louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06174155: Comparative Study Between Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
Official title: Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand-burned Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE: The study aims to compare study between Botulinum toxin-A injection and shock waves therapy on hypertrophic scars in hand-burned children.

BACKGROUND: Burn injuries can cause significant physical and psychological distress, especially when they result in hypertrophic scarring. In children, who are particularly vulnerable to these injuries, it is important to accurately assess the severity of these scars and their impact on functionality.

HYPOTHESES: There is no significant difference between the combined effect of the traditional physical therapy program with botulinum toxin-A injection and the traditional physical therapy program with shock waves therapy on improving wrist extension, ulnar deviation, radial deviation, hand grip strength, and severity of the scar on hypertrophic scars in hand-burned children.


Eligibility criteria: Inclusion Criteria:

* Age will range from 6-18 years
* Diagnosed with hypertrophic scars resulting from hand burns.
* Has burn injuries caused by flame, scald or chemical agents.
* With a total body surface area (TBSA) varied from 10 to 30%
* A resistant partial or complete loss of wrist flexion attributable to wrist flexor contracture
* After wound and skin graft healing (\~ 90 days post-surgery),

Exclusion criteria:

* Children with underlying medical conditions that could interfere with scar healing or treatment outcomes
* Skin flap surgery, malignancies, cardiac arrhythmias, pacemaker implantation, coagulopathies, fractures about the treatment area, articular adhesions, and psychiatric co-morbidities

Primary outcomes:
measure: Electronic goniometer
timeFrame: 3 months
measure: Hand grip Dynamometer
timeFrame: 3 months
measure: Vancouver scar scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Reham Alsakhawi
Study officials:
affiliation: Assistant Professor
name: Reham Alsakhawi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02317055: Magnetic Resonance Imaging Evaluation of the Tissular Oxygen Saturation in Brain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Tumor
Stroke
Keywords: MRI
Oxygenation
nirs
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Université Joseph Fourier
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre National de la Recherche Scientifique, France
First posted: 2014-12-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic resonance imaging on subjects and to correlate the results with near infrared spectroscopy measurements.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers or Patients with cerebral lesion

Exclusion Criteria:

* claustrophobia
* MRI exclusion criteria

Primary outcomes:
measure: MRI measurements of local oxygen saturation in the brain
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
References:
Clinical trial NCT02327455: Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography
Official title: Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-12-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The specific aim of this clinical trial is to translate the investigators new 4DE (three sptial dimensions pluse time) stress echocardiographic method to patients with coronary artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the reproducibility of the technique in this clinical setting.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, referred for clinically indicated dobutamine rest/stress TTE
* Provide written informed consent to participate in the study
* Availability for repease rest/stress TTE within on eweek of clinically indicated study

Exclusion Criteria:

* Unable to give informed consent
* Unstable hemodynamics that would not allow for repease rest/stress dobutamine transthoracic imaging
* Recurrent life threatening arrhythmias
* Heart rate \>110 BPM
* Inadequate windows for transthoracic imagine
* Patients that have a narrow-angle glaucoma (contraindication for atropine)
* Change in cardiac medications or management including, coronary revascularization beween intial and repeat TTE study.

Primary outcomes:
measure: Number of Subjects With an Interpretable 4DE Image
timeFrame: After Stress Echocardiography (Approximately 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Albert Sinusas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03719755: Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid
Official title: Comparison of Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 152
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Our study will compare the rates of postoperative urinary tract infections (UTI) between patients who undergo cystoscopy using 50% dextrose injection plus bladder washout versus normal saline after hysterectomy for benign indications. Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

Detailed description: This will be a prospective cohort study of the rate of UTIs after cystoscopic distention media of normal saline with maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.

A pre-operative urine culture will be obtained via mid-stream clean catch prior to administration of routine pre-operative prophylactic antibiotics.

At 6-9 days post-operatively, a repeat urine culture will be obtained via mid-stream clean catch. Appropriate treatment will be administered if the urine culture is positive.Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

Eligibility criteria: Inclusion Criteria:

* Preoperative scheduling CPT codes for hysterectomy

Exclusion Criteria:

* Discharged home with indwelling foley catheter
* Indwelling foley catheter \> 24 hours
* Ureteral injury
* Chronic immunosuppression
* History of diabetes
* Recurrent UTIs (≥2 infections in six months or ≥3 infections in one year)
* Reported Chronic Kidney Disease
* Renal anomalies

Primary outcomes:
measure: rates of urinary tract infections at 6-9 days post-operative
timeFrame: 6-9 days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Johnny Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02387814: A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
Official title: A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated.

This study will last approximately 3 weeks for each participant, including check-in and follow-up.


Eligibility criteria: Inclusion Criteria:

* Female participants must be of non-child-bearing potential
* Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

Exclusion Criteria:

* No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
* Have known allergies to abemaciclib, related compounds, or any components of the formulation
* No human immunodeficiency virus (HIV) infection or antibodies

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites
timeFrame: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites
timeFrame: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research
state: Colorado
city: Miami
country: United States
facility: Clinical Pharmacology of Miami (CPMI)
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center (OCRC)
state: Florida
city: Indianapolis
country: United States
facility: Indiana University - Digestive and Liver Diseases
state: Indiana
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02859714: Detection of Colorectal Adenomas in Côte-d'Or
Official title: Detection of Colorectal Adenomas in Côte-d'Or: Impact of Organized Screening on Socio-geographic Disparities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Adenoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 11600
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008.

Brief summary: Previous studies have shown geographic disparities in the detection of colorectal adenomas in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological deprivation index (EDI). On the other hand, the extremely low detection rates for these lesions in everyday practice before the implementation of organized screening for colorectal cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce socio-geographic inequalities in access to care and prevention. Yet, participation in screening also varies depending on the socio-economic level. In this context, the Côte-d'Or Polyps Registry, the only body to have data for the pre-screening period (before 2003), will make it possible to determine whether the implementation of organized screening led to the elimination of socio-geographic disparities concerning the detection of adenomas.


Eligibility criteria: Inclusion Criteria:

* The study population will include all patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008

Exclusion Criteria:

* Absence of address
* history (or suspected history) of previously resected adenoma
* personal history of colorectal cancer or colorectal cancer discovered in the year following resection of the adenoma (because the cancer was probably not seen at the initial colonoscopy)
* familial polyposis or known HNPCC
* chronic inflammatory bowel disease

Primary outcomes:
measure: Detection rates for colorectal adenomas
timeFrame: through the study completion up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03842150: Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
Official title: Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Atresia
Neonatal Cholestasis
Infantile Hepatitis Syndrome
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants with cholestasis inclduing biliary atresia

Brief summary: Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth

Exclusion Criteria:

Severe congenital malformation Subjects with missing data

Primary outcomes:
measure: Development and Validation a Screening Score for the biliary atresia in infantile cholestasis
timeFrame: 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT00172250: The Study of Relationship of Plasma Concentrations of Folic Acid, Vitamin B and Homocysteine With Carotid Atherosclerosis and Endothelium-Dependent Vasodilatation of Geriatric and Young Patients in the Ambulatory Care Department of NTUH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Homocysteine
Coronary Artery Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Elevation of plasma homocysteine has been recognized as one of the risk factors of atherosclerotic disease. The objectives of this study are: (1) to investigate the level of plasma homocysteine and the prevalence of hypehomocysteinemia (2) to find out the role of homocysteine in coronary artery disease and the proper cut-off point of plasma homocysteine to evaluate the presence of coronary artery disease; (3) to understand the control condition of tranditional risk factors of cardiovascular disease, especially hypertension, dyslipidemia, and diabetes mellitus.

The study subjects were recruited from the ambulatory setting of cardiology in National Taiwan University Hospital.


Eligibility criteria: Inclusion Criteria:

Patient \> 65 y/o or \< 50y/o Scr\<=1.5mg/dL

Exclusion Criteria:

* Scr\> 1.5mg/dl pregnancy alcohoism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Juey-Jen Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815550: Delirium Related to Proton Pump Inhibitors Use
Official title: Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proton Pump Inhibitor Adverse Reaction
Delirium
Hyponatremia
Keywords: Proton Pump Inhibitor
Delirium
Drug safety
Hyponatremia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 19081
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators describe the profile of patients who are reported in the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, as having experienced a delirium. In particular, the number of patients who use proton pomp inhibitors (PPIs), the number of patients who presented associated illnesses known to induce delirium, the number of patients who presented associated drug prescriptions known to induce delirium.

Brief summary: Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium.

Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.


Eligibility criteria: Inclusion Criteria:

* PPI use
* Delirium mentioned in the safety report

Primary outcomes:
measure: Delirium occuring when using PPI
timeFrame: 09/02/2022
Secondary outcomes:
measure: Association between PPI use and occurrence of delirium
timeFrame: 09/02/2022
measure: Association between PPI use and occurrence of delirium and hyponatremia
timeFrame: 09/02/2022
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT04237350: Video Screening for Visual Impairment of Infants
Official title: Video Screening for Visual Impairment of Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavioral Dynamics
Visual Impairment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 3652
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. Having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system.

Brief summary: An individual senses the world and reflects feedbacks via independent behaviors. Such precise collaboration of the sensory and behavioral systems is fundamental to survival and evolution. When a sensory modality is altered, the behavioral system has the potential to fit in a substitute modality. However, the specific dynamics of human behaviors in response to sensory loss remain largely unknown due to the paucities of representative situations and large-scale samples.

Here, the investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. Having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system and develop a domestic apparatus for screening visual impariment of infants.


Eligibility criteria: Inclusion Criteria:

* Younger than 4 years of age

Exclusion Criteria:

* Any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns

Primary outcomes:
measure: The AUC of model based on analyzing the behavioral dynamics
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
name: Yizhi Liu, Ph.D
role: STUDY_CHAIR
References: