louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04020900: Respiratory Management of Children Under Anaesthesia
Official title: Respiratory Management of Children Under Anaesthesia: a French Prospective Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Peroperative Complication
Keywords: Children
Respiratory
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 701
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children \< 18 years of age, admitted for a general anaesthesia

Brief summary: Ventilation management in paediatric anaesthesia remains difficult because of the wide range of age and weight, and therefore practices are heterogeneous. In adults, protective ventilation during anesthesia is now a standard of care but in children there is no level of evidence to recommend it. The aim of the study was to describe current practice and the factors associated with the use of high tidal volume during anaesthesia in children in France.


Eligibility criteria: Inclusion Criteria:

* Children less than 18 years of age
* Admitted in one of the participating centers
* over 2 days (21 and 22 June 2017)

Exclusion Criteria:

* Children extracorporeal circulation
* Children who required ventilation with lung exclusion
* Opposition of the parents or legal guardians

Primary outcomes:
measure: Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight
timeFrame: up to 1 hour (during a stable period in anaesthesia)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Florent BAUDIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04925700: The Oral Microbiome in OSCC
Official title: The Oral Microbiome in Oral Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous work by a number of scientific teams has revealed that the types of bacteria that colonize the mouth differ between health and pre-cancerous or cancerous oral lesions. The purpose of this study is to investigate the extent of these changes and to correlate the changes with alterations in the activities of the host's own oral tissues. In doing so, we believe we can gain a better understanding of how particular bacterial species, or consortia of species, can result in an individual having an increased risk of the most common type of oral cancer -- oral squamous cell carcinoma. This knowledge may also lead to the identification of salivary biomarkers that can be used for clinical evaluation or screening. In addition, we seek to determine the extent to which a probiotic regimen can help prevent or rectify the disease-related changes in the types of bacterial colonizing the mouth. The microbiome in health, pre-cancerous lesions, and cancerous lesions will be determined from remnant microbial DNA in banked tissue samples. The effects of probiotics on the oral microbiome will be determined from DNA collected from swabs of oral tissue at baseline and then after 3 to 6 months of probiotic usage.


Eligibility criteria: Inclusion Criteria:

1. Adults (21-70 years old) who have been diagnosed with oral dysplasia or that have been treatment-planned as wait and watch or
2. Adults (21-70 years old) or who have been diagnosed with oral squamous cell carcinoma, or matched healthy controls free of any oral lesions

Exclusion Criteria:

1. Adults who have had a course of antibiotics that was completed less than 3 months prior to the study;
2. Adults with any immunosuppressive condition or medication that would put the subject at risk of consuming daily probiotics;
3. Adults who regularly use probiotic dietary supplements
4. Adults that have alcohol/tobacco use history that does not match study population - this if for the healthy controls arm only.

Primary outcomes:
measure: Assessment of changes in the oral microbiome composition over time
timeFrame: Up to 3 months
measure: Determine the Effect of ProDentis on the Oral Microbiome
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry and Dental Clinics
state: Iowa
Study officials:
affiliation: University of Iowa College of Dentistry
name: David Drake, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00835900: An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Official title: Extended Varenicline for Smoking Cessation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: smoking cessation
varenicline
smoking cessation treatment
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-02-04
Enrollment: 60
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: The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.

Detailed description: This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.

Eligibility criteria: Inclusion Criteria:

* currently smoking at least 15 cigarettes daily
* in good health
* able to read and speak English fluently
* have a home telephone and plan to reside in Western New York for 6 months
* willing to make quit attempt
* signed informed consent
* who planned quit attempt.

Exclusion Criteria:

* serious medical condition
* depression or mental health condition requiring treatment in the past year
* history of panic disorder, psychosis, bipolar disorder
* alcohol or drug abuse in the past year
* use of tobacco products other than cigarettes
* current use of other cessation pharmacotherapies
* pregnancy/planned pregnancy.

Primary outcomes:
measure: Change in Smoking Behavior
timeFrame: Change in cigarettes per day from Week 2 to Week 5
Secondary outcomes:
measure: Rates of Smoking Cessation.
timeFrame: 12 weeks after quit date.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Martin C Mahoney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004500: Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Official title: A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome (MAS) in Newborn Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Meconium Aspiration
Keywords: cardiovascular and respiratory diseases
meconium aspiration syndrome
rare disease
Lead sponsor: Windtree Therapeutics
Sponsor class: INDUSTRY
First posted: 1999-10-19
Enrollment: 69
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.

Detailed description: PROTOCOL OUTLINE:

This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.

Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.

Patients are followed for 12 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of meconium aspiration syndrome (MAS)
* Continuous mechanical ventilation (CMV) at time of entry
* Enrollment within 48 hours of birth
* Gestational age of ≥ 37 weeks
* Oxygenation index of ≥ 5 and ≤ 30
* Written informed consent signed and dated by the infant's parent(s) or legal guardian(s)

Exclusion Criteria:

* Congenital anomalies likely to affect any primary or secondary endpoints
* Uncontrollable air leaks
* Hydrops fetalis
* Rupture ≥ 3 weeks of the fetal membranes
* Evidence of overwhelming bacterial infection at time of randomization
* Markedly labile persistent pulmonary hypertension at time of randomization
* Profound neurologic manifestations
* Sustained postductal SpO₂of \< 87% for ≥ 15 minutes at an FiO₂of 1.00

Primary outcomes:
measure: Number of Days Receiving Mechanical Ventilation (MV)
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of Death
timeFrame: 28 days
measure: Number of Participants With Air Leaks
timeFrame: 28 days
Other outcomes:
Locations:
city: Warrington
country: United States
facility: Discovery Laboratories, Inc.
state: Pennsylvania
Study officials:
affiliation: Windtree Therapeutics
name: Thomas E Wiswell
role: STUDY_CHAIR
References:
Clinical trial NCT02576600: Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI
Official title: Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Elective gynecological surgery
* No ophtalmologic or neurologic disease
* No chronic analgesic medication
* Expected length of surgery 60 minutes minimum

Exclusion Criteria:

* ophtalmologic or neurologic disease
* chronic analgesic medication

Primary outcomes:
measure: peroperative remifentanil consumption in µg/kg/min
timeFrame: duration of surgery
Secondary outcomes:
measure: post-operative morphine requirements in mg/kg
timeFrame: 24 hours
measure: peroperative propofol consumption in mg/kg/h
timeFrame: duration of surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
affiliation: Hôpital Armand Trousseau
name: Isabelle Constant, MD-PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01836900: Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy
Official title: Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Upper Gastrointestinal Hemorrhage
Keywords: OTSC
Upper gastrointestinal bleeding
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: University Hospital Augsburg
name: Marienkrankenhaus Frankfurt
name: Klinikum Stadt Hanau
name: Klinikum Garmisch-Patenkirchen
name: University of Zurich
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2013-04-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the OTSC \[Over The Scope Clip\] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.


Eligibility criteria: Inclusion Criteria:

* Recurrence of bleeding from gastroduodenal ulcers

Exclusion Criteria:

* Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC

Primary outcomes:
measure: Persistent bleeding or Rebleeding with 7 days
timeFrame: 7 days
Secondary outcomes:
measure: blood units transfused
timeFrame: 30 days
measure: duration of hospital stay
timeFrame: 30 days
measure: duration of intensive care unit stay
timeFrame: 30 days
measure: 30 d Mortality
timeFrame: 30 days
measure: Amount of endoscopic reinterventions
timeFrame: 7 d
measure: Necessity of surgical or angiographic therapy
timeFrame: 7 d
measure: Complications during or after OTSC (Over The Scope Clip) placement
timeFrame: 7 d
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
Study officials:
References:
citation: Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding of Peptic Ulcers. Gastroenterology. 2018 Sep;155(3):674-686.e6. doi: 10.1053/j.gastro.2018.05.037. Epub 2018 May 24.
Clinical trial NCT04586400: Chromosome 9 P Minus Syndrome
Official title: Genotype-Phenotype Correlation in Patients With Chromosome 9 P Minus Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chromosome 9P Deletion Syndrome
9p Minus Syndrome
Alfi Syndrome
9P Monosomy
9P Partial Monosomy Syndrome
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Dickson, Patricia I., M.D.
name: Milbrandt, Jeffrey, MD, PhD
name: Mitra, Rob, PhD
name: Turner, Tychele, PhD
First posted: 2020-10-14
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Principal Investigator and members of the study team in collaboration with the 9 P Minus Network (http://9pminus.org/), Unique (https://www.rarechromo.org/), and other members of the 9 P Minus community will identify candidate participants with 9 P minus syndrome.

Brief summary: Patients with deletion of chromosome 9 P are rare (\~200 in the medical literature) and have a diverse set of phenotypic characteristics. We propose using state of the art genome sequencing methods to define the location and size of the deleted portion of chromosome 9 P as well as the genetic background in affected patients (whole genome sequencing) and correlate the genes in the deleted portion of chromosome 9 P with specific phenotypic characteristics of each patient. Enrolled participants will be asked to complete a detailed questionnaire, complete a medical release form, and provide a biospecimen sample.


Eligibility criteria: Inclusion Criteria:

* Having 9P minus syndrome/ deletions on the 9th chromosome
* Parents and siblings of affected individuals may also be included to determine contribution of genetic background to phenotypic characteristics

Exclusion Criteria:

* No exclusion criteria for either affected individuals or their parents or siblings.

Primary outcomes:
measure: Genotypic and Phenotypic Correlation
timeFrame: As enrollment increases the team hopes to have preliminary results by 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: F. S Cole, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01852500: Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prematurity
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 250
Sex: ALL
Minimum age (years): 29
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.

The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.


Eligibility criteria: Inclusion Criteria:

* preterm infants born at age between 29 and 37 weeks
* sham osteopathic treatment performed \< 14 days after birth
* preterm infants born in the same hospital

Exclusion Criteria:

* gestational age \< 29, \> 37 weeks;
* sham osteopathic treatment performed \> 14 days after birth;
* newborn transferred to/from other hospital;
* newborn from to HIV seropositive and/or drug addict mother;
* newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Primary outcomes:
measure: Evaluate the effectiveness of sham OMT in reducing LOS
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: pre-post difference in weight gain
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Francesco Cerritelli
state: PE
Study officials:
affiliation: European Institute for Evidence Based Osteopathic Medicine
name: Francesco Cerritelli, DO, MS
role: STUDY_CHAIR
References:
citation: Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65.
citation: Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.
Clinical trial NCT02432300: The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Official title: The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Alexithymia
Keywords: Traumatic Brain Injury
Alexithymia
Emotions
Lead sponsor: EmotEd
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-05-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine a web-based training program for treating emotional problems in people who have suffered a traumatic brain injury (TBI).

Detailed description: This is a pilot study to examine how subjects with TBI feel about the virtual reality program as a treatment and to assess the effectiveness of the virtual reality program at increasing subjects' awareness and understanding of emotions.

Eligibility criteria: Inclusion Criteria:

* TBI (injury due to an external physical force);
* Moderate to severe TBI, defined either by74 Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes);
* ≥1 year post-injury;
* between 18-65 years old;
* Have a moderate to high alexithymia score (≥52) on the TAS-2070 at screening.

Exclusion criteria:

* Diagnosed with pre-morbid neurological disorders (e.g. stroke, autism, alzheimer's disease, Parkinson's disease);
* Formerly diagnosed with a developmental disability;
* Pre-morbid diagnosis of major psychiatric disorders (e.g. schizophrenia);
* Unable to follow directions;
* Uncorrected visual or hearing impairments that would prevent sufficient task participation;
* No access to reliable transportation.

Primary outcomes:
measure: Toronto Alexithymia Scale-20 (TAS-20)
timeFrame: Week 6
measure: Levels of Emotional Awareness Scale (LEAS)
timeFrame: Week 6
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression
timeFrame: Week 6
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Week 6
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Facilities
state: Indiana
Study officials:
affiliation: Indiana University
name: Dawn Neumann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neumann D, Malec JF, Hammond FM. Reductions in Alexithymia and Emotion Dysregulation After Training Emotional Self-Awareness Following Traumatic Brain Injury: A Phase I Trial. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):286-295. doi: 10.1097/HTR.0000000000000277.