louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00813371: Airway Pressure Release Ventilation as a Preventative Strategy
Official title: Airway Pressure Release Ventilation as a Preventative Strategy in Patients at Risk for Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Acute Lung Injury
Respiratory Failure
Trauma
Keywords: Acute Respiratory Distress Syndrome
acute lung injury
Airway Pressure Release Ventilation
ARDSnet
Bi-level
respiratory failure
trauma
APRV
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The early initiation of Airway Pressure Release Ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and Acute Respiratory Distress Syndrome and allows faster recovery of lung function.


Eligibility criteria: Inclusion Criteria:

* Trauma patients age 16 or older
* Trauma patients requiring ventilatory support within 48 hours of injury
* Those with anticipated ventilatory support ≥ 24 hours
* Subject or authorized representative (AR) has signed an informed consent form (ICF)
* Subjects age 16 or 17 who have signed an assent document and/or AR has signed an ICF

Exclusion Criteria:

* Significant chronic lung disease defined as lung pathology requiring home O2 use
* Chronic heart disease defined as NYHC III or higher
* Persistent bronchopulmonary air leak
* Contraindications to permissive hypercapnia (ex. Intracerebral bleeding, brain tumor, fulminant hepatic failure, and hemodynamic instability)
* Pulmonary artery occlusion pressures ≥ 18 mmHg
* Severe neurologic injury that may prevent the patient from having a reasonable opportunity for weaning as determined by the clinical study team
* Immuno-compromised patients secondary to drugs or disease
* Neuromuscular disease that impairs ability to ventilate spontaneously (ex. Spinal injury at or above C5, ALS, Guillain-Barre syndrome, Myasthenia Gravis)
* History of pneumonectomy
* Pregnancy
* Burns with TBSA ≥ 20%
* Acute MI as the cause of ALI/ARDS
* All other contraindications to APRV
* Patients who cannot be randomized within 12 hours of intubation

Primary outcomes:
measure: The primary endpoint will be the number of ventilator-free days.
timeFrame: from randomization to study termination
Secondary outcomes:
measure: effects of ventilator mode on ventilation
timeFrame: duration of ventilatory assistance
measure: duration of ICU stay
timeFrame: time in ICU
Other outcomes:
Locations:
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Jack Shannon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University Health Sciences Center
name: John Griswold, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02752971: Wound Infiltration With Sodium Diclofenac vs Bupivacaine for Postoperative Pain Following Appendectomy
Official title: Surgical Wound Infiltration With Sodium Diclofenac Versus Bupivacaine in the Treatment of Acute Postoperative Pain Following Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Hospital Central Dr. Luis Ortega
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The infiltration of the surgical wound is an effective strategy for postoperative analgesia. Nonsteroidal antiinflammatories are useful in this way.

Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies.

Method: Comparative, double blind, American Society Anesthesiologist classification I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3 (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.


Eligibility criteria: Inclusion Criteria:

* American Society Anesthesiologist I- II
* aged 18 and 65
* both sexes
* patients diagnosed with acute appendicitis operated under general anesthesia

Exclusion Criteria:

* Patients known to any allergy of the drugs used in the study
* Different incision approach Mc Burney
* Some intraoperative surgical complications
* Pregnant patients

Primary outcomes:
measure: rest and dynamic postoperative pain with visual analogue scale
timeFrame: 24 hours of postoperative period
measure: rescue analgesic consumption
timeFrame: 24 hours of postoperative period
measure: appearance of bowel sounds
timeFrame: 24 hours of postoperative period
measure: changes in rest and dynamic postoperative pain with visual analogue scale
timeFrame: 24 hours of postoperative pain
Secondary outcomes:
measure: number of participants with skin suture removal after 10 days
timeFrame: 10 days of postoperative pain
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05510271: Pain in Newborn Heel Blood Collection
Official title: The Effect of White Noise and Therapeutic Touch on Pain in Newborn Heel Blood Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn, Disease
Pain, Acute
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: MSc Reyhan YALÇIN
name: MSc Meral Güven
First posted: 2022-08-22
Enrollment: 65
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.Questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and previous heel blood collection were collected with the "Information Form".The Newborn Infant Pain Scale (NIPS) was used to evaluate the pain levels of newborns.


Eligibility criteria: Inclusion Criteria:

* gestational week 37 and above,
* fasting time \< 1 hour,
* without comorbidity and congenital anomalies,
* not receiving oxygen or mechanical respiratory support,
* no analgesic sedation before the procedure
* neonates with stable physiological findings before the procedure

Exclusion Criteria:

• newborns whose heel blood cannot be taken at once

Primary outcomes:
measure: The Newborn Infant Pain Scale (NIPS)
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT01191671: Language and Deglutition in Children
Official title: Feeding and Sociolinguist Profile in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child
Development
Keywords: Child Development
Child
Daycare centers
Language
Lead sponsor: Fortaleza University
Sponsor class: OTHER
First posted: 2010-08-31
Enrollment: 89
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 89 children, 41 children in public kindergarten and 48 children in daycare facilities.

Brief summary: The first years of life are considered essential to child development, as there is greater brain growth and formation of more neural connections. Therefore, the stimulation of children in various fields of development becomes relevant to the acquisition of knowledge and skills.

Detailed description: Child development, food and language, particularly in young children in different socioeconomic and cultural, as this is the basis for the growth conditions, socialization and learning.

Eligibility criteria: Inclusion Criteria:

* children aged one to three years of chronological age, of both genders, enrolled full-time, ie more than six hours in childcare elected for search

Exclusion Criteria:

* children with minor changes or deviations in child development, who did at least one major meal (lunch or dinner) in the nursery, or other educational institution attended, in addition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: University of Fortaleza
state: Ceará
Study officials:
affiliation: University of Fortaleza
name: Priscilla ME Barbosa, Graduate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05818371: Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting
Official title: Non-invasive Neuromonitoring Through Point-of-care Determination of ONSD and Assessment of Dynamic Properties of the Optic Nerve Sheath in a Neurointensive Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Brain
Subarachnoid Hemorrhage
Intracranial Hypertension
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center, prospective, open diagnostic study, proof-of-concept
Primary purpose: DIAGNOSTIC

Brief summary: Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.

Detailed description: During the intensive care stay, patients with implemented invasive intracranial pressure monitoring will have sonographic recording of the optic nerve sheath (video clip) with a parallel recording of the underlying ICP. The obtained image material is then i) analyzed by a machine-learning algorithm and ii) manually by 2 blinded differently experienced examiners (expert, novice) with respect to the ONSD. For the manual procedure, three individual measurements are made for each eye and the mean value is determined.

Subsequently, the measured values of the two examiners and the automated procedure are correlated with the ICP recorded during the sonographic examination.

Eligibility criteria: Inclusion Criteria:

* Traumatic or non-traumatic (e.g. SAH) brain injury
* Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular)

Exclusion Criteria:

* Soft tissue damage to orbital or periorbital region
* Fracture of the Orbita
* Status post decompressive craniectomy

Primary outcomes:
measure: Sonographic monitoring of optic nerve sheath
timeFrame: Single measurement post-trauma up to day 10
Secondary outcomes:
measure: Invasively measured intracranial pressure
timeFrame: Continuously from time of admission up to day 10
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Wuerttemberg
Study officials:
affiliation: University Hospital of Tuebingen
name: Jonas Tellermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01924871: Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Extubation
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep extubation. The purpose of this study is to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing) during emergence from general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Age 20-60
* patients undergoing elective surgery take more than an hour
* Under general anesthesia using an LMA
* ASA I,II

Exclusion Criteria:

* Patients on CNS depressants
* Chronic opioid use
* Corticosteroid
* Pregnant patients
* Full stomach
* Morbidly obese (BMI \>35kg/m2)
* Hepatitis B
* Hepatitis C
* Coronary artery disease
* Liver disease
* Renal disease
* Seizure disorder

Dropout criteria:

* Need for reintubation due to breath holding
* high ETCO2 during self ventilation (ETCO2\>50)
* Surgeon or patient request

Primary outcomes:
measure: Awakening Time
timeFrame: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.
Secondary outcomes:
measure: Success Rate & Complication Rate Including Cough
timeFrame: assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.
Other outcomes:
measure: Postoperative Pain
timeFrame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT06807671: Effect of Planned Visual Training on Heart Failure Patients
Official title: Does Planned Visual Training Affect the Attitudes, Beliefs and Symptoms of Individuals with Heart Failure Towards Their Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
health belief model
patient training
nursing
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 110
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: SUPPORTIVE_CARE

Brief summary: This study was conducted to evaluate the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of heart failure patients towards their disease. Planned visual education based on the Health Belief Model has positive effects on the attitudes, beliefs, and symptoms of heart failure patients towards their disease.

Detailed description: This study, which evaluated the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of patients with heart failure towards their disease, was conducted with 110 heart failure patients. The study was planned as a randomized controlled experimental study conducted on two groups as intervention (n = 55) and control group (n = 55). The study was conducted between September 2021 and March 2022 at Manisa Celal Bayar University (MCBU) Hafsa Sultan Hospital Cardiology Polyclinic. Simple randomization method was used in assigning the sample group to the experimental and control groups. Data were collected using "the Patient Identification Form", "the Health Belief Model Scale - Heart Failure" and "Memorial Symptom Assessment Scale - Heart Failure".

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 65,
* Those with no communication problems,
* Those diagnosed with NYHA I-II heart failure,
* Those without cognitive impairment,
* Those who can understand and speak Turkish,
* Those who agree to participate in the study.

Exclusion Criteria:

* Patients who do not agree to participate in the study,
* Patients who want to leave the study,
* Patients with NYHA III-IV heart failure diagnosis,
* Patients diagnosed with cancer,
* Patients with diabetic foot or amputation.

Primary outcomes:
measure: Data collection tool
timeFrame: Pre-test
Secondary outcomes:
measure: Data collection tool
timeFrame: 3 month
Other outcomes:
measure: Data collection tool
timeFrame: 6-months / Post-test
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
Study officials:
References:
Clinical trial NCT03899571: Prophylactic Treatment With Oseltamivir
Official title: Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the efficacy of 5-day versus 10-day oseltamivir prophylactic treatment in patients who had been exposed to influenza.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* exposure to influenza during hospitalization
* risk factors for influenza complications
* consent for participation obtained

Exclusion Criteria:

* younger than 18 years
* hematological malignancy
* hospitalized in intensive care unit
* refusal to participate

Primary outcomes:
measure: Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy
timeFrame: 10 days after oseltamivir prophylactic therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical center Ljubljana
Study officials:
References:
citation: Lepen L, Blagus R, Veluscek M, Saletinger R, Petrovec M, Bajrovic FF, Stupica D. Five-Day vs 10-Day Postexposure Chemoprophylaxis With Oseltamivir to Prevent Hospital Transmission of Influenza: A Noninferiority Randomized Open-Label Study. Open Forum Infect Dis. 2020 Jun 19;7(8):ofaa240. doi: 10.1093/ofid/ofaa240. eCollection 2020 Aug.
Clinical trial NCT04541771: The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants
Official title: The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Necrotizing Enterocolitis
Sepsis
Keywords: Necrotizing Enterocolitis,
lactobacillus reuteri ds 17938
Lead sponsor: Children's Hospital and Institute of Child Health, Multan
Sponsor class: OTHER_GOV
First posted: 2020-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be divided in two groups. one is control group and the other Interventional group. control group will receive the drug under study and control will be given placebo for the period of until they complete 35 weeks of gestation or discharged.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan.

Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration


Eligibility criteria: Inclusion Criteria:

* Preterm neonate\< 34 weeks and \>28 weeks of gestation of both genders Hemodynamically stable

Exclusion Criteria:

* Preterm neonates \>34 weeks gestational age \< 28 weeks of gestation Cardiorespiratory illness Parental refusal

Primary outcomes:
measure: narcotizing enterocolitis
timeFrame: up to 35 weeks of gestation
Secondary outcomes:
measure: sepsis
timeFrame: At time of addmission and 15 days after intervention
Other outcomes:
Locations:
Study officials:
affiliation: CH&ICH
name: summera tabasum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01324271: inVENT-In-Office Study
Official title: A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: Tympanostomy tube placement
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2011-03-29
Enrollment: 85
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo tympanostomy tube insertion
* At least 6 months old
* Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

Exclusion Criteria:

* History of sensitivity or reaction to anesthesia chosen for the procedure
* Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
* Otitis externa
* Anatomy that precludes sufficient visualization of and access to the tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Primary outcomes:
measure: Percentage of Subjects With In-office Tube Placement Procedure Success
timeFrame: Day 0
measure: Percentage of Tubes Successfully Placed Using a TTDS Device
timeFrame: Day 0
Secondary outcomes:
measure: Number of Retained (TTDS-placed) Tubes
timeFrame: 14 days
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
References: