louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04399811: Near-infrared Vision for Microcirculatory Status
Official title: Machine Learning-Based Near-infrared Vision to Evaluate the Microcirculatory of Critical Ill Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Near-infrared Vision
Machine Learning
Microcirculatory Status
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General critical ill patients who required evaluation of perfussion.

Brief summary: The investigators aimed to combine the image of near-infrared vision and machine learning method to evaluate the microcirculatory status of critical ill patients.

Detailed description: The heat distribution of body is determined by the circulatory status. The investigators plan to the near-infrared vision to collect heat distribution information of limbs. Then, the machine learning method will be performed to recognize the subtle differences between images. Due to lack of golden standard of microcirculatory status, indirect parameters (such as lactate clearance, capillary refill time) and clinical outcomes will be recorded to evaluate the performance of maching learning model.

Eligibility criteria: Inclusion Criteria:

* Age≥18 years;
* Patients who were transfered to our ICU.

Exclusion Criteria:

* Abnormalities of lower limbs arteries

Primary outcomes:
measure: Hospital mortality
timeFrame: From date of admission to our ICU until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 2 months.
Secondary outcomes:
measure: Lacteta clearance rate
timeFrame: When the near-infrared image is taken for a patient, the blood gas analysis will be performed immediately to get the value of lactate. After 2-hours, another blood gas analysis will be conducted to get the second value of lactete.
measure: Capillary refill time (CRT)
timeFrame: When the near-infrared image is taken for a patient, the capillary refill time will be measured immediately.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04206111: Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation
Official title: Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Ultrasound
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults

Brief summary: Check in gastric ultrasound for lack of stomach insufflation during preoxygenation with high-flow nasal cannulas


Eligibility criteria: Inclusion Criteria:

* Adults Volunteers

Exclusion Criteria:

* History of gastric surgery
* Facial or oropharyngeal abnormality

Primary outcomes:
measure: no gastric insufflation
timeFrame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Javillier
Study officials:
References:
Clinical trial NCT04519411: Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
Official title: Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID 19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.


Eligibility criteria: Inclusion Criteria:

* Patients 0-17 years of age, 10 kg or greater, with suspected or confirmed Covid-19 respiratory failure requiring endotracheal intubation and mechanical ventilation admitted to Mayo Clinic Hospital, St. Mary's Campus Pediatric Intensive Care Unit.

Exclusion Criteria:

* Patients \<10 kg
* Patients with pre-existing chronic mechanical ventilation (chronic respiratory failure)
* Patients with known esophageal disease (strictures, known esophageal anatomic abnormalities)
* Patients with severe coagulopathy (for which placement of esophageal balloon or other gastric tube via nose or mouth is contraindicated)
* Patients who are pregnant (as determined by standard pregnancy testing criteria for Pediatric ICU admission).

Primary outcomes:
measure: Transpulmonary pressure
timeFrame: Through study complication, usually 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Stephen J Gleich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02676011: Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery
Official title: Prevention of Brad Arrhythmia Induced by Repeated Succinylcholine by Atropine Sulfate During Gynecological Laparoscopic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bradycardia
Keywords: Atropine
Succinycholine
Laparoscopy
Gynecology
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim of this study was to evaluate the efficacy of atropine sulfate for prevention of brad arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.

Detailed description: 120 candidates, ASA 1 in the age range 18-40 years scheduled for elective diagnostic gynecological laparoscopic surgery were randomly assigned into 4 groups to receive either atropine sulfate or normal saline solution (as placebo).

Eligibility criteria: Inclusion Criteria:

* Female patients 18-50 years scheduled for elective diagnostic gynecological laparoscopic surgery

Exclusion Criteria:

* Cardiac
* Diabetes Mellitus
* Thyroid disease
* Any endocrine disease

Primary outcomes:
measure: Occurrence of bradycardia
timeFrame: within the first 2 hours during surgery
Secondary outcomes:
measure: Nasopharyngeal secretion
timeFrame: within the first 4 hours during surgery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy, M
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02614911: Characterization of Phenotype and Genotype of Early Onset Enteropathies
Official title: Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease
Keywords: Early Onset Entheropathy
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 1445
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion of patients with chronic severe entheropathy and of their healthy relatives

Brief summary: This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies.

In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.

Detailed description: This study specifically aims at the genetic analysis of early onset enteropathies with the goal in mind to delineate human pathways necessary to maintain intestinal homeostasis despite the considerable density of microbes colonizing the distal part of the human intestine.

Eligibility criteria: Main Inclusion Criteria:

* Severe chronic enteropathy
* Patients developing their first symptoms within the first 6 years of life and, in priority within the first two years of life, or patients with a disease of later onset, in case of a familial history suggestive of inherited mutations notably in families comprising several affected members
* OR : Be a patient's relative, even if presenting with enteropathy of later onset.

Main Exclusion Criteria:

* Subject having participated to any therapeutical clinical study in the 30 days preceding the inclusion in this study,

Primary outcomes:
measure: Increasing the current rate (20%) of genetic characterization of early onset entheropathies
timeFrame: 40 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Pellegrin-Enfants
city: Bron
country: France
facility: Hôpital pédiatrique de Lyon
city: Lille
country: France
facility: Hôpital Jeanne de Flandre, CHRU de Lille
city: Marseille
country: France
facility: Hôpital d'enfants de la Timone
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Necker - Enfants Malades Hospital
city: Paris
country: France
facility: Hôpital Robert Debré
city: Paris
country: France
facility: Hôpital Trousseau
city: Rennes
country: France
facility: Hôpital Sud
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Toulouse
country: France
facility: Hôpital des Enfants
city: Tours
country: France
facility: Hôpital Clocheville, CHU de Tours
Study officials:
affiliation: Necker - Enfants Malades Hospital
name: Frank Ruemmele
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01106911: Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
Official title: Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Abnormalities
Keywords: digital breast tomosynthesis
baseline screening mammography
recall rates
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 1080
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

Detailed description: The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 34 and 56.
* Women presenting for their baseline screening mammography examination

Exclusion Criteria:

* Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
* Women who may be or are pregnant by self report
* Women older than 55 years of age or younger than 35.
* Women with known fatty breast tissue
* Males and children
* Women who are unable to understand or execute written informed consent

Primary outcomes:
measure: Number of Participants Without Cancer Who Were Recalled
timeFrame: upon recruitment/enrollment phase completion
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jules H Sumkin, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02215811: Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
Official title: Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Respiratory Distress Syndrome, Adult
Keywords: Extracorporeal membrane oxygenation
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2014-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, non-randomized controlled trial. Patients with viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be performed postoperatively. All available data will be collected prospectively. Follow-up is 12 months. Informed consent will be obtained from relatives to patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Viral-induced acute respiratory distress syndrome
* Ventilator treatment
* Extracorporeal membrane oxygenation treatment
* Relatives provide written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: In-hospital mortality
timeFrame: During hospital stay, an expected average 2 months
Secondary outcomes:
measure: Pulmonary compliance
timeFrame: During ventilator treatment, an expected average of 1 month
measure: Pulmonary tidal volume
timeFrame: During ventilator treatment, an expected average of 1 month
measure: Adverse events
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 12 months
measure: Recovery of organ functions
timeFrame: 12 months
Other outcomes:
measure: Immune modulation
timeFrame: 3 months
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Karl-Henrik Grinnemo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01607411: A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Official title: A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-30
Enrollment: 55
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
timeFrame: Baseline to 4 hours
Secondary outcomes:
measure: %SMHR of Enamel Specimens Exposed to Test Treatments
timeFrame: Baseline to 4 hours
measure: Percent Net Acid Resistance (%NAR) of Enamel Specimens
timeFrame: Baseline to 4 hours
measure: Enamel Fluoride Uptake
timeFrame: Baseline to 4 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073.
Clinical trial NCT06758011: ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting
Official title: Feasibility Study for ivWatch® in Prevention of Extravasation of Vesicants in an Oncology Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncology
Extravasation
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 2395
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to determine the feasibility of using the ivWatch (registered trademark) device to determine if there is an infiltration at the site of a peripheral intravenous (PIV) catheter. An infiltration is when the IV fluid leaks out of a vein and into the surrounding tissue. If medication starts leaking outside the vein, it can cause damage to the surrounding tissue. Using the ivWatch device may identify leaking fluid before the nurse is able to visually observe the signs or symptoms of the leaking fluid.

Detailed description: PRIMARY OBJECTIVE:

I. Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory population.

SECONDARY OBJECTIVE:

I. Evaluate the clinical outcomes of extravasations that occur with the use of the ivWatch device.

Eligibility criteria: Inclusion Criteria:

* Patients requiring a peripheral IV for infusion of vesicant or vesicant-like agents (chemotherapy, other vesicant medications).
* PIV must be inserted
* Participant (or legal representative) must understand the nature of this study and verbally consent with the Research Study Information Sheet prior to receiving any study related procedure

Exclusion Criteria:

* Patients who are not getting a vesicant, irritant or vesicant like fluid infused.
* Patients who are bruised, scarred, or tattooed in the area of the PIV.
* Patients with skin integrity issues at the site of the PIV.
* Patients who are on "light precautions."
* Not for use in power injectors.
* Not for use on mediports, implanted ports, IVAD, central lines, PICC lines.
* Patients without a cancer diagnosis.

Primary outcomes:
measure: Ratio of number of ivWatch devices used for vesicant therapy
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change in number of extravasations while wearing ivWatch
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT01836211: High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain
Official title: High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chest Pain
Acute Coronary Syndrome
Keywords: Chest pain
Acute coronary syndrome
Cardiac biomarkers
Computed coronary tomography angiography
Emergency department
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: * The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy.
* Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).


Eligibility criteria: Inclusion Criteria:

* Patients with chest pain consistent with possible acute coronary syndrome.
* Age \> 18 years.
* Informed consent.

Exclusion Criteria:

* Previous history of coronary artery disease.
* Electrocardiogram diagnostic or suggestive of myocardial ischemia.
* Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
* Chronic kidney disease (GFR \<30 mL/min/1,73 m2).
* Iodine contrast allergy.
* Incapability to perform treadmill stress test.
* Barthel activity of daily living scale index \< 100.

Primary outcomes:
measure: All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
timeFrame: 1 month after index event
Secondary outcomes:
measure: All cause mortality
timeFrame: 1 month
measure: Myocardial infarction
timeFrame: 1 month
measure: Unstable angina
timeFrame: 1 month
measure: Heart Failure
timeFrame: 1 month
measure: Hospital admission
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Cruz y San Pablo
Study officials:
References: