louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06287684: Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis
Official title: Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Septic Shock
Pneumonia
Lead sponsor: Mater Dei Hospital, Malta
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
name: University of Malta
First posted: 2024-03-01
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sepsis secondary to community- or hospital-acquired pneumonia

Brief summary: Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Acute respiratory tract infection due to community- or hospital-acquired pneumonia

Exclusion Criteria:

* Consent card not signed
* Pregnancy
* Prisoners
* Aspiration pneumonitis
* Patients with ventilator-associated pneumonia

Primary outcomes:
measure: Patient stratification as transcriptomic endotypes
timeFrame: Through study completion, an average of 1 year
measure: Lung endothelial barrier integrity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Imsida
country: Malta
facility: Mater Dei hospital, Intensive Care Unit
Study officials:
References:
Clinical trial NCT05043584: Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions
Official title: Autofluorescence-guided Thyroid Surgery: Impact on Parathyroid Preservation and Hypoparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autofluorescence
Thyroidectomy
Hypoparathyroidism
Hypocalcemia
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
Collaborators: name: Esbjerg Hospital - University Hospital of Southern Denmark
First posted: 2021-09-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: PREVENTION

Brief summary: Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.

In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.

Detailed description: Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery.

PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.

Eligibility criteria: Inclusion Criteria:

* Patients referred for total thyroidectomy
* Age \> 18
* Able to understand patient information
* Able to give informed consent

Exclusion Criteria:

* Previous thyroid surgery
* Need for accelerated surgery
* Insufficient biochemical profile

Primary outcomes:
measure: Rate of hypoparathyroidism
timeFrame: Will be assessed on postoperative day one, minimum two months and one year following surgery.
Secondary outcomes:
measure: Parathyroid gland identification rate
timeFrame: Will be assessed at the time of surgery
measure: Parathyroid autotransplantation rate
timeFrame: Will be assessed at the time of surgery
measure: Rate of inadvertently excised parathyroid glands
timeFrame: Will be assessed 1 month following surgery
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Department of Otorhinolaryngology, Hospital South West Jutland
city: Holstebro
country: Denmark
facility: Department of Otorhinolaryngology, Regional Hospital West Jutland
Study officials:
References:
Clinical trial NCT05909384: Management of Sepsis in Resource Limited Settings Using a Delphi Method.
Official title: Expert Consensus Statements for the Management of Sepsis in Resource Limited Settings Using a Delphi Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis
Septic shock
Low- and middle- income countries
LMIC
Delphi
Resource-limited setting
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: Asia Pacific Sepsis Alliance
First posted: 2023-06-18
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recognized experts meeting pre-defined criteria from a wide geographical distribution with approximately 70% from LMICs

Brief summary: Rapid evolution of sepsis syndromes means that timely diagnosis and treatment are critical in improving outcomes but this may be difficult to achieve in many low- and middle- income countries (LMICs) and there is a lack of high quality clinical evidence to guide diagnosis and management in LMIC settings. The wide variability in health systems in LMICs means that additional areas of guidance may be required where staff or facilities are lacking. In the absence of clinical data, to address some of these issues, the investigators aim to use Delphi methodology to obtain experts consensus statements on some specific aspects of sepsis management in LMICs.

Detailed description: The investigators aim to use a Delphi process to generate expert consensus practice statements in the context of diagnosis and management of sepsis in LMICs, including identification of aspects of sepsis diagnosis and management in LMICs not covered by existing guidelines. The questions will undergo several iterative rounds and will be in multiple-choice or Likert scale format. A study steering group will review the results of each round via video conference and design the questionnaire for the next survey. Summary results of each round will be presented to experts, along with the survey questionnaire for the next round. The survey process will be repeated with the modified questionnaire. The Delphi rounds will continue until the desired consensus and stability are achieved.

Eligibility criteria: Inclusion Criteria:

* Recognized experts meeting pre-defined criteria (below) from a wide geographical distribution with approximately 70% from LMICs.

  1. Clinical expertise in adult sepsis management, AND
  2. Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities

     Exclusion Criteria:

Primary outcomes:
measure: Questionnaire statements which have reached pre-defined consensus
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Oxford University Clinical Research Unit
Study officials:
affiliation: The George Institute
name: Brett Abbenbroek, BSc,MPH,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02880384: Pathogen Detection and Community Acquired Pneumonia
Official title: Projected Influence of Enhanced Pathogen Detection on the Clinical Management of Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Acquired Pneumonia
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: BioFire Diagnostics, LLC
First posted: 2016-08-26
Enrollment: 570
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to compare the number of community-acquired pneumonia (CAP) pathogens detected using current diagnostic tests to the number detected using the BioFire Diagnostics investigational polymerase chain reaction (PCR) platform.

Detailed description: Patients diagnosed in the emergency department with CAP that requires hospitalization provide a sputum sample for culture and sensitivity testing, urine for detection of S. pneumonia and L. pneumophila, an anterior nasal swab for S. aureus PCR, a nasopharyngeal swab for S. pneumonia PCR and the FilmArray LRTI v.2.0 IUO Panel, and blood for procalcitonin testing and, in cases in which the patient is suffering rigors and hypotension, cultures. As part of this study, sputum or sputum equivalent will be acquired for testing using the FilmArray LRTI v.2.0 IUO Panel.

Eligibility criteria: Inclusion Criteria:

* Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion Criteria:

* Inability to obtain sputum or sputum equivalent

Primary outcomes:
measure: Pathogen Detection
timeFrame: 5 Days
Secondary outcomes:
measure: Treatment Influence
timeFrame: 5 Days
measure: Nasopharyngeal swabs compared to sputum
timeFrame: 5 Days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland Providence Medical Center
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: David Gilbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02448784: Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).
Official title: Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia With Lewy Body Disease
Keywords: Donepezil Hydrochloride
ARICEPT
Dementia
Lewy bodies
Dementia with Lewy bodies
Post-marketing surveillance
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 591
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)

Brief summary: To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.


Eligibility criteria: Inclusion Criteria:

1. Naive participants diagnosed as DLB

Exclusion Criteria:

1. Participants with a history of donepezil hydrochloride product administration in the past
2. Participants who have already been registered in this surveillance
3. Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives

Primary outcomes:
measure: Mean Mini-Mental State Examination (MMSE) score
timeFrame: At Week 12
measure: Mean Mini-Mental State Examination (MMSE) score
timeFrame: At Week 24
measure: Mean Mini-Mental State Examination (MMSE) score
timeFrame: At Week 52
measure: Mean Revised Hasegawa's Dementia Scale (HDS-R) score
timeFrame: At Week 12
measure: Mean Revised Hasegawa's Dementia Scale (HDS-R) score
timeFrame: At Week 24
measure: Mean Revised Hasegawa's Dementia Scale (HDS-R) score
timeFrame: At Week 52
Secondary outcomes:
measure: Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)
timeFrame: From Week 0 to Week 52
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
name: Kazuhiro Omata
role: STUDY_DIRECTOR
affiliation: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
name: Syoya Yamakawa
role: STUDY_DIRECTOR
References:
Clinical trial NCT00709384: Prevention of Atrial Tachycardia After a Right Atriotomy II
Official title: Prevention of Atrial Tachycardia After a Right Atriotomy II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Flutter
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2008-07-03
Enrollment: 14
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: The investigators performed a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy and the atriotomy with the inferior caval vein to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction time between electrodes placed on both sides of the lesions is measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line are performed three month after the operation.

Detailed description: We perform a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy (surgical dissection plus cryoablation) and the atriotomy with the inferior caval vein (cryoablation alone) to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction times between electrodes placed on both sides of the lesions are measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line and to try to induce atrial flutter are performed three month after the operation.

Eligibility criteria: Inclusion Criteria:

1. Clinical indication for corrective operation for congenital heart disease with the use of a right lateral atriotomy,
2. Age \>18 years,
3. Ability to give an informed consent.

Exclusion Criteria:

1. Acute operation
2. Chronic atrial fibrillation
3. Indication for MAZE procedure

Primary outcomes:
measure: completeness of the lines of block
timeFrame: 3 month
Secondary outcomes:
measure: safety
timeFrame: 3 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby Hospital
Study officials:
References:
Clinical trial NCT00005084: Magnetic Resonance Imaging in Treating Children With Progressive Low-Grade Astrocytoma
Official title: Pediatric Low Grade Astrocytoma: Treatment Guidance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: childhood low-grade cerebral astrocytoma
childhood low-grade cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-09
Enrollment: 24
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability to determine the growth rate of progressive astrocytoma.

PURPOSE: Phase II trial to study the effectiveness of magnetic resonance imaging in treating children who have progressive low-grade astrocytoma.

Detailed description: OBJECTIVES: I. Determine if tumor growth rate can be decreased by targeting areas of increased choline activity, as measured by magnetic resonance spectroscopic imaging, in pediatric patients with progressive low grade astrocytoma treated with surgical resection and/or focal radiotherapy. II. Improve the quality of life without use of aggressive surgery or radiotherapy in this patient population.

OUTLINE: Patients undergo magnetic resonance spectroscopic imaging (MRSI) over 60 minutes prior to surgery and/or radiotherapy. Patients are assigned to one of two treatment arms based on tumor accessibility and may crossover to either arm. Arm I: Patients undergo conventional surgery. Arm II: Patients with inaccessible tumors undergo focal radiotherapy. Following surgery and/or radiotherapy, patients are followed every 4 months for up to 2 years with MRSI or MRI for tumor response and growth.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study over 2 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Diagnosis of low grade astrocytoma in the hypothalamus, brain stem, or thalamus of 5 cm on T2 weighted scans Incomplete surgical resection Previously treated with evidence of tumor progression No hemispheric or cerebellar masses

PATIENT CHARACTERISTICS: Age: 12 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Jeffry Alger, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05520684: Asymptomatic Bacteriuria, Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors and UTI Risk
Official title: Urinary Tract Infection Risk in Women With Asymptomatic Bacteriuria or Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection
Lead sponsor: Trabzon Arakli Bayram Halil Public Hospital
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 120
Sex: FEMALE
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: The female Type 2 Diabetes Mellitus patients followed and initiated SGLT2 inhibitors by an internal medicine specialist in a public hospital covering a district

Brief summary: The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors are risk factors for UTI in women. There is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of SGLT2 inhibitors. The aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors on UTI risk in a prospective cohort of women with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Female
* \>18 years old
* Type 2 Diabetes Mellitus
* Initiated SGLT2 inhibitors
* Available informed consent

Exclusion Criteria:

* Having urinary tract or genital tract symptoms at the enrollment
* Treated for urinary tract or genital tract infection in the last 3 months

Primary outcomes:
measure: Urinary tract infection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Trabzon Araklı Bayram Halil Public Hospital
Study officials:
affiliation: Trabzon Arakli Bayram Halil Public Hospital
name: Erman Akkus, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03880084: Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)
Official title: Longitudinal Assessment of Delirium, Agitation/Sedation, Pain and Dyspnea in Patients Admitted to Respiratory Intensive Care Unit for Acute Respiratory Failure (NIVILIUM)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Delirium
Agitation,Psychomotor
Pain
Dyspnea
Mechanical Ventilation Complication
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation not known for psychiatric disease or dementia

Brief summary: Non-Invasive Mechanical Ventilation (NIV) has been increasingly used in the treatment of acute respiratory failure. Notwithstanding failure rates still remains high, ranging from 5% to 60%. The onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. The aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to Respiratory Intensive Care Unit undergoing Non-Invasive Mechanical Ventilation for Acute Respiratory Failure.


Eligibility criteria: Inclusion Criteria:

* patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation

Exclusion Criteria:

* age lower than 18
* Glasgow Coma Scale lower than 10 within 24 hours from Respiratory Intensive Care Unit admission
* need for immediate orotracheal intubation
* pregnancy
* previously established psychiatric disease or dementia

Primary outcomes:
measure: Incidence of delirium
timeFrame: 7 days from Respiratory Intensive Care Unit admission
measure: Incidence of agitation
timeFrame: 7 days from Respiratory Intensive Care Unit admission
measure: Incidence of pain
timeFrame: 7 days from Respiratory Intensive Care Unit admission
measure: Incidence of dyspnea
timeFrame: 7 days from Respiratory Intensive Care Unit admission
Secondary outcomes:
measure: The impact of delirium on Non Invasive Ventilation Success
timeFrame: 30 days from Respiratory Intensive Care Unit admission
measure: The impact of agitation on Non Invasive Ventilation Success
timeFrame: 30 days from Respiratory Intensive Care Unit admission
measure: The impact of pain on Non Invasive Ventilation Success
timeFrame: 30 days from Respiratory Intensive Care Unit admission
measure: The impact of dyspnea on Non Invasive Ventilation Success
timeFrame: 30 days from Respiratory Intensive Care Unit admission
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico di Modena
Study officials:
References: