linjc16/ctgov huggingface dataset:
Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort

Study Overview
=================
Brief Summary
-----------------
Establish a structured clinical database for sepsis screening, and establish a special data set standard for sepsis throughout the life cycle.

Official Title
-----------------
Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sepsis who meet the Sepsis 3.0 standard proposed by the 2016 International Sepsis Expert Consensus, that is, for patients with infection or suspected infection, when sepsis-related sequential organ failure (Sequential (Sepsis-related) Organ Failure) Assessment (SOFA) score increased by ≥ 2 points from the baseline can be diagnosed as sepsis; It is estimated that the patient's ICU stay ≥24 hours; Obtain informed consent and sign an informed consent form. Exclusion Criteria: The patient's ICU hospital stay is less than 24 hours; Participated in other clinical research; Failed to sign the informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis organ function status and survival analysis. | Safety indicators include: prognosis: mortality, intensive care unit (ICU) treatment time and hospital stay, incidence of nosocomial infections, treatment-related complications. | 2022.09.30 |
Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging

Study Overview
=================
Brief Summary
-----------------
In this study, it is aimed to compare the lesion location, lesion size, local and distant metastases detection rates of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer. The pathologies of the patients who were decided to undergo radical prostatectomy as a treatment will also be compared with the staging tests.

Official Title
-----------------
Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging

Conditions
-----------------
Prostate Cancer, Prostate Cancer Stage

Intervention / Treatment
-----------------
* Diagnostic Test: Multiparametric Prostate MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with prostate cancer Gleason score 7 or above / 6 with high risk No other treatment Exclusion Criteria: treated with radiotherapy treated with ADT
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 47 male patients who will be evaluated with both imaging studies will be included in the study.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Multiparametric Prostate MRI|Comparison of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion location | Both MRI and PET results will be compared. Lesion location will be defined as left, right, apical, basal, midline. | Between prostate biopsy and curative treatment decision , usually 2 month | 
| Lesion Size | Both MRI and PET results will be compared, Lesion size will be stated in milimeters. | Between prostate biopsy and curative treatment decision , usually 2 month | 
| Lymph node involvement | Both MRI and PET results will be compared. Involvement will be stated as exist, non-exist. | Between prostate biopsy and curative treatment decision , usually 2 month | 
| Extraprostatic involvement | Both MRI and PET results will be compared. Involvement will be stated as exist , non-exist. | Between prostate biopsy and curative treatment decision , usually 2 month | 
| Local and distant metastasis | Both MRI and PET results will be compared. Metastasis will be stated as exist , non-exist. | Between prostate biopsy and curative treatment decision , usually 2 month |
A-line/CareTaker Comparison Study in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and Intra-Arterial Catheters in ICU Patients

Detailed Description
-----------------
The object of the work presented here was to validate a new approach to tracking blood pressure that is based on the pulse analysis of the peripheral arterial pressure pulse. The approach, referred to as the Pulse Decomposition Analysis (PDA) model, goes beyond traditional pulse analysis by invoking a physical model that comprehensively links the components of the peripheral pressure pulse envelope with two reflection sites in the central arteries. In these experiments, approved by the University of Virginia Institutional Review Board, the arterial blood pressures of patients (23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height: 173.3 cm, SD: 9.4 cm, mean weight: 95.3 kg, SD: 27.4 kg) hospitalized in University of Virginia Medical Intensive Care Units (MICUs) were monitored using radial intra-arterial catheters, while the CareTaker system collected pulse line shapes at the lower phalange of the thumb of the ipsilateral hand. Systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements and a Bland-Altman analysis was created. Results were within the limits established for the validation of automatic arterial pressure monitoring (AAMI/ANSI/ISO 81060-1:2013).

Official Title
-----------------
A-line/CareTaker Comparison Study in ICU Patients

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

Intervention / Treatment
-----------------
* Device: continuous non-invasive blood pressure monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female age 18 to 45 presence of a radial arterial catheter informed consent by subject or surrogate available digital pulse Exclusion Criteria: failure to meet all of the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: continuous non-invasive blood pressure monitor|continuous blood pressure monitoring using device in parallel with Gold Standard (A-line)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance comparison according to AAMI/ANSI/ISO 81060-1:2013 | Correlation and standard deviation between both blood pressure measurement systems were assessed according to 81060 standards. | 40 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous, non-invasive
The Role and Effect of Anemia in Children With Pneumonia

Study Overview
=================
Brief Summary
-----------------
This study will measure the effect of anemia on the outcomes of hospitalized children with severe pneumonia.

Official Title
-----------------
The Role and Effect of Anemia in Children With Pneumonia

Conditions
-----------------
Anemia, Pneumonia

Intervention / Treatment
-----------------
* Other: none - observational only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 months to 59 months WHO-defined severe pneumonia Exclusion Criteria: Congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: none - observational only|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery from pneumonia |  | participants will be followed for the duration of hospital stay, an expected average of 5 days |
Acute Kidney Injury After Cardiac Surgery on CPB

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.

Detailed Description
-----------------
The investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the PICU after cardiac surgery on CPB from 01.01.2014 to 31.12.2016. They will asses for AKI. The first step is to determine the incidence and severity, the second step is to determine the risk factors for AKI and/or protecting factors.

Official Title
-----------------
Incidence of Acute Kidney Injury After Cardiac Surgery on Cardiopulmonary Bypass in the Pediatric Intensive Care Unit of Lausanne. A Retrospective Study

Conditions
-----------------
Acute Kidney Injury, Congenital Heart Disease, Surgery, CBP, Child, Only

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion of all pediatric patients (0-16 years) admitted to PICU after cardiac surgery with CPB. - Exclusion Criteria: Preexisting kidney injury, no preoperative creatinine lab value -

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and severity of an AKI occurring during stay in the PICU | Scoring AKI with pRiffle | up to 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PICU stay and ventilation time | correlation between AKI and invasive ventilation/duration and PICU stay | up to 3 month | 
| Persisting AKI after release from PICU according to RIFLE score | After leaving ICU | more than 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute kidney injury, AKI
Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.

Detailed Description
-----------------
In spring 2020 four regions of France faced a surge of severe Coronavirus (COVID) patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded ICUs to other French regions and neighbouring countries. The study aims at assessing the impact of these inter-ICU transfers on the short and medium term physical and psychological outcomes in this population of severe COVID 19 patients. All transferred patients between ICUs outside the origin region are invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (+/-4 days of transfer date). Clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.

Official Title
-----------------
TRANSCOV Cohort. An Epidemiological Study Assessing the Impact of Critically Ill COVID-19 Patients Long Distance Transfers Between Intensive Care Units

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Inter ICU long distance patient transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 patients diagnosed biologically or by imaging Admission in ICU between 03/13/2020 and 04/10/2020 Exclusion Criteria: none

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transferred group<br>The transferred group includes all severe COVID patients admitted in a French ICU ward and then transferred between the 03/13/2020 and 04/10/2020 to another ICU located outside the region of the initial ICU stay. | Other: Inter ICU long distance patient transfer<br>* Individual or grouped transportation between ICU of severely ill patients using ambulance, plane, helicopter, train or boat, with specialist medical assistance.<br>|
| Control group<br>The control group includes patients selected out of those whose entire ICU care has taken place in one of the hospitals which transferred patients. Up to 4 control patients will be selected for each transferred patient. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Status alive or dead | 1 year |
Effect of Denileukin Diftitox on Immune System in CTCL Patients

Study Overview
=================
Brief Summary
-----------------
This is a blood and tissue study to determine the effect of the drug called denileukin diftitox on the immune system cells that may be involved in patient response to their cutaneous t-cell lymphoma. Patients who are undergoing standard of care therapy with denileukin diftitox will be invited to participate. Blood and tissue samples will be obtained at baseline, day 5 and day 19 in up to the first 4 cycles of denileukin diftitox.

Detailed Description
-----------------
Although the etiology of CTCL is not fully understood, it is believed to be a malignancy proliferation of a memory T-cell in the context of Th2-type cytokine profile and suppressed cytotoxic T-cell (CTL) immunity. T-regulatory (T-regs) cells may be important in CTCL in the setting of immunotherapy. Removal of T-regs would result in enhanced immune responses in vitro, which may translate into augmentation of the anti-tumor immune response and durable clinical responses in vivo. We propose to evaluate effects of ONTAK on the T-reg cell subset in patients undergoing routine therapy with ONTAK. We will evaluate T-reg subsets in peripheral blood and tumor tissues from the patients both phenotypically using multi-color FACS analysis and confocal microscopy, and functionally in MLRs and ELISpot assays with baseline, day 5 and 19 blood samples in up to four cycles. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients

Conditions
-----------------
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 and older diagnosed with CTCL able and willing to provide informed consent will be receiving denileukin diftitox per standard guidelines Exclusion Criteria: prior history of receiving Ontak pregnancy

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides, Denileukin Diftitox
Depression Management Project

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an eight-lesson self-help intervention delivered online will result in a reduction of depressive symptoms.

Official Title
-----------------
Depression Management Project (DMP)

Conditions
-----------------
Major Depression, Depression

Intervention / Treatment
-----------------
* Behavioral: Self-help cognitive-behavioral online course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be 18 years of age or older, Participants will have regular (>1 time/week) access to internet and email, with a valid email address, Participants will be fluent or almost fluent in English, and Participants will be looking for information to help themselves, rather than another person. Only those invited to participate will be eligible. Exclusion Criteria: Participants under 18 years of age, Participants will with sporadic (< 1 time/week) access to internet and email, Participants who fail to provide an email address, Participants with English difficulties, Participants looking for information to help someone else, and Participants not invited will be ineligible.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help course<br> | Behavioral: Self-help cognitive-behavioral online course<br>* A self-help online course based on cognitive behavioral therapy for major depression.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptoms - Self-report |  | Baseline, 1, 2, and 5 months post consent | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Behavioral Therapy, Mood Management, Self-help, Internet
Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the impact of sleep quality on intubation rate in intensive care units patients with acute respiratory failure

Official Title
-----------------
Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

Conditions
-----------------
Sleep Quality, Hypoxemic Acute Respiratory Failure, Intubation Risk

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute respiratory failure hypoxemia with PaO2/FiO2 ratio < 300 mmHg aged of 18 years or more Exclusion Criteria: Need of immediate intubation Need of vasopressor drugs coma with Glasgow scale < 8 Acute respiratory failure linked to cardiogenic pulmonary oedema Chronic respiratory insufficiency Peripheral or central nervous system pathology Known psychiatric pathology or agitation Patient with decision of no intubation Patient refusal Pregnant or breastfeeding women Patient under legal guardianship or protection Patients with no health insurance coverage

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 |
| --- |
|Other: Polysomnography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the intubation rate of patients with hypoxemic acute respiratory failure between those who have a poor quality of sleep and those who have a good quality of sleep |  | 24h |