louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03681327: Sleep Infra-slow Oscillations III
Official title: Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Neurocenter of Southern Switzerland
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.


Eligibility criteria: Inclusion Criteria:

* Willingness to participate and written informed consent
* Aged 20 to 40 years at the time of screening
* Body mass index (BMI) ≤ 30

Exclusion Criteria:

* Pregnancy or breast feeding at the time of screening
* Sleep related breathing disorders
* Any other sleep related breathing disorder according to AASM criteria
* Current history of psychiatric disorders according to DSM-V
* Current chronic treatment that may affect sleep
* Any significant neurological disorder or other medical disease that may affect sleep
* Any unstable medical condition
* Any clinically significant sleep disorder

Primary outcomes:
measure: Arousal probability
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland
state: Ticino
Study officials:
affiliation: Neurocenter of Southern Switzerland
name: Stephany Fulda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04954027: Attachment and Prognostic Factor: the Implicit Approach
Official title: Place of Attachment as a Post-weaning Prognostic Factor: Interest of the Implicit Approach
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dependence Addictive
Keywords: implicit approach
post-weaning prognostic factor
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a use-related disorder weaning for a substance, supported within the addictology sector of Henri Laborit Hospital

Brief summary: This is a prospective longitudinal study aimed at better understanding the determinants of the prognosis of patients with substance dependence.

5 visits are planned during the study :

* the inclusion visit : during this visit the patient's non-opposition is obtained and then the patient answer to self-administered questionnaires online
* 4 telephone interviews for follow-up by investigator.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years old
* Patients with a use-related disorder as defined by DSM5
* Patients weaning for a substance, supported within the addictology sector of Henri Laborit Hospital
* Having expressed non-opposition to participating in the study after receiving written information.

Exclusion Criteria:

* Person who cannot read or write
* Simultaneous participation in a therapeutic trial involving oxytocin
* Patients protected by law
* Patients who do not have French as their native language
* Patients who, in the opinion of the investigator, are unable to complete the questionnaires

Primary outcomes:
measure: Implicit attachment and onsumption
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: Wilfried SERRA, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02396927: 3D HD Versus 2D HD in Cholecystectomy
Official title: Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholelithiasis
Gall Bladder Disease
Keywords: 3D
Three-dimensional
laparoscopy
cholecystectomy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment.

Detailed description: Conventional laparoscopy can be very challenging, especially with the requirement of converting the two-dimensional image of the operating field to a three-dimensional perception. This can potentially lead to a detrimental effect on the learning curve as well for the feasibility of the operation for the more inexperienced surgeon. In our hospital, the high frequency of cholecystectomy serves as a basis for the minimally experienced surgeons to explore whether three-dimensional laparoscopy provides a better ability for solving complex intraoperative tasks than the conventional laparoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective cholecystectomy (out-patient treatment)

Exclusion Criteria:

* Previous upper abdominal surgery
* ASA-score 3 or above

Primary outcomes:
measure: Number of errors during the dissection of the Calot´s triangle
timeFrame: Expected duration: 20 minutes
Secondary outcomes:
measure: Duration of the dissection of the Calot´s triangle
timeFrame: Expected duration: 20 minutes
measure: Duration of surgery
timeFrame: Expected duration: 1 hour
measure: The need for conversion to open surgery
timeFrame: intraoperative, expected duration of surgery: 1 hour
measure: Estimated blood loss in ml
timeFrame: intraoperative, expected duration of surgery: 1 hour
measure: Intraoperative complications
timeFrame: intraoperative, expected duration of surgery: 1 hour
measure: Subjective assessment (Assessment of fatigue and perceived exertion)
timeFrame: an expected average of 15 minutes before and after the operation
measure: Subjective assessment (optical modality and mental load assessment)
timeFrame: an expected average of 15 minutes after the operation
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: Charlotte Fergo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967873: Child Asthma : What Parents Attitude During an Asthma Attack at Home Before Consulting the Pediatric Emergencies
Official title: Prevalence of Preoperative Short-acting Mimetic beta2 Therapy by Parents of Asthmatic Children Attending Emergency Room for Asthma Attack
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Asthma Attack
Therapeutic Adherence
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 350
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children between 2 and 15 years old in Quimper or Brest emergency department for asthma attacks whose parents agree to fill in a questionnaire about their pre-hospital attitude.

Brief summary: prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home.

The main objective is to calculate the prevalence of placement of short-acting bronchodilators. The secondary objectives are to describe the factors associated with their implementation.


Eligibility criteria: Inclusion Criteria:

* child over 2 years emergency room consultant for asthma attack
* child whose parents did not express their opposition to participate and completed the non-objection form
* child consultant in pediatric emergencies of Quimper and Brest

Exclusion Criteria:

* child whose age is not between 2 and 15 years old
* cough equivalent of asthma
* history of cardiac or pulmonary pathology or prematurity
* refusal to participate

Primary outcomes:
measure: prevalence of short-acting bronchodilator induction in children attending emergency room for asthma attack
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Quimper
country: France
facility: Ch Quimper
Study officials:
References:
Clinical trial NCT06787573: Complications After Appendectomy in Elderly
Official title: Appendectomy in Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendectomy
Keywords: appendectomy;elderly
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-01-22
Enrollment: 585
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly patients with AA

Brief summary: this study evaluate postoperative complications after appendectomy


Eligibility criteria: Inclusion Criteria:

* elderly patients with AA

Exclusion Criteria:

* conservative treatment, psychological factors

Primary outcomes:
measure: incidence of postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: risk factors for complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine Zagazig University
state: Sharkia
Study officials:
References:
Clinical trial NCT04441073: Lignocaine Nebulization for Attenuation of Intubation Stress Response
Official title: Lignocaine Nebulization for Attenuation of Intubation Stress Response in Patients With Severe Pre-eclampsia: a Prospective Double-blinded Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pressor Response
Keywords: pressor response
pre-eclampsia
Lignocaine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the effect of lignocaine nebulization on attenuation of the pressor response during induction and emergence of anesthesia in patients with severe pre-eclampsia

Detailed description: The pressor response to laryngoscopy and tracheal intubation is a very important issue in hypertensive pregnant patients that can lead to increased maternal intracranial pressure, cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal mortality. The catecholamine release associated with laryngoscopy and intubation also causes uteroplacental vasoconstriction and adversely affect the neonate well-being.

Therefore, the precise control of stress is necessary during general anesthesia in pre-eclamptic patients.Various drugs are used to suppress the pressor response including opioids, lidocaine, along with α and β adrenergic blockers.

in this study the investigators will evaluate the effect of lignocaine nebulization on attenuation of the pressor response.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) II , III with severe pre-eclampsia
* Scheduled for caesarean deliveries under general anesthesia

Exclusion Criteria:

* severe obesity (BMI ≥ 40 )
* Cardiac patients
* History of diabetes
* Renal dysfunction (Elevated creatinine ≥ 2 mg\\dl)
* Hepatic dysfunction (Elevated hepatic enzymes three times above normal value)
* Known fetal anomalies

Primary outcomes:
measure: Systolic, diastolic, mean arterial blood pressure
timeFrame: Preoperative-Intraoperative
measure: Heart rate
timeFrame: Preoperative-Intraoperative
measure: Peripheral oxygen saturation
timeFrame: Preoperative-Intraoperative
measure: Cough score during emergence
timeFrame: Up to one hour after extubation
Secondary outcomes:
measure: APGAR score
timeFrame: One, 5 and 10 minutes after delivery of the fetus
measure: Sore throat and hoarseness of voice
timeFrame: Postoperative (one, 6 and 24 hours)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT03360773: Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population.
Official title: Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population (FEDD).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Happiness
Personal Satisfaction
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Madrid, Spain.

Brief summary: The aim of this study is to analyze both depressive symptomatology and psychological well-being fluctuation in a day-to-day basis in the general population, in order to identify contextual determinants of the mood and well-being changes

Detailed description: Introduction: The Experience Sampling Method is a research tool to study what people do and feel in their day to day. It allows to analyse temporal relationships between variables and has a high ecological validity.

Aim: To evaluate fluctuations of depressive symptoms and subjective well-being and to analyse the factors related to these fluctuations.

Methodology: Longitudinal study that will follow up for two weeks a representative sample of the population aged 18 to 65 years living in Madrid using the Experience Sampling Method. An interviewer will visit the participants at their home to carry out a structured interview on mental health and well-being and to install a mobile app on the smart phone of participants in order for them to fill out information about their emotional state during the following two weeks. Participants will use the smart phone screen to fill out a brief questionnaire about their feelings, the activities they are doing and the people with whom they are interacting. Multilevel analysis based on lineal hierarchical models will be employed for data analysis as well as methods based on machine learning.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Non-institutionalized resident in Madrid
* To own a smart phone

Exclusion Criteria:

* To present noticeable cognitive or other limitations that impede following the interview

Primary outcomes:
measure: Positive and Negative Affect as measured by PANAS
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Autónoma de Madrid. Department of Psychiatry. School of Medicine
Study officials:
affiliation: Universidad Autonoma de Madrid
name: Marta Miret García, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865773: HFR Cartridge and Inflammation
Official title: Role of HFR Cartridge in the Removal of Mediators of Inflammation and P-cresol in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Status
P-cresol
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A major limitation of standard hemodialysis is that it does not clear the plasma from interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular risk in end stage renal disease (ESRD). In the present study, we evaluated whether these compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge. We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240 minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session. The proinflammatory activity of UFin and UFout was determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8 healthy volunteers and cultured in vitro for 24 hr.


Eligibility criteria: Inclusion Criteria:

* HD patients undergoing three weekly haemodialysis \> 1 year

Exclusion Criteria:

* none

Primary outcomes:
measure: IL-6 removal by a single session of HFR-Supra
timeFrame: The evaluation will be performed for the duration of a single HFR session of 240 minutes
measure: P-cresol removal by a single HFR session
timeFrame: The evaluation will be performed for the duration of a single HFR session of 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: federico II university, department of nephrology
Study officials:
References:
citation: Riccio E, Cataldi M, Minco M, Argentino G, Russo R, Brancaccio S, Memoli A, Grumetto L, Postiglione L, Guida B, Memoli B. Evidence that p-cresol and IL-6 are adsorbed by the HFR cartridge: towards a new strategy to decrease systemic inflammation in dialyzed patients? PLoS One. 2014 Apr 22;9(4):e95811. doi: 10.1371/journal.pone.0095811. eCollection 2014.
Clinical trial NCT05978076: Serum Lipase and Severity of Pancreatic Injury.
Official title: Serum Lipase and Severity of Pancreatic Injury.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Injury
Keywords: Lipase
Pancreatic trauma
Pseudocysts
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 91
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 15 years 3 months with elevated lipase serum level after trauma will be included.

Brief summary: Diagnosis of pancreas injury is not easy at first consult. It's a retrospective study, in children under 15 years and 3months, between January 1st 2010 to August 31th 2019, to prove that the first level of lipase is correlated with the severity of pancreatic injury.

Every children with elevated serum lipase after trauma during those years will be selected.

The children with pancreatic tumors will be excluded. American Association of Surgeon Trauma (AAST) classification of pancreas injury will be used to grade severity.

Children will be divided in two groups : one including pancreatic lesion with duct injury and one without duct injury.

Data will include mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications will be noted.

Detailed description: The main objective of this study is to determine if there is a correlation between the initial serum lipase and the severity of the pancreatic injury.

Eligibility criteria: Inclusion Criteria:

* Children under 15 years 3 months with elevated lipase serum level after trauma.

Exclusion Criteria:

* Elevation of lipase secondary to pancreatic tumor

Primary outcomes:
measure: lipase level in severe pancreatic injury (duct injury)
timeFrame: Month: 9 (end of study)
measure: lipase level in light pancreatic injury (without duct injury)
timeFrame: Month: 9 (end of study)
Secondary outcomes:
measure: Local complications
timeFrame: Month: 9 (end of study)
measure: Maximal lipase level
timeFrame: Month: 9 (end of study)
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Aurélien SCALABRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209076: Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer
Official title: Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Neoplasms
Sexual Dysfunction
Urinary Incontinence
Quality of Life
Keywords: rectal neoplasms
sexual dysfunctions
Urinary incontinence
Quality of life
robotic surgical procedures
laparoscopy
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Hospital de Câncer de Barretos
name: Hospital dos Servidores do Estado do Rio de Janeiro
First posted: 2017-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial
Primary purpose: TREATMENT

Brief summary: Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.

Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.

Detailed description: Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.

The Aim of the study is to compare two surgical approaches (robotic versus laparoscopic) for rectal cancer treatment regarding functional outcomes (sexual and urinary dysfunctions), quality of life, post operative outcomes and oncologic outcomes.

Patients with the diagnosis of T3 mid and low rectal cancer will be randomized to robotic or laparoscopic procedure after neoadjuvant chemoradiation. Quality of life questionnaires and Urodynamic test will be applied before and after the surgical procedures.

Eligibility criteria: Inclusion Criteria:

* Mid or low Rectal Adenocarcinoma
* Performance Status (ECOG) 0 - 2

Exclusion Criteria:

* Metastatic disease
* Congestive heart failure
* Renal failure
* Diabetes
* Pregnancy
* Neurologic disorders
* Alfa blockers user
* Patients who are candidates to APR ( Abdomino-perineal resection)

Primary outcomes:
measure: Urinary dysfunction
timeFrame: Change from Before surgery to 3 months after surgery
Secondary outcomes:
measure: Sexual dysfunction
timeFrame: Change from Before surgery to 3 months after surgery
measure: Post operative outcomes
timeFrame: Within the first 30 days after the surgical procedure
measure: Costs
timeFrame: From the surgical procedure until the last follow up, which will be 24 months or the day of death.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer- INCA
state: RJ
Study officials:
affiliation: Instituto Nacional de Câncer-INCA
name: Marcus Valadão, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Jesus JP, Valadao M, de Castro Araujo RO, Cesar D, Linhares E, Iglesias AC. The circumferential resection margins status: A comparison of robotic, laparoscopic and open total mesorectal excision for mid and low rectal cancer. Eur J Surg Oncol. 2016 Jun;42(6):808-12. doi: 10.1016/j.ejso.2016.03.002. Epub 2016 Mar 23.