louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05553795: Drainless Robot-assisted Minimally Invasive Esophagectomy
Official title: Drainless Robot-assisted Minimally Invasive Esophagectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophagectomy
Enhanced Recovery after Surgery (ERAS)
Robot-assisted minimally invasive esophagectomy (RAMIE)
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2022-09-23
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled multicentric trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
* American Society of Anesthesiologists (ASA) score ≤ III
* Eastern Cooperative of Oncology Group (ECOG) status ≤ II
* Patient suitable for both surgical techniques
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent

Exclusion Criteria:

* Open esophagectomy (either abdominal or during the thoracic part)
* Emergency operations
* ASA IV
* ECOG \> II
* Chronic pain syndromes requiring routine analgesics
* Simultaneous lung resection
* Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)
* Participation in an interventional trial, which interferes with the outcome
* Impaired mental state

Primary outcomes:
measure: Postoperative pain
timeFrame: Day 2 after surgery
Secondary outcomes:
measure: Mean postoperative pain
timeFrame: Day 4 after surgery
measure: Additional analgesic drug use
timeFrame: Day 4 after surgery
measure: Postoperative mobilization
timeFrame: Day 7 after surgery
measure: Postoperative morbidity
timeFrame: Through hospital stay, an average of 14 days
measure: Postoperative mortality
timeFrame: Through hospital stay, an average of 14 days
measure: Daily postoperative pain
timeFrame: Day 7 after surgery
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
state: Saxony
Study officials:
affiliation: Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus
name: Johanna Kirchberg, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545595: Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Morbid Obesity
Keywords: General anaesthesia
Curarization with rocuronium
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2015-09-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio \< 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.


Eligibility criteria: Inclusion Criteria:

* General anaesthesia
* Neuromuscular blockade induce by rocuronium
* Body Masse Indice ≥ 40 kg/m2
* informed consent

Exclusion Criteria:

* Contraindication to rocuronium or sugammadex
* Pregnant women
* Severe renal insufficiency

Primary outcomes:
measure: determine a profound neuromuscular blockade reversal on ideal body weight
timeFrame: 30 minutes
Secondary outcomes:
measure: Compare dosages based on ideal body weight to real body weight
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
Clinical trial NCT01759914: Ocular Pressure in Steroid-treated Dermatology Patients
Official title: Intraocular Pressure in Corticosteroid-treated Dermatology Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Topical Corticosteroid-treated Dermatology Patients
Intra-ocular Pressure
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2013-01-03
Enrollment: 25
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: Dermatology clinic

Brief summary: Ocular hypertension and glaucoma are eye conditions associated with abnormally high fluid pressure in the eye (called intraocular pressure or IOP). If left untreated, the elevated IOP may eventually cause damage to the nerve of the eye and potential impairment of vision.

The use of certain drugs has been identified as a risk factor for raised IOP, including various forms of administration of corticosteroids. Corticosteroids can also lead to cataract, which is clouding of the lens in the eye that can affect vision.

In this research study, we would like to find out whether the use of corticosteroids in our dermatology clinic leads to raised IOP, in order to identify patients at risk and to allow them to be more closely monitored than others. It is important to identify those patients who have a corticosteroid-induced pressure rise early enough to prevent them from permanent glaucomatous visual loss.


Eligibility criteria: Inclusion Criteria:

* patients on whom corticosteroid treatment is being introduced for a duration of at least 12 weeks

Exclusion Criteria:

* pregnant women
* patients already under glaucoma treatment
* patients unable to give informed written consent or those unable to cooperate fully with the assessments

Primary outcomes:
measure: Change in intraocular pressure from baseline
timeFrame: after 1, 2 and 3 months
Secondary outcomes:
measure: Whether there is any clinical evidence of cataract at the final visit of the study.
timeFrame: After 1, 2 and 3 months
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
state: West Midlands
Study officials:
References:
Clinical trial NCT05204095: Intelligent Cataract Screening With Portable Slit-lamp
Official title: Intelligent Cataract Screening With Portable Slit-lamp
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catarct Screening
Artificial Intelligence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 3000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The prospective population aged 0 to 100 with or without senile cataracts and received ocular examination.

Brief summary: Based on the portable slit-lamp connected to the smartphone, the artificial intelligence machine learning algorithm is used to establish a cataract screening model by prospectively collecting the anterior segment photographic data, and a portable slit lamp intelligent screening referral model based on the smartphone connection is also established.


Eligibility criteria: Inclusion Criteria:

* 0 to 100 years old

Exclusion Criteria:

* (1) History of eye disease except for age-related cataracts (2) History of eye trauma or eye surgery (3) Unable to cooperate with ophthalmology and general examination (4) Individuals with incomplete information (5) Unwilling to participate in this study

Primary outcomes:
measure: The accuracy of referral
timeFrame: Baseline
Secondary outcomes:
measure: The accuracy of cataract diagnosis
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
name: Yizhi Liu, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06446895: Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
Official title: Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
MINOCA
Inflammation
Biomarkers
Endothelial Dysfunction
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 400
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: Patients older than 18 years old admitted to our hospital with Myocardial Infarction and undergo a coronariography.

Brief summary: Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with those with MI and obstructive coronary arteries (MICAD).

Detailed description: Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.

Eligibility criteria: Inclusion Criteria:

* Patients admitted with Myocardial Infarction and undergo a coronariography
* Patients must sign informed consent.

Exclusion Criteria:

* Patients who don´t sign informed consent

Primary outcomes:
measure: Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml)
timeFrame: At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
measure: Levels of endhotelial disfunction biomarkers
timeFrame: At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
measure: Levels of high-sensitivity C-reactive protein (mg/L)
timeFrame: t three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
Secondary outcomes:
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
Study officials:
References:
Clinical trial NCT04411095: The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
Official title: The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fascia; Inflammation
Thoracic
Rotation
Lead sponsor: International Academy of Osteopathy
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.

Detailed description: Subjects in the experimental group will undergo a technique for stretching the intrathoracic fascia. Before and after, a measurement will be performed with a goniometer, to see if there is a difference in thoracic rotation mobility.

Subjects in the placebo group get a different technique, where the hands of the therapists are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there is a measurement in thoracic rotation mobility.

Data will be compared and statistical analyse will be done to see of there is a difference in rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic rotation mobility, will be accepted or rejected.

Eligibility criteria: Inclusion Criteria:

* Subjects between the age of 18 and 65
* Both men and women

Exclusion Criteria:

* Structural disease of cervical or/and thoracic spine and/or head and/or thorax
* Acute mobility restriction of cervical and/or thoracic spine
* Acute and/or intense pain
* A history of trauma and/or operation on cervical and/or thoracic spine
* Treatment for cancer like chemo or radiation
* Baby's and children
* Elderly people

Primary outcomes:
measure: Change in thoracic rotation mobility
timeFrame: Before and immediately after the test
Secondary outcomes:
Other outcomes:
Locations:
city: Scherpenheuvel
country: Belgium
facility: Practice for fysiotherapy and osteopathy
state: Vlaams-brabant
Study officials:
affiliation: The International Academy of Osteopathy
name: IAO Administration
role: STUDY_DIRECTOR
References:
Clinical trial NCT05737095: Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital
Official title: Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Respiratory Distress
Preterm Birth
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 69
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants

Brief summary: Monocentric study carried out in the Neonatal and Intensive Care Units of the Dijon University Hospital.

The objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are hospitalized for initial respiratory distress.

Pulmonary ultrasound is performed within 6 hours of admission and an ultrasound score is calculated according to the images observed.

Continued management according to protocols without taking into account the ultrasound data.

Follow-up of patients until discharge from hospital or D28 of life (whichever comes first)


Eligibility criteria: Inclusion Criteria:

* Verbal consent from at least one legal guardian
* Premature infant (between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days) admitted for neonatal respiratory distress that began in the first 2 hours of life
* Hospitalized at the Dijon University Hospital in the Neonatal Pediatrics and Intensive Care Units

Exclusion Criteria:

* individual is not affiliated to the national health care system
* major intrathoracic or abdominal malformation

Primary outcomes:
measure: Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria
timeFrame: Within 6 hours of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04313595: Device for Breathing Frequency Monitoring in Muscular Dystrophy
Official title: A Wearable Device for Breathing Frequency Monitoring: a Pilot Study on Patients With Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophies
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. Continuous monitoring of respiratory activity pattern at home could give additional understandings about disease progression, flanking traditional, intermittent, cardiopulmonary evaluations, allowing prompt clinical intervention, and anticipating respiratory dysfunction. The main objective of the present study is thus to investigate the feasibility of using an innovative wearable device for respiratory monitoring, especially breathing frequency variation assessment, in patients with muscular dystrophy. The comparison between the measurements of breathing frequency obtained by using the IMU-based device and by using the reference method provided optimal results, in terms of accuracy errors, correlation and agreement. Participants positively evaluated the device for what concerns ease of use, comfort, usability and wearability. Moreover, preliminary results confirmed that breathing frequency is an interesting breathing parameter to monitor, at the clinic and at home, because it strongly correlates with the main indexes of respiratory function


Eligibility criteria: Inclusion criteria:

* documented DMD or LGMD2
* loss of independent ambulation (wheelchair-bound patients)
* ability to understand and follow test instructions and to report pain and discomfort.

Exclusion criteria:

* presence of metal implants and cardiac pacemakers
* relevant concomitant comorbidities (e.g.epilepsy)
* behaviour and/or psychiatric disorders (e.g. emotional problems, anxiety, panic attacks).

Primary outcomes:
measure: Safety of the device
timeFrame: After 24 hours of continued use
measure: Usability of the device (System Usability Scale)
timeFrame: After 24 hours of continued use
measure: Acceptability of the device (Technological Acceptance Measure)
timeFrame: After 24 hours of continued use
Secondary outcomes:
measure: Accuracy in measuring the breathing frequency
timeFrame: Immediately after application of the device
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Medea
state: Lecco
Study officials:
References:
Clinical trial NCT04327895: Surgery in Context of Terrorist Attack : a Survey of French Surgeons
Official title: Surgery in Context of Terrorist Attack : Report of the 121st Annual Congress of French Association of Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
War Injury
Surgical Procedure, Unspecified
Keywords: need for surgical training
surgery and terrorist attack
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
Collaborators: name: Association Francaise de Chirurgie
First posted: 2020-03-31
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French General Surgeons who are working as Resident or Licensed Surgeons in Public or Private Hospitals, and who are amenable to manage massive casualties due to Terrorist Attack

Brief summary: The aim of the study is to assess the surgical knowledge of French Surgeons in cas of Terrorist Attack.

Detailed description: Survey was sent by email to French Surgeons affiliated to French Association of General Surgeons.

First series of questions are relative to age, qualification, usual surgical practice, in order to define different "surgical profiles".

Second series of questions are relative to knowledge in the field of knowledge about trauma and massive casualties surgery.

Third series of questions are relative to the feeling of easiness in case of various situations involving severe trauma and massive casualties.

Results are analyzed in order to assess the need for learning and training in the field of trauma and massive casualties surgery.

Eligibility criteria: Inclusion Criteria:

* French Licensed and Resident Surgeons

Exclusion Criteria:

* Medical Doctor, not Resident

Primary outcomes:
measure: assessing the knowledge and the skills of general surgeons in the field of trauma surgery
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulon
country: France
facility: Military Hospital
Study officials:
affiliation: Direction Centrale du Service de Santé des Armées
name: Paul R Balandraud, MD
role: STUDY_DIRECTOR
References: