linjc16/ctgov huggingface dataset:
Tobacco's Impact on Postoperative Complications in Acute Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see whether intensive smoking intervention on the day of operation can reduce per- and postoperative complications in patients operated for acute ischaemic disease compared to control group with no intervention.

Official Title
-----------------
Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial

Conditions
-----------------
Vascular Disease

Intervention / Treatment
-----------------
* Behavioral: Smoking intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute admittance in a vascular department current smoker surgery within 7 days informed/written consent Exclusion Criteria: alcohol intake > 35 units pr. week dementia or mental disease > 90 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smoking intervention, Nicotine replacement therapy.<br> | Behavioral: Smoking intervention.<br>* Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.<br>|
| No Intervention: Controlgroup<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications. |  | After 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | Patients self-assessed health status. | After 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute admittance, Current smoker
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 18 years from birth.

Detailed Description
-----------------
All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.

Official Title
-----------------
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy Exclusion Criteria: Pregnant female patients younger than 18 years of age Confirmed multiple gestation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Determine whether children born to women with IBD have higher rates of developmental delay compared to their age matched non-IBD peers, as measured by the Ages and Stages Questionnaire (ASQ-3) at ages 12, 24, 36, and 48 months |  | December 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether the rate of any adverse pregnancy outcomes in a prospective national sample of women from the United States with IBD differ with respect to exposure to azathioprine/6MP or anti-TNF therapy |  | December 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnant IBD patients
Diabetes Cohort in French Amazonia

Study Overview
=================
Brief Summary
-----------------
CoDiAm aims to collect clinical, biological and social data of diabetic patients in French Guiana.

Detailed Description
-----------------
Diabetes is a very common disease in French Guiana. This disease is caused by the body's inability to metabolise sugar properly. A diet and treatment with tablets are enough for some patients, while others may need insulin injections. In the long term, high blood sugar levels may cause problems to the small and large blood vessels in the body. This is complicated by nerve, renal and retinal damage, as well as increased risks of cardiac and vascular events (such as strokes or heart attacks.) It appears that diabetes is more common and more severe in French Guiana than in other parts of France. It seems that the types of diabetes found here are more variable than those found in France, and that patients tend to be diagnosed at a later stage. We would this like to better understand diabetes and its evolution in French Guiana. This research is aimed at diabetic patients and it is being carried out in the Andrée Rosemon Hospital Centre, the Ouest Guyanais Hospital Centre as well as in other Primary Healthcare Centres. At some point in the future, some private health centres may also invite their patients to take part in this study.

Official Title
-----------------
Diabetes Cohort in French Amazonia

Conditions
-----------------
Adults, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes At least 18 years old Exclusion Criteria: Less than 18 years old Patients under legal guardianship Patients' refusal to participate Patients living outside French Guiana

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 |
| --- | --- | --- |
| Improvement of patient care | Number of health complications in diabetes mellitus ... | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabete, French Guiana
Real World Study of Lapatinib Among Metastatic Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
A multicenter, retrospective, real world study of Lapatinib among Metastatic Breast Cancer (MBC) Patients in Clinical Practice.

Detailed Description
-----------------
This study collected patients used Lapatinib-base therapy among MBC, and tried to figure out if there was difference between single anti-Her2 treatment and dual anti-Her2 treatment. Furthermore, this study investigated the treatment after Lapatinib.

Official Title
-----------------
Real World Study of Lapatinib Among Metastatic Breast Cancer Patients in Clinical Practice: a Multicenter, Retrospective Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were treated with Lapatinib between June 2014 to June 2018. Patients experienced progression on prior trastuzumab-containing regimens and a taxane. Complete medical history was available. Exclusion Criteria: Medical history was incomplete.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Continuing Lapatinib<br>Patients continued using treatment containing Lapatinib after progression on Lapatinib. | |
| Change HER-2 treatment<br>Patients changed to another HER-2 targeted treatment after progression on Lapatinib (ado-trastuzumab emtansine, trastuzumab, etc.). | |
| Lapatinib plus capetabine<br>Patients used lapatinib plus capetabine. | |
| Lapatinib plus Trastuzumab and one chemotherapy<br>Patients used lapatinib plus trastuzumab and one chemo regimen. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 
| Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HER2, Lapatinib
Analysis of the Role of T-cell Response in Patients With Atrial Fibrillation for Clinical Application

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is 1) to characterize T-cell response in patients with atrial fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency catheter ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling of T cells from patients with atrial fibrillation will performed. Next the difference of T-cell immunity among various type of atrial fibrillation patients will be analyzed. Finally the changes of T-cell response and cytokines after radio-frequency catheter ablation of atrial fibrillation will be assessed.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: radio-frequency catheter ablation of atrial fibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who consent with study patients with age more than19 patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation Exclusion Criteria: Patients who do not agree with study inclusion Permanent AF refractory to electrical cardioversion AF with rheumatic valvular disease Patients with left atrial diameter greater than 60mm Patients with age less than 19 Patient with malignant tumor and chronic infection disease Patient are given immune inhibitor and steroidal anti-inflammatory drug within 2weeks

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| group 1<br>Atrial fibrillation patients | Other: radio-frequency catheter ablation of atrial fibrillation<br>* radio-frequency catheter ablation of atrial fibrillation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency (%) of specific marker-expressing cells among CD4 or CD8 T-subsets | Immunosenescence marker: CD28, CD57 Activation marker: CD38, HLA-DR Differentiation marker: CCR7, CD45RA | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency (%) of cytokine-secreting cells among CD4 or CD8 T-subsets | Proinflammatory cytokine: IFN-gamma, TNF-alpha Cytotoxic molecule: granzyme B, perforin | 1 year |
Morbidity and Mortality in Solo Adult Traumatic Brain Injury Patients in Minia University Hospital

Study Overview
=================
Brief Summary
-----------------
Tracking post-traumatic brain injury sequale

Official Title
-----------------
Incidence Of Morbidity And Mortality After Isolated Traumatic Brain Injury In Adult Neuro-intensive Care Unit In Minia University Hospital

Conditions
-----------------
Statistical Analysis of Traumatic Brain Injury Victims

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solo non penetrating neurotrauma victims Exclusion Criteria: 1- Penetrating head trauma. 2- Polytrauma patients. 3- Coexist of Psychiatric disorders or history of neuronal disorders. 4- Refusal of patient relatives to participate in the assignment. 5- Pregnant females with TBI. 6- Patients who died during 24 hours from admission to ICU . 7- Patients more than 65 years of age . 8- combined abdominal or orthopedic trauma.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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 |
| --- | --- | --- |
| mortality and morbidity | number of deaths from neurotrauma | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction | to examine the predictors of outcome including age , gender , admission systolic blood pressure < 90 mmHg , GCS score ,APACHE II score ,lateralization of pupil , brain CT findings ,serum sodium &potassium ,mechanical ventilation and length of stay in ICU | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurotrauma, traumatic brain injury
Atrial Fibrillation Incidence, Risk Factors and Genetics

Study Overview
=================
Brief Summary
-----------------
To assess the risk of incident atrial fibrillation after stopping anti-hypertensive medication including beta-blockers and ACE inhibitors. Also, to assess the role of genetics in subsequent risk of stroke among patients with atrial fibrillation.

Detailed Description
-----------------
BACKGROUND: Prevention and treatment of atrial fibrillation (AF) is a significant public health issue. Atrial fibrillation affects 9 percent of persons aged 80 to 89. It is associated with elevated risk of stroke and death. The condition is likely to increase as survival rates from myocardial infarction continue to improve, prevalence of congestive heart failure grows, and treatment approaches evolve. The study will assess the safety of commonly used medications in relation to the risk of incident atrial fibrillation, and will assess the association of several genetic polymorphisms with stroke risk after AF onset. Several lines of evidence suggest that both beta-blockers and ACE inhibitors may prevent or inhibit the atrial electrical remodeling that allows AF to become established and maintained. Withdrawal of these medications may be associated with increased risk of AF in individuals at risk. Genetic polymorphisms that promote thrombosis are associated with an increased risk of venous thrombosis, and in some studies, with arterial thrombosis including stroke or myocardial infarction. Although several recently published trials indicate that warfarin or aspirin treatment of patients with AF decreases the risk of stroke, little is known about the risk of stroke as a complication of AF in relation to genetic variants that affect clotting. DESIGN NARRATIVE: The main tasks of the case-control study are: 1) identification of cases with incident AF and controls; 2) review of outpatient and inpatient medical records to assess eligibility and collect information on risk factors and medical history; 3) classification of medication use over time; 4) for AF patients, telephone interview and collection of blood samples; 5) blood specimen processing, DNA extraction, and genotyping; and 6) data analysis of the associations of medication use and genotype with AF onset and stroke complications.

Conditions
-----------------
Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Hypertension, Cerebrovascular Accident, Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Interest of Procore Needle® for Diagnosis of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.

Conditions
-----------------
Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore

Intervention / Treatment
-----------------
* Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mediastinal lymphadenopathy >10 millimeters lung cancer suspected Exclusion Criteria: coagulopathy contraindication for midazolam contraindication for bronchoscopy

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: Other
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: needle Procore ®<br> | Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration<br> <br> |
| Active Comparator: needle Cook®<br> | Procedure: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of histological diagnoses for each needle |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endobronchial transbronchial needle aspiration lung cancer procore
Quantification of Human Adipogenesis

Study Overview
=================
Brief Summary
-----------------
This pilot study is using a novel technology to measure the rate of turnover of new fat cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling new volunteers.

Official Title
-----------------
Quantification of Human Adipogenesis

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: 15N-Thymidine, 2H-Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-49 years. Healthy. Exclusion Criteria: Significant chronic medical illness. Illicit substance or alcohol abuse. Body mass index > 27 kg/meters squared. Underweight (BMI < 20 kg/m2). History of keloid formation (excessive scarring). Pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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 subjects<br>18-49 year old healthy men and women. Free of significant chronic medical illness and illicit substance abuse. Body mass index from 20 to 27. | Biological: 15N-Thymidine, 2H-Water<br>* Stable isotope 15N-thymidine, infused IV (15mg/hour) for 72 hours (phase 1 pilot). Stable isotope 2H-water, ingested by mouth once per day for 3 days (phase 1 pilot) or 28 days (phase 2 pilot).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantifying human adipogenesis-counting the number of new fat cells. |  | 4 weeks-7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
No specific experimental conditions
Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients

Study Overview
=================
Brief Summary
-----------------
Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen the patient self-position to avoid complications such as accidental extubation or loss of the iv line. The aim of our retrospective study is to describe our experience in the laryngeal mask use for airway management in patient submitted to spine surgery in neurosurgery

Detailed Description
-----------------
Retrospective analysis of our experience in the last 8 years with the airway management in spine surgery in prone position. A total of 358 cases were reviewed from 2008 to 2013. Airway management (need for LM repositioning, orotracheal intubation because of failed LM insertion), anticipated difficult airway, and airway complications were registered. Statistics were compared between groups with the t test or the χ test, as appropriate.

Official Title
-----------------
Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients

Conditions
-----------------
Airway Management, Spine Surgery, Prone Position

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective spinal surgery Exclusion Criteria: emergency cases complex spine surgery

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 |
| --- | --- | --- |
| safety in the use of laryngeal mask in knee chest position in spine surgery | Analyse in a 3 years period of time, the incidence of complications in patients submitted to spinal surgery with tracheal intubation versus Laryngeal mask in prone position. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngeal mask, prone position, spine surgery