linjc16/ctgov huggingface dataset:
Vaccine Therapy for Patients With Stage III Melanoma

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Official Title
-----------------
Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: CancerVax vaccine (CANVAXIN)


Participation Criteria
=================
Eligibility Criteria
-----------------
Must have Stage III melanoma Must have had all clinically-detectable disease surgically removed Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy) Cannot have HIV or Hepatitis A, B, or C

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CancerVax vaccine (CANVAXIN)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Characteristics of Non Diabetic Hyperglycemic Inpatients

Study Overview
=================
Brief Summary
-----------------
Retrospective nested non-matched case control study comparing patients by glycemic status

Detailed Description
-----------------
This retrospective nested non-matched case control study compared patients directly admitted to the General Medicine Wards, not transferred from ICU with hyperglycemia on admission but no previous diagnosis of diabetes diabetic hyperglycemic patients non hyperglycemic non diabetic patients from the same nested population. The investigators' hypothesis is that the clinical characteristics and endpoints of the non diabetic hyperglycemics should be similar to the diabetic population and different from the non diabetic non hyperglycemic population.

Official Title
-----------------
Hyperglycemic Non Diabetic (HND) Hospital Patients: Are They Different From Diabetic Hyperglycemic and Non-Hyperglycemic Non-Diabetic(NHND) Patients?

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to John H. Stroger Jr. Hospital Admitted to Internal Medicine Service from March-April 2006 and in October 2007 Exclusion Criteria: Transfer from any intensive care unit (medical or surgical)

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 |
| --- | --- |
| Hyperglycemic without previous DM diagnosis<br>Patients with hyperglycemia, without previous diagnosis of diabetes | |
| Previous diagnosis of DM<br>Patients that have previous diagnosis of Diabetes Mellitus | |
| No previous DM diagnosis and no hyperglycemia<br>Patient with NO previous diagnosis of diabetes, and no hyperglycemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Hospital stay measured in days | Measured 24 hours after patient is discharged. From day 1 of admission until day of discharge | 
| Inpatient Mortality | Mortality measured in number of events | From day 1 of admission until day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of SIRS on admission | Number of SIRS | Measures obtained 24 hours after patient is discharged. Clinical data obtained on day 1 of admission | 
| Frequency of inpatient infection | Measured in number of events | From day 1 of admission until day of discharge | 
| Rate of use of intravenous glucose drip | Rate of use | From day 1 of admission until day of discharge | 
| Frequency of steroid use | Frequency of use | From day 1 of admission until day of discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Inpatient, Hospital, Hyperglycemia
Testing of New Method in Sanitizing Breast Pump Equipment in the NICU

Study Overview
=================
Brief Summary
-----------------
This study will evaluate a newly developed device, Q. Basin. The Q. Basin is a multifunctional, single patient use device that can sanitize breast pump parts, bottles, and reusable feeding devices for patients admitted under one year of age. Improving the current sanitation method would provide a quick and efficient sanitation process for breast pump parts. This study will compare the Q. Basin to the current method of steam bag sanitation.

Detailed Description
-----------------
Firstly, 10 participant's breast pump parts are collected, divided, washed, and dried before comparing the two methods of steam sanitation. We will test to compare the safety of the Q. Basin compared to the current method of steam bag sanitation. We will collect participant's breast pump parts and complete surface swab testing for bacteria and mold immediately after sanitation and additionally 24 hours later. Secondly, 20 participant questionnaires will measure satisfaction ratings of participants pumping human milk for hospitalized infants using two different wash, dry and steam sanitation methods. This study design will determine if participant satisfaction improves with breast pump part sanitation using the Q. Basin, compared to the current steam sanitization bag method.

Official Title
-----------------
Testing of New Method in Sanitizing Breast Pump Equipment in the NICU

Conditions
-----------------
Breast Pumping

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers who are pumping human milk for hospitalized infants in the Neonatal Intensive Care Unit. Exclusion Criteria: Mothers under the age of 18 years.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Rate | The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing | Immediately after steam bag sanitation | 
| Safety Rate | The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing | 24 hours later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Rate Questionnaire | The satisfaction rate is measured by participants comparing two different methods of breast pump part sanitation | At the end of 2 cycles (each cycle is 3 hours) of steam bag sanitation |
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
This study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. The identification of unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

Detailed Description
-----------------
Subjects are being asked to participate in a research study that is investigating the way the lung is damaged in a condition called pulmonary fibrosis. These research studies are conducted in the laboratory on a portion of the tissue from the subject's lung biopsy that was performed by a surgeon. The lung biopsy is to be performed for clinical purposes to diagnose the cause of the subject's lung disease. The tissue used for the research study will in no way interfere with the ability of the pathologist to establish a diagnosis. In addition, the results of your breathing tests, chest X-rays and CT scans, and diagnosis made from the lung biopsy (and slides) will be collected. The goal of the study is to gain an understanding of the causes of pulmonary fibrosis and why it gets worse, which may ultimately lead to new therapies for this disease. Once the lung biopsies are obtained, the pathologist will examine the tissue and determine if there is a sufficient amount available to use in the study without compromising their ability to make a diagnosis. If so, the lung biopsy will be divided. One portion will be submitted to the research study and the other processed by the pathologist in the usual manner to make a diagnosis. The decision to use tissue for the research study will be at the complete discretion of the pathologists. The tissue used in the study will be further processed in the laboratory in order to analyze for the presence of genetic markers in the scarred tissue that are not present in normal. The identification of these unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

Official Title
-----------------
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or age or older Diagnosis of pulmonary fibrosis Undergoing open lung biopsy Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
Lung, Fibrosis, Idiopathic, Microarray, Tissue, Biopsy
Investigation on Diagnosis and Treatment of Helicobacter Pylori Infection by Gastroenterologists in Shandong Province

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori can lead to a variety of digestive system diseases.The eradication of Helicobacter pylori plays an importment role for the treatment of gastrointestinal ulcer and prevention of gastric cancer .Compared with other countries and regions in the world, the infection rate of Helicobacter pylori in China can reach more than 50%. The non-standard diagnosis and treatment of Helicobacter pylori greatly reduces its eradication rate and increases its drug resistance.Therefore, it is very important to strengthen the standardization of diagnosis and treatment to improve the eradication rate. The purpose of this study is to investigate the diagnosis and treatment status of Helicobacter pylori among gastroenterologists in general hospitals in Shandong Province.It can help us to understand the actual situation of diagnosis and treatment of Helicobacter pylori in hospitals at all levels, and to provide targeted diagnosis and treatment training for doctors.

Official Title
-----------------
Investigation on Diagnosis and Treatment of Helicobacter Pylori Infection by Gastroenterologists in Shandong Province

Conditions
-----------------
Helicobacter Pylori Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the gastroenterologists in secondary and tertiary general hospitals of Shandong province Exclusion Criteria: A hospital that does not include gastroenterology Hospitals and gastroenterologists that refuse to sign informed consent
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the results of the questionnaires | the results of each question of the questionnaires | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
questionnaire, Helicobacter Pylori Infection, cross-sectional survey
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

Study Overview
=================
Brief Summary
-----------------
The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake. The primary outcome will be differences in nutrition intake between the groups. Secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea & vomiting. The study will include 40 patients at Aarhus University Hospital, Denmark.

Official Title
-----------------
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

Conditions
-----------------
Malnutrition, Liver Diseases, Alcoholic

Intervention / Treatment
-----------------
* Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock)
* Device: Jejunal tube (Nutricia Flocare® Bengmark®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcoholic liver disease nutrition intake less than 75% of needed intake Signed informed consent form Exclusion Criteria: Hepatic encephalopathy, grade 3 - 4 Anatomic barriers to have a tube placed

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric tube<br>A gastric tube is used | Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock)<br>* Nutricia Flocare® Pur Tube Enlock, Ch. 12<br>|
| Active Comparator: Jejunal tube<br>A jejunal tube is used | Device: Jejunal tube (Nutricia Flocare® Bengmark®)<br>* Nutricia Flocare® Bengmark®, Ch. 10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in nutrition intake | Nutrition intake, protein intake, oral intake versus tube intake | Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in patients reported outcomes | Questionnaires | Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months |
Prevalence and Predictive Factors of Portal Vein Thrombosis in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Several studies have confirmed that patients with cirrhosis possess an imbalance in procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein C. Moreover, in the last two decades there has been an increased recognition that not only bleeding but also thrombosis complicates the clinical course of cirrhosis. The prevalence and pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis without hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess the prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The patients are going to follow up for one year and evaluate at baseline and every 6 months by liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical events will be evaluated at every follow up.

Official Title
-----------------
Prevalence and Predictive Factors of Portal Vein Thrombosis in Patients With Cirrhosis

Conditions
-----------------
Liver Cirrhosis, Portal Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis of any etiology and severity, Aged 18-80 years, Signed Informed Consent. Exclusion Criteria: Hepatocellular carcinoma, other intrahepatic/extrahepatic cancers, documented history of congenital coagulation disorders, pregnancy, human immunodeficiency virus (HIV) positivity, recent (<7 d) transfusion with blood products, use of anticoagulant/antiaggregation drugs in the past 10 d.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Presence of portal vein thrombosis | To estimate the prevalence of PVT evaluated by US in a cohort of patients with liver cirrhosis of any etiology and severity. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cirrhosis Complications | Occurrence of digestive or other bleeding complications; Occurence of other cirrhosis-related complications ( onset or progression of oesophageal varices, ascites or refractory ascites, hepatic encephalopathy, onset of liver cancer, infections, spontaneous bacterial peritonitis, onset of hepato-renal or hepato-pulmonary syndrome) | 1 year | 
| Incidence of portal vein thrombosis | To estimate the incidence of new onset PVT evaluated by US in a cohort of patients with cirrhosis. | 1 year | 
| mortality | Overall mortality in a cohort of patients with cirrhosis without HCC | 1 year |
A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects

Official Title
-----------------
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects

Conditions
-----------------
Healthy, ADME

Intervention / Treatment
-----------------
* Drug: [14C]RIST4271


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males Must provide written informed consent Body mass index (BMI) 18.0 to 30.0 kg/m2 as measured at screening Weight ≥50 kg and ≤100 kg inclusive at screening Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 Evidence of current SARS-CoV-2 infection Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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 |
| --- | --- |
| Experimental: [14C]RIST4721<br>[14C]RIST4721 oral solution | Drug: [14C]RIST4271<br>* [14C]RIST4271 oral solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery of total radioactivity in all excreta: CumAe |  | Day 1 to Day 17 | 
| Mass balance recovery of total radioactivity in all excreta: Cum%Ae |  | Day 1 to Day 17 | 
| Determination of routes and rates of elimination of [14C]RIST4721 by Ae |  | Day 1 to Day 17 | 
| Determination of routes and rates of elimination of [14C]RIST4721 by %Ae |  | Day 1 to Day 17 | 
| Determination of routes and rates of elimination of [14C]RIST4721 by CumAe |  | Day 1 to Day 17 | 
| Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval |  | Day 1 to Day 17 | 
| Collection of plasma, urine and fecal samples for metabolite profiling |  | Day 1 to Day 17 | 
| Collection of plasma, urine and fecal samples for structural identification |  | Day 1 to Day 17 | 
| Collection of plasma, urine and fecal samples for quantification analysis |  | Day 1 to Day 17 |