linjc16/ctgov huggingface dataset:
SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit

Study Overview
=================
Brief Summary
-----------------
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate

Detailed Description
-----------------
The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.

Official Title
-----------------
SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection

Conditions
-----------------
Anastomotic Leakage

Intervention / Treatment
-----------------
* Device: LifeSeal® Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age at screening visit Written informed consent obtained Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis* created within 15 cm from the anal verge. Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU Exclusion Criteria: 1. Subject with American Society of Anesthesiology (ASA) status > 3.

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 |
| --- | --- |
| LifeSeal® Kit<br>creation of a coloanal or colorectal anastomosis | Device: LifeSeal® Kit<br>* used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative clinical anastomotic leaks at discharge |  | discharge from hospital 3-14 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery |  | up to 4 weeks post surgery |
Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.

Study Overview
=================
Brief Summary
-----------------
Although outpatient surgery is increasing in France, particularly in paediatrics, compliance with analgesics prescriptions and pain management on return home remain poorly controlled parameters, although they are essential for optimal care. This is due, among other things, to parents' lack of knowledge and fears about the medicines prescribed to them. The paediatric anaesthesia unit of the Rouen University Hospital has set up a website for families to improve understanding of and compliance with the prescription of painkillers and thus improve the management of postoperative pain.

Official Title
-----------------
Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.

Conditions
-----------------
Paediatric Surgery, Analgesics Prescriptions

Intervention / Treatment
-----------------
* Other: Website access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a Physical status score equal or II Ages 2-12 Receiving outpatient surgery according to the eligibility criteria established in the latest expert recommendations in 2009 and in accordance with the service's practices Exclusion Criteria: Lack of access to internet Cognitive dysfunction in children that interfere with understanding instructions Patient already receiving a analgesic treatment

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: website access for families<br> | Other: Website access<br>* website access will be provide to families<br>|
| No Intervention: standard care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of analgesic treatment taken |  | day 1 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of analgesic treatment taken |  | day 2 after surgery |
A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women

Study Overview
=================
Brief Summary
-----------------
Advancing age in itself is associated with changes in body composition. However, during transitional life stages, such as retirement, detrimental changes on diet and physical activity may occur. This might lead to weight gain and accumulation of abdominal fat. To prevent these changes, participants receive a low-intensity intervention on energy balance and related behaviours. After six months, one and two years, the effects will be studied by comparing the intervention group with the control group.

Official Title
-----------------
An Individual-based Diet and Physical Activity Intervention Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women

Conditions
-----------------
Retirement, Weight Gain

Intervention / Treatment
-----------------
* Behavioral: Behavior change on physical activity and diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy and recently retired Exclusion Criteria: Using drugs that might influence body composition, digestion or physical activities

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior change on physical activity and diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure) |  |  | 
| Energy intake (Food Frequency Questionnaire) |  |  | 
| Physical activity level (Physical Activity Scale for the Elderly) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial factors (attitude, social influence, self-efficacy etc.) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention, Retirement, Physical activity, Diet, Weight gain, Body composition
Study of Daclizumab in Patients With Chronic, Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate an investigational medication to treat chronic persistent asthma. The research is being conducted at up to 22 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 10-month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Official Title
-----------------
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Daclizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of asthma for 6 or more months History of chronic persistent asthma requiring daily high dose inhaled corticosteroid for 3 or more months prior to enrollment Exclusion Criteria: Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment No significant disease other than asthma

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daclizumab|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
-----------------
Asthma, Daclizumab, anti-Tac monoclonal antibody, anti-IL-2, Zenapax
Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media

Study Overview
=================
Brief Summary
-----------------
The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.

Detailed Description
-----------------
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Official Title
-----------------
Growth Factors Supplementation to Single-Step Culture Medium

Conditions
-----------------
In Vitro Human Embryo Development

Intervention / Treatment
-----------------
* Other: Growth Factors and Cytokine adding to embryo culture media
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients Exclusion Criteria: over 40 years old

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culture media with growth factors and Cytokine<br>Growth factors and Cytokine adding to culture media to detect the deference and monitor the embryological outcome. | Other: Growth Factors and Cytokine adding to embryo culture media<br> <br> |
| Placebo Comparator: In Vitro culture media<br>culture media to monitor the embryological outcome as control group | Other: No Intervention<br>* Nothing to Add<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy rate ( % ) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing Pregnancy rate ( % ) |  | 6 months | 
| rates of blastocyst formation and quality |  | 6 days of culture |
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values > 4.0 ng/ml.

Official Title
-----------------
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: MRI guided prostate biopsy and TRUS guided biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PSA > 4.0 ng/ml written informed consent age >18 Exclusion Criteria: patients with prostate cancer patients with prior prostate biopsy patients with contraindications against MRI or biopsy

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequentially MRI guided and TRUS guided biopsy<br>Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy | Device: MRI guided prostate biopsy and TRUS guided biopsy<br>* MRI guided prostate biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate cancer detection rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a measure of Safety and Tolerability |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate biopsy, MRI guided biopsy, TRUS guided biopsy
Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary

Study Overview
=================
Brief Summary
-----------------
Background Intra-abdominal abscess (IAA) is one of the most serious surgical infectious complications on pancreaticoduodenectomy (PD) patients. Preoperative biliary drainage (PBD) is considered as a risk of surgical infectious complications. However, the reason why PBD caused IAA was unknown. In this study, we hypothesize that bile contamination may increase the rate of IAA as bile from residual common bile duct (CBD) leaks and contaminates the abdominal cavity. Methods We retrospectively collected PD patients with performance of bile culture between 2007 and 2019 in our institute. As to bile culture, we used a swab to do intraoperative bile cultures after transection of the CBD. IAA was defined as a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture.

Official Title
-----------------
Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary

Conditions
-----------------
Intraabdominal Abscess After Procedure

Intervention / Treatment
-----------------
* Other: Pancreaticoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pancreaticoduodenectomy patients Exclusion Criteria: no bile cultures

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| IAA group<br>Intraabdominal abscess (IAA) is defined as either a turbid discharge from the intraoperatively placed drain or a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture. | Other: Pancreaticoduodenectomy<br>* The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA<br>|
| Non-IAA group<br>No IAA formation | Other: Pancreaticoduodenectomy<br>* The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraabdominal abscess | The abscess formation after surgery | 1 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreaticoduodenectomy, biliary drainage, positive bile culture, intra-abdominal abscess, surgical complication
Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers

Study Overview
=================
Brief Summary
-----------------
Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.

Official Title
-----------------
Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers

Conditions
-----------------
Pressure Ulcers

Intervention / Treatment
-----------------
* Behavioral: Musical prompt
* Behavioral: Delayed musical prompt
* Other: No musical prompt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Long-term care resident MDS qualified Exclusion Criteria: Self pay long-term care residents
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Musical prompt<br> | Behavioral: Musical prompt<br>* Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 12 months.<br>|
| Active Comparator: Delayed musical prompt<br> | Behavioral: Delayed musical prompt<br>* Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 6 months.<br>|
| No Intervention: No musical prompt<br> | Other: No musical prompt<br>* No intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Facility Acquired Pressure Ulcers |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organizational Change |  | 2 years |
First in Man Aer-O-Scope

Study Overview
=================
Brief Summary
-----------------
A single center study intended to evaluate the Aer-O-Scope Colonoscope System.

Detailed Description
-----------------
A clinical study in Zagreb Croatia, intended to evaluate the Aer-O-Scope Colonoscope System. The study includes 120 subjects and has the following endpoints: Evaluation of the Aer-O-Scope advancement, imaging and retraction throughout the Colon. Safety: No occurrence of any device related major adverse event (for details see section 9.5) Efficacy: Advancement of device towards the ceacum and retraction Visualization of the colon mucosa by the traveling imaging device Procedure duration Handling and operation (assessment by operator)

Official Title
-----------------
A Single-center Study to Evaluate the Safety & Performance of the Aer-O-Scope for Traveling Through the Colon in Healthy Volunteers

Conditions
-----------------
Screening Colonoscopy for Low Risk Subjects

Intervention / Treatment
-----------------
* Biological: screening colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between 18 and 65 years of age. Sign informed consent. Exclusion Criteria: Subjects with any known GI related symptoms complaints or GI diseases. Subjects with cancer or other life threatening diseases or conditions. Pregnant women. Subjects who underwent any abdominal surgery. Morbid Obesity (BMI > 40). Drug abuse or alcoholism. Bed-ridden subject. Inadequate communication with the subject. Subjects under custodial care. Participation in any clinical study within the last 30 days. Subjects with known cardiovascular and pulmonary diseases.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>single arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device. | Biological: screening colonoscopy<br>* performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy<br>* Other names: colonoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to traverse the colon using the aer-o-scope | a propulsion system using low pressure co2 gas and balloons is used to propel the system through the colon | under 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
crc, colonoscopy, colon cancer