linjc16/ctgov huggingface dataset:
Standard PET/CT vs. Digital PET/CT

Study Overview
=================
Brief Summary
-----------------
The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.

Detailed Description
-----------------
There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.

Official Title
-----------------
Comparison of Standard PET/CT vs. Digital PET/CT

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Digital PET/CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is ≥ 18 years old at the time of the scan Patient provides written informed consent Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT Patient is capable of complying with study procedures Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT) Exclusion Criteria: Patient is pregnant or nursing

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 |
| --- | --- |
| Other: Patients undergoing digital PET/CT<br>Single arm prospective study of paired imaging studies. Patients who are referred to Nuclear Medicine and are scheduled to undergo imaging on the standard PET/CT will also have imaging performed on the digital PET/CT. | Diagnostic Test: Digital PET/CT scan<br>* The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Image Quality | Diagnostic image quality will be determined using a 5-point Likert Scale that reads: 5 - Diagnostic: Excellent diagnostic image quality; 4 - Diagnostic: Good diagnostic image quality; 3 - Diagnostic: Acceptable diagnostic image quality; 2 - Sub-optimal diagnostic: image quality with limited additional clinical information; 1 - Non-diagnostic: non-diagnostic image quality | an expected average of 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, digital PET/CT
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection

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

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with C. diff.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection

Conditions
-----------------
Microbiome, Clostridium Difficile, Clostridium Difficile Infection, CDI

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to sign informed consent Diagnosis of C. difficile infection Age of 18 and older Exclusion Criteria: Refusal by patient to sign informed consent form Treatment with antibiotics 2 weeks prior to screening Treatment with probiotics 6 weeks prior to screening 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 of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

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 |
| --- | --- |
| Patients with CDI<br>Patients who are infected with C. diff | 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 with C. diff infection | 1 year |
Functional Magnetic Resonance Imaging (fMRI) of Brain in ICU Survivors With Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
Long-term cognitive dysfunction greatly influences patient's quality of life after critical illness. However,its neurophysiological basis remains unknown.This is a one year fMRI study conducted at the Jiangyin people's Hospital. This study utilize resting-state functional magnetic resonance imaging(fMRI) to investigate the regional alterations in survivors with cognitive impairment.Further, the investigators hypothesize that these regional changes in fMRI activity are predictive of cognitive impairment.

Detailed Description
-----------------
Critically ill patients who had hospitalized in ICU at least 2 days and who consented to participate will take the examination of brain fMRI and cognitive assessment before ICU discharge. Individuals of healthy control group are recruited from the community will be made to match them on age,sex and education to individuals recruited for groups of ICU Survivors.Those healthy people will also take the examination of brain fMRI and cognitive assessment.

Official Title
-----------------
Mechanism of Cognitive Impairment in ICU Survivors :a Study Using Resting-stage fMRI Technique

Conditions
-----------------
Cognitive Impairment, Functional Magnetic Resonance Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU Survivors Men and women older than 18;Hospitalized in the ICU more than 2 days and Ready to discharge from ICU; Exclusion Criteria: MRI incompatibility; history of neurological disease;poor visual or auditory acuity;Severe brain injury;malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| ICU Survivors<br>Patients with high risk of cognitive impairment who discharge from ICU | |
| Healthy Control<br>The control group have to be medically and cognitively healthy(MMSE ≥ 28). These individuals are recruited from the community and all attempts will be made to match them on age,sex and education to individuals recruited for groups of ICU Survivors. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of cognitive impairment | cognitive impairment assessed with help of MMSE(Mini-mental State Examination).The MMSE has 5 scaled scores; the scores are weighted sums of the questions in each section. The 5 sections and their range of score are listed below:Orientation 0-10;Registration 0-3;Attention and calculation 0-5;Recall 0-3;Language 0-9.Total score range from 0-30. Lower scores = more disability, higher scores = less disability. | 1 day before discharge |
A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).

Official Title
-----------------
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of the Combination of Pegylated Interferon Alfa Plus NM283 (Valopicitabine) in Treatment-Naive Patients With Chronic Hepatitis C

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: valopicitabine
* Drug: Pegylated Interferon Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection) Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with HIV or Hepatitis B Other protocol-defined exclusion criteria may apply.

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valopicitabine|nan|
|Drug: Pegylated Interferon Alfa|nan|

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
-----------------
Genotype-1, Chronic Hepatitis C
Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

Study Overview
=================
Brief Summary
-----------------
The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.

Detailed Description
-----------------
Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs. early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.

Official Title
-----------------
Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

Conditions
-----------------
Glioblastoma, Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histology: Glioblastoma (grade 4 astrocytoma) Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression. Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties. Methylation status of tumor available in medical record. Able to provide written informed consent. Exclusion Criteria: Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC). Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest. Special subjects such as minors, mentally disabled persons, or prisoners.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 82 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 |
| --- | --- |
| GBM patients undergoing MRI<br>GBM patients undergoing standard-of-care post-operative combination chemoRT and clinically indicated MRI including standard DSC-PWI for follow-up. | Procedure: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A novel high resolution DSC-PWI imaging method | A novel high resolution DSC-PWI method will be compared to the standard DSC-PWI method to determine whether novel method improves image quality in tumor regions. | 2 years |
Informed Consents for Withholding/Withdrawing Life Support in Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
End-of- life care is a major issue in medical ethics with life support technology progress. Intensive care may prolong the dying process in patients who have been unresponsive to the treatment already provided. Withholding or withdrawing of life support (WLS) care was introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult and affected by several factors including not only disease severity but also ethics, religion, culture, and legal background. In western countries, advance directives had an important role to WLS for dying patients and honor patient autonomy. However, the illegality of advance directives in Korea and Korean culture under Confucianism, requiring children to do the best to treat their parents in the name of filial piety make physicians and family members difficult to WLS in terminally ill patients. Additionally, WLS in intensive care unit had been usually decided without official documentation before the final legal decision by Supreme Court in Korea. Scanty information exists about end-of-life practices because informed consents of WLS were taken after the legal decision. Thus, we aimed to investigate the current status of informed consent at the time of decision to WLS and difference between WLS group and non-WLS group in Korea.

Conditions
-----------------
Death Occurring in Intensive Care Units

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU) at Severance Hospital, Yonsei University Health System, in Seoul, Korea. Exclusion Criteria: Patients diagnosed with brain death

Ages Eligible for Study
-----------------
Maximum Age: 92 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 |
| --- | --- |
| WLS group<br>patients with informed consents for withholding/withdrawing life support | |
| non-WLS group<br>patients without informed consents for withholding/withdrawing life support | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signing of informed consents for withholding/withdrawing life support | Primary outcome was existence of informed consents for withholding/withdrawing life support. Data from informed consents for WLS included main family members who signed the WLS and type of the life support modalities withheld or withdrawn. | 1 year after ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Informed consents, Withholding/withdrawing life support (WLS), Intensive care unit (ICU)
Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. To test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the investigators will measure parental strictness, parental attachment, and parental monitoring), parent ability to cope with stress, parent comfort with the parenting role, parent and child level of depression and parent perception of financial resources. The investigators will also measure parent and child's perception of the child's underlying temperament and parent-child conflict. The investigators will correlate these findings with both parent and child subjective measures of adherence to therapy. The investigators will also obtain objective measures of therapy adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number of missed outpatient appointments. These measures will be correlated with our other findings.

Official Title
-----------------
Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetics Aged 9 - 18 years Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum 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 |
| --- | --- |
| Parents<br>Parents or caregivers of type 1 diabetics | Other: Questionnaires<br>* Parenting and behavioral questionnaires<br>|
| Child<br>Type 1 diabetics | Other: Questionnaires<br>* Parenting and behavioral questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting styles |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child behavior traits |  | Baseline | 
| Adherence to therapy |  | Baseline |
Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation

Study Overview
=================
Brief Summary
-----------------
This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.

Official Title
-----------------
Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.

Conditions
-----------------
Acute Decompensation in Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation. Age 18-70 years Valid consent Exclusion Criteria: HepatoCellular Carcinoma Admitted and survival less than 48 hrs Pregnant Acute Liver Failure Post transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Cirrhotics with no previous decompensation<br> | |
| Cirrhotics with previous one or more than one decompensation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous recovery or liver transplant or death in both groups |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause of acute decompensation |  | 3 months | 
| Severity and duration of prior as well as present decompensation |  | 3 months | 
| Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups. |  | 3 months | 
| Causes of death in both groups |  | 3 months | 
| Profile of patient undergone transplant in both groups |  | 3 months | 
| Sepsis in both groups |  | 3 months | 
| Systemic Inflammatory Response Syndrome in both groups |  | 3 months | 
| Improvement in severity assessment Indices Child Pugh Turcotte in both groups. |  | 3 months | 
| Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups |  | 3 months | 
| Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups |  | 3 months | 
| Improvement in severity assessment Indices CLIF score in both groups |  | 3 months |