louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03382028: Development of Child With Equinus Deformity Idiopathic
Official title: Development of Child With Equinus Deformity Idiopathic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Equinus Deformity
Keywords: developmental abnormalities
psychomotor development
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 112
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Equinus Deformity

Brief summary: Identification and characterization of the link between psychomotor development and the appearance of associated signs in children with "Equinus Deformity " considered isolated at birth.

Detailed description: The main objective of this study is to define the frequency of developmental abnormalities in children with "Equinus Deformity Idiopathic" compared to the general population

The secondary objective is to identify the prenatal and / or neonatal characteristics that could be predictive of the occurrence of developmental abnormalities in

Prenatal and postnatal follow-up data are derived from the child's medical file. To complete these data and after inclusion, parents of children carrying "Equinus Deformity Idiopathic" will be sent a questionnaire that assesses overall psychomotor development and lists the medical events since the birth of their child (scoliosis, epilepsy ...).

Eligibility criteria: Inclusion Criteria:

* Children born between January 2002 and August 2015
* Prenatal or postnatal diagnosis of idiopathic or syndromic Equinus Deformity
* Followed by the pediatric orthopedic service of Rennes University Hospital
* Parent having received the information on the protocol and having not expressed their opposition.

Exclusion Criteria:

* Parents opposing the study

Primary outcomes:
measure: Frequency of developmental abnormalities (with the exception of Equinus Deformity) in children with Equinus Deformity idiopathic compared to the general population.
timeFrame: through study completion an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Laurent Pasquier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02230228: Phase 1 Safety Study of ALK-001 in Healthy Volunteers
Official title: A Phase 1, Open Label, Repeat Dose Study to Investigate the Safety and Pharmacokinetics of 4-week Daily Dosing of ALK-001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stargardt Disease
Age-related Macular Degeneration
Other Retinal Dystrophies
Lead sponsor: Alkeus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.


Eligibility criteria: Main Inclusion Criteria

* Adult between 21 and 70 years old (inclusive)
* Healthy subject, as judged by investigator
* Subject is able and willing to comply with study requirements (study medication compliance, schedule of follow-up visits)
* Subject has provided informed consent to participate
* If female, subject uses a medically accepted birth control method and agrees to use such a method for entire clinical trial period

Main Exclusion Criteria:

* Subject has taken disallowed items during the past 30 days
* Female with a positive urine pregnancy test at screening
* Lactating woman
* Subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days
* History or current evidence of gastrointestinal malabsorption
* Subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study
* Subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ECG, which makes subject unsuitable for participation.

Primary outcomes:
measure: Safety of 4-week daily dosing of ALK-001 in healthy adults.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05679128: Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
Official title: Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Management
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised to either "palpation" or "ultrasonography"

The participants are thus arandomised to use either "palpation" or to use "ultrasonography" to DIAGNOSE the position of the cricothyroid membrane
Primary purpose: DIAGNOSTIC

Brief summary: test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography. The larynx-model is deviated to one of the sides to simulate a patient with neck pathology

Detailed description: test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography. The larynx-model is deviated to one of the sides to simulate a patient with neck pathology.

The test persons are randomised to use other palpation or ultrasonography. Al attempts are video-taped

Eligibility criteria: Inclusion Criteria:

* Participants in a course of airway management

Exclusion Criteria: unwillingness to participate

-

Primary outcomes:
measure: Correct identification of the cricothyroid membrane within a minute
timeFrame: 1 minute
Secondary outcomes:
measure: Time taken to identification of the estimated location of the cricothyroid membrane.
timeFrame: up to 3 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06910228: Changes in Cerebral Oxygenation Related to Intraoperative Position Changes
Official title: Changes in Cerebral Oxygenation Related to Intraoperative Position Changes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Scoliosis Patients
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having surgery at Nationwide Children's Hospital.

Brief summary: This is a prospective, observational study. This study will assess the effect of temporary changes in body position (supine, head of bed elevated 30 degrees, head of bed elevated 60 degrees) in anesthetized patients. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy (NIRS) by a device that is used in our operating rooms and the ICU setting to assess cerebral and tissue oxygenation.


Eligibility criteria: Inclusion Criteria:

* Patients 10-21 years of age undergoing posterior spinal fusion, requiring neurophysiologic monitoring and an arterial cannula

Exclusion Criteria:

* Patients in whom an arterial cannula is not indicated for the surgical procedure
* Patients with comorbid conditions that may impact cerebral blood flow, cerebral perfusion or place them at risk for cerebral hypoperfusion
* Patients in whom an invasive arterial cannula cannot be placed

Primary outcomes:
measure: Change in cerebral oxygenation at 30 degrees
timeFrame: 5-10 minutes after start of study
measure: Change in cerebral oxygenation at 60 degrees
timeFrame: 10-15 minutes after start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01546428: A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
Official title: A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: c-MET
Advanced solid tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Good organ (hepatic, kidney, BM) function at screening/baseline visit.

Exclusion criteria:

* Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.
* Undergone a bone marrow or solid organ transplant.
* Women who are pregnant or breast feeding.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part
timeFrame: 4 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events and serious adverse events, changes in laboratory values
timeFrame: 4 months
measure: Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2
timeFrame: 1 month
measure: Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM
timeFrame: 4 months
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04445428: OPV as Potential Protection Against COVID-19
Official title: Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Poliovirus Vaccine, Oral
COVID
Mortality
Morbidity
Non-Specific Effects of Vaccines
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 3400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and \>400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms.

In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.


Eligibility criteria: Inclusion Criteria:

* Living in a household which has had a census visit conducted after 1 January in 2017. Age above 50.

Exclusion Criteria:

* Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.

Primary outcomes:
measure: Mortality or infectious disease causing consultation or admission (Composite outcome)
timeFrame: 6 months
Secondary outcomes:
measure: Self-reported morbidity
timeFrame: 6 months
measure: Suspected COVID-19 infection
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
measure: Hospital admission for infectious disease
timeFrame: 6 months
measure: Consultations for infectious disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
Study officials:
affiliation: Bandim Health Project
name: Ane Fisker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00012428: Prenatal PCB Exposure
Official title: Prenatal PCB Exposure and Cognitive Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Exposure
Keywords: Cognitive development
Prenatal exposure
PCBs
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-03-08
Enrollment: 224
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This project is designed to investigate the association between prenatal exposure to environmental contaminants on cognitive development of school-age children


Eligibility criteria: Pregnant mothers carrying full-term infants between 1991 and 1994. No longer recruiting. This is not a clinical trial. This is an epidemiological study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05415228: Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
Official title: Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Prostate Adenocarcinoma
Keywords: Prostate Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-06-13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11).

The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.

Detailed description: Imaging and staging of prostate cancer is critical for surgical and treatment planning. Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use in a formulation utilized at the University of California in Los Angeles UCLA) and San Francisco (UCSF).

The production process for 68Ga-PSMA-11 at the University of Michigan (UM) is different and not FDA approved. This expanded access program was established to allow a continued use of 68Ga-PSMA-11 produced at the University of Michigan for clinical management for prostate cancer at the University of Michigan.

Eligibility criteria: Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma
* Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL
* Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA
* Ability to understand a written informed consent document and the willingness to sign it

Exclusion Criteria:

* Current investigational therapy for prostate cancer
* Unable to lie flat, still, or tolerate a PET/CT scan

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, Jariwala N, Rodnick M, Hope TA, Hearn J, Montgomery JS, Alva A, Reichert ZR, Spratt DE, Johnson TD, Scott PJH, Piert M. A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients. J Nucl Med. 2022 Apr;63(4):567-572. doi: 10.2967/jnumed.121.262412. Epub 2021 Jul 29.
Clinical trial NCT05948228: Prevention of White Spot Lesions Using Bioactive Gel
Official title: Principal Investigator,Resident at Cairo University
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: White Spot Lesions
Keywords: white spot lesions
orthodontic treatment
Prevention
bioactive gel
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 330
Sex: ALL
Minimum age (years): 15
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.

Detailed description: Dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. It is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment.

The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . Orthodontic treatment is a major risk factor for the development of WSL. They are reported in up to 96% of orthodontic patients.

Many materials are being used to prevent white spot lesions with fluoride being the most commonly used . New materials have been emerged such as giomer based bioactive gel with the ability to release six ions Fluoride inhibits demineralization and promotes deposition of fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro complexes. Borate reduces biofilm formation beside its antibacterial effect.

Silica promotes remineralization by inducing apatite nucleation on the tooth surface. Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and have acid buffer capacity.

Eligibility criteria: Inclusion Criteria:

* Patients assigned for orthodontic treatment with fixed appliances
* Sound teeth with fixed orthodontic appliances
* Either maxillary or mandibular teeth or both

Exclusion Criteria:

* Patients with poor oral hygiene
* Allergic reaction to the materials used.
* Lack of compliance.
* xerostomia
* Evidence of parafunctional habits.
* Active carious lesions
* Dental fluorosis
* Hypocalcified teeth
* Systemic diseases affecting teeth such as Amelogenesis imperfecta
* Severe periodontal affection

Primary outcomes:
measure: incidence of white spot lesions using DIAGNOdent
timeFrame: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
Secondary outcomes:
measure: incidence of white spot lesions using ICDAS (international caries detection and assessment system)
timeFrame: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06603428: Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone
Official title: Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone: (cohort Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Greater Tuberosity Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Constant score for functional outcome in operative and non-operative management in isolated greater tuberosity fractures of humerus bone.

Detailed description: Fractures of the greater tuberosity (GT) often occur with more complex proximal humerus fractures and are less frequently observed as an isolated pathology. Only 14-20% of proximal humerus fractures are isolated lesions of the GT. Up to 30% of these fractures are associated with anterior glenohumeral dislocations. According to Neer, a displacement of the fragment \>5mm and 30°, or \>3 mm of displacement in active patients involved in frequent overhead activity is believed to be an indication for operative treatment. However, indication for all other fractures had managed by nonoperative treatment is unclear. Currently, there is a lack of evidence in the literature to support either conservative or operative treatment strategies in GT humerus fractures. The fracture type and the etiology of the fracture impact the decision- making and the final outcome also remains unclear. age of more than 65 years as an important risk factor for secondary displacement in the conservative management of fractures of the greater tuberosity. Furthermore, fracture type and shoulder joint dislocations were factors associated with show increased relative risks for secondary fragment displacement.

Eligibility criteria: Inclusion Criteria:

* 1-history of traumatic isolated GT fracture.

Exclusion Criteria:

- 1- associated proximal humeral fracture.

2 - previous shoulder pathology.

Primary outcomes:
measure: Constant score for functional outcomes
timeFrame: follow up 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Kerolos Zaghlol Thabet
Study officials:
affiliation: Assiut University
name: Kerolos Z Thabet, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schliemann B, Heilmann LF, Raschke MJ, Lill H, Katthagen JC, Ellwein A. Isolated fractures of the greater tuberosity: When are they treated conservatively?: A baseline study. Obere Extrem. 2018;13(2):106-111. doi: 10.1007/s11678-018-0459-z. Epub 2018 May 15.