louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01880034: Availability of Lipid Emulsion to Regional Anesthesia Programs at US Academic Anesthesia Departments
Official title: Availability of Lipid Emulsion to Regional Anesthesia Programs at US Academic Anesthesia Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Local Anesthetic Systemic Toxicity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regional Anesthesia Section heads at academic anesthesia institutions.

Brief summary: Significant data exists to suggest that lipid emulsion administration in the setting of local anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of potential barriers exist to routine lipid emulsion administration for those performing regional anesthesia including drug availability, drug cost and drug location. Inadequate training or lack of established protocols also have the potential to negatively impact patient outcomes. A previous study by Toledo et al (Availability of lipid emulsion in United States obstetric units. Anesth Analg 2013;116:406-408.) evaluated lipid emulsion availability on obstetric units and found that it was nearly universally available.

The Accreditation Council for Graduate Medical Education (ACGME) publishes a list of contact information for each anesthesia institution that engages in resident training. Investigators will contact these institutions by phone or email to obtain contact information for their regional anesthesia program director. In the absence of a program director, investigators will send a survey and consent information via email to the faculty physician most involved in regional anesthesia. Survey completion instructions (survey itself to be completed on Qualtrics Survey Hosting Service) and copy of the study consent form will be attached to the initial contact email. The study consent form will contain a description of the study itself. Survey participants will be allowed time to complete their survey in private at their discretion. Non-responders will receive two follow-up emails at one month intervals.


Eligibility criteria: Inclusion Criteria:

* Regional Anesthesia Section heads at academic anesthesia institutions.

Primary outcomes:
measure: Is lipid emulsion available at all locations where regional anesthesia is practiced in your institution?
timeFrame: Two months
Secondary outcomes:
measure: If lipid emulsion is available to those practicing regional anesthesia at your institution, how long would it take to obtain it?
timeFrame: Two Months.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
References:
Clinical trial NCT05400434: Natural Helpers and PCIT
Official title: The Development and Implementation of a Natural Helpers Program to Increase the Recruitment, Retention, and Engagement of Underserved Families in Parent-Child Interaction Therapy (PCIT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior
Parenting
Keywords: Community Health Workers
Mental Health Disparities
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Children's Trust, Miami FL
name: ConnectFamilias
First posted: 2022-06-01
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial was originally designed as a parallel randomized trial. Due to the coronavirus pandemic, the study has been amended to a non-randomized trial.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of a time-limited (i.e., 18 weeks) community health worker (CHW) intervention, referred to as the Parent Child Interaction Therapy (PCIT) plus natural helper (NH) model, on treatment engagement, retention, and child and caregiver outcomes.


Eligibility criteria: Inclusion Criteria:

1. Families of children 2 years of age to 12 years of age.
2. Children 2 to 7 years of age with a history of child abuse or neglect and/or child behavior problems or children ages 8 years to 12 years of age with history of or risk for abuse and the child does not exhibit clinically significant behavior problems.
3. At the time of enrollment, participants must agree that, within the upcoming six months, they will not move away to a location where they would no longer be able to regularly attend weekly sessions (i.e., moving out of Miami Dade County).

Exclusion Criteria:

1. Families with child younger than 2 years of age or older than 7 years of age with clinically significant behavior problems
2. Adults who are unable to consent and prisoners

Primary outcomes:
measure: Child externalizing behavior as measured by ECBI Intensity Scale
timeFrame: Up to 26 weeks
measure: Child externalizing behavior as measured by ECBI Problem Scale
timeFrame: Up to 26 weeks
measure: Parenting Skills as measured by the Dyadic Parent-Child Interaction Coding System (DPICS-IV)
timeFrame: Up to 26 weeks
measure: Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4)
timeFrame: Up to 26 weeks
measure: Family conflict as measured by Bloom's Family Processes Scale
timeFrame: Up to 26 weeks
measure: Family cohesion as measured by Bloom's Family Processes Scale
timeFrame: Up to 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: ConnectFamilias
state: Florida
city: Miami
country: United States
facility: Mailman Center for Child Development
state: Florida
Study officials:
affiliation: University of Miami
name: Jason Jent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741934: Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
Official title: Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Low Birth Weight Infants
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: KangWon National University Hospital
First posted: 2016-04-18
Enrollment: 111
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among the infants who were born and admitted to Seoul National University Hospital from 2008 to 2009, the birth weight of the infants less than 1,500g or gestational age less than 32 weeks patients were enrolled.

The infants who were born from 2008 to 2009 with term gestational age will also be enrolled.

Brief summary: This study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.

Detailed description: There are lots of studies published that school-aged children who were born preterm has some behavioral problems in school and they also have poor academical achievement.

Eligibility criteria: Inclusion Criteria:

* children former preterm infants \< 32 weeks of gestation or 1,500gm of birth weight
* children former normal term infants

Exclusion Criteria:

* major congenital anomaly
* neuromuscular disease
* chromosomal anomaly

Primary outcomes:
measure: Cognitive function test
timeFrame: 8 Years old
Secondary outcomes:
measure: Brain MRI
timeFrame: 8 Years old
measure: Korean Child Behavior Checklist
timeFrame: 8 Years old
measure: Korean ADHD Rating Scale-IV
timeFrame: 8 Years old
measure: Wechsler Scale of Intelligence-IV
timeFrame: 8 Years old
measure: Advanced Test of Attention
timeFrame: 8 Years old
measure: Children's color trails test
timeFrame: 8 Years old
measure: STROOP
timeFrame: 8 Years old
measure: Wisconsin Card Sorting Test
timeFrame: 8 Years old
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03612934: The Impact of SPC on Advanced Breast Cancer Patients
Official title: The Influence of Specialist Palliative Care on the Exacerbation of Negative Symptoms, Life Quality and Performance Status of Patients With Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Palliative Care
Quality of Life
Cancer, Breast
Keywords: Breast Cancer
palliative care
life quality
performance status
esas
Lead sponsor: Silesian University of Medicine
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 144
Sex: FEMALE
Minimum age (years): 33
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced stage breast cancer refered for a SPC treatment at palliative care department in Poland, Będzin.

Brief summary: The aim of this prospective, observational study is the evaluation of the effectiveness of a 14-day Specialist Palliative Care therapy in participants with advanced breast cancer carried out in a stationary palliative care unit in Poland. The length of the entire study will be 36 months.


Eligibility criteria: Inclusion Criteria:

the patient's conscious consent for examination and the ability to fill in the form by the patient herself.

-

Exclusion Criteria:

* patients with cognitive disturbances disabling credible answers in the questionnaire, deceased patients or those discharged from the ward before 14 days of hospitalisation.

Primary outcomes:
measure: Variation of intensification of patients negative symptoms before and after SPC
timeFrame: 14 days
measure: Variation of performance status of patients before and after SPC
timeFrame: 14 days
measure: Variation of quality of life of patients before and after SPC
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 4. Chair and Department of Medicine and Environmental Epidemiology Medical University of Silesia in Katowice
name: Jadwiga Jośko-Ochojska, prof
role: STUDY_CHAIR
affiliation: 1. Medical University of Silesia, department of palliative medicine
name: Łukasz Pietrzyńsi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02879734: Prophylactic Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheter
Official title: Comparison Between Performing Prophylactic Omentopexy and Lack of Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheters in Terms of Complications and Catheter Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Complication of Peritoneal Dialysis Catheter
Keywords: peritoneal dialysis
laparoscopy
omentum
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 40
Sex: ALL
Standard ages: CHILD
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 function of the peritoneal dialysis catheter in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.

Detailed description: Peritoneal dialysis is a know and accepted treatment in patients with end stage renal diseases. The is a safe, easy and cheap treatment modality in these patients. After introduction and development of laparoscopic procedures for insertion of peritoneal dialysis catheters, some prophylactic surgical techniques have been proposed as measures to reduce catheter malfunction. Omentopexy is among these techniques. The purpose of this study is to compare function of the peritoneal dialysis catheter (including inflow and outflow failure) in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.

Eligibility criteria: Inclusion Criteria:

• End-stage renal failure in need of prolonged dialysis referred for insertion of peritoneal dialysis catheter

Exclusion Criteria:

* Contraindications to laparoscopic surgery
* Coagulative disorder
* Death of participant due to other reasons before usage of peritoneal catheter

Primary outcomes:
measure: Ability of the peritoneal catheter to pass the dialysis fluid
timeFrame: One months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Reza Keramati
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Reza Keramati, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274334: Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis
Official title: Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: De Novo Lipogenesis (DNL)
Keywords: deuterium resolved mass spectrometry
exhaled breath
deuterium enrichment
metabolome of exhaled breath
deuterated exhaled metabolites
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Fondation Botnar
First posted: 2022-03-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One arm, Proof of Concept Study assessing metabolites in exhaled breath of healthy adults.
Primary purpose: BASIC_SCIENCE

Brief summary: This proof of concept- study is to measure de novo lipogenesis (DNL) non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry.

Detailed description: The study objective is to measure the DNL by ingestion of a single oral dose of 70% 2H2O at 2 g/kg body-water. The subjects will consume a Yoghurt consisting of 300g of 'Excellence Joghurt Nature gezuckert' which contains 410 Kcal, 28g fat, 34g carbohydrates and 9g protein. The exhaled air of the subjects will be measured several times per hour to analyse de novo lipogenesis (DNL) non-invasive by deuterium resolved mass spectrometry.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers
* English speaking, or good knowledge of the English language
* Able to understand the study
* Able to give informed consent

Exclusion Criteria:

* Current pregnancy

Primary outcomes:
measure: Variation of signal intensity of deuterated exhaled metabolites across the approximately lasting 4.5 hours trial
timeFrame: approximately 4.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel (UKBB)
Study officials:
affiliation: Universitäts-Kinderspital beider Basel (UKBB)
name: Pablo Sinues, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01369134: Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique
Official title: Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: self-etch adhesive
selective enamel etching
Adper Easy Bond
Supreme Ultra
Molar and premolar teeth
Adult
Class I and II cavities
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2011-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental patients

Brief summary: Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.

Detailed description: There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* written informed consent
* regular dental attender, can return to clinic for study recalls
* good medical health
* normal saliva flow
* has one or two pairs of back teeth that require a Class I or II restoration of appropriate size
* study teeth that are vital

Exclusion Criteria:

* currently in an evaluation of other dental materials
* an irregular dental attender
* has unacceptable oral hygiene standards
* has chronic periodontitis or rampant caries
* has teeth with signs of periapical pathology
* has history of pulp problems, and/or needs pulp treatment
* women who are pregnant or breast-feeding
* has known allergy to resin composite or latex
* has serious chronic disease requiring hospitalization
* has oral soft tissue pathologies
* takes medications which, in the opinion of the investigator, could interfere with the conduct of the study
* has current or recent history of alcohol or other substance abuse
* is an employee of the sponsor or the study site, or members of their immediate family
* has had any restorative treatment of teeth involved in the study in the last twelve months

Primary outcomes:
measure: Retention of the Restoration
timeFrame: one year
Secondary outcomes:
measure: Clinical performance of the study restoration
timeFrame: one year
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: School of Dental Medicine
state: New York
Study officials:
affiliation: Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214
name: Carlos Munoz, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00570934: Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
Official title: Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Juvenile Rheumatoid Arthritis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2007-12-11
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Detailed description: Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Eligibility criteria: Inclusion Criteria:

* Juvenile Rheumatoid arthritis

Exclusion Criteria:

* Steroid use

Primary outcomes:
measure: Percent true calcium absorption
timeFrame: After 6 months of treatment
Secondary outcomes:
measure: Bone Mineralization by Dual Energy x-ray absorption
timeFrame: After 6 months treatment plus 3 month washout
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospitals and clinics
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Laura S Hillman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hillman LS, Cassidy JT, Chanetsa F, Hewett JE, Higgins BJ, Robertson JD. Percent true calcium absorption, mineral metabolism, and bone mass in children with arthritis: effect of supplementation with vitamin D3 and calcium. Arthritis Rheum. 2008 Oct;58(10):3255-63. doi: 10.1002/art.23809.
Clinical trial NCT01789034: Difficult Intubation With Glidescope Video Laryngoscope
Official title: Incidence and Predictors of Difficult Intubation Adopting an Institutional Algorithm Glidescope Based: a Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difficult Intubation
Complications
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 2600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing neurosurgical procedures eligible for intubation in a tertiary neurosurgical centre

Brief summary: A prospective observational study on predictors available and on variables of difficult intubation adopting Gliscope video laryngoscope routinely.

Primary hypothesis of the current study is that the rate of difficult intubation with Glidescope is low and multiple predictors interact favorably in anticipating difficulties.

Detailed description: All possible factors involved in difficult intubations were included in this prospective analysis.

Main predictors were considered: time to Cormack Lane using Glidescope intubation, Cormack Lane score, experience of the operator (staff or resident), number of bag mask ventilation, number of intubation attempts.

Eligibility criteria: Inclusion Criteria:

* any patient up to ASA4 eligible for intubation for neurosurgical procedures
* any anesthesiologist in charge for GA

Exclusion Criteria:

* children
* patient not suitable for clinical evaluation of predictors for difficult intubation (ie. Parkinson's disease)

Primary outcomes:
measure: incidence of difficult intubation using Adnet score modified
timeFrame: 3 years
Secondary outcomes:
measure: incidence of difficult intubations in novices vs experts and complication in the overall cohort
timeFrame: 3 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Neurologico Besta
Study officials:
affiliation: Istituto Nazionale Neurologico Carlo Besta
name: Paolo Cortellazzi, MD
role: PRINCIPAL_INVESTIGATOR
References: