louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03308422: Parental Representations of the Impact of the Use of Screens on Their Preschool Children Health and Development.
Official title: Parental Representations of the Impact of the Use of Screens on Their Preschool Children Health and Development. An Opinion Survey of Parents of 1096 2-6-years-old Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parenting
Keywords: screens
preschool children
parenting education
social perceptions
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 1096
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of 2-6-years-old children educated in Nancy agglomeration

Brief summary: The main objective of this study was to evaluate the distribution of parental representations concerning the use of screens by preschool children, expressed in qualitative surveys: perceptions of screens as a source of learning, a source of appeasement, a source of behavioral difficulties and a source of reduction in the social interactions of young children.

The hypothesis of this study was the representations expressed in the qualitative studies were the reflection of the opinion of a majority of parents of young children.


Eligibility criteria: Inclusion Criteria:

* parents of 2-6-years-old preschool children

Exclusion Criteria:

* Minor parents

Primary outcomes:
measure: screens as a source of learning, of appeasement, of behavioral difficulties and of reduction in the social interactions of young children
timeFrame: baseline (J0)
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Dulong
Study officials:
References:
Clinical trial NCT05110222: Cataract Lens Hardness Based on Phaco Tip Resistance
Official title: Evaluation of Cataract Lens Hardness Based on Phacoemulsificator Tip Resistance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract Senile
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we plan to enroll 20 consecutive patients with cataract who did not undergo previous surgery

Brief summary: Phacoemulsificaton tip elongation depends upon voltage once resonant frequency of piezoelectric crystals has been reached.

Purpose of the study is to record voltage data of 20 consecutive cataract surgeries in order to evaluate correlation between voltage and LOCS classification of lens nuclei using a system that deploys a feedback mechanism capable of keeping invariant elongation regardless of enountered resistence

Detailed description: The R-Evolution (Optikon 2000 Rome, Italy) phaco machine is equipped with a patented system named "minimal stress" that used the direct piezoelectric effect from the resonant ceramics that drive the phacoemulsificator tip to assess in real time and adjust phaco tip elongation that continuously varies according to encountered resistance.

After priming in balanced salt solution, phaco tip elongation and the amount of potential difference (voltage) needed to obtain a ginev elongation in balanced solution is assessed. Once the phaco tip is used during surgery, the resistence offered by the crystalline lens material to the phaco tip reduces actual elongaton which in turn reduces the voltage produced by the directo piezometric effect. The machine uses voltage produced by actual elongation to adjust the diving voltage and therefore can ensure accurate pahco tip elongation under any condition of lens material resistance.

Purpose of the study is to record driving voltage and its variations and evaluate if there is a correlation between phaco tip resistence and drving voltage.

This is evaluated both in vitro activating the phaco tip in increasingly dense glycerol solutions and in real life phaco surgery recording the voltage requested by phaco tip resistence and correlating it to the classification of lens opacity (LOCS III system) clinically used to grade cataract hardness.

Eligibility criteria: Inclusion Criteria: diagnosis of nuclear or cortical cataract

Exclusion Criteria: previous ocular trauma, previous ocular surgery, connective tissue disease

Primary outcomes:
measure: cataract lens hardness according to LOCS III classification system
timeFrame: at enrolling
measure: average voltage
timeFrame: at the time of surgery
measure: peak voltage
timeFrame: at the time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Policlinico San Martino
Study officials:
affiliation: IRCCS Policlinico San MArtino
name: Tommaso Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06965322: Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis
Official title: Prospective Observational Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatic Arthritis
Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Keywords: rheumatoid arthritis
interstitial lung disease
risk prediction
RA-ILD
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 800
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 aged 18 years or older, currently residing in Austria, diagnosed with rheumatoid arthritis according to the current ACR/EULAR criteria, will be eligible for study entry.

Brief summary: The aim of the study is to develop a standardized, risk-adapted screening protocol for detecting pleuropulmonary manifestations in patients with rheumatoid arthritis. To assess the risk of these manifestations, a comprehensive range of functional and clinical evaluations will be performed and correlated with structural lung assessments using computed tomography (CT).

Detailed description: The objective of the study is the establishment of a standardized risk-adapted screening protocol for detecting pleuropulmonary manifestations in patients with rheumatoid arthritis. To determine the risk of pleuropulmonary manifestation in RA, clinical (pulmonological and rheumatological specialist examination including standardized disease activity and symptom scores), laboratory (e.g. RF, ACPA, CRP, CEA), lung function (incl. body plethysmography, TLCO, FeNO, SMWT), sonographic (thoracic ultrasound, joint ultrasound), and demographic (e.g., age, gender) factors will be considered. A machine learning (ML) based risk-modeling approach will be utilized to create the screening tool. For further external validation and clinical application, a freely accessible online tool and a mobile app will be developed based on the existing model.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years diagnosed with rheumatoid arthritis according to current ACR/EULAR criteria
* Residence in Austria
* Signed and dated consent of the patient in accordance with ICH-GCP guidelines

Exclusion Criteria:

* pregnancy
* age below 18 years
* Contraindications to study-related routine examinations (e.g., inability to draw blood due to needle phobia, no CT scan possible due to claustrophobia, pregnancy, etc.)

Primary outcomes:
measure: Number of RA patients with pleuropulmonary involvement according to an AI-supported multiparametric risk profile analysis
timeFrame: single point (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
Study officials:
References:
Clinical trial NCT05595122: EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
Official title: EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Biliary Obstruction
Pancreas Neoplasm
Distal Cholangiocarcinoma
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2022-10-26
Enrollment: 25
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: A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.


Eligibility criteria: Inclusion Criteria:

* Radiographically (CT or EUS) distal malignant bile duct obstruction
* Histology or cytology proven malignancy of the primary tumour or metastasis; onsite cytology evaluation after EUS guided fine-needle sampling that is highly suspected of a malignancy suffices
* Indication for biliary drainage; in case of a resectable tumour this should be discussed during a clinical multidisciplinary meeting
* Written informed consent

Exclusion Criteria:

* Age \< 18 year
* Surgically altered anatomy after previous gastric, periampullary or duodenal resection
* Cancer extending into the antrum or proximal duodenum
* Extensive liver metastases
* WHO performance score of 4 (in bed 100% of time)
* Uncorrectable coagulopathy, defined by INR\>1.5 or platelets \< 50 x 10\^9/L\*
* Clinically relevant gastric-outlet obstruction
* Unable to complete sign informed consent

  * Inclusion is allowed after corrective treatment measures are taken, according to local protocol and treating physician.

Primary outcomes:
measure: Stentdysfunction after technical successful EUS-CDS
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with technical success of LAMS placement
timeFrame: 1 day (directly after intervention)
measure: Number of participants with technical success of FCSEMS through LAMS
timeFrame: 1 day (directly after intervention)
measure: Number of participants with clinical success
timeFrame: 14 days
measure: Procedure time
timeFrame: 1 day (directly after intervention)
measure: Adverse events
timeFrame: 6 months
measure: Time to stent dysfunction
timeFrame: 6 months
measure: Number of re-interventions
timeFrame: 6 months
measure: Time to start treatment (chemotherapy or surgery)
timeFrame: 6 months
measure: Hospitalization
timeFrame: 30 days
measure: Survival
timeFrame: 6 months
measure: Costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location VUmc
Study officials:
References:
Clinical trial NCT02303522: Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)
Official title: A Retrospective Pooled Analysis of Complete Remission Among Pediatric Patients With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Keywords: ALL, pediatric, leukemia, childhood, lymphoblastic, lymphoma, acute, Precursor Cell
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-12-01
Enrollment: 207
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Brief summary: An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

Detailed description: A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)

Eligibility criteria: Inclusion criteria:

* Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
* 2nd or later relapse after chemotherapy (with no prior transplantation),
* Relapse after HSCT, or
* Refractory disease
* Had treatment for relapsed or refractory disease between 2005-2012
* Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT

Exclusion criteria:

* No CNS involvement at relapse
* No previous treatment with blinatumomab

Primary outcomes:
measure: Hematological Complete Remission (CR)
timeFrame: Approx. 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: Approx. 1 year
measure: Molecular CR
timeFrame: Approx. 1 year
measure: Relapse Free Survival (RFS)
timeFrame: Approx. 1 year
measure: Time to hematological CR
timeFrame: Approx. 1 year
measure: Receipt of HSCT after salvage treatment
timeFrame: Approx. 1 year
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Roma
country: Italy
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00954122: Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia
Official title: A 3 Weeks Open Label Study to Evaluate the Efficacy in Agitation and Safety of Quetiapine Fumarate XR in Treatment of Patients With Acute Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Acute schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.


Eligibility criteria: Inclusion Criteria:

* Requirement for treatment of acute episode of schizophrenia (according to DSM-IV diagnostic criteria)
* PANSS total score of ³ 75
* CGI \> 4

Exclusion Criteria:

* Any DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) Axis I disorder not defined in the inclusion criteria
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Substance or alcohol dependence at enrollment

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score
timeFrame: Baseline and Day 21
Secondary outcomes:
measure: Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.
timeFrame: Baseline and Day 21
measure: Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores
timeFrame: Baseline and Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline and Day 21
measure: Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)
timeFrame: Baseline and Day 21
measure: Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: Baseline and Day 21
measure: Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.
timeFrame: Baseline and Day 21
Other outcomes:
Locations:
city: Johor
country: Malaysia
facility: Research Site
state: Johor Bahru
city: Kuala Lumpur
country: Malaysia
facility: Research Site
Study officials:
affiliation: University of Malaya
name: Ahmad Hatim Sulaiman,, M Psyc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Permai
name: Badiah Yahya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04244422: Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
Official title: Clinical And Radiographic Outcomes Of Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RADICULAR CYSTS
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 14
Sex: ALL
Minimum age (years): 31
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AIM: The study was intended to evaluate the effectiveness of piezosurgery in enucleation of radicular odontogenic cysts in comparison to the conventional technique from both the clinical and radiographic perspectives.

Detailed description: METHODS: Fourteen (8 females and 6 males) patients with age range of 30-55 years who had radicular cysts associated with non-vital teeth, were operated at the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. The patients were randomly divided into 2 groups;1) the study group (7 patients) in which cyst enucleation using piezosurgery was employed, 2) control group in which the cysts were removed using the conventional technique. The following parameters were assessed; postoperative pain, time of operation, hemorrhage control and field visibility, ease of operation, neurosensory evaluation and radiographic percentage of change in bone defect volume between preoperative and 3-months postoperative values.

Eligibility criteria: Inclusion Criteria:

* 1) Periapical cysts involving more than one tooth in close relation to the maxillary sinus, nasal cavity or inferior alveolar neurovascular bundle,
* 2) Intact labial/buccal cortical plate with no perforation.

Exclusion Criteria:

* 1) Patients with systemic diseases contraindicating surgery
* 2) Cases in suspicion of malignancy

Primary outcomes:
measure: Time of operation in minutes
timeFrame: Intraoperative
measure: Hemorrhage control and ease of operation using a visual analogue scale
timeFrame: Intraoperative
measure: Objective assessment of neurosensory function using a probe (to detect nerve injury after the surgeries)
timeFrame: 1 month
measure: Radiographic percentage of change in bone defect volume using cone beam computed tomography
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of dentistry-Alexandria University
Study officials:
References:
Clinical trial NCT01416922: oncoFISH Cervical Test for Detection of 3q26 Region Gain
Official title: The oncoFISH Cervical Test for Detection of 3q26 Region Gain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
LSIL
Lead sponsor: Ikonisys, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 21 years of age or greater with LSIL cytology diagnosis who are scheduled for a colposcical assessment.

Brief summary: The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.


Eligibility criteria: Inclusion Criteria:

* Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment.
* Women with previous or current STD or HIV may be included
* Women with previous LSIL history may be included.

Exclusion Criteria:

* pregnant women,
* women with vaginal intraepithelial lesions,
* women on a chemotherapeutic agent,
* women with previous or current cancer except for non-cervical squamous cell carcinoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Ikonisys
state: Connecticut
Study officials:
affiliation: Ikonisys, Inc.
name: Michael W Kilpatrick, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03324022: Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease
Official title: Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graves Ophthalmopathy
Keywords: Fibroblast growth factors
Fibroblast growth factors receptors
Thyroid orbitopathy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thyroid eye disease

Brief summary: Graves' orbitopathy (GO) affects about 50% of patients with Graves' disease (GD), and some cannot be cured by current treatments. Orbital fibroblasts involves in the pathogenesis of GO by producing glycosaminoglycans and inflammatory cytokines. Since fibroblast growth factors (FGFs) binding to FGF receptors (FGFRs) can induce proliferation and differentiation of fibroblasts, investigators would like to measure the expression of FGFs and FGFRs in GO patients to see if inhibition of FGF-FGFR pathway has potential in treatment.


Eligibility criteria: Inclusion Criteria:

* diagnosed as thyroid eye disease
* suggested to accept orbital decompression

Exclusion Criteria:

* age below 20 or above 80
* pregnancy

Primary outcomes:
measure: Serum concentration of selected growth factors
timeFrame: 1 year
Secondary outcomes:
measure: RNA expression level of selected growth factor receptors
timeFrame: 1 year
measure: RNA expression level of selected growth factor receptors
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Taipei, Taiwan
Study officials:
References:
citation: Shih SR, Liao SL, Shih CW, Wei YH, Lu TX, Chou CH, Yen EY, Chang YC, Lin CC, Chi YC, Yang WS, Tsai FC. Fibroblast Growth Factor Receptor Inhibitors Reduce Adipogenesis of Orbital Fibroblasts and Enhance Myofibroblastic Differentiation in Graves' Orbitopathy. Ocul Immunol Inflamm. 2021 Jan 2;29(1):193-202. doi: 10.1080/09273948.2019.1672196. Epub 2019 Oct 28.