linjc16/ctgov huggingface dataset:
The Influence of Output on Skin Covered by Adhesive With Topfilm

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.

Official Title
-----------------
The Influence of Output on Skin Covered by Adhesive With Topfilm

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: New adhesive strip
* Other: Standard adhesive strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had an ileostomy for more than one year Have intact skin on the area used in the evaluation Has an ileostomy with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) Participating in other interventional clinical investigations or have previously participated in this evaluation -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 8<br>This is a sub-study testing the effect of real output on the skin applied under two adhesive strips. New adhesive strip Standard adhesive strip | Other: New adhesive strip<br>* This is a newly developed adhesive strip that in the future might be part of an ostomy device<br>Other: Standard adhesive strip<br>* This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | the condition of the skin (trans epidermal water loss) is measured after removing the adhesive from the skin | 6 hours |
Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

Study Overview
=================
Brief Summary
-----------------
In response to the evidence supporting tight glucose control (70 - 110) in the critical care setting, the MMH ICU developed a protocol utilizing regular intravenous insulin. This protocol was initiated in 2002. Monitoring of the data collected revealed effective glycemic control when this protocol was used. However, limited utilization has led to overall ineffective glycemic control in this ICU. The poor utilization is largely due to a general reluctance of physicians to start their patients on an intravenous insulin infusion. As contributing to this poor compliance is the open nature of the ICU. The MMH ICU is an open ICU, meaning that many physicians across multiple subspecialties admit to this unit. Approaches to controlling hyperglycemia vary greatly, depending largely upon the treating physician. In an attempt to improve overall glycemic control in this open ICU, the Subcutaneaous Insulin Aspart Hyperglycemia Protocol (SIAP) was developed which incorporates a subcutaneous insulin aspart regimen that triggers the use of a regular insulin infusion protocol when the SIAP is not adequately controlling the patient's blood glucose. This study aims to evaluate 1) the effect the SIAP on overall glycemic control in the ICU, 2) the effectiveness that the SIAP has on controlling blood glucose as compared with past practices using regular insulin, and 3) the effect the SIAP has on patient complications and outcomes in the MMH ICU.

Official Title
-----------------
Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Procedure: Hyperglycemia Protocol Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Valid physician order of the protocol. - Exclusion Criteria: No valid phycician order for the protocol -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hyperglycemia Protocol Procedure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) to evaluate the effect a subcutaneous insulin aspart hyperglycemia protocol on overall glycemic control in an ICU. |  |  | 
| 2) to evaluate the effect an insulin aspart hyperglycemia protocol has on controlling blood glucoses as compared with past practices of a regular insulin regimen. |  |  | 
| 3) to assess the effect a hyperglycemis i9nsulin aspart protocol has on patient outcomes in this ICU |  |  |
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Detailed Description
-----------------
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Official Title
-----------------
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Drug: lidocaine patch
* Drug: Sham patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with an indication for ofﬁce hysteroscopy Exclusion Criteria: patient refuse to participant contraindication for lidocaine patch

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blinded randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine patch<br>5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy. | Drug: lidocaine patch<br>* 5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.<br>* Other names: Experimental;|
| Placebo Comparator: Sham patch<br>Sham patch applied at 6 hours before the scheduled office hysteroscopy. | Drug: Sham patch<br>* Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.<br>* Other names: Placebo Comparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity will be assessed by visual analogue scale | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10 | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination | 15 minutes |
Molecular Phenotypes for Cystic Fibrosis Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop an integrated view of molecular mechanisms underlying CF lung disease severity.

Detailed Description
-----------------
BACKGROUND: Cystic fibrosis (CF) is a recessive genetic disorder caused by mutations in CF transmembrane conductance regulator (CFTR) gene. CF has multi-organ involvement, but respiratory disease is the major cause of morbidity and mortality. The median age of survival in CF is only 37 years, but there is a broad range of disease severity in the lung, even among patients with identical CFTR genotypes, including deltaF508 homozygotes. DESIGN NARRATIVE: This project holds great promise for defining a robust molecular phenotype for CF lung disease, which relates to prognosis, and new targets for therapy. By using a large and well-defined population of deltaF508 homozygotes who also have whole genome single nucleotide polymorphism (SNP) data, and by studying gene expression across the whole transcriptome in a large number of samples of two relevant tissues (respiratory epithelium and transformed lymphocytes), we will be uniquely positioned to develop an integrated view of molecular mechanisms underlying CF lung disease severity.

Official Title
-----------------
Molecular Phenotypes for Cystic Fibrosis Lung Disease

Conditions
-----------------
Cystic Fibrosis, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with CF Participation in Genetic Modifiers of CF Lung Disease study (NCT00037765) Exclusion Criteria: History of lung transplant Fully anticoagulated or clotting abnormalities Large nosebleed in the last 2 months Acutely ill

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
Clinical Investigation for New Filter to Ostomy Bags

Study Overview
=================
Brief Summary
-----------------
The aim of the current clinical investigation is to evaluate a new filter.

Detailed Description
-----------------
The new filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Official Title
-----------------
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Conditions
-----------------
Colostomy

Intervention / Treatment
-----------------
* Device: Morfeus
* Device: SenSura


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age and have full legal capacity. Have given written informed consent. Be able to fill in the Case Report Form. Be colostomy operated and have had a stoma for at least 6 months. Experience ballooning at least once per week. Be able to manage the bags themselves (application, removal). Be able to use a flat base plate. Have a stoma with a diameter less than 60 mm Exclusion Criteria: Persons who irrigate Currently suffer from peristomal skin problems (i.e. bleeding or broken skin). Currently receiving or have within the past 2 months received radio- and/or chemotherapy. Pregnant or breastfeeding. Participate in other test at the same time.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SenSura<br>The reference product is the CE marked and launched SenSura product which is commercially available | Device: SenSura<br>* The CE marked ostomy bag filter will be tested for a period of 14 days<br>|
| Experimental: Morfeus<br>The test product is the product with the proposed new Morfeus filter | Device: Morfeus<br>* The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Ballooning in the Morfeus and SenSura Test Period. | Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period. | Daily or at every change of bag in a period of a maximum of 28 days |
Identifying the Needs of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore and potentially increase the capacity of the non-VA community mental health system within the state of Colorado to provide a comprehensive and coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health issues.

Detailed Description
-----------------
The focus of this project is on qualitative data collection to facilitate product development including assessment and treatment guidelines to improve non-VA community mental health care for OEF/OIF Veterans with TBI and co-occurring behavioral health issues within the state of Colorado. In addition to the development of assessment and treatment guidelines, other products developed through this study will include a training and accompanying toolkit, which may be used for annual educational training of mental health providers. As such, there are no hypotheses associated with this study. This statewide initiative may not only improve quality and access to non-VA community mental health care for persons with TBI and co-occurring behavioral health issues within Colorado, but also serve as a model for implementation across the country.

Official Title
-----------------
Identifying the Needs of OEF/OIF Veterans and Their Families: TBI and Co-Occurring Behavioral Health Issues

Conditions
-----------------
Traumatic Brain Injury, Co-Occurring Behavioral Health Issues

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorado Behavioral Health Organization (BHO) mental health providers OEF/OIF United States Veterans Family members and/or friends of OEF/OIF United States Veterans Ages 18-65 Exclusion Criteria: - N/A

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OEF/OIF Veterans with TBI<br> | |
| Family Members and Friends<br>Family Members and Friends of OEF/OIF Veterans with TBI | |
| Community Mental Health Center Providers<br>Community Mental Health Center providers working with OEF/OIF Veterans with TBI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Focus Groups |  | One Time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OEF/OIF Veterans, Traumatic Brain Injury, Community Mental Health
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy

Study Overview
=================
Brief Summary
-----------------
To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy To determine the optimal time interval for re-screening in average risk individuals To determine potential baseline characteristics that predicts adenoma recurrence

Detailed Description
-----------------
Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. However, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown. This study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.

Official Title
-----------------
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy

Conditions
-----------------
Colonic Cancer

Intervention / Treatment
-----------------
* Procedure: colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are previously participated in one of our two screening colonoscopy studies [Sung, Gastroenterol 2003; Leung, AJG 2004] Asymptomatic on first screening colonoscopy Age>50and <75 No family history of CRC No other colonoscopy except the baseline screening colonoscopy Exclusion Criteria: Subjects who refused consent Subjects who are not warrant follow up colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| A<br>colonic adenoma | Procedure: colonoscopy<br>* proform a follow up colonoscopy in the 5 year period from index colonoscopy<br>* Other names: follow up colonoscopy;|
| B<br>colonic without adenoma | Procedure: colonoscopy<br>* proform a follow up colonoscopy in the 5 year period from index colonoscopy<br>* Other names: follow up colonoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of advanced colonic adenoma in the re-screening population |  | 5 year from index colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings |  | 5 years from index colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonic adenoma, colonic advanced neoplasm
Effect of Liking on Fruit Intake

Study Overview
=================
Brief Summary
-----------------
Increased dietary variety has been shown to increase intake in animals, as well as humans, as compared to a diet or meal composed of one food. While most studies investigating dietary variety have focused on energy-dense foods (i.e., snack foods) and have emphasized the negative component that variety has on intake, very little research has been conducted with variety to determine if this food characteristic can be used to increase consumption of healthy foods (i.e., fruits). We hypothesize that increasing variety of fruits provided in an eating bout will lead to increased intake of these foods. Therefore, the aim of this investigation is to test the environmental factor of variety on fruit intake in males and females aged 18 to 45 years.

Conditions
-----------------
Intake of Fruit

Intervention / Treatment
-----------------
* Behavioral: variety


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking Non-obese Unrestrained males and females Exclusion Criteria: Health condition or use medications that influence food intake Require specialized diet therapy Following a weight loss diet, an athlete, or pregnant or breastfeeding Have allergies or aversions to foods used in study Report being a binge eater

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: variety|variety and nonvariety|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fruit intake |  | 5 weeks |
Sonoelastography of the Uterine Cervix Before Induction of Labor

Study Overview
=================
Brief Summary
-----------------
The investigators aim to measure sonoelastographically the elasticity of the uterine cervix in pregnant patients at term before induction of labor and compare between patients with successful and failed inductions.

Detailed Description
-----------------
Softening of the uterine cervix in pregnant patients at term causes changes in its elasticity.these changes may affect success or failure in induction of labor.The elasticity of the uterine cervix is usually evaluated clinically and subjectively by vaginal examination (bishop's score) which is not very predictive.We aim to measure the elasticity quantitatively and objectively.The difference in strain, in the area of the internal os , is often illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.The color maps will be compared between patients with successful and failed inductions.

Official Title
-----------------
Sonoelastography of the Uterine Cervix Before Induction of Labor

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Device: Accuvix SnonAce UGEO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant patients before induction of labor Exclusion Criteria: pregnant patients undergoing caesaren section following induction of labor not in active labor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Accuvix SnonAce UGEO|vaginal ultrasonography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity of the uterine cervix as measured sonoelastographically in successful and failed inductions of labor |  | 48-72 hours |