louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04473742: Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages
Official title: Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: History of Exposure to Silica or Asbestosis
Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases
Keywords: efferocytosis
macrophages
silica
asbestosis
HMGB1
osteopontin
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from patients with a history of asbestosis or silica exposure and comparison of these capacities with those of MDM from healthy donors.

Detailed description: Patients with a proven history or current exposure will have 4 EDTA tubes drawn, approximately 24mL of fresh whole blood for efferocytosis assessment and :

* 2 x 6mL serum tubes for the assessment of Antinuclear Antibody (ANA) positivity, serum high-mobility group box 1 (HMGB1) and osteopontin for patients exposed to asbestos
* 1 x 6mL serum tube for serum HMGB1 and osteopontin for patients exposed to silica

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 Yo
* Addressed to the department of occupational disease
* With a history of asbestosis or silica exposure evaluated by a dedicated questionnaire and a throughout examination of the history of occupations, according to standard procedures for the follow-up of at risk workers.
* Persons who received an oral and written information on the protocol and signed the informed consent form

Exclusion Criteria:

* Pregnant or breastfeeding women
* Subject legally protected (under judicial protection, guardianship), persons deprived of liberty

Primary outcomes:
measure: Efferocytosis Index (EI) calculation (%) defined as the number of efferocyte MDM / total number of MDM
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: EI calculation in patients positive for ANA vs patients negative for ANA
timeFrame: Through study completion, an average of 2 years
measure: Serum concentration of HMGB1 and Osteopontin (SPP1) by ELISA
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT01564342: Tap Water Versus Normal Saline for Wound Irrigation
Official title: A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection Rate
Keywords: wound irrigation
tap water irrigation
wound infection
wound irrigation solution
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 660
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the infection rates in wounds irrigated with sterile normal saline to those irrigated with chlorinated tap water. The hypothesis is that the wound infection rate subsequent to irrigation with tap water is not significantly different than the infection rate for wounds irrigated with sterile normal saline.

Inclusion criteria are patients older than 1-year of age who present to the emergency department with a soft-tissue laceration requiring repair. Exclusion criteria include patients with any underlying immunocompromising illness, current use of antibiotics, puncture or bite wounds, underlying tendon or bone involvement, or wounds more than nine hours old.

Patients are randomized to have their wounds irrigated either with tap water or sterile normal saline prior to closure, controlling for the volume and irrigation method used. Structured follow-up is completed at 48 hours and 30 days to determine the presence of infection.

The primary outcome measure is the difference in wound infection rates between the two randomized groups.


Eligibility criteria: Inclusion Criteria:

• Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.

Exclusion Criteria:

* Diabetes mellitus
* Asplenism
* primary immune disorder
* Mechanical heart valve
* Chronic alcoholism
* Steroid use,
* Antibiotics use
* Immunosuppressive chemotherapy
* Wounds older than 9 hours or from a human or animal bite
* Puncture wounds
* Wounds associated with bone, tendon, or neurovascular injury

Primary outcomes:
measure: Wound Infection at 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: wound infection manifest at 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References:
Clinical trial NCT05999942: A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants
Official title: A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants.


Eligibility criteria: Inclusion Criteria:

* Participants with a body mass index (BMI) of 20-28.
* Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results.
* Participants with no clinically significant findings in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.

Exclusion Criteria:

* Participants who had clinically diagnosed asthma.
* Participants with a known allergic reaction to amikacin, liposomes or any of the radiolabelling products (i.e. \[\^99m\]Tc, or \[\^111\]In, and \[\^81m\]Kr).
* Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or metabolic dysfunction.
* History of smoking within the past 12 months.
* History of chronic cough or wheezing within the previous 21 days.
* Participants who had an upper respiratory illness or infection within the previous 21 days.
* A history of drug or alcohol abuse.
* Donation of 450 milliliters (mL) or more blood within the previous 12 weeks.

Note: Other inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs
timeFrame: Pre-administration and 2 hours post-administration on Day 1
Secondary outcomes:
measure: Percent Dose Deposited in Oropharyngeal and Stomach Region
timeFrame: At multiple timepoints post-administration up to Day 2
measure: Percent Dose Remaining in the Device Including the Mouthpiece
timeFrame: At multiple timepoints post-administration up to Day 2
measure: Percent Dose Remaining in the Low Resistance Exhalation Filter
timeFrame: At multiple timepoints post-administration up to Day 2
measure: Penetration Index Based on the Ratio of Counts in the Central:Peripheral Lung Regions, Corrected for Regional Lung Volume (sC/P)
timeFrame: Pre-administration and 2 hours post- administration on Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01461642: E-support for Healthcare Processes - ASTHMA
Official title: E-support for Healthcare Processes - ASTHMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
ICT Support
ACT
PEF
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
Collaborators: name: University of Primorska
First posted: 2011-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.

Detailed description: A mobile environment to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated. The study will include 120 patients diagnosed with asthma that is poorly managed. The study will use the ACT (Asthma Control Test) questionnaire and an evaluation questionnaire that will cover issues regarding the satisfaction of subjects with asthma care offered. Subjects with a PEF meter, will be able to enter the value of PEF (Peak Expiratory Flow).

In addition to this, users can enter values (1) physical activity (type, duration, intensity), and (2) food (type, quantity).

Eligibility criteria: Inclusion Criteria:

* ACT points \<19
* Daily symptoms\> = 2 days/week
* Night symptoms\> = 1 night/week
* Rescue medication \> 2days/week
* At least one asthma exacerbation in the past year, but not in the last month, which was treated with oral glucocorticoid

Exclusion Criteria:

* Worsening of asthma in the last 4 weeks (treated with oral corticosteroids)
* Age \>70 or \<18 years
* Significant co-morbidity
* Does not own or know how to handle a mobile phone
* No internet access
* Not able to perform a PEF measurment
* Not able to use inhalor

Primary outcomes:
measure: Number of exacerbations.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Golnik
country: Slovenia
facility: University Clinic of Pulmonary and Allergic Disease
Study officials:
References:
Clinical trial NCT00493142: Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty
Official title: Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Heritage Foundation for Medical Research
name: Canadian Institutes of Health Research (CIHR)
First posted: 2007-06-28
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.

Detailed description: Patients with lower levels of function prior to total knee arthroplasty (TKA) attain lower functional endpoints after surgery. Therapeutic exercise improves function in patients with arthritis of the knee, yet little evidence has examined the impact of pre-operative exercise for TKA.

Single blinded randomized clinical trial comparing a pre-operative home exercise program to pre-operative usual care for patients who are waiting for TKA.Comparison group is usual care within the health region which does not include pre-operative rehabilitation program.

Primary outcome: WOMAC function subscale. Secondary outcomes: 1) quality of life; 2) ambulation; 3) self-efficacy; 4) anxiety; 5) patient satisfaction; 6) cost-effectiveness of this intervention.

Total Enrollment: 230 patients

If the intervention improves function prior to surgery, results will be clinically applicable for patients waiting for surgery

Eligibility criteria: Inclusion Criteria:

* primary unilateral total knee arthroplasty
* poor functional status (WOMAC=50 or greater)
* 50 yrs or older
* reside within health region
* understands English

Exclusion Criteria:

* unicompartmental total knee arthroplasty
* revision surgery

Primary outcomes:
measure: Self-reported function
timeFrame: 5 evaluations within 6 months after surgery
Secondary outcomes:
measure: Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction
timeFrame: 5 evaluations within 6 months after surgery
measure: self-efficacy
timeFrame: 5 evaluations within 6 months after surgery
measure: ambulation, anxiety and patient satisfaction
timeFrame: 5 evaluations within 6 months after surgery
measure: anxiety
timeFrame: 5 evaluations within 6 months after surgery
measure: patient satisfaction
timeFrame: 5 evaluations within 6 months after surgery
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta- Capital Health
state: Alberta
Study officials:
affiliation: University of Alberta
name: Allyson Jones, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Health- UAH
name: Lauren Beaupre, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04464642: Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis
Official title: Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis tofacitinib methotrexate
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label Randomization controlled clinical study
Primary purpose: TREATMENT

Brief summary: It is a randomized controlled study

Detailed description: Randomization controlled study on Rheumatoid arthritis patients whos disease activity is high, controlled subjects will be given methotrexate and study subjects will get tofacitinib

Eligibility criteria: Inclusion Criteria:1. age greater than 18 years 2. patients fulfill the ACR-EULAR classification criteria for RA 3.DAS-28 CRP more than 5.1

-

Exclusion Criteria:

1. systemic infection
2. hemoglobin less than 9 mg/dl
3. WBC \<4000, neutrophil \<1000, platelet \<100000/mm
4. live vaccine within 3 months
5. GFR \< 50 ml/min
6. ALT \> 2 times ULN
7. pregnancy

Primary outcomes:
measure: DAS-28 CRP at 6 month
timeFrame: 6 months
Secondary outcomes:
measure: SDAI at 6 months
timeFrame: 6 months
measure: HAQ-DI at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Seikh Mujib Medical University
Study officials:
affiliation: Resident doctor, BSMMU
name: Mohammad M Khan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05095142: The Role of Genetic Factors in the Development of Idiopathic Osteoarthritis of the Knee in the Kazakh Population
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Osteoarthritis
Keywords: SNP
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons of Kazakh nationality

Brief summary: The purpose of this study is to identify genetic determinants of susceptibility to idiopathic osteoarthritis of the knee . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic osteoarthritis of the knee


Eligibility criteria: Inclusion Criteria:

1. Patients with bilateral idiopathic gonarthrosis aged 18 to 65 years;
2. Representatives of the Kazakh ethnic group up to the 3rd generation;
3. Hereditary history of arthrosis;
4. Persons who are able and willing to provide written informed consent;

Exclusion Criteria:

1. Patients with bilateral idiopathic gonarthrosis under 18 years of age and over 65 years of age;
2. Representatives of other ethnic groups;
3. Representatives of the Kazakh ethnic group less than 3 generations;
4. No family history of bilateral idiopathic gonarthrosis;
5. Patients with an acute period of the inflammatory process (laboratory and clinical signs);
6. Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
7. Pregnant or lactating women;
8. Tuberculosis of any localization in the active phase and in history;
9. Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
10. Severe and decompensated course of endocrine diseases;
11. Autoimmune diseases;
12. Systemic diseases;
13. Oncological diseases;

Primary outcomes:
measure: enotyping for the SNP associated with liver cirrhosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Scientific center of traumatology and orthopedics named after academician Batpenova ND
Study officials:
affiliation: Scientific center of traumatology and orthopedics named after academician Batpenova ND
name: Olzhas Bekarisov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06756542: Evaluating the Use of Artificial Intelligence to Improve Family Conversations for Intensive Care Patients and Their Families
Official title: Utilizing Large Language Models to Augment Family Conversations in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Medicine
Critical Care
Keywords: intensive care
artificial intelligence
large language models
administration reduction
patient satisfaction
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care professionals performing formal family conversations and family members of patients admitted to the adult intensive care.

Brief summary: This study looks at how artificial intelligence (AI), like generative pre-trained transformer (GPT-4), can help doctors in the intensive care unit (ICU) save time and improve communication with families. Right now, doctors spend a lot of time writing notes after family conversations, which takes time away from patient care. The investigators are testing whether AI can create accurate and easy-to-understand summaries of these conversations, making it quicker for doctors to document and clearer for families to understand. ICU doctors and adult family members of patients will take part in this study, with their full consent. The goal is to see if this new technology can make life easier for doctors while helping families better understand medical information.


Eligibility criteria: Inclusion Criteria:

* Informed-consent is signed by all participating family members during the conversation.
* Informed-consent is signed by the ICU healthcare professionals.
* The patient of the family must be admitted to the adult ICU.
* All participating family members must be 18 years or older.
* The family conversation must be in Dutch.

Exclusion Criteria:

* Trained to interpret medical jargon and/or intensive care terminology specifically
* Difficulty reading and/or writing in the Dutch language

Primary outcomes:
measure: Documentation quality of family conversations
timeFrame: Within 30 days after the family conversation.
Secondary outcomes:
measure: Time spent on documentation by ICU clinicians
timeFrame: Within one day after the family conversation.
measure: Family satisfaction
timeFrame: Within 30 days after the family conversation.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Intensive Care Adults, Erasmus University Medical Center, Rotterdam, the Netherlands
name: Diederik Gommers, MD PhD
role: STUDY_DIRECTOR
affiliation: Intensive Care Adults, Erasmus University Medical Center, Rotterdam, the Netherlands
name: Michel E. van Genderen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04796142: Medication Reconciliation in Oncologic Patients
Official title: An Integrated Model to Increase Medication Recognition and Reconciliation in Oncologic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Reconciliation
Keywords: Medication reconciliation
IT platform
Pharmacies
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To improve medication reconciliation in oncologic patients in healthcare transitions through an alliance between a Cancer Institute and the community pharmacies and a new integrated IT platform.

Detailed description: This trial will explore the alliance between a Cancer Institute and the community pharmacies to improve medication reconciliation in healthcare transitions, and will validate a new integrated IT platform.

Cancer patients receiving an oncologic treatment will be asked to choose a pharmacy participating to the trial, and to perform the pharmacological survey before every cycle of chemotherapy.

This will be sent through the new IT platform to the electronic medical record of IRST, and the Oncologist will perform the reconciliation.

Data about concomitant medications and possible interactions will be exensively analyzed.

Eligibility criteria: Inclusion Criteria:

* Adult ≥18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Patients receiving an anticancer treatment
* Clear understanding of the Italian language; written informed consent.

Exclusion Criteria:

- None

Primary outcomes:
measure: medication recognition and reconciliation maintenance
timeFrame: At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Alessandro Passardi
state: FC
Study officials:
affiliation: IRCCS IRST
name: martina minguzzi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Passardi A, Serra P, Donati C, Fiori F, Prati S, Vespignani R, Taglioni G, Farfaneti Ghetti P, Martinelli G, Nanni O, Altini M, Frassineti GL, Minguzzi MV. An Integrated Model to Improve Medication Reconciliation in Oncology: Prospective Interventional Study. J Med Internet Res. 2021 Dec 20;23(12):e31321. doi: 10.2196/31321.