hypereosinophilic syndromes are included provided they belong to one of the following categories: previously treated and showing documented resistance or refractoriness to, or intolerance of, prednisone, hydroxyurea or interferon-alpha. not previously treated but with documented Fip1L1-PDGFRA fusion protein Exclusion Criteria: Other diseases associated with hypereosinophilia Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit. ECOG performance status >3 Other protocol-defined exclusion criteria may apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STI571<br> | Drug: imatinib mesylate<br> <br> * Other names: Gleevec/Glivec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete and partial response and relapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Marrow Analysis |  |  | 
| Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase |  |  | 
| Disease-Related Symptoms and Signs |  |  | 
| Organ Involvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypereosinophilic syndrome, Imatinib
A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support

Study Overview
=================
Brief Summary
-----------------
Objective:to Study the clinical outcomes of hepatectomy with Nutritional risk After Preoperative Nutritional Support. Study design: 1.Prospective，randomized, controlled clinical study;2.Patients: The subjects were from Peking Union Medical College Hospital (PUMCH). Study arrangement: The collection of patients with selected standard Preoperative evaluation included nutritional status,liver function and tumor characteristics The experimental group received Preoperative Nutritional Support for 4 days,the control group got nothing Both groups received conventional therapy after operation The comparation of the clinical outcomes in both groups

Official Title
-----------------
A Clinical Study to Evaluate the Clinical Outcomes of Hepatectomy With Nutritional Risk After Preoperative Nutritional Support

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Procedure: nutritional support before operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of hepatocellular carcinoma (HCC) was made before operation Nutritional Risk Screening 2002(NRS-2002) was Greater or equal 3 points with in 24 hours after admission

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: nutritional support before operation|nutritional support before operation for more than 4 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | postoperative complications especially infectious complications | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization expenses and length of stay | hospitalization expenses:nutrition-related expenses length of stay:from the date of the operation to the date of Discharge | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver Tumor
Children and Adolescent Registry for Diabetes Study in Jiangxi

Study Overview
=================
Brief Summary
-----------------
This study aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

Detailed Description
-----------------
Background:With the development of economy and the improvement of people's living standards, the incidence of childhood diabetes is rapidly increasing.The multicenter, prospective,retrospectively in children and adolescents registry for diabetes in jiangxi aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life. Methods:The province's multi-center, prospective、retrospective study, the number of cases planned to be included in 300 cases.The inclusion criteria:A diagnosis of diabetes;reported for diabetes by parents and patients or by doctors and medical records to prove all of the patients;0-30 years old, gender not limited;voluntary participation and sign a consent form.Exclusion criteria :At the same time, other test drugs or are other clinical trials;Due to other reasons, the researchers think that the person doesn't fit into the group;Diabetes during pregnancy;Besides diabetes diagnosis of tumor, cardiovascular disease and other interfere with the results of the study of disease.

Official Title
-----------------
Children and Adolescent Registry for Diabetes Study in Jiangxi

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 1 days to 30 years who were diagnosed with diabetes according to the World Health Organization criteria; Gender is not limited. Exclusion Criteria: Gestational diabetes mellitus; Patients with malignant tumor,cardiovascular disease and other interference with the results of the study of the disease. Patients are participating in any other clinical studies;

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 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 |
| --- | --- | --- |
| HbA1C | HbA1c <7% | About 3 months after the visit | 
| blood pressure | systolic blood pressure <130mm Hg, diastolic blood pressure<80mmHg | About 3 months after the visit | 
| TC | TC<5.2mmol/L | About 3 months after the visit | 
| TG | TG<1.7mmol/L | About 3 months after the visit | 
| LDL-C | LDL-C<2.6mmol/L | About 3 months after the visit | 
| HDL-C | HDL-C>1.0mmol/L | About 3 months after the visit |
Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.

Detailed Description
-----------------
Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.

Official Title
-----------------
Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer in Reducing Early Cardiac Injury: a Phase II Prospective Study

Conditions
-----------------
Breast Cancer, Cardiac Event

Intervention / Treatment
-----------------
* Device: Deep inspiration breath-hold technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary left-sided breast cancer post surgery Planning for adjuvant breast/chest wall +-RNI Exclusion Criteria: History of cardiovascular disease Previous chest radiation Bilateral breast cancers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiotherapy at free-breathing<br>breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at free-breathing | |
| Radiotherapy at deep inspiration breath-hold<br>breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at deep inspiration breath-hold | Device: Deep inspiration breath-hold technique<br>* Selective application of deep inspiration breath-hold technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinical or subclinical cardiac injury | predefined cardiac events | two years |
Long Term Administration Study of OPC-12759 Ophthalmic Suspension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Official Title
-----------------
Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: OPC-12759 Ophthalmic suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out patient; Ocular discomfort severity is moderate to severe; Corneal-conjunctival damage is moderate to severe; Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less; Best corrected visual acuity of 0.2 or better in both eyes. Exclusion Criteria: Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca; Ocular hypertention patient or glaucoma patient with ophthalmic solution; Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study; Anticipated use of contact lens during the study; Patient with punctal plug; Any history of ocular surgery within 12 months; Female patients who are pregnant, possibly pregnant or breast feeding; Known hypersensitivity to any component of the study drug or procedual medications; Receipt of any investigational product within 4 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: OPC-12759 Ophthalmic suspension<br>Instillation, 4times/day | Drug: OPC-12759 Ophthalmic suspension<br>* Instillation,4times/day,for 52weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score | FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test). | Baseline, Week2, Week4, Week28, Week52 |
User Experience of a Mobile Application

Study Overview
=================
Brief Summary
-----------------
To evaluate the user experience of the use of the different modules / trackers in the mobile application in recording primary caregiver reported outcomes of infants

Detailed Description
-----------------
Using a questionnaire to collect overall user experience, frequency of usage, feedback of each module in the mobile application

Official Title
-----------------
Evaluating the User Experience of a Mobile Application in Recording Primary Caregiver Reported Outcomes of Infants

Conditions
-----------------
User Experience of Mobile Application

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants from birth to ≤ 12 months of age. Primary caregiver should have access to the internet and a smartphone or tablet to access the mobile application. Primary caregiver should be able to comprehend the content in the mobile application and complete the questionnaires in English. Primary caregiver takes care of the infant more than 50% of the time Exclusion Criteria: Incapability of the primary caregiver to access the mobile application using a smartphone or tablet with internet

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Caregiver and infant pair<br>Primary Caregiver and infant who is less than or equal to 12 months old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall User experience | Using a questionnaire to assess primary caregiver reported overall experience on a 5-point scale (Very Poor to Very Good) of the mobile application | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User experience (ease of use) - Primary Caregiver | Using a questionnaire to assess primary caregiver ease of use (Very Poor to Very Good or Did Not Use) of use of different modules/trackers in the mobile application | Day 14 | 
| User experience (frequency of use) - Primary Caregiver | Using a questionnaire to assess primary caregiver frequency (Rarely to Always) of use of different modules/trackers in the mobile application | Day 14 | 
| User experience (usefulness) - Healthcare Professionals (HCP) | Using a questionnaire to assess HCP reported usefulness (not useful at all to very useful) of the data generation by the mobile application | Day 14 | 
| User experience (relevance) - Healthcare Professionals (HCP) | Using a questionnaire to assess HCP reported relevance (not relevant at all to very relevant) of the data generation by the mobile application | Day 14 |