linjc16/ctgov huggingface dataset:
Haemodynamic Stability of Ketamine/Propofol Admixture Ketofol in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient & doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.

Official Title
-----------------
Haemodynamic Stability of Ketamine / Propofol Admixture Ketofol in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography

Conditions
-----------------
Pancreatitis, Cholangitis

Intervention / Treatment
-----------------
* Drug: Ketamine / Propofol Admixture
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists ( I ,II ) Exclusion Criteria: Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity. History of substance abuse or dependence. History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Ketamine / Propofol Admixture<br>Ketamine / Propofol Admixture: I.V propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+ 4 ml saline in a 20-ml syringe which resulted in 0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol. | Drug: Ketamine / Propofol Admixture<br>* propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+4 ml saline in a 20-ml syringe which resulted in0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol<br>|
| Active Comparator: Propofol<br>I.V propofol 2 mg/kg | Drug: Propofol<br>* 2 mg/kg I.V<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography |  | every 5 minutes up to 30minutes | 
| saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography |  | every 5 minutes up to 30 minutes | 
| Heart rate( beat/minute) from baseline of patient |  | every 5 minutes up to 30 minutes | 
| Recovery score of patient |  | up to 10 minutes after the end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient and doctor satisfaction score |  | through study completion, an average of 1 year |
Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube

Study Overview
=================
Brief Summary
-----------------
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.

Detailed Description
-----------------
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before the intervention and 12 months after the eustachian tube dilatation. This patients are refractory to the reference medical treatment.

Official Title
-----------------
Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube

Conditions
-----------------
Eustachian Tube Disorder

Intervention / Treatment
-----------------
* Device: Balloon catheter for the Eustachian tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients between 20 and 80 years old tubal score lower than 5 patients who already used reference medical treatment Exclusion Criteria: patients who already do a major surgery of middle ear tympanic perforation pregnant or breastfeeding woman. patients who can't be follow during 14 months

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: concept proof<br>Balloon catheter for the Eustachian tube | Device: Balloon catheter for the Eustachian tube<br>* Balloon catheter is inserted in the Eustachian tube to dilate it.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tubal score |  | at 1st day, and 2 months |
Hydration and Outcome in Older Patients

Study Overview
=================
Brief Summary
-----------------
Dehydration is recognised as a major issue in healthcare. Recovery after illness, extended length of stay, pressure sores and slow tissue recovery can all be impacted by dehydration. One of the biggest problems for many people with regard to getting a drink is easy, independent access - if they can't reach the jug/cup without a struggle then they often will go thirsty and potentially become dehydrated. The purpose of this study is to investigate the impact of dehydration on outcome in patients 65 years and over. Furthermore we aim to assess the impact of providing easy, 24 hour, independently accessible fluids on reducing dehydration as well as improving patient experience. We hypothesise that patients who are dehydration will take longer to recover from illness and stay in hospital for longer periods.

Official Title
-----------------
Hydration and Outcome in Older Patients

Conditions
-----------------
Dehydration

Intervention / Treatment
-----------------
* Device: The Hydrant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients of 65 years and over that are admitted acutely to medical wards - Ward staff who have been working in the clinical area for the duration of the trial (The Hydrant part of the study). Exclusion Criteria: - Patients who are moribund - Patients who are doubly incontinent - Patients on the end of life pathway - Patients with terminal illness with a known life expectancy less than 3 months

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Patients aged 65 years and over<br>All patients aged 65 years and over admitted to acutely to medical wards | Device: The Hydrant<br>* The Hydrant is a new form of drinking system that may be used to provide continuous access to hydration will be given to 20 patients. 10 of the patients will have mild cognitive impairment with Mini Mental State Examination less than 24 and 10 with normal cognitive function. Patients and staff will be interviewed to assess the feasibility of the hydrant.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Osmolality |  | At admission and 48hrs post admission to hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydration, Elderly patients, Age 65 years and over, Admitted acutely to medical admissions ward
Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for LVT in ANT-MI With Left Ventricular Dysfunction

Study Overview
=================
Brief Summary
-----------------
To investigate the predictive value of inflammatory indexes and CHA2DS2-VASc score for anterior myocardial infarction (ANT-MI) with left ventricular thrombus(LVT) (LVT).

Detailed Description
-----------------
The clinical data were collected from 371consecutive patients with ANT-MI in our hospital from January 2014 to January 2021.As a result,totally 62 patients with LVT were selected as the experimental group and 186 patients with non-LVT as the control group .The observation indexes included baseline data, coronary angiography, disease course, laboratory examination and auxiliary examination.Patients with severe organic disease and having previous history of left ventricular aneurysm( LVA) and LVT were excluded.Data was analyzed by software SPSS 22.0 for statistical analysis,and the logistic regression model was established.A P<0.05 was considered statistically significant, and the risk factors of LVT formation were retrospectively analyzed.

Official Title
-----------------
Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for Left Ventricular Thrombus in Acute Anterior Myocardial Infarction With Left Ventricular Dysfunction

Conditions
-----------------
Left Ventricular Thrombus, Acute Anterior Myocardial Infarction, Left Ventricular Dysfunction

Intervention / Treatment
-----------------
* Other: inflammatory indexes and CHA2DS2-VASc score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute anterior myocardial infarction with left ventricular dysfunction Exclusion Criteria: end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LVT group<br>left ventricular thrombus in acute anterior myocardial infarction patients with left ventricular dysfunction | Other: inflammatory indexes and CHA2DS2-VASc score<br>* inflammatory indexes and CHA2DS2-VASc score<br>|
| non-LVTgroup<br>acute anterior myocardial infarction patients with left ventricular dysfunction while without LVT | Other: inflammatory indexes and CHA2DS2-VASc score<br>* inflammatory indexes and CHA2DS2-VASc score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the predictive of the inflammatory indexes and CHA2DS2-VASc score in LVT | the logistic regression model was established between the indexes and LVT | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk factors, left ventricular thrombus;anterior myocardial infarction
Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis

Study Overview
=================
Brief Summary
-----------------
Ertapenem is an antibiotic that is highly bound to plasma protein (> 95%). The effects of this high protein binding on tissue distribution of antibiotics have been few evaluated yet. In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed, these 2 populations show changes in binding capacity of drugs to plasma proteins due to a decrease of protidaemia and of the affinity of drugs to transport proteins. It seems therefore important to clarify the consequences of a modification in protein binding on distribution of antibiotics. That's why we have decided to characterize tissue distribution of ertapenem in healthy volunteers and critically ill patients by assessing: free and total concentrations in plasma and free concentrations in muscle by microdialysis.

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

Intervention / Treatment
-----------------
* Drug: Ertapeneme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: from 18 to 80 years Patients with infection due to ertapenem susceptible bacteria. Exclusion Criteria: Patients who received ertapenem within 7 days prior to inclusion Known allergy to ertapenem or any excipients Neutropenia < 500/mm3 Hemoglobin concentration < 9g/dl Renal failure (creatinin clearance < 30ml/min/1.73m²) Decompensated heart failure Patients receiving vasopressor (adrenalin, noradrenalin), > 0.5µg/kg/min Known hypersensitivity to Elma® Positive pregnancy test or currently lactating

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

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

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

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

Arms and Interventions

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

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
-----------------
patients infected with a bacteria sensible to ertapeneme
Photodynamic Therapy in Occult-Only Lesions (POOL)

Study Overview
=================
Brief Summary
-----------------
Age related macular degeneration is the leading cause of blindness for people over 50 in the western world. Blood vessels which start to grow form a lesion in the back of the eye. Verteporfin may stabilize the disease, by closing the blood vessels. This study will assess the efficacy and safety of verteporfin in patients with occult only lesions.

Official Title
-----------------
An Open-Label, Multicenter, Phase 4 Study of the Effect of Verteporfin for Injection Therapy in Subjects With Occult With No Classic Choroidal NeoVascularization Secondary to Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Verteporfin for injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years or older Must see better or equal to 34 letters (visual acuity) Choroidal neovascularization (CNV) lesion must be occult only Exclusion Criteria: Evidence of classic CNV in the lesion Prior treatment of disease in study eye Have a history of moderate to severe hepatic impairment Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Verteporfin for injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity measurements, baseline, 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age related Macula Degeneration,, AMD,, choroidal neovascularisation (CNV),, occult CNV lesion,, verteporfin for injection,, photodynamic therapy (PDT)
Dynamic Aspects of Amino Acid Metabolism

Study Overview
=================
Brief Summary
-----------------
This protocol seeks to define aspects of intestinal and hepatic uptake and metabolism of several amino acids. The major hypothesis to be tested is that the splanchic bed (intestine and liver) conserves essential amino acids and metabolites while synthesizing and metabolizing nonessential amino acids. The aims of the study include defining the relative roles of enteral and hepatic extraction/metabolism in the disposition of glutamate, alanine, methionine and other amino acids. Emphasis will also be placed on studies of the transamination of alpha-ketoisocaproic acid (KIC) to leucine since this reaction is of potential importance in the design of nutritional regimens for patients with renal disease.

Conditions
-----------------
Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal weight-for-height weight 50-80 kg normal physical activity no significant medical history healthy by medical exam and lab blood testing Exclusion Criteria: subjects who exercise vigorously subjects who smoke

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?
-----------------
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
-----------------
Amino Acid Metabolism
Abdominal Plain X-ray in the Emergency Departement

Study Overview
=================
Brief Summary
-----------------
There are only few recognized indications for the realization of plain abdominal X-rays in the emergency departement. The objective of this study is to explore the reasons for abdominal plain X-rays prescription in the Emergency departments (EDs) of two hospitals.

Detailed Description
-----------------
All abdominal plain x-rays prescription will be reviewed in order to identify reasons for prescribing this exam. The indications will be compared to international guidelines in order to identify whether abdominal plain x-rays are overprescribed. Reasons for overprescription will be identify by chart review.

Official Title
-----------------
Abdominal Plain X-ray in the Emergency Departement: Really Usefull?

Conditions
-----------------
Emergencies, Diagnostic Imaging, Abdomen, Acute

Intervention / Treatment
-----------------
* Other: abdominal plain x-ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 16 years prescription of an abdominal plain x-ray during their stay in the ED Exclusion Criteria: < 16 y no abdominal plain x-ray prescribed

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Plain abdominal x-ray<br>All patients admitted to 2 EDs and with a prescription of an abdominal plain x-ray. | Other: abdominal plain x-ray<br>* Abdominal plain x-ray as prescribed by the emergency physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indications for abdominal plain x-ray prescription | Identification of the indications for abdominal plain x-ray and of the number of patients with appropriate indications accordingly to international guidelines | Within 24 hours after ED admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and types of other prescribed radiological exams | Describe whether other radiological exams (CT, ultrasonography, MRI) have been performed and their indications. | Within 24 hours after ED admission |
Respiratory Volume Measure Using ExSpiron 1Xi

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.

Detailed Description
-----------------
The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients. In addition, the investigators investigated the decrease in respiratory volume in opioid infusion after ventilator weaning in this patient, and to measure the one-time respiratory volume change by RVM during deep breathing induction using Inspirometry exercise.

Conditions
-----------------
ICU(Intensive Care Unit) Patients, Mechanical Ventilation After Surgery

Intervention / Treatment
-----------------
* Device: Respiratory Volume Monitor(RVM)
* Device: artificial respirator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An adult patients ( ≥ age 19) patients who receive mechanical ventilation in the ICU of the Severance Hospital after surgery and plans to wean the mechanical ventilation within 3 days. Exclusion Criteria: severe respiratory illness patients (pneumothorax, chest tube intubation status, severe restrictive respiratory disease, unilateral lung ventilation, lung transplantation status, chronic restrictive respiratory disease, hydrothorax, diaphragmatic movement disorder) If the candidate can not understand and carry out the experiment contents and process

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory monitoring group<br> | Device: Respiratory Volume Monitor(RVM)<br>* The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.<br>* Other names: ExSpiron™ 1Xi;Device: artificial respirator<br>* The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory volume measure using ExSpiron 1Xi | During mechanical ventilator, we obtained respiratory parameter from ventilator and also we collected same parameter via RVM. | during 10-minute |