linjc16/ctgov huggingface dataset:
Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Detailed Description
-----------------
Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. Anastomotic leakage severely compromises the recovery after surgery. It increases the overall burden of patients and hospital resources. Postoperative mortality is higher in patients with anastomotic leakage. Human albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Official Title
-----------------
Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery

Conditions
-----------------
Gastric Cancer, Anastomotic Leak

Intervention / Treatment
-----------------
* Biological: Human albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed gastric cancer Patients who underwent radical gastrectomy Exclusion Criteria: Patient who did not undergo gastrectomy

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 |
| --- | --- |
| Human albumin support<br>Patients who received intravenous human albumin after gastric cancer surgery | Biological: Human albumin<br>* Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.<br>|
| No human albumin support<br>Patients who did not receive intravenous human albumin after gastric cancer surgery | Biological: Human albumin<br>* Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the rate of anastomotic leakage | The rate of anastomotic leakage were compared among both groups | Up to one months after the discharge of last patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, Anastomotic leakage, Human albumin
Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.

Study Overview
=================
Brief Summary
-----------------
The prilocaine is a very common local anesthetic that has the disadvantage of being metabolized to o-toluidine, a human carcinogen. Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in blood.

Official Title
-----------------
Dosing of Carcinogenic Complexes Such as Urinary O-toluidine and Hemoglobin Adducts From O-toluidine in Blood After Intrathecal Administration of 50 mg Hyperbaric Prilocaine

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : > 18 years and < 80years American Society of Anesthesiology (ASA) score : I-II Height between 160cm and 180cm Exclusion Criteria: Cardiac Disease (Aortic stenosis, heart failure...) coagulation disorder (International Normalized Ratio (INR) > 1.3; platelets <80 000/mm³) Allergic to local anesthetics Smoker

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 |
| --- | --- | --- |
| Hemoglobin adducts from o-toluidine in blood | Hemoglobin adducts from o-toluidine in blood is measured before surgery (at admission) | Time 0 (before surgery) | 
| Hemoglobin adducts from o-toluidine in blood | Hemoglobin adducts from o-toluidine in blood is measured at 24 hours after intrathecal prilocaine injection | Time 24 hours after intrathecal prilocaine injection | 
| Urinary o-toluidine | Urinary o-toluidine is measured before surgery (at admission) | Time 0 (before surgery) | 
| Urinary o-toluidine | Urinary o-toluidine is measured at 6 hours after intrathecal prilocaine injection | Time 6 hours after intrathecal prilocaine injection | 
| Urinary o-toluidine | Urinary o-toluidine is measured at 12 hours after intrathecal prilocaine injection | Time 12 hours after intrathecal prilocaine injection | 
| Urinary o-toluidine | Urinary o-toluidine is measured at 24 hours after intrathecal prilocaine injection | Time 24 hours after intrathecal prilocaine injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemoglobin adducts from o-toluidine in blood, Urinary o-toluidine, Intrathecal anesthesia, Hyperbaric prilocaine, Ambulatory surgery
Evaluation of Rumination, Frailty and Tanatophobia in Cancer Patients Over 65 Years of Age

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Detailed Description
-----------------
No studies were found in the literature evaluating the relationship between frailty and lack of social support with tanatophobia and rumination. The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Official Title
-----------------
Evaluation of Rumination, Frailty and Tanatophobia in Cancer Patients Over 65 Years of Age

Conditions
-----------------
Cancer, Death, Rumination, Frailty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years or older Conscious and no communication problems Being literate Willing to participate in our study voluntarily Cancer patient receiving active chemotherapy treatment Exclusion Criteria: Not being willing to participate in the research Serious life-threatening condition (critical illness, intensive care unit stay, acute complication) Dementia, Alzheimer's, cognitive dysfunction Major psychiatric illness

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

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 |
| --- | --- | --- |
| Rumination | Evaluation of rumination in patients over 65 years of age receiving cancer chemotherapy | 1 week | 
| Tanatophobia | Evaluation of tanatophobia in patients over 65 years of age receiving cancer chemotherapy | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fraility | Evaluation of fraility in patients over 65 years of age receiving cancer chemotherapy | 1 month | 
| lack of social support | Evaluation of lack of social support in patients over 65 years of age receiving cancer chemotherapy | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, tanatophobia, rumination, fraility, elderly
Ultrasound in Undifferentiated Hypotension

Study Overview
=================
Brief Summary
-----------------
Background Symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality. Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions. Aim - The aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency. Methods Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins. On the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed). The diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician). The statistical agreement is calculated by the k of Cohen with p-value, confidence intervals and raw agreement (Ra).

Official Title
-----------------
Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

Conditions
-----------------
Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arterial pressure <100 mm/Hg at presentation At least one of the following symptoms: Unresponsive Syncope Impaired mental status Respiratory distress Severe malaise and fatigue Exclusion Criteria: Patients undergoing cardiopulmonary resuscitation Trauma patients Electrocardiographic and clinical diagnosis of STEMI or NSTEMI Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose) Late evolution of shock state in a patient already treated with known diagnostic tests

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Correlation between the ultrasound primary diagnosis and the clinical final diagnosis |  | Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency ultrasound, Focused ultrasound, Point-of-care ultrasound, Undifferentiated hypotension
Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI

Study Overview
=================
Brief Summary
-----------------
Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.

Official Title
-----------------
Outcome of Treatment of Women With Urinary Stress Incontinence Treated by Tension-free-vaginal-tape-obturator (TVTO) Compared to Tension-free-vaginal-tape-Secur (TVTS)

Conditions
-----------------
Urinary Stress Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with USI who underwent TVTS or TVTO procedure, more than 6 months ago Exclusion Criteria: Women who have not undergone TVT procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Women with urinary stress incontinence<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of stress incontinence | We will collect data from the files, question the women for possible urinary stress incontinence after one month, 6 months and 12 months after surgery. Data of physical examination will also be incorporated. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of side effects: tape erosion, pain, bleeding | We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary stress incontinence, TVT
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)

Study Overview
=================
Brief Summary
-----------------
Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease. S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.

Official Title
-----------------
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial

Conditions
-----------------
Cerebral Infarction

Intervention / Treatment
-----------------
* Drug: MCI-9042
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral infarction except cardiac source of embolism Onset ≧ 1 week to ≦ 6 months before randomization Neurological signs persisting ≧ 1 day from onset Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site Age ≧ 20 years Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg Exclusion Criteria: Functional outcome at randomization: Modified Rankin Scale = 4, 5 Previous or planned vascular surgery for cerebral infarction History of intracranial hemorrhage History of systemic bleeding, or other history of bleeding diathesis or coagulopathy Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.) Pregnant or possibly pregnant women, or nursing mothers History of sarpogrelate and aspirin sensitivity Treating malignant tumor or treated within 5 years Current peptic ulceration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCI-9042<br> | Drug: MCI-9042<br> <br> * Other names: ANPLAG(R);|
| Active Comparator: Aspirin<br> | Drug: Aspirin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of cerebral infarction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death |  |  |
Depression And Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

Official Title
-----------------
A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Patients must provide written and informed consent. Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks. Exclusion Patients must not be suicidal. Patients must not have a history of non-response to antidepressant treatment. Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry. Patients must not have had epilepsy or hypothyroidism.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: lamotrigine<br>* Experimental treatment<br>* Other names: Placebo;|
| Experimental: lamotrigine<br> | Drug: Placebo<br>* Experimental treatment arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD (Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I) |  | Eight weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder
The Conflicts of Ethics and Law on Patient's Surrogate

Study Overview
=================
Brief Summary
-----------------
This study is a prospective cross-sectional survey study. The investigators developed self-administrated questionnaire and recruit 120 physicians in two hospitals and 60 lawyers from some law firms to this study. To realize and compare the opinions of physicians and lawyers about controversial decision-making of surrogate.

Detailed Description
-----------------
This study provides three real scenarios regarding dilemma between ethics and law when patient's surrogate may not represent patient's best interest：1. Parents ask physician resect their mentally handicapped daughter's uterus. 2. A son refuse physician's suggestion of surgical treatment for his mother, instead, wishes donating his mother's kidney to his son. 3. A mother decides to give up treatment for her son's head injury because of his rebel behavior before. T-test, ANOVA and Logistic Regression will be used to analyze in this study.

Official Title
-----------------
Health Service Administration China Medical University (Chih-Jaan Tai)

Conditions
-----------------
Physician's Role

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resident visiting Staff chief resident Exclusion Criteria: intern clerk
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ethics, law, surrogate, conflict
Brain Ion Homeostasis, Lithium and Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
In this project, investigators intend to carry out the first simultaneous, in vivo, imaging study of lithium content and sodium ion homeostasis in the brain of Bipolar Disorder (BPD) patients under Lithium therapy.

Detailed Description
-----------------
The purpose of this study is to validate a new method for the measurement of the amount of lithium (also known as lithium concentration) in the brain of subjects undergoing lithium treatment for bipolar disorder. The method involves the use of Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) techniques. These are non-invasive techniques, with no known harmful effects, that allow investigators to measure the amount of lithium in an individual's brain. There will be no contrast dye used in this study.

Official Title
-----------------
Brain Ion Homeostasis, Lithium and Bipolar Disorder

Conditions
-----------------
Healthy, Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychiatrically stable patients (diagnosed according to the Diagnostic and Statistical Manual, DSM-IV, criteria) On steady state serum lithium levels (0.8-1.2mEq/L) Exclusion Criteria: Subjects who have a history of head trauma Subjects who have a contraindication for an MRI exam, including a claustrophobia, surgical or vascular implants, pregnancy, pacemakers, neurostimulators, history of metal in the eyes, and orthodontia or extensive bridgework (with have a particular impact on gradient echo imaging).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Healthy Volunteers<br>MRI on 3 Tesla (3T) or 7 Tesla (7T) scanner, without contrast | |
| Bipolar Patients<br>MRI on 3 Tesla (3T) or 7 Tesla (7T) scanner, without contrast | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the relationship between BLC and brain sodium ion homeostasis, as measured by concurrent Single / Triple quantum sodium MRI in BPD patients |  | 1 Hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the measurement of sodium ion homeostasis in the brain of BPD patients, at clinical magnetic field strengths (3 Tesla), as a non-invasive surrogate marker of BLC during Lithium Carbonate therapy |  | 1 Hour |