louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04232865: Biop System's Safety and Performance
Official title: Biop System's Safety and Performance in Increased Detection of High-grade Lesions of the Cervical Epithelium in Women Scheduled for Colposcopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: BIOP Medical
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 320
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy

Detailed description: Biop system's safety and performance in increased detection of high-grade lesions of the cervical epithelium in women scheduled for colposcopy.

This is a multi-center, prospective, open label, non-randomized study to train the Biop System's algorithm and evaluate the safety and performance of the Biop system in women undergoing cervical colposcopy.

Eligibility criteria: Inclusion Criteria:

* Female Age ≥ 22 years and ≤ 65.
* Referred for colposcopy, following abnormal cervical cytology;
* Participant provides signed informed consent

Exclusion Criteria:

* Currently pregnant (through six weeks postpartum) or nursing
* Currently menstruating
* Previous hysterectomy
* Currently has intrauterine device (IUD)
* Cervical biopsy or therapeutic procedure since the referral cervical cytology,
* Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycythemia vera.
* Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) (Applicable to training stage only)
* A known latex allergy
* Psychological instability, inappropriate attitude or motivation
* Cervical cytology tests within the prior seven days
* Use of vaginal medications within the last 48 h or photosensitizing agents within 72 h
* History of photosensitivity or other diseases affected by UV radiation,
* An observable and untreated gynecological infection.
* Previous history of CIN therapy

Primary outcomes:
measure: SAE
timeFrame: through study completion, an average of 1 year
measure: Performance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06277765: Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis
Official title: A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
* With Atopic Dermatitis.

Exclusion Criteria:

* Not enough washing-out period for previous therapies.
* Any major surgery planned during the research period.
* With intestinal parasitic infection within the 6 months before screening.
* With any circumstance that is not suitable to participate in this study.
* Major surgeries are planned during the study period.

Primary outcomes:
measure: Proportion of subjects achieving EASI-75 at week 18
timeFrame: Up to week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
affiliation: Peking University People's Hospital
name: jianzhong Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04061265: Articaine Efficacy and Safety for Children Below Age of 4-years
Official title: Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Behaviour Assessment
Pain
Keywords: Articaine, local anaesthesia, child, pain
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 184
Sex: ALL
Minimum age (years): 37
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.


Eligibility criteria: Inclusion Criteria:

* Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion Criteria:

* The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Primary outcomes:
measure: Pain assessment
timeFrame: During the procedures
measure: Behavior
timeFrame: before and after the procedures
Secondary outcomes:
measure: postoperative complications
timeFrame: 24 hours after the procedures
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Ngwa Khattab
state: Minia
Study officials:
affiliation: Cairo University
name: Ahmad Elheeny
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204165: Comparison of MR Enteroclysis and MRI With Per Oral Contrast Using a 6 % Mannitol Solution.
Official title: MRI of the Small Bowel. Comparison of Different Techniques and Contrast.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Magnetic Resonance Imaging, Intestine Small, Crohn Disease.
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare MRI enteroclysis with MRI of the small bowel with a per oral 6%mannitol solution.Our hypothesis is that the peroral technique preform the same way as MRI Enteroclysis.


Eligibility criteria: Inclusion Criteria:

* above 18 years
* known Crohns disease or strong suspicion.
* need of a small bowel examination

Exclusion Criteria:

* pregnant
* electrolyte disturbances.
* Any MRI contraindications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kirkeveien 166
country: Norway
facility: Ulleval Universitets sykehus
state: Oslo
Study officials:
affiliation: Ulleval Universitetssykehus
name: Nils-Einar Kløw, Prof. MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04845165: Study of Cortisol Metabolism in Familial Partial Lipodystrophy Type 2
Official title: Study of Cortisol Metabolism in Familial Partial Lipodystrophy Type 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Partial Lipodystrophy Type 2
Keywords: Cortisol
Lipodystrophy 3
Hydroxysteroid 11-β dehydrogenase 1 (HSD11B1)
Insulin Resistance
Hypertriglyceridemia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from FPL2 with the R482 codon mutation of the LMNA gene treated in the department of endocrinology at Lille University Hospital.

Brief summary: Familial partial lipodystrophic syndromes are characterized by an increase in visceral adipose tissue and an atrophy of subcutaneous adipose tissue. They are associated with a severe metabolic syndrome especially when linked to the mutation of the R482 codon of the LMNA gene (Familial partial lipodystrophy type 2, FPL2). Data in lipodystrophy induced by antiretroviral therapy of HIV suggests an increase in the activity of 11β-hydroxysteroid dehydrogenase type 1 (11bHSD1). This enzyme reactivates cortisone in cortisol in adipose tissues and liver and has associated to obesity and type 2 diabetes mellitus. Hence, the hypothesis is that in patients suffering from FPL2 with the R482 codon mutation of the LMNA gene, there is an increase in the activity of HSD11B1 which could participate to the metabolic phenotype of the disease.


Eligibility criteria: Inclusion Criteria:

* Familia partial lipodystrophy type 2 (FPL2) with the R482 codon mutation of the LMNA gene
* Social insured
* Ability to give consent

Exclusion Criteria:

* urinary incontinence or inability to collect urine for 24 hours
* moderate and severe kidney insufficiency
* hepatic insufficiency
* history of hypercortisolism or adrenal insufficiency
* treatment interfering with the cortisol metabolism: taking oral or inhaled glucocorticoids within the last 6 months
* pregnant and lactating woman.

Primary outcomes:
measure: THE/(THF+αTHF) ratio measured in the 24h urine collections in patients
timeFrame: Baseline
Secondary outcomes:
measure: 11BHSD1 expression in subcutaneous adipose tissue in patients
timeFrame: Baseline
measure: Cortisol metabolites excretion in patients
timeFrame: Baseline
measure: Correlation of 11BHSD1 activity and metabolic parameters in patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Stéphanie ESPIARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01258465: Research in Autism: Parent Intervention
Official title: Research in Autism: Parent Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: Communication
Pivotal Response Training
Picture Exchange Communication System
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 39
Sex: ALL
Minimum age (years): 24
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research project was to systematically compare two widely used types of intervention programs for children with autism within a parent training model. In one condition, randomly assigned children were provided with an intervention that typically results in acquisition of expressive words in a large percentage of children diagnosed as having autism, using a well-documented manualized intervention focused on verbal expressive communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly assigned children received a widely used intervention on the same social communication functions using a well-documented manualized augmentative system of intervention (Picture Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal communication in large percentages of children diagnosed with autism. Children in the two conditions were compared for development of verbal and nonverbal communication, changes in disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In addition, parent satisfaction and stress measures were gathered in order to assess the effects of each intervention on family functioning.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autistic Disorder or At Risk of Autistic Disorder
* Age 2-0 to 3-11 years of age
* Use of fewer than 10 functional words at intake

Exclusion Criteria:

* Primary diagnosis of mental retardation
* Neurologic pathology (e.g., PKU, encephalitis, brain trauma)
* Major sensory impairment

Primary outcomes:
measure: Mullen Scales of Early Learning
timeFrame: 23 weeks with three months follow-up
Secondary outcomes:
measure: Vineland Adaptive Behavior Scales
timeFrame: 23 weeks and 3 month follow up
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego Psychology Department
state: California
city: Santa Barbara
country: United States
facility: University of California, Santa Barbara, School of Education, Department of Clinical, Counseling, and School Psychology
state: California
Study officials:
affiliation: University of California, San Diego
name: Laura E Schreibman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Santa Barbara
name: Robert L Koegel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06034665: Estimation of the MCID for Patients With Knee Osteoarthritis
Official title: Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
mcid
exercise
rehabilitation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment.

It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed.

Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.


Eligibility criteria: Inclusion Criteria:

* To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA)
* Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
* Participants with age between 50 and 70 years old
* Being able to walk without using an assistive device
* Having a body mass index of less than 30 kg/m²
* Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale

Exclusion Criteria:

* Patients who received physical therapy or intra-articular injections in the last 6 months
* Receiving an indication for surgery
* Have severe hearing, vision and speech impairment
* Having serious systemic and cardiovascular diseases that interfere with exercise
* Having a lower extremity deformity
* Patients with acute inflammation of the knee

Primary outcomes:
measure: WOMAC
timeFrame: Baseline, after 15 session and 4 months follow up
measure: KOOS
timeFrame: Baseline, after 15 session and 4 months follow up
measure: LEFS
timeFrame: Baseline, after 15 session and 4 months follow up
measure: Knee Range of Motion
timeFrame: Baseline, after 15 session and 4 months follow up
Secondary outcomes:
measure: 30s sit to stand test
timeFrame: Baseline, after 15 session and 4 months follow up
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University Physiotherapy and Rehabilitation Application and Research Center
Study officials:
References:
Clinical trial NCT02847065: The Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum RC15_0421
Official title: Study Single-center, Uncontrolled, Retrospective, the Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Beta-lactamase Extended Spectrum, E. Coli, Elderly, Mortality, Risk Factor
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All data concerning blood cultures analyzed in the bacteriology department of University Hospital of Nantes are stored digitally, particularly E. coli ESBL. Thus, the extraction of these data will allow the retrospective inclusion of patients and enhance the feasibility of the study.

Brief summary: In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes. E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia. In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public health, causing increased mortality, particularly in the elderly, and an increase in the average hospital stay. However, few studies have specifically concerned with the criteria associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally, improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E. coli has importance in terms of public health and is a prerequisite to the development of preventive strategies and to improve the short-term prognosis.


Eligibility criteria: Inclusion Criteria:

* All patients with positive blood culture E. coli BLSE will be included in the study. Bacteremia E. coli BLSE will be defined as the identification of one or more blood cultures positive for E. coli BLSE in patients with clinical criteria of systemic inflammatory response, at least two of the following 4 criteria:

  * temperature\> 38 ° C or \< 36 ° C;
  * heart rate\> 90 beat / min;
  * respiratory rate \> 20 c / min or PaCO2 \< 32 mmHg;
  * WBC \> 12,000 / microL or \< 4000 / microL or 10% immature forms

Exclusion Criteria:

* For each patient included, only the first episode of bacteremia will be included in the study

Primary outcomes:
measure: Association between advancing age and mortality at 30 days in patients with bacteremia E. coli beta-lactamase phenotype extended spectrum.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References:
Clinical trial NCT00628173: Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-03-04
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose:To compare the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation in the superior versus inferior quadrants.

Methods: In a non-randomized clinical trial and over a period of two years, consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP), number of glaucoma medications, complications and success rate (defined as at least 30% IOP reduction below preoperative values and 5\<IOP\<22 mmHg with or without glaucoma medications). Other criteria for failure included implant removal, additional glaucoma surgery, phthisis bulbi or loss of light perception.


Eligibility criteria: Inclusion Criteria:

* Patients with refractory glaucoma who need AGV implantation

Exclusion Criteria:

* Eyes with less than 3 months follow-up
* Severe conjunctival adhesions and scarring for the site of surgery
* Presence of thin sclera and staphyloma for the site of surgery
* The presence or anticipated need for silicone oil for superior implantation
* Active neovascular glaucoma for inferior implantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01614873: Comparison of Breathing Pattern During Neurally Adjusted Ventilatory Assist Ventilation and Pressure Support Ventilation
Official title: Comparison of Breathing Pattern During PSV and NAVA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory System Abnormalities
Keywords: Breathing Pattern
Mechanical Ventilation
Pressure support ventilation
Neurally Adjusted Ventilatory Assist
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Adep Assistance
First posted: 2012-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist)

Detailed description: Eligibility : healthy subject without respiratory complications in the past

Subjects will breath spontaneously without mechanical ventilation, with Pressure Support Ventilation and with Neurally Adjusted Ventilatory Assist during.

Three levels of pressurisation will be tested : 5 cmH2O, 8 cmH2O and 12 cmH2O Duration of each condition will be about 15 minutes.

Measurements will include:Flow, airway pressure, SaO2, PtCO2, diaphragmatic electromyography, chest wall motion by optoelectronic plethysmography

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Healthy Subject without any chronic disease

Exclusion Criteria:

* Absence of consent
* Pregnant

Primary outcomes:
measure: Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
timeFrame: 2h
Secondary outcomes:
measure: Tidal volume evaluated by optoelectronic plethysmography
timeFrame: 2h
measure: Electrical diaphragmatic activity recorded by mechanical ventilator
timeFrame: 2h
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: Hopital Raymond Poincare - Garches - France
name: Frédéric Lofaso, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Caen - INSERM U1075 - France
name: Nicolas Terzi, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratoire TIMC-IMAG - La Tronche - France
name: Pascale Calabrese, PhD
role: STUDY_DIRECTOR
affiliation: EA 4497 - Hopital Raymond Poincare - Garches -France
name: Henri Meric
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meric H, Calabrese P, Pradon D, Lejaille M, Lofaso F, Terzi N. Physiological comparison of breathing patterns with neurally adjusted ventilatory assist (NAVA) and pressure-support ventilation to improve NAVA settings. Respir Physiol Neurobiol. 2014 May 1;195:11-8. doi: 10.1016/j.resp.2014.01.021. Epub 2014 Feb 5.