louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04292886: Thin Endometrium Undergoing Frozen-thawed Embryo Transfer
Official title: Hormone Replacement Versus Tamoxifen Combined Of Hormone Replacement in Women With a Thin Endometrium Undergoing Frozen-thawed Embryo Transfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thin Endometrium
Keywords: thin endometrium
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The endometrium is essential for embryo implantation. The clinical pregnancy rate and live birth rate of patients with thin endometrium are significantly lower than those of normal endometrium. Previous studies have shown that tamoxifen has advantages for improving endometrial thickness. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy between hormone replacement and Tamoxifen combined Of hormone replacement.This is a prospective, randomized placebo-controlled, double-blind clinical trial that includes 120 patients younger than 38 years old with a thin endometrium preparing for frozen embryo transfer. Participants will be randomly assigned (1: 1) into two parallel groups: estrogen replacement and tamoxifen combined with estrogen replacement.Frozen embryo resuscitation transfer cycle for thin endometrium patients。This is the first randomized controlled trial to comparing estrogen and estrogen combined with tamoxifen for endometrial improvement，The results of this study will provide evidence for the efficacy of the strategy of frozen embryo transfer cycle for thin endometrium patients.


Eligibility criteria: Inclusion Criteria:

1) Younger than 38 years old, basal serum level of follicle stimulating hormone \<10 IU / L; (2) Endometrium is less than 8mm in at least 2 cycles: superovulation cycle / natural cycle / estrogen replacement therapy / ovarian stimulation cycle; (3) at least 1 high quality frozen embryo; (4) There are no comorbidities that clearly affect pregnancy, such as adenomyosis, endometriosis, and intrauterine adhesions;

Exclusion Criteria:

1. abnormal karyotype;
2. Accompanying other diseases of the uterus: uterine muscular wall myomas that affect the uterine cavity shape, more severe adenomyosis, severe endometriosis, congenital uterine malformations, endometrial tuberculosis, etc .;
3. Contraindications to hormone replacement therapy;
4. Participating in other clinical research;
5. History of previous fundus diseases;

Primary outcomes:
measure: Endometrial thickness
timeFrame: within the 15 days (plus or minus 5 days) after oral drugs
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
name: Haixiang Sun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05978986: Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence
Official title: Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Varicose Veins of Lower Limb
Telangiectasia
Lead sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 1530
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Purpose: To evaluate the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases using the Ivenus application (within C0-C2 according to CEAP).

Materials and methods: Patients who applied to several phlebology clinics for an initial consultation are consistently included in a multicenter prospective study. At the appointment, a doctor with at least 5 years of experience takes photographs of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP, without showing the results to the surgeon (blinding). Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register.

The object of the study is a photograph of a certain area of the lower limb.


Eligibility criteria: Inclusion Criteria:

* C0-C2 CEAP clinical class;
* Signed consent to take part in investigation.

Exclusion Criteria:

* C3-C6 CEAP clinical class;
* Skin diseases of the lower extremities;
* Immobilization.

Primary outcomes:
measure: Determination of the sensitivity and specificity
timeFrame: 1 day
Secondary outcomes:
measure: Number of participants with complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Azbuka zdoroviya ltd.
city: Ekaterinburg
country: Russian Federation
facility: Vasculab ltd.
city: Perm
country: Russian Federation
facility: Phlebolog ltd.
Study officials:
affiliation: VenoClinica, "Vasculab" ltd.
name: Denis Borsuk
role: STUDY_CHAIR
References:
Clinical trial NCT01317186: The Role of FGF23 and Asymmetric Dimethylarginine (ADMA) in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Diseases
Chronic Kidney Disease
Keywords: FGF 23
ADMA
chronic kidney disease
Ca-P metabolism disorder
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2011-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage 2-4 Non-diabetic Chronic Kidney Disease patients

Brief summary: In chronic kidney disease calcium (Ca) and phosphate (P) metabolism disorders are very common and also they are one of the leading causes of morbidity in these population. FGF23 is a novel factor that contributes Ca-P disorders. It has been hypothesized that FGF 23 increase is mediated by asymmetric dimethylarginine (ADMA). The aim of the study is to evaluate this hypothesis.


Eligibility criteria: Inclusion Criteria:

* between ages of 18 - 65 years old
* chronic kidney disease of stage 2-4

Exclusion Criteria:

* presence of diabetes mellitus or ischemic hearth disease
* taking vitamin d therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Education and Research Hospital
Study officials:
References:
Clinical trial NCT02626663: The Role of Microparticles as a Biomarker
Official title: The Role of Microparticles as a Biomarker in Distinguishing Between Thrombotic Thrombocytopenic Purpura (TTP) and Atypical Hemolytic Uremic Syndrome (aHUS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atypical Hemolytic Uremic Syndrome
Thrombotic Thrombocytopenic Purpura
Microparticles
Microangiopathic Hemolytic Anemia
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with Microangiopathic Hemolytic Anemias (MAHA), TTP, and/or aHUS are eligible.

Brief summary: The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.


Eligibility criteria: Inclusion Criteria:

* Patients with MAHA, TTP, and/or aHUS

Exclusion Criteria:

* Prisoners

Primary outcomes:
measure: Microparticle/Nanoparticle number (an absolute number)
timeFrame: an average of 3 months
measure: Microparticle/Nanoparticle size (in nanometers or micrometers)
timeFrame: an average of 3 months
measure: Microparticle/Nanoparticle identity (identity of cell type from which they are derived)
timeFrame: an average of 3 months
Secondary outcomes:
measure: Morbidities
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Amy Schmidt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755663: Comparison of Efficacy of Ivabradine Versus Metoprolol
Official title: Comparison of Efficacy and Safety of Ivabradine Versus Metoprolol for Controlling Heart Rate Prior to 640-Slice Computed Tomographic Angiography in Elective Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: CT coronary
Coronary arterial disease
ivabradine
metoprolol
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
Collaborators: name: Phramongkutklao College of Medicine and Hospital
First posted: 2012-12-24
Enrollment: 60
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: DIAGNOSTIC

Brief summary: Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.


Eligibility criteria: Inclusion Criteria:

* elective patient on scheduled for 640 slices CT coronary at Phramonkutklao hospital
* Resting heart rate \> 70 BPM
* age \> 18 years and informed consent

Exclusion Criteria:

* Heart rate \> 100 BPM
* BP \<100/60 mmHg
* recent congestive heart failure in 1 mo.
* SA node, AV node disease and AF
* on permanent pacemaker
* CrCL \< 15ml/min. , AST or ALT \> 3x UNL
* on HR reducing drug such as diltiazem, verapamil, digitalis
* contraindication for ivabradine or metoprolol

Primary outcomes:
measure: Heart rate of patient before CT coronary
timeFrame: 1 January 2013 to 31 december 2013
Secondary outcomes:
measure: safety and side effect of Metoprolol and Ivabradine
timeFrame: 1 january 2013 to 31 december 2013
Other outcomes:
measure: Image quality
timeFrame: 1 january 2013 to 31 december 2013
Locations:
city: Bangkok
country: Thailand
facility: Phramonkutklao Hospital
Study officials:
affiliation: Phramongkutklao College of Medicine and Hospital
name: Purich - Surunchupakorn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333163: GLP-1: Acute Effects on Kidney Function in Healthy Men
Official title: GLP-1: Acute Effects on Kidney Function in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Functional
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2011-04-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect on kidney hemodynamics.


Eligibility criteria: Inclusion Criteria:

* Healthy young men

Exclusion Criteria:

* Any chronic diseases

Primary outcomes:
measure: Glomerular Filtration Rate
timeFrame: Every 20 minutes for 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Klinisk Institut, Afd. MEA, Aarhus Sygehus, NBG
Study officials:
affiliation: University of Aarhus
name: Jeppe Skov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skov J, Dejgaard A, Frokiaer J, Holst JJ, Jonassen T, Rittig S, Christiansen JS. Glucagon-like peptide-1 (GLP-1): effect on kidney hemodynamics and renin-angiotensin-aldosterone system in healthy men. J Clin Endocrinol Metab. 2013 Apr;98(4):E664-71. doi: 10.1210/jc.2012-3855. Epub 2013 Mar 5.
Clinical trial NCT05663463: Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
Official title: Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Organ Transplant
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.


Eligibility criteria: Inclusion Criteria:

* \>=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) \> 1 year prior to enrollment
* At least 1-year post-transplant
* Able and willing to provide informed consent
* Able and willing to undergo all study activities throughout the duration of the study

Exclusion Criteria:

* Confirmed pregnancy
* Receipt of ATG or carfilzomib within the past 3 months
* Receipt of rituximab within the past 3 months
* Receipt of basiliximab within the past 3 months
* Prednisone dose \>= 20 mg/day at the time of enrollment
* History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)

Primary outcomes:
measure: Neutralizing antibody levels- Immunogenicity
timeFrame: Baseline
measure: Neutralizing antibody levels- Immunogenicity
timeFrame: 4-6 weeks after dose 1
measure: Neutralizing antibody levels- Immunogenicity
timeFrame: 3 months after 2nd dose
Secondary outcomes:
measure: clinical outcome- pneumonia
timeFrame: 2 years
measure: clinical outcome- hospitalization rates
timeFrame: 2 years
measure: clinical outcome- ICU admissions
timeFrame: 2 years
measure: clinical - death rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lauren Fontana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02665663: Tongue Strength in Amyotrophic Lateral Sclerosis (ALS)
Official title: Measure of the Strength of the Tongue in Patients With Amyotrophic Lateral Sclerosis and Relation With Swallowing Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis that occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants.

Swallowing disorders occur during evolution and involve the prognosis of patients in the short term by the association of dysphagia with severe malnutrition, and aspiration. The issue of phoniatric monitoring is to detect early onset of the swallowing disorders to develop strategies for respiratory protection, food adapted to disturbances, and speech therapy.

The objective of this study is to compare the tongue force in patients with amyotrophic lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the measurement of the strength and duration of the pression of the tongue on the palate.


Eligibility criteria: Inclusion Criteria:

* Adults and legally responsible/ valid medical insurance
* patients : ALS diagnostic already announced
* healthy subjects : EAT-10 score\<2

Exclusion Criteria:

* Non pregnant and non baby feeding
* Presence of risk factor or suspicion of Creutzfeld Jacob Disease
* Allergy/intolerance to the glueing paste
* Antecedent of pathology of the aerodigestive tract
* Other neurologic disease
* Morphologic anomaly of the aerodigestive tract
* Excessive gag reflex

Primary outcomes:
measure: Maximum tongue strength
timeFrame: 30 minutes
measure: Tongue contact duration
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service ORL Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT04419363: Burosumab in Children and Adolescents With X-linked Hypophosphatemia
Official title: 12-months of Treatment With Burosumab in Children and Adolescents With X-linked Hypophosphatemia: a Prospective Longitudinal Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rare Diseases
X-linked Hypophosphatemia
Keywords: X-linked hypophosphataemia
fibroblast growth factor 23
burosumab
hyperparathyroidism
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 57
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this prospective longitudinal cohort study we studied the efficacy and safety of burosumab in real-clinical practice for \<13- and \>13-years old children affected with X-linked hypophosphatemia.

57 children with XLH were switched from conventional treatment to burosumab. After 12 months we assessed the efficacy and safety of treatment with burosumab on the whole cohort and separately on the cohort of \>13-years old adolescents.


Eligibility criteria: Inclusion Criteria:

* insufficient response or refractory to conventional therapy;
* complications of conventional therapy: hypercalciuria and/or nephrocalcinosis, and/or persistent secondary hyperparathyroidism;
* need for rapid restoration of phosphate metabolism, e.g., late diagnosis (aged \>8 years) and/or preparation for planned orthopaedic surgery.

Primary outcomes:
measure: Radiological changes in rachitic lesions evaluated with knee MRI
timeFrame: 12 months
Secondary outcomes:
measure: serum phosphate
timeFrame: 12 months
measure: renal phosphate reabsorption
timeFrame: 12 months
measure: alkaline phosphatase
timeFrame: 12 months
measure: 1,25(OH)vitaminD
timeFrame: 12 months
measure: parathyroid hormone
timeFrame: 12 months
measure: height
timeFrame: 12 months
measure: functional capacity
timeFrame: 12 months
measure: incidence of dental abcesses
timeFrame: 12 months
measure: incidence of hearing problems
timeFrame: 12 months
measure: incidence of neurological problems (craniosynostosis, Chiari I malformation)
timeFrame: 12 months
measure: incidence of nephrocalcinosis
timeFrame: 12 months
measure: incidence of hyperparathyroidism
timeFrame: 12 months
measure: incidence of any side effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hospital Bicetre
Study officials:
References:
Clinical trial NCT00477763: Oasys vs. Extreme H20 Xtra 59
Official title: Oasys vs. Extreme H20 Xtra 59
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.


Eligibility criteria: Inclusion Criteria:

* Male or Female at least 19 years of age
* Contact Lens Wearers
* Patients with mild to moderate symptoms of dry eye

Exclusion Criteria:

* male or female younger than 19 years of age

Primary outcomes:
measure: comparing performance of contact lens
timeFrame: 10 months
Secondary outcomes:
measure: Dry eye
timeFrame: 10 months
Other outcomes:
Locations:
city: Hazleton
country: United States
facility: Hazleton Eye Specialists
state: Pennsylvania
Study officials:
affiliation: Hazleton Eye Specialists
name: Thomas Kislan, OD
role: PRINCIPAL_INVESTIGATOR
References: