linjc16/ctgov huggingface dataset:
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery

Study Overview
=================
Brief Summary
-----------------
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be enrolled and tissue oximetry measurement will be collected throughout the surgical procedure and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of delirium will be collected using a standardized questionnaire. The relationship between cerebral oximetry measures and delirium scores will be explored.

Detailed Description
-----------------
See Eligibility Criteria section

Official Title
-----------------
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery

Conditions
-----------------
Heart; Dysfunction Postoperative, Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Weigh at least 40 kg Undergoing Coronary Artery Bypass Graft (CABG) and/or valvular surgery requiring the use of Cardio Pulmonary Bypass (CPB) or Left Ventricular Assist Device (LVAD), inclusive of any concomitant procedure Willing and able to provide informed consent Able to communicate and read in English Exclusion Criteria: Emergency procedure such that informed consent may not be obtained Known cognitive impairment, history of delirium or dementia Known hemodialysis or fistula graft Delirium Observation Score (DOS) Score of >6 prior to surgery Pre-existing skin condition at the site of sensor application (e.g. eczema, dermatitis) Any known contraindication or sensitivity to the cerebral oximeter sensor

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 |
| --- | --- | --- |
| Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery. |  | Completion of cardiovascular surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values. |  | Patient discharge (on average 7 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIRS Technology, Cardiovascular surgery, valvular surgery with cardiopulmonary bypass
SSP-002358 Drug Interaction Study With Omeprazole

Study Overview
=================
Brief Summary
-----------------
This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.

Official Title
-----------------
A Phase 1, Open-label, Randomized, 2-period Crossover Drug Interaction Study in Healthy Adult Subjects to Evaluate the Effect of the Proton Pump Inhibitor Omeprazole on the Pharmacokinetics of SSP-002358

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: SSP-002358
* Drug: SSP-002358 + omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 18-55 years inclusive at the time of consent. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: Male, or Non-pregnant, non-lactating female Females must be at least 90 days post-partum or nulliparous. Exclusion criteria: Any current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments. Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSP-002358 alone<br> | Drug: SSP-002358<br>* 1 mg, oral, once<br>|
| Experimental: SSP-002358 + omeprazole<br>SSP-002358 + omeprazole | Drug: SSP-002358 + omeprazole<br>* SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) for SSP-002358 | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | Assessed over 48 hours post-dose | 
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 | Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. | Assessed over 48 hours post-dose |
iCOMtrain, Development and Evaluation of a Combined Training of Technical and Non-Technical Skills During the Management of Simulated Incidents in Intensive Care

Study Overview
=================
Brief Summary
-----------------
The normal, the anticipated difficult and the unanticipated difficult airway are trained in the patient safety simulation center (University Hospital Zürich) and the training is being observed by video installation. Step 1: normal airway (Phantom), technical training Step 2: difficult airway (SimMan 3G), technical training Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical and non-technical (CRM - crew resource management) training.

Conditions
-----------------
Technical and Non-technical Training of Airway Management on ICU

Intervention / Treatment
-----------------
* Procedure: SAFE (situation, all together, fly on, evaluate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: doctors and nurses with a minimum of 12 moths of work experience. Exclusion criteria: staff members that deny participation or don't meet the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SAFE (situation, all together, fly on, evaluate)|Video-assisted, structured debriefing after simulated critical airway-events.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Open-label Study of KW-3357

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.

Official Title
-----------------
An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection

Conditions
-----------------
Disseminated Intravascular Coagulation (DIC)

Intervention / Treatment
-----------------
* Drug: KW-3357
* Drug: Plasma-derived antithrombin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the ACCP/SCCM-defined sepsis criteria Japanese Association for Acute Medicine-defined DIC criteria score >= 4 Antithrombin activity <= 70% Written informed consent from patient or guardian Exclusion Criteria: Anamnesis or complication of serious drug allergy Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis Pregnant, nursing, or possibly pregnant woman

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KW-3357<br> | Drug: KW-3357<br>* Intravenous infusion once a day<br>|
| Active Comparator: Plasma-derived antithrombin<br> | Drug: Plasma-derived antithrombin<br>* Intravenous infusion once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DIC resolution | Japanese Association for Acute Medicine-defined DIC criteria score < 4 | 6 days (or discontinuation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DIC score | Based on the Japanese Association for Acute Medicine-defined DIC criteria score | Screening, 2, 3, 4, 5, 6 days (or discontinuation) | 
| Mortality |  | 28 days | 
| Organ symptoms | Sepsis related organ failure assessment score | Screening, 4, 6 days (or discontinuation) | 
| Severity | The Acute Physiology and Chronic Health Evaluation II score | Screening, 4, 6 days (or discontinuation) | 
| Plasma antithrombin activity |  | Screening, 2, 3, 4, 5, 6 days (or discontinuation) | 
| Number of patients with adverse events |  | up to 6 days (or discontinuation) |
Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation

Conditions
-----------------
Pregnancy Complication

Intervention / Treatment
-----------------
* Dietary Supplement: Ergocalciferol
* Dietary Supplement: Ergocalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women initiating IVF treatment Exclusion Criteria: Women that have entered the study before

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose Vitamin D<br> | Dietary Supplement: Ergocalciferol<br>* 100 000 U drops is given once<br>* Other names: Made by the Swedish APOTEKET;|
| Sham Comparator: Low dose Vitamin D<br> | Dietary Supplement: Ergocalciferol<br>* 500 U drops given once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate |  | 4 weeks to 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy complications (pregnancy hypertension, SGA, diabetes) |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy rate (pos test, live fetus at 12 weeks, baby home), Pregnancy complication (Pregnancy hypertension, SGA, diab), Thrombin generation
Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate long-term clinical performance of a self-adhering flowable resin composite in comparison with a conventional flowable resin composite used with an etch&rinse adhesive system in minimally invasive class I cavities. Twenty-five patients will receive at least one pair of class I restorations. After class I cavities were prepared they were restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR) or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch&rinse adhesive (Teco/DMG) [according to the manufacturers' instructions. Restorations will be evaluated at baseline and yearly according to FDI criteria by two evaluaters. Statistical analysis will be carried out with Pearson Chi-Square test and Cochran Q-test followed by Mc Nemar's.

Official Title
-----------------
Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities

Conditions
-----------------
Tooth Diseases

Intervention / Treatment
-----------------
* Device: Vertise Flow
* Device: LuxaFlow
* Device: Teco Adhesive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having no medical or behavioral problems preventing then from attending review visits, absence of previously placed restorations,having antagonist teeth Exclusion Criteria: poor gingival health,uncontrolled, rampant caries,bruxism,removable partial dentures, xerostomia

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertise Flow<br>Superficial Class I cavities restored with Vertise Flow | Device: Vertise Flow<br>* Composite resin<br>* Other names: Self-adhering flowable composite;|
| Experimental: LuxaFlow<br>Superficial Class I cavities restored with LuxaFlow | Device: LuxaFlow<br>* Composite resin<br>* Other names: Flowable composite with Teco adhesive system;Device: Teco Adhesive<br>* Adhesive system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of flowable composite resins | Five year results according to FDIcriteria | Five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
composite resin, occlusal caries
Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation

Study Overview
=================
Brief Summary
-----------------
Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness?

Detailed Description
-----------------
60 subjects, 30 with hypertension and 30 without will attend two visits to the GCRC. At each visit, pulsatile hemodynamics (by using tonometry-a non-invasive means to obtain arterial pressure tracings) and Doppler tissue imaging relaxation velocity (a measurement of myocardial relaxation obtained by echocardiography) data will be collected before and after administration of vasodilator medication. At the first visit, each patient will receive an oral dose of the vasodilator hydralazine (does not effect aortic stiffness), and at the second visit each patient will receive intravenous nesiritide (does effect aortic stiffness). The relationship between timing of the reflected pulse wave and myocardial relaxation velocity will be studied at baseline and following administration of each vasodilator to determine if changing aortic stiffness has an impact on myocardial relaxation.

Official Title
-----------------
The Effect of Aortic Impedance on Myocardial Relaxation

Conditions
-----------------
High Blood Pressure

Intervention / Treatment
-----------------
* Drug: oral hydralazine and intravenous nesiritide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over the age of 65 Exclusion Criteria: Have known or suspected coronary artery disease Have known or suspected left ventricular dysfunction Have significant valvular, infiltrative, pericardial, or congenital heart disease Have a resting systolic blood pressure < 100 mmHg Have had an adverse reaction to nesiritide or hydralazine Have a serum creatinine > 2 mg/dl at Visit 1

Ages Eligible for Study
-----------------
Minimum 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oral hydralazine and intravenous nesiritide|vasodilators|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart myocardium relaxation (diastole) |  | before and after administration of vasodilator medication | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arterial stiffness, echocardiography, nesiritide
International Ataxia Rating Scale in Younger Patients

Study Overview
=================
Brief Summary
-----------------
The project will collect information on the mapping of clinical ratings on a number of scales that are used in the assessment of patients with ataxias.

Official Title
-----------------
APPLICABILITY OF THE INTERNATIONAL ATAXIA RATING SCALE (ICARS) IN YOUNGER PATIENTS AND DEVELOPMENT OF GLOBAL RATING INSTRUMENTS FOR PATIENTS WITH ATAXIA TELANGIECTASIA (AT)

Conditions
-----------------
Ataxia Telangiectasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients aged 6-18 years with diagnosed with ataxia, preferably AT will be included. The diagnosis of AT will be made based on the criteria: typical clinical picture plus one of the following: 1. a proven mutation in the ATM gene 2. Deficient ATM protein proven by Western blotting 3. Elevated α-fetoprotein, cerebellar atrophy on MRI and immune deficiency/ chromosomal breakage/ T- cell lymphoreticular malignancy. Children aged 6-18 years with suspected AT (fulfilling partially the above criteria will be included) Children aged 6-18 years with AT like disease, with or without proven mutation in the MRE11 gene will be included Children aged 6-18 years of age with ataxia of other known or unknown etiologies might be included, but their total number should not exceed 20% of the cohort in each site

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| No Treatment<br>Collect pilot data on the performance of the ICARS in patients younger than 10 years of age, as well as to introduce definitions for the various clinically defined stages of AT, and attempt to develop descriptors of change that could help in the assessment of patients longitudinally. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Analysis | The primary outcome is validity of ICARS in children younger than 10 years of age (by comparing the mean scores and subscores between children aged 6-10 years of age to those aged 10-18 years of age). | single visit |
Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis

Study Overview
=================
Brief Summary
-----------------
Primary purpose : To develop a method to automatically extract and structure the information included in numerous medical records from breast cancer patients. Secondary purpose : With this procedure we can analyze the content of ten thousand anonymized textual medical records. This information should enable us to explore many subjects, such as: The impact of certain therapeutic procedures The characteristics of sub-groups of patients Pregnancy associated breast cancers Risk factors

Official Title
-----------------
SENOMETRY : Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: retrospective medical records analyze


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Majority (age > 18) Malignant breast tumors signed informed consent Exclusion Criteria: Benign breast pathology Patients not initially treated at the Hôpitaux Universitaires de Strasbourg

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 |
| --- | --- |
| Breast cancer patients between 2000 and 2016<br>Patients treated for a breast cancer between 2000 and 2016 in the Hospital of Strasbourg (France). | Other: retrospective medical records analyze<br>* Ten thousand medical records (between years 2000 and 2016) will be analyzed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the reliability of a computer-based, automatic information retrieval method specific to medical records from breast cancer multidisciplinary meetings |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer recurrence rate after some therapeutic procedures | Study of the recurrence rate of different subgroups of patients where various procedures were performed | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Text mining, Big Data, Machine Learning