louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06149468: CAP48 - Autism in Children and Adolescents
Official title: CAP48 Medical Research Project: Autism Spectrum Disorders in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
name: Université de Namur
name: University of Mons
name: Université de Liège
First posted: 2023-11-29
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center.

Brief summary: Evaluation and follow-up of children diagnosed with an autism spectrum disorder in French-speaking Belgium in order to optimize diagnostic protocols, the quality of care required and its accessibility, and to determine the impact of an autism spectrum disorder on schooling, family and society.

Detailed description: The aims of the research project:

* To collect a wide range of data in order to improve knowledge of children with autism spectrum disorder (ASD) in French-speaking Belgium by prospectively including all children and adolescents making a request to the centres of reference. The creation of a common database will make it possible to collect general socio-demographic, geographical and epidemiological data, to characterise the different profiles and to accurately monitor developmental trajectories.
* Evaluate the feasibility and practical implementation of the treatment proposed following a diagnosis of ASD in a child.
* Implement protocols to improve the quality of care for beneficiaries.
* To enable the development of fundamental research protocols. Many questions remain unanswered about the genetic, neuro-cognitive and linguistic characteristics of autism. Only rigorous studies carried out on large, carefully defined samples can advance research.
* Increase public knowledge and understanding of the ASD.

Eligibility criteria: Inclusion Criteria:

* children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center from French-speaking region of Belgium.

Exclusion Criteria:

* refusal by the family to allow their child's data to be included in the database.

Primary outcomes:
measure: Creation of an ADS register
timeFrame: Throughout the entire study, approximately during 5 years
Secondary outcomes:
measure: Feasability assessment
timeFrame: Throughout the entire study, approximately during 5 years
measure: Protocols development
timeFrame: Throughout the entire study, approximately during 5 years
measure: Schooling evaluation
timeFrame: Throughout the entire study, approximately during 5 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: UCLouvain
Study officials:
affiliation: Université Catholique de Louvain
name: Marine Houssa, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03223168: Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
Official title: Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failing Fontan Physiology
Pediatric Congenital Heart Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators


Eligibility criteria: Inclusion Criteria:

1. Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist).

Exclusion Criteria:

1. Patients which will likely require intubation for catheterization
2. Severely depressed systemic ventricular systolic function
3. Baseline airway obstruction
4. Plastic bronchitis
5. Significant OUTFLOW obstruction

Primary outcomes:
measure: Hemodynamics as characterized by change in pulmonary artery pressure
timeFrame: Baseline, 45 Minutes
measure: Hemodynamics as characterized by change in pulmonary blood flow
timeFrame: Baseline, 45 Minutes
measure: Hemodynamics as characterized by change in systemic arterial saturation
timeFrame: Baseline, 45 Minutes
measure: Hemodynamics as characterized by change in cardiac output
timeFrame: Baseline, 45 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of MIchigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: David Peng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06590168: Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets
Official title: Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Socket Shield
Socket Preservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.

Detailed description: The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.

In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.

Eligibility criteria: Inclusion Criteria:

Adults from the age of 18 - 60 years Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).

Intact gingival tissue with at least 2mm keratinized tissue Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index . Patients accepts to provide informed consent

Exclusion Criteria:

Pregnant and lactating females. Smokers as smoking is a contraindication for any plastic periodontal surgery. Patients with BOP\&gt;15%. Patients with periodontal diseases . Handicapped and mentally retarded patients. Patients undergoing radiotherapy. Presence of systemic disease that would affect wound healing. Presence of active infection with soft tissue communication.

Primary outcomes:
measure: Linear buccal distance (mm)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in the height of the socket buccal and palatal ridges (mm)
timeFrame: 6 months
measure: Labiopalatal volumetric ridge contour analysis (mm)
timeFrame: 6 months
measure: Patient satisfaction (Yes/No)
timeFrame: 2 weeks
measure: Pain (1-10)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT06031168: 1% Metformin Gel-coated Implants and Osteointegration and Crestal Marginal Bone Loss
Official title: Evaluation the Effect of Topically Coated Dental Implants With 1% Metformin Gel on Osteointegration and Crestal Marginal Bone Loss (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteointegration
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Achieving and maintaining a long term osseointegrated dental implant is a golden goal of success in field of dentistry. Osteointegration depends on surface treatment of dental implants. various techniques of implant coating have been introduced to enhance and accelerate osteointegration. The purpose of present study is to clinically and radiographically evaluate the osseointegration around hydrophilic dental implants coated with 1% Metformin gel Materials and Methods: We executed a randomized controlled clinical trial. The sample will include patients demanding dental implant treatment. Patients will be randomly allocated into the two groups of the study. The group A will be treated with 1% concentrated metformin gel coated hydrophilic dental implant. Group B will be treated with uncoated hydrophilic dental implant. The primary outcome variable will be implant osteointegration and crestal marginal bone loss around implants. It will be measured at time of implant placement and reevaluated after 4, 6-months with periapical x-ray and 3-dimensional imaging.


Eligibility criteria: Inclusion Criteria:

* Good general periodontal health and maintenance.
* Adequate amount of bone volume at implant site, allowing to perform the dental implant surgery procedure without bone grafting techniques

Exclusion criteria

* Heavy smokers who smoke more than ten cigarettes per day
* Diabetic patients who have received metformin as antidiabetic drug
* local or systemic conditions that will interfere with routine implant placement (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease
* Patients who had subjected to intravenous and/or oral bisphosphonate therapy.

Primary outcomes:
measure: Change in implant stability
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: change in marginal bone loss
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00881868: Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
Official title: A Multi-Center, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Clobetasol Propionate Spray Versus Vehicle for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scalp Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.


Eligibility criteria: Inclusion Criteria:

* Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp

Exclusion Criteria:

* Subjects who need systemic treatment for their body psoriasis
* Subjects who have surface area involvement too large (\>20% Body Surface Area \[BSA\]) that would require more than 50 grams per week of study product

Primary outcomes:
measure: Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)
timeFrame: baseline to week 4
Secondary outcomes:
measure: Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
timeFrame: baseline to week 4
measure: Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
timeFrame: baseline to week 4
measure: Number of Participants in Each Category of Pruritus at Baseline and Week 4
timeFrame: baseline to week 4
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: New York
country: United States
facility: Research Division of The Skin Specialty Group
state: New York
city: Seattle
country: United States
facility: Dermatology Associates, PLLC
state: Washington
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03600168: Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery
Official title: A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of Purastat Absorbable Haemostatic Material for the Management of Bleeding After Open Liver Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Resection
Lead sponsor: 3-D Matrix Europe SAS
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been previously treated with PuraStat®

Brief summary: The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.


Eligibility criteria: Main Inclusion Criteria:

* Male or female patient ≥ 18 years old
* Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent
* Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent
* Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up.

Main Exclusion Criteria:

* Known allergy or hypersensitivity to any component of the investigational treatment PuraStat®
* Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
* Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints

Primary outcomes:
measure: Total Time-To-Haemostasis
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St James' University Hospital
Study officials:
References:
Clinical trial NCT03072368: Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
Official title: Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eye Color
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns.


Eligibility criteria: Inclusion Criteria:

* Any baby born between the 24-42 week of gestation admitted to the well-baby nursery or the NICU whose parents have signed an informed consent.

Exclusion Criteria:

* Neonatal conjunctivitis
* Neonatal sepsis
* Inborn error of metabolism or genetic syndrome
* Eye abnormalities
* Parental refusal

Primary outcomes:
measure: Change in eye color
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Amit Hochberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554368: A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage
Official title: A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage After Stroke Thrombectomy: Derivation, Validation and Comparison With Other Scores
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Thrombectomy
Stroke
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
First posted: 2020-09-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute anterior circulation stroke

Brief summary: This study sought to develop and validate a new risk stratification score (Henan predicting the risk of intracerebral hemorrhage score, Henan-PRIHS) based on intra-arterial contrast enhanced Flat Detector CT (IA-CEFDCT) to predict symptomatic intra-cerebral hemorrhage (sICH) after stroke thrombectomy.

Detailed description: The Henan-PRIHS was developed from 95 patients who underwent IA-CEFDCT and MT for acute anterior stroke. Patients were classified as having one of three grades according to the presence of contrast filling within the occluded vascular territory. Grade 0 was normal or less contrast filling in affected hemisphere, grade 1 and 2 were small and medium-large area without contrast filling, respectively. The Youden index was used to determine the optimum no contrast filling area cutoff for defining grade 1 and 2. The score was subsequently validated in a different population of 208 patients and compared with three established scores.

Eligibility criteria: Inclusion Criteria:

1. age ≥18 years,
2. occlusion of internal carotid artery and/or middle cerebral artery (MCA) M1 or M2 segments confirmed by CTA or MRA or DSA,
3. baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points,
4. MT was performed within 16 hours from stroke onset,
5. baseline CT scan and IA-CEFDCT scan must be performed; 24 hours post-treatment CT scan was done and when the patient's neurological state had deteriorated.

Exclusion Criteria:

1. bilateral infarcts,
2. history of hemorrhagic stroke,
3. post-procedure ICH (including SAH) due to iatrogenic complications,
4. missing clinical and demographic data,
5. poor-quality IA-CEFDCT scans (i.e., motion artifact) that limited accurate identification of the region of interest. Bridge treatment (combined intravenous thrombolysis with MT) was not excluded from this study.

Primary outcomes:
measure: Henan predicting the risk of intracerebral hemorrhage score
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
Study officials:
References:
Clinical trial NCT01908868: A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2013-07-26
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.

Detailed description: Diagnostic procedures like transbronchial lung biopsy (TBLB), transbronchial needle aspiration (TBNA) and endobronchial biopsy (EBB) are routinely used to obtain pathological confirmation of pulmonary sarcoidosis. Real-time convex probe endobronchial ultrasound-guided TBNA (EBUS-TBNA) has shown immense potential, however it is costly, labor intensive and still has limited availability, especially in low and middle income countries. In the past, TBLB has been the bronchoscopic procedure of choice for diagnosis of sarcoidosis however currently its role is being debated with the advent of EBUS. We have observed that EBUS even though has high yield yet the optimal diagnosis is obtained only when combined with EBB and TBLB. The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.

The study compares the diagnostic yield of EBUS-TBNA (plus EBB and TBLB) vs. conventional TBNA (plus EBB and TBLB) for diagnosis of sarcoidosis.

Eligibility criteria: Inclusion Criteria:

Consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration

Exclusion Criteria:

* Pregnancy
* Hypoxemia (SpO2 \<90%) on room air
* Poor lung function (forced expiratory volume in first second \[FEV1\] \<1L)
* Patients with deranged clotting profile (prothrombin time \>3 seconds above control; activated partial thromboplastin time \>10 seconds above control, platelet count \<50000/µL)
* Patients already initiated on glucocorticoids
* Diagnosis of sarcoidosis possible on minimally invasive techniques such as skin biopsy or peripheral lymph node biopsy and failure to provide informed consent

Primary outcomes:
measure: Diagnostic yield
timeFrame: 18 months
Secondary outcomes:
measure: Safety
timeFrame: 18 months
measure: Diagnostic yield of individual sampling techniques
timeFrame: 18 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Chest Clinic, PGIMER
Study officials:
References:
citation: Gupta D, Dadhwal DS, Agarwal R, Gupta N, Bal A, Aggarwal AN. Endobronchial ultrasound-guided transbronchial needle aspiration vs conventional transbronchial needle aspiration in the diagnosis of sarcoidosis. Chest. 2014 Sep;146(3):547-556. doi: 10.1378/chest.13-2339.