linjc16/ctgov huggingface dataset:
Efficiency of the Hepatitis B Sci-B-Vac Vaccine in HIV Positive Patients

Study Overview
=================
Brief Summary
-----------------
HBV vaccination is of paramount importance among HIV positive persons due to an increased risk of infection and disease progression. The most widely used ENGERIX B vaccine reaches a lower rate of vaccination (20-70%) among HIV positive vaccinees (compared to over 90% in the normal population). Sci-B-Vac is novel vaccine containing 3 antigens and is therefore more immunogenic (as opposed to one in ENGERIX B). Its use has been associated with higher and more rapid vaccination rates. Therefore, it has a theoretical advantage in HIV positive individuals.

Detailed Description
-----------------
A cohort of 100 HIV positive, HBV negative individuals who have not been vaccinated against HBV before will be prospectively given 3 doses of Sci-B-Vac at 0, 1 and 6 months. HBV antibodies will be checked one month after every dose given.

Official Title
-----------------
Efficiency of the Novel Hepatitis B Vaccine Sci-B-Vac in HIV Positive Patients, a Prospective Cohort Study

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Biological: Sci-B-Vac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBV negative HIV positive individuals Above the age of 18 Treated at the TASMC Aids clinic, who have signed and informed consent and have never been vaccinated against HBV before Exclusion Criteria: Pregnant women HBV positivity Previous HBV vaccination

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sci-B-Vac<br>The study involves only one, open label arm. Rate of immunization will be compared to results obtained using the ENGERIX B vaccine among HIV positive persons in formerly published, historical cohorts. | Biological: Sci-B-Vac<br>* 10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV immunization rate after 1, 2 and 3rd dose of Sci-B-Vac | HBV Surface antibodies will be obtained one month after each Sci-B-Vac dose for each vaccinee. Rate and rapidity of immunization will be measured. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV, HIV, Immunization, HBV Immunization rate among HIV positive individuals
Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

Study Overview
=================
Brief Summary
-----------------
This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.

Detailed Description
-----------------
Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.

Official Title
-----------------
Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder

Conditions
-----------------
Over Active Bladder

Intervention / Treatment
-----------------
* Drug: Fesoterodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over-active bladder Prescribed with Fesoterodine Exclusion Criteria: Hypersensitivity Urinary retention

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 |
| --- | --- |
| Patients prescribed with Fesoterodine<br>Patients diagnosed with Over-active bladder and prescribed with fesoterodine. | Drug: Fesoterodine<br>* Any dose of Fesoterodine<br>* Other names: Toviaz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment | Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE). | Baseline up to 28 days after last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational
Automated Early Warning Scoring on Surgical Normal Wards

Study Overview
=================
Brief Summary
-----------------
Establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care. Upon meeting of predefined trigger criteria Medical Emergency Teams (MET) should be directed to these patients. The present study analyses the effect of introduction of an automated early warning and trigger system on two peripheral wards hosting a highly complex surgical patient cohort.

Detailed Description
-----------------
The deployment of an electronic monitoring and notification system is accompanied by data acquisition over 12 months (intervention) using four routine databases: Hospital patient data management, anesthesia database, local data of the German Resuscitation Registry, and measurement logs of the automated patient monitoring and alert system (intervention period only). A preceding time period of 12 months served as control.

Official Title
-----------------
Detection of Deteriorating Patients on Peripheral Surgical Wards by an Automated Notification System

Conditions
-----------------
Safety Issues, Emergencies

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to one of the participating wards Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reference<br>All patients admitted to the participating surgical wards from 2015-01-01 to 2015-12-31 | |
| Intervention<br>All patients admitted to the participating surgical wards from 2016-07-01 to 2017-06-30 | Other: Intervention<br>* The emergency notification system is linked to a paging system to the surgeon in charge and to the Hospital Medical Emergency Team. Depending on individual Multiparameter Early Warning Score communication protocols are activated.<br>* Other names: Automated early warning score and notification system;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In hospital cardiac arrests | Patient cardiac arrests during stay | on average 14 days per patient, cumulative over 12 months in each observed cohort |
Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10

Study Overview
=================
Brief Summary
-----------------
The aim of the study are to assess the persistence of immunity against vaccine serotypes (VSTs) and vaccine-related serotypes in PCV10 vaccinated children in Finland.

Detailed Description
-----------------
The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.

Official Title
-----------------
Persistence of Humoral Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With the 10-valent Pneumococcal Conjugate Vaccine in Finland

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: 10-valent pneumococcal conjugate vaccine, PCV10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed PCV10 vaccination with 3 or 4 doses (2+1 or 3+1 schedule) before blood sampling at age of 13 months Age at sample collection 13 months, 2 years or 3 years PCV10 vaccination received 2-6 weeks before sample collection at the age of 1 year Informed consent obtained covering the planned analyses Exclusion Criteria: PCV13 or PPV23 dose received Informed consent withdrawn

Ages Eligible for Study
-----------------
Minimum Age: 13 Months
Maximum Age: 3 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 |
| --- | --- |
| PCV10 2+1 schedule<br>Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). | Biological: 10-valent pneumococcal conjugate vaccine, PCV10<br>* 10-valent pneumococcal conjugate vaccine, PCV10<br>|
| PCV10 3+1 schedule<br>Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). | Biological: 10-valent pneumococcal conjugate vaccine, PCV10<br>* 10-valent pneumococcal conjugate vaccine, PCV10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of Humoral Immunity Following PCV10 Vaccination | Persistence of humoral immunity to vaccine- and vaccine-related pneumococcal serotypes after vaccination with PCV10. The serotype 19A specific geometric mean IgG antibody concentrations are reported as micrograms per ml with 95% confidence intervals. | Two years following last PCV10 vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Streptococcus pneumoniae, antibody
Machine Learning for Identification of Future Disease Development: A Nationwide Cohort Study (MILESTONE)

Study Overview
=================
Brief Summary
-----------------
To develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease

Detailed Description
-----------------
The MILESTONE trial is retrospective and data review study with health checkup data from the National Health Insurance Services(NHIS) in Korea. The data will be included general health examination for individuals , type of health insurance, medical bill details, medical histories, treatment and prescriptions about 514,795 individuals who were over 40 years old.

Official Title
-----------------
MachIne LEarning for Identification of Future Development of cardiovaScular and meTabOlic Disease: a NationwidE Time-series Cohort Study (MILESTONE)

Conditions
-----------------
Cardiovascular Disease, Metabolic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Subject who is got health checkup between 2002 and 2013, and had been recorded the health checkup result to the National Health Insurance Service(NHIS) in South Korea. Exclusion Criteria: Persons whose disease development is not identified from the records due to emigration or disappearance

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Accuracy in prediction of development of cardiovascular and metabolic disease using machine learning algorithm |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy in prediction of development of cardiovascular and metabolic disease using logistic regression analysis |  | 6months | 
| Accuracy in prediction of development of cardiovascular and metabolic disease using Framingham risk score |  | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine learning, cohort study
Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea

Study Overview
=================
Brief Summary
-----------------
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.

Detailed Description
-----------------
Study Design:

Official Title
-----------------
Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more. Exclusion Criteria: Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram |  | 6 weeks |
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

Official Title
-----------------
A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: AEB071


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Male and female patients of any race 18 years or older Adult recipients of kidney transplant from a deceased or living donor Recipients of a functioning kidney within 24 hours post transplant Exclusion: Need for medication prohibited by the protocol Patients or donors infected with Hepatitis B,C or HIV Patients with a history of cancer within last 5 years Patients with history of significant cardiac disorder Patients of high-risk immunological status Other protocol-defined inclusion/exclusion criteria may apply.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AEB071|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplantation, rejection, AEB071, tacrolimus, mycophenolic, basiliximab, immunosuppression
Improving Household Air Quality in Homes With Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if real-time feedback (lights/sounds) from small smoke particle monitors and brief coaching will encourage parents to reduce young children's secondhand tobacco smoke exposure in their home.

Detailed Description
-----------------
The purpose of this efficacy study is to test whether children's home secondhand tobacco smoke exposure (measured by cotinine & nicotine assays, fine particulates and reports of smoking in the home and/or home smoking bans) can be reduced by using custom particle monitors to provide real-time feedback to household residents plus brief advice/praise.

Official Title
-----------------
Innovation for Smoke-Free Homes: Real-Time Feedback

Conditions
-----------------
Lung Diseases, Asthma

Intervention / Treatment
-----------------
* Behavioral: Real-Time Intervention
* Behavioral: Usual Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families with at least one parent or guardian (18 years of age or older), Household resident who smokes tobacco, Child under fourteen years old exposed to tobacco smoking in the home Plans to live in San Diego County for at least three months.

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time Intervention<br> | Behavioral: Real-Time Intervention<br>* Lights and Sound Brief Coaching<br>|
| Active Comparator: Usual Education<br>Participants will receive usual education about secondhand and thirdhand smoke. | Behavioral: Usual Education<br>* Participants will receive usual education about secondhand smoke and thirdhand smoke.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondhand Smoke Reduction | Parental report and child urine cotinine. | Measured from baseline upto 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home Smoking Ban | Parental report of home smoking ban and environmental data collection. | Measured from baseline upto 5 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secondhand smoke
Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Transvaginal hybrid procedures are of interest as an available NOTES procedure for the clinical routine. The gynaecologists' experiences and the available studies report on low morbidity related to the transvaginal access. However, little is known about the vaginal and intraabdominal microbial contamination due to the transvaginal approach. The aim of this cohort study is to evaluate the microbial colonisation and contamination in patients with transvaginal hybrid and conventional laparoscopic cholecystectomy. Therefore, pre- and intraoperative microbiological evaluations will be performed in patients with transvaginal hybrid cholecystectomy and laparoscopic cholecystectomy.

Conditions
-----------------
Cholecystectomy

Intervention / Treatment
-----------------
* Procedure: Smear test vaginally, intraabdominally
* Procedure: Smear test vaginally, intraabdominally


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for elective cholecystectomy informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy Exclusion Criteria: cholecystitis intraabdominal infection existing antibiotic therapy adnexitis pelvic inflammatory disease infection (CRP > 10 mg /l; Lc > 11 G/l)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transvaginal hybrid cholecystectomy<br> | Procedure: Smear test vaginally, intraabdominally<br>* Pre- and intraoperative smear tests of the vagina and douglas are performed.<br>|
| laparoscopic cholecystectomy<br> | Procedure: Smear test vaginally, intraabdominally<br>* Pre- and intraoperative smear tests of the vagina and douglas are performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial colonisation and contamination vaginally and intraabdominally |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transvaginal access for cholecystectomy