louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00588406: Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Official title: Emergency Department (ED) Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: acute, emergency department
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Jacobi Medical Center
name: Nassau University Medical Center
First posted: 2008-01-08
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.

Detailed description: This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1\<50% predicted. The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1\<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).

Eligibility criteria: Inclusion Criteria:

* FEV1\<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma

Exclusion Criteria:

* other chronic lung disease, \>15 pack years smoking

Primary outcomes:
measure: FEV1 Percent Predicted
timeFrame: 4 hours post-randomization
Secondary outcomes:
measure: Hospitalization
timeFrame: 6 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: East Meadow
country: United States
facility: Nassau University Medical Center
state: New York
city: Queens
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Northwell Health
name: Robert Silverman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02303106: Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
Official title: Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: AUC exposure to lamotrigine
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers.

Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be repeated.

Primary outcome parameter is Lamotrigine AUC before and after coadministration of paracetamol.


Eligibility criteria: Inclusion Criteria:

* Healthy no medication use
* Informed consent

Exclusion Criteria:

* Allergy to paracetamol or lamotrigine

Primary outcomes:
measure: Lamotrigine AUC
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: Head Consultant Clinical Pharmacology
name: Per Damkier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837706: The Impact of Emergency Physician Empathy on Litigation Propensity
Official title: The Impact of Emergency Physician Empathy on Litigation Propensity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Empathy
Keywords: Empathy
Communication
Physician litigation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency room patients

Brief summary: The purpose of this study is to observe whether people would report being less likely to sue a physician who shows more empathy when giving a patient potentially bad news regarding their medical condition.

Detailed description: The investigators hypothesized that patients will have less propensity to sue emergency physicians after a poor outcome if the physician demonstrated empathy by verbalizing that they recognize the patient is concerned about their symptoms, and that the patient knows their typical state of health better than a physician seeing them for the first time. Accordingly, the investigators will assess whether the presence or absence of emergency physician empathetic statements in videotaped simulated encounters will alter patient propensity towards litigation. Secondary objectives are to assess whether the presence or absence of empathetic statements alters patient perceptions of discharge instruction clarity, physician expertness, physician caring, and physician desirability.

Eligibility criteria: Inclusion Criteria:

* Emergency Room Patient

Exclusion Criteria:

* Non-English speaking
* Not healthy enough to be in waiting room

Primary outcomes:
measure: Intention to sue
timeFrame: Immediately after viewing
Secondary outcomes:
measure: Assessment of physician expertise
timeFrame: Immediately after viewing
measure: Assessment of physician caring
timeFrame: Immediately after viewing
measure: Assessment of whether subject would want to be physician's patient
timeFrame: Immediately after viewing
measure: Assessment of clarity of physician instructions
timeFrame: Immediatley after viewing
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Emergency Department
state: California
Study officials:
affiliation: Loma Linda University
name: Dustin Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University
name: Ellen Reibling, PhD
role: STUDY_DIRECTOR
affiliation: Loma Linda University
name: Jesse Kellar, MD
role: STUDY_DIRECTOR
affiliation: Loma Linda University
name: Steve Green, MD
role: STUDY_DIRECTOR
affiliation: Loma Linda University
name: Elizabeth Walters, MD
role: STUDY_DIRECTOR
References:
citation: Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21.
Clinical trial NCT03513406: Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
Official title: Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Keywords: muscle function
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.


Eligibility criteria: Inclusion Criteria:

* Undergoing burn surgery under general anesthesia

Exclusion Criteria:

* Patients without a non-burned upper extremity
* Renal insufficiency or failure
* Sensitivity or hypersensitivity reaction to sugammadex
* Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol

Primary outcomes:
measure: Time to return to a 90% Train of Four (TOF) neuromuscular twitch
timeFrame: Within 24 hours after surgery
Secondary outcomes:
measure: Time to endotracheal extubation
timeFrame: Within 24 hours after surgery
measure: Time to discharge from the operating room
timeFrame: Within 24 hours after surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Anthony Kovac, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04016506: Epidemiology, Management and Complications Related to Pancreatic Trauma in Children
Official title: Retrospective and Prospective Study on the Epidemiology, Management and Complications Related to Pancreatic Trauma in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Injury
Child, Only
Keywords: Pancreas Injury
Child
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 150
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Child aged ˂18 years at the time of the trauma
* Child regularly followed in paediatric gastroenterology consultation
* Positive history of pancreatic trauma
* Child with at least one blood lipase measurement
* Child with at least one pancreatic imaging available

Brief summary: The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.

Detailed description: The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.

Through this study, the investigators hope to be able to understand:

1. The epidemiology of pancreatic trauma in Belgium. How these traumas occur (accident, fall,...).
2. Pancreatic trauma management in Belgian hospitals according to severity grade.
3. Short- and medium-term complications associated with the trauma
4. Long-term complications of trauma on growth and on the endocrine and exocrine function of the pancreas.

On the basis of all the information collected, the investigators hope to be able to provide indicators on the epidemiology of pancreatic trauma in children, short-term risks as well as nutritional and functional risks, taking into account the initial management of the patient.

Eligibility criteria: Inclusion Criteria:

* Child aged ˂18 years at the time of the trauma
* Child regularly followed in paediatric gastroenterology consultation
* Positive history of pancreatic trauma
* Child with at least one blood lipase measurement
* Child with at least one pancreatic imaging available

Exclusion Criteria:

* age \>18 years

Primary outcomes:
measure: incidence of pancreas injury in children
timeFrame: from start of inclusion to 2 years thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Bruxelles
country: Belgium
facility: Erasme/HUDERF
city: Liège
country: Belgium
facility: ULG La Citadelle
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Isabelle Scheers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01135706: Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension
Official title: Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Fractal dimension
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 6
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: Patients having a right heart catheterization and CT pulmonary angiogram

Brief summary: The investigators propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.

Detailed description: Pulmonary hypertension (PH) is an insidious disorder that can occur in isolation or as a result of various other pulmonary and systemic conditions. If left untreated PH may progress to right heart failure and death. Numerous tests are suggestive but not diagnostic of PH including cardiac echo, pulmonary function testing and chest x-ray. Definitive diagnosis requires right heart catheterization that is invasive, costly and time consuming. The fractal dimension (FD) is an index of the space-filling properties of an object so that the closer the dimension is to the topological dimension in which the object is embedded, the greater the space filling properties. No investigations have been performed to analyze the fractal dimension of pulmonary arteries in patients with PH. We propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.

Eligibility criteria: Inclusion Criteria:

* Patients having a right heart catheterization and CT pulmonary angiogram

Exclusion Criteria:

* None

Primary outcomes:
measure: FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH.
timeFrame: 24 Months
Secondary outcomes:
measure: FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC.
timeFrame: 24 Months
measure: FD will correlate with the functional capacity of the PH patients as quantified by distance during six-minute walk and NYHA functional class.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Karen Wood, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125306: Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Hypertension
Keywords: Drug consumption
The Xal-Ease device
Patient's compliance
Using a novel Pfizer-Pharmacia device to facilitate the Xalatan/Xalacom instillation and to avoid loss of eye drops
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect instillation.

Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the Clalit Health Services database, will use the Xal-Ease device for a year. The device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.


Eligibility criteria: Inclusion Criteria:

* Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study.

Exclusion Criteria:

* Patients younger than 18 years,
* Patients with severe manual disabilities,
* Patients with impaired cognition and mentality.

Primary outcomes:
measure: Consumption of Xalatan/Xalacom bottles per year per patient.
timeFrame: 12 months.
Secondary outcomes:
measure: Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease
timeFrame: 12 months
measure: Characterizing the optimal conditions for proper usage of the Xal-Ease device
timeFrame: 12 months
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Ophthalmology department, Meir Medical Center
Study officials:
References:
citation: Semes L, Shaikh AS. Evaluation of the Xal-Ease latanoprost delivery system. Optometry. 2007 Jan;78(1):30-3. doi: 10.1016/j.optm.2006.06.016.
citation: Nordmann JP, Baudouin C, Bron A, Denis P, Rouland JF, Sellem E, Renard JP. Xal-Ease: impact of an ocular hypotensive delivery device on ease of eyedrop administration, patient compliance, and satisfaction. Eur J Ophthalmol. 2009 Nov-Dec;19(6):949-56. doi: 10.1177/112067210901900609.
Clinical trial NCT03816306: Six Months Clinical and Echocardiographic Outcome of ARNI LCZ696 Therapy in HFrEF Patients
Official title: Six Months Clinical and Echocardiographic Outcome of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) LCZ696 Therapy in Heart Failure Patients With Reduced Ejection Fraction (HFrEF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 100
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: Any Patients with HFrEF (EF ≤ 40%) above 18 year old.

Brief summary: To evaluate the clinical and echocardiographic outcome of LCZ696 therapy in HFrEF (NYHA Class II - IV and EF =≤ 40%).patients, in addition to the efficacy of LCZ696 in reducing mortality and rehospitalisation rate.


Eligibility criteria: Inclusion Criteria:

1. ≥18 year old.
2. Functional class using New York Heart Association (NYHA) classification class II, III or IV %).
3. Left ventricular systolic dysfunction using transthoracic echocardiography with EF ≤ 40%.
4. Who was already taking ACE inhibitors or ARBs.

Exclusion Criteria:

1. Symptomatic hypotension.
2. Systolic blood pressure \<100 mm Hg.
3. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.
4. History of angioedema.
5. Hisotry of unacceptable side effects while on while on treatment with an ACE-inhibitor or ARBs.

Primary outcomes:
measure: Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.
timeFrame: 6 Months after starting LCZ696 Therapy
measure: Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ).
timeFrame: 6 Months after starting LCZ696 Therapy
Secondary outcomes:
measure: Number of Patients - All-cause Mortality.
timeFrame: 6 Months after starting LCZ696 Therapy
measure: Number of Patients With First Confirmed Renal Dysfunction.
timeFrame: 6 Months after starting LCZ696 Therapy
measure: Number of Patients with Changes in The Left Ventricular Systolic Function (EF).
timeFrame: 6 Months after starting LCZ696 Therapy
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor of Cardiovascular Medicine, Cairo University
name: Magdy Abdelhamid, MD, FACC, FESC, FSCAI
role: STUDY_DIRECTOR
References:
Clinical trial NCT00256906: Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome
Official title: Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fetal Development
Keywords: lateral ventricles
fetal ventriculomegaly
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children up to the age of 10 years who were diagnosed with isolated mild ventriculomegaly as fetuses

Brief summary: Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations.

When the ventricular diameter is more than 15 mm it is usually considered as severe and connected to other malformations. Most of these children will be severely affected later in life. Less than 10 mm ventricular width considered as normal.

The current medical knowledge can not answer questions regarding future development of children who were diagnosed to suffer from mild (10-14.9 mm) brain ventriculomegaly during the pregnancy.

We would like to assess the development and neurological status of all children who were diagnosed as "mild ventriculomegaly" during the pregnancy in the last 6 years and to prospectively follow up all the children who will be diagnosed from the beginning of the study on for 6 years.

We hypothesized that the course of their development is different than of other children.

Detailed description: Study design:

Patients:

1. All children who are currently 5-6 year-old who suffered from isolated fetal mild brain ventriculomegaly during the pregnancy.
2. All children who will be diagnosed with isolated fetal mild brain ventriculomegaly during the pregnancy from the beginning of the study for 6 years.

Methods:

1. All children will be examined by a pediatric neurologist who will perform a neuro-developmental assessment appropriate for age. The neurologist will decide individually whether there is a need for more medical tests.
2. All children will be assessed by a psychologist who will perform WIPPSI or BAYLEY tests according to age.

Eligibility criteria: Inclusion Criteria:

* All children who were or are diagnosed with isolated fetal mild ventriculomegaly

Exclusion Criteria:

* Anatomic malformations
* IVH
* Hydrocephalus
* Metabolic disorder
* CNS infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Itai Berger
Study officials:
affiliation: Hadassah University Medical Center
name: Itai Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: