louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06939205: Body Surface Area Prediction Impacts on Ventricular Dilatation Prevalence
Official title: The Impact of Different Body Surface Area Prediction Equations on Ventricular Dilatation Prevalence in Youth Soccer Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathies
Keywords: 3-D optical imaging
Body surface area
soccer
transthoracic echocardiography
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Soccer players of both genders

Brief summary: The goals of this observational study are to investigate the accuracy of different predictive equations for body surface area (BSA) estimation and to evaluate the impact of different BSA normalizations on ventricular dilatation prevalence in youth soccer players. Two convenience samples of young soccer players of both genders will be recruited. Acquisition of optical images (for the players of the first sample), two-dimensional echocardiographic assessment (for the players of the second sample), and weight and height measurements (for the players of both samples) will be performed. BSA estimates will be derived from optical images (for the players of the first sample) and from ten different predictive equations obtained from the literature (for the players of both samples). Comparisons between optical imaging - derived BSA and BSA estimates obtained with the ten predictive equations will be performed for the players of the first sample. Absolute and relative values of different echocardiographic variables will be considered for the players of the second sample to assess the ventricular dilatation prevalence.


Eligibility criteria: Inclusion Criteria:

* healthy subjects
* regular sports participation

Exclusion Criteria:

- athletic heart syndrome

Primary outcomes:
measure: Body surface area (BSA)
timeFrame: Baseline (preseason investigation)
measure: Left ventricular dilatation prevalence
timeFrame: Baseline (preseason investigation)
measure: Right ventricular dilatation prevalence
timeFrame: Baseline (preseason investigation)
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: University of Turin
Study officials:
affiliation: University of Turin, Italy
name: Marco Alessandro Minetto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733005: Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)
Official title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 324
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* A subject must be 12 years of age or older, of either sex, and of any race.
* A subject must have at least a 2-year history of SAR which exacerbates during the study season.
* A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
* A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
* A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
* A subject who is participating in any other clinical study.
* A subject who is part of the staff personnel directly involved with this study.
* A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
* A female subject who is breast-feeding, pregnant, or intends to become pregnant.
* A subject previously randomized into this study.
* A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

Primary outcomes:
measure: The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.
timeFrame: 15 days of treatment
Secondary outcomes:
measure: The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
timeFrame: 15 days of treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01003405: Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder
Official title: A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Overactive bladder
Frequency
Micturition
Urgency
Urge urinary incontinence
OAB
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Patients who have successfully completed the Phase III double-blind study.

Exclusion Criteria:

* Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.

Primary outcomes:
measure: The long-term safety of KUC-7483 for the treatment of overactive bladder.
timeFrame: 52 weeks
Secondary outcomes:
measure: The long-term efficacy of KUC-7483 for the treatment of overactive bladder.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu
country: Japan
facility: Japan
Study officials:
affiliation: Clinical Development Department, Kissei pharmaceutical Co., Ltd.
name: Yasuhiro Omori
role: STUDY_DIRECTOR
References:
Clinical trial NCT05193305: Study of Healthy Cohort for Early Detection of Cancer
Official title: Study of Healthy Cohort for Early Detection of Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-01-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective participants who are to undergo upper or lower gastrointestinal endoscopies as part of their normal medical care and deemed necessary by their physicians

Brief summary: Cancer produces a significant burden on society with a majority diagnosed at late stages when the chance of cure is low. Early diagnosis improves patient outcomes. Data consisting of lifestyle factors, medications, physical activity, years before conventional cancer diagnosis is also worthwhile for to determine early detection. This is only achievable with longitudinal tracking of a large number of healthy individuals and identifying those who do develop cancer over time.

Detailed description: To conduct a longitudinal cohort study of patients who do not have a malignancy at the time of enrollment and are followed over a 20 year period to see if patients develop a malignancy and associate clinical and lifestyle factors as well as collection of blood. All adults 18 years of age and older undergoing upper or lower endoscopy for routine medical care will be eligible for this study.

Eligibility criteria: Inclusion Criteria:

* All adults 18 years of age of older undergoing upper or lower endoscopy for routine medical care.

Exclusion Criteria:

* Persons with current malignancy
* Persons with history of malignancy and treatment within last 5 years of enrollment, excluding non-melanoma skin cancer or cervical in-situ.
* Persons who are unable or unwilling to provide repeat blood samples and complete follow-up questionnaires
* Persons who lack the capacity to provide consent
* Persons who do not speak English
* Persons who are visually or hearing impaired.

Primary outcomes:
measure: Development of malignancy
timeFrame: Up to 20 years
Secondary outcomes:
measure: Development of biomarkers
timeFrame: Up to 20 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elham Afghani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06068205: COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Official title: COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type I diabetes mellitus with (case group) and without (control group) microvascular complications. The two groups will be balanced for age (50-70 years), age of disease (\>10 years), glycaemic control and BMI value.

Brief summary: The aim of the study is to analyse the biomechanical stiffness of red blood cells extracted from subjects with type I diabetes with and without microvascular complications through a biophysical characterization of red blood cells using microscopy, spectroscopy and scattering measurements. 48 subjects with type 1 diabetes, 24 with and 24 without microvascular complications will be enrolled. From all subjects a single blood sample will be taken to perform the analysis of red blood cells morpho-mechanical properties.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least 10 years
* Stable metabolic control (HbA1c \<7.5%) for at least 6 months
* BMI between 18.5 and 30 Kg/m\^2
* Systolic blood pressure \< 140 mmHg and diastolic blood pressure \<90 mmHg

Exclusion Criteria:

* Blood pressure higher than 140/90 mmHg
* Unstable metabolic control (HbA1c \>7.5%)
* BMI \> 30 Kg/m\^2 or \< 18.5 Kg/m\^2
* Liver failure
* Concomitant acute infections
* Uncontrolled thyroid diseases
* Pregnancy

Primary outcomes:
measure: In 48 subjects with type 1 diabetes with and without microvascular complications, the average stiffness of red blood cells, measured using atomic force microscope and quantified using Young's modulus, will be measured.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03452605: The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes
Official title: Effect of Acute Cocoa Flavanol Intake on the BOLD Response and Cognitive Function in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral blood flow and better cognitive function. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.


Eligibility criteria: Inclusion Criteria:

* non-smoking T1D patients or matched healthy controls
* having diabetes for more than 1 year
* males and females older than 18 years
* stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)
* adequate visual and auditory acuity to allow neuropsychological testing.

Exclusion Criteria:

* participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
* history in the past 2 years of epileptic seizures or any major psychiatric disorder
* history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,
* significant history of alcoholism or drug abuse
* unstable cardiac, renal, lung, liver, or other severe chronic disease
* hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pres-sure ≥100 mmHg) or hypotension (systolic blood pressure \<100 mmHg)
* pacemaker or other medical metal devices that precludes performing MRI,
* chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatic
* macrovascular complications
* retinopathy, nephropathy or neuropathy (microvascular complications)

Primary outcomes:
measure: cognitive function
timeFrame: 5 min
measure: BOLD fmri response
timeFrame: 5 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02969005: Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure
Official title: Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure in Resection Small Femur Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Diseases
Keywords: radiopaque localizer grid
methylene blue
reduce radiation exposure
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Localization of small femur lesions for resection can be challenging and may be associated with the need for significant fluoroscopic imaging and tissue dissection.

Detailed description: This study was performed to evaluate the use of a radiopaque localizer grid along with methylene blue staining for resection of small femur lesions in children, and to determine this technique's effectiveness at reducing radiation exposure and tissue injury.

Eligibility criteria: Inclusion Criteria:

* patients with lesions \<20.0 mm

Exclusion Criteria:

* patients with lesions \>20.0 mm

Primary outcomes:
measure: The times of C-arm fluoroscopy used
timeFrame: intraoperative
Secondary outcomes:
measure: incision length
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00280605: ALF-ONE : ALFuzosin ONcE Daily
Official title: Study of the Outcome of Patients With Lower Urinary Symptoms Suggestive of Benign Prostatic Hyperplasia and Treated With Alfuzosin 10 mg Once Daily for 3 Months in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-01-23
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

Exclusion Criteria:

* Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months
* Patients previously not improved by an alpha 1-blocker treatment
* Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Combination with other alpha 1-blockers
* Hepatic insufficiency
* Unstable angina pectoris
* Severe concomitant condition threatening life

Primary outcomes:
measure: Spontaneous adverse events
measure: Blood pressure and heart rate measured in sitting position
measure: International Prostate Symptom Score (IPSS) and quality of life index
measure: DAN-PSS sexual function score
measure: PSA levels measured at baseline
measure: Maximum flow rate and residual urine
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Benedict Blayney, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03564405: Pilot Clinical Trial to Evaluate the UNI-DEB for Unresectable Hepatocellular Carcinoma
Official title: A Open, Single-arm, Uncontrolled, Single Center, Pilot Study to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma


Eligibility criteria: Inclusion Criteria:

* Over 19 years
* Diagnosis of HCC
* Unresectable asymtomatic uninodular or multinodular tumor.
* Subject who maintain clinically normal hepatopetal flow without main portal vein closure
* At least one measurable target lesion by CT or MRI which 10 mm or more.
* ECOG Performance Status of 0 or 1.
* Child-Pugh class A or B
* Life expectancy of at least 6 months.

Exclusion Criteria:

* Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
* Hepatic resection, liver transplantation or Percutaneous local treatment
* Previously received HCC related medical procedure
* Previously treated with anthracyclines
* Only measurable disease is within an area of the liver previously subjected to radiotherapy.
* Child Pugh C
* Active gastrointestinal bleeding within 6 months from screening.
* Total bilirubin \> 3mg/dL
* WBC \< 3,000cells/mm3
* ANC \< 1,500cells/mm3
* Platelet \< 50,000mm3
* Serum creatinine \> 2mg/dL
* INR \> 1.4
* ALT and AST \> 5 times UNL
* Diffuse HCC defined as \>50% tumor involvement of the whole liver.

Primary outcomes:
measure: Objective Response Rate
timeFrame: 4 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic University Seoul St. Mary Hospital
Study officials:
References:
Clinical trial NCT01606605: Treatment Resistance Related With Gene Expression Profile of Diffuse Large B-cell Lymphoma
Official title: Retrospective Analysis of Diffuse Large B-cell Lymphoma: Identification of Factors Associated With Treatment Resistance Via Gene Expression Profile
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Lymphoma
Prognosis
Relapse
Gene
microRNA
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 350
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diffuse large B-cell lymphoma

Brief summary: The investigators perform a retrospective microarray gene expression profiling study of FFPE from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is correlated with clinical outcomes of diffuse large B-cell lymphoma.

Detailed description: 1. Whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay

   * Diffuse large B-cell lymphoma patients
   * Paraffin-embedded tissue
   * End points: Progression-free survival, overall survival
   * Statistics: Leave one-out method
2. Nano string assay for microRNA

   * Diffuse large B-cell lymphoma patients
   * Paraffin-embedded tissue
   * End points: Progression-free survival, overall survival
   * Statistics: Leave one-out method

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with diffuse large B-cell lymphoma
* Patients with tissue blocks available for study
* Patients with adequate medical records

Exclusion Criteria:

* Patients diagnosed with other subtypes of lymphoma

Primary outcomes:
measure: Number of patients who relapse or progress after 1st line chemotherapy
timeFrame: two years
Secondary outcomes:
measure: Number and type of genes and microRNA which are significantly related with relapse or progression (P < 0.05)
timeFrame: two years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Cancer Research Institute
Study officials:
affiliation: Samsung Medical Center Cancer Research Institute
name: Won Seog Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: