linjc16/ctgov huggingface dataset:
Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

Study Overview
=================
Brief Summary
-----------------
Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

Detailed Description
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Two hundred patients have to be enrolled in 2 years in the Grenoble Teaching Hospital and in the Saint Louis hospital in Paris between November 2010 and November 2012. Each lung cancer patient with at least one organ failure, admitted in emergency, thoracic oncology or directly in ICU will be included. The objectives are to identify patients' characteristics associated with proposition for intensive care unit admission and those associated with the decision of intensive care unit admission.

Official Title
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Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: lung cancer Organ failure Exclusion Criteria: -

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 |
| --- | --- |
| lung cancer<br>Each lung cancer patient with organ failure, admitted in emergency, thoracic oncology or directly in ICU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify an association between patients' characteristics and proposition for intensive care unit admission. | univariate and multivariate logistic regression | at day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify an association between patients' characteristics and decision of intensive care unit admission among patients proposed for ICU admission | univariate and multivariate logistic regression | at day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
organ failure, intensive care, palliative care, patient's wishes
HCV Treatment in a Low-threshold Clinic

Study Overview
=================
Brief Summary
-----------------
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Detailed Description
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This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f The secondary aims are to: Evaluate adherence to DAA treatment (Work Package 1) Identify factors associated with SVR and adherence (Work Package 1) Characterize reinfection using next generation sequencing (Work Package 2) Identify factors associated with reinfection (Work Package 2) Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2) Identify factors associated with changes in risk behaviours (Work Package 2) The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours. The study will include 300 patients and are close to achieving that aim the summer of 2019

Official Title
-----------------
Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection

Conditions
-----------------
Hepatitis C, Substance Use Disorders

Intervention / Treatment
-----------------
* Drug: Elbasvir / Grazoprevir Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV RNA positive Attending the low-threshold HCV clinic in Oslo Exclusion Criteria: -

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

| Intervention/Treatment |
| --- |
|Drug: Elbasvir / Grazoprevir Oral Tablet|HCV treatment according to Norwegian guidelines|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response | HCV RNA undetectable 12 weeks post treatment | 12 weeks | 
| Reinfection | HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12 | 2 years |
Impact of Computerized Physician Order Entry on Medication Prescription Errors in the Intensive Care Unit: a Controlled Cross-Sectional Trial.

Study Overview
=================
Brief Summary
-----------------
Device: computerized physician order entry. We wanted to investigate if the introduction of a computerized intensive care unit system reduced the incidence and severity of medication prescription errors (MPEs). A prospective trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. The registration of different classes of MPEs was done by a clinical pharmacist. An independent panel evaluated the severity of MPEs.

Official Title
-----------------
Impact of Computerized Physician Order Entry on Medication Prescription Errors in the Intensive Care Unit: a Controlled Cross-Sectional Trial.

Conditions
-----------------
Medication Errors, Patient Safety

Intervention / Treatment
-----------------
* Device: computerized physician order entry


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Adult patients admitted to the Surgical Intensive Care Unit Exclusion Criteria: Adult Patients admitted to other units Pediatric patients

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: computerized physician order entry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the the incidence and severity of medication prescription errors between a CPOE unit and a paper-based unit at completion of the study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of MPEs in both units at completion of the study. |  |  |
Comparison Between Two Different Protocols in Polycystic Ovary Symdrome Women Undergoing Intra-cytoplasmic Injection

Study Overview
=================
Brief Summary
-----------------
Stein and Leventhal were the first to recognize an association between the presence of polycystic ovaries and signs of hirsutism and amenorrhea (eg,oligomenorrhea, obesity), After women diagnosed with Stein-Leventhal syndrome underwent successful wedge resection of the ovaries, their menstrual cycles became regular, and they were able to conceive. As a consequence, a primary ovarian defect was thought to be the main culprit, and the disorder came to be known as polycystic ovarian disease.

Official Title
-----------------
CLASSICAL ANTAGONIST PROTOCOL IN COMPARISON WITH AGONIST STOP PROTOCOL IN Polycystic Ovary Symdrome WOMEN UNDERGOING Intra-cytoplasmic Injection TRIAL: a Randomized Controlled Trial

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Cetrorelix
* Drug: Leuprolide Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women under 35 years with polycystic ovary syndrome criteria Normal male semen parameters Normal tubes either by hysterosalpingography &/or laparoscopy Free from other endocrine abnormalities Exclusion Criteria: NON polycystic ovary syndrome Criteria More than 35 years Abnormal semen parameters Pathological tube& pelvic factor Other endocrine disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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: Study group<br>the antagonist protocol group where they will do intra-cytoplasmic injection using classical antagonist protocol | Drug: Cetrorelix<br>* 0.25 mg subcutaneous injection daily for 6 days<br>|
| Active Comparator: control group<br>agonist stop/antagonist protocol group where they will receive mid luteal agonist in the preceding intra-cytoplasmic injection cycle before starting classical antagonist protocol | Drug: Cetrorelix<br>* 0.25 mg subcutaneous injection daily for 6 days<br>Drug: Leuprolide Acetate<br>* 0.1 mg subcutaneous injection daily for 12 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in clinical pregnancy rate in both groups | ultrasound detection of fetal heart pulsations | 6 weeks |
A Study to Evaluate Seroprevalence and Seroconversion of Antibodies to Adeno-Associated Virus (AAV) in Patients With Hemophilia A

Study Overview
=================
Brief Summary
-----------------
To quantify the seroprevalence of antibodies to AAV5, AAV6, and AAV8 and the seroconversion rate over varying follow-up intervals in subjects with hemophilia A

Detailed Description
-----------------
This is a single-center, decentralized, patient-centered, prospective, observational study utilizing biospecimen samples collected from hemophilia A subjects across the United States to evaluate and characterize seroprevalence and the rate of seroconversion of antibodies against AAV serotypes and exploratory vectors, and to investigate the associated factors that may influence the vector titers. Relevant medical findings will also be collected from the subject, as well as symptoms related to hemophilia A. The collection of medical history may include major illnesses, diagnoses, and surgeries.

Official Title
-----------------
A Prospective, Observational Study Evaluating Seroprevalence and Rate of Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes and Exploratory Vectors in Subjects With Hemophilia A in the United States

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Procedure: Blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with Hemophilia A Subjects aged 18years or over at time of entry Exclusion Criteria: Currently participating in an interventional study of any investigational product, device or procedure. Subjects who have been previously treated with AAV vector gene therapy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sample collection|Blood sample collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A | To assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A at Baseline | Baseline | 
| Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A |  | Change from baseline through Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe and characterize AAV vector titer values in subjects with Hemophilia A | To describe and characterize AAV vector titer values in subjects with Hemophilia A | Change from baseline through Week 12 | 
| To describe and characterize AAV vector titer values in subjects with Hemophilia A | To describe and characterize AAV vector titer values in subjects with Hemophilia A | Change from baseline through Week 24 |
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.

Detailed Description
-----------------
Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat, moisture, maceration, friction, or lack of air circulation. It is typically chronic with insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo frequently worsened or colonized by infection, which most commonly is candidal but also may be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis, has been used by physicians for the treatment of intertrigo; however, there is a paucity of data in the literature regarding the use of Vusion ointment in this indication. This study is the first to formally investigate the efficacy and safety of Vusion ointment for the treatment of intertrigo.

Official Title
-----------------
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo

Conditions
-----------------
Intertrigo

Intervention / Treatment
-----------------
* Drug: Vusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of intertrigo Exclusion Criteria: Pregnancy Use of systemic or topical antifungal or corticosteroid treatment in the previous 14 days or during the 3-month treatment period allergy of sensitivity to Vusion undergoing warfarin anticoagulation alcohol or drug abuse Investigator determines they cannot particpate history of non-compliance or poor cooperation participation in an investigaitonal drug study within 30 days of Baseline Visit

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vusion ointment<br> | Drug: Vusion<br>* Vusion will be applied to areas of intertrigo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients for whom Vusion effectively treated intertrigo |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intertrigo, Vusion
Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries

Study Overview
=================
Brief Summary
-----------------
Impairing drugs and alcohol are major risk factors for traumatic injuries. Still there is to date little knowledge to what extent these factors affect the epidemiology of trauma. Detailed mapping of risk factors improve targeting and efficiency of primary injury prevention. The aim of this project is therefore to facilitate injury prevention through improved data collection and analysis on impairing drugs and alcohol as a contributing and modifiable factor in injury morbidity and mortality. Study question: What is the toxicological profile among patients with suspected severe traumatic injury? Study design: a prospective population-based and national observational study will analyse toxicology from blood samples of all trauma admission during a 12 month study period.

Official Title
-----------------
Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries - a National Study on Injury Prevention

Conditions
-----------------
Trauma Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission to any Norwegian Trauma Hospital (n=37) AND trauma team activation, during study period Exclusion Criteria: age foreign citizens

Ages Eligible for Study
-----------------
Minimum Age: 16 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 alcohol in blood samples. | Alcohol is reported in grams per liter. Analysis of alcohol is performed with an automated enzymatic method using alcohol dehydrogenase. | Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period. The database is analyzed after study period is completed. | 
| Presence of impairing illicit and medicinal drugs in blood samples. | Impairing substances are reported as nanogram per milliliter. Analysis is performed using liquid chromatography coupled with mass spectrometry. | Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period. |
Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Study Overview
=================
Brief Summary
-----------------
Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound

Detailed Description
-----------------
During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following: the ability of MSCs to stimulate tissue regeneration positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats). In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 months after injection.

Official Title
-----------------
Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells

Conditions
-----------------
Trophic Ulcer

Intervention / Treatment
-----------------
* Biological: Autologous adipose-derived mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trophic Ulcers Exclusion Criteria: diagnosed cancer acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis mental disorders pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with trophic ulcers received standard treatment and mesenchymal stem cells
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC<br>Patients with trophic ulcers received standard treatment and MSC | Biological: Autologous adipose-derived mesenchymal stem cells<br>* Autologous adipose-derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with tropic ulcers cured | Number of patients cured | 1 month | 
| Number of patients with treatment-related adverse events | MSC injection related adverse events assessed by blood count and function tests | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trophic Ulcer, Mesenchymal stem cells