louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05698940: Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy
Official title: Subjective and Objective Outcome of Septoplasty With or Without Infundibulotomy/Uncinectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasal Blockage
Nasal Obstruction
Septum; Deviation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Septoplasty is one of the most common procedures in rhinology. In many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. Often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. If a significantly better outcome can be shown, one would have a first evidence for the extended procedure.


Eligibility criteria: Inclusion Criteria:

Unilateral breathing impairment due to septal deviation

Primary outcomes:
measure: Single sided VAS Scores for breathing impairment
timeFrame: 3 months
Secondary outcomes:
measure: SNOT Score
timeFrame: 3 months
measure: NOSE Score
timeFrame: 3 months
measure: PNIF
timeFrame: 3 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
References:
Clinical trial NCT05882240: Performance of PLR as Predicting Preload Responsiveness
Official title: Evaluation of the Correct Performance and Knowledge About the Passive Leg Raise Test to Detect a Volume Reagibility in Critical Care Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Volume
Keywords: passive leg raise
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 292
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Critical care physicians

Brief summary: We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients.

Detailed description: The points of concern for PLR include the following: the indication and contraindication of PLR; the choice of initial position: starting from a semi-recumbent position or supine position for PLR; how to interpret and apply the changes of CO, blood pressure, and central venous pressure (CVP) to identify fluid response during PLR; and how to identify spontaneous variation and sympathetic stimulation during PLR.

Eligibility criteria: Inclusion Criteria:

* All Critical care physicians of different medical disciplines

Exclusion Criteria:

* not completely responses

Primary outcomes:
measure: We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients
timeFrame: through study completion, an average of Measurement in 5 Minutes
Secondary outcomes:
measure: Profession
timeFrame: < 10 Minutes
measure: Measurement of cardiac output
timeFrame: < 10 Minutes
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Centre
name: Marc Kriege
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06965140: CP376 OCT Exploratory Skin Study
Official title: An Explorative Study Investigating Differences on the Peristomal Skin Condition by Optical Coherence Tomography (OCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2025-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.

The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period .The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.

Detailed description: An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT)

12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled. Subjects will use their standard of care ostomy device as intended and remove the device at the test visit.

The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period when the OCT scan and other skin measurements has been completed. The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.

The OCT scans and other skin measurements (TEWL, Hydration and Erythema measurements) will be performed on the skin when the ostomy device has been removed.

Eligibility criteria: Inclusion Criteria:

1. Has given written informed consent
2. Is at least 18 years old
3. Has full legal capacity
4. Has an ileostomy
5. Is using a flat 1-piece open ostomy device
6. Have had the ileostomy for a year

Exclusion Criteria:

1. Is currently receiving or have within the past two months received radio-and/or chemotherapy
2. Is currently receiving or have within the past month received steroid treatment in the skin area used in the investigation, e.g. lotion, spray, injection or tablet
3. Is pregnant or breastfeeding

Primary outcomes:
measure: Thickness of the epidermal layer (assessed by OCT)
timeFrame: immediately after the OCT scan
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of dermatology and venerology
Study officials:
References:
Clinical trial NCT04170140: Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update
Official title: A Cross-sectional Survey to Evaluate Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Virus Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare professionals who are current or past prescribers of Dengvaxia

Brief summary: The primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages provided in the material.

The secondary objective of the study is to evaluate if healthcare professionals know Dengvaxia product information, namely, age indication and contraindications.

Detailed description: The study is a cross-sectional Survey. Study data are collected through a questionnaire.

Eligibility criteria: Inclusion criteria:

- Healthcare professionals who are current or past prescribers of Dengvaxia

Exclusion criteria:

* Healthcare professionals who have never prescribed Dengvaxia
* Healthcare professionals who may have a conflict of interest with the survey (i.e. Healthcare professionals employed by regulatory bodies, pharmaceutical industries)
* Healthcare professionales who have participated in testing the questionnaire for comprehensibility, consistency and the appropriateness of medical terms

The above information is not intended to contain all considerations relevant to participation in the survey.

Primary outcomes:
measure: Healthcare professionals' knowledge and understanding of key safety messages provided in risk minimization measures materials
timeFrame: Day 0
Secondary outcomes:
measure: Healthcare professionals' knowledge of Dengvaxia product information
timeFrame: Day 0
Other outcomes:
Locations:
city: La Defense
country: France
facility: Real World Evidence Solutions IQVIA
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Almas MF, Toussi M, Valero E, Moureau A, Marcelon L. A cross-sectional survey to evaluate prescribers' knowledge and understanding of safety messages following Dengvaxia(R) product information update. Pharmacoepidemiol Drug Saf. 2022 Jul;31(7):758-768. doi: 10.1002/pds.5447. Epub 2022 May 13.
Clinical trial NCT06766240: the Role of MRI in Evaluation of Low Back Pain
Official title: the Role of MRI in Evaluation of Low Back Pain in Middle Aged Females
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: middle aged females complaining of low back pain in Sohag.

Brief summary: This study aims to evaluate the role of MRI to diagnose different causes of low back pain among middle aged females at Sohag university hospital.


Eligibility criteria: Inclusion Criteria:

- middle aged female patients aged from 40 to 60 years with complaints of low back pain who were referred to the department of radiology of sohag university hospital for Lumbosacral spine MRI.

Exclusion Criteria:

* Male patients.
* female patients aged less than 40 years or more than 60 years.
* Contraindication to magnetic resonance imaging including cochlear implant, pacemaker, claustrophobia.
* Non-cooperative sick patients.

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI) for diagnosis of low back pain in middle aged females
timeFrame: 6 months postmenopausal
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Bailey A. Risk factors for low back pain in women: still more questions to be answered. Menopause. 2009 Jan-Feb;16(1):3-4. doi: 10.1097/gme.0b013e31818e10a7. No abstract available.
citation: Chou R, Fu R, Carrino JA, Deyo RA. Imaging strategies for low-back pain: systematic review and meta-analysis. Lancet. 2009 Feb 7;373(9662):463-72. doi: 10.1016/S0140-6736(09)60172-0.
citation: Cousins JP, Haughton VM. Magnetic resonance imaging of the spine. J Am Acad Orthop Surg. 2009 Jan;17(1):22-30. doi: 10.5435/00124635-200901000-00004.
Clinical trial NCT01637740: Pseudoexfoliation Syndrome in Myopes
Official title: Pseudoexfoliation Syndrome in Myopes Defined With Optical Low Coherence Reflectometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudoexfoliation Syndrome in Cataract Myopic Eyes
Keywords: myopia
pseudoexfoliation syndrome
optical low coherence reflectometry
ocular optical components
cataract
Lead sponsor: General Hospital Sveti Duh
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 5753
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5753 eyes of cataract surgery patients ≥ 40 years old

Brief summary: A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic. Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group without pseudoexfoliation syndrome.

Detailed description: A retrospective study of 5753 eyes of cataract surgery patients was conducted at investigators Clinic in a period of 2.5 years. Pseudoexfoliation syndrome was found in 255 eyes. There were only 26 cataract myopic eyes with pseudoexfoliation syndrome. Refractive eye state was defined by preoperatively calculated emmetropization intraocular lens (IOL) value done by optical low coherence reflectometry biometer LENSTAR LS 900®. Ocular optical components of the cataract myopic eyes with pseudoexfoliation syndrome measured by this biometer were put in comparison with matched cataract myopic eyes group without pseudoexfoliation syndrome that have emmetropization IOL value within the same range as the cataract myopic eyes with pseudoexfoliation syndrome.

Eligibility criteria: Inclusion Criteria:

* cataract surgery patients ≥ 40 years old

Exclusion Criteria:

* cataract surgery patients \< 40 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05098340: Circulating circRNA in Acute Ischemic Stroke
Official title: Clinical Significance of Circulating circRNA in Acute Ischemic Stroke (CRAST)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: circRNA
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be 100 patients suspected of AIS (such as transient ischemic attack), 300 AIS patients and 100 Healthy controls，whose data will be applied for construction and validation of diagnostic and predictive models of circRNA from the circulating blood.

Brief summary: CRAST is to analyze the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.

Detailed description: Circular RNAs have been highlighted to be involved in the pathological process of ischemic stroke (IS). The purpose of this protocol will investigate the expression pattern of circular RNA (circRNA) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. The candidate circRNA will be verified as biomarkers for the detection and prognosis of acute ischemic stroke. Distinctive expression patterns of circRNA will be identified by individual quantitative real time polymerase chain reaction (qRT-PCR). A diagnostic or predictive model will be established using logistic regression. The panel of these altered circRNAs may be associated with acute IS and could serve as a novel diagnostic or predictive method.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Confirmed acute ischemic stroke by a diffusion-weighted imaging-position lesion on magnetic resonance imaging (MRI) and a new lesion on a brain computed tomography (CT) scan
* Within 72 hours of symptom onset
* Good performance status
* Signed an approved informed consents

Exclusion Criteria:

* a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases

Primary outcomes:
measure: Differential expression pattern of circRNA
timeFrame: 90 days
Secondary outcomes:
measure: Dynamic changes of circRNA during the follow-up period
timeFrame: 90 days
measure: Correlation of circRNA and stroke-associated infection
timeFrame: 30 days
measure: Correlation of circRNA and inflammatory factors in acute ischemic stroke
timeFrame: 7 days
measure: Prognostic value of circRNA in acute ischemic stroke
timeFrame: 90 days
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Neurology
state: Jiangsu
Study officials:
References:
Clinical trial NCT05700240: Effect of Orthokeratology on Myopia Progression in French Children
Official title: Effect of Orthokeratology on Myopia Progression in French Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia Progression
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 64
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 64 consecutive myopic children who underwent OK treatment or single-vision spectacle correction at a private ophthalmology clinic in Nancy from November 2019 to December 2020

Brief summary: To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French myopic children.


Eligibility criteria: Inclusion Criteria:

* 7 to 17 years old
* Myopia between 0,50 D and 7.00 D
* Astigmatism ≤ 4.00 D with-the-rule 180+-20
* Anisometropia ≤ 1.50 D
* Myopia evolution ≥ 0.25 D over 6 months
* Best-corrected visual acuity (BCVA) ≥ 20/20 (Snellen equivalent)
* Follow-up period \> 6 months

Exclusion Criteria:

* Prior history of any other myopia control treatment (except for single vision distance spectacles)
* Contraindication for contact lens wear or orthokeratology
* Preexisting ocular (amblyopia, strabismus, ocular inflammation, trauma, or surgery) or systemic disease
* Poor compliance to lens wear, examination or follow-up

Primary outcomes:
measure: Changes in axial length at one year
timeFrame: one year
Secondary outcomes:
measure: changes in refractive error
timeFrame: one year
measure: changes in choroidal thickness
timeFrame: one year
Other outcomes:
Locations:
city: Nancy
country: France
facility: Jean-Baptiste CONART
Study officials:
References:
Clinical trial NCT01546740: Prevalence of Glaucoma in the Israeli Arab Population
Official title: Glaucoma Prevalence in the Israeli Arab Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Glaucoma, Compliance, Prevalence
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-03-07
Enrollment: 15000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinics from 1 Arab city in the center of Israel

Brief summary: there is a variety of glaucoma prevalence within different populations. this study examine the prevalence of glaucoma in the Arab population in Israel' as well as the demographic variables and the compliance to treatment in the population.

Detailed description: from Medical records of primary care clinic in the city of Tira. the patients are recruited, all glaucoma patients are above age of 20 years. they must suffer from CDR \>= 0.5 with/without asymmetry with the other eye. or they suffer from glaucomatous damage to the visual fields.

Eligibility criteria: Inclusion Criteria:

* Cup-to-disk ratio (CDR) \> 0.5 with asymmetry between the eyes
* Intraocular pressure (IOP) \> 23 mm Hg
* Damage to the field of vision
* Age- above 20 Yrs. old

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: Joseph Pikkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547040: Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
Official title: Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplant
Atherosclerosis
Arterial Stiffness
Keywords: calcification
bone lesions
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2007-10-19
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: incident renal transplant recipients

Brief summary: The purpose of this study is to determine the:

* Natural history of calcification posttransplantation
* Natural history of BMC following renal transplantation
* Reverse correlation between calcification score and aortic calcifications following renal transplantation
* Correlation of IMT, BMC, PWV and biochemical variables
* Correlation of IMT, BMC, PWV, biochemical variables and outcome
* Predictors of CV disease after transplantation
* Predictors of IMT progression, BMC loss and PWV progression after renal transplantation


Eligibility criteria: Inclusion Criteria:

* Incident renal transplant patients or combined renal/pancreas transplant patients

Primary outcomes:
measure: cardiovascular outcome
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
Study officials:
affiliation: UZ Leuven
name: kathleen Claes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.
citation: Claes KJ, Heye S, Bammens B, Kuypers DR, Meijers B, Naesens M, Vanrenterghem Y, Evenepoel P. Aortic calcifications and arterial stiffness as predictors of cardiovascular events in incident renal transplant recipients. Transpl Int. 2013 Oct;26(10):973-81. doi: 10.1111/tri.12151. Epub 2013 Jul 19.
Clinical trial NCT06322667: A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab
Official title: A Multicenter, Postmarketing Observational Study to Evaluate Safety Regarding Amyloid-Related Imaging Abnormalities and Their Management in Patients With Early Alzheimer's Disease and Treated With Lecanemab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease
Keywords: Early Alzheimer's Disease
Lecanemab
ARIA
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 5000
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: Participants prescribed lecanemab by a physician in routine clinical practice.

Brief summary: The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.


Eligibility criteria: Inclusion Criteria:

* All participants who are treated with lecanemab in routine clinical practice

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H)
timeFrame: Up to 156 weeks
measure: Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA
timeFrame: Up to 156 weeks
Secondary outcomes:
measure: Number of Participants With Infusion Related Reaction
timeFrame: Up to 156 weeks
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Eisai trial site 2
city: Kyoto
country: Japan
facility: Eisai trial site 3
city: Tokyo
country: Japan
facility: Eisai trial site 1
Study officials:
References: