linjc16/ctgov huggingface dataset:
Association of Cephalosporin Resistance and Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.

Official Title
-----------------
Association of Cephalosporin Resistance in Intraoperative Biliary Cultures With Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy - A Retrospective Cohort Study

Conditions
-----------------
Surgical Site Infection, Pancreaticoduodenectomy, Biliary Tract Infection Bacterial

Intervention / Treatment
-----------------
* Procedure: Preoperative biliary drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing pancreaticoduodenectomy between May 23rd 2016 to October 29th 2020 Exclusion Criteria: Patients without intraoperative biliary culture Patients with unknown date of preoperative biliary culture

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 |
| --- | --- |
| No PBD<br>Patients without preoperative biliary drainage before pancreaticoduodenectomy | |
| PBD < 2 months<br>Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was in 2 months after the drainage. | Procedure: Preoperative biliary drainage<br>* Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.<br>|
| PBD ≥ 2 months<br>Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was at 2 months or later after the drainage. | Procedure: Preoperative biliary drainage<br>* Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of surgical site infections |  | 30 days post operatively | 
| Prevalence of cephalosporin resistance in intraoperative biliary cultures |  | At the time of operation |
Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults With Neurofibromatosis Type 1

Study Overview
=================
Brief Summary
-----------------
The main goal of this protocol is to develop a well-phenotyped genetic biobank to identify genetic variants associated with the heterogeneous clinical presentations of Neurofibromatosis Type 1 (NF1). This will allow for improve understanding of NF1 pathogenesis and more personalized disease management. The investigators will conduct a GWAS analysis to identify common genetic risk variants associated with the development of cutaneous neurofibromas.

Official Title
-----------------
Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults With Neurofibromatosis Type 1

Conditions
-----------------
Neurofibromatosis 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40 or older. NF type 1 diagnosed using clinical criteria. At least one neurofibroma present at time of enrollment. Patient able to read and understand consent form (or equivalent translation) and able to give consent. Patient able and willing to complete all study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Determination of genetic variants associated with clinical presentations of NF1. | GWAS analysis will identify common genetic risk variants associated with the development of cutaneous neurofibromas in patients with NF1. | Day 1 |
Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.

Official Title
-----------------
Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women

Conditions
-----------------
Cytochrome P450 Interaction

Intervention / Treatment
-----------------
* Drug: Lu AF35700
* Drug: Itraconazole (200 mg)
* Drug: Itraconazole (300 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, aged ≥18 and ≤55 years. body weight ≥50 kg women, aged ≥18 and ≤45 years, body weight ≥50 kg Good general health as assessed using detailed medical history, laboratory tests, and physical examination Known CYP2D6 and CYP2C19 genotype Exclusion Criteria: Pregnant or lactating Subject has previously been dosed with Lu AF35700 Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF35700<br>Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg | Drug: Lu AF35700<br>* Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg<br>|
| Experimental: Lu AF35700 AND itraconazole<br>Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole | Drug: Lu AF35700<br>* Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg<br>Drug: Itraconazole (200 mg)<br>* 100 mg Capsules for oral use, 200 mg/day. In a fed state<br>Drug: Itraconazole (300 mg)<br>* 100mg Capsules for oral use, 300 mg/day. In a fasted state.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-inf) | Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs | Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose | 
| Cmax | Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs | 0-24 hours postdose (Day 1 and day 32) |
Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale

Study Overview
=================
Brief Summary
-----------------
Purpose of the study is the validity and reliability of the Turkish version of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an assessment tool for dysphagia patients.

Detailed Description
-----------------
The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured scales. There are many questionnaire and scales for assessment of swallow but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Pharyngeal Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.

Official Title
-----------------
Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T)

Conditions
-----------------
Swallowing Disorder, Validation, Pharyngeal Dysphagia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years at least having undergraduate education on health profession agree to participant Exclusion Criteria: out of age 18-70 years out of having undergraduate education mental disorder cognitive limitations visual limitations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Group A<br>Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. After 2 weeks, the participants match again. | |
| Group B<br>Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Pharyngeal Residue Severity Rating Scale | To match between Fiberoptic Endoscopic Evaluation of Swallowing Images with Yale Pharyngeal Residue Severity Rating Scale Scores by health professionals. High match scores give high reliability, low match scores give low reliability. Match scores were compared and evaluated as statistically. High match score is better, low score is worse. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharyngeal, residue, swallow, scale, Yale
Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology

Study Overview
=================
Brief Summary
-----------------
For diagnosis of external and middle ear diseases, an otoscope is a key instrument to use. A microscope has been used as a reference standard to confirm pathology. An endoscope has been also widely used. Both microscope and endoscope provide an excellent image quality, can record and capture the images, and the images can be visualized with an export system. A digital otoscope is widely available and more affordable. A comparative study of the efficacy of the endoscope and the digital endoscope will be performed.

Detailed Description
-----------------
A comparative study for the diagnosis of middle ear disease usingTeslong digital otoscope, model MS450D39, and the otoendoscope will be performed. The participants will be recruited at the ENT clinic, University Hospital. A handheld otoscope will be used to identify the patients who have the pathology of the middle ear. The images will be captured with both endoscopes and will be reviewed by staff, residents training in ENT, and residents training in ENT and family medicine.

Official Title
-----------------
Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.

Conditions
-----------------
Middle Ear Disease, Diagnosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed with middle ear disease after examination by conventional otoscope at ENT clinic, Chiang Mai University Hospital Had otoscopic examination with both digital otoscope and otoendoscope in the same visit in one ear or both ears Exclusion Criteria: Having abnormal external ear canals such as external auditory canal stenosis, otitis external, otomycosis, or pus/ debris in the ear canal that obscures the view of the eardrum Changing the pathology of the ear canal or middle ear in the same visit Trauma after otoscopic examination can not record or focus the entire view of the eardrum by both otoscopes

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 |
| --- | --- | --- |
| efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology | agreement percentage | 6 months | 
| efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology | Cohen's kappa coefficient | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Middle Ear Disease, otoscope, Diagnosis
The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis

Study Overview
=================
Brief Summary
-----------------
Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.

Official Title
-----------------
The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial

Conditions
-----------------
Vestibular Neuritis

Intervention / Treatment
-----------------
* Drug: Corticosteroids
* Other: Vestibular exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance. Horizontal-rotatory spontaneous nystagmus. Exclusion Criteria: History of vestibular disfunction before the acute onset of symptoms Simultaneous Hearing loss Neurologic disorder Pregnancy or lactation History of psychiatric disorders History of glaucoma Diabetes Hypertension Contraindication in receiving corticosteroids

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroids<br>Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os | Drug: Corticosteroids<br>* Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days<br>Other: Vestibular exercises<br>* Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist<br>|
| Placebo Comparator: Vestibular exercises<br>Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist | Drug: Corticosteroids<br>* Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days<br>Other: Vestibular exercises<br>* Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical recovery of vestibular function | clinical examination (nystagmus, Romberg test, head-thrust test, head-shaking test) and questionnaires (Greek edition of Dizziness Handicap Inventory and European Evaluation of Vertigo Scale) | 1 year | 
| Laboratory recovery of vestibular | caloric test and vestibular evoked myogenic potentials | 1 year |
Prophylactic Effect of Memantine in Chronic Tension-Type Headache

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches.

Official Title
-----------------
Prophylactic Effect of Memantine in Chronic Tension-Type Headache

Conditions
-----------------
Tension-Type Headache

Intervention / Treatment
-----------------
* Drug: memantine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic tension-type headache Normal urine pH Exclusion Criteria: More than 1 migraine attack/month Other major illnesses Overuse of medicine/alcohol Women not using AC Pregnant/breast-feeding women Allergy to memantine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: memantine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache duration |  |  | 
| Headache intensity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency |  |  | 
| The use of simple analgesics |  |  | 
| Side effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic tension-type headache
Acetaminophen and AKI After Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury is commonly accompanied major complication after aortic surgery. Cardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. This increases plasma free hemoglobin, F2-isoprostane, and isofuran concentration. Cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death. Acetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. Thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.

Official Title
-----------------
Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest

Conditions
-----------------
Aortic Surgery

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest. Exclusion Criteria: patients with chronic kidney disease or with dialysis, eGFR < 15ml/min/1.73m2 allergy to acetaminophen or propacetamol HCl history of liver cirrhosis or total bilirubin > 2.0mg/dL 3) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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: Acetaminophen group<br>patients receiving acetaminophen | Drug: Acetaminophen<br>* Acetaminophen 1g IV every 6 hours for a weight > 50kg (maximum of 4g per 24 hours) or 15mg/kg every 6 hours for a weight < 50kg (maximum of 75mg/kg per 24 hours)<br>|
| Placebo Comparator: Placebo group<br>patients receiving equal amount of normal saline | Other: Placebo<br>* Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest | Compare the incidence of acute kidney injury within 7 days after surgery. Acute kidney injury is defined using KDIGO criteria. | Postoperative 7 days |
Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

Study Overview
=================
Brief Summary
-----------------
This study is an observational study to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Detailed Description
-----------------
Tamoxifen is an antiestrogen drug with concentration dependent properties, with z-endoxifen known as active metabolite. Until know therapeutic range for z-endoxifen to improve treatment response was not known. Variation response on tamoxifen can be cause of genetic polymorphism CYP2D6 that can be different between interindividul and ethnic. The aim of this study is to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Official Title
-----------------
Genotyping and Phenotyping of CYP2D6 as Predictor of Z-endoxifen Plasma Levels in Breast Cancer Patients on Tamoxifen Treatment

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

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients on tamoxifen treatment for at least 4 months Exclusion Criteria: Abnormalities in liver markers (AST >2.5 x ULN)
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients on tamoxifen<br>Patients currently on treatment with tamoxifen for at least 4 months. | Other: No intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype and phenotype of CYP2D6 | Number of subjects with CYP2D6 genotype and phenotype who had steady state level | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z-endoxifen | Number of subjects with plasma levels of Z-endoxifen more than 5.9 ng/mL | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tamoxifen, breast cancer, Z-endoxifen