linjc16/ctgov huggingface dataset:
Retention and Retrieval for Three Different Training Methods

Study Overview
=================
Brief Summary
-----------------
The hypotheses that will be studied are: H0: Providers trained by a web based application for skill competency in basic life support (BLS) and automated external defibrillation (AED) are as competent as those who were trained by certified instructors using the European Resuscitation Council (ERC) curriculum H00-1: Providers who trained themselves with the used of web based training are more competent when they had a personal manikin for home exercise compared to providers who trained themselves with only a web based training H0-2: Providers who did not receive any training will score lower than those who did. Research questions for this study are: What are the results in skill competency for non trained people? What are the results in skill competency for trained people immediately after training? What is the retention of skills for trained and non trained people after six months?

Official Title
-----------------
Do we Need an Instructor, or a Manikin to Learn BLS/AED, or is Web Based Training as Good as Instructor Based Training?

Conditions
-----------------
Improvement of BLS/AED Training Methods

Intervention / Treatment
-----------------
* Other: ERC-training by instructor
* Other: Web-based training only
* Other: Web-based training with a personal training manikin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to follow a BLS/AED course Exclusion Criteria: CPR training within the last five years professional health care provider

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control-1<br>ERC-training by instructor | Other: ERC-training by instructor<br>* Standard way of training with an instructor<br>|
| No Intervention: Control-2<br>No intervention | |
| Experimental: Experimental-1<br>Web-based training only | Other: Web-based training only<br>* Experimental way of training with a web based training application<br>|
| Experimental: Experimental-2<br>Web-based training with a personal training manikin | Other: Web-based training with a personal training manikin<br>* Experimental way of training with a web based training application and a simple personal training manikin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kruskal-Wallis |  | 10-2007 - 03-2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Education, Retention, Retrieval
Saline Instillation Before Tracheal Suctioning and the Incidence of Ventilator Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic saline instillation before tracheal suctioning

Conditions
-----------------
Mechanical Ventilation, Critically Ill Patients

Intervention / Treatment
-----------------
* Procedure: Saline Instillation before Tracheal Suctioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients foreseen to receive mechanical ventilation for more than 72 hours Exclusion Criteria: Previous mechanical ventilation in the last month Mechanical ventilation for more than 6 hours before arrival at ICU, Contraindication to bronchoscopy and Be expected to die or undergo withdrawal treatment within 48 hours-

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Saline Instillation before Tracheal Suctioning|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of ventilator associated pneumonia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atelectasis |  |  | 
| tube occlusion |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, Ventilator Associated Pneumonia, Prevention
Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.

Official Title
-----------------
Clinical Pharmacology Study of FYU-981 for Subjects With Renal Insufficiency.

Conditions
-----------------
Renal Insufficiency, Healthy

Intervention / Treatment
-----------------
* Drug: FYU-981, (Oral single dosing)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese adult subjects Body mass index: >=18.5 and <30.0 Exclusion Criteria: Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderately-decreased group<br>(eGFR: >=30mL/min/1.73m^2 and < 60mL/min/1.73m^2) | Drug: FYU-981, (Oral single dosing)<br>* FYU-981, (Oral single dosing)<br>|
| Experimental: Slightly-decreased group<br>(eGFR: >=60mL/min/1.73m^2 and < 90mL/min/1.73m^2) | Drug: FYU-981, (Oral single dosing)<br>* FYU-981, (Oral single dosing)<br>|
| Experimental: Normal group<br>(eGFR: >=90mL/min/1.73m^2) | Drug: FYU-981, (Oral single dosing)<br>* FYU-981, (Oral single dosing)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax: Maximum plasma concentration) |  | 48 hours | 
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |  | 48 hours | 
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) |  | 48 hours | 
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) |  | 48 hours | 
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (kel: Elimination rate constant) |  | 48 hours | 
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (MRT: Mean residence time) |  | 48 hours | 
| Pharmacokinetics (Ae: Amount of drug excreted in urine) |  | 48 hours | 
| Pharmacokinetics (fe: Fraction of dose excreted in urine) |  | 48 hours |
Characteristics of Patients With Type 2 Diabetes Mellitus (CVD-RNDR)

Study Overview
=================
Brief Summary
-----------------
This observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes Registry data.

Official Title
-----------------
Retrospective Study to Describe Characteristics of Patients With Type 2 Diabetes Mellitus Who Were Initiating Use or Treatment With Sodium-glucose Co-transporter-2 Inhibitors and Other Diabetes Medications (Other Glucose Lowering Drugs) in 2015-17 Based on National Russian Diabetes Registry Data

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria are: New user receiving or dispensed prescription of SGLT-2 inhibitor medication or other GLD treatments oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups; T2DM diagnosis on or prior to the index year; ≥ 18 years old at index year. Exclusion criteria are: Patients with a T1DM diagnosis on or prior to index year and only insulin use in the year prior to index; Patients with a gestational diabetes in the index year or 1 year prior to index.
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 proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016, 2017 | The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016 2017 among T2DM patients initiated use of antidiabetic treatment in these years according to Russian National Diabetes Registry data. | 2015-2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with abdominal laboratory values | Number of participants with abdominal laboratory values glycosylated haemoglobin (Hb1Ac), total Cholesterol, low Density Lipids (LDL), high Density Lipids (HDL), creatinine, estimated Glomerular Filtration Rate (EGFR) | 2015-2017 | 
| Number of participants with co-morbidities | Number of participants with co-morbidities: myocardial infarction (MI), stroke (ischemic or hemorrhagic )Transient Ischemic Attack (TIA)Peripheral Artery Disease (PAD), Heart Failure, Hypertension, Hyperlipidemia, Neuropathy, Nephropathy, Retinopathy, Therapies, Diabetes medications, Hypertension medications, Diuretics, Lipid lowering drugs, Anti-platelets. | 2015-2017 |
Molecular Genetics in Infantile Spasms

Study Overview
=================
Brief Summary
-----------------
Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters with an onset in the first year of life. West syndrome represents a subset of ISs that associates spasms in clusters, a hypsarrhythmia EEG pattern and a developmental arrest or regression. Aetiology of ISs is widely heterogeneous including many genetic causes. Many patients, however, remain without etiological diagnosis, which is critical for prognostic purpose and genetic counselling. In the present study, the investigators performed genetic screening of 73 patients with different types of ISs by array-CGH and molecular analysis of 5 genes: CDKL5, STXBP1, KCNQ2, and GRIN2A, whose mutations cause different types of epileptic encephalopathies, including ISs, as well as MAGI2, which was suggested to be related to a subset of ISs.

Official Title
-----------------
Molecular Characterization of a Cohort of 73 Patients With Infantile Spasms Syndrome

Conditions
-----------------
Infantile Spasms, West Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infantile spams or West syndrome Exclusion Criteria: brain malformation clinical features of tuberous sclerosis abnormal metabolic assays

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- | --- |
| Presence of deleterious gene variants in candidate genes for infantile spasms/west syndrome and for deleterious Copy-Number variations (CNV). A pan-genome analysis by microarray |  | Day one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infantile spasms, West syndrome, variant, mutation, CNV, sequencing
A Study of Compliant Behaviors and Associated Factors of Women Breast Screening

Study Overview
=================
Brief Summary
-----------------
There were a breast cancer screening activity in Taipei Medical University-Shuang Ho Hospital. We did an intervention with woman who joined the activity.The most important part in the intervention was to know health behavior about the breast cancer prevention.By doing the study, the investigators will know how to promote the health activity in our community.

Detailed Description
-----------------
When the investigators get these women's health behavior imagination, the investigators can know how much breast cancer screening activity do these people have. The most important part for us is to understand how to promote health behavior to women who live around Shuang area.

Official Title
-----------------
A Study of Compliant Behaviors and Associated Factors of Women Breast Screening in the Shuang Ho Region of Taipei City.

Conditions
-----------------
Health Behaviors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women can read words Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| female<br>Women who live in the Shuang Ho Region of Taipei City. Women can read and write chinese language. | |

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
-----------------
women health behaviors
Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)

Study Overview
=================
Brief Summary
-----------------
In the current project we aim to study the oncological process of pancreatic cancer, from a perspective of the CSC-theory and in particular through the 'side population' (SP)-approach. The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After isolation from pancreatic cancer resection specimens, SP cells will be characterized by gene-expression profiling based on microarray analysis. We'll identify markers and pathways (with emphasis for stem cell and cancer -related ones) that are differentially expressed in SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant molecular targets and pathways obtained from the Nanostring results.

Official Title
-----------------
Prognostic and Therapeutic Relevance of the 'Side Population' in Pancreatic Cancer

Conditions
-----------------
Neoplasm, Pancreas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resected pancreatic ductal adenocarcinoma (PDAC) Informed consent Exclusion Criteria: Age < 18years Pregnancy Pre-operative radiotherapy Pre-operative chemotherapy IPMT

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| SP in PDAC<br>Side population cells isolated from resection specimens obtained from patients with pancreatic cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreas, cancer, stem cell
Iressa Expanded Access Program (EAP)

Study Overview
=================
Brief Summary
-----------------
A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.

Official Title
-----------------
An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Carcinoma, Non-small-cell Lung, Metastases, Neoplasm

Intervention / Treatment
-----------------
* Drug: ZD1839 (Gefitinib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria For inclusion in this trial, patients must fulfill all of the following criteria: previous documented histologically or cytologically confirmed non-small cell lung cancer; locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy. age 18 years or older; written informed consent to participate in the trial. Exclusion Criteria Any of the following will exclude a patient from entering the trial: receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. * Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission; patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission; having other active malignancies; incomplete healing from previous oncologic or other major surgery; evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial; pregnancy or breast feeding (women of child-bearing potential).

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 |
| --- |
|Drug: ZD1839 (Gefitinib)|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
-----------------
Locally advanced and/or metastatic non-operable, non-small cell lung cancer (stage III or IV), patients who have failed standard therapy.
PS150 Total Knee Arthroplasty Outcomes Registry

Study Overview
=================
Brief Summary
-----------------
This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.

Official Title
-----------------
Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: P.F.C. Sigma PS150 RP Total Knee System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant. Signed Informed Patient Consent Exclusion Criteria: There are no exclusion criteria for this registry.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>P.F.C. Sigma PS150 RP Total Knee System | Device: P.F.C. Sigma PS150 RP Total Knee System<br>* Total Knee Arthroplasty - surgical procedure to replace knee with metal implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship | Lack of revision with revision meaning no removal or replacement of any TKA component. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score - Knee Score | Descriptive statistics, including change from baseline (post-op minus pre-op) | 1, 3 & 5 years | 
| Knee Society Score - Function | Descriptive statistics, including change from baseline (post-op minus pre-op) | 1, 3 & 5 years | 
| Pain sub-question of the Knee Society Score | Descriptive statistics, including change from baseline (post-op minus pre-op) | 1, 3 & 5 years | 
| Flexion | Descriptive statistics, including change from baseline (post-op minus pre-op) | 1, 3 & 5 years | 
| Extension | Descriptive statistics, including change from baseline (post-op minus pre-op) | 1, 3 & 5 years | 
| Radiographic Analysis | Descriptive statistics | 1, 3 & 5 years | 
| Adverse Events | Type and frequency of adverse events | 1, 3 & 5 years |