linjc16/ctgov huggingface dataset:
Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma

Study Overview
=================
Brief Summary
-----------------
Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.

Official Title
-----------------
Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma

Conditions
-----------------
Trauma, Burns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed written consent 18 years and older severe trauma (ISS > 15) burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface) SIRS Exclusion Criteria: not fulfilling the inclusion criteria failure to adhere

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 |
| --- | --- |
| polytrauma patients<br>Patients with severe traumatic injury, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital. | |
| burns patients<br>Patients with burns trauma, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement | By using Point-of-care measurement of serum cholinesterase activity (U/l) and by observing a change in the enzyme activity over time (reduction of serum cholinesterase activity within the first 6 hours after traumatic injury) would allow an additional tool in early diagnosis and treatment of systemic inflammation. | after completed patient recruitment, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of the cholinesterase activity and the trauma/disease severity scores | To evaluate the correlation of the serum cholinesterase activity change with the trauma severity, the obtained serum cholinesterase activities (U/l) will be compared to the trauma severity scores (ISS, %TBSA). | after completed patient recruitment, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serum cholinesterase, plasma cholinesterase, pseudocholinesterase, systemic inflammation, SIRS, polytrauma
Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled Study to Determine the Efficacy of Soluble Beta-1,3/1,6-glucan in Chronic Foot Ulcers in Diabetes

Conditions
-----------------
Chronic Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Drug: Soluble beta-glucan (SBG)
* Drug: Placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or Type 2 diabetes mellitus Age ≥ 18 years One or more full-thickness ulcers at or below the level of the malleoli, which do not extend to tendon, joint, or bone The ulcer (or index ulcer, if appropriate) must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years Ankle:brachial pressure index (ABPI) >0.7, or the presence of two palpable pulses on the affected foot Ulcer area >25 mm2 but <500 mm2 Written informed consent Exclusion Criteria: Pregnancy, lactation or absence of adequate contraception for women with child bearing capacity ABPI < 0.7 Serum albumin < 2.0 g/dL Gangrene on any part of the foot with the study ulcer Presence of signs of clinically significant foot infection on Day 0 Chronic renal failure with calculated GFR <30 ml/min Surgical procedure (other than debridement) on the foot with the study ulcer in the 28 days prior to Day 0 HbA1c 12% or more Current alcohol or drug abuse Participation in other studies in the preceding 28 days An ulcer on a foot affected by acute Charcot osteoarthropathy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SBG | Drug: Soluble beta-glucan (SBG)<br>* Topical application of SBG to the wound, at least twice a week until complete healing or for 8 maximum weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo comparator<br>* Topical application of placebo to wound, at least twice a week until compleate healing or for maximum 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Trial Comparing Tissue Adhesive Vs. Absorbable Suture Vs. Non-Absorbable Suture

Study Overview
=================
Brief Summary
-----------------
Standard suture is superior to both tissue adhesive (2-octyl cyanoacrylate) and absorbable sutures with respect to cosmetic outcome of, complication rate of and parental satisfaction with the closure of low tension facial, neck and shoulder, wounds in children and adolescents

Official Title
-----------------
A Randomized Clinical Trial Comparing Tissue Adhesive (2-Octylcyanoacrylate) Vs. Absorbable Suture Vs. Non-Absorbable Suture for the Closure of Low Tension Facial and Neck Wounds in Children and Adolescents

Conditions
-----------------
Cyst of Face, Neck or Shoulder, Pilomatrixoma of Face, Neck or Shoulder

Intervention / Treatment
-----------------
* Device: standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age less than or equal to 18 Pre-operative diagnosis of cyst or pilomatrixoma of neck, face or shoulder outpatient scheduled for outpatient or day surgery at Children's Hospital San Diego Exclusion Criteria: known hypersensitivity to cyanoacrylate or formaldehyde lesions with any evidence of active infection or gangrene lesions on or across mucocutaneous surfaces lesions in which skin may be regularly exposed to body fluids lesions located in areas of dense natural hair (ie scalp) patients with peripheral vascular disease, insulin dependent diabetes mellitis or blood clotting disorders patients with known immunodeficiencies inability to return for follow-up

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: standard suture (5-0 prolene), topical skin adhesive (dermabond), absorbable suture (5-0 Chromic gut)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

Study Overview
=================
Brief Summary
-----------------
We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.

Detailed Description
-----------------
This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study.

Official Title
-----------------
the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study

Conditions
-----------------
Common Cold, Gastroenteritis

Intervention / Treatment
-----------------
* Drug: dietary supplement--echinacea, propolis, and vitamin c


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3-6 Exclusion Criteria: Cystic fibrosis Immunodeficiency Bronchopulmonary dysplasia Anatomic abnormalities of respiratory tract Intestinal malabsorption Allergy to sunflower seeds

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dietary supplement--echinacea, propolis, and vitamin c|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper respiratory tract infections |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin c, echinacea, propolis, upper respiratory tract infection, common cold, gastroenteritis, dietary supplement, herbal remedy
Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic.

Official Title
-----------------
Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project WOMAN 2005

Conditions
-----------------
Menopause, Hormone Replacement Therapy, Post-Menopausal

Intervention / Treatment
-----------------
* Drug: Marketed low dose hormone replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low dose HRT<br> | Drug: Marketed low dose hormone replacement therapy<br>* A low dose of marketed HRT products prescribed at the discretion of the treating physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast tenderness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient treatment satisfaction after switch to low dose HRT |  |  |
The Effect of Preoperative Anxiety Level on the Induction Dose of Propofol and Minimum Alveolar Concentration (MAC) Hour of Sevoflurane During Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the level of anxiety, and to check the correlation of induction dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing thyroidectomy.

Official Title
-----------------
The Effect of Preoperative Anxiety Level on the Induction Dose of Propofol and MAC-hour of Sevoflurane During Thyroidectomy

Conditions
-----------------
Thyroidectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients (ASA physical status I and II) aged between 20-65 years and scheduled elective thyroidectomy Exclusion Criteria: cardiovascular, renal, liver disease, or psychiatric disorder

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

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

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 |
| --- | --- | --- |
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

Study Overview
=================
Brief Summary
-----------------
The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.

Official Title
-----------------
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: Nalmefene hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have completed Study 339-14-001 Patients who have signed the informed consent form for Study 339-14-002 Exclusion Criteria: The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder) The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Nalmefene hydrochloride 20 mg<br>As-needed; tablets, orally | Drug: Nalmefene hydrochloride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 24-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Number of Heavy Drinking Days (HDDs) From Baseline |  | Week 24 | 
| Change in Total Alcohol Consumption (TAC) From Baseline |  | Week 24 |
Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections

Study Overview
=================
Brief Summary
-----------------
The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Detailed Description
-----------------
The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Official Title
-----------------
Effect of Vaginal Douching With Betadine Versus Non Douching Before CS for Prevention of Post Operative Infections

Conditions
-----------------
Puerperal Infection

Intervention / Treatment
-----------------
* Behavioral: Betadine douches


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing CS Exclusion Criteria: • Betadine allegy. Rupture membranes. Accidental Hemorrhage. H/O suggestive chorioamnionitis ; uterine tenderness, offensive vaginal discharge, fever medical disorders as diabetes, hypertension , cardiac or renal diseqases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Betadine douches<br>subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery | Behavioral: Betadine douches<br>* subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery<br>|
| No Intervention: Non betadine douches<br>subjects didnot received a vaginal preparation prior to caesarean delivery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum endometritis | a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy. | 6 weeks after Cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative wound infection | erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy | 6 weeks after Cesarean section | 
| Postoperative fever | temperature higher than 38 degrees C | 3 weeks after Cesarean section |
Study of Stomatognathic System of the Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects.

Detailed Description
-----------------
The aim of this study was to identify differences in the stomatognathic system between obese and normal weight subjects. The habitual chewing of a French bread and deglutition of solids and liquid was evaluated five times in obese subjects and controls. The tonus of the lips, tongue, cheeks, masseter and temporal muscles were evaluated by clinical observation and palpation and defined as either normal or reduced. Twenty obese patients (body mass index (BMI) > 30kg/m2) and twenty volunteers of normal weight (BMI 18.5-24.9 Kg/m2) were evaluated.

Official Title
-----------------
Study of Stomatognathic System,Chewing and Deglutition Functions in the Obese Subjects

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults male and female healthy dentate body mass index (BMI) higher than 30 Kg/m2 for the obesity group and (BMI) lower than 25/m2 for the normal weight group. Exclusion Criteria: face deformity alterations in morphology of lips and tongue without teeth or with lack of one tooth (excluding third molars) Malocclusion Angle's Class II and III pain during chewing pathology of the temporomandibular joint neurological pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 58 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 |
| --- | --- |
| 1<br>Obese subjects | |
| 2<br>Normal-weight subjects | |

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
-----------------
chewing, deglutition, orofacial motricity, obesity
Adverse Events During Upper Gastrointestinal Endoscopy

Study Overview
=================
Brief Summary
-----------------
The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population

Official Title
-----------------
Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai

Conditions
-----------------
Patients Need Upper Gastrointestinal Endoscopy, Peptic Ulcer, Gastric Cancer, Esophagus Cancer, Oesophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will undergo upper gastrointestinal endoscopy Age > 18 years old Signed informed consent form Exclusion Criteria: Pregnant Allergy to propofol or soybean or albumen

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 |
| --- | --- |
| Sedation<br>patients underwent upper gastrointestinal endoscopy with sedation | |
| non-sedation<br>patients underwent upper gastrointestinal endoscopy without sedation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Investigate the adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy with and without sedation. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse events, Upper gastrointestinal endoscopy, Sedation