louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01812499: Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports
Official title: Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Transfusion Events
Keywords: blood transfusion
adverse event
incident reporting
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in a university hospital which experienced a transfusion event

Brief summary: Inhospital the blood transfusion process consists of many phases: ordering the blood product, analysis of the blood sample, delivery, transport and storage of the blood product and administration. In each of these phases (near) accidents may occur. A severe transfusion incident refers to the transfusion of a wrong blood product, whereas a near miss is detected before transfusion.

In 2010 the University Hospitals Leuven introduced a new electronic patient incident report system for transfusion events.

In this study the investigators will analyze the reported blood transfusion events to detect the most common causes of blood transfusion events and the weakest link in the blood transfusion chain.

Detailed description: A retrospective survey will be conducted of all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012. Both severe accidents and near misses will be included.

Data will be drawn from the incident report system. Data concerning the number of transfused blood products will be required from the Medical Administration Service.

Events will be classified according to the severity and the cause of the event. The different settings where the events took place will be compared using a chi-square test (p\<0,05).

Eligibility criteria: Inclusion Criteria:

* all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012
* Both severe accidents and near misses were included

Exclusion Criteria:

* Transfusion reactions

Primary outcomes:
measure: Severity of inhospital blood transfusion events
timeFrame: up to 1,5 years
Secondary outcomes:
measure: Causes of inhospital blood transfusion events
timeFrame: up to 1,5 years
Other outcomes:
measure: Incidence of inhospital blood transfusion events
timeFrame: up to 1,5 years
measure: Is there a relation between misidentification events and the setting where the event took place?
timeFrame: up to 1,5 years
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium
name: Timothy Devos, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Hematology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium
name: Els Costermans, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04805099: Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease
Official title: Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Checkpoint Inhibitor
Immunotherapy
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diverse tumor types (early-stage or metastatic) who had received checkpoint inhibitors at HeCOG-affiliated Departments of Oncology Eligible patients had a history of AID, and had received treatment with checkpoint inhibitors as any of line of treatment

Brief summary: Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Patients with cancer
* Patients with autoimmune disease
* Treated at HeCOG-affiliated Departments of Oncology
* Early-stage or metastatic

Exclusion Criteria:

* diagnosis of the autoimmune disease after initiation of immunotherapy

Primary outcomes:
measure: progression-free survival
timeFrame: Through the completion of the study, for an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Oncology Cooperative Group
Study officials:
References:
citation: Fountzilas E, Lampaki S, Koliou GA, Koumarianou A, Levva S, Vagionas A, Christopoulou A, Laloysis A, Psyrri A, Binas I, Mountzios G, Kentepozidis N, Kotsakis A, Saloustros E, Boutis A, Nikolaidi A, Fountzilas G, Georgoulias V, Chrysanthidis M, Kotteas E, Vo H, Tsiatas M, Res E, Linardou H, Daoussis D, Bompolaki I, Andreadou A, Papaxoinis G, Spyratos D, Gogas H, Syrigos KN, Bafaloukos D. Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group. Cancer Immunol Immunother. 2022 Feb;71(2):327-337. doi: 10.1007/s00262-021-02985-6. Epub 2021 Jun 23.
Clinical trial NCT00557999: Mechanical Ventilation Weaning Protocol in the Coronary Care Unit
Official title: Evaluation of the Effects of the Use of Mechanical Ventilation Weaning Protocol in the Coronary Care Unit: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Cardiomyopathy
Keywords: Cardiology
Mechanical ventilation
Intensive care
Lead sponsor: Hospital de Base
Sponsor class: OTHER
Collaborators: name: Sao Jose do Rio Preto Medical School
First posted: 2007-11-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The following objectives were used for comparison: 1) primary objective: reintubation rate during hospitalization; 2) secondary objectives: length of hospitalization at the Coronary Care Unit; time from intubation to start of weaning; time from start of weaning to extubation; time from SBT and extubation; presence of respiratory infection in patients requiring reintubation; mortality of patients requiring reintubation.

Detailed description: Once the cause leading to the need of MV was resolved, patients from both groups underwent a daily clinical evaluation in the mornings, to determine whether they were ready for mechanical ventilation weaning, according to the following clinical SBT criteria: 1) Cause of MV: resolution of the cause and abnormalities leading to MV; 2) neurological stability: patient awake, without or with minimal infusion of sedatives/narcotics, with effective cough and Glasgow scale ≥ 9; 3) cardiovascular stability: mean blood pressure (MBP) ≥ 60 mm Hg, without vasopressors or with low vasopressor doses, heart rate (HR) ≤ 140 / min, hemoglobin (Hb) ≥ 8,0 - 10,0 g/L, partial arterial oxygen pressure (PaO2) ≥ 60 mm Hg with fraction of inhaled oxygen (FiO2) ≤ 0.4, oxygenation index (PaO2 / FiO2) ≥ 150 - 300 without significant respiratory acidosis; 4) metabolic stability: temperature \< 37.8° C (armpit) and lack of hydroelectrolytic disorders.

Eligibility criteria: Inclusion Criteria:

* patients hospitalized at the CCU with MV for over 24 hours;
* age over 18 years;
* both genders;
* patients capable of spontaneous ventilation;
* patients with indication for MV weaning.

Exclusion Criteria:

* conditions and/or circumstances that might result in difficulty to understand the informed consent (psychiatric disorder, alcohol or drug addiction, mental disability);
* patient denies to sign the informed consent;
* end-stage diseases and
* dependence on mechanical ventilation.

Primary outcomes:
measure: Measure: reintubation rates after mechanical ventilation weaning protocol
timeFrame: 48 hours after extubation
Secondary outcomes:
measure: Duration of mechanical ventilation weaning
timeFrame: within the first 7 days after indication of mechanical ventilation weaning
Other outcomes:
Locations:
Study officials:
affiliation: Sao Jose do Rio Preto Medical School
name: Lilia N Maia, phD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06375499: Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
Official title: Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.

The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.


Eligibility criteria: Main Inclusion Criteria (At Screening visit):

* Informed consent signed and dated (obtained prior to initiating any procedures).
* Patient aged ≥18 years old.
* Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit

Main Exclusion Criteria (At both Screening and Randomisation visits):

* Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 letters Early Treatment Diabetic Retinopathy Study (ETDRS)).
* Patient with previous or current ophthalmic condition

Primary outcomes:
measure: To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score).
timeFrame: Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: OFTEX, s.r.o.
city: Praha
country: Czechia
facility: Axon Clinical, s.r.o.
city: Pécs
country: Hungary
facility: Ganglion Medical Center
state: Baranya
city: Létavértes
country: Hungary
facility: Ermellek Egeszsegcentrum
state: HB
Study officials:
References:
Clinical trial NCT05936099: Adolescent Inpatient Tobacco and ENDS Intervention
Official title: Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaping
Smoking
Keywords: Vaping
Adolescents
Cessation
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-07-07
Enrollment: 144
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.

Detailed description: Use of electronic nicotine delivery system (ENDS), which are noncombustible tobacco products (e.g., e-cigarettes), has increased dramatically among youth and is associated with numerous adverse health outcomes as well as use of alcohol and other illicit substances. National guidelines recommend counseling to address tobacco use at every adolescent clinical visit; however, many at-risk adolescents do not routinely attend primary care. Although evidence supports treatment of tobacco use during an adult hospitalization, no interventions have been developed or tested in the pediatric hospital setting. Based on promising theoretically-based evidence from the primary care and hospital settings, we will design, iteratively refine and assess implementation of a novel tobacco and ENDS use intervention for hospitalized adolescents and young adults (AYAs). We do so by conducting a randomized controlled pilot study (n=144) with 3-month follow up to evaluate preliminary efficacy as well as implementation outcomes (i.e., acceptability, feasibility, fidelity).

Eligibility criteria: Inclusion Criteria:

* Admitted to the hospital
* Screens positive for past 30 day e-cigarette use
* Parent/guardian agrees to leave the room

Exclusion Criteria:

* Age is less than 14 years or over 21 years
* Not comfortable speaking/reading English
* Too ill to participate
* Severe psychiatric illness
* Too developmentally delayed/cognitively impaired

Primary outcomes:
measure: Self-reported 30-day abstinence
timeFrame: 3 month follow up
Secondary outcomes:
measure: Acceptability of intervention in pediatric inpatient hospital setting
timeFrame: End of study (enrollment completion)
measure: Feasibility of intervention
timeFrame: End of study (enrollment completion)
measure: Fidelity of intervention delivered by a health educator
timeFrame: End of study (enrollment completion)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Hospital Los Angeles
name: Abbey Masonbrink, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05744999: HOW TO PERFORM SAFELY CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS
Official title: THE COCONUT TECHNIQUE - A NEW METHOD TO PERFORM SAFE CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS: Our Initial Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystectomy
Keywords: acute cholecystitis
cholecystectomy
cystic duct
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 3
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two females and 1 male with a mean age of 50 years were diagnosed by CT scan with stage II acute cholecystitis according to the Tokyo guidelines and were operated on within three days of symptom onset.

Brief summary: The aim of this manuscript is to illustrate a new method permitting safe cholecystectomy in terms of complications with respect to the common bile duct (CBD).

The core of this new technique is identification of the continuity of the cystic duct with the infundibulum. The cystic duct can be identified between the inner gallbladder wall and inflamed outer wall.

In the last 2 years, 3 patients have been treated with the reported technique without complications.

Among the various cholecystectomy procedures, this is a new approach that ensures the safety of the structures of Calot's triangle while providing the advantages gained from total removal of the gallbladder.


Eligibility criteria: Inclusion Criteria:

* stage II acute cholecystitis according to the Tokyo guidelines
* symptom onset

Exclusion Criteria:

- stage I cholecystectomy

Primary outcomes:
measure: A new technique of subtotal cholecystectomy
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Isidoro Di carlo
state: CT
Study officials:
References:
Clinical trial NCT01228799: Trabeculectomy Versus Canaloplasty
Official title: Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Canaloplasty
Trabeculectomy
Keywords: trabeculectomy,
canaloplasty,
glaucoma surgery
non-penetrating surgery
Lead sponsor: University Eye Hospital, Würzburg
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.


Eligibility criteria: Inclusion Criteria:1. diagnosed primary or secondary open-angle glaucoma 2. IOP \> 16 mmHg (\<60 days prior surgery) 3. IOP \> 21 mmHg 4. no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed

Exclusion Criteria:

1. angle closure glaucoma
2. congenital glaucoma
3. combined procedures (glaucoma and cataract)

Primary outcomes:
measure: success rate (complete and qualified success)
timeFrame: 1 year
measure: success rate (complete and qualified success)
timeFrame: 2 years
Secondary outcomes:
measure: IOP, medication, complications
timeFrame: 1 year
measure: IOP, medication, complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Eye Hospital
state: Bavaria
Study officials:
affiliation: University Eye Hospital, Würzburg
name: Thomas Klink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05352399: Artificial Intelligence + Care Coach Intervention
Official title: Artificial Intelligence + Care Coach Intervention for Persons Living With Dementia and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Caregiver
Emergency Department
Artificial Intelligence
Care Transition
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Emergency Medicine Foundation
name: West Health Institute
First posted: 2022-04-28
Enrollment: 290
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to develop and test an artificial intelligence intervention for emergency department (ED) discharge care transitions experienced by caregivers of older adults with cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* age ≥65 years with a diagnosis of dementia within the electronic health record OR new cognitive impairment identified during an ED visit
* be fluent in English or Spanish
* discharge after an ED visit
* possession of a smart device (either a phone, tablet, or computer) that has internet access to utilize and interact with NeuViCare AI services

Exclusion Criteria:

- evidence of delirium, by the 4-AT screening tool

Primary outcomes:
measure: Intervention Appropriateness Measure
timeFrame: Day 30
measure: Feasibility of Intervention Measure
timeFrame: Day 30
measure: Acceptability of Intervention Measure
timeFrame: Day 30
measure: System Usability Scale
timeFrame: Day 30
Secondary outcomes:
measure: Dementia Knowledge Assessment Scale
timeFrame: Day 30
measure: Zarit Caregiver Burden Scale
timeFrame: Day 30
measure: General Self-Efficacy Scale
timeFrame: Day 30
measure: Emergency Department revisits
timeFrame: Day 30
measure: Hospitalizations
timeFrame: Day 30
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Cameron Gettel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01597999: Benefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer
Official title: Accuracy of Magnetic Resonance Imaging (MRI) in Predicting Aggressiveness of Early Breast Cancer According to Molecular Subtypes Identified by ER PR and HER-2 Status
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Invasive Breast Cancer
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features.

Detailed description: Dedicated Contrast-enhanced Magnetic Resonance Imaging (DCE-MRI)

Eligibility criteria: Inclusion Criteria:

* Patients with invasive ductal carcinoma
* Patients undergoing DCE-MRI scan which are assessed according to BI-RADS lexicon
* Breast cancer patients with pathological diagnosed invasive ductal carcinoma with hormonal receptor (ER, PR and HER-2) response
* Patients who have signed on informed consent form Patients will undergo MRI imaging and the physicians will practice according to practice guidelines.

Exclusion Criteria:

* Patients under 18 years old or during pregnancy
* Patients with MRI's contraindications e.g. patients with cardiac pacemaker or are allergic to MRI contrast agent Patients with unstable clinical abnormality and might get unexpected clinical treatment

Primary outcomes:
measure: study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer
timeFrame: 1 year
Secondary outcomes:
measure: ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Pornpim Korpraphong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098799: Urotensin II in Chronic Kidney Diseases and Kidney Transplants
Official title: Urotensin II in Chronic Kidney Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Disease
Keywords: Urotensin II,Chronic renal disease
Lead sponsor: Vakif Gureba Training and Research Hospital
Sponsor class: OTHER
First posted: 2010-04-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls,CRF patients and kidney transplants aged more than 18

Brief summary: The investigators are planning to study the serum level of Urotensin II in chronic kidney disease patients, kidney transplants, and healthy controls.

Detailed description: The investigators will determine the urotensin II levels in Chronic kidney disease patients, kidney transplants, and healthy controls.

Eligibility criteria: Inclusion Criteria:

* Age more than 18

Exclusion Criteria:

* Inability to give a written consent

Primary outcomes:
measure: serum Urotensin II(UII)level
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Vakif Gureba Training & Research Hospital
Study officials:
affiliation: Vakif Gureba Training & Research Hospital
name: Tufan Tukek, MD
role: STUDY_DIRECTOR
References: