louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01985152: A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers
Official title: A Placebo-Controlled, Phase I, Single-center Evaluation of the Single-dose Pharmacokinetics Study of Azilsartan Trimethylethanolamine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Health
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan Trimethylethanolamine in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy males or females
* Aged from 18 years to 45 years
* Body mass index (BMI) 19 to 25kg/m2

Exclusion Criteria:

* Has a known sensitivity to angiotensin II receptor blocker（ARB）
* With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor
* Has known or suspected history of alcoholism or drug abuse or misuse
* With a history of laboratory results that show the presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV)
* Pregnant,lactating，menstrual
* Vegetarian
* Postural hypotension
* Systolic blood pressure\<100mmHg，or\>130mmHg;and/or diastolic blood pressure\<70mmHg,or\>90mmHg

Primary outcomes:
measure: To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis
timeFrame: Pre-dose to 72 hours post-dosee
measure: Number of participants with adverse reactions
timeFrame: Pre-dose to 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
Study officials:
affiliation: TEDA International Cardiovascular Hospital
name: Jie Hou, Associate Chief Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06997952: Febuxostat Effect on Chronic Kidney Disease Progression And Carotid Intima-Media Thickness
Official title: Impact of Febuxostat on Disease Progression and Carotid Intima-Media Thickness in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carotid Intima- Media Thickness
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to evaluate the impact of febuxostat on both carotid intima-media thickness and disease progression in individuals with chronic kidney disease

Detailed description: For all participants, comprehensive data collection was performed, encompassing detailed medical histories including patients' clinical and demographic characteristics (age, gender, BMI, associated comorbidities as HTN, and DM, etiology of CKD.) Laboratory investigations were conducted at baseline and after a three-month follow-up period. These investigations included: serum uric acid., creatinine, blood urea nitrogen, calcium, phosphorus., albumin., magnesium, intact parathyroid hormone (iPTH), lipid profile (cholesterol, triglycerides, LDL, HDL), urine protein to creatinine ratio. Radiological investigations: Carotid artery duplex (medial wall thickness) was also conducted at baseline and after a three-month follow-up period. Thickening of the artery wall is a hallmark of atherosclerosis and vascular calcification.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* CKD stages III to IV
* Asymptomatic hyper uricemia
* Stable dose of all medications including ACEIs or ARBs for blood pressure control at least three months before enrolling

Exclusion Criteria:

* Comprised active infections.
* Acute kidney injury.
* Active and advanced malignancy.
* History of hypersensitivity to febuxostat.
* Women who are taking oral contraceptives, pregnant or lactating
* Patients with established cardiovascular disease.
* Patients with liver disease.
* Patients receiving mercaptopurine, theophylline and azathioprine.
* Patients on steroids or other immunosuppressive treatment.

Primary outcomes:
measure: slowing CKD progression
timeFrame: 3 month
Secondary outcomes:
measure: improvement of carotid intima-media thickness
timeFrame: 3 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04196452: A Retrospective Observational Study on the Long-term Effects of Ipilimumab-treated Pediatric Participants in the Dutch Melanoma Treatment Registry (DMTR)
Official title: Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled in the Dutch Melanoma Treatment Registry (DMTR)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 10
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes participants who are under 18 years old who are diagnosed with advanced (unresectable or metastatic) melanoma who have been treated with ipilimumab and enrolled in the DMTR

Brief summary: This is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the DMTR in the Netherlands


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trials, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Less than 18 years of age at first dose of monotherapy Ipilimumab used for treatment of advanced melanoma
* Histological or cytological confirmation of advanced (unresectable or metastatic) melanoma

Exclusion Criteria:

-Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently

Other inclusion/exclusion criteria apply

Primary outcomes:
measure: Frequency of Adverse Events (AEs) Grades 3-4
timeFrame: up to 10 years
Secondary outcomes:
measure: Baseline assessment of population demographics
timeFrame: up to 10 years
measure: Baseline assessment of comorbidities
timeFrame: up to 10 years
measure: Baseline assessment of disease characteristics
timeFrame: up to 10 years
measure: Baseline assessment of treatment history
timeFrame: up to 10 years
measure: Assessment of ipilimumab dose exposure
timeFrame: up to 10 years
measure: Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations
timeFrame: up to 10 years
measure: Assessment of Ipilimumab dose frequency
timeFrame: up to 10 years
measure: Assessment of ipilimumab treatment duration
timeFrame: up to 10 years
measure: Assessment of ipilimumab number of infusions
timeFrame: up to 10 years
measure: Overall Survival (OS)
timeFrame: up to 10 years
measure: Time to progression (TTP)
timeFrame: up to 10 years
measure: Assessment of physical growth and development
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02025452: Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis
Official title: Rapid Diagnostics and Probiotic Therapy for Paediatric Acute Gastroenteritis - a Randomized, Factorial, Controlled, Placebo-controlled, Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gastroenteritis
Keywords: diarrhoea
gastroenteritis
rapid diagnostics
probiotics
sub-Saharan Africa
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: BioGaia AB
First posted: 2014-01-01
Enrollment: 76
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. We will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. We will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.


Eligibility criteria: Inclusion Criteria:

* acute non-bloody gastroenteritis

Exclusion Criteria:

* diarrhoea \> 14 days
* sepsis, pneumonia, UTI, meningitis requiring empiric antibiotic therapy
* malignancy, IBD
* known link to another patient with diarrhoea of defined aetiology
* transferred in already on antimicrobials
* live outside study area
* children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm

Primary outcomes:
measure: Height z-score (HAZ) adjusted for initial HAZ
timeFrame: 60 days post-enrollment
Secondary outcomes:
measure: mortality
timeFrame: 60 days post-enrollment
measure: environmental enteropathy score
timeFrame: 60 days post-enrollment
measure: duration of diarrhoea
timeFrame: estimated average duration ~ 4 days.
measure: Weight z-score (WAZ) adjusted for initial WAZ
timeFrame: 60 days after enrolment
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
city: Molepolole
country: Botswana
facility: Scottish Livingstone Hospital
city: Ramotswa
country: Botswana
facility: Bamalete Lutheran Hospital
Study officials:
affiliation: McMaster University
name: Jeffrey Pernica, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263652: Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients
Official title: The Relationship Between Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain Relief
Keywords: Pain
intramuscular
oral
spine
preference
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2010-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients.

The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic and acute back pain

Exclusion Criteria:

* Recent Spine Surgery

Primary outcomes:
measure: pain scores on visual analog scale
timeFrame: visual analog scale will be mesuered before and one hour following every pain medication delivery
Secondary outcomes:
measure: Patient Questionnaire assessing pain and pain relief
timeFrame: Before administaration of pain control medication and one hour following analgesic administration
measure: patient preference Questionnaire
timeFrame: before first analgesic administration at the current hositalization
Other outcomes:
Locations:
Study officials:
affiliation: Western Galilee Hospital
name: Nimrod Rahamimov, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06470152: A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity
Official title: Pelvic Incidence-Dependent Clustering of Sagittal Spinal Alignment: A Novel Classification to Aid Surgical Planning for Adult Spinal Deformity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adult Spinal Deformity
Sagittal Deformity
Sagittal Alignment
Sagittal Imbalance
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score \[SAAS\], global alignment and proportion \[GAP\] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age at the time of treatment;
2. Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;
3. Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°.

Exclusion Criteria:

1. Any type of previous spinal surgery;
2. Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson\&#39;s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy;
3. Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;
4. Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.

Primary outcomes:
measure: Proximal Junctional Kyphosis
timeFrame: Two years after surgery
Secondary outcomes:
measure: Scoliosis Research Society-22
timeFrame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
measure: Oswestry disability index
timeFrame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
measure: Achievement of minimal clinically important difference
timeFrame: Two years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03272152: Comprehensive DNA Methylation Profiling in Crohn's Disease
Official title: Comprehensive DNA Methylation Profiling of Inflammatory and Non-Inflammatory Mucosa in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Methylation
Illumina Human Methylation 850k BeadChip
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active Crohn's disease who underwent colonoscopy at Jinling Hospital

Brief summary: Previous studies have indicated that abnormal DNA methylation frequently occurs in the mucosa in Crohn's disease. Comprehensive DNA methylation profiling of the inflamed and non-inflamed ileal mucosa of patients with Crohn's disease was performed. Genome-wide DNA methylation was determined using the Illumina HumanMethylation 850k BeadChip.


Eligibility criteria: Inclusion Criteria:

* Active Crohn's disease(CDAI score≥ 150)

Exclusion Criteria:

* No ileal lesions
* Under treatment of immunomodulators, biologic agents or steroids

Primary outcomes:
measure: Intestinal inflammation under colonoscopy
timeFrame: Jan 2017 to Sep 2017
Secondary outcomes:
measure: CDAI
timeFrame: Jan 2017 to Sep 2017
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT05917652: The Actuate-CBC Study
Official title: THE Actuate-CBC Study: Accelerating the Uptake of Telemedicine for Crisis Burn Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Telemedicine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 2183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physicians and other staff members treating burn patients

Brief summary: The study team will use implementation science to accelerate the uptake of teleconsultationfor burn patients by 1) examining the relationships between clinician perceptions of acceptability, feasibility, intention to use, and actual use of burn teleconsultation 2) identifying the optimal process for burn teleconsultation and the barriers and facilitators for its use during a crisis or prolonged care situation, and 3) designing and testing the effectiveness of a specific, tailored burn teleconsultation toolkit intervention to increase burn teleconsultation use.

Detailed description: The principal investigator's central hypothesis is that a tailored implementation intervention (toolkit) that integrates the known advantages of using telemedicine for burn consultation with new knowledge regarding clinician perceptions and the setting in which they work will improve the feasibility, acceptance, intention to use, and uptake of burn teleconsultation. The implementation intervention will enable rapid burn teleconsultation implementation under crisis circumstances and assist clinicians to virtually connect the person caring for a burn patient anywhere to the entire burn team's expertise. The study results will lead to more robust national crisis, wartime, and disaster response plans, improve quality of burn care, and decrease morbidity and mortality from serious burn injury, regardless of injury location.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older and
* are providing burn care to patients at the 4 burn centers and the non-burnhospitals are eligible for inclusion.

Exclusion Criteria:

* do not meet inclusion criteria,
* decline to participate or do not give consent to participate in the study, •
* directly express uneasiness about the participation

Primary outcomes:
measure: Examine the relationships between clinician perceptions of feasibility, acceptability, intention to use, and the actual use of acute burn teleconsultation.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Health Regional Burn Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital Sumner Redstone Burn Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Paul
country: United States
facility: Regions Hospital Burn Center
state: Minnesota
Study officials:
References:
Clinical trial NCT00682552: Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
Official title: Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Relationship between HPV infection and cervical cancer is well established. Among the HPV types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV has been proposed to optimize cervical cancer screening.

Detailed description: A prospective detection and quantification of HR-HPV in patients with proven CIN1 will be performed. Relationship between HR-HPV initial viral load and the CIN1 persistence will be evaluated.

Eligibility criteria: Inclusion Criteria:

* The women whose last one FCV of screening put in evidence a LIEBG of the neck of the womb having been confirmed by the colposcopie.
* The inclusive patients will be of more than 18 years old. All the patients will be profitable of a regime of Social Security.

Exclusion Criteria:

* The patients whose result of the colposcopie is clashing with that of the FCV of initial screening (normal collar, LIEHG or the other one).
* The patients having an antecedent of DREGS of the neck of the womb, that this one was or not handled
* The patients having had a hysterectomy.
* The patients incapable to receive the information enlightened on the progress and the objectives of the study
* The patients not having signed enlightened assent

Primary outcomes:
measure: The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18
timeFrame: 48 months
Secondary outcomes:
measure: The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)
timeFrame: 48 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Nord- Service de gynécologie-obstétrique
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Xavier CARCOPINO, MD
role: PRINCIPAL_INVESTIGATOR
References: