linjc16/ctgov huggingface dataset:
Wettability of Contact Lenses With a Multi-Purpose Solution

Study Overview
=================
Brief Summary
-----------------
Measure wettability of hydrogel and silicone hydrogel contact lenses presoaked in a Multi-Purpose Solution.

Conditions
-----------------
Vision

Intervention / Treatment
-----------------
* Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with normal eyes who have successfully worn contact lenses on a daily basis for at least two weeks prior to the study. Must be wearing lenses a minimum of eight hours a day Vision must be correctable to 20/30 (snellen) or better in each eye at a distance with soft contact lenses Use no topical ocular OTC or prescribed ocular medication Exclusion Criteria: Subjects with current lid or conjunctival infections, abnormalities, inflammation, abnormal corneal opacities, significant lenticular inclusions, iritis, ocular disease or condition, corneal surgery, cataract surgery, intraocular lens implants, or glaucoma filtering surgery. Subjects using systemic medications, upper respiratory infections or colds, history of seasonal allergies with significant ocular side effects

Ages Eligible for Study
-----------------
Minimum Age: 18 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: 1<br>Polyquaternium-preserved Multi-purpose solution | Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182<br>* Lens Cleaning Solution Formulation Identification Number 109182<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Wettability - ex-vivo wetting angle |  | From baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit-lamp findings Corrected visual acuity (snellen) Adverse events |  | From baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multi-purpose solution, contact lens wearers, Contact lense wearers
Evaluation of a New Enteral Feeding Tube for the Measurement of Esophageal and Gastric Pressure

Study Overview
=================
Brief Summary
-----------------
Investigators aim to evaluate the accuracy in the measurement of the esophageal and gastric pressure of a new enteral feeding tube

Official Title
-----------------
Evaluation of a New Enteral Feeding Tube for the Measurement of Esophageal and Gastric Pressure

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: Enteral feeding tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requiring the placement of an enteral feeding tube Exclusion Criteria: esophageal ulcers severe coagulophaty thrombocytopenia

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 |
| --- | --- |
| New enteral feeding tube<br> | Device: Enteral feeding tube<br>* The esophageal and gastric pressure, measured with this new device, will be recorded and compared with those ones measured with a standard esophageal catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the measurement of the esophageal and gastric pressure |  | 1 hour |
Gastric Acid Rebound Secretion Measured by Alkaline Tide

Study Overview
=================
Brief Summary
-----------------
Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the Western population. These millions of patients are treated continuously with PPI for different periods, many for many years. Recently, rebound acid hypersecretion was recognized as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to daily PPI therapy causes increased acid-secretory capacity that appears when the drug is stopped. The transient increase in blood and urinary pH following gastric secretion has been termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral chloride bicarbonate exchanger. The investigators have shown in several studies that this phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal increased base excess maximally after 45 minutes and these changes parallel peak acid output measured in gastric aspirate. The investigators hypothesize that gradual step down cessation of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI cessation the investigators may prove this hypothesis.

Official Title
-----------------
Gradual Cessation of Proton Pump Inhibitor (PPI) Treatment May Prevent Rebound Acid Secretion in Dyspeptic and Reflux Patients, Measured by the Alkaline Tide Method.

Conditions
-----------------
Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI

Intervention / Treatment
-----------------
* Drug: Stop PPI gradually
* Drug: Stop PPI gradually


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyspepsia and reflux patients older than 18 Exclusion Criteria: patients on PPI, patients with severe diseases, younger than 18 y, older than 80 y, un-cooperative, COPD, uncompensated IHD, CRF

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PPI abrupt cessation<br>Abrupt cessation | Drug: Stop PPI gradually<br> <br> |
| Active Comparator: PPI gradual step down cessation<br>Gradual cessation | Drug: Stop PPI gradually<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of acid rebound phenomenon after stoping PPI | Comparing gradual and abrupt PPI cesation | 30 days |
Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal

Study Overview
=================
Brief Summary
-----------------
Medial upper eyelid pad of fat bulge is a common problem. Small incision surgery could be a time-efficient, minimally invasive and scar formation procedure .

Detailed Description
-----------------
Traditional upper eyelid blepharoplasty: an entire length upper eyelid crease followed by proper dissection are applied . identification and removal of medial pad of fat. Small Incision technique: 4 mm medial upper eyelid small incision followed by proper dissection to gain direct access to the medial fat pad removal

Official Title
-----------------
Comparison of the Efficacy Between Small Incision Technique and Upper Blepharoplasty in Treatment of Upper Eyelid Medial Pad Fat Bulge

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Procedure: upper eyelid blepharoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: upper eyelid medial pad of fat bulge Exclusion Criteria: Other eyelid diseases and previous eyelid surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: upper eyelid blepharoplasty<br>traditional upper eyelid blepharoplasty : upper eyelid entire length incision followed by proper dissection medially to medial pad fat. medial pad fat identification and excision. closure of the wound with subcuticular 6/0 vicryl suture | Procedure: upper eyelid blepharoplasty<br>* upper eyelid blepharoplasty<br>|
| Experimental: small incision technique<br>medial upper eyelid 4 mm length incision followed by proper dissection medially to medial pad fat. medial pad fat identification and excision. closure of the wound with interrupted 6/0 vicryl sutures | Procedure: upper eyelid blepharoplasty<br>* upper eyelid blepharoplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global aesthetic improvement scale | calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of surgery | time of surgery in minutes measured by stopwatch | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper eyelid pad fat, blepharoplasty
Physical Activity Tracking in Paediatric Elective Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
This pilot study will investigate the feasibility of physical activity tracking in patients aged 4-16 years before and after elective tonsillectomy as an innovative tool in paediatric research. The participating patients will receive a wearable physical activity tracker (CE-certified) that will continuously measure the patients' physical activity before and after an elective tonsillectomy, in addition to their parents' documentation of their child's activity in a conventional diary.

Official Title
-----------------
Physical Activity Tracking in Paediatric Elective Tonsillectomy

Conditions
-----------------
Tonsillectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 4 to 16 years old, in 2 subgroups (4-7 years, 8-16 years) Inpatient surgery at University Children's Hospital Basel (UKBB), Switzerland Children undergoing an elective tonsillectomy or tonsillotomy. Children having additional ENT procedures, such as adenectomy, tympanostomy, etc. may be included as well. Exclusion Criteria: Children with mental or physical impairment during daily-life activities. Children undergoing additional surgical procedures other than Ear, Nose & Throat (ENT) procedures impacting the recovery period.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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 |
| --- | --- |
| Children aged 4-7 years<br> | |
| Children and adolescents aged 8-16 years<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of physical activity tracking in children | Difference in proportions of patients having complete activity measurement data, comparing the electronic tracker with the conventional diary. | up to 6 weeks |
Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are receiving standard wound care treatment. The MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping), as per current standard of care in the principal investigator's wound care clinic. The acquired tissue sample will then be analysed using conventional gold standard semi-quantitative culture methods to determine bacterial species present, also as per current standard of care in this clinic.

Official Title
-----------------
A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X™ Imaging Device to Predict the Presence of Pseudomonas Aeruginosa in Chronic Wounds

Conditions
-----------------
Wound, Chronic Leg Ulcer, Wound Contamination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients presenting with a chronic wound (wound duration > 4 weeks) e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable aetiology 18 years or older Exclusion Criteria: Treatment with an investigational drug within 1 month before study enrolment Inability to consent to medical photography (i.e. inability to understand consent process) Any contra-indication to routine wound care and/or monitoring Prior participation of the patient in this study (for the same wound or a different wound).

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 |
| --- | --- |
| All Subjects<br>All subjects in this study will have their wounds imaged and assessed in the following manner: Capture and save ST-image Capture and save FL-image Identify discrete locations of cyan (blue/green) fluorescent bacteria (FL_C) Acquire sample of tissue where cyan fluorescent bacteria are present (using curette method) Consent patient for inclusion in this study Note location of sample acquisition by annotating FL-image obtained in step 2 Send sample for microbiology analysis Note naming of microbiology sample on Case Report Form | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds | Primary endpoint: correlation of localized cyan fluorescence signals in device acquired images with microbiological samples indicating Pseudomonas aeruginosa | 1 hour |
Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.

Official Title
-----------------
Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)

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

Intervention / Treatment
-----------------
* Drug: Pharmaton® with DMAE
* Drug: Pharmaton® without DMAE
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy man or woman, between 20 to 70 years Fit to work Volunteers have given informed consent and signed the consent form Exclusion Criteria: Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc) Treatment with other drugs that might interfere with the evaluation of the safety of the test drug Known hypersensitivity to any ingredients of the study drug Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive Drug and alcohol abuse Participation in another trial Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaton® with DMAE<br> | Drug: Pharmaton® with DMAE<br> <br> |
| Active Comparator: Pharmaton® without DMAE<br> | Drug: Pharmaton® without DMAE<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 60 days | 
| Assessment of overall tolerability rate on a 4-point scale |  | Day 30 and 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with abnormal changes in laboratory parameters |  | Day 0, 30 and 60 | 
| Number of patients with abnormal findings in physical examination |  | Day 0, 30 and 60 |
Assessment of Hemodynamic Response in Surgery of Circumcision in Children

Study Overview
=================
Brief Summary
-----------------
The surgery stress relives systemic inflammatory response by hormones and adrenergic receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the physiologic status is impaired and the patient is more susceptible an infection and cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved more safety to the patient. This study is a double blind controlled trial with 40 patients divided in two groups (EMLA and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory rate, arterial pressure, involuntary movements during the surgery and pain in the pos-operatory. With this study, the investigators can define what tactic (EMLA or DPNB) associated a general anesthesia is more effective to relive the pain when children are submitted a postectomy by Plastbell®.

Official Title
-----------------
Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children

Conditions
-----------------
Children Who Need Circumcision

Intervention / Treatment
-----------------
* Procedure: circumcision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA status physical 1 children between 3 and 13 years old Exclusion Criteria: parents don't accept the study classic circumcision

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 13 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 |
| --- | --- |
| Active Comparator: anaesthesia, circumcision<br> | Procedure: circumcision<br>* circumcision by plastbell<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local anesthesia relieve the circumcision pain |  | per-operatory; 1h and 24h pos-operatory | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local anesthesia relieve the circumcision pos-operatory pain |  | 1h and 24h pos-operatory | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DPNB, pain, hemodynamics effects, circumcision
Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia

Study Overview
=================
Brief Summary
-----------------
For children aged 6 months to 10 years old under general anesthesia, intraoperative lung ultrasound pictures are acquired, grades are evaluated for each pictures and machine learning is used to learn and apply it.

Detailed Description
-----------------
routine general anesthesia is performed in the selected children. After mechanical ventilation, the degree of lung atelectasis is evaluated using transthoracic lung ultrasonography in the anterior, lateral, posterior regions of the upper and lower points of both lungs(a total of 12 regions). Atelectasis is checked by the presence of B-line and juxta pleural consolidation. Machine learning is used to educate the photos of 70 people and grading system, and process is checked whether it applies well to the photos of the remaining 30 people.

Official Title
-----------------
Biobank of Lung Ultrasonography in Children Undergoing General Anesthesia

Conditions
-----------------
Children Aged 6 Months to 10 Years Old Under General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged 6 months to 10 years old under general anesthesia ASA I-III Exclusion Criteria: If the parents of the patient cannot communicate in Korean If mechanical ventilation is not planned (for example, A1 pulley) emergency operation a child whose ultrasound image quality is expected to deteriorate due to diseases such as thoracic deformity, scoliosis, or rib fractures If lateral position was not available

Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- | --- |
| consolidation score | Sum of the consolidation scores at 12 lesions by the lung ultrasonography | After intubation and before the surgery start or after the surgery complete and before the extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-line score | Sum of the B-line scores at 12 lesions by the lung ultrasonography | After intubation and before the surgery start or after the surgery complete and before the extubation |