louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05175898: ECMELLA vs. ECMO on 30-day Mortality
Official title: Treatment With Leftventricular Impella® Micro-axial Pump and Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) During Extracorporeal Cardiopulmonary Resuscitation (eCPR) on Mortality - An International Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Cardiopulmonary Arrest
Extracorporeal Membrane Oxygenation Complication
Cardiogenic Shock
Acute Myocardial Infarction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or VA-ECMO and Impella (so called "ECMELLA") during extracorporeal cardiopulmonary resuscitation.

Brief summary: This international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (eCPR) during cardiac arrest.

Detailed description: Left ventricular unloading with Impella® micro-axial pump has been shown to improve survival in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This study aims to investigate whether treatment with VA-ECMO and Impella ® (so called "ECMELLA") during extracorporeal cardiopulmonary resuscitation is associated with improved outcomes.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Cardiac arrest
* Treatment with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or "ECMELLA" (that is VA-ECMO plus left ventricular Impella® micro-axial pump)

Exclusion Criteria:

* Non-adult patients
* No treatment with VA-ECMO or "ECMELLA"

Primary outcomes:
measure: 30-day mortality
timeFrame: Mortality within 30 days after cardiac arrest event.
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Through study completion - an average of 1 year.
measure: Intensive Care Unit (ICU) length of stay
timeFrame: Through study completion - an average of 1 year.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University
name: Carsten Skurk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University
name: Tharusan Thevathasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108898: Progenitor Cells in Human Esophagus
Official title: Progenitor Cells in Human Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progenitor Cells
Aging, Cells
Esophagus Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing esophageal surgery at Mayo Clinic Rochester

Brief summary: The purpose of this study is to better understand how esophageal cells change with age.

Detailed description: The researchers will collect information from the patient's medical record and collect esophageal tissue at the time of the patient's surgery in excess of clinical diagnosis (i.e. tissue that would otherwise be discarded). There will be no patient contact after the patient's surgery. The researchers will analyze sections of adult esophagus tissue for the presence of CD34+ sox2+ progenitor cells to determine the number of progenitors present at a particular age. The researchers will also examine sections of different portions of the esophagus, to determine whether certain sections contain more progenitors, and thus perhaps a greater ability to regenerate, than others.

This study involves testing DNA and patients will not be notified of the genetic test results and the results will not be put into their medical record. Patients will be asked to give consent to have any remaining esophageal tissue used for future studies of esophageal disease at Mayo Clinic, learn about, prevent, or treat any other health problems and give their sample and related information to researchers at other institutions.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Esophagus surgery at Mayo Clinic

Exclusion Criteria:

* \<18 years old

Primary outcomes:
measure: Amount of Progenitor Cells
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04835298: Breathlessness Assessment in Adult Patients With Myotonic Dystrophy Type 1
Official title: Characters) Dyspnea Assessment in Adult Patients With Myotonic Dystrophy Type 1: a Monocentric Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myotonic Dystrophy Type 1 (DM1)
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with myotonic dystrophy type 1

Brief summary: Myotonic dystrophy type 1 (DM1) is one of the most common neuromuscular diseases in adults. As respiratory dysfunction is the most common cause of death in patients with DM1, a respiratory disease progression must be monitored combining symptom screening and respiratory function testing, in order to identify the appropriate time to initiate non invasive ventilation (NIV).

Dyspnea, one of the main respiratory symptoms, has been little studied in patients with DM1.

The main objective of this study is to provide the first multidimensional description of dyspnea in patients with DM1.

The secondary objectives are:

* To compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate NIV
* To assess associations between dyspnea and respiratory function testing
* To assess associations between dyspnea and number of Cytosine Thymine Guanine (CTG) repeats
* To assess associations between dyspnea and muscular strength
* To assess associations between dyspnea and BMI
* To assess associations between dyspnea and anxiety or depression
* To assess associations between dyspnea and cognitive impairment
* To assess associations between dyspnea and quality of life.


Eligibility criteria: Inclusion Criteria:

* patient with myotonic dystrophy type 1 confirmed by genetic analysis
* with an age older than 18 years

Exclusion Criteria:

* an ongoing or recent (i.e. within the last 4 weeks prior to study recruitment) medical condition, including pulmonary exacerbations
* patient already under non-invasive mechanical ventilation

Primary outcomes:
measure: Dyspnea
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT04069598: Statin Intolerance in Patients With Myocardial Infarction
Official title: Statin Intolerance in Patients With Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Statin Adverse Reaction
Lead sponsor: Turkish Society of Cardiology
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute coronary syndrome patients

Brief summary: Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months.


Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome

Exclusion Criteria:

* Being on statin, having statin related side effects

Primary outcomes:
measure: Statin intolerance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki
city: Istanbul
country: Turkey
facility: Siyami Ersek
city: Izmir
country: Turkey
facility: Tepecik
city: Mugla
country: Turkey
facility: Ozcan Basaran
Study officials:
References:
Clinical trial NCT03280498: Effectiveness of Ultrasonography and The Cole Formula on the Evaluation of the Appropriate Endotracheal Tube Size
Official title: Effectiveness of Ultrasonography and The Cole Formula on the Evaluation of the Appropriate Endotracheal Tube Size
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 110
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study the effectiveness of the use of Cole formula and USG were compared in determining the number of the appropriate uncuffed ETT to be used for clinically adequate ventilation.

Detailed description: Aim: The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.

Material and methods: ASA I-II pediatric patients (n=110) in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation, were enrolled in this study. Once patients were properly positioned after premedication and anesthesia induction, the subglottic diameter was measured using ultrasonography, and endotracheal tube (ETT) size was also calculated with the Cole formula. Subsequently patients were entubated with uncuffed ETT with sizes based on the patient's age in compliance with current clinical guide lines. To ensure adequate ventilation, the tube was replaced with an ETT of larger or smaller diameter as needed. The ETT was fastened after the placement ring had passed through the vocal cords and breath sounds were confirmed to be equal by auscultation. The size of the used ETT was compared with the size estimated from the subglottic diameter measured by ultrasonography to the size calculated with the Cole formula

Eligibility criteria: Inclusion Criteria:Children between 2 and 10 years of age, in the ASA I-II classification for whom elective surgery

-

Exclusion Criteria:

Children having a diagnosed syndrome, any anomaly of the upper respiratory tract and the head-neck region, recent or active upper respiratory tract infection, previous tracheastomy, requiring nasotracheal entubation, requiring surgery on an emergency basis and being in the ASA III-IV classification -

Primary outcomes:
measure: : The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.
timeFrame: 12 months
Secondary outcomes:
measure: To determine the correlation of weight, height and age of child with USG based endotracheal tube size, Cole formula endotracheal tube size and clinically used endotracheal tube size
timeFrame: 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty
state: Cerrahpasa
Study officials:
References:
Clinical trial NCT01869998: Implication of Left veNtricle Vortex Flow Guided aNticOagulation Therapy for preVenting Apical Thrombus Formation In Patients With Acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Thrombus Formation
Acute Myocardial Infarction
Keywords: Vortex
Thrombus
Contrast echocardiography
Prediction and prevention of apical thrombus formation in acute myocardial infarction patient by using Vortex parameters.
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 111
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram

Brief summary: Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION study


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥ 30 years old
2. Acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram
3. Left ventricular ejection fraction less than 40%

Exclusion Criteria:

1. Prior history of myocardial infarction
2. Chronic medication with Coumadin
3. Contraindication of contrast echocardiography
4. Significant atrial or ventricular arrhythmia
5. Valvular heart disease more than moderate degree
6. Decompensated heart failure
7. Very poor echo window, which cannot evaluate the presence of apical thrombus

Primary outcomes:
measure: Apical thrombus formation in echocardiography
timeFrame: 30 days after initial echocardiography
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance cardiovascular hospital
Study officials:
References:
citation: Son JW, Park WJ, Choi JH, Houle H, Vannan MA, Hong GR, Chung N. Abnormal left ventricular vortex flow patterns in association with left ventricular apical thrombus formation in patients with anterior myocardial infarction: a quantitative analysis by contrast echocardiography. Circ J. 2012;76(11):2640-6. doi: 10.1253/circj.cj-12-0360. Epub 2012 Aug 7.
Clinical trial NCT01083498: Fractional Laser as Treatment Option for Various Pigment Disorders
Official title: Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pigmentation Disorder
Keywords: Becker's nevus
ablative fractional laser therapy
randomized controlled trial
split-lesion design
Lead sponsor: Netherlands Institute for Pigment Disorders
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
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 determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.

Detailed description: Becker's nevus (BN) is an uncommon pigment disorder of the epidermis characterized by increased pigmentation, a slightly elevated, verrucous surface of the affected skin and sometimes hyperpigmentation. No effective treatment is available. Several laser modalities have been applied in the treatment of Becker's nevus in uncontrolled studies with varying results. Recently, fractional laser therapy was suggested as treatment option for Becker's nevus. In fractional laser therapy, microscopic columns of skin are coagulated or ablated, leaving the surrounding tissue intact, which enhances healing of the treated skin. In this study, the efficacy and safety of ablative fractional laser therapy was assessed in the treatment of Becker's nevus.

Eligibility criteria: Inclusion Criteria:

* Becker nevus
* Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
* Age at least 18 years
* Subject is willing and able to give written informed consent

Exclusion Criteria:

* use of bleaching creams during the past six weeks
* history of keloid
* active eczema
* suspected hypersensitivity to lidocaine or triple therapy
* use of isotretinoin in the past six months
* high exposure of the lesion to sunlight or UV light (UVA or UVB).

Primary outcomes:
measure: Physician's global assessment
timeFrame: T0, 3 and 6 months follow-up
Secondary outcomes:
measure: L-value
timeFrame: T0, 3 and six months follow-up
measure: Melanin index
timeFrame: T0, 3 and 6 months follow-up
measure: Patient's global assessment
timeFrame: 3 and 6 months follow-up
measure: Patient's satisfaction
timeFrame: 3 and 6 months follow-up
measure: Histopathologic assessment
timeFrame: 3 months follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03626298: Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia
Official title: Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia: A Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 125
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acne vulgaris (AV) is a chronic inflammatory disease of the pilosebaceous unit that affects seborrheic areas such as the face, back and chest. AV is characterized by blackheads, papules, pustules nodes and cysts with sequelae of hyperpigmentation and scarring. It is one of the most common skin disorders treated by dermatologists. Acne vulgaris can be found at any age, although it is more frequent in teenagers and young adults. The prevalence of AV in a population of 11 to 30 years old is approximately 80%. Due to its involvement of the face, it is considered to be a cosmetic problem, thus bearing a psychosocial burden.


Eligibility criteria: Inclusion Criteria:

* moderate acne vulgaris
* 12 and up to 50 years old,
* agreed to become research participants and has signed the informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02838498: Practice With Simulator Improves Basic ERCP Skills of Surgical Trainees
Official title: Practice With ERCP Mechanical Simulator (EMS) Improves Basic ERCP Skills of Novice Surgical Trainees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hands-on Training
Keywords: ERCP
EMS
Cannulation
Successful rate
Trainee
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.

Detailed description: Practicing Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using the EMS provides opportunities for novice endoscopists to learn basic ERCP skills without a patient. In two randomized controlled trials (RCT), coached EMS practice increased selective bile duct cannulation success rate of novice endoscopists. Surgical trainees do not have sufficient endoscopy experience to meet the perceived basic requirement for ERCP training. However, ERCP is done with a side-viewing scope and even experienced GI trainees have difficult initially mastering the basic skill with scope manipulation and cannulation. It is not known whether EMS can provide additional benefit to novice surgical ERCP trainees.

Eligibility criteria: Inclusion Criteria:

* No experienced surgical trainees receiving ERCP training

Exclusion Criteria:

* Experienced surgical ERCP trainees or who are not receiving ERCP training

Primary outcomes:
measure: Success rate of bile duct cannulation
timeFrame: 12 months
Secondary outcomes:
measure: Intubation time before cannulation
timeFrame: 12 months
measure: Successful cannulation time from first achieve the papilla
timeFrame: 12 months
measure: Total time
timeFrame: 12 months
measure: performance score of selective cannulation
timeFrame: 12 months
measure: Complication rate
timeFrame: 12 months
measure: Trainer assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Xun Li, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao WC, Leung JW, Wang HP, Chang WH, Chu CH, Lin JT, Wilson RE, Lim BS, Leung FW. Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial. Endoscopy. 2013 Oct;45(10):799-805. doi: 10.1055/s-0033-1344224. Epub 2013 Jul 29.
citation: Lim BS, Leung JW, Lee J, Yen D, Beckett L, Tancredi D, Leung FW. Effect of ERCP mechanical simulator (EMS) practice on trainees' ERCP performance in the early learning period: US multicenter randomized controlled trial. Am J Gastroenterol. 2011 Feb;106(2):300-6. doi: 10.1038/ajg.2010.411. Epub 2010 Oct 26.
Clinical trial NCT02561598: A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia
Official title: A Case Control Study of Patients With Diagnosis of Malignant Hyperthermia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Malignant Hyperthermia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases are selected from the medical records at Cincinnati Children's Hospital Medical Center who have a current malignant hyperthermia diagnosis. Control cases are selected based on previous participation in pharmacogenetic research and had exposure to agents known to trigger malignant hyperthermic episodes.

Brief summary: The purpose of the study is to develop methods to identify predictors of Malignant Hyperthermia.

Detailed description: The current study will use the combination of electronic medical records and genomic information in samples of persons who have exhibited signs of Malignant Hyperthermia (MH) or have family history or high risk of MH to see if risk factors can be identified. These will be compared with control samples of children who have been exposed to the same agents which could induce MH, yet showed no signs of the disorder.

Eligibility criteria: Inclusion Criteria:

* Malignant hyperthermia cases: Diagnosis of malignant hyperthermia
* Control cases: children who participated

Exclusion Criteria:

* Not meeting the inclusion criteria stated above

Primary outcomes:
measure: Number of clinical manifestations of malignant hyperthermia
timeFrame: Within data collection period (3 years total).
Secondary outcomes:
measure: number of Genetic indications for malignant hyperthermia
timeFrame: Within data collection period (3 years total).
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: John McAuliffe, MD
role: PRINCIPAL_INVESTIGATOR
References: