louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00854243: Role of Greyscale and Power Doppler Sonography in Therapy Monitoring in Early Rheumatoid Arthritis (RA)
Official title: Therapy Monitoring in Early Rheumatoid Arthritis: The Role of Greyscale and Power Doppler Sonography A Prospective Study Of 20 Egyptian Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult onset Rheumatoia Arthritis patients with a disease duration of less than 3 months

Brief summary: The purpose of this study is to evaluate the role of musculoskeletal ultrasound and power Doppler in early therapy monitoring of rheumatoid arthritis patients.


Eligibility criteria: Inclusion Criteria:

* Adults: age at disease onset \>18 years and \< 50 years
* Disease duration \< 3 month
* Fulfilling ARA criteria for classification of RA
* DMARD naive

Exclusion Criteria:

* Age at diagnosis \< 18 years
* Disease duration \> 3 month
* Previous use of DMARDS
* Previous use of biologics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00184743: Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Official title: Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.


Eligibility criteria: Inclusion Criteria:

* Subjects who completed GHLiquid-1518.
* If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded.
* Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.

Exclusion Criteria:

* Subject with a history of acromegaly.
* Subject with diabetes mellitus.
* Subject suffering from malignancy.
* Several medical conditions

Primary outcomes:
measure: Percent change in truncal fat (kg)
timeFrame: from the baseline to the end of treatment
Secondary outcomes:
measure: Adverse events
measure: Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment
measure: Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
measure: FPG, insulin, and HbA1C
measure: IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio
measure: Clinical laboratory tests
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Chihara K, Kato Y, Shimatsu A, Tanaka T, Kohno H. Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency. Growth Horm IGF Res. 2008 Oct;18(5):394-403. doi: 10.1016/j.ghir.2008.02.002. Epub 2008 Apr 18.
Clinical trial NCT06056843: Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists
Official title: Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Carcinoma in Situ
Keywords: Breast cancer
Screening
Low- and middle-income countries
Clinical breast examination
Portable ultrasound device
Triage
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Malabar Cancer Care Society Kannur, India
name: Bhabha Atomic Research Centre (BARC), India
First posted: 2023-09-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm study in which women with a positive clinical breast examination will be triaged using a portable ultrasound device by non-radiologists. The gold standard is mammography, ultrasound and histology if needed.
Primary purpose: SCREENING

Brief summary: Cross sectional study to evaluate estimate accuracy of portable ultrasound device in correctly differentiating the benign breast lesions from the malignant ones in the women referred with a positive Clinical breast examination (CBE) screening test.

Detailed description: More than two million new cases of breast cancer occur each year worldwide. Implementing mammography screening is complex and resource-intensive, making it impractical in resource-limited settings. Clinical breast examination (CBE) has been recommended as an alternative screening option for low- and middle-income countries. Several studies have shown a significant shift towards earlier stage tumours detected by CBE. However, the high false-positive rate and low positive predictive value of CBE expose women to unnecessary and costly further diagnostic procedures, as well as the negative psychological consequences. There is an urgent need for a more accurate, cost-effective and reliable triage technology that can be performed by any healthcare provider.

Eligibility criteria: Inclusion Criteria:

* Clinical breast examination positive women with no debilitating illness.
* Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers.

Exclusion Criteria:

* Women with confirmed diagnosis of breast cancer or those already treated for the disease.

Primary outcomes:
measure: Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Agreement between portable ultrasound device and mammography/ultrasound
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kannur
country: India
facility: Malabar Cancer Care Society Kannur
Study officials:
References:
Clinical trial NCT04214743: Ocular Microvascular Changes in Patients With Sepsis
Official title: Ocular Microvascular Changes in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Retinal Microcirculation Disorder
Conjunctiva; Disorder
Keywords: Conjunctival microcirculation
retinal vessels
fundus imaging
IDF imaging
sepsis
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Research Council of Lithuania
First posted: 2020-01-02
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with sepsis or septic shock within the first 24 hours after ICU admission

Brief summary: This study evaluates differences in the ocular microcirculation between septic patients and healthy subjects and the course of ocular microvasculature in survivors and non-survivors over a 24 hours period of time in septic patients

Detailed description: Conjunctival imaging, using IDF video microscope, and retinal imaging, using portable digital fundus camera, as well as systemic hemodynamic measurements, were performed in septic patients at three time points: at baseline, 6 hours and 24 hours. Baseline conjunctival and retinal microcirculatory parameters were compared with healthy controls.

Eligibility criteria: Inclusion Criteria:

* adult patients with sepsis or septic shock within the first 24 hours after ICU admission

Exclusion Criteria:

* psychiatric disorders, brain diseases, chronic alcoholism, autoimmune rheumatic diseases
* ophthalmological diseases, such as glaucoma, age-related macular degeneration, diabetic retinopathy and cataract

Primary outcomes:
measure: Microvascular flow index in conjunctival small vessels
timeFrame: 24 hours
Secondary outcomes:
measure: Central retinal arteriolar equivalent of retinal vessels
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian university of health sciences
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Andrius o Pranskunas
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simkiene J, Pranskuniene Z, Vitkauskiene A, Pilvinis V, Boerma EC, Pranskunas A. Ocular microvascular changes in patients with sepsis: a prospective observational study. Ann Intensive Care. 2020 Apr 7;10(1):38. doi: 10.1186/s13613-020-00655-x.
Clinical trial NCT02929043: Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity
Official title: Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentine Hypersensitivity
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2016-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dentine hypersensitivity (DH) is characterized by a short, sharp pain arising from exposed dentin.

Brief summary: Up to date, devices capable of delivering controlled, calibrated, non-contact cold air stimuli in a MR environment are unavailable for quantitative sensory testing. This project therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold air stimulation device that produces air puffs in a broad flow and cold temperature range. By means of this device, detailed psychophysically testing and subsequent brain scanning of dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH mechanisms.


Eligibility criteria: Inclusion Criteria:

* Age and between 18 - 60

Exclusion Criteria:

* Caries
* Defective restorations
* Full crowns
* Orthodontic bands
* Bleeding on probing and periodontal pockets deeper than 3 mm
* Subjects with gross periodontal disease or treatment of periodontal disease in the past 12 months.

Primary outcomes:
measure: Subjective ratings using the BORG scale
timeFrame: May 1, 2016
measure: blood oxygenation level dependent (BOLD) response
timeFrame: October 1, 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Center of Dental Medicine
Study officials:
affiliation: University of Zurich
name: Dominik Ettlin, MD,DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00794443: ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
Official title: A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoporosis
Bone Loss, Age-Related
Keywords: ONO-5920
YM529
Bone mineral density
Minodronic acid
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2008-11-20
Enrollment: 692
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.


Eligibility criteria: Inclusion Criteria:

* Patients whose bone mineral density is \<70% of Young Adult Mean (YAM), or \<80% of YAM who have fragile fracture history
* Patients can walk on his/her own
* Written informed consent has been obtained from the patient.

Exclusion Criteria:

* Sequential osteoporosis patients or patients with other disorders showing low bone mass
* Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
* Patients who are unable to keep raising or standing for ≥30 min
* Patients with peptic ulcer
* Patients who have experienced anamnesis or gastrectomy (total extraction)

Primary outcomes:
measure: Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
timeFrame: At the final evaluation point
Secondary outcomes:
measure: Time-course changes in the percent change of bone metabolism markers
timeFrame: Through the treatment period
measure: Time-course changes in the total femoral bone mineral density by the DXA method
timeFrame: Through the treatment period
measure: Assessment of adverse events, lab test values
timeFrame: Through the treatment period
measure: Frequency of fracture
timeFrame: At the final evaluation point
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Toshiomi Minamide
role: STUDY_DIRECTOR
affiliation: Clinical Development Administration Dept., Astellas Pharma Inc.
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04247243: Rapid POC GAS Diagnostics in the Paediatric ED
Official title: Streamlining Care Delivery in the Paediatric Emergency Department Using Rapid Point-of-care Diagnostics for Group a Streptococcus: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Streptococcal Pharyngitis
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 392
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Randomized trial evaluating effectiveness of rapid point-of-care molecular GAS diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to McMaster Children's Hospital Emergency Department.


Eligibility criteria: Inclusion Criteria:

* all those presenting who have a throat swab ordered for GAS testing

Exclusion Criteria:

* those who took antibiotics effective against GAS within 72 h of ED presentation

Primary outcomes:
measure: Appropriate antibiotic treatment
timeFrame: 3-5 days post-enrolment
Secondary outcomes:
measure: Time to resolution of symptoms
timeFrame: 3-5 and 7-10 days post-enrolment
measure: Caregiver satisfaction with testing
timeFrame: 3-5 days post-enrolment
measure: Number of days of missed school/daycare
timeFrame: 3-5 and 7-10 days post-enrolment
measure: Number of days of missed work (caregiver)
timeFrame: 3-5 and 7-10 days post-enrolment
measure: Number of healthcare visits for pharyngitis or sinopulmonary infections
timeFrame: 7 days post-enrolment
measure: ED MD satisfaction with testing
timeFrame: At enrolment
measure: Number of household contacts subsequently diagnosed with GAS pharyngitis
timeFrame: 7-10 days post-enrolment
measure: Proportion of point-of-care GAS tests that are uninterpretable
timeFrame: at enrolment
measure: Time required to utilize point-of-care testing
timeFrame: at enrolment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
References:
citation: Pernica JM, Smaill F, Kam AJ, Bartholomew A, Doan Q, Smieja M, Khan S, Sung M, Thabane L, Goldfarb DM. Single-centre, open-label, randomised, trial to compare rapid molecular point-of-care streptococcal testing to standard laboratory-based testing for the management of streptococcal pharyngitis in children: study protocol. BMJ Open. 2021 Aug 11;11(8):e047271. doi: 10.1136/bmjopen-2020-047271.
Clinical trial NCT01150643: Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab
Official title: Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-25
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E4402 from whom samples were submitted for research

Brief summary: RATIONALE: Studying the effects of rituximab in blood and tumor tissue samples from patients with cancer in the laboratory may help doctors learn more about the effects of rituximab on cancer cells. It may also help doctors identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with follicular lymphoma treated with rituximab.

Detailed description: OBJECTIVES:

* Correlate immunoglobulin Fc receptor (FcγR) polymorphisms with response, response duration, and time to resistance in samples from patients with follicular lymphoma (FL) treated with single-agent rituximab on ECOG-E4402.
* Identify gene expression profiles that correlate with response, response duration, and time to rituximab resistance in these patients.
* Determine whether the FL microenvironment is predictive of initial response and duration of response to rituximab.

OUTLINE: DNA and RNA from banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples are analyzed for immunoglobulin-receptor polymorphism, gene expression profile, and follicular lymphoma microenvironment by real-time PCR, microarray hybridization, and IHC.

PROJECTED ACCRUAL: A total of 259 PBMC samples and 300 FFPE blocks will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with follicular lymphoma
* Treated on ECOG-E4402 comprising 1 of 2 different rituximab-dose strategies
* Banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Brad S. Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05042843: Effect of Deproteinization on the Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets
Official title: Effect of 5,25% Sodium Hypochlorite Enamel Deproteinization on the Initial Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets Bonded With a Self-etching Primer: An In Vitro Study on Human Bicuspids.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontic Appliance Complication
Keywords: glue penetration
orthodontic brackets
self-etching bracket
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient with orthodontic treatment involving bicupids extractions

Brief summary: The aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a Raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.


Eligibility criteria: Inclusion criteria:

- All patient with orthodontic treatment involving bicupids extractions

Exclusion criteria:

- Patients with damaged teeth

Primary outcomes:
measure: Number of resistance to tearing of orthodontic brackets stuck to extracted premolars
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Stéphane BARTHELEMI, PhD
role: STUDY_DIRECTOR
References: