louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01832077: Uptake of Telemedicine System Trial in Rual Canton
Official title: The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Retinopathy
Diabetes Macular Edema
Keywords: sensibility
specificity
positive predictive value
negative predictive value
Cost-effectiveness
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Orbis
name: The World Diabetes Foundation
First posted: 2013-04-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: age \> 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients

Brief summary: To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema.

Detailed description: Telemedicine system mainly contains a comprehensive eye examination electric-records (E-record), which can transfer the fundus pictures from rural hospitals to professional Graders (golden standard for a diagnose of Diabetes Retinopathy (DR) and Diabetes Macular Edema(DME)). In Zhongshan Ophthalmic Center (ZOC). By this system, the investigators can evaluate the capacity of rural eye doctors about the diagnosis of DR/DME, and give proper suggestions for the treatment and revisit plan.

Eligibility criteria: Inclusion Criteria:

* age \> 40y, diagnosed (Diabetes Retinopathy) DR,10% normal patients

Exclusion Criteria:

* unconsciousness, history of diabetic ketoacidosis, cardiac insufficiency, Severe atrioventricular block, hepatic insufficiency , allergic to mydriatic

Primary outcomes:
measure: Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading
timeFrame: 2 years after the telemedicine begin to use
measure: cost-effectiveness
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of comprehensive eye examination taken by rural doctors
timeFrame: 2 years
measure: comprehensive eye examination rate among patients in rural hospitals
timeFrame: 2 years
measure: the usage rate of Electric-Record
timeFrame: 2 years
measure: Cost-effectiveness of van
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, No.54, Xianlienan Road
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Nathan Congdong, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04224077: Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)
Official title: Optimisation of Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) : a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy Lumbar
MRI
Diffusion Tensor Imaging
Keywords: Radiculopathy Lumbar
MRI
Diffusion tensor imaging
Multiband technique
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 20
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: DIAGNOSTIC

Brief summary: Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging. The aim of this work is therefore to improve DTI sequences by specifically evaluating the contribution of the multiband technique in healthy volunteers.

Detailed description: For every healthy volunteer will be acquired:

* a morphological sequence
* a reference diffusion tensor sequence covering three lumbar stages (reference DTI),
* a diffusion tensor sequence acquired in multiband technique, covering three lumbar stages (optimized DTI),
* a diffusion tensor sequence acquired in a multiband technique, covering a lumbar stage, of higher spatial resolution (centred DTI)

Eligibility criteria: Inclusion Criteria:

* Person without history of lumbar surgery
* Person who has previously consented

Exclusion Criteria:

* MRI contraindications (pace maker, cardiac defibrillator,...)
* Claustrophobia
* Pregnant woman
* Person without social security
* Person with a guardianship
* Person carrying metallic surgical material (spine, pelvis, abdomen)

Primary outcomes:
measure: Image quality measured as signal-to-noise ratio and contrast-to-noise ratio
timeFrame: Day 0
Secondary outcomes:
measure: Fraction of anisotropy and apparent diffusion coefficient
timeFrame: Day 0
measure: Concordance of observed agreement measured by Cohen's kappa coefficient
timeFrame: Day 0
measure: Concordance of observed agreement measured by Intra-class correlation coefficient
timeFrame: Day 0
Other outcomes:
Locations:
city: Lomme
country: France
facility: Lille Catholic Hospitals
Study officials:
affiliation: GHICL
name: Jean-François BUDZIK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01964677: MR-HIFU for Bone Metastases
Official title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Bone Metastases
Keywords: Magnetic Resonance Imaging (MRI)
High Intensity Focused Ultrasound (HIFU)
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
First posted: 2013-10-17
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: TREATMENT

Brief summary: The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.

Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation.

The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases


Eligibility criteria: Inclusion Criteria:

* radiologic evidence of bone metastases from any solid tumour
* diagnosis of dominant painful bone metastasis
* target lesion less than 8cm

Exclusion Criteria:

* primary bone tumours rather than metastases
* Inability to tolerate stationary position during treatment
* pregnancy
* MRI incompatible metal implants

Primary outcomes:
measure: Pain response
timeFrame: 30 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: ICR
name: Nandita deSouza, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03291977: Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)
Official title: Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glioblastoma, Adult
Keywords: surgery - glioblastoma - fluorescein
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma cells through a metabolic abnormality and thus helps in defining tumoral edges through a modified microscope. A multicentric, randomized study comparing 5ala guided surgery with conventional procedures showed that this technique doubles the rate of complete removal on post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free survival. More recently, fluorescein appeared as an interesting alternative fluorophore for glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its use remains scarcely studied and its clinical benefit unsure. In that context, the investigators propose a randomized trial comparing conventional " white light " surgery with fluorescein-guided resection of glioblastomas, in order to assess the relevance of this technique in glioblastomas removal.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 79
* Karnofsky index \> 70 %
* Brain MRI showing a parenchymal lesion with typical features of glioblastoma, \< 1week
* Achievable gross total removal, as assessed by the neurosurgical staff
* Written consent

Exclusion Criteria:

* Contraindication to fluorescein
* Contraindication to MRI
* History of brain surgery \<6 months
* Guardianship, tutelage or deprivation of liberty
* Pregnancy or breastfeeding
* Participation to other interventional clinical studies

Primary outcomes:
measure: Gross total removal rates
timeFrame: under 72 hours post-op
Secondary outcomes:
measure: Absolute volumes of tumor remnants
timeFrame: under 72 hours post-op
measure: Relative volumes of tumor remnants
timeFrame: under 72 hours post-op
measure: Occurrence of new neurological deficits
timeFrame: under 72 hours post-op
measure: Occurrence of anaphylactic events related to the administration of fluorescein
timeFrame: under 72 hours post-op
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Pierre-Jean LE RESTE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06800677: Methylated Biomarkers Predictive of Endometrial Cancer Risk
Official title: Methylated Biomarkers Predictive of Endometrial Cancer Risk
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Cancer
Keywords: risk
prevention
prediction
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
First posted: 2025-01-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing an elective hysterectomy at St Mary's Hospital, Manchester, UK for either endometrial cancer or a benign indication

Brief summary: The goal of this observational study is to identify endometrial cancer risk predictive biomarkers and to optimise the methodology for their detection and quantification in non-invasive samples.


Eligibility criteria: Inclusion Criteria:

1. Women aged 45-70 years
2. Attending St Mary's Hospital, Manchester for an elective hysterectomy by any route for either the treatment of endometrial cancer or a benign gynaecological condition
3. Able to consent to participation in the study

Exclusion Criteria:

1. Presence of malignancy asides from endometrial cancer
2. Undergoing elective hysterectomy for suspected ovarian cancer

Primary outcomes:
measure: Sensitivity, specificity, negative and positive predictive value of single gene methylation classifiers in predicting the presence of endometrial cancer in minimally- and invasive samples
timeFrame: 1 day
Secondary outcomes:
measure: Sensitivity, specificity, positive and negative predictive value of a multi-gene methylation classifier for predicting the presence of endometrial cancer
timeFrame: 1 day
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References:
Clinical trial NCT05215977: Efficacy and Safety of MW031 in PMO Subjects
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 448
Sex: FEMALE
Minimum age (years): 55
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 is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .


Eligibility criteria: Inclusion Criteria:

* BMD -4.0\<T-score ≤-2.5 at either the lumbar spine or total hip or femoral neck
* All subjects must have at least one of following additional the risk factors:history of fracture, parental history of hip fracture, increased bone turnover rate at screening, low body weight, elderly (age≥65year)，current smoker
* Postmenopausal is defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea, or bilateral oophorectomy \>2 years after surgery. If bilateral oophorectomy status is unknown, use follicle-stimulating hormone (FSH) levels \> 40 mIU/mL to confirm surgical postmenopausal status.

Exclusion Criteria:

* Bone/metabolic disease
* Hyperparathyroidism or hypoparathyroidism
* Thyroid condition: Hyperthyroidism or hypothyroidism
* Rheumatoid arthritis
* Malignant tumors
* Malabsorption syndrome
* Oral bisphosphonates

Primary outcomes:
measure: Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
timeFrame: Baseline and Month 6
measure: Percent change in BMD at the total hip, femoral neck from Baseline up to 6 months and 12 months
timeFrame: Baseline, Month 6 and Month 12
measure: Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 12 months
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00988377: The Effect of Whey Protein on Short-Term Food Intake and Post-Meal Blood Glucose Response in Young Men
Official title: The Effect of Whey Protein on Short-term Food Intake and Post-meal Blood Glucose Response in Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Obesity Prevention
Keywords: whey protein
subjective appetite
shor-term food intake
blood glucose
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Mondelēz International, Inc.
First posted: 2009-10-02
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study was to describe relationships among whey protein when consumed before a meal on food intake and pre- and post-meal satiety, blood glucose in healthy young adults.

Detailed description: A randomized, cross-over design study was conducted. Whey protein preloads (10-40 g) were provided in 300 ml water. At 30 min following consumption, subjects were fed an ad libitum pizza meal. Satiety, and blood glucose were measured at baseline and selected intervals pre- (0, 15 and 30 min) and post-meal (50, 65, 80 and 95 min).

Eligibility criteria: Inclusion Criteria:

* healthy
* normal weight ( 18-24.9 kg/m²)
* young aged 20-27 year old

Exclusion Criteria:

* breakfast skippers
* smokers
* dieters
* individuals with diabetes (fasting BG ≥ 7.0 mmol/L) or other metabolic diseases

Primary outcomes:
measure: Blood glucose subjective appetite Food intake at 30 min
timeFrame: 0-95 min
Secondary outcomes:
measure: physical comfort palatability
timeFrame: 0-95 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akhavan T, Luhovyy BL, Brown PH, Cho CE, Anderson GH. Effect of premeal consumption of whey protein and its hydrolysate on food intake and postmeal glycemia and insulin responses in young adults. Am J Clin Nutr. 2010 Apr;91(4):966-75. doi: 10.3945/ajcn.2009.28406. Epub 2010 Feb 17.
Clinical trial NCT05228977: Prevalence of Cervical Extension of the Thymus in Children
Official title: Prevalence of Cervical Extension of the Thymus in Children- A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevalence of Cervical Extension of the Thymus
Keywords: Thymus; Cervical extension; Pediatrics;
Lead sponsor: Kabul University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the radiology department for the neck US with various clinical indications between August-October 2018 were included in the study.

Brief summary: This prospective, observational study included all pediatric patients who were referred to the radiology department for neck ultrasonography between August-October 2018. A high-frequency probe was implemented and 220 patients were examined.

Detailed description: This prospective single-centered study was approved by the Institutional Review Board for Ethical Issues in Clinical Research and is compatible with the Declaration of Helsinki. The patients referred to the radiology department for the neck US with various clinical indications between August-October 2018 were included in the study. The informed consent was taken from the parents of the patients. The patients who had any systemic illness, were treated for malignancy or had any history of lower neck or chest surgery, were excluded.

The neck US was performed by two radiologists. The length of the extended thymus, from the upper margin of the manubrium to the superior edge of the thymic tissue on the transverse plane, was measured in millimeters and recorded.

al analysis of the data was performed in SPSS, Version 24 program (IBM, Armonk, New York). Pearson Chi-Square Test was used in comparing categorical data between groups.

Eligibility criteria: Inclusion Criteria:

* The patients referred to the radiology department for the neck US with various clinical indications between August-October 2018 were included in the study.

Exclusion Criteria:

* The patients who had any systemic illness, were treated for malignancy, or had any history of lower neck or chest surgery, were excluded.

Primary outcomes:
measure: 0
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kabul
country: Afghanistan
facility: Habib Ahmad Esmat
state: None Selected
city: Kabul
country: Afghanistan
facility: KUMs
Study officials:
affiliation: KMUs
name: Mohammad wali Nasary, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01247077: Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
Official title: Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis
Potential Effect of Selenium
Keywords: selenium
neuropsychological testing
autoantibodies
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this

Detailed description: In the County of Södermanland we include 44 patients with Graves´thyrotoxicosis. They are treated with methimazole and thyroxin, and randomised to selenium or placebo. Neuropsychological investigation is performed, before medical treatment is commenced and repeated after 9 month. Serum concentration of thyroid hormon levels, autoantibodies and selenium are followed.

Eligibility criteria: Inclusion Criteria:

* New diagnose of autoimmune thyrotoxicosis
* biochemically proven with increased thyroxin
* low TSH and elevated TRAb/or positive scintigraphy.
* Age 18 - 55. Willing to participate -

Exclusion Criteria:

* No previous head trauma,
* No difficulties with swedish language,
* No medication which could affective neuropsychological testing,
* No planned or ongoing pregnancies.
* Normal intellectual capacity.
* No severe ophthalmopathy, or other severe disease

Primary outcomes:
measure: Effect on neuropsychological well-being
timeFrame: Inclusion going on until the end of 2011
Secondary outcomes:
measure: Potential effect on autoantibodies
timeFrame: Inclusion for the rest of 2011
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Jan Calissendorff, Medical clinic, Eskilstuna, Sweden
state: Södermanland
city: Eskilstuna
country: Sweden
facility: Emil Mikulski
Study officials:
affiliation: Karolinska Institutet
name: Jan Calissendorff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: