linjc16/ctgov huggingface dataset:
Employee Wellness Survey

Study Overview
=================
Brief Summary
-----------------
The aims of this study are 1) To assess the prevalence of tobacco use and cessation treatment preferences among YKHC employees, 2) To assess employee's current levels of perceived stress, engagement in physical activity, and feelings of resiliency to inform future tobacco cessation interventions, and to examine the relationship between these factors and tobacco use, and 3) To assess YKHC employees' perceptions and opinions of the hospital's current workplace tobacco policy and expansion of these regulations to all YKHC properties.

Detailed Description
-----------------
All employees at YKHC will be invited to complete an online survey that took approximately 10-15 minutes to complete. All employees will receive information via email, which includes an overview of the project, information regarding privacy and consent, and a link to the survey. Those who wish to do so were able to print a copy of the information for their reference. Employees who wish to participate did so by clicking on the survey link. Those who do not wish to participate could simply delete the email. Participants will be given two weeks to complete the online survey. Individuals who do not respond within the first week, will be sent an automated email reminder. All employees who participate will received a small incentive (approximately $10 in value).

Official Title
-----------------
Assessing Tobacco Use and Treatment Preferences Among Alaska Yukon-Kuskokwim Health Corporation Employees

Conditions
-----------------
Tobacco Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: YKHC employee aged 18 years or older provides consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| employees<br>YKHC employees | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| current tobacco use |  | 7 days |
The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers (HDJ-SPI)

Study Overview
=================
Brief Summary
-----------------
The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).

Official Title
-----------------
The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers

Conditions
-----------------
Cancer, Advanced

Intervention / Treatment
-----------------
* Other: Hospital day care follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18 years old with advanced solid tumor Addressed for the first time to the palliative care team according to current criteria (medico-psycho-social symptoms, progressive risks) With or without anti-cancer treatment With estimated life expectancy of more than 2 months and less than 12 months Able to communicate in French and answer questionnaires Affiliated with a social security system Having signed informed consent, co-signed by the partner if designated by the patient Exclusion Criteria: Patient with primitive brain tumor or malignant hemopathy Severe psychopathological disorders Pregnant patient or childbearing potential without effective method of birth control Unable to be followed at the cancer center until death Patient deprived of liberty or under guardianship -

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No hospital one day care<br>No hospital one day care | |
| Other: Hospital one day care<br>Hospital one day care | Other: Hospital day care follow-up<br>* Regular follow up every month in hospital day care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer | Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer Outcome shall be evaluated by assessing Survival without quality of life deterioration,measured by EORTC QLQ-C30 scale with monthly evaluation targeting three dimensions : global quality of life/ fatigue/ patient emotional state | 12 months |
Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale

Study Overview
=================
Brief Summary
-----------------
stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?

Detailed Description
-----------------
324 patients included in EPIC-FOP study (2009 to 2015) were followed annually to collect data about the recurrence of VTE, cardiovascular events and treatments.

Official Title
-----------------
Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale (29BRC21.0082)

Conditions
-----------------
Foramen Ovale, Patent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients included in EPIC-FOP study Exclusion Criteria: refusal to participate

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke | documented stroke | pulmonary embolism (2009 to 2015) to 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIA or stroke | documented TIA or stroke | pulmonary embolism (2009 to 2015) to 2021 | 
| death | all deaths and cardiovascular deaths | pulmonary embolism (2009 to 2015) to 2021 | 
| bleeding | Major and clinically pertinent bleeding (ISTH classification) | pulmonary embolism (2009 to 2015) to 2021 | 
| VTE | recurrent VTE | pulmonary embolism (2009 to 2015) to 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
foramen ovale, patent, stroke, pulmonary embolism
Alcohol Use During Pregnancy in Finland According to Meconium Samples

Study Overview
=================
Brief Summary
-----------------
Meconium samples are collected anonymously from newborns in Helsinki University Hospital maternity ward. The study tries to to find how many women continue to use alcohol during the second half of the pregnancy. Meconium samples are tested for ethylglucuronide (EtG), a metabolite of ethanol, that accumulates in the meconium. Altogether 1000 samples are taken. The sample results are compared to anonymously answered questionnaire about alcohol use.

Official Title
-----------------
Raskaudenaikaiset Elintavat ja Etyyliglukuronidin Esiintyminen Mekoniumissa Suomessa

Conditions
-----------------
Fetal Alcohol Spectrum Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn baby Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 3 Days

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 |
| --- | --- |
| HUCS, NKL<br>Newborns and their mothers at the Helsinki University Central Hospital maternity ward. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EtG | The meconium samples from newborns are tested for ethyl glucuronide using LC-MS/MS mass spectrometry. | Once |
Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS

Official Title
-----------------
A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

Conditions
-----------------
De Novo Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion / Exclusion Criteria - All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium. Other protocol-defined inclusion / exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess glomerular filtration rate at month 3 post transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function. |  |  | 
| Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function. |  |  | 
| Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months |  |  | 
| Incidence of graft and patient survival within 6 and 12 months |  |  | 
| Safety and tolerability based on adverse event (AE) reporting. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enteric-Coated Mycophenolate Sodium (EC-MPS), de novo, kidney transplantation, long-term safety.
Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.

Official Title
-----------------
Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.

Conditions
-----------------
Conscious Sedation, Remifentanil, Hysteroscopic Surgery, Anesthesia Recovery Period, Ambulatory Surgery

Intervention / Treatment
-----------------
* Other: local anaesthesia and remifentanil sedation
* Other: total intravenous anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, ASA classification I-II Speaks and writes danish Signed informed consent Exclusion Criteria: ASA classification III-VI Emotional disorder - medically treated within a week before surgery Patients in risk of perioperative aspiration - who must be intubated BMI > 35 Patients who have been using pain medicine within a week before surgery (except PCM and NSAID) Patients who have been using sleeping medicine or sedatives within a week before surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Local anaesthesia and remifentanil sedation | Other: local anaesthesia and remifentanil sedation<br> <br> |
| Other: 2<br>Total intravenous anaesthesia | Other: total intravenous anaesthesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total time spent in the operating room |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
conscious sedation, remifentanil, hysteroscopic surgery, anesthesia recovery period, ambulatory surgery, patient satisfaction, length of stay
Tramadol Infiltration for Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol infiltration or intravenous for tonsillectomy.

Detailed Description
-----------------
The study will be prospective, double-blind, randomized study of 40 children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy under general anesthesia. Patients will be allocated into two groups. Group 1 patients will receive tramadol 2 mg / kg intravenously and saline 0.9% infiltration in tonsils; group 2, will receive tramadol 2 mg / kg infiltration and intravenous saline. There will be evaluated: postoperative pain intensity by facial scale, supplementary analgesics and interleukin-6. For statistical analysis of the results will be used parametric and nonparametric tests, taking into account the nature of the variables. The level of statistical significance will be set at < 0.05.

Official Title
-----------------
Comparative Study of Analgesic Effect and Serum IL-6 With Tramadol Infiltration or Intravenous After Tonsillectomy

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Tramadol 2mg/kg
* Drug: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy Exclusion Criteria: coagulopathy, cancer, hepatic or renal alteration

Ages Eligible for Study
-----------------
Minimum Age: 4 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tramadol infiltration<br>infiltration of tramadol 2mg/kg | Drug: Tramadol 2mg/kg<br>* 2mg/kg<br>* Other names: Opioid;|
| Placebo Comparator: Saline solution<br>Infiltration of saline | Drug: Saline solution<br>* saline solution- 1 dose<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic effect |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tramadol infiltration, Analgesic effect, Serum IL-6
Customer Outcomes & Value Experiencing A New Monitoring Technology

Study Overview
=================
Brief Summary
-----------------
To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.

Official Title
-----------------
Customer Outcomes & Value Experiencing A New Monitoring Technology

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: LifeScan's new BGMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Summary: Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening Currently performing self-monitoring of blood glucose (SMBG) at home for diabetes management decisions Willingness to notify the study staff if they become pregnant during the study Willing to sign an informed consent Exclusion Criteria Summary: Currently using a continuous or flash glucose monitoring Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn. Conflict of Interest

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 01<br>Subjects use new LifeScan provided BGMS for 12 weeks. | Device: LifeScan's new BGMS<br>* LifeScan new Blood Glucose Monitoring System (BGMS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c change from baseline after 12 weeks | A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control | 12 weeks |
Mutations, Hormone Therapy (HRT) and Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
To assess the interaction between hormone replacement therapy and the prothrombotic mutations, Factor V Leiden and the recently described prothrombin mutation (20210A) on the incidence of venous thromboembolism (VTE) in a population-based case-control study conducted at Group Health Cooperative of Puget Sound (GHC).

Detailed Description
-----------------
BACKGROUND: Epidemiologic studies have identified Factor V Leiden as the most common cause of heritable thrombophilia, a prothrombotic mutation associated with a 5 to 7-fold increase in the risk of venous thromboembolism (VTE). In pre-menopausal women, the use of oral contraceptives is associated with a 4-fold increase in VTE risk, and the joint effects of oral contraceptive use and Factor V Leiden carriership increase the VTE risk of by a factor of 35. Recently, the results of several observational studies and randomized clinical trials suggest that in post-menopausal women, the use of hormone replacement therapy is associated with a 3-fold increase in VTE risk. Whether post-menopausal women with prothrombotic mutations experience a similar 20-fold increase in risk when they take post-menopausal hormones remains unknown. DESIGN NARRATIVE: In this case-control study, post-menopausal women with a first episode of objectively confirmed venous thromboembolism, and population-based controls were identified and recruited from the GHC enrollment files. Controls were frequency matched to the cases on age and calendar-year. Data collection included a review of ambulatory medical record and a telephone interview. The GHC computerized pharmacy database was used to assess exposure to hormone replacement therapy. A venous blood specimen was obtained from consenting subjects, processed into aliquots of white cells, plasma, and red cells, and stored at 70 degrees C prior to laboratory analysis. DNA was extracted from white cells, and molecular genotyping assays were conducted to assess carriership of prothrombotic mutations.

Conditions
-----------------
Cardiovascular Diseases, Venous Thromboembolism, Postmenopause

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 89 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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