louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05045742: Prediction of Patient Deterioration Using Machine Learning
Official title: Prediction of Patient Deterioration Using Machine Learning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Heart Failure
Chronic Obstructive Pulmonary Disease
Asthma
Gout Flare
Chronic Kidney Diseases
Hypertensive Urgency
Atrial Fibrillation Rapid
Anticoagulants; Increased
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Biofourmis Inc.
First posted: 2021-09-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects admitted at Brigham and Women's Hospital and Brigham and Women's Faulkner Hospital who meet primary diagnosis, age, and geographic residence requirements and are enrolled in home hospital.

Brief summary: This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict patient deterioration throughout a patient's admission. This algorithm was then validated in a validation cohort.


Eligibility criteria: Inclusion Criteria:

Cared for in the Brigham and Women's Home Hospital study

Exclusion Criteria:

Incomplete continuous monitoring data

Primary outcomes:
measure: Alarm burden
timeFrame: From admission to discharge, measured in hours, on average 5 days
Secondary outcomes:
measure: Sensitivity for recognition of a safety composite
timeFrame: From admission to discharge, on average 5 days
measure: Specificity for recognition of a safety composite
timeFrame: From admission to discharge, on average 5 days
measure: Positive predictive value for recognition of a safety composite
timeFrame: From admission to discharge, on average 5 days
measure: Negative predictive value for recognition of a safety composite
timeFrame: From admission to discharge, on average 5 days
measure: Rate of alarms with clinical utility
timeFrame: From admission to discharge, on average 5 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Associate Physician
name: David Levine, MD MPH MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00537342: Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
Official title: Prospective, Randomised, Double Blind, Placebo Controlled Study of Treatment With Sublingual Immunotherapy of Depigmented and Polymerised Allergen Extract of O. Europaea in Two Groups of Patients With Allergic Rhinitis /Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Rhinoconjunctivitis
Keywords: Immunotherapy
Allergoid
Depigmented
Polymerized
Allergen-extract
Rhinoconjunctivitis
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis

Detailed description: Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.

Eligibility criteria: Inclusion Criteria:

* Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
* Patients of both gender \> 18 years old
* Positive prick test results using non modified Olea europaea allergen extract (wheal size \> 3mm2)
* Specific IgE to Olea europaea
* Written informed consent

Exclusion Criteria:

* Use of immunotherapy during the last four years.
* Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
* Treatment with ß-blockers
* Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
* Patients suffering from immune deficiencies
* Patients with serious psychiatric / psychological disturbances
* In addition, the following was considered as exclusion criteria:
* Pregnant or/ in lactation patients
* Patients aspirin intolerance

Primary outcomes:
measure: Symptom score
timeFrame: 1 year
Secondary outcomes:
measure: Dose-response skin prick-test
timeFrame: 1 year
measure: Medication score
timeFrame: 1 year
measure: Rhinoconjunctivitis quality of life questionnaire
timeFrame: 1 year
measure: Analogical visual scale
timeFrame: 1 year
measure: Serology
timeFrame: 1 year
measure: Record of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Hospital Universitatio Ciudad de Jaén
Study officials:
name: Juan Luis Anguita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02327442: 68Ga-NOTA-NFB: Radiation Dosimetry in Healthy Volunteers and Applications in Glioma Patients or Breast Cancer Patients
Official title: Prospective Imaging Study of 68Ga-NOTA-NFB in Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Breast Cancer
Keywords: chemokine receptor
galium
dosimetry
glioma
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6 healthy volunteers. 10 patients with glioma before surgery. 30 patients with breast cancer before and after neoadjuvant chemotherapy.

Brief summary: The purpose of this study is to assess the safety, biodistribution, dosimetric properties of the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To preliminarily evaluate its application in glioma diagnosis.

To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant chemotherapy in patients with breast cancer before and after the therapy.

Detailed description: 6 healthy volunteers with whole-body PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

8-10 patients with glioma will be enrolled for the clinical study of diagnosing glioma, they will be performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of CXCR4 will be determined by immunohistochemical staining of the resected brain tumor tissues.

30 patients with breast cancer will be underwent 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before and after the neoadjuvant chemotherapy. SUV of lesions before and after therapy will be contrasted.

Eligibility criteria: Inclusion Criteria:

* volunteers : healthy patients with glioma: diagnosed by MR and ready for surgery patients with breast: cancer appropritate of neoadjuvant chemotherapy.

Exclusion Criteria:

* patients with glioma: refuse or cannot endure surgery. patients with breast: refuse neoadjuvant chemotherapy.

Primary outcomes:
measure: SUV of organs
timeFrame: 0, 0.5, 1.0, 2.0, and 3.0hours after injection
measure: radioactivity of blood sample
timeFrame: 1, 3, 5, 10, 30,60, 90, 120, 150, and 180minutes
measure: SUV of glioma
timeFrame: 1 hour after injection
measure: SUV of Breast Cancer
timeFrame: 1 hour after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital Nuclear Medicine Department
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Jing Wang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06617442: Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings
Official title: Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation (AF)
Esophageal Perforation
Esophageal Perforation, Traumatic
Keywords: Pulmonary Vein Isolation
PVI
HPSD
High Power Short Duration
Esophageal injury
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open label
Primary purpose: TREATMENT

Brief summary: Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation. High power short duration (HPSD) and very high power short duration e.g., 90W and 4 sec) are increasingly popular technologies, featuring higher power and shorter application durations compared to previous methods. vHPSD offers similar efficacy to HPSD, while further reducing procedure times. Atrioesophageal fistula (AEF) is a rare but deadly complication of PVI, while endoscopically detected esophageal lesions are surrogate markers for the risk of AEF. Furthermore, thermal complications include vagal lesions leading to gastroparesis. While there is considerable data on the thermal safety of HPSD technology, most studies of vHPSD focus on efficacy and a direct comparison in terms of esophageal safety is lacking. In this randomized, single-center study, we aim to compare the thermal safety of vHPSD to HPSD. Furthermore, we aimed to determine the anatomical and biophysical factors that predict thermal injury. Patients undergoing their first PVI for AF are randomized to either HPSD or vHPSD power setting. The primary endpoint of the study is the composite of esophageal mucosal lesion and gastroparesis, as assessed at the post-procedural endoscopy within 15 days after the PVI.


Eligibility criteria: Inclusion Criteria:

- Patients with paroxysmal or persistent atrial fibrillation undergoing their first pulmonary vein isolation procedure

Exclusion Criteria:

* Additional ablation performed outside PVI
* Contraindications to postoperative upper endoscopy

Primary outcomes:
measure: Thermal injury detected during post-procedural endoscopy
timeFrame: Post-procedural endoscopy was performed within 15 days after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
Study officials:
References:
Clinical trial NCT06633042: The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD
Official title: The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Autoimmune Disease
Keywords: Universal BCMA CART
AQP4 Antibody Positive
RefractoryNeuromyelitis Optica Spectrum Disease
Lead sponsor: Bioray Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Wenzhou Medical University Affiliated Ophthalmology Hospital
First posted: 2024-10-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Total target count of CD3+CAR+ viable cells of 1E6/kg 、2E6/kg and 4E6/kg
Primary purpose: TREATMENT

Brief summary: This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.

Detailed description: This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).

Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years ; both genders eligible.
* Meets the criteria for Refractory NMOSD.
* Anticipated survival of ≥ 12 weeks as judged by the researcher.
* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
* Provides written informed consent.

Exclusion Criteria:

* History of solid organ transplantation.
* Malignant tumor within the last two years.
* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
* Primary immunodeficiency (congenital or acquired).
* Severe cardiac disease.
* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
* Allergic constitution or a history of severe allergies.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: DLT
timeFrame: Within28 Days After BRL-302 Infusion
measure: AEs
timeFrame: Up to 12 Months After BRL-302 Infusion
Secondary outcomes:
measure: Annualized relapse rate (ARR)
timeFrame: 1,3,6,12 month after BRL-302 infusion
Other outcomes:
Locations:
Study officials:
affiliation: Wenzhou Medical University Affiliated Ophthalmology Hospital
name: Xiaohui Wang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01595542: A School Health Center Intervention to Increase Adolescent Vaccination
Official title: A School Health Center Intervention to Increase Adolescent Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization Program
School Health Services
HPV Vaccines
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 3417
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents.


Eligibility criteria: Inclusion Criteria:

* All students enrolled at target schools

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change from Baseline In The Number of Adolescent Vaccines
timeFrame: 4 months post intervention
Secondary outcomes:
measure: Number of Returned Consent Forms Authorizing Vaccination
timeFrame: 4 months post intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Student Health Centers
state: North Carolina
Study officials:
affiliation: University of North Carolina Chapel Hill, Department of Health Behavior and Health Education
name: Noel T Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03376542: Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
Official title: Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Surgery--Complications
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2017-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective cohort study of patients undergoing coronary artery bypass graft surgery. Prior to surgery, participants will undergo submaximal cardiopulmonary exercise testing on a treadmill. Participants will be followed for one month after surgery to assess mortality and non fatal complications.

Detailed description: Coronary artery bypass surgery (CABG) is a complex and expensive procedure with great potential for morbidity and mortality. Preoperative evaluation is of paramount importance to optimize results. There is much evidence about the benefits of the cardiopulmonary exercise testing (CPET) in the evaluation of preoperative risk in non-cardiac surgeries. Thus, it is important to evaluate the relationship between parameters obtained in the CPET and the outcomes after cardiac surgery, especially CABG.

This is a prospective cohort study in which participants undergo submaximal CEPT on a treadmill prior to CABG. Participants will be followed up for one month after surgery to assess mortality and non fatal complications. It is expected that poor cardiopulmonary fitness is related to worse outcomes in CABG, as already observed in other cardiac pathologies and in non-cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing coronary artery bypass grafting surgery at the National Institute of Cardiology, Ministry of Health, Rio de Jnaeiro, Brazil.

Exclusion Criteria:

* Angina CCS IV, heart failure NYHA IV, inability to walk on a treadmill, severe left main coronary artery lesion.

Primary outcomes:
measure: Mortality after cardiac surgery
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Laranjeiras, Brazil
name: Eduardo Tibiriça, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01383642: Physiology of Vestibular Dysfunction and Clinical Implications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysfunction of Vestibular System
Accidental Falls
Frailty
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2011-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community-dwelling adults age \>70

Brief summary: Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a precursor to the frailty phenotype seen in the elderly population. A recent study found that vestibular dysfunction is common in the US population, and that the prevalence of this impairment increases steeply with age. However, it is unknown whether the aging process has global effects on the vestibular end-organ or whether specific structures, e.g. the semicircular canals or the otoliths, are selectively impaired. Moreover, the clinical implications of specific deficits of the vestibular end-organ are unclear. As such, the aims of this proposed research are: 1) to evaluate whether the normative aging process is predominantly associated with dysfunction of the semicircular canals (as measured by caloric and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by vestibular-evoked myogenic potential (VEMP) testing); 2) to determine if there are any characteristic clinical features associated with the subtypes of vestibular dysfunction; and 3) to assess whether dysfunction of the semicircular canals or of the otoliths is associated with a higher risk of frailty and falls. The investigators plan to pursue these aims through a cross-sectional and prospective cohort study of a group of individuals age 70 and above. Vestibular physiologic tests will be administered to all study participants, and test results will be correlated with baseline clinical symptoms and frailty status as well as prospective one-year fall risk. A greater understanding of vestibular physiologic deficits and clinical implications in older individuals can inform the development of rational vestibular rehabilitation strategies that may more effectively mitigate the frailty phenotype and reduce fall risk.


Eligibility criteria: Inclusion Criteria:

* Participant's age is 70 years and over?
* Participant is willing and able to give informed consent?

Exclusion Criteria:

* Participant has diabetes mellitus
* Participant has blindness, limited neck range of motion or cervical spine instability

Primary outcomes:
measure: vestibular function
timeFrame: baseline
Secondary outcomes:
measure: Number of participants who report one or more falls in a one-year follow-up period
timeFrame: one year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
References:
Clinical trial NCT04157842: The Influence of Hip Replacement on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
Official title: The Influence of Hip Replacement (Subtrochanteric Osteotomy vs. Non-osteotomy) on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Dysplasia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient.

Detailed description: Changes of limb length after total hip replacement is common, especially for Crowe Ⅳ hip dysplasia patient. Such change potentially increases tension of vessel and influence lower extremity hemodynamics. Till now, little is known in this area.

Eligibility criteria: Inclusion Criteria:

* Unilateral Crow IV hip dysplasia;
* Bilateral Crow IV hip dysplasia without osteoarthritis on the other side

Exclusion Criteria:

* Patients with serious medical disease;
* Patients with lower extremity vascular disease; 3. Patients with severe mental illness.

Primary outcomes:
measure: Hip Harris Score
timeFrame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
measure: Leg Length Change
timeFrame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
measure: Radiographic Results
timeFrame: 1 week, 12 weeks, 24 weeks and 1 year after the surgery.
measure: Lower Limb Arterial CT Angiography
timeFrame: preoperative, 1 week, 12 weeks after the surgery.
measure: Vascular Ultrasound Examination
timeFrame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
measure: Blood Viscosity
timeFrame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 2nd affiliated hospital, School of Medicine, Zhejiang University
name: SHIGUI YAN, MD
role: STUDY_CHAIR
References: