linjc16/ctgov huggingface dataset:
Cryo-Touch II for the Treatment of Wrinkles

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.

Conditions
-----------------
Facial Wrinkles

Intervention / Treatment
-----------------
* Device: Cryo-Touch II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 30-70 years Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)* Subject has signed IRB-approved informed consent form Exclusion Criteria: Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites The investigator is unable to substantially lessen facial lines by physical separation Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months Subject is participating in another facial cosmetic research study Patient has any of following conditions: History of facial nerve palsy Marked facial asymmetry Ptosis Excessive dermatochalasis Deep dermal scarring Thick sebaceous skin History of neuromuscular disorder Chronic dry eye symptoms Allergy or intolerance to lidocaine

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryo-Touch II<br> | Device: Cryo-Touch II<br>* Percutaneous treatment with the device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Effectiveness and Safety Success | Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale Safety success: the absence of a device-related serious adverse event (DSAE) | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With One Point Improvement in Line Severity | • Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline | Baseline and up to 4 months | 
| Participants With an Improvement in Global Appearance | • Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline | Up to 4 months |
Influences of Leadership Style on Team Climate for Quality

Study Overview
=================
Brief Summary
-----------------
This study is to discuss how different personalities of leaders and employees result in the effect of quality and efficiency in different organizational climate and also how the leadership style of different leaders affect the organizational climate. The investigators hope that this study will improve the key factor of quality and efficiency among leaders. Besides, the investigators want to provide the reference of quality control for the groups of healthcare quality in order to avoid unnecessary time and costs and achieve the goal of improvement quality.

Detailed Description
-----------------
The specific purpose of this study is the following: to discuss the relationship of organizational climate due to different leadership styles. to discuss the relationship of quality efficiency due to different organizational climates. to discuss the relationship of quality efficiency due to different leadership styles.

Official Title
-----------------
Influences of Leadership Style on Team Climate for Quality

Conditions
-----------------
Leadership Style

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: employees in the hospitals Exclusion Criteria: none employees in the hospitals

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
Leadership Style, Team Climate
Osteopathic Approach Into Neonatology Ward: the NE-O Model

Study Overview
=================
Brief Summary
-----------------
Background Several studies have shown the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results obtained, there is still lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (NICU). The aim of this research is to provide a guideline on osteopathic approach in treating hospitalized newborns. Specific evaluation tests and treatments have been developed to tailor osteopathic method according to preterm and term infants' needs, NICU environment, medical and paramedical assistance.

Official Title
-----------------
Osteopathic Approach Into Neonatology Ward: the NE-O Model

Conditions
-----------------
The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.

Intervention / Treatment
-----------------
* Other: Osteopathic Manipulative Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn admitted to neonatal intensive care unit informed consent signed from parent or legal guardian Exclusion Criteria: post surgery patients

Ages Eligible for Study
-----------------
Minimum Age: 29 Weeks
Maximum Age: 40 Weeks

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Osteopathic Manipulative Treatment|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
-----------------
osteopathic manipulative treatment, newborns, preterm infants, procedures
Young Adult Smoker's Treatment Demand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether tailored online advertisements will drive young adult smoker's (18 to 26 years old), who are motivated to quit, to use Internet-based cessation treatment.

Official Title
-----------------
Increasing Young Adult Smoker's Demand for Internet-based Cessation Treatment

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Online advertisement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 30 years old smoke on some days or everyday enrollment in specified online cessation program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- |
| No ad exposure<br>Young adults, who enroll in the cessation program, one month prior to presenting the online advertisements (intervention). | |
| Ad exposure<br>Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention). | Behavioral: Online advertisement<br>* Internet advertisement with messages tailored for young adult smoker's motivated to quit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Enrollment | Rates of enrollment will be calculated as the proportion of visitors who enroll in treatment (e.g., number of enrollments/number of click-throughs from banner ads). | 1-month intervals over 7 months |
Effect of Head Rotation on Overlap and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children: A Study of the Anatomy Using Ultrasonography

Study Overview
=================
Brief Summary
-----------------
Effect of head rotation on overlap and relative position of internal jugular vein to carotid artery in infants and children: A study of the anatomy using ultrasonography.

Official Title
-----------------
Effect of Head Rotation on Overlap and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children: A Study of the Anatomy Using Ultrasonography

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric patients scheduled for elective urologic surgery were enrolled on a convenience basis, irrespective of their diagnosis or whether central venous access was planned. Exclusion Criteria: Infants or children with possible c-spine disorders or haemodynamic instabilities.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- |
| surgery with general anesthesia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of internal jugular vein's relative position to carotid artery in children |  | noninvasive ultrasonographic observation after inducing general anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infants and children undergoing surgery with general anesthesia
Oral Bioavailability of Two Solid Formulations of GLPG0259.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.

Official Title
-----------------
A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: GLPG0259 fumarate
* Drug: GLPG0259 free base


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years BMI between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single oral dose, single capsule<br> | Drug: GLPG0259 free base<br>* single oral dose, GLPG0259, 50 mg solid formulation<br>|
| Experimental: Single oral dose, two capsules<br> | Drug: GLPG0259 fumarate<br>* single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of two solid dosage formulations of GLPG0259 |  | up to 96 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of GLPG0259 |  | up to 96 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics
The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer

Official Title
-----------------
The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: surgery(robot versus laparoscopy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 75 > age > 20 Rectal cancer Non-distance metastasis Agree with this study Exclusion Criteria: Benign prostate hyperplasia Previous history of urinary bladder or prostate gland operation Severe erectile dysfunction Defined as patients whose erectile scores were less than 10 in a preoperative questionnaire of the International Index of Erectile Function (IIEF)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| robotic surgery group<br> | Procedure: surgery(robot versus laparoscopy)<br> <br> |
| laparoscopic surgery group<br> | Procedure: surgery(robot versus laparoscopy)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in 1 month between two surgical methods in terms of Bladder function. | The robotic surgery for rectal cancer seemed to be associated with a much earlier recovery of normal voiding and sexual function compared to those of laparoscopic surgery although it needs to be verified by larger prospective comparative studies | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in 3 months between two surgical methods in tems of Sexual function. |  | 3 months | 
| The serial change of Bladder and sexual function according to times, in each operation method. |  |  |
Study of the Touch® Trapezo-metacarpal Prosthesis

Study Overview
=================
Brief Summary
-----------------
Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis

Detailed Description
-----------------
Prospective observational study of implanted patients with a new orthopaedic implant: the Touch double mobility trapezo-metacarpal prosthesis, 15 years follow up.

Official Title
-----------------
Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis

Conditions
-----------------
Thumb Osteoarthritis, Complications Due to Internal Joint Prosthesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients implanted with the Touch® prosthesis by one of the three investigating surgeons Exclusion Criteria: Patient not in capacity to understand the study Patient not in capacity to consent to the study
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 |
| --- | --- | --- |
| Implant Survival at 3 years | Failure rate of the implant | 3 Years | 
| Implant Survival at 5 years | Failure rate of the implant | 5 Years | 
| Implant Survival at 10 years | Failure rate of the implant | 10 Years | 
| Implant Survival at 15 years | Failure rate of the implant | 15 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Outcome at 3 years | QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better | 3 Years | 
| Functional Outcome at 5 years | QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better | 5 Years | 
| Functional Outcome at 10 years | QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better | 10 Years | 
| Functional Outcome at 15 years | QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better | 15 Years |
Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.

Official Title
-----------------
An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Candesartan
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers af aged between 20 years to 45 years Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive Eligible subjects with acceptable medical history and physical examination Exclusion Criteria: - Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: Candesartan<br> <br> |
| Experimental: Treatment B<br> | Drug: Rosuvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss of candesartan | 0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h | 22 points | 
| Cmax,ss of candesartan | 0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h | 22 points | 
| AUCτ,ss of rosuvastatin | 0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h | 28 points | 
| Cmax,ss of rosuvastatin | 0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h | 28 points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax,ss of candesartan | 0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h | 22 points | 
| CLss/F of candesartan | 0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h | 22 points | 
| Cmin,ss of candesartan | 0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h | 22 points | 
| tmax,ss of rosuvastatin | 0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h | 28 points | 
| CLss/F of rosuvastatin | 0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h | 28 points | 
| Cmin,ss of rosuvastatin | 0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h | 28 points |
Magnesium and TKA Pain

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that in staged bilateral total knee arthroplasty (TKA, magnesium sulfate administered during the perioperative period of the first TKA may decrease pain after the second TKA. It is known that pain is greater in the second TKA than in the first. Therefore, we compared pain of the second TKA between the magnesium and control groups.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Magnesium Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American society of anesthesiologist physical status 1 - 2. patients scheduled to undergo staged bilateral TKA Exclusion Criteria: American society of anesthesiologist physical status >3 -

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control group receive same volume of normal saline as in the magnesium group | |
| Experimental: magnesium<br>This group receive magnesium sulfate perioperatively. | Drug: Magnesium Sulfate<br>* The magnesium group receive intravenous magnesium sulfate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain measured with visual analogue scale (VAS) | from the end of the TKA until 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic | analgesic consumptions from the end of the TKA until 48 hours | from the end of the TKA until 48 hours |