louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04746196: Galectin-3 Level in Ankylosing Spondylitis Patients
Official title: Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ankylosing spondylitis patients and healthy controls

Brief summary: Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients diagnosed with AS according to Modified New York criteria were included in the study. Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of AS patients were performed and compared with age and BMI matched control group.

Detailed description: Detailed histories of all participants were obtained, and systemic and rheumatologic examinations were performed. We excluded all participants who had a history of hyperlipidemia, liver, renal, hematological, familial thyroid, neoplastic, autoimmune infectious diseases and receiving anti-inflammatory drugs.

We measured serum galectin-3 levels using a commercial chemiluminescent microparticle immunoassay. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess disease activity in AS patients.

Eligibility criteria: Inclusion Criteria:

* Ankylosing spondylitis patients
* Healthy controls

Exclusion Criteria:

* Hyperlipidemia
* Liver diseases
* Renal diseases
* Hematological diseases
* Familial thyroid diseases
* Neoplastic diseases
* Autoimmune infectious diseases
* Receiving anti-inflammatory drugs.

Primary outcomes:
measure: Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02510196: Assessment of Skill Retention in Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Risk Reduction
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day - Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding of written English used in the questionnaires

Stage 1 - training The aims and requirements of the teaching program will be explained to the participants at the start of the workshop. All participants will be given a sticker with a number and a questionnaire numbered about current ultrasound practice which is numbered according to participant number to allow for blinding. Anyone not wishing to participate can either remove their sticker or not return the questionnaire at the end of the session. The number on the questionnaire correlated to participant number. This will be recorded against the participant name to allow for further follow up. All participants will rotate normally throughout the sessions. At the end of the neuraxial session participants will be scored by the session leader according to their ability to adequately carry out the procedure. Scores will be correlated to participant number.

Stage 2 - assessment of skill retention

Following the training day participants will randomly be allocated into two groups. One group will receive regular reminders to use ultrasound for all neuraxial anesthesias they perform in the OR or labor ward. They will be reminded on a regular basis that ultrasound is a new tool to assist them in performing neuraxial ultrasound. The other group with be allowed to continue with their regular practice and will not receive reminders to use ultrasound for neuraxial anesthesia insertion. Two months after the initial training day all participants with be observed performing neuraxial anesthesia and re-assesed according to the original scoring system. Each participant will be assessed 3 times over a 6 month period.


Eligibility criteria: Inclusion Criteria:

* Practicing anesthesiologists of all levels at Hadassah Ein Kerem hospital

Exclusion Criteria:

* Unwillingness to complete questionnaire, poor English comprehension

Primary outcomes:
measure: Ultrasound Performance on a model
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04834596: Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal Adenocarcinoma
Official title: Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Detection of Liver Metastases
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with colorectal cancer

Brief summary: Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer

Detailed description: The aim of this study is to evaluate the performance of a software for liver nodule detection in patients with colorectal cancer compared to the consensus of two radiologists analysis.

300 hepatic scanners will be analysed.

Eligibility criteria: Inclusion Criteria:

* Patients consecutively treated for colorectal cancer a
* Availability of imaging by injected abdominal scanner including at least one portal phase
* Age over 18

Exclusion Criteria:

* Patients with treatment of the hepatic nodule by ablation or previous hepatic surgery
* Imaging follow-up \<12 months
* Non-interpretable scanner (artefact, injection quality, etc.)
* Patients with more than 10 liver metastases

Primary outcomes:
measure: To evaluate the performance of the software for detection of hepatic nodules on CT scan of patients with colorectal cancer compared to a reference constituted by the evaluation established by two radiologists in consensus.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: UHAngers
Study officials:
References:
Clinical trial NCT01334996: Use of Tamoxifen in Systemic Mastocytosis
Official title: Treatment of Systemic Mastocytosis With Tamoxifen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Mastocytosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic mastocytosis having up to 20% bone marrow involvement or clinical symptoms not controlled on current medications.

Brief summary: In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic agent, to improve quality of life, biochemical parameters, and bone marrow involvement in systemic mastocytosis patients having 1) up to 40% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 40 mg/day and the duration of treatment will be for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine will be excluded until these medications have been stopped.

Detailed description: Not desired

Eligibility criteria: Inclusion Criteria:

* Systemic Mastocytosis

Exclusion Criteria:

* Current treatment with Imatinib mesylate, cladribine or interferon alpha.

Primary outcomes:
measure: Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype.
timeFrame: 1 year
Secondary outcomes:
measure: Stability or improvement in biochemical markers of systemic mastocytosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joseph H Butterfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05511896: Effects of a 60-min Repeated Trunk Flexion Protocol on Trunk Neuromuscular Properties.
Official title: Effects of Repeated Trunk Flexion on Trunk Neuromuscular Properties.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Exposure
Keywords: bending, load, stiffness, elastography, deformation
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: An interventional study on the effects of repeated trunk flexion exposure on trunk neuromuscular properties.

Detailed description: An interventional study will include 16 healthy young adults. All participants will complete a 60-min protocol of intermittent trunk flexion. Measurements of trunk neuromuscular properties will be performed prior to and following the 60-min protocol.

Eligibility criteria: Inclusion Criteria:

* Physically active at least 3 hours a week

Exclusion Criteria:

* Low back pain in the past 6 months
* History of chronic low back pain
* History of spinal or pelvic operation
* Hypermobility, more than 4 points on Beighton scale
* Cardiovascular or systemic diseases
* Pregnancy

Primary outcomes:
measure: Change in muscle stiffness
timeFrame: 90 minutes
Secondary outcomes:
measure: Change in range of motion
timeFrame: 90 minutes
measure: Change in length of the spine
timeFrame: 90 minutes
measure: Change in muscle activity
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
state: Primorska
Study officials:
affiliation: University of Primorska, Faculty of Health Sciences
name: Matej Voglar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03687996: Pratical Assessment of DSAEK in the Management of Endothelial Decompensation Following Penetrating Keratoplasty
Official title: Pratical Assessment of Descemet'Sstripping Automated Endothelial Keratoplasty (DSAEK) in the Management of Endothelial Decompensation Following Penetrating Keratoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Descemet's Stripping Automated Endothelial Keratoplasty
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who profited of the first Descemet's stripping endothelial keratoplasty to endothelial decompensation after penetrating keratoplasty

Brief summary: Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.

Detailed description: A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.

Eligibility criteria: Inclusion Criteria:

* with endothelial decompensation after penetrating keratoplasty
* surgery realised by the same surgeon

Exclusion Criteria:

* None

Primary outcomes:
measure: visual acuity
timeFrame: change from visual acuity at 6 month
Secondary outcomes:
measure: cornea thickness at 6 months
timeFrame: change from cornea thickness at 6 months
measure: cornea thickness at 10 years
timeFrame: change from cornea thickness at 10 years
measure: postoperative complications
timeFrame: month 6
measure: visual acuity at 10 years
timeFrame: change from visual acuity at 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05429996: Ultrastructural Collagen Markers in Ehlers Danlos Syndromes
Official title: Decrypting the Ultrastructural Collagen Markers Using Quantitative Nano Histology: A Quest for Newer Diagnostic Test in Hypermobile Ehlers-Danlos Syndrome
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ehlers-Danlos Syndrome
Classical Ehlers-Danlos Syndrome
Hypermobile EDS (hEDS)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with classical EDS and hypermobile EDS

Brief summary: Establishing the diagnosis of Ehlers Danlos Syndromes (EDS)/generalized hypermobility spectrum disorders (G-HSD) is often problematic for patients. The absence of a precise unifying diagnosis in patients results in a significant emotional burden on the patient and caregivers, not to mention the hidden costs, including multiple recurring visits to several medical specialists and associated social and economic costs. To date, while collagen ultra-scale morphological heterogeneity has been used to comment on an EDS diagnosis, the mechanical properties of the collagen remain mostly unexplored.

From a biophysical point of view, collagen affected with hEDS can be described as biomechanically deficient. In the case of EDS, the skin's abnormal elasticity can be directly related to the organization of the collagen network within the dermis. Quantitative Nanohistology (QNH) is a newer method to evaluate both the structural and mechanical properties of collagen in-situ histological sections.

Therefore, the aim of this study is to define histo-biophysical markers of two most common types of EDS i.e. classical EDS (cEDS) \& hypermobile EDS (hEDS) at the single collagen fibrils level and matrix and to further explore the origin of collagen fibril properties deficiency in hEDS and cEDS.


Eligibility criteria: Inclusion Criteria:

* Adults aged between 18 and 60 years who can provide informed consent in English
* Able to read, speak, and comprehend English without the assistance of a translator
* Have been diagnosed with hypermobile EDS as per the 2017 EDS criteria; or with genetically confirmed classical EDS (age and sex-matched). This diagnosis is carried out by the UHN GoodHope EDS clinic routinely for all patients on the basis of clinical exam and genetic testing, if indicated.

Exclusion Criteria:

* Subjects under the age of 18
* Unable to speak, read and comprehend English
* Unable to provide consent (cognitive impairment)
* Pregnant women

Primary outcomes:
measure: to analyze percentage prevalence of abnormal morphological markers of single collagen fibril using atomic force microscopy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: GoodHope EDS - Toronto General Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00670696: A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel
Official title: A Randomised, Controlled, Single-blinded, Cross Over Comparison Study to Compare the Efficacy of the Rapydan Medicated Plaster Versus Tetracaine Gel
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Healthy
Anesthesia
Keywords: Topical anesthesia
Rapydan
Topical anaesthesia for venous cannulation
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively.

Detailed description: Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively. This study has been withdrawn and no additional data is available.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects of any race, 18 yrs or older
* No clinically significant findings on physical exam
* Signed informed consent

Exclusion Criteria:

* Damaged, denuded or broken skin at the designated site for application of the medicated plaster or gel.
* Know allergies to lidocaine, tetracaine or other local anaesthetics
* Concomitant use of prescription strength analgesics

Primary outcomes:
measure: To demonstrate superiority for Rapydan medicated plaster applied 30 minutes over tetracaine gel applied for 45 minutes in terms of reducing pain associated with venous cannulation as assessed by the subject on a 100 mm visual analog scale (VAS)
timeFrame: VAS post venous cannulation
Secondary outcomes:
measure: To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gel
timeFrame: Up to 14 days post exposure
Other outcomes:
Locations:
city: Merthyr
country: United Kingdom
facility: Merthyr Tydfill Industrial Estate
state: Tydfill
Study officials:
affiliation: EUSA Pharma, Inc.
name: Rahul Dimber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066896: Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
Official title: Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: KERATOCONJUNCTIVITIS SICCA
XEROSTOMIA
SICCA SYNDROME
PRIMARY SJOGREN SYNDROME
Keywords: Sjogrens Syndrome
Syndrome, Sjogren's
Sjogren Syndrome
Sicca Syndrome
Syndrome, Sicca
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.

Detailed description: The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands.

The xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. The absent saliva can cause increase of dental caries and decays.

Until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. These drugs can cause unpleasant collateral effects.

Eligibility criteria: Inclusion Criteria:

* Patients with primary Sjogren Syndrome according criteria american european 2002.
* Salivary flux non stimulated \< 0,1 ml/min.

Exclusion Criteria:

* hepatitis B and/or C
* radiotherapy in the glandular area (previous)
* other connective diseases
* thyroidopathy non compensated
* GVHD graft-versus-host disease
* HIV
* Sarcoidosis

Primary outcomes:
measure: The Xerostomia Inventory
timeFrame: 6 weeks
Secondary outcomes:
measure: Salivary Biomarker Analysis. Beta 2 Microglobulin.
timeFrame: 6 weeks
measure: Salivary Flux Measurement
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Tania S A Fidelix
Study officials:
affiliation: Federal University of São Paulo
name: Virginia M Trevisani, PhD
role: STUDY_CHAIR
References:
citation: Fidelix T, Czapkowski A, Azjen S, Andriolo A, Neto PH, Trevisani V. Low-level laser therapy for xerostomia in primary Sjogren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.
Clinical trial NCT00917696: Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)
Official title: A Randomized, Double Blind, Placebo Controlled, Crossover Clinical Trial to Evaluate the Effects of ATP-Induced Pain (AIP) and ATP-induced Dermal Vasodilation (AIDV) by Iontophoresis in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis Pain
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as target engagement tools for future development of analgesics.


Eligibility criteria: Inclusion Criteria:

* Subject is in generally good health
* Subject is willing to abstain from smoking within 24 hours of each iontophoresis treatment and limit smoking to 5 or less cigarettes per week during the study

Exclusion Criteria:

* Subject has a history of dermatitis, psoriasis, or eczema
* Subject has active asthma and/or hay fever at the time of the screening visit
* Subject is unable to refrain from use of analgesics within 3 days prior to each treatment period

Primary outcomes:
measure: Degree of pain induced by ATP vs. saline iontophoresis
timeFrame: 4 minutes
measure: Increase in blood flow induced by ATP iontophoresis
timeFrame: 8 minutes
Secondary outcomes:
measure: Test-retest reproducibility and intra-subject variability of AIP and AIDV
timeFrame: 8 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: