louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02907957: Infrared Thermography for Assessment of Caudal Block in Children
Official title: A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Conduction
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients following urological and lower extremity procedures. The injection of local anesthetic into the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a vasodilation, or increased blood flow, to the lower extremities.

The purpose of this study is to determine whether the FLIR ONE thermographic camera, a smartphone attachment which utilizes an application ("app") to measure the temperature at a site on an image of the lower extremity, will be able to differentiate between caudal, non-caudal, and failed caudal images.


Eligibility criteria: Inclusion Criteria:

* Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure

Exclusion Criteria:

* Patients with preexisting conditions that could affect the skin temperature on the lower extremities such as infection, edema, vascular disorder, etc.
* American Society of Anesthesiologists comorbidity ranking of 4 or greater
* Patient with contraindications for a caudal block such as: history of allergic, reactions to local anesthetics, coagulopathy, infection at the injection site, spinal abnormality, peripheral neurological disease, Raynaud's disease

Primary outcomes:
measure: Predictive value of FLIR ONE
timeFrame: Assessments will be done through study completion, an average of 1 week following procedure.
Secondary outcomes:
measure: Inter- and Intra- rater reliability
timeFrame: Assessments will be done through study completion, an average of 1 week following procedure.
measure: Temperature differences between pre-caudal and 5 minute post-caudal images
timeFrame: Images will be captured prior to caudal and 5 minutes immediately afterwards. Assessments will be done through study completion, an average of 1 week following procedure.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Luis Sequera-Ramos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.
Clinical trial NCT06362057: Biomechanical Effects of Digitally Constructed Subperiosteal Implants
Official title: Biomechanical Effects of Digitally Constructed Subperiosteal Implants From Different Materials With Different Prosthetic Superstructures on Atrophied Maxilla: A Finite Element Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Loss
Keywords: Polyetherketoneketone
Titanium
Polyethereetherketone
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a three dimentional finite element analysis

Brief summary: Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.

Detailed description: With the advancement of digital technology for the fabrication of materials and the emerging of new materials, subperiosteal implants can be fabricated from a wide variety of materials, and there is a lack of evidence regarding which material could be suitable.

Eligibility criteria: Inclusion Criteria:

* A 3D image of an edentulous maxilla bone derived from a computed tomography scan of an adult patient.
* Maxilla with Cawood and Howell class 4 or 5 classification

Exclusion Criteria:

* A 2D image of an edentulous maxilla bone
* A non atrophied maxilla

Primary outcomes:
measure: bone loss under the implants
timeFrame: 10-15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mohammed A. El-Sawy
Study officials:
affiliation: Menoufia University
name: Mohammed A. El-Sawy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01921257: Paediatric Safety Study in Cat-PAD
Official title: A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis
Keywords: Cat Allergy
Rhinoconjunctivitis
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: inVentiv Health Clinical
First posted: 2013-08-13
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects


Eligibility criteria: * Inclusion Criteria

  * Male or female, aged 5-12 years.
  * Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
  * Subjects may optionally also have GINA Step 1 controlled asthma.
  * Positive skin prick test to cat hair.
  * Cat dander specific IgE ≥0.35 kU/L.
* Exclusion Criteria

  * Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
  * FEV1 \<80% of predicted.
  * Clinically relevant abnormalities detected on physical examination.
  * History of severe drug allergy, severe angioedema or anaphylactic reaction to food.

Primary outcomes:
measure: Number of Subjects With AEs
timeFrame: up to 36 weeks after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
city: Tarnow
country: Poland
city: Warsaw
country: Poland
Study officials:
References:
Clinical trial NCT06228157: Efficacy of Stellate Ganglion Block in Children With Autistic Disorder
Official title: A Randomized Controlled Trial To Explore the Efficacy of Stellate Ganglion Block in Children With Autistic Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autistic Disorder
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Detailed description: Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as Autistic Disorder.
* Aged between 6 years old and 12 years old.
* No contraindications to stellate ganglion block.

Exclusion Criteria:

* Other significant physical or neurodevelopmental disorders.
* Other significant medical conditions

Primary outcomes:
measure: Childhood Autism Rating Scale
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Children's Communication Checklist
timeFrame: day 1 and day 20
measure: Social Interaction Assessment Scale
timeFrame: day 1 and day 20
measure: Children's Depression Inventory
timeFrame: day 1 and day 20
measure: Childhood Anxiety Sensitivity Index
timeFrame: day 1 and day 20
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng Da yi Yuan Hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_CHAIR
References:
Clinical trial NCT04695457: Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps
Official title: Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Nursing Home
Keywords: covid19
nursing home
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NH which are part of the French Alps in the ARA area.

The questionnaire was made available on the internet 24 h/day, 7 days/week using the dedicated link sent to each NH through email by the research team on 15th of July. NH's managers had to respond to the survey.

Brief summary: Since the beginning of the COVID-19 outbreak in France, nursing homes (NH) have been heavily affected. In this study, the investigators want to evaluate the factors associated with the occurrence of COVID-19 epidemic clusters within the nursing homes in the French Alps

Detailed description: In France, between 1st of March and 29th of June 2020, the situation of NH was critical, with a total of 5,203 outbreaks (≥ 1case), of which 651 (13%) occurred in the Auvergne-Rhône-Alpes (ARA) area. In the ARA area, 3,885 residents of NH were confirmed cases (positiveness of the polymerase chain reaction (PCR) or of the serology testing), of which 1,772 (46%) subsequently died. To manage this crisis, the French government decided to first, ban the visits to residents and to reinforce hygiene measures targeting care workers, and secondly, of a national lock down. In the same time, shortage of personal protective equipment (PPE) had happened worldwide.

In this context, one can hypothesize that the occurrence of outbreaks and its spread among the residents of NH would have been initiated by the staff members. Nonetheless, the implementation of local actions might have been efficient to mitigate the epidemic, while on the other hand, shortage of PPE might have worsen the epidemic.

Therefore the investigators aimed to investigate the relationship between the occurrence of outbreak in residents and in staff members of nursing home, as well as the factors influencing this relationship, using data from a multicentric cross-sectional survey conducted in the French Alps, a part of ARA area.

Eligibility criteria: Inclusion Criteria:

* Hospital based NH in the French Alps
* Non Hospital based NH in the French Alps
* Study participation agreement from the NH's managers

Exclusion Criteria:

* Refusal of the NH's managers to participate

Primary outcomes:
measure: Identification of factors associated with the occurrence of COVID-19 outbreak in French Alps' nursing homes
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Pringy
country: France
facility: Ch Annecy Genevois
Study officials:
References:
Clinical trial NCT05643157: Structure and Function of Retinal Disease
Official title: Structure and Function of Retinal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Toxicity
Keywords: retinal toxicity
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Current clinical cameras do not allow clinicians to see the cells of the retina. This study will evaluate a new electronic camera's ability to image the human retina in finer detail.

Detailed description: This research study will (1) test the ability of a new electronic camera developed in Dr. Miller's laboratory to collect extremely sharp volumetric images of the retina in human subjects, and (2) use the camera for addressing fundamental questions about how disease progresses in the eye. This new camera integrates cutting-edge technologies in adaptive optics (AO) and optical coherence tomography (OCT) that enable the camera to capture sharp images. However, many aspects of the camera are already employed in clinical instruments used routinely by eyecare practitioners worldwide. The objective of our study is to find out (1) whether the AO-OCT camera will allow researchers to observe and quantify finer detail in the retina than current clinical cameras, and (2) whether this finer detail is useful for understanding the progression of disease in the eye.

To address the second objective, the study will look at two subgroups of retinal disease. The first is age-related macular degeneration (AMD), a leading cause of blindness in the developed world. Because this disease is difficult to study directly as it takes years to progress, we will study it indirectly using subjects with a form of retinal toxicity that exhibits a retinal phenotype similar to that of AMD but progresses on a much faster time scale. The second disease subgroup is inherited retinal degeneration that affects as many as 1 in every 2,000 people worldwide. For this subgroup, the researchers will test the exquisite sensitivity of the AO-OCT imaging system to detect minute changes in disease progression over short periods of time covering weeks and months.

Eligibility criteria: Inclusion Criteria:

* Retinal disease of either inherited retinal degeneration or retinal toxicity

Exclusion Criteria:

* Ocular media opacities
* High refractive error
* Pupil dilation imposes a risk to ocular health

Primary outcomes:
measure: Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers
timeFrame: 2 years
measure: RPE cell morphology changes
timeFrame: 2 years
measure: Cone Photoreceptor Dysfunction
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Optometry
state: Indiana
Study officials:
References:
Clinical trial NCT04501757: Naxitamab and GM-CSF in People With Neuroblastoma
Official title: Expanded Access Use of Naxitamab/GM-CSF Immunotherapy for Consolidation of Complete Remission or Relapsed/Refractory High-Risk Neuroblastoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: High-Risk Neuroblastoma
Keywords: Remission High-Risk Neuroblastoma
Relapsed/Refractory High-Risk Neuroblastoma
Naxitamab
GM-CSF
20-227
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-08-06
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an Expanded Access Program (EAP) that will give the participants access to the drug naxitamab before it is approved by the FDA. Naxitamab will be combined with granulocyte-macrophage colony stimulating factor (GM-CSF). Participants in this study will have high-risk neuroblastoma that either went away completely after treatment (complete remission) or has come back (relapsed/refractory).

Researchers think the combination of naxitamab and GM-CSF will be effective because naxitamab and GM-CSF strengthen the immune system's response to cancer cells in different ways. Naxitamab is an antibody, like the proteins made by the immune system to protect the body from harm. Naxitamab helps the cells of the immune system to find and attack cancer cells. GM-CSF is a protein that strengthens the immune system by increasing the number of immune cells called granulocytes. Granulocytes are white blood cells that fight off cancer cells. The combination of naxitamab and GM-CSF is a type of immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients who are ineligible to participate in study NCT03363373 (IRB# 18-375), will be considered for treatment under this expanded access protocol.
* Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels
* Patients must have HR-NB (MYCN-amplified stage 2/3/4/4S of any age and MYCNnonamplified stage 4 in patients greater than 18 months of age).
* Patients must be in first or greater CR or have refractory or relapsed disease
* If previously treated with any anti-GD2 mAb, human anti-hu3F8 antibody (HAHA) titer must be negative.

Exclusion Criteria:

* Active life-threatening infection
* Pregnant women or women who are breastfeeding
* HAHA titer positive
* History of anaphylaxis CTCAE grade 4 to naxitamab

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Brian Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03853057: Positive Pressure and Gravity Affect Volumetric Capnography
Official title: The Effect of Positive Pressure and Body Position on Volumetric Capnography Assessed by Electrical Impedance Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoventilation
Keywords: volumetric capnography
gravity
mechanical ventilation
EIT
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 10
Sex: MALE
Minimum age (years): 28
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.

Detailed description: In this interventional study awake and healthy volunteers will be submitted to spontaneous, pressure support and control pressure ventilation using a tight nasal mask. Volumetric capnography and electrical impedance tomography (EIT) will be continuously recorded during the protocol. Different body positions were randomly tested. Analysis of global and regional distribution of ventilation using EIT will be matched with changes observed in volumetric capnography-derived parameters.

Eligibility criteria: Inclusion Criteria:

* American Society Anesthesia physical status I.
* Age between 25-39 years old,
* Body mass index between 23-28 kg/m2,
* Non-smokers.

Exclusion Criteria:

* Presence of pulmonary or cardiac diseases.
* Abnormal spirometry.

Primary outcomes:
measure: Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation.
timeFrame: 4 hours
Secondary outcomes:
measure: Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.
timeFrame: 4 hours
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Hospital Privado de Comunidad
name: Gerardo H Tusman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
citation: Tusman G, Scandurra A, Bohm SH, Suarez-Sipmann F, Clara F. Model fitting of volumetric capnograms improves calculations of airway dead space and slope of phase III. J Clin Monit Comput. 2009 Aug;23(4):197-206. doi: 10.1007/s10877-009-9182-z. Epub 2009 Jun 11.
Clinical trial NCT03347357: Pharmacokinetics of Tacrolimus in Children
Official title: Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrotic Syndrome
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.


Eligibility criteria: Inclusion Criteria:

* patients have been diagnosed with nephrotic syndrome;
* age range: 1 month to 18 years old
* tacrolimus used as part of regular treatment

Exclusion Criteria:

* expected survival time less than the treatment cycle;
* patients with other factors that researcher considers unsuitable for inclusion.

Primary outcomes:
measure: change of plasma concentration of Tacrolimus
timeFrame: at 1,2,3,6,9,12 hours after oral administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: