louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04362345: Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia
Official title: Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: Covid_19
SARS-CoV-2
ARDS
risk factors
infection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients with Covid-19

Brief summary: The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care


Eligibility criteria: Inclusion Criteria:

* Major patient (≥18 years of age)
* Admitted in March 2020 for confirmed Covid-19 lung disease (nasopharyngeal smear or sputum with SARS-CoV-2 positive PCR).

Exclusion Criteria:

* Patient who has expressed opposition to participation in the study.
* Mild forms of infection that do not require hospitalization,
* Subject under safeguard of justice
* Subject under guardianship or trusteeship

Primary outcomes:
measure: Identification of risk factors for severity (death or transfer to resuscitation) of Covid-19 infection
timeFrame: Files analysed retrospectively from March 1st, 2020 to April 15, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales
Study officials:
References:
Clinical trial NCT01644045: Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation
Official title: Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
COPD
Keywords: Asthma
COPD
emergency medical service
teleconsultation
telemedicine
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the quality of prehospital emergency care in acute respiratory emergencies, when paramedics are supported telemedically by an EMS physician.

Detailed description: Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of acute obstructive, respiratory emergencies the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient was obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures (taken with a smartphone), 12-lead-ECGs and video streaming from the inside of the ambulance can also be carried out, if indicated. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

Eligibility criteria: Inclusion Criteria:

* Obstructive, respiratory emergency
* Verbal consent for teleconsultation obtained or patient is not able to consent due the severity of the emergency

Exclusion Criteria:

* No respiratory emergency
* Refused consent for teleconsultation

Primary outcomes:
measure: Oxygen Saturation
timeFrame: average 1 hour
Secondary outcomes:
measure: Quality of emergency care
timeFrame: average 1 hour
measure: Rate of ventilation
timeFrame: average 1 hour
measure: Rate of complications
timeFrame: 2 hours
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
affiliation: University Hospital Aachen, Germany, Department of Anesthesiology
name: Rolf Rossaint, Prof. Dr.
role: STUDY_CHAIR
affiliation: University Hospital Aachen, Germany, Emergency Department
name: Jörg C Brokmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04263545: The Staff Stop Smoking Project
Official title: A Randomised Feasibility Study Comparing a Novel Intervention for Smoking Cessation in NHS Staff to Standard Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: meeting with a smoking cessation counsellor to discuss their individual requirements for smoking cessation and be offered their choice of pharmacological intervention. They will be provided with their choice of pharmacotherapy on site.They will then be invited to attend a group session, where they will have some brief lung function tests and check carbon monoxide levels. Participants will be offered refreshments and receive a bespoke group session to address various aspects of smoking cessation.
Primary purpose: PREVENTION

Brief summary: Participants will be randomised to either standard care or to receive our help to quit programme. The study will only be available to Portsmouth Hospital Trust staff member.

Detailed description: A randomised controlled feasibility study to trial a novel intervention to help NHS staff stop smoking compared to standard care. Participants will attend one-on-one interviews and a support group where they will undertake CO monitoring and mini-spirometry. They will complete questionnaires about their quality of life, other health problems and their general state of health. They will attend the support groups on a weekly basis and have access to support outside of these times.

Eligibility criteria: Inclusion Criteria:

* Male or Female, aged 18 years or over
* Willing and able to give informed consent for participation in the study.
* Must work for PHT at QAH and be able to attend weekly meetings for the duration of the study period
* Must be a current smoker

Exclusion Criteria:

-Unable to comprehend the study and provide informed consent e.g. insufficient command of English in the absence of someone to adequately interpret.

Primary outcomes:
measure: Behavioural outcomes
timeFrame: 4 weeks
measure: Behavioural outcomes
timeFrame: 12 weeks
measure: Behavioural outcomes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
state: Hampshire
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT00409045: Evaluation of Obstructive Sleep Apnea as a Risk Factor for Pulmonary Embolism
Official title: Evaluation of Obstructive Sleep Apnea as a Risk Factor for Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Pulmonary Embolism
Keywords: Obstructive Sleep Apnea
Pulmonary Embolism
male and female patients suspected of having a pulmonary embolism.
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female patients age 18 years and older

Brief summary: we evaluate the presence of OSA in patients that have a computed tomography (CT) of the chest to rule out pulmonary embolism (PE) to determine if OSA constitutes an independent risk factor for PE.


Eligibility criteria: Inclusion Criteria:

* male and female patients age 18 years and older with suspected PE

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
Study officials:
affiliation: Atlantic Health System - Morristown Memorial Hospital
name: Matthew Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein MD, Segal LN, Ibrahim SM, Friedman N, Bustami R. Snoring and the risk of obstructive sleep apnea in patients with pulmonary embolism. Sleep. 2010 Aug;33(8):1069-74. doi: 10.1093/sleep/33.8.1069.
Clinical trial NCT03162445: Bone Mass Accrual in Children With Autism Spectrum Disorder
Official title: Bone Mass Accrual in Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Bone Diseases, Developmental
Keywords: bone mineral density
Autism Spectrum Disorder
Autism
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 49
Sex: MALE
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent boys, ages 8-17 years, recruited from a clinic population (ASD) or community advertisements (ASD and control) matched for age.

Brief summary: This is a observational study to investigate the degree to which bone mineral density is impaired in boys with autism compared with typically developing controls.

Detailed description: Studies have shown that bone cortical thickness is decreased in children with autism and other developmental disabilities. However it is not known whether bone mineral density (BMD) of these children is lower; neither is it known whether there is any correlation between BMD and the child's diet. The overall goal of this study is to improve the long term health of children and adolescents with autism spectrum disorder; more specifically the investigators aim to develop a pilot study to investigate the degree to which BMD is impaired in boys with autism and to explore specific additional risk factors. In addition, the aim is to investigate the degree to which BMD is impaired in boys with Autism Spectrum Disorder (ASD) and to explore specific contributing risk factors including nutritional analysis.

Eligibility criteria: Inclusion Criteria:

* Boys 8-17 years chronological age
* BMI between the 3rd and 97th percentiles
* Meets DSM-IV criteria for Autism Spectrum Disorder (ASD group)
* Scores \<15 on the Social Communication Questionnaire (control group)

Exclusion Criteria:

* Use of medications directly affecting bone metabolism including estrogen/ progesterone preparations and glucocorticoids except local application of glucocorticoid
* Use of anticonvulsants which affect bone density including diphenylhydantoin, phenobarbital, topiramate carbamazepine and valproic acid and also use of lithium
* Children with diseases known to affect bone mineral density including Crohn's disease, celiac, thyroid and renal
* Children who will not tolerate lying still for 30 seconds

Primary outcomes:
measure: Bone Mineral Density
timeFrame: Bone mineral density will be assessed within one month of enrolling in the study.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Ann M Neumeyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06872645: Exploring Water-free Sodium Storage
Official title: Exploring Water-free Sodium Storage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peritoneal Dialysis, Heart Failure
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, blinded crossover study
Primary purpose: OTHER

Brief summary: The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.

Detailed description: This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.

Eligibility criteria: Inclusion Criteria:

* ESRD Patients actively undergoing PD with a reliably functioning PD catheter
* Systolic blood pressure \> 130 mmHg
* Serum sodium \>135 mmol/L
* daily urine output \< 400ml
* stable PD prescription for at least 2 months without requirement of 4.25% glucose PD solution
* PD vintage of at least 6 months
* Euvolemic as defined by the patient at their dry weight and free of any signs or symptoms of volume overload, per referring nephrologist

Exclusion Criteria:

* Poorly controlled diabetes with hemoglobin A1C\>9%
* 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
* Anemia with hemoglobin \<8g/dL
* Inability to give written informed consent or follow study protocol.
* Urinary incontinence
* Body weight \< 60kg
* gastrointestinal disease that causes diarrhea or expectation of sodium losses in stool.
* use of amiodarone in the last 6 months (which will interfere with tissue iodine ascertainment).

Primary outcomes:
measure: Water free Na removal over the 5-day intervention
timeFrame: Daily for 5 days
Secondary outcomes:
Other outcomes:
measure: Change in total extracellular Na and osms
timeFrame: Day 1 and day 5
Locations:
Study officials:
affiliation: Yale University
name: Jeffrey Testani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01030445: Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children
Official title: A Pilot Study: Cardiac Function as Measured by Non-invasive Electrical Velocimetry Cardiac Monitor in Hospitalized Children From Acute Illness (Disease) to Recovery (Health).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Blood Pressure
Keywords: non-invasive cardiac output monitor
electrical velocimetry
Aesculon
Icon
pediatrics
normal reference
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 83
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: Hospitalized children

Brief summary: To assess whether a non-invasive cardiac output monitor can follow heart function in children during treatments in the hospital. To establish a normal reference for children who are well and awake.

Detailed description: The aim of the study is to evaluate the ability of a new FDA-approved non-invasive Electrical Velocimetry (EV) cardiac monitor called AESCULON (Cardiotronic Inc, La Jolla CA) to detect and trend hemodynamic changes in hospitalized ambulatory pediatric patients during recovery from acute illness. We postulate that if the cardiac monitor can trend hemodynamic changes in hypertensive patients whose mean arterial pressure (MAP) decreases to normal levels, or hypotensive patients whose MAP increases to normal levels over several days, it may improve our understanding of different disease processes and allow us to improve care. We also seek to establish normative data for different measures provided by the AESCULON monitor - specifically cardiac output (CO) and systemic vascular resistance (SVR), which are the prime determinants of MAP.

Eligibility criteria: Inclusion Criteria:

* Medical patients without complex medical history with expected hospital stay for less than 10 days
* Uncomplicated Medical Patients as define as (1) Previously healthy children or (2) Children with diagnosis of a single chronic medical disorder that is not associated with cardiac dysfunction

Exclusion Criteria:

* Congenital heart disease with and without repair (includes PFO, ASD and PDA, cardiac valve disease or pulmonary hypertension
* Chronic lung disease (except asthma)
* Abnormal Hemoglobin (SSD)

Primary outcomes:
measure: To document trends in cardiac output (CO) and systemic vascular resistance (SVR) in subjects undergoing systematic changes in mean arterial pressure (MAP) and to assess intra-individual variability for those with normal blood pressure
timeFrame: During hospitalization until discharge
Secondary outcomes:
measure: To establish age relevant hemodynamic norms as measured by the electrical velocimetry (EV) cardiac monitor for trend parameters
timeFrame: Measurements obtain on day of discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT02638545: Hemodynamic Effects of Dexmedetomidine in Septic Shock
Official title: Effects of Dexmedetomidine on Pressor Response to Norepinephrine in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Septic Shock
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current treatment regimen of patients with septic shock requires a sufficient hemodynamic support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral resistance and preserve organ perfusion, a continuous infusion of catecholamines is often needed. Because sepsis is usually associated with adrenergic receptor and post-receptor abnormalities, the efficacy of such treatment regimens often gradually decreases over time, thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists increase pressor responsiveness following lipopolysaccharide administration. This study will assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine requirements in patients with septic shock.

Detailed description: The present study was designed as a prospective study. All patients enrolled in the study will require norepinephrine to maintain MAP between 65 and 75 mmHg despite adequate volume resuscitation and will be sedated according to istitutional guidelines with propofol and remifentanyl. After 8 h had elapsed during stable hemodynamic conditions, an initial set of measurements will be obtained during the sedation with propofol and remifentanyl. This set of measurements will be considered as baseline. In the patients in which conventional sedation will be replaced by dexmedetomidine and remifentanyl, a second set of measurements will be obtained after 4 h had elapsed during stable conditions. A final set of mesurements will be obtained after another 8-h period in stable conditions after switcheing back again to propofol and remifentanyl, .

During the observational period the dosage rate of norepinephrine will be adjusted to maintain the same threshold MAP of 65-75 mmHg All other medications were held constant.

Eligibility criteria: Inclusion Criteria:

* septic shock
* need for sedation

Exclusion Criteria:

-

Primary outcomes:
measure: norepinephrine dose
timeFrame: 4 hours
Secondary outcomes:
measure: cardiac output
timeFrame: 4 hours
measure: mean arterial pressure
timeFrame: 4 hours
measure: heart rate
timeFrame: 4 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02351245: Clinical Characteristics of Lip Hemangiomas
Official title: Clinical Characteristics and Complications of Infantile Hemangiomas Located in Lips
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemangioma
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 39
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients of lip hemangiomas after Dr. Zhang in Dermatology Clinic of Zhujiang Hospital.

Brief summary: Lip hemangiomas are at higher risk than those located in other sites. However, studies about clinical characteristics of lip hemangiomas have not been enough. The investigators want to conduct a prospective study on the clinical features of lip hemangiomas.

Detailed description: Hemangiomas involving lip are of special concern, since they occur in a prominent location on the face and can distort lip anatomy and lead to disfunction. Infantile hemangiomas in lip had significantly higher incidence than the others. It is often difficult to decide which patient with an lip hemangioma is at higher risk.

The investigators are interested in conducting a study on the clinical features of lip hemangiomas. The investigators are collecting medical records and photos of lip hemangiomas, including demographic information, maternal process, birth, location, size and complication. Based on the data, sum up the main points of clinical characteristics and complication.

Eligibility criteria: Inclusion Criteria:

* Only lip hemangiomas visiting between June 1, 2010 and October 1, 2014 were included in this study, which was defined as any infantile hemangioma covering any part of vermilion.

Exclusion Criteria:

* Perioral hemangiomas which did not involve vermilion were excluded.

Primary outcomes:
measure: appearance time, location, size, complication of lip hemangiomas
timeFrame: up to 2 months
Secondary outcomes:
measure: demographic information
timeFrame: up to 1 month
measure: maternal specific events
timeFrame: up to 1 month
Other outcomes:
Locations:
Study officials:
References: