louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04228107: Treatment Phenotypes for Adolescents With Asthma
Official title: Treatment Phenotypes for Adolescents With Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Adherence, Treatment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.

Detailed description: This study will look at how adolescents use both their controller and rescue medications using an electronic medication monitoring platform, for the period of one year. Participants will be enrolled in a medication monitoring platform, and their asthma care provider will have access to medication usage information. The study team will collect data on medication use patterns in a real world setting for 12 months per participant. Additionally, healthcare providers will be enrolled in focus groups to determine barriers and facilitators to optimal medication use for their patients.

Eligibility criteria: For adolescent participants:

Inclusion Criteria:

* Diagnosis of asthma On an inhaled controller and rescue medication for which a propeller health device is available

Exclusion Criteria:

* Other significant chronic lung disease (from problem list)

  * Cystic fibrosis
  * Chronic respiratory failure
  * Tracheostomy status
  * Intersititial lung disease
* Significant developmental delay
* Taking more than 3 asthma related medications
* Primary language other than English, Spanish, Catalan, Dutch, French, German or Italian

Healthcare providers will be recruited as well to participate in focus groups as part of specific aim 2.

Primary outcomes:
measure: Treatment Phenotypes
timeFrame: 12 months
Secondary outcomes:
measure: Qualitative information regarding barriers for medication use
timeFrame: 12 months
measure: Qualitative information regarding barriers for medication use
timeFrame: 12 months
measure: Qualitative information regarding facilitators for medication use
timeFrame: 12 months
measure: Qualitative information regarding facilitators for medication use
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Heather EH De Keyser, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03666507: Vegetative Monitoring During Brainstem-associated Surgery
Official title: Vegetative Monitoring During Brainstem-associated Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor, Recurrent
Vestibular Schwannoma
Brainstem Neoplasm
Brainstem Glioma
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain tumor patients

Brief summary: Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.


Eligibility criteria: Inclusion Criteria:

* age 0-99
* brain tumor

Exclusion Criteria:

* no consent

Primary outcomes:
measure: Heart rate variability (HRV)
timeFrame: intraoperatively
Secondary outcomes:
measure: Rate of cardiovascular complications
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Neurosurgery
Study officials:
affiliation: University Hospital Tuebingen
name: Martin U Schuhmann, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06880107: Genetic Variants of Annexin A2 and Cryptogenic Stroke
Official title: Genetic Variants of Annexin A2 and Cryptogenic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Annexin A2
Stroke
Genetic Variants of Host
Fibrinolysis
Keywords: annexin A2
stroke
genetic variants
fibrinolysis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Stroke is the third most common cause of death in developed countries. Various mechanisms of ischemic stroke exist. However, in young population, in a third of cases, the cause of a stroke cannot be determined despite an extensive evaluation. Many studies have highlighted the link between stroke and fibrinolysis. Genetic variants of tPA and PAI-1 genes have been suggested to be the risk factors for stroke.

ANXA2 plays a pivotal role in plasmin generation and fibrinolysis. Several studies showed the role of ANXA2 and S100A10 subunits in regulation of fibrinolysis in vivo. Recently, the efficacy of recombinant ANXA2 for fibrinolytic therapy in a rat embolic stroke has been demonstrated. Some single nucleotide polymorphisms in ANXA2 gene could be associated with increased risk of stroke in sickle cell disease.

Therefore, these data invite us to test hypothesis that genetic variants of ANXA2 gene could be associated with ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Completed ischemic stroke defined as a rapidly developing focal neurologic deficit with no apparent cause other than a vascular origin that persisted beyond 24 hours in surviving patients
* Age from 18 years old

Exclusion Criteria:

* Transient ischemic attack
* Pregnancy

Primary outcomes:
measure: genetic variants of ANXA2
timeFrame: day 1
measure: genetic variants of S100A10
timeFrame: day 1
Secondary outcomes:
measure: blood ANXA2 concentration
timeFrame: day 1
measure: blood S100A10 concentration
timeFrame: day 1
measure: concentration of Autoantibodies directed against ANXA2
timeFrame: day 1
measure: concentration of S100A10 directed against ANXA2
timeFrame: day 1
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT06339307: A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for LNM in GC Patients
Official title: A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for Lymph Node Metastasis in Gastric Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Predictive Cancer Model
Gastric Cancer
Lymph Node Metastasis
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patietns who were diagnosed with gastric cancer pathologically and underwent curative gastrectomy.

Brief summary: In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability.

Detailed description: The study was a single-centre, prospective study. Data prospectively accrued were employed to evaluate the concordance between observed patient outcomes, with respect to lymph node metastasis status post-curative gastrectomy, and the prognostications tendered by the established risk scoring model, thereby appraising the model's clinical applicability and validity.

Eligibility criteria: Inclusion Criteria:

1. Primary gastric adenocarcinoma;
2. Curative surgery (with R0 resection, excluding palliative surgery and cases with distant metastasis).

Exclusion Criteria:

1. Patients with autoimmune diseases, inflammation, or hematological disorders;
2. Patients with a history of or concurrent other cancers;
3. Presence of active infection and inflammation (based on WBC count, patients with count of 10×10\^9 or higher should be evaluated through medical record examination for the presence of infection);
4. Active bleeding (as determined by endoscopic ultrasound and HGB ≤ 90);
5. Post neoadjuvant radiotherapy or chemotherapy;
6. History of blood transfusion, corticosteroid use, or leukocyte-stimulating medications within the past month prior to blood draw;
7. Incomplete clinical and pathological data.

Primary outcomes:
measure: lymph node metastasis
timeFrame: 1 month after curative surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Cancer Hospital of Tianjin Medical University
state: Tianjin
Study officials:
References:
Clinical trial NCT02042807: To Evaluate the Effect of MCS® in Prostate Cancer Prevention
Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 702
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment.


Eligibility criteria: Inclusion Criteria:

1. high-risk subjects of prostate cancer.
2. Male subject with age from 50 to 75 years old.
3. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).

Exclusion Criteria:

1. Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
2. Subjects with a PSA \> 10.0 ng/ml.
3. Subjects with a history of prostate cancer.
4. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
5. Subjects are considered ineligible for the study as judged by the investigator.

Primary outcomes:
measure: Cumulative biopsy-detectable prostate cancer rate
timeFrame: Week 104 (Month 24)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Urology, National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02440607: Effect of an Electronic Cognitive Aid Versus Static Cognitive Aid on the Management of a Simulated Crisis
Official title: The Effect of an Electronic Dynamic Cognitive Aid Versus a Static Cognitive Aid on the Management of a Simulated Crisis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aids
Keywords: Randomization
cognitive aids types
aids
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical decision support tools with in the electronic medical record can improve clinical care processes. To date, there is little evidence evaluating crisis management with such decision support tools. The investigators aim to create an electronic cognitive aid with embedded decision support to aid clinicians during the management of a crisis. In order to test the effectiveness of this tool, investigators seek to compare the simulated medical management of a crisis (malignant hyperthermia) using a traditional cognitive aid (laminated card) versus a dynamic electronic visual aid with decision support.


Eligibility criteria: Inclusion Criteria:

* resident physicians training in Anesthesia

Exclusion Criteria:

* Non resident anesthesia providers

Primary outcomes:
measure: Performance on Task Checklist
timeFrame: Time 0-30min
measure: Anesthesia Nontechnical skills score
timeFrame: Time0-30min
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Grainger Center for Simulation
state: Illinois
Study officials:
References:
citation: Shear TD, Deshur M, Benson J, Houg S, Wang C, Katz J, Aitchison P, Ochoa P, Wang E, Szokol J. The Effect of an Electronic Dynamic Cognitive Aid Versus a Static Cognitive Aid on the Management of a Simulated Crisis: A Randomized Controlled Trial. J Med Syst. 2018 Nov 22;43(1):6. doi: 10.1007/s10916-018-1118-z.
Clinical trial NCT01057407: A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
Official title: A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Renal Dialysis
Renal Insufficiency
Keywords: Hyperphosphatemia
hemodialysis
CKD
ASP1585
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease patients on hemodialysis
* Hyperphosphatemia
* Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention

Primary outcomes:
measure: Serum phosphorus level at the end of treatment
timeFrame: After 12-week or at the treatment discontinuation
Secondary outcomes:
measure: Change in serum phosphorus level
timeFrame: After 12-week or at the end of treatment
measure: Time-course changes in serum phosphorus levels
timeFrame: During Treatment
measure: Changes in serum Ca x P
timeFrame: During treatment
measure: Changes in intact PTH levels
timeFrame: During Treatment
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00181207: Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Official title: A Randomized, Sham-controlled, Double-blinded Pilot Study to Assess the Effects of High Frequency Chest Wall Oscillation (HFCWO) Therapy in Patients With Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Chronic Bronchitis
Emphysema
Keywords: COPD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: Hill-Rom
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to show that one form of mechanical airway clearance techniques, High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish exacerbations of COPD which will improve respiratory health status.

Detailed description: Approximately 60 to 70% of people with COPD have chronic cough and phlegm, the cardinal symptoms of chronic bronchitis or chronic mucus hypersecretion (CMH). Once thought to be a relatively benign condition, recent evidence shows that CMH in patients with established COPD is associated with greater decline in lung function, more frequent respiratory infections, more frequent exacerbations and increased mortality.Using mechanical airway clearance techniques (The Vest) will diminish exacerbations of COPD which will improve respiratory health status.

Comparison: Patients randomly assigned to the vest will have fewer exacerbations of COPD,better quality of life and less health care use compared to patients assigned to a sham vest.

Eligibility criteria: Inclusion Criteria:

* Physician Diagnosis of COPD,chronic bronchitis and/or emphysema
* Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) \< or = 70%
* FEV1 \< or = 65%
* Current or former smoker \> or = 20 pack years
* History of 1 or more COPD exacerbations in past 6 months necessitation hospitalization, Emergency Department (ED) visit, antibiotic or steroid prescription

Exclusion Criteria:

* Other lung diseases
* Co-morbid illnesses such as cancer, liver disease, cardiomyopathy
* Recent chest wall or abdominal trauma or surgery that would preclude using the vest

Primary outcomes:
measure: The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gregory B Diette, M.D.,M.H.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06582407: Machine Learning Models for Predicting Unforeseen Hospital Admissions or Discharges After Anesthesia
Official title: Machine Learning Models for Predicting Unforeseen Hospital Admissions or Discharges After Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Complication
Surgery-Complications
Pain, Postoperative
Keywords: anesthesiology
ambulatory surgery
artificial intelligence
machine learning
post operative complication
Lead sponsor: HUmani
Sponsor class: NETWORK
First posted: 2024-09-03
Enrollment: 68683
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hospitalized or outpatient patients who have undergone anesthesia for a diagnostic or therapeutic procedure, in a scheduled or emergency condition, in the institution's hospitals.

Brief summary: Unexpected hospital admissions after ambulatory surgery not only bring discomfort to patients but also causes a decrease in the efficiency of the healthcare system. In addition, unanticipated patient's orientation carry the risk of unsuitable post operative orders. The hypothesis of this project is that artificial intelligence models will outperform traditional models in predicting which patients will require hospital admission after ambulatory surgery or unforeseen hospital discharge after surgery.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing anesthesia for a therapeutic or diagnostic procedure

Exclusion Criteria:

* Incomplete informatic data
* Error in the encoding system

Primary outcomes:
measure: Rate of patient reorientation
timeFrame: On the day of the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Mons
country: Belgium
facility: Université de Mons
Study officials:
affiliation: Université de Mons, Belgium
name: Rémi Florquin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02655107: Non-invasive Measurement of Hemoglobin in Infants and Neonates
Official title: Non-invasive Measurement of Hemoglobin in Infants and Neonates: Comparison With CO-oximetrie and Point-of-care Devices.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoglobins
Keywords: blood gas monitoring
non-invasive
hemoglobin
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and neonates undergoing congenital heart surgery weighing between 3kg and 20kg

Brief summary: Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere).

Detailed description: Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere). Data collection whenever an arterial blood gas analysis is indicated by the experienced attending anesthetist - before and after cardiopulmonary bypass.

Eligibility criteria: Inclusion Criteria:

* scheduled for elective congenital heart surgery
* routine use of an arterial line
* weight \>= 3000g

Exclusion Criteria:

* urgent surgery
* premature birth
* parents refuse

Primary outcomes:
measure: Hemoglobin measurement non-invasively compared to gold standard hemoglobin
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Jochen Renner, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: