linjc16/ctgov huggingface dataset:
East-West Hepatocellular Carcinoma Study Group

Study Overview
=================
Brief Summary
-----------------
The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. The aim of this study was to investigate the role of hepatic resection in a large retrospective multicentric cohort of patients resected for HCC regardless of the BCLC indications.

Official Title
-----------------
EAST-WEST HEPATOCELLULAR CARCINOMA STUDY GROUP

Conditions
-----------------
Carcinoma, Hepatocellular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of hepatocellular carcinoma candidate to liver resection as a curative treatment Exclusion Criteria: uncertain diagnosis of hepatocellular carcinoma uncertain follow-up data
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 |
| --- | --- | --- |
| Overall survival of resected patients for HCC | The primary endpoint of the study was the overall survival of patients resected for HCC in any stage of the BCLC classification. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival of resected patients for HCC | The secondary endpoint was the disease-free survival of patients resected for HCC among the BCLC stages. |  |
Schizophrenia for Life - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The elderly demographic is on the rise - and this includes elderly living with schizophrenia. Yet very little is known about their lives, how they cope with their condition and how it develops over time. Research in this patient-group is sparse; overall there seem to be a tendency for elderly patients to manifest fewer psychotic symptoms and experiencing an increase in the psychological quality of life with older age. Opinions are divided on the degree and extent to which this tendency reflects remission and/or recovery in older patients. In order to identify factors associated with a positive outcome we: Investigate the course and the outcomes of the illness over the lifespan, as well as the life course and outcomes. Investigate the current status of mental and physical health, quality of life as well as functional competence of elderly (55+ yr) with schizophrenia. Also the investigators - Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type 1 diabetes (a chronic somatic illness). This study will yield vital insights into how schizophrenia develops over time, isolating factors that determine how well patients fare. The perspective is to advance knowledge of elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the interventions offered to this group.

Official Title
-----------------
Schizophrenia for Life - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initial schizophrenia diagnosis between the ages 18-40 (both incl) in the period 1970-1979 (both incl) Interview study: Residence in Region of Southern Denmark Exclusion Criteria: Interview study: Mental retardation -

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Ageing with schizophrenia | Prognosis measured by use of healthcare system, use of medicine, co-morbidity, mortality, causes of mortality, and socio-demographic data, including highest level of education, years of employment/un-employment, use of health- and welfare services. | up to 45 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Questionnaire | 1 month | 
| Remission | Questionnaire | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, elderly, lifelong, quality of life, register, questionaire
Personality Profiles, Values and Empathy: Differences Between Ovo/Lacto-vegetarians and Vegans

Study Overview
=================
Brief Summary
-----------------
Main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and vegans with respect to their personality profiles, values and empathy through validated questionnaires. Main hypothesis: vegans and ovo / lacto-vegetarians differ in their personality, empathy and values

Official Title
-----------------
Personality Profiles, Values and Empathy: Differences Between Ovo/Lacto-vegetarians and Vegans

Conditions
-----------------
Personality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years of age Exclusion Criteria: Age under 18 and above 80 years of age

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

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

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 |
| --- | --- | --- |
| Big Five SOEP Inventory | Validated Questionnaire | Once at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Validated Questionnaires | WHO Quality of Life Questionnaire Empathizing Scale (Short Form) Portraits Value Questionnaire Likert Scales | Once at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
personality profiles, values, empathy, quality of life, vegetarians, vegans
Study to Obtain Full Thickness Bladder Tissue From Subjects Undergoing Cystectomy Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to obtain bladder tissue specimens from patients otherwise undergoing cystectomy for use in research and training of personnel at Tengion, Inc.

Official Title
-----------------
A Multi-Center Study to Obtain Full Thickness Bladder Tissue Specimen From Subjects Undergoing Cystectomy Surgery

Conditions
-----------------
Cystectomy

Intervention / Treatment
-----------------
* Other: tissue procurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 to 90 years and undergoing a cystectomy surgery Willing and able to give signed informed consent Exclusion Criteria: Known active infection Known colonization with MRSA or VRE Receipt of blood or blood products for transfusion during the previous 3 months

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 |
| --- | --- |
| cystectomy group<br>Subjects undergoing planned cystectomy who agree to provide bladder tissue from removed bladder post cystectomy and/or cystoscopic biopsy tissue prior to cystectomy | Other: tissue procurement<br>* No intervention. Tissue procurement study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of bladder tissue from patients underogoing radical cystectomy |  | ongoing throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystectomy
Longitudinal Interaction Between APOA5 -1131T>C and Overweight Accelerates Arterial Stiffness

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether the longitudinal interaction between APOA5 -1131C variants and overweight could accelerate age-related increases in arterial stiffness and circulating triglycerides in healthy subjects.

Official Title
-----------------
Longitudinal Interaction Between APOA5 -1131T>C and Overweight

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Genetic: rs662799 (APOA5 -1131T>C)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nondiabetic (fasting serum glucose concentration < 126 mg/dL) Nonobese (BMI ≥ 25 kg/m2) Exclusion Criteria: Current and/or past history of cardiovascular disease Diabetes mellitus (fasting glucose levels ≥126 mg/dL) Abnormal liver or renal function Thyroid or pituitary disease Pregnancy or lactation Regular use of any medication

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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 |
| --- | --- |
| Normal weight<br>nondiabetic and nonobese individuals (18.5 kg/m2 ≤ BMI < 25 kg/m2, n=349) | Genetic: rs662799 (APOA5 -1131T>C)<br>* Among the 349 normal-weight individuals, 168 were homozygous (TT) for the T allele, 155 were heterozygous for the C allele (TC) and 26 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism. Among the 154 overweight individuals, 68 were homozygous (TT) for the T allele, 75 were heterozygous for the C allele (TC) and 11 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism.<br>|
| Overweight<br>nondiabetic and nonobese individuals (25 kg/m2 ≤ BMI < 30 kg/m2, n=154) | Genetic: rs662799 (APOA5 -1131T>C)<br>* Among the 349 normal-weight individuals, 168 were homozygous (TT) for the T allele, 155 were heterozygous for the C allele (TC) and 26 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism. Among the 154 overweight individuals, 68 were homozygous (TT) for the T allele, 75 were heterozygous for the C allele (TC) and 11 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial-ankle PWV (baPWV) | cm/s | at baseline | 
| Brachial-ankle PWV (baPWV) | cm/s | 3-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride | mg/dL | at baseline | 
| Triglyceride | mg/dL | 3-year follow-up |
Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Darbepoetin Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin Alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacy |  |  | 
| Assess PROs |  |  | 
| Assess relationship between PROs and hemoglobin concentration |  |  | 
| Assess safety of dose and frequency |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-myeloid malignancies, myeloma, Anemia of Cancer
Delirium in Home-dwelling Old People Receiving Home Nursing Care

Study Overview
=================
Brief Summary
-----------------
Study the prevalence of delirium among old persons with home-nursing care living in the community. By recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function.

Official Title
-----------------
Delirium in Home-dwelling Old People Receiving Home Nursing Care

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Home nursing service at least once a week. Home dwelling (not permanently institutionalised) Age 65 years or more Informed consent by the patient or a close relative (if the patient is unable to give a valid informed consent) Exclusion Criteria: Patient or relative denies inclusion Terminal illness Patients diagnosed with dementia with Lewy bodies (its fluctuating course makes the diagnosis of delirium challenging) Patients with chronic diseases that have needed assistance from the home nursing service before the age of 65. Assistance from the home nursing service is due to addictive substances. Assistance from the home nursing service is due to psychiatric illnesses other than dementia.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Trajectory of cognitive function using the MoCa test | The impact of an episode of delirium upon cognitive function measured by the Montreal Cognitive Assessment every 6th months for two years. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium, Dementia, Physical function
Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. We will perform an observational study where we follow up patients with uncontrolled type 2 Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6 months in the diabetic clinic. Our hypothesis is that glucose control will improve the response to aspirin in those patients.

Official Title
-----------------
Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients

Conditions
-----------------
Diabetes Mellitus, Type II

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Type 2 DM. Patients that take aspirin. Antecubital forearm veins allowing technically good sampling for platelet studies. Reduced Laboratory response to aspirin. HbA1c > 8 % The physician decides that there is an indication for glucose control. Exclusion Criteria: Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months. Acute kidney disease or chronic kidney disease with creatinine clearance <30. Acute liver disease or chronic liver disease with severe liver impairment. Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones. Thrombocytopenia (platelet count <150 x 109/L)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br>Type 2 diabetic patients with reduced laboratory response to aspirin.(Aspirin Resistance)and with HbA1c >8%. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome measure is the laboratory Aspirin Resistance. |  | 3 and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence of laboratory aspirin resistance in type 2 DM in stable out-patients in the diabetic clinic, and possibly related factors. |  | On screening visit. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type II, Aspirin, Resistance
Low Birth Weight Fetuses With Caffeine Use

Study Overview
=================
Brief Summary
-----------------
Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined as birthweight less than 2,500 g .

Detailed Description
-----------------
Low birth weight is not only associated with neonatal mortality and morbidity. but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular diseases in adult life

Official Title
-----------------
Association of Low Birth Weight Fetuses With Caffeine Use

Conditions
-----------------
Low; Birthweight, Extremely (999 Grams or Less)

Intervention / Treatment
-----------------
* Other: Questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group: 18-40 Pregnant females attending regular post-natal care visits Exclusion Criteria: • Female patients with other acute or chronic illness Cardiovascular disease Neoplasms Current diabetes mellitus, pregnancy induced diabetes Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant ladies who are caffeine using<br>ladies who uses caffeine during pregnancy | Other: Questionaire<br>* A questionaire will be made to pregnant ladies who take caffeine during pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of pregnant ladies who will have low birth weight babies | Mothers who will give birth to low birth weight infants | within 2 months |
Australian Multicentre Colonic Endoscopic Mucosal Resection Study

Study Overview
=================
Brief Summary
-----------------
A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis.

Detailed Description
-----------------
A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis. Detailed data regarding lesion characteristics (size, location, Paris classification, granular or non-granular surface morphology and Kudo pit pattern), procedural, clinical and histological outcomes and complications are noted. Multivariate analysis will be performed to identify risk factors for Endoscopic Mucosal Resection failure and adenoma recurrence at follow-up colonoscopy.

Official Title
-----------------
Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study

Conditions
-----------------
Colonic Polyps

Intervention / Treatment
-----------------
* Procedure: Endoscopic Mucosal Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Large sessile polyp (equal to or greater than 20mm) Intention to perform EMR Aged 18 years or older Exclusion Criteria: Colonic polyps less than 20mm Aged younger then 18 years.

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 |
| --- | --- |
| Colonic Polyps<br>Patients who present with colonic polyps >20mm | Procedure: Endoscopic Mucosal Resection<br>* Endoscopic Mucosal Resection of large sessile colonic polyps.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success for Endoscopic resection | To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps. The utility of endoscopic criteria to stratify for the risk of Submucosal Invasive Cancer was also assessed. | 6-60 months |