louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01403935: Sepsis Institutional Registry in Hospital Italiano de Buenos Aires
Official title: Sepsis Institutional Registry in Hospital Italiano de Buenos Aires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Severe Sepsis
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 7472
Sex: ALL
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: Adults with sepsis

Brief summary: The purpose of this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

Detailed description: The main goal is to describe the occurrence of sepsis and the characteristics of clinical presentation, evolution and predisposing factors within the population of the Hospital Italiano de Buenos Aires.

Eligibility criteria: Inclusion Criteria:

1. Over 17 years
2. Two or more sirs criteria
3. Active infection

Exclusion Criteria:

1. Refusal to register or to the informed consent process
2. Ambulatory patients

Primary outcomes:
measure: clinical features, mortality
timeFrame: Clinical characteristics are evaluated during the acute event and in-hospital mortality and annual monitoring
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires, Gascon 450
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Diego H Giunta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04618835: Physical Activity a Vital Sign? 40 Steps to Safety Test for Patients With COVID-19
Official title: Exertional Desaturation as a Marker of Risk - Validation Study for the 40-steps-test; A Multi-centre Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Medical Emergencies
Keywords: Exercise tolerance test
Vital signs
Readmission
Mortality
Lead sponsor: Betsi Cadwaladr University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: Oxford Brookes University
First posted: 2020-11-06
Enrollment: 1000
Sex: ALL
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: All alert and mobile acutely ill patients with mild symptoms and little or no vital sign derangement being considered for discharge to independent care

Brief summary: Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.


Eligibility criteria: Inclusion Criteria:

* Patients are being considered for discharge to independent care
* Participant is willing and able to give informed consent for participation in the study.
* Patient with independent, stable, gait
* Patient is alert, attentive, coherent, and calm
* Male or Female, aged 18 years or above.

Exclusion Criteria:

* Minor injuries
* Elective surgery patients
* Post-operative patients at discharge
* Requires supplemental oxygen
* Shortness of breath at rest (i.e. Borg or Numerical Rating Scale \>=2)
* Unstable angina
* Patients on long-term-oxygen therapy
* Pregnancy as stated by patient
* Oxygen saturations \< 95% on room air
* Resting heart rate \> 100 bpm
* Resting respiratory rate \> 25 bpm
* ECG with signs of acute ischemia in patients where an ECG has been requested by the treating clinician
* National Early Warning Score of 5 or more
* Nursing home residents, or those being transferred to a nursing home or similar care facility

Primary outcomes:
measure: Change in decision to discharge
timeFrame: 24 hours
measure: Hospital
timeFrame: 30 days
measure: Death
timeFrame: 30 days
Secondary outcomes:
measure: Feasibility of the 40-steps test
timeFrame: 12 months
measure: Change in heart rate
timeFrame: Within 2 minutes of completion of the test
measure: Change in oxygen saturations
timeFrame: Within 2 minutes of completion of the test
measure: Change in respiratory rate
timeFrame: Within 2 minutes of completion of the test
measure: Change in breathlessness
timeFrame: Within 2 minutes of completion of the test
Other outcomes:
Locations:
city: Menai Bridge
country: United Kingdom
facility: Ysbyty Gwynedd
state: Gwynedd
Study officials:
References:
Clinical trial NCT06294535: The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant
Official title: The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orbital Fractures
Keywords: orbital wall reconstruction
prebent titanium mesh
patient specific implant
PEEK
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Detailed description: under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Eligibility criteria: Inclusion Criteria:

* patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia

Exclusion Criteria:

* systemic disease interfere with bone healing enophthamous less than 2 mm

Primary outcomes:
measure: restoring the accurate position of eye
timeFrame: one month- six months
measure: motility of eye
timeFrame: one month
measure: volume of orbit
timeFrame: one to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University
Study officials:
affiliation: Tanta University
name: mona s sheta, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06239935: Early Rehospitalization of Persons Aged 75 Years or Older Admitted to a Geriatric Post-emergency Unit.
Official title: Early Rehospitalization of Persons Aged 75 Years or Older Admitted to a Geriatric Post-emergency Unit: Rates and Predictive Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Early Rehospitalization of the Elderly
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-02-02
Enrollment: 687
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the geriatric post-emergency medicine unit at angers university hospital

Brief summary: The older population is increasing, and one of the challenges is to prevent functional disability. Longer hospital stays are a recognized factor in dependency. Older subjects may present multiple complications, and therefore be frequently readmitted to hospital. Readmission to hospital is a costly and iatrogenic event in terms of independence, and must therefore be limited. The most vulnerable older patients therefore require specific care to avoid these iatrogenic complications, and various innovative structures have been developed, such as mobile geriatric teams, carrying out assessments in emergency departments, or geriatric post-emergency units with a shorter length of stay to reduce the iatrogenic impact of hospitalization.In November 2022, a temporary hospitalisation unit based on this model was opened at the CHU d'Angers with 11 beds. The aim of this study is to estimate the rate of early rehospitalisation (\< 30 days) between December 2022 and September 2023, and the factors associated with it. Once identified, these factors will allow us to further select patient profiles that are suitable for care in these very short stay units.


Eligibility criteria: Inclusion Criteria:

- Patient admitted to the temporary geriatric hospitalization unit between December 1, 2022 and September 30, 2023

Exclusion Criteria:

* Patients moved to another medical, surgical or obstetrics department of the Angers University Hospital during their stay.
* Death during stay.
* Patient assigned to a unit other than the temporary geriatric hospitalization unit.
* Patient already hospitalized in the unit during the recruitment campaign.
* Opposition to data use

Primary outcomes:
measure: Early rehospitalization (< 30 days after hospital discharge)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00703235: Intravitreal Bevacizumab for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Macular Edema
Diabetic Retinopathy
Lead sponsor: Isfahan Ophthalmology Research Center
Sponsor class: NETWORK
First posted: 2008-06-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of edema.

This study designed to evaluate the effect of Intravitreal injection of a recombinant monoclonal anti-VEGF antibody, Bevacizumab, for treatment of diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* Clinically significant macular edema
* Possibility of performing macular OCT
* Consent of patient for inclusion in the study

Exclusion Criteria:

* History of macular photocoagulation in less than 6 months of inclusion in the study
* Necessity of surgical intervention
* Rejection of the remaining in the study by patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01439035: Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults
Official title: Pilot Study to Evaluate Use of Optical Frequency Domain Imaging (OFDI) for Duodenal Imaging in Celiac Disease in Children, Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: Celiac Disease
Duodenal
OCT
Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 6
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this research is to conduct a pilot clinical study to image Celiac disease characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease.

Detailed description: The Optical Frequency Domain Imaging(OFDI) catheter will be used in conjunction with a standard pediatric endoscope. The endoscopist will introduce the OFDI imaging catheter through the biopsy channel of the endoscope already in place. The catheter will be passed into the view of the endoscope so that the tip of the catheter can be directly visualized throughout the procedure. The catheter will be placed adjacent to the bowel wall in the vicinity of the target locations. Once the OFDI probe is in place, OFDI imaging will start and data will be continuously collected during helical pullback scanning of the inner catheter drive shaft over a predetermined length of approximately 3 cm.

It is expected that the total experimental procedure including the insertion of the OFDI catheter, OFDI imaging, and removal of the catheter will add approximately 10 minutes to the total length of the procedure.

Eligibility criteria: Inclusion Criteria:

* Age 7 years and above undergoing upper endoscopy for evaluation of celiac disease
* Clinical history, physical findings, family history, or serologic evaluation suggestive of celiac disease
* Parents/guardian available to sign informed consent

Exclusion Criteria:

* Patients with a history of hemostasis disorders
* Use of Nonsteroidal anti-inflammatory drugs(NSAIDS) within ten days preceding initiation of the study
* Use of any oral anticoagulation medication within one month preceding initiation of the study
* Any known blood coagulation disorder

Primary outcomes:
measure: Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging
timeFrame: during imaging session
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Aubrey Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844935: Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients
Official title: The Value of Electrocardiographic Autonomic Nervous System Function Measures for Predicting Cardiopulmonary Recovery of Mechanically Ventilated Patients in Intensive Care
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disorders of the Autonomic Nervous System
Cardiovascular Abnormalities
Respiratory Disorders
Keywords: Heart rate variability, mechanical ventilation, weaning,
spontaneous breathing trial
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients in intensive care

Brief summary: This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. The second is to determine if heart rate variability, (HRV) a reflection of autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring MV.

Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF, respiratory rate, and blood pressure;

Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation awakening (a period immediately prior to SBT when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay;

Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.


Eligibility criteria: Inclusion Criteria:

* Receiving mechanical ventilation in medical-surgical intensive care unit;
* Eighteen years of age or older;
* Expectation of receiving initial spontaneous breathing trial within the next 24 hours.

Exclusion Criteria:

* Pregnant;
* Expectation of non-survival when ventilator is discontinued;
* Cardiac rhythm of atrial fibrillation;
* Paced cardiac rhythm.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Barbara Drew, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646735: Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients
Official title: A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2016-01-06
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.

Detailed description: To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy

Eligibility criteria: Inclusion Criteria:

* Signed informed consent document on file;
* Age over 60 years;
* Age \< 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
* Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
* ER + and/or PgR +;
* Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
* WHO performance status 0, 1 or 2;
* Patients with life expectancy of more than 3 months.

Exclusion Criteria:

* Presence of life-threatening metastatic visceral disease;
* Previous systemic chemotherapy for advanced breast cancer;
* Received systemic endocrine therapy for advanced disease;
* Extensive radiation therapy within the last 4 weeks ;
* Platelets \< 100\*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
* Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
* History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.

Primary outcomes:
measure: PFS
timeFrame: 3 years
Secondary outcomes:
measure: ORR
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: XU Binghe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609335: Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults
Official title: Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.

The investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for AD biomarkers. The investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. The lower age bound for a group of subjects used to establish normative AD biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. Thus, taking the above into consideration, the ideal age range for establishing normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages 30-49 years old.


Eligibility criteria: Inclusion Criteria:

* Cognitively normal males or females aged 30 to 49 years old.

Exclusion Criteria:

1. Subjects unable to lie down without moving for up to 45 minutes.
2. Women who are pregnant or cannot stop breast feeding for 24 hours.
3. Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
4. Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

Primary outcomes:
measure: Normal values for amyloid PET, FDG and Magnetic Resonance Imaging
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Josie Williams, BS
role: STUDY_DIRECTOR
References: