louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06259487: Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.
Official title: Study on the Impact of Coordinated Immunizations Against RSV and Influenza on the Prognosis in Patients With Chronic Heart Failure.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
RSV Infection
Influenza
Vaccines
Keywords: heart failure
RSV
Influenza
Vaccination
Immunization
Prognosis
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure.

The main question it aims to answer is:

• Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure?

Detailed description: The study aims to determine whether coordinated care in the form of administering protective vaccinations affects the prognosis of patients with chronic heart failure. The study will involve analyzing epidemiological data for each participant, followed by randomization into two treatment paths: receiving vaccinations against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits) versus following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). All vaccinations will be administered using vaccines registered with the appropriate authorities and approved for use in the EU and Poland.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Willingness to provide informed consent for participation in the study
* Diagnosis of heart failure
* No previous vaccination against RSV or influenza

Exclusion Criteria:

* History of an anaphylactic reaction to vaccination
* Hypersensitivity to any component of the vaccine
* Receipt of vaccination against RSV or influenza in the current infectious
* Active infection
* Pregnancy

Primary outcomes:
measure: Composite endpoint: All-cause mortality, hospitalization due to heart failure, and the clinical signs of infection, characterized by a body temperature exceeding 38 degrees Celsius.
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
state: Dolnyslask
Study officials:
References:
Clinical trial NCT04314687: Stem Cell and Conditioned Medium for Cerebral Palsy
Official title: Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cerebral Palsy
Keywords: Allogeneic Mesenchymal Stem Cells
Umbilical Cord Mesenchymal Stem Cells
Intrathecal Injection
Cerebral Palsy
Conditioned Medium
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy.

Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as Cerebral palsy with total body involvement type
* Age between 6 month - 3 years old
* Parents requesting for cell therapy
* The parents give sign in informed consent form do to examination, therapy, blood sampling collection and observation for their child

Exclusion Criteria:

* Head circumference less than -3 SD (more than 3 cm) Nellhaus standard
* Have diagnosed meningitis and encephalitis
* Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital, cytomegalovirus
* Have diagnosed metabolic disorder, chromosome disorder, congenital malformation or neuroregeneratif disease
* Progressive disorder
* Regressive development disorder
* Severe anatomical abnormalities in Brain MRI

Primary outcomes:
measure: Gross Motor Function
timeFrame: 3 month after stem cells
measure: Gross Motor Function
timeFrame: 6 month after stem cells
measure: Gross Motor Function
timeFrame: 3 month after stem cells
measure: Gross Motor Function
timeFrame: 6 month after stem cells
measure: Cognitive Function
timeFrame: 3 month after stem cells
measure: Cognitive Function
timeFrame: 6 month after stem cells
Secondary outcomes:
measure: Chemical Marker
timeFrame: 3 month after stem cells
measure: Chemical Marker
timeFrame: 6 month after stem cells
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Indonesian National Brain Center
Study officials:
References:
Clinical trial NCT05242887: Validation of the 3D-CAM and the UB-CAM in French
Official title: Validation of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM) and the Ultra-Brief CAM (UB-CAM) in French.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
CAM
UB-CAM
3D-CAM
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Older adults hospitalized in acute geriatric units

Brief summary: Delirium is very common in hospitalized older patients and associated with serious clinical bad outcomes (e.g. increased risk of functional decline and death). Despite its high prevalence in the hospital setting, delirium remains underdiagnosed. A better identification would allow an early management and a reduction of its complications.

The validation of easy-to-use and quick and formalized tools for the identification of delirium and their implementation in the clinical practice are necessary.

Recently, the 3D-CAM (3-minutes Diagnostic interview for Confusion Assessment Method -defined delirium) and the UB-CAM (Ultra-Brief CAM) showed very high sensitivity and specificity (\> 90%), compared to the reference standard (Diagnostic and Statistical Manual of Mental Disorders (DSM criteria)) for the diagnosis of delirium.

The investigators aimed to evaluate the sensitivity and specificity of the French versions of the 3D-CAM and the UB-CAM used in delirium screening in older adults hospitalized in geriatric units, compared to reference standard.


Eligibility criteria: Inclusion Criteria:

* Adults hospitalized in acute geriatric units
* Aged 65 or older
* Patient (or relative) not objecting to participating in the study

Exclusion Criteria:

- Legal protection regimes (guardianship, curatorship)

Primary outcomes:
measure: Evaluation of the performance of a rapid diagnostic tool (UB-CAM) for acute confusional state, translated into French
timeFrame: At inclusion
Secondary outcomes:
measure: Evaluation of the time taken to use this tool
timeFrame: At inclusion
measure: Evaluation of the diagnostic performance of another diagnostic tool (3D-CAM), already translated into French
timeFrame: At inclusion
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon
state: Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Antoine GARNIER-CRUSSARD, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06644287: The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Soft Tissue Sarcomas
Official title: The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Soft Tissue Sarcomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Soft Tissue Sarcomas
Keywords: 68Ga-grazytracer PET/CT
Immunotherapy
advanced soft tissue sarcomas
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced soft tissue sarcomas.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility criteria: Inclusion Criteria:

1. Pathological and clinical diagnosis of advanced soft tissue sarcomas, pathological types include: fibrosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, rhabdomyosarcoma, synovial sarcoma, alveolar soft-part sarcoma, leiomyosarcoma, clear cell sarcoma, malignant schwannoma, angiosarcoma.
2. Consider immunotherapy or combined immunotherapy based on clinical judgement.
3. Signed and dated informed consent form.
4. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
5. Aged 6-80 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person

Primary outcomes:
measure: Evaluation the responses to immunotherapy of advanced soft tissue sarcomas
timeFrame: up to about 10 weeks
measure: Standardized uptake value(SUV)
timeFrame: up to about 10 weeks
measure: Target-to-background ratio(TBR)
timeFrame: up to about 10 weeks
Secondary outcomes:
measure: Progress free survival
timeFrame: 1 years
measure: Overall survival
timeFrame: 1 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT00874887: A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anti-biotic Resistance
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* At least 50 years of age
* In good general health

Exclusion Criteria:

* Any ocular surgery or use of topical antibiotics or antiseptics in either eye within the last 3 months
* Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within 30 days of Baseline (or anticipated during the study)
* Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during the study)

Primary outcomes:
measure: Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14
timeFrame: Day 14
Secondary outcomes:
measure: Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14
timeFrame: Day 14
measure: Minimum Inhibitory Concentration 50 (MIC50) at Day 14
timeFrame: Day 14
measure: Minimum Inhibitory Concentration 90 (MIC90) at Day 14
timeFrame: Day 14
measure: Minimum Inhibitory Concentration (MIC) Range at Day 14
timeFrame: Day 14
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00664287: Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Dyslipidemic Patients Deemed Appropriate for Further Lipid Modification.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 0
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 purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older and on a stable dose of lipid therapy

Exclusion Criteria:

* Patients lipid level is outside the recommended range
* Patients that are HIV positive

Primary outcomes:
measure: Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks.
timeFrame: 3 months
Secondary outcomes:
measure: Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01012687: Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Perindopril Erbumine Tablets 8 mg Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to perindopril or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 20 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
References:
Clinical trial NCT02767687: Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery
Official title: Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Coronary Artery Disease
Keywords: Postoperative Care
Postoperative Period
Heart Surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.

Detailed description: Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter.

Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear.

This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.

Eligibility criteria: Inclusion Criteria:

* Presence of central venous catheter
* Invasive arterial pressure catheter
* Invasive mechanical ventilation

Exclusion Criteria:

* Chronic obstructive pulmonary disease
* Morbid obesity
* Hemodynamic instability
* Spontaneous breathing
* Need of invasive mechanical ventilation for more than 24 hours
* Intolerance to noninvasive mechanical ventilation
* Extubation failure

Primary outcomes:
measure: Evaluation of central venous oxygen saturation to determine tissue perfusion
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of arterial lactate to determine tissue perfusion
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Respiratory complications during hospitalization
timeFrame: Through study completion, an average of 1 year
measure: Hemodinamycs complications during hospitalization
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Solange Guizilini, PhD
role: STUDY_DIRECTOR
References:
citation: Marcondi NO, Rocco IS, Bolzan DW, Pauletti HO, Begot I, Anjos NR, Moreira RSL, Nasrala ML, Arena R, Gomes WJ, Guizilini S. Noninvasive Ventilation After Coronary Artery Bypass Grafting in Subjects With Left-Ventricular Dysfunction. Respir Care. 2018 Jul;63(7):879-885. doi: 10.4187/respcare.05851. Epub 2018 Jun 12.
Clinical trial NCT00893087: Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care
Official title: Comparison of Pressure-, Flow- and NAVA-triggering in Pediatric and Neonatal Ventilatory Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration
Keywords: Ventilatory care, children, intensive care, asynchrony, triggering
Children needing ventilatory care
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2009-05-05
Enrollment: 18
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care.

Our study hypothesis is that NAVA-technology is more accurate than currently used methods in detecting and assisting spontaneous breathing in children, and thus the patient-ventilator synchrony will improve.

Detailed description: Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In this study we will compare two currently used methods pressure- and flow-triggering with a neurally adjusted ventilatory assist in synchronization of the ventilator support with patients own efforts.

Eligibility criteria: Inclusion Criteria:

* All children born over 30 weeks of gestation needing ventilatory care

Exclusion Criteria:

* Craniofacial malformation which does not allow feeding tobe positioning. Critical ventilatory or perfusion problems.

Primary outcomes:
measure: The time in ventilator-patient synchrony in each of the assist modes.
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University Hospital of Oulu
Study officials:
References: