louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06062212: Effect of Transpulmonary MP on Prognosis of Patients with Severe ARDS Treated with VV-ECMO
Official title: Effect of Transpulmonary Mechanical Power on the Prognosis of Patients with Severe Acute Respiratory Distress Syndrome Treated with Venovenous Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Extracorporeal Membrane Oxygenation
Mechanical Power
Transpulmonary Mechanical Power
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe ARDS patients treated with VV-ECMO

Brief summary: Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a salvage treatment for severe acute respiratory distress syndrome (ARDS). With the large-scale implementation of VV-ECMO in critical care medicine departments in China, significant progress has been made in treating severe ARDS. However, the patient mortality rate remains high. The pathophysiological essence of ARDS is an imbalance between the body's oxygen supply and demand, causing tissue and cell hypoxia, organ dysfunction, and even death. The VV-ECMO treatment process still requires mechanical ventilation assistance. However, inappropriate mechanical ventilation settings can lead to ventilator-related lung injury (VILI). In recent years, mechanical power has gradually attracted everyone's attention and is considered the cause of VILI. The transpulmonary mechanical power is more accurate to the energy directly performed to the lung tissue. Transpulmonary mechanical energy has a specific value in judging the prognosis of mechanically ventilated patients, but its clinical significance in treating patients with VV-ECMO is unclear. This study aimed to explore the value of transpulmonary mechanical power in predicting the prognosis of patients with severe ARDS patients treated with VV-ECMO.


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of Berlin's definition for ARDS;
2. Receiving VV-ECMO support.

Exclusion Criteria:

1. Patients had been on high pressure (Ppeak \>35 cm H2O) and a high fraction of inspired oxygen (FiO2\>0.8) ventilation for \>7 days;
2. Patients had a contraindication to heparinization;
3. Patients had an irreversible neurological injury;
4. Patients had severe chronic lung disease with life expectancy \<6 months.

Primary outcomes:
measure: Patients successfully weaned from VV-ECMO
timeFrame: After patients enrolled 60 days
Secondary outcomes:
measure: 60-day mortality
timeFrame: After patients enrolled 60 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
name: Rui Wang, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05413512: Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress
Official title: Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Psychological Stress
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will examine the relationship between metabolically excessive cardiovascular and neural responses to acute psychological stress using a cross-sectional approach.

Detailed description: All participants in this study will undergo an acute psychological stress paradigm, there will be no randomization or assignment since all participants will complete the same tasks. Sample size was calculated based off of recent papers examining multivariate pattern brain responses predicting cardiovascular responses to stress.

Eligibility criteria: Inclusion Criteria:

18-30 years old

Exclusion Criteria:

Chronic medical or neurological condition Pregnant Current illness or infection Any condition that would prohibit engaging in physical exercise Any metal implants in body Claustrophobia

Primary outcomes:
measure: Oxygen consumption
timeFrame: 20 minutes
measure: Heart rate (bpm) measured by electrocardiogram
timeFrame: 20 minutes
measure: Neural activity measured by fMRI
timeFrame: 20 minutes
measure: Additional heart rate
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
References:
Clinical trial NCT05976412: Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer
Official title: Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 1355
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.


Eligibility criteria: Inclusion Criteria:

Voluntarily participate and sign an informed consent form; Age\>18 years old, female； received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection； Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB)； including two or more high-risk factors based on four clinical high-risk recurrence factors \[tumor size (\>2cm), tumor site (medial and central quadrants), Ki-67 level (\>14%), and vascular status (positive)\]; KPS ≥ 80, estimated survival time \>5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study

Exclusion Criteria:

Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;

Primary outcomes:
measure: 5 year disease free survival rate
timeFrame: 5 year
Secondary outcomes:
measure: 5 year local reginal recurrence rate
timeFrame: 5 year
measure: 5 year distant metastases rate
timeFrame: 5 year
measure: 5 year overall survival rate
timeFrame: 5 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT02506712: Evaluation of Physiological and Biomechanical Efficiency of the PAPAW
Official title: Evaluation of Physiological and Biomechanical Efficiency of the PAPAW
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Fondation Garches
First posted: 2015-07-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:

Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.

Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

Detailed description: Prospective study mono-centric, controlled, randomized cross over. Randomization of the equipment (without and with SmartDrive).

22 SCI manual wheelchair users. 22 caregivers (healthy subjects)

Eligibility criteria: Inclusion Criteria:

* men and women aged between 18 and 70 years
* spinal cord injury
* having given free and informed consent

Exclusion Criteria:

* No affiliation to a social security scheme
* Refusal to participate in the clinical trial
* Patient under guardianship
* Major cognitive disorder
* Bedsores
* Acute complication or systemic organ

Primary outcomes:
measure: measure of oxygen consumption per unit time (VO2) during propulsion
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: hopital R Poincare
Study officials:
affiliation: Raymond Poincaré Hospital
name: Caroline Hugeron, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037512: User Evaluation of BGM VGM77
Official title: Evaluierung Des Blutglukose Monitoring Systems VGM77 Der Firma Beurer GmbH gemäß DIN EN ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with DIN EN ISO 15197:2015


Eligibility criteria: Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03934112: Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit
Official title: Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transfusion Related Complication
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 150000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated in medical and surgical resuscitation units of Besançon and Dijon university hospitals during the study period (from 01/01/2012 to 31/12/2017) are concerned.

Brief summary: This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria.

These data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies.

It will also bring information about the actual transfusion monitoring in intensive care unit (ICU), in the period following the stay in the ICU and after hospital discharge.


Eligibility criteria: Inclusion criteria:

* Patient admitted to medical and surgical resuscitation units of Besançon and Dijon university hospitals, all causes considered
* Patient admitted between 1st January 2012 to 31st December 2017

Primary outcomes:
measure: Survival at 90 days after leaving ICU
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT01757912: Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients
Official title: Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation With Oral Intubation
Keywords: mechanical ventilation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: General Hospital Sint-Blasius Dendermonde
First posted: 2012-12-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The endotracheal tube secures free airway in patients undergoing surgical procedures or mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A cuff pressure in excess of the target range is associated with a risk of tracheal injury, whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is unknown whether the cuff pressure changes following changes in body position of the patient. The objective of this study is to investigate to which extent - if any - cuff pressures change after body position changes of the patient.


Eligibility criteria: Inclusion criteria are age 18 - 70 years, oral intubation with a taperguard EVAC endotracheal tube (Covidien®), conventional mechanical ventilation, adequate sedation (Richmond Agitation-Sedation Scale -5) and analgesia (Behavior Pain Scale 3 to 4).

Exclusion criteria are factors with potential influence on the cuff pressure or factors that disturbed the safety or well-being of the patient: pregnancy, palliative care, difficult intubation, decreased mobility of the neck, history of neck surgery, temperature of \<35°C or \>37.5°C, morbid obesity (body mass index \>35) and every potential contra-indication for position changes such as unstable spinal cord injury or hemodynamic and/or respiratory instability.

Primary outcomes:
measure: absolute values of cuff pressure (in cm H20) an number of measurement outside target range.
timeFrame: During surgical procedure or mechanical ventilation.
Secondary outcomes:
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: General Hospital Sint Blasius
Study officials:
affiliation: University Ghent
name: Stijn Blot, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02008812: Ad Sensor-based Real-time Diagnosis of Adenovirus
Official title: Ad Sensor-based Real-time Diagnosis of Adenovirus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenovirus
Keywords: Adenovirus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To develop a real-time diagnostic technique with Ad sensor for Adenovirus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Adenovirus, the investigators evaluate the performance of Ad sensor , including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give Adenovirus patients early treatment to reduce the complications and case-fatality rate.

Detailed description: 1. Sample acquirement： At National Taiwan University Hospital in Taiwan, we will enroll patients who have Adenovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Ad sensor - based real-time diagnosis.
2. Ad sensor diagnosis： Ad sensor (structural chip-based optosensing virus probing system), which is for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-Adenovirus and its Adenovirus antigen present in patients'and normal samples.
3. Gold standard： viral isolation and RT-PCR

Eligibility criteria: Inclusion Criteria:

A: The patients with confirmed or suspected infection. B: The healthy person without disease.

Exclusion Criteria:

-

Primary outcomes:
measure: The performance of Ad sensor
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00140712: Ropinirole Tablets In Young Patients With Restless Legs Syndrome
Official title: A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Restless Legs Syndrome
Keywords: RLS
PLMS
Adolescent
Periodic Limb Movements of Sleep
Ropinirole
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.


Eligibility criteria: Inclusion Criteria:

* Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).

Exclusion Criteria:

* Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.

Primary outcomes:
measure: AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy).
timeFrame: Up to 3 years
Secondary outcomes:
measure: PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Macon
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Edison
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02714712: SR-BI and Antiviral Treatment Response in HCV
Official title: Influence of Scavenger Receptor Class B Type I (SR-BI) Gene Polymorphisms on Antiviral Treatment Response, and Metabolism in Chronic Hepatitis C Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCV genotype 1 or 2 patients who received pegylated interferon alfa-2a (Peg-IFN alfa-2a) plus ribavirin therapy were consecutively enrolled from the gastroenterological clinics

Brief summary: The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins (HDL) and one of entry factors for hepatitis C virus (HCV). The investigators aimed to examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian chronic hepatitis C (CHC) patients.

Detailed description: 1. Purpose of study: To examine the impacts of single nucleotide polymorphisms (SNPs) relevant to SR-BI on CHC patients.
2. Study Design To enroll 400 CHC patients during a 3-year period
3. Specify objectives of study when collecting extra specimen from participants Collect blood samples for genomic DNA to examine the SR-BI gene polymorphisms.
4. Expected Endpoints of Treatment Sustained virologic response (SVR) means undetectable serum HCV RNA levels 24 weeks after completion of antiviral therapy.

Eligibility criteria: Inclusion Criteria:

1. Naive to IFN treatment and other experimental antiviral or immunosuppressive therapy before enrollment.
2. Serum alanine aminotransferase levels, at least, twice the upper limit of normal on two occasions within the previous 6 months.

Exclusion Criteria:

1. Positive for hepatitis B surface antigen
2. Positive for human immunodeficiency virus antibody
3. Had a known history or evidence of autoimmune liver disease, inheritable disorders, renal insufficiency, malignancy
4. Had a history of daily alcohol consumption greater than 20 gram or active drug abuse.

Primary outcomes:
measure: Serum HCV RNA levels
timeFrame: at 24 weeks after the end of treatment
Secondary outcomes:
measure: serum fasting blood glucose levels
timeFrame: at 24 weeks after the end of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Hsu CS, Hsu SJ, Liu WL, Chen DS, Kao JH. Association of SCARB1 Gene Polymorphisms with Virological Response in Chronic Hepatitis C Patients Receiving Pegylated Interferon plus Ribavirin Therapy. Sci Rep. 2016 Aug 26;6:32303. doi: 10.1038/srep32303.