louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04292522: Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort
Official title: Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort : Matching to the National Health Data System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Keywords: Care pathway
Health administrative database
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 903
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with ASD included in the ELENA Cohort

Brief summary: Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...).

The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.


Eligibility criteria: Inclusion criteria:

- Included in ELENA Cohort

Exclusion criteria:

- Opposable to reuse data

Primary outcomes:
measure: Care pathway
timeFrame: 1 day
measure: Clinical characteristics
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Amaria Baghdadli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449722: OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
Official title: Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis


Eligibility criteria: Inclusion Criteria (main):

* Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
* Established or new diagnosis
* Disease activity at baseline: Clinical Activity Index (CAI) \>4 and Endoscopic Index (EI) \>= 4

Exclusion Criteria (main):

* Crohn's disease
* Toxic megacolon
* Present or past colorectal cancer
* Symptomatic gastrointestinal disease
* Serious secondary disease(s)
* Baseline stool positive for germs causing bowel disease
* Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
* Current relapse occurred under maintenance treatment with \>2g/day mesalazine
* Serum creatinine \>= 1.2x upper limit of normal (ULN) and creatinine clearance \< 60 ml/min per 1.73 m2
* Serum transaminase (ALT and/or AST), and/or alkaline phosphatase \>= 2x ULN

Primary outcomes:
measure: Rate of clinical remission
Secondary outcomes:
measure: Rate of clinical response
measure: time to resolution of symptoms
measure: rate of endoscopical remission
measure: rate of endoscopical response
measure: rate of histological remission
measure: rate of histological response
measure: PGA
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Evangelisches Krankenhaus Kalk
Study officials:
affiliation: Evangelisches Krankenhaus Kalk, Cologne, Germany
name: Wolfgang Kruis, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruis W, Kiudelis G, Racz I, Gorelov IA, Pokrotnieks J, Horynski M, Batovsky M, Kykal J, Boehm S, Greinwald R, Mueller R; International Salofalk OD Study Group. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial. Gut. 2009 Feb;58(2):233-40. doi: 10.1136/gut.2008.154302. Epub 2008 Oct 2.
Clinical trial NCT06866522: Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy
Official title: Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy: Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photobiomodulation Therapy
Phototype
Keywords: photobiomodulation
low-level laser therapy
skin optics
melanin
light reflection
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Photobiomodulation therapy (PBMT) is based on exposing biological tissues to low-intensity light, with effects depending on the light-tissue interaction. When irradiated without skin contact, part of the incident light is reflected and lost. In this context, the amount of reflected light in PBMT applied without skin contact, as well as the influence of skin phototype, has not yet been established. Objective: To quantify the reflection of light from PBMT on the skin of men and women aged 18 to 30 years, considering skin phototypes. Methodology: Participants will be divided into three groups based on skin phototype (Group 1: phototypes I and II; Group 2: phototypes III and IV; Group 3: phototypes V and VI) and sex. They will be subjected to whole-body PBMT with red light (660 nm; 31.85±3.85 mW; 45.50±5.07 mW/cm²) and infrared light (850 nm; 25.29±2.99 mW; 36.13±4.27 mW/cm²) at 20 cm from the light-emitting source, with measurement of light reflection in the regions of the brachial biceps, abdomen, lumbar, anterior and posterior thigh, and calf using a power and energy analyzer (powermeter PM100D and sensor S130C, 0.7 cm²). Data will be analyzed for normality and groups were compared with a significance level of 5%


Eligibility criteria: Inclusion Criteria:

* male and female
* age between 18 and 30 years
* body mass index (BMI) between 18.5 and 29.9 kg/m2.

Exclusion Criteria:

* tattoo in the light reflection assessment areas
* history of skin cancer
* skin lesions such as open wounds in the mid-thigh, abdomen, biceps brachii, back and calf
* patients with cognitive difficulty reporting thermal sensation

Primary outcomes:
measure: Light Reflection
timeFrame: Acute measurement. The measurement will be performed just during the light therapy irradiation, on the day of the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos (UFSCar)
state: SP
Study officials:
References:
Clinical trial NCT05513222: Flipped Autograft for Treating Surgical Wound Dehiscence
Official title: Flipped Autograft: a Novel Approach for Management of Wound Dehiscence in Implant Dentistry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Dehiscence
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: British University In Egypt
First posted: 2022-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This case report describes a novel technique for management of peri-implant wound dehiscence that involves using auto graft from the same surgical site to seal the dehiscence defect.


Eligibility criteria: Inclusion Criteria:

1. Adult patients in a healthy systemic condition.
2. Both genders
3. Patients should have single missing tooth.
4. Seibert Class I ridge defect.
5. Patients should approve to deliver a signature to a written consent after study nature explanation.

Exclusion Criteria:

* 1- Patients with any smoking habits. 2- Pregnant females, decisional impaired individuals, Prisoners and handicapped patients.

  3- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.

  4- Patients with infections either periodontally or periapically.

Primary outcomes:
measure: complete primary intention healing of the wound dehiscence
timeFrame: 3 months
Secondary outcomes:
measure: esthetic outcome and patient satisfaction.
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Hamdy
Study officials:
References:
Clinical trial NCT06034522: Clinical Investigation Evaluating the Safety and Feasibility of Adipearl
Official title: A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mid-face Volume Deficiency
Lead sponsor: Volumina Medical S.A.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Adipearl is an injectable filler intended to be injected subcutaneously in the face.


Eligibility criteria: Inclusion Criteria:

* Subject having given freely and expressly informed consent;
* Subject deemed by the Investigator to be medically fit for injection of the product;
* Female or male subjects aged 22 to 65 years (inclusive);

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject participating to another research study.
* Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.

Primary outcomes:
measure: Safety of Investigational Medical Device
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Art Clinic
Study officials:
References:
Clinical trial NCT06624722: Postural Habits, Awareness and Spine
Official title: Evaluation of Relationships Between Postural Habits and Awareness With Spine Pain, Spine Functions and Quality of Life in Research Assistant Physicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine
Posture
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 72 volunteer participants between the ages of 20-50 who were working as research assistant physicians.

Brief summary: Alterations in posture are frequently seen as a risk factor for the development of spine pain. Postural awareness is essential for sustaining healthy postural habits in daily life. The first of the contribution to literature of our study is that the Postural Habits and Awareness Scale, which is a new questionnaire that provides easy inquiry about postural habits and awareness, is a low-cost method and has not been used in the literature before, was used to confirm the relationships between spine pain and functionality and scale parameters in accordance with the literature. Another contribution is that it is underlined that even among doctors, who are the direct managers of health, low postural awareness and bad postural habits that can lead to spinal problems are quite common.


Eligibility criteria: Inclusion Criteria:

* participants between the ages of 20-50
* who were working as research assistant physicians

Exclusion Criteria:

* with a history of previous trauma or surgery that could cause pain or postural disorders in the spine,
* known systemic, neurological, psychiatric, infectious, inflammatory, rheumatic, tumoral or degenerative diseases

Primary outcomes:
measure: Postural Habits and Awareness Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
Study officials:
References:
Clinical trial NCT00362622: Determinants of Compliance With Glaucoma Therapy
Official title: Determinants of Compliance With Glaucoma Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Keywords: Travalert
open angle glaucoma
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2006-08-10
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients.

Brief summary: To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device.

Detailed description: To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device. All participants will have open angle glaucoma.

Eligibility criteria: To be eligible to participate in the study, patients had to be (1) 19 years or older; (2) have a diagnosis of open angle glaucoma (OAG) in 1 or both eyes or ocular hypertension; and (3) using a prostaglandin ocular hypotensive medication in 1 or both eyes.

The protocol excluded patients with uncontrolled IOP control, known contraindications to Travoprost, clinically significant systemic disease that would interfere with the study, participation in any other research study within 30 days, or change in systemic medications that may alter IOP within 30 days before recruitment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Christopher A Girkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Jason Swanner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Matthew Sapp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02865122: Safety and Efficacy Study in Infant With SBS
Official title: A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group Trial to Assess the Efficacy and Safety of NTRA-9620 in Infants With Short Bowel Syndrome (SBS) Following Surgical Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Short Bowel Syndrome
Lead sponsor: Elgan Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 2
Sex: ALL
Minimum age (years): 2
Maximum age (years): 52
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection


Eligibility criteria: Inclusion Criteria

1. Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment.
2. Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.
3. After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for nutrient absorption.

Exclusion Criteria

1. Subject has undergone any bowel lengthening procedure.
2. Subject has a malabsorption disorder due to:

   * congenital etiology (such as microvilli inclusion disease, tufting enteropathy)
   * Untreated Hirchsprung's disease
3. Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study.
4. Subjects with hyperinsulinemia.
5. Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.

Primary outcomes:
measure: Percent Change in %PN/IV
timeFrame: baseline and end of treatment or 24 weeks, whichever occurs first
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Hartford
country: United States
facility: Connecticut Children's Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
Clinical trial NCT02592122: Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Disease,Obstructive
Keywords: Mechanical ventilation
Chronic obstructive pulmonary disease
Airway resistance
Bronchial dilation test
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Primary-investigator,Bing Sun
First posted: 2015-10-30
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the patients with COPD mechanical ventilation, the bronchial dilatation is very common. However, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index. For patients with mechanical ventilation, the risk of cross infection can not only increase the risk of cross infection, but also increase the workload of clinical doctors and nurses. Therefore, this study proposes an objective evaluation method to evaluate the response of COPD patients to bronchial dilation. The hypothesis of this study can be used to guide the clinical medication through the test of the bronchus. If the patients with bronchial dilation test positive were used in the test, the patients were not used. In this evaluation method, the changes of airway resistance were measured by the accurate measurement of the patients with inhaled bronchial dilatation.


Eligibility criteria: Inclusion Criteria:

* Acute exacerbation of chronic obstructive pulmonary disease
* The mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours

Exclusion Criteria:

* asthma
* has received tracheotomy
* long term mechanical ventilation (which has been accepted for more than 21 days).
* severe pneumonia
* Patients who cannot use a patient with bronchial dilation
* there's a taboo on the use of a sedative.
* refusal to participate in the study
* 48 hours to pull out the tube

Primary outcomes:
measure: airway resistance
timeFrame: 1 day
measure: Respiratory mechanics index:PEEPi
timeFrame: 1 day
Secondary outcomes:
measure: Mechanical ventilation time
timeFrame: 28 days
measure: length of hospital stay
timeFrame: 30 days
measure: Costs of hospitalization expenses
timeFrame: 30 days
measure: Routine blood test:Eosinophilic cells
timeFrame: 7days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Bing Sun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Chen Y, Wang P. Application of impulse oscillometry and bronchial dilation test for analysis in patients with asthma and chronic obstructive pulmonary disease. Int J Clin Exp Med. 2015 Jan 15;8(1):1271-5. eCollection 2015.
Clinical trial NCT04743622: Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost
Official title: Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: Samil Pharmaceutical Co., Ltd.
First posted: 2021-02-08
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Study

Detailed description: Not provided

Eligibility criteria: Inclusion Criteria:

* IOP \>/= 15mmHg and \< 40 mmHg in each eye using Goldmann applanation tonometry at visit 2
* Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

* Patients with closed-angle, congenital glaucoma or secondary glaucoma caused by steroid drugs, etc.
* best-corrected visual acuity 20/80 or less
* Patients who have ongoing medical history of ocular inflammation
* central corneal thickness is not in between 470um and 591um.
* Patients who have received lacrimal duct procedure within the last 3 months or who have plans to have it.
* pregnant or nursing women

Primary outcomes:
measure: Corneal staining test
timeFrame: (12-week-point)
measure: Conjunctival staining test
timeFrame: (12-week-point)
measure: Ocular surface disease index (OSDI)
timeFrame: (12-week-point)
measure: Compliance check
timeFrame: (12-week-point)
Secondary outcomes:
measure: Corneal staining test
timeFrame: (4-week-point)
measure: Conjunctival staining test
timeFrame: (4-week-point)
measure: Ocular surface disease indext (OSDI)
timeFrame: (4-week-point)
measure: IOP (intraocular pressure)
timeFrame: (4- / 12-week-point)
measure: Tear break up time (TBUT)
timeFrame: (4- / 12-week-point)
measure: Limbal and bulbar hyperemia
timeFrame: (4- / 12-week-point)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA University Bundang Medical Center
state: Bundang-gu
Study officials:
affiliation: CHA Bundang Medical Center
name: Seungsoo Rho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: