linjc16/ctgov huggingface dataset:
The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients

Detailed Description
-----------------
The increase of Corrected QT (QTc) interval is associated with age. It is known that most inhalation anesthetics or intravenous anesthetics can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients.

Conditions
-----------------
General Surgery With Endotracheal Intubation

Intervention / Treatment
-----------------
* Drug: remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 65 years ASA class I-II who received surgery with endotracheal intubation Exclusion Criteria: emergency surgery electrocardiography abnormality hypertension diabetes mellitus end stage renal disease moderate to severe cardiac disease moderate to severe liver dysfunction

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male<br>To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method | Drug: remifentanil<br>* The effect site concentration of remifentanil<br>|
| Experimental: Female<br>To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method | Drug: remifentanil<br>* The effect site concentration of remifentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect site concentration for preventing QTc interval prolongation |  | 2 min |
Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.

Official Title
-----------------
Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Diclofenac topical sodium gel 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion criteria: • Osteoarthritis of the hand Key Exclusion Criteria: Other rheumatic disease, such as rheumatoid arthritis Active gastrointestinal ulcer during the last year Known allergy to analgesic drugs

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diclofenac topical sodium gel 1%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OA pain intensity in target hand at Week 4 and 6 |  |  | 
| Total AUSCAN score in target hand at Week 4 and 6 |  |  | 
| Global rating of disease activity by patient at Week 4 and 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8 |  |  | 
| AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8 |  |  | 
| OA pain intensity in target hand and use of rescue medication recorded in diary |  |  | 
| Global evaluation of treatment at final visit |  |  | 
| Treatment responder rate according to OARSI criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand osteoarthritis, Topical NSAID, Diclofenac sodium
Influence of Body Posture on Pulmonary Aerosol Deposition

Study Overview
=================
Brief Summary
-----------------
To compare deposition in two different positions.

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

Intervention / Treatment
-----------------
* Device: AKITA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Free of respiratory disease Exclusion Criteria: Smokers

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lying<br>Nebulization in lying position | Device: AKITA<br> <br> |
| Active Comparator: Sitting<br>Nebulization in sitting position | Device: AKITA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung deposition by scintigraphy |  | 1 day |
Comparability of Invasive and Non-invasive Haemodynamic Monitoring

Study Overview
=================
Brief Summary
-----------------
During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called extended hemodynamic monitoring depending on the operation and patient. Frequently an invasive arterial cannula is used to provide continuous information on the blood pressure. This invasive method is very accurate and clinically established, but can be linked to adverse effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a non-invasive manner. It thus offers beat-to-beat information even about the extended hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform EV1000 (Edwards Lifescience). Assuming that the two methods are equal we plan to measure extended hemodynamic parameters before, during induction and during ongoing anesthesia both invasive and non-invasive. Data will be recorded every 30sec. Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters is to our knowledge rare and further assessment in this field is needed to offer patients a potentially equally reliable but less invasive monitoring. Furthermore the study should model the effect of remifentanil, propofol or its combination on haemodynamics .

Official Title
-----------------
Clinical Comparison of Hemodynamic Parameters Using Invasive Versus Non-invasive Continuous Blood-pressure Technology During a Total Intravenous Anaesthesia (TIVA).

Conditions
-----------------
Anesthesia, Anesthesia, Intravenous

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery with the necessity of an arterial catheter Exclusion Criteria: patient not consented peripheral vascular disease

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 |
| --- | --- | --- |
| Mean arterial pressure |  | during anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output |  | during anesthesia induction | 
| Stroke volume variation |  | during anaesthesia induction | 
| Stroke volume |  | during anesthesia induction | 
| Heart rate |  | during anaesthesia induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive arterial pressure, extended hemodynamic monitoring, propofol, remifentanil
Multimodal Imaging of Retinal Vessels

Study Overview
=================
Brief Summary
-----------------
Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial. Different imaging modalities might provide divergent results. Thus, quantification of such differences is valuable. The present study aims to reveal and quantify differences in vessel morphology between fundus photography, fundus angiography, and optical coherence tomography in health and disease.

Detailed Description
-----------------
This is considered a pilot study and will pe performed on patients scheduled for routine fluorescein angiography. During the study day the following procedures will be performed: Medical history and concomitant medication Blood pressure and heart rate Assessment of visual acuity using Snellen vision charts Biomicroscopy Intraocular pressure Funduscopy IOL-Master axial length measurement Fundusphotography Optical coherence tomography Fluorescein Angiography Fundus photography analysis will be performed with an automated software and analysis of both angiography and optical coherence tomography will be performed via the devices inbuilt software.

Official Title
-----------------
Retinal Vessel Morphology in Multimodal Imaging

Conditions
-----------------
Retinal Blood Vessels, Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Device: Optical coherence tomography
* Device: Fluorescein angiography
* Device: Fundus photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent, clear media Exclusion Criteria: any abnormality preventing reliable vessel measurement, pregnancy,

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

| Intervention/Treatment |
| --- |
|Device: Optical coherence tomography|Sections including the retinal vasculature will be taken.|
|Device: Fluorescein angiography|Video fluorescein angiography from one eye of each subject will be performed|
|Device: Fundus photography|30 and 50 degree fundus images|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal vessel diameter |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal vessel reflectivity |  | 5 minutes |
Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

Study Overview
=================
Brief Summary
-----------------
AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone Mineral Density.

Official Title
-----------------
Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: AAE581


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low spine Bone Mineral Density 0 to 1 prevalent fracture in non lumber spine Exclusion Criteria: History or presence of any bone disease other than osteopenia /osteoporosis Previous treatment with other anti-osteoporosis agent(Wash out required) Evidence of vitamin D deficiency Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AAE581|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of lumbar spine(L1-L4)BMD at 12 months |  |  | 
| Safety of 12 month treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BMD of lumbar spine(L1-L4,L2-L4)、total hip, femoral neck, forearm and total body at 3, 6, 9 and 12 months |  |  | 
| Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months |  |  | 
| Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Postmenopausal women, Cathepsin K inhibitor
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of intragastric balloon on bone, metabolic and respiratory parameters in 50 patients with metabolic syndrome.

Official Title
-----------------
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Conditions
-----------------
Overweight, Obesity, Metabolic Syndrome

Intervention / Treatment
-----------------
* Device: Silimed Intragastric balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome (IDF criteria) Exclusion Criteria: menopause older than 50 years diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Intragastric balloon<br>Patients submitted to six-month intragastric balloon | Device: Silimed Intragastric balloon<br>* Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density and body composition | Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA) | Baseline and 6 months | 
| Change in fasting and postprandial glucose |  | Baseline and 6 months | 
| Change in Pulmonary function tests | Pulmonary function tests consiste of spirometry, body plethysmograph, diffusing capacity for carbon monoxide (DLco), and respiratory muscle strength. Measurements are conducted using the Collins Plus Pulmonary Function Testing Systems (Warren E. Collins, Inc., Braintree, MA, USA). | Baseline and 6 months | 
| Change in bone microarchitecture | Bone microarchitecture by high-resolution peripheral quantitative computed tomography | Baseline and 6 months | 
| Change in lipid profile | Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol | Baseline and 6 months |
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.

Study Overview
=================
Brief Summary
-----------------
Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant. Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.

Official Title
-----------------
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.

Conditions
-----------------
Health Preterm Infants With no Active Disease, Human Milk Nutrition, Incubator Stay

Intervention / Treatment
-----------------
* Other: adding pad with maternal milk in hte incubator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants at least 1 week of age no active disease or treatment (like respiratory support) place in incubator Exclusion Criteria: active disease or treatment

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 4 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 preterm infants<br>20 preterm infants without active disease | Other: adding pad with maternal milk in hte incubator<br>* 2 days prior to intervention - recording infants data and taking saliva cortisol adding pad with maternal milk - during 2 days - recording infants data and taking saliva cortisol. stopping intervention and for other 2 days recording infants data and taking saliva cortisol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology.

Official Title
-----------------
Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci

Conditions
-----------------
Cancer of Prostate

Intervention / Treatment
-----------------
* Other: Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old, with prostate cancer and scheduled for radical prostatectomy Exclusion Criteria: Medical history of prostate surgery or radiotherapy of prostate Medical history of abdominal perinéanal amputation or whole of state which prevent to use endorectal probe

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elastography<br> | Other: Elastography<br>* The elastography in vivo will be performed before the prostatectomy. The elastography ex vivo will be performed after radical prostatectomy.<br>* Other names: Supersonic Imagine Aixplorer scanner;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young's modulus(kPa) of cancerous tumor foci |  | 2 years | 
| Young's modulus(kPa) of normal peripheral zone |  | 2 years | 
| Young's modulus(kPa) of normal transition zone |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, elastography, elasticity