linjc16/ctgov huggingface dataset:
Arterial Endothelial Function--An Epidemiologic Study

Study Overview
=================
Brief Summary
-----------------
To determine if risk factors measured in childhood can predict the development of atherosclerotic coronary and carotid artery disease in adulthood.

Detailed Description
-----------------
BACKGROUND: Many young adult subjects have some degree of atherosclerotic coronary and carotid artery disease and experience no symptoms. As time passes, many die suddenly and unexpectedly and only limited therapeutic process begins in youth, a measure of the early manifestations of atherosclerosis may have the potential of identifying subjects at risk for premature coronary and carotid occlusive vascular disease when therapeutic options can be administered. Impaired brachial artery flow mediated dilatory (FMD) capacities have been shown to exist in children and young adults with hypercholesterolemia, hyperhomocysteinemia, diabetes and in those who smoke. Impaired brachial artery FMD has been shown to related to impaired endothelial function, which is an early manifestation of the atherosclerotic process. If impaired brachial artery FMD is a predictor of the process, then it may be used to non-invasively assess atherosclerosis early in its development and to evaluate the effect of therapeutic interventions. DESIGN NARRATIVE: In this longitudinal study using previously studied members of the Muscatine study, measurements are made of contemporaneous risk factors, and brachial artery FMD, along with coronary artery calcification (CAC) and carotid artery intimal-medial thickness (IMT) (the latter two established measures of early atherosclerosis) and again three years later. The effort is designed to examine the following hypotheses: 1) Established risk factor levels measured in childhood, adulthood and across the years form childhood through adulthood are predictive of brachial artery flow mediated dilatory (FMD) capacities; 2) Putative risk factor levels measured in adulthood are related to the degree of brachial artery FMD, CAC and carotid artery IMT; 3) Brachial artery FMD, CAC and carotid artery IMTare related in adults; and 4) Brachial artery FMD is predictive of increased carotid artery IMT.

Official Title
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Arterial Endothelial Function--An Epidemiologic Study

Conditions
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Cardiovascular Diseases, Heart Diseases, Coronary Arteriosclerosis, Carotid Artery Diseases

Participation Criteria
=================
Eligibility Criteria
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Participated in at least on school survey examination, at least one young-adult follow-up survey examination and the first Longitudinal Adult Cohort examination

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

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

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilatation |  | 1999 to 2008 |
TCI vs Manually Controlled Infusion of Propofol

Study Overview
=================
Brief Summary
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Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion. The aim of the study is to verify differences in time to extubation and amount of drugs used. anesthetize

Official Title
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TCI vs Manually Controlled Infusion of Propofol in Patients Sceduled for Laparoscopic Surgery; a Case-control Study

Conditions
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Anesthesia, Intravenous, Laparotomy, Airway Extubation

Intervention / Treatment
-----------------
* Device: Target controlled infusion


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: - Patients to laparoscopic surgery Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| TCI<br>Patients receiving Target Controlled Infusion (TCI) Anesthesia | Device: Target controlled infusion<br>* Target controlled infusion vs manually controlled infusion<br>|
| MCI<br>Patients receiving Manually Controlled Infusion (MCI) Anesthesia | Device: Target controlled infusion<br>* Target controlled infusion vs manually controlled infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post procedural awakening | Time from the surgical procedure has ended until arrival at the post anesthesia unit (PACU) | 10 minutes |
Early Periprosthetic Joint Infection and Outcome Debridement, Antibiotics and Implant Retention

Study Overview
=================
Brief Summary
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Introduction Periprosthetic joint infection (PJI) is a severe complication to hip arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention (DAIR) is recommended in early PJI in association with stable implants. Few studies have evaluated the outcome of DAIR in this fragile population.The purpose of this study was to analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with a hip arthroplasty. Methods A consecutive series of patients had been treated with either a total hip arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were retrospective analysed.

Official Title
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Early Periprosthetic Joint Infection and Debridement, Antibiotics and Implant Retention in Arthroplasty for Femoral Neck Fracture

Conditions
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Femoral Neck Fracture, Infection

Intervention / Treatment
-----------------
* Procedure: Hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Displaced femoral neck fracture Treated with a primary hip arthroplasty
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Femoral neck fractures<br>Patients admitted to Sundsvall hospital for a displaced femoral neck fracture and treated with a hip arthroplasty | Procedure: Hip arthroplasty<br>* Treatment with a hip arthroplasty (semi- or total hip arthroplasty) for a displaced femoral neck fracture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of periprosthetic joint infection | The incidence of periprosthetic joint infection | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of healed periprosthetic joint infections after treatment with surgical debridement. | The rate of healed periprosthetic joint infections after treatment with surgical debridement. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Hip arthroplasty, periprosthetic joint infection, outcome
Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery

Study Overview
=================
Brief Summary
-----------------
Pancreatectomy represents the classic approach for resectable lesions of the pancreas, duodenum and periampullary region. Due to the technical skills required, the complex anatomy and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still considered to be at risk of postoperative complication mainly due to pancreatic juice leaks. Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the activation of pancreatic enzymes and the following infectious and hemorrhagic complications. Severe complications negatively affect postoperative outcomes, long-term survival, quality of life, and costs. Operative mortality traditionally has been defined as the rate within 30 days or during the initial hospitalization. But in pancreatic surgery mortality rates within 90 days after pancreatic resection are double those at 30 days. In the present study, the investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh postoperative day before discharging the patients to detect undiagnosed postoperative complication.

Official Title
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Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery

Conditions
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Pancreatectomy

Intervention / Treatment
-----------------
* Procedure: CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Will be included in this study, patients: Having an indication of pancreatic surgery In scheduled surgery Agreeing to participate in the research (ie who signed the informed consent to research participation) >18yo Exclusion Criteria: Will not be included in this study, patients: With emergency surgery Protected by law Under 18 years Presenting an against-indications to the scanner: documented severe allergy to contrast material, kidney failure against-showing the contrast medium injection, pregnancy, lactation and/or MRI (pacemaker, metallic intraocular foreign body)

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pancreatic surgery<br> | Procedure: CT scan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of undiagnosed postoperative complication by CT scan |  | Day 7 |
How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?

Study Overview
=================
Brief Summary
-----------------
Objective: To study the effect of fast food-based hyper-alimentation on liver enzymes and hepatic triglyceride content (HTGC)and metabolism. Design: Prospective interventional study with parallel control group. Setting University Hospital of Linköping, Sweden. Participants: 12 healthy men and six healthy women with a mean (SD) age of 26 (6.6) years and a matched control group. Intervention: Subjects in the intervention group aimed for a body weight increase of 5-15% by eating at least two fast food-based meals a day with the goal to double the regular caloric intake in combination with adoption of a sedentary lifestyle for four weeks. Main outcome measures: Weekly changes of serum aminotransferases and HTGC measured by proton nuclear magnetic resonance-spectroscopy at baseline and after the intervention.

Official Title
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How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?

Conditions
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Hyper-Alimentation, Healthy

Intervention / Treatment
-----------------
* Procedure: Fast food arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-obese subjects Exclusion Criteria: General diseases, obesity.

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?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Fast food intake, doubling of caloric intake, in combination with sedentary behavior (no exercise) | Procedure: Fast food arm<br>* Doubling of regular caloric intake based on fast food, no exercise allowed<br>|
| No Intervention: 2<br>Control group, parallel | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight, metabolism, cholesterol, insulin
The Satiety Effect After Okara Compared to Porridge Eating

Study Overview
=================
Brief Summary
-----------------
To examine the satiety effect after eating of Okara.

Detailed Description
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This will be a single blind, cross-over design. Study population will include 10 subjects. The patients will be randomly assigned to receive one of two meals, 48 gram Okara or 40 gram (similar caloric value) semolina in two occasions (two visits). After the eating, the subject will stay in a closed room, without watch or any irritation. After three hours, the patient will fill a VAS questionnaire, and will get a standard meal. The meal will be weighed before and after. Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.

Conditions
-----------------
Healthy People

Intervention / Treatment
-----------------
* Dietary Supplement: Nutrigal Okara - 100


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Age 20-65 years old Written Informed Consent Exclusion Criteria: History of gastro-intestinal surgery On medication that may influence gastric emptying, or medication for weight loss Patient on PPI treatment, H2 Blockers or medication for weight loss Known allergies to soy Pregnancy or breast-feeding Smoking Athletes Metabolic syndrome or diabetes mellitus Family history of metabolic syndrome or diabetes mellitus Weight loss > 2 kg during two months before the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Nutrigal Okara - 100|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating. |  |  |
The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to analyze the 15-year cumulative incidence of advanced colorectal neoplasia and CRC-related mortality after the index colonoscopy.

Detailed Description
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This is a territory-wide retrospective observational cohort study using the Clinical Data Analysis and Reporting System (CDARS). We will identify patients from CDARS with colonoscopy performed from 1 January 2000 to 31 October 2020. Other relevant diagnoses, procedures, concomitant drugs, laboratory parameters and pathology results will be retrieved and studied.

Official Title
-----------------
The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong

Conditions
-----------------
Colorectal Neoplasia, Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 1. All patients with colonoscopy performed in HA hospitals during the study period would be eligible for screening. Exclusion Criteria: 1. Patients with documented personal history of colorectal cancers before the study period would be excluded.
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 finding<br>Colonoscopy finding normal | |
| Hyperplastic polyps<br>Colonoscopy finding of hyperplastic polyps | |
| Low-risk adenomas<br>Colonoscopy finding of low-risk adenomas | |
| High-risk adenomas<br>Colonoscopy finding of high-risk adenomas | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culumative incidence of advanced colorectal neoplasia | high-risk adenomas or CRC after 15 years of index conoloscopy | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRC-related mortality rate | the rate of mortality due to CRC-related incidents | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy
Casodex - Nolvadex Combination

Study Overview
=================
Brief Summary
-----------------
This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.

Official Title
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Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of Gynaecomastia and Breast Pain Associated With CASODEX 150 mg (Oral Tablet), and to Assess the Tumour Control…..

Conditions
-----------------
Gynaecomastia, Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Casodex
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically Subjects in need of immediate hormonal therapy. PSA equal or above 4 ng/ml Exclusion Criteria: Presence of gynaecomastia and/or breast pain at screening visit Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent. Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia . Previous mastectomy or radiation to chest wall
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: 1<br> | Drug: Casodex<br>* 150mg once daily<br>|
| Active Comparator: 2<br> | Drug: Tamoxifen<br> <br> * Other names: Nolvadex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the extent of gynaecomastia and breast pain by treatment group |  |  | 
| To describe the relative change from baseline in sex hormones concentrations by treatment group |  |  | 
| To describe the pharmacokinetics of tamoxifen, N-desmethyltamoxifen and R-bicalutamide when nolvadex is co-administered at varying doses with CASODEX 150 mg once daily |  |  | 
| To assess the tolerance of nolvadex when co-administered at varying doses with CASODEX 150 mg once daily |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Casodex, bicalutamide, Tamoxifen, Gynaecomastia, Prostate Cancer
Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds

Study Overview
=================
Brief Summary
-----------------
Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness. It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene. Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology. It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.

Official Title
-----------------
Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds

Conditions
-----------------
Type 2 Diabetes, Foot Wound

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of type 2 diabetes patient > 18 years old with a diabetic foot wound person who has expressed non-opposiyion to participation in the study Exclusion Criteria: a person who is not affiliated to national health insurance person subject to legal protection (curatorship, guardianship) person under limited judicial protection pregnant, parturient or breastfeeding woman adult unable to consent minor

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 |
| --- | --- |
| Type 2 diabetic patients with foot wounds<br> | Other: questionnaire<br>* Bortner self questionnaire: 14 items Cohen PSS Perceived Stress scale: 10 items quality of life scale: 32 items depression scale: 14 items<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the Bortner self-questionnaire |  | Baseline |