linjc16/ctgov huggingface dataset:
The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.

Detailed Description
-----------------
Given the physiologic and experimental evidence regarding temperature regulation; it remains convincing that forced air warming is protective against the development of SSI. We will set out to prospectively study the effect of forced air warming on patients undergoing cesarean section.

Official Title
-----------------
The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Device: forced-air warming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥ 18 years old) female subjects who will undergo cesarean delivery regardless of indication. Subjects who have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Patients scheduled to receive prophylactic antibiotic therapy. Exclusion Criteria: Patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices. Patients undergoing general anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| No Intervention: A<br>Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities | |
| Active Comparator: B<br>Patients in Group B will have a forced-air warming device applied to the upper body above the waist at the 43 degree Celsius setting. | Device: forced-air warming<br>* forced-air warming device<br>* Other names: Bair Hugger device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment effects on wound infection |  | As is current standard of care post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment effects on endometritis |  | as is current standard of care post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
forced-air warming, Bair Hugger, cesarean section, postoperative infection, surgical site infections
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Study Overview
=================
Brief Summary
-----------------
Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and manifests as a difficulty in waking up in the morning, going to sleep early enough at night, and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this study is to determine if brief flashes of light, that are scheduled to occur during sleep, are effective in treating DSPD.

Official Title
-----------------
Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep

Conditions
-----------------
Delayed Sleep Phase Disorder

Intervention / Treatment
-----------------
* Device: Flashes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Full-time in high school primary sleep complaint consistent with delayed sleep phase disorder Exclusion Criteria: sleep only in prone position currently taking medications specifically for the treatment of a sleep disorder

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light<br>one hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during hour immediately prior to desired waketime | Device: Flashes<br>* one hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during the hour immediately prior to desired waketime<br>|
| Placebo Comparator: Fake light<br>during hour immediately prior to desired waketime, subjects will receive one light flash (insufficient to cause phase shift) | Device: Flashes<br>* one hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during the hour immediately prior to desired waketime<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Determined by questionnaire (Adolescent Sleep Wake Scale) | weekly for four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Center for Epidemiologic Studies Depression Scale for Children (depressive symptoms) SNAP-IV 26 (ADHD symptoms) | at the begining and end of intervention (4 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
teen, sleep, circadian, delayed sleep phase disorder, adolescent
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive FloWave™ 1000 device.

Official Title
-----------------
Validation Study Comparing the Cardiac Output Pulmonary Arterial Catheter (Swan Ganz) to the FloWave™ 1000 Device

Conditions
-----------------
Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation, Aortic Valve Disease, Tricuspid Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Only: The FloWave device is intended for use on adult patients only. All subjects will be 18 years or older. Existing placement of a Pulmonary Arterial Catheter placed for medical reasons other than our study. Exclusion Criteria: Patients with aortic balloon pumps and cardiac mechanical assist devices will be excluded from study enrollment if the devices are present during the screening process. If patients have cardiac assist devices inserted after enrollment in the study, cardiac output data will be collected with both the PAC and FloWave device and will be evaluated as a subset analysis population at the conclusion of the study. Patients with intracardiac shunts will be excluded from this study. FloWave cardiac output determinations are dependent on detection of a pulse. If no peripheral pulse can be detected the device will not be able to perform a measurement and this will be indicated to the user. Patients who are not in a steady hemodynamic state shall be excluded from the study. Presence of arrhythmias: Patients with arrhythmias are excluded from the study when not in a steady hemodynamic state. If a patient has a history of arrhythmia or is currently experiencing an arrhythmia but is in a maintained hemodynamic state, they will not be excluded from enrollment into the study. Their clinical symptoms and cardiac rhythm will be evaluated and noted in the patient data record. Inability or unwillingness of subject or the subject's legally authorized representative to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Correlation of FloWave 1000™ Device estimated cardiac output results with Pulmonary Catheter Themodilution Push derived cardiac output results. |  | Simultaneous data collection during procedure. No follow-up required. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-invasive Cardiac Output
Early Intelligent Diagnosis of Limb Deformity in Children by AI and Clinic Application

Study Overview
=================
Brief Summary
-----------------
The limb deformity in children include congenital limb malformations or acquired from the damage of epiphyseal plate which caused by tumor, inflammation and trauma. Due to the complexity of the disease itself, rapid dynamic development and the characteristics of children's growth and development, the deformities are constantly changing. In addition, the serious lack of clinical diagnosis and treatment resources in the Department of Pediatric Orthopedics has led to the misdiagnosis and improper treatment of children's limb deformities. Thus, its necessary to find an intelligent way to help doctor to early diagnosis of limb deformity and provide a proper treatment in children.

Detailed Description
-----------------
The extraction and application of big data of children's limb deformities, intelligent labeling of image data, precise positioning, and perfecting the anatomical data of children's limb deformities.Improve the positioning accuracy of key points in X-ray images of children's limb deformities by means of step-by-step supervision to improve the accuracy of diagnosis.Realize an intelligent report generation system that combines patient background information, establish an end-to-end auxiliary diagnosis and treatment suggestion demonstration application system; realize a full set of artificial intelligence solutions for children's skeletal deformities, early screening and diagnosis of children, and forming an intelligent referral system of children's limb deformities.

Official Title
-----------------
The Studies of Early Intelligent Diagnosis of Limb Deformity in Children by AI and Clinic Application

Conditions
-----------------
Limb Deformity

Intervention / Treatment
-----------------
* Other: No interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with limb deformity Exclusion Criteria: Children without limb deformity

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| limb deformity children<br>the imaging of limb deformity diagnosis by AI | Other: No interventions<br>* It is an observational study. No interventions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deformity detection | It is a binary variable (1/0). The radiographic features of children would be evaluated by artificial Intelligence. If the deformity was detected, variable would be setted into 1. | At enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Limb deformity; Pediatrics ; Artificial intelligence
Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

Study Overview
=================
Brief Summary
-----------------
Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.

Detailed Description
-----------------
Cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. Routinely cholecystectomy specimens sent for histopathologic examination. The histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. The histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. Also there is additional cost for the patients. Because of that the idea of selective histopathologic examination has been raised.

Conditions
-----------------
Cholelithiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has cholelithiasis Exclusion Criteria: Subject has acute cholecystitis Subject has perforated gallbladder Subject has malignancy Subject has polyps in the gallbladder Subject has increasing wall thickness of the gallbladder Subject has malignancy in the preoperative ultrasonography in the gallbladder Subject has pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Benign<br>Benign pathology specimens with macroscopically | |
| Suspicious<br>Suspicious group includes the conditions such as increasing of the gallbladder wall thickness, having calcifications or polyps in the gallbladder. | |
| Malign<br>Malign group includes the conditions such as detecting mass or irregularities in the gallbladder wall. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases | The 1000 cholecystectomy specimens will be evaluated macroscopically by two experienced surgeons with a longitudinal incision to the gallbladder. The specimens will be grouped as benign, suspicious, malign according to the surgeon's decision. To confirm the surgeon's macroscopic evaluation, all of the specimens will be evaluated histopathologically. The results of macroscopic and histopathological examinations will be compared. | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
histopathology, gallbladder, specimen
ICS/LABA Adherence and COPD Exacerbation

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.

Detailed Description
-----------------
This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.

Official Title
-----------------
Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Other: Non-Interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least one prescription fill for ICS/LABA combination during identification period. COPD diagnosis 40 years or older at index date > or = 12 months of continuous health plan enrollment prior to and following index date 1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period. Exclusion Criteria: Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period Patients with cancer diagnosis in 12 month pre-index period

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 99 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 |
| --- | --- |
| ICS/LABA Patients<br>ICS/LABA Patients following standard of care | Other: Non-Interventional Study<br>* Non-Interventional Study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation rate | Rate of COPD exacerbation occurring during the 12 months after therapy initiation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Exacerbation rate | Severe exacerbation rate during the 12 months after therapy initiation | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Chronic Bronchitis, Pulmonary Emphysema
Sunscreen: Persistence of Sun Protection Factor and the Influence on Vitamin D

Study Overview
=================
Brief Summary
-----------------
The investigators want to investigate whether sunscreen is removed by clothing and to what extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to investigate the persistence of sunscreen during eight hours indoor. How much does the SPF reduces? Furthermore, we want to investigate whether sunscreen in the layers 2, 1, and 0.5 mg/cm2 reduce the vitamin D production in the skin.

Official Title
-----------------
Sunscreen Removal by Clothing Meassured in Vivo. Sun Protection Factor Persistence During a Day Indoor Without Physical Activity. Does Sunscreen Reduce Vitamin D?

Conditions
-----------------
Vitamin D Production in the Skin, Sunscreen Persistence

Intervention / Treatment
-----------------
* Other: sunscreen MATAS sunlotion SPF 8
* Radiation: UVB light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants. > 18 years. Skin type I, II, and III. Exclusion Criteria: Pregnancy. Medicin use. Skin or other diseases. The participants must not have been in solarium or gotten sun on their trunks in the 3 months before the study start and during the study. Skin types IV and above.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>No sunscreen applied | Radiation: UVB light<br>* duration 4 times 1 minute radiation on the trunk.<br>|
| Active Comparator: 2<br>Sunscreen applied 0.5 mg/cm2 | Radiation: UVB light<br>* duration 4 times 1 minute radiation on the trunk.<br>|
| Active Comparator: 3<br>Sunscreen applied 1mg/cm2 | Radiation: UVB light<br>* duration 4 times 1 minute radiation on the trunk.<br>|
| Active Comparator: 4<br>Sunscreen applied 2mg/cm2 | Other: sunscreen MATAS sunlotion SPF 8<br> <br> * Other names: MATAS sollotion. Matas Denmark, 3400 Alleroed;Radiation: UVB light<br>* duration 4 times 1 minute radiation on the trunk.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D (nmol) meassured in a blood sample. |  | 5 days after sunscreen use and UV light exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sunscreen, Application, Vitamin D, Sun protection factor, Clothing
Systemic Pharmacokinetics of BOL-303224-A

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.

Official Title
-----------------
Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis

Conditions
-----------------
Conjunctivitis, Bacterial

Intervention / Treatment
-----------------
* Drug: BOL-303224-A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be at least 18 years of age, any race must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test Exclusion Criteria: Pregnant or nursing women known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication use of any antibiotic within 72 hours of enrollment participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOL-303224-A<br>Systemic exposure of BOL-303224-A following single and multiple topical doses | Drug: BOL-303224-A<br>* 1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).<br>* Other names: Besifloxacin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing |  | Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection |  | Througout the study |