linjc16/ctgov huggingface dataset:
Molecular Typing of Community-acquired Pneumonia Based on Multiple-omic Data Analysis

Study Overview
=================
Brief Summary
-----------------
Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity, mortality and health care burden globally. Typing methods for discriminating different clinical conditions of the same disease are essential to a better management of CAP. Traditional typing systems based separately on clinical manifestations (such as PSI and CURB-65), pathogens(bacterial types, virulence, drug resistance, etc) or host immune state (immunocompetent, immunocompromised or immunodeficiency). Thus, they are barely able to represent the real disease status nor to precisely predict the mortality. As the development of multi-omic technologies, the relatedness of different phenotypes at a molecular level have revolutionized our ability to differentiate among patients. Our study is aimed at establishing a novel molecular typing method of CAP. Multi-omic (including genomics, transcriptomes, and metabolisms) data obtained from enrolled CAP patients and isolated pathogens would be integrated analyzed and interpreted. Tthe investigators believe that an appropriate molecular typing method would lead to revolutionary changes in current arrangements of CAP.

Official Title
-----------------
Molecular Typing of Adult Community-acquired Pneumonia in China

Conditions
-----------------
Respiratory Infections, Genetic Disorder, Community-Acquired Infections, Host-Pathogen Interactions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult (aged > 16 years) diagnosed as community-acquired pneumonia Exclusion Criteria: being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy history of long-term nursing home stays history of recently hospitalized (<90 days)

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| community-acquired pneumonia<br>all adult patients (aged > 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP will be enrolled | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality | all-cause death in 30 days after the onset of CAP | 30 days after the onset of CAP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | nonfatal complications including critical organic or systematic dysfunction | 30 days after the onset of CAP |
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression, and quality of life measures for the subject and caregiver will be assessed using validated scales.

Conditions
-----------------
Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
-----------------
* Drug: SPN-810
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication. Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale. Exclusion Criteria: Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified. Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis. Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose SPN-810<br>Subjects will be treated with low dose of SPN-810 | Drug: SPN-810<br> <br> |
| Experimental: High dose SPN-810<br>Subjects will be treated with high dose of SPN-810 | Drug: SPN-810<br> <br> |
| Placebo Comparator: Placebo<br>Subjects will be treated with a Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of impulsive aggression behaviors per 7 days over a period of 7 weeks. | The frequency of impulsive aggression behaviors will be assessed using an impulsive aggression diary, a newly developed and validated electronic observer reported outcome measurement tool. | 7 weeks |
An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast

Study Overview
=================
Brief Summary
-----------------
The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.

Conditions
-----------------
Breast Enhancement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject treated with NASHA-gel in the breasts in study 31GB0607 signed informed consent Exclusion Criteria: no exclusion criteria in this study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 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 |
| --- | --- |
| Breast enhancement<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI |  | 4 years | 
| Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography. |  | 4 years | 
| Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos |  | 4 years | 
| Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s) |  | 4 years | 
| Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography. |  | 6 years | 
| Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos |  | 6 years | 
| Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s) |  | 6 years |
Evaluation of Drainable Volume Measurements During VA-ELS

Study Overview
=================
Brief Summary
-----------------
Veno-arterial extracorporeal life support (VA-ELS) is used to support patients with acute cardiac failure. In that context, sufficient drainable venous volume is crucial for reliable and adequate support. To date, no reliable measurement method exists to monitor drainable volume adequately. Furthermore, it is still unresolved how to diagnose adequate cardiac recovery. Previous (pre)clinical studies showed that the calculation of the dynamic filling index may provide a valuable parameter to monitor the drainable volume in patients supported by VAELS. In addition, a case report showed that measurement of the dynamic filling index could successfully be used to estimate cardiac recovery in a single patient supported by VA-ELS in the ICU. This study will assess the dynamic filling index as a representation for drainable volume and cardiac recovery using standard recorded perfusion data in patients supported by VA-ELS

Official Title
-----------------
Evaluation of Drainable Volume Measurements and Their Usage for Predicting Optimal Cardiac Support in Patients Supported by Veno-arterial Extracorporeal Life Support

Conditions
-----------------
Heart Arrest

Intervention / Treatment
-----------------
* Device: VA-ELS pump speed variations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent of the relative(s) or legal representative(s) Supported by VA-ELS at the ICU >18 years Exclusion Criteria: - Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pump speed variation<br>VA-ELS pump speed variations | Device: VA-ELS pump speed variations<br>* Small variations in the pump speed of the veno-arterial extracorporeal life support (VA-ELS) pump<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEE results |  | participants will be followed for the duration of the VA-ELS support, an expected average of 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal Membrane Oxygenation, Cardiopulmonary Bypass
A Pilot Study to Explore the Role of Gut Flora in Elevated Cholesterol

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Elevated Cholesterol.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Elevated Cholesterol.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Elevated Cholesterol

Conditions
-----------------
Cholesterol, Elevated, Elevated Cholesterol

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients of any age (interest is given to children to compare with mothers). LDL>100 Total Cholesterol>200 Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with Elevated Cholesterol | Other: No Intervention<br>* There is no intervention for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year |
Cancer Development In Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The investigators will determine the cancer risk in organ transplant recipients compared to the general population with the help of statistical analysis. Secondly the investigators will try to characterize the different cancer types.

Detailed Description
-----------------
This cohort analyses will focus on incident and recurrent cases of development of non-skin cancer over time. We will consider time to first formation of non-skin solid cancer after solid organ transplantation as well as the cumulative number of non-skin solid cancer formation over time. Both aspects are equally important and will be reflected in the analytic methods of this study. Theses analyses will be restricted to the most prevalent transplantation types of heart, kidney, liver, and lung.

Official Title
-----------------
Cancer Development In Organ Transplant Recipients

Conditions
-----------------
Heart Cancer, Kidney Cancer, Lung Cancer, Pancreas Cancer, Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We will select all patients within the STCS based on the date of the first solid organ transplantation. Patients with multiple organ transplantations will be included as well. Patients contribute to the study observation time until death or end of follow-up due to other reasons. Exclusion Criteria: We will exclude patients with non-solid organ transplantation (e.g. hematopoietic stem cell transplantation), because the detailing of information in the STCS is insufficient to allow for detailed analysis of cancer development and control of relevant confounders. We will exclude
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Organ transplant recipients<br>Follow-ups in regular intervals following the organ transplant date. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of solid cancers | Number of solid cancers | Ten Year followup |
RESECTED LYMPH NODES AND SURVIVAL OF PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA: AN OBSERVATIONAL STUDY

Study Overview
=================
Brief Summary
-----------------
To clarify the effect of the number of lymph node dissection and the number of stations on survival

Official Title
-----------------
Increasing the Number of Resected Lymph Nodes Improves Overall Survival of Patients With Esophageal Squamous Cell Carcinoma With Positive Lymph Nodes: a Retrospective Analysis of 1656 Cases at a Single Cancer Center

Conditions
-----------------
the Records of Esophageal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Since the data were collected retrospectively, there were no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18-85; Histologically confirmed primary thoracic esophageal squamous cell carcinoma, Staging PT1-4A, N0-3, M0 AJCC eighth edition; Excluding lymph node dissection < 15,(meeting the guideline criteria) Exclusion Criteria: Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux Patients with distant metastasis confirmed by imaging; Patients with obvious surgical contraindications.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| N0A Group<br>patients with negative lymph nodes and resected lymph nodes less than 15 | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|
| N0B Group<br>patients with negative lymph nodes and resected lymph nodes no less than 15 | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|
| N+A Group<br>patients with positive lymph nodes and resected lymph nodes less than 15 | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|
| N+B Group<br>patients with positive lymph nodes and resected lymph nodes no less than 15 | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of lymph nodes | Surgical data were retrospectively collected | 2010.1.1-2017.12.30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lympha nodes, esophageal cancer
Evaluation of the Coping Long Term With Active Suicide Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior.

Official Title
-----------------
Evaluation of the Coping Long Term With Active Suicide Program

Conditions
-----------------
Suicide

Intervention / Treatment
-----------------
* Behavioral: CLASP
* Behavioral: SAFE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current patient at Butler Hospital Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS Age > 18 years Have a reliable telephone Ability to speak, read, and understand English well to complete the procedures of the study Exclusion Criteria: Current psychotic symptoms severe enough to impair study participation Participation in a treatment program with established efficacy in preventing suicidal behavior Cognitive impairment which would interfere with adequate participation in the project (MMSE< 20). 4. Currently in state custody or pending legal action 5. Already enrolled current or previous CLASP trial

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SAFE<br>Safety Assessment and Follow-up Evaluation Protocol | Behavioral: SAFE<br> <br> |
| Experimental: CLASP<br>Coping Long Term with Active Suicide Program Protocol | Behavioral: CLASP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite composed of the number of participants with either a suicide attempt or death by suicide | As assessed by both the Columbia Suicide Severity Rating Scale and record review | 52 weeks following discharge from hospital |