linjc16/ctgov huggingface dataset:
Long Term Follow-Up of Burn Injuries

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the psychological effects of burn injuries as experienced by patients.

Detailed Description
-----------------
We are interested in determining how people adjust to burn injuries as a way of facilitating optimal recovery. This is done by conducting several questionnaires at the time of the discharge in the hospital, and later follow up with the patients up to two years.

Official Title
-----------------
Long Term Follow-Up of Burn Injuries

Conditions
-----------------
Burn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with more than a 30% total surface area burn English speaking Exclusion Criteria: Patients with less than a 30% total surface area burn Non English speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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
-----------------
Long Term Follow-Up
Early Vision Screening in High-risk Children

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of early vision screening with automated photorefraction device in high risk children

Detailed Description
-----------------
Pre-term, low-birth-weight, and development delay are well-known risk factors related to higher incidence of high refractive error and strabismus, which can potentially lead to amblyopia and is regarded as amblyopia risk factors. This project is a cross-sectional controlled study. Our study includes high-risk group and normal group. High-risk group includes children with birth history of pre-term, low-birth-weight and the diagnosis of development delay in FEMH. Normal group enrolled age-matched children without those risk factors. Vision screening by FDA-approved photorefraction device as well as comprehensive ophthalmic exams for definite diagnosis will be performed on the high-risk group and the normal group.

Official Title
-----------------
Early Vision Screening With Automated Photorefraction in Pre-term, Low-birth- Weight and Development-delay Children in Far-Eastern Memorial Hospital, Taiwan

Conditions
-----------------
Amblyopia, Child

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk group: children with gestational age less than 36weeks, birth weight less than 2500g and children diagnosed as develop delay Normal group: children with normal birth history and normal development Exclusion Criteria: Children with known ophthalmic diseases Children with congenital systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 2 Years

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 |
| --- | --- |
| high-risk group<br>children with birth history of pre-term, low birth weight children with develop delay | |
| normal group<br>children with normal birth history and normal development | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive predictive value of vision screening | positive predictive value | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odds ratio of having amblyopia risk factors | Odds ratio | one year |
Safety Study of Human Milk Oligosaccharides in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).

Official Title
-----------------
Phase 1 Safety Study of Human Milk Oligosaccharide Concentrate PBCLN-003 in Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: PBCLN-003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) between 18.5 and 24.9 kg/m2 Age between 18 and 50 years old No diagnosed medical conditions No significant change to diet in the 2 weeks prior to enrollment Agreement to use contraception for female subjects Exclusion Criteria: Lactose intolerance Pregnancy Lactation Enrollment in another clinical study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days<br> | Drug: PBCLN-003<br>* Human Milk Oligosaccharide Concentrate<br>|
| Experimental: PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days<br> | Drug: PBCLN-003<br>* Human Milk Oligosaccharide Concentrate<br>|
| Experimental: PBCLN-003, 9 g daily in 3 divided oral doses for 7 days<br> | Drug: PBCLN-003<br>* Human Milk Oligosaccharide Concentrate<br>|
| Experimental: PBCLN-003, 18 g daily in 3 divided oral doses for 7 days<br> | Drug: PBCLN-003<br>* Human Milk Oligosaccharide Concentrate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Adverse events include those reported by questionnaire or detected as an abnormality on physical examination, laboratory testing (hematology, biochemistry, urinalysis), and 12-lead electrocardiogram. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool, saliva, and vaginal microbiome | 16S ribosomal RNA gene sequencing and shotgun metagenomics will be performed to detect relative abundances of bacteria at the level of 97% operational taxonomic units. Alpha diversity will be measured using the Shannon index. | 28 days | 
| Serum cytokine levels | IL2, IL4, IL5, IL6, IL10, IL12, TNFα, IFNγ, and TGFβ measured by ELISA | 28 days |
Evaluation of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images

Study Overview
=================
Brief Summary
-----------------
cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cASPECTS for scoring ASPECTS Score compared to the sensitivity and specificity levels of human expert.

Official Title
-----------------
An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Device: cASPECTS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 19 years old Brain CT acquired Exclusion Criteria: Patients with ischemic stroke in posterior circulation Poor or incomplete brain CT image quality

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Ischemic stroke positive<br>Patients diagnosed with acute ischemic stroke after a brain CT scan | Device: cASPECTS<br>* Clinical decision support system for scoring ASPECTS score<br>|
| Ischemic stroke negative with other brain disease<br>Patients who has not been diagnosed with acute ischemic stroke after a brain CT scan, but has been diagnosed with other brain diseases. | Device: cASPECTS<br>* Clinical decision support system for scoring ASPECTS score<br>|
| Ischemic stroke negative and no brain disease<br>Patients who has not been diagnosed with acute ischemic stroke after a brain CT scan and has not been diagnosed with other brain diseases. | Device: cASPECTS<br>* Clinical decision support system for scoring ASPECTS score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between ASPECTS scores in golden standard and in cASPECTS | Mean difference between ASPECTS scores calculated by human experts and ASPECTS scores calculated by cASPECTS | Within 4 weeks after collecting data |
Placental Volume Analysis During Pregnanay

Study Overview
=================
Brief Summary
-----------------
Placenta grows with advancing gestational age amonitoring of placental growth is important in pregnancy evaluation

Detailed Description
-----------------
assessment of placental size is very important in evaluating the pregnancy Placenta is one of the most important organs that control pregnancy outcome

Official Title
-----------------
Placental Volume Analysis and Monitoring and Vascularity Assessment

Conditions
-----------------
Placenta Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant ladies between 20 - 40 years old ladies pregnant from 14 weeks till term Exclusion Criteria: pregnant ladies in first trimester

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasonography|Ultrasonography to assess placental volume|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the volume of every placenta at the given time of scan | volume of placenta that will increase with time | within 2 months |
Samsung Medical Center-Lymphoma Cohort Study-II

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.

Detailed Description
-----------------
Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess factors which may affect the treatment outcome and the risk of treatment-related morbidity. 1.Biologic factors associated with the aggressiveness of lymphoma molecular markers in serum, cytogenetic markers 2.Factors associated with the risk of treatment-related morbidity comorbidity, nutrition status, performance status, quality of life at diagnosis

Official Title
-----------------
Prospective Observation Cohort Study of Malignant Lymphoma Patients

Conditions
-----------------
Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as lymphoma Over 19 years old Patients who agreed the enrollment of study Informed consent for sampling Exclusion Criteria: •Patients who do not want to join the study

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Lymphoma<br>Lymphoma patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Disease and non-disease-related mortality including treatment-related death | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | Response to primary and salvage treatment Revised response criteria for lymphoma should be used (J Clin Oncol 2007;25(5):579-586). Complete response: disappearance of all evidence of disease Partial response: regression of measurable disease and no new sites Stable disease: failure to attain CR/PR or PD Relapsed disease or Progressive disease: Any new lesion or increase by >=50% of previously involved sites from nadir | 1 year | 
| Rate of occurrence of toxicity | Infectious complications and other toxicities | 2 years from the start of the 1st therapy | 
| Quality of life | Change of quality of life | 5 years | 
| Biomarker development | Biomarkers associated with treatment outcome | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Prognosis, Biomarker, Quality of life
A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.

Official Title
-----------------
An Exploratory,Open-label,and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).

Conditions
-----------------
Relapsed or Refractory B-cell Malignancy(NHL/ALL)

Intervention / Treatment
-----------------
* Biological: ET-02


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients volunteer to participate in the study and sign the ICF; Male or female aged≥18 years old； Patient with relapsed or refractory CD19 positive B-ALL orNHL，as evidenced by 2 or more lines of prior therapy ; Estimated life expectancy≥12 weeks ; ECOG performance status ≤1; Adequate organ function. Exclusion Criteria: Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy； History of central nervous system (CNS) involvement by malignancy； Women who are pregnant or breastfeeding； Any situations that may increase the risk of patients or interfere with the results of study，which judged by investigator.

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: Four escalating dose-levels of ET-02 will be evaluated using a 3+3 design.<br> | Biological: ET-02<br>* A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Adverse events assessed according to NCI-CTCAE v5.0 criteria | up to 2 years after lymphodepleting chemotherapy |
A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.

Official Title
-----------------
A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Knee Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A combined deformity of <30 degrees = group 1 A combined deformity of >30 degrees = group 2 Patient is willing to consent to participate in the study Patient is available for follow-up through at least 2 years but preferably 5 years Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk Patients who are fluent in English and are able to understand their role in a clinical trial Exclusion Criteria: Active, local infection or systemic infection Fibromyalgia patients Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combined Deformity <30 degrees<br> | Device: Knee Implant<br>* Total knee replacement with Genesis II posterior stabilized knee<br>|
| Combined Deformity >30 degrees<br> | Device: Knee Implant<br>* Total knee replacement with Genesis II posterior stabilized knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness and Safety | Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Clinical Rating |  | Pre-op, 6 months, 1 year, 2 years, 5 years | 
| Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) |  | Pre-op, 6 months, 1 year, 2 years, 5 years |
Virtual Reality Education Module in Reducing Anxiety and Increasing Knowledge in Patients With Prostate Cancer Undergoing Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
This pilot clinical trial studies a virtual reality education module in reducing anxiety and increasing knowledge in patients with prostate cancer undergoing radiation therapy. A virtual reality education module may be useful in helping patients understand what they can expect to happen during their radiation treatments and help reduce stress relating to the radiation treatments.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine if a virtual reality education module for prostate cancer patients is effective in increasing patient comprehension and decreasing patient anxiety related to radiation treatments. SECONDARY OBJECTIVES: I. This pilot study could have implications for a broader patient base undergoing radiation therapy.

Official Title
-----------------
A Pilot Study to Determine if the Use of a Virtual Reality Education Module Reduces Anxiety and Increases Comprehension in Patients Receiving Radiation Therapy

Conditions
-----------------
Prostate

Intervention / Treatment
-----------------
* Other: Educational Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking males capable of giving informed consent Must be able to read English language Receiving pre-treatment cone beam and volumetric modulated arc therapy (VMAT) for prostate cancer on the A or B treatment machines at the Bodine Center Must be able to walk two city blocks Must not have any auditory or visual deficits Exclusion Criteria: If inclusion criteria are not met Previous radiation therapy treatment Employment in radiation oncology
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (virtual reality education module)<br>After undergoing a previously planned CT simulation scan, patients complete a virtual reality education module to learn more about radiation therapy for prostate cancer. Patients also complete questionnaires before and after the module. | Other: Educational Intervention<br>* Complete virtual reality education module<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation for difference in questionnaire response from pre-education to post-education | A one-sided one-sample t-test will be used to analyze the average change score (pre - post) for each questionnaire. | Through study completion, an average of 2 years |