louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06146296: THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE
Official title: THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Orthodontic Relapse
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate and compare the effect of locally injected and orally administered (systemic) Vitamin C on post-orthodontic treatment relapse


Eligibility criteria: Inclusion Criteria:

* Patients who were indicated for non-extraction orthodontic treatment.
* Adult patients with finished orthodontic treatment, using fixed appliance therapy.
* Patients with good oral hygiene, and a healthy periodontal condition.

Exclusion Criteria:

* Patients who received sectional fixed appliance therapy.
* Patients with hypodontia requiring tooth replacement in the retainer, as a temporary measure.
* Patients requiring fixed bonded retainers.
* Pregnant and lactating women.
* Patients with hereditary hemochromatosis.
* Cancer patients, receiving chemotherapy.
* Patients with chronic diseases such as diabetes, or those receiving drugs such as corticosteroids, both of which that may affect tooth movement.

Primary outcomes:
measure: Measurement of post-orthodontic relapse
timeFrame: up to 8 months
measure: Analysis of salivary alkaline phosphatase levels
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Samar M Adel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Farah Y Eid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03658096: Quantitative Assessment of Distal Radioulnar Joint Stability With Pressure-Monitor Ultrasonography
Official title: Quantitative Assessment of Distal Radioulnar Joint Stability With Pressure-Monitor Ultrasonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radioulnar Joint Sprain
Triangular Fibrocartilage Complex Injury
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients and healthy controls
Primary purpose: DIAGNOSTIC

Brief summary: To quantitatively assess distal radio ulnar joint (DRUJ) stability, a pressure-monitor ultrasound system was developed. The objective of this study was to evaluate the force-displacement relationship of DRUJ in patients and normal subjects. Each subject will be imaged sitting with elbow flexed and forearm pronated. The dorsal surface of distal radius and the center of ulnar head will be displayed at DRUJ level. The pressure toward palmar direction will be applied to distal ulna with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm. The distance between the dorsal surface of the ulnar head and the dorsal surface of the distal radius will be measured. At the same time, the pressure to the transducer will be measured.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* DRUJ instability patients

Exclusion Criteria:

* the participants who had a history of previous wrist trauma and wrist pain will be excluded

Primary outcomes:
measure: Instability of distal radioulnar joint (pressure)
timeFrame: 1 year
measure: Instability of distal radioulnar joint (dsiplacement)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ami
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
Study officials:
affiliation: Tokyo Medical University Ibaraki Medical Center
name: Tomoo Ishii
role: STUDY_DIRECTOR
References:
Clinical trial NCT02335996: Hypercortisolism and Epicardial Adipose Tissue
Official title: Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercortisolism
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Identifying hypercortisolism patients at risk for cardio-vascular events despite biological cure, and determine which patients should be particularly followed. Hypercortisolic patients represent an ideal in vivo model to determine the interactions between glucocorticoids and ectopic fat development.


Eligibility criteria: Inclusion Criteria:

* Major, male or female
* Introducing an active or healed hypercortisolism caused by Cushing's disease
* signed informed consent.

Exclusion Criteria:

* Elderly patients under 18 years
* Pregnant or lactating women
* Previous history of myocardial infarction
* Antecedent congenital cardiomyopathy
* Adrenocorticotropic hormone-independent Hyperadrenocorticism
* Hyperadrenocorticism by ectopic Adrenocorticotropic hormone secretion
* Treatment with corticosteroids or insulin
* Specific contraindication to the achievement of Nuclear Magnetic Resonance (metal heart valves, pacemakers, metallic foreign body, claustrophobia)
* Persons deprived of liberty
* Persons not affiliated to a social security scheme
* People unable to give their consent in writing (in person or with the assistance of a third party).

Primary outcomes:
measure: measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.
timeFrame: 36 months
measure: Assess insulin resistance by the blood sugar and insulin levels
timeFrame: 36 months
measure: Assess cardiovascular risk by a blood complete lipid profile
timeFrame: 36 months
Secondary outcomes:
measure: Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level
timeFrame: 36 months
measure: Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux Marseille
Study officials:
affiliation: Asistance Publique Hôpitaux Marseille
name: Urielle DESALBRES, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00025896: Safety and Efficacy of Recombinant Human Acid Alpha-Glucosidase in the Treatment of Classical Infantile Pompe Disease
Official title: A Prospective Multinational, Multicenter, Clinical Trial of the Safety and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) in Cross-Reacting Immunologic Material-Positive Patients With Classical Infantile Pompe Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pompe Disease
Glycogen Storage Disease Type II
Acid Maltase Deficiency Disease
Glycogenosis 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2001-11-01
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pompe disease is caused by a deficiency of a critical enzyme in the body called acid alpha glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In infants with severe cases of Pompe disease (called Classical Infantile Pompe disease), an excessive amount of glycogen accumulates and is stored in various tissues, especially heart, skeletal muscle, and liver, which prevents their normal function. This study being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for Pompe disease. Patients diagnosed with Classical Infantile Pompe disease who have a small, but inactive, amount of natural GAA enzyme present in their bodies (called Cross-Reacting Immunologic Material-Positive or "CRIM (+)" patients), will be studied.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Classical Infantile Pompe Disease
* endogenous GAA activity \< 1.0%
* cardiomegaly
* cardiomyopathy
* CRIM (+)
* ability to comply with the clinical protocol which will require extensive clinical evaluations

Exclusion Criteria:

* respiratory insufficiency
* cardiac failure
* major congenital abnormality
* any other medical condition that could potentially decrease survival
* CRIM (-)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: Kishnani PS, Goldenberg PC, DeArmey SL, Heller J, Benjamin D, Young S, Bali D, Smith SA, Li JS, Mandel H, Koeberl D, Rosenberg A, Chen YT. Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab. 2010 Jan;99(1):26-33. doi: 10.1016/j.ymgme.2009.08.003.
Clinical trial NCT01268696: Genetic Assessment of the Patients With Metabolic Syndrome
Official title: Genetic Assessment of the Patients With Metabolic Syndrome in Polish Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Keywords: diabetes
obesity
hypertension
dyslipidemia
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metabolic syndrome

Brief summary: Metabolic syndrome is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. The exact mechanisms of the complex pathways of metabolic syndrome are not yet completely known. The pathophysiology is extremely complex and has been only partially elucidated. Most patients are older, obese, sedentary, and have a degree of insulin resistance. Stress can also be a contributing factor. The most important factors are:

weight, genetics, aging, sedentary lifestyle,excess caloric intake. In our study we will assess the role of some polymorphisms in the pathology of metabolic syndrome.

Detailed description: Eligibility criteria to the study:

* patients with metabolic syndrome
* with written consent

Eligibility criteria: Inclusion Criteria:

* patients with metabolic syndrome according to IDF,AHA and NHLBI 2009

Exclusion Criteria:

* diabetes type 1
* cancer
* not consent
* steroid therapy
* alcohol or drug abuse
* chronic inflammatory disease
* pregnancy or lactation
* severe hypothyroidism
* immunosuppressive treatment
* operation or severe injury during the last month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of medical biotechnology Medical University of Lodz
Study officials:
affiliation: Department of medical biotechnology
name: Tadeusz Pietrucha, prof.
role: STUDY_CHAIR
References:
Clinical trial NCT04648696: Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin
Official title: Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin in Outpatient Parenteral Antibiotic Therapy: a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infection
Keywords: infusion therapy
continuous infusions
nephrotoxicity
outpatient parenteral antibiotic therapy
vancomycin
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and outcomes associated between the two treatment modalities

Detailed description: Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting

Eligibility criteria: Inclusion Criteria:

* Adult patients at least 18 years of age
* Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy (OPAT) services
* Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy
* Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration
* Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment

Exclusion Criteria:

* Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg
* Pre-existing leukopenia: White Blood Cell (WBC) \< 4,000 x 103 cells/µL

Primary outcomes:
measure: Number of Nephrotoxicity in Subjects
timeFrame: week 8
Secondary outcomes:
measure: Number of Leukopenia in Subjects
timeFrame: week 8
measure: Number of Infusion-related Reactions
timeFrame: week 8
measure: Number of Serum Vancomycin Measurements Within Therapeutic Range
timeFrame: week 8
measure: Number of Participants With Resolutions of Symptoms Associated With the Infection
timeFrame: week 8
measure: Number of Participants With Treatment Failures
timeFrame: week 21
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: John Williamson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06373796: Ultrasound Index Fat Fraction
Official title: Comparison of the Ultrasound Index Fat Fraction (FAT PLUS) With the MRI-PDFF Score for Quantification of Hepatic Steatosis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Steatosis of Liver
Lead sponsor: SuperSonic Imagine
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years old.
* Subject is able to understand and sign the Informed Consent Form.
* Subject is able to stand and walk independently.
* Subject must have at least one or more routine ultrasound imaging procedures of the abdomen, at one of the participating study sites.
* Subject must have at least one routine liver MRI with PDFF score performed within 30 days before or after the ultrasound examination
* Subject is affiliated to National Social Insurance or a Health Insurance Regimen

Exclusion Criteria:

* Subject is unable or unwilling to adhere to Study procedures
* Subject is unable to understand the Informed Consent
* Subject is unable to express its consent
* Subject is under legal protection
* Subject is deprived of liberty by judicial or administrative decision
* Subject undergoes psychiatric treatment under constraint
* Subject is pregnant or breastfeeding
* Subject has latex allergy
* Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure

Primary outcomes:
measure: FAT PLUS
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00164996: Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
Official title: Comparison of Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patients With or Without Local Pharyngeal Anaesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: upper endoscopy
local pharyngeal anaesthesia
ultrathin endoscope
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether an ultrathin endoscope will improve a patient's tolerance during the procedure. In addition, this study will look at whether local pharyngeal anaesthesia is necessary during ultrathin endoscopy.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-70

Exclusion Criteria:

* Previous experience of upper endoscopy
* Allergy to local pharyngeal anaesthesia
* Patient requesting sedation during endoscopy

Primary outcomes:
measure: patient's tolerance and anxiety in visual analog scale (VAS) score
Secondary outcomes:
measure: patient's satisfaction; procedure time; complications
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Wilfred Lik-Man Mui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723796: Study of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis
Official title: Study of Nasal Mucosa Histopathological Changes in Patients With Chronic Hypersensitivity Pneumonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity Pneumonitis
Nasal Mucosal Disorder
Keywords: hypersensitivity pneumonitis
nasal mucosa histopaholgical changes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 29
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background:Hypersensitivity pneumonitis (HP) is an interstitial lung disease that develops after inhalation of organic or inorganic antigens in susceptible individuals. The nasal mucosa is constantly exposed to these antigens that can irritate the respiratory mucosa.

Objectives: to assess the burden of sinonasal symptoms in HP patients and to evaluate the nasal histopathology in those patients.


Eligibility criteria: Inclusion Criteria:

* all patients with clinical and radiological features of HP

Exclusion Criteria:

* respiratory failure
* patients on anticoagulants

Primary outcomes:
measure: percentage of patients with HP developed nasal mucosa granuloma and lymphocytic infiltrations as detected by nasal endoscopy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy school of medicine
Study officials:
References:
Clinical trial NCT06653296: A Dose-Response Safety Study of ENX-102 in Patients With GAD
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ENX-102 and Determine a Dose-response for ENX-102 in Patients With Generalized Anxiety Disorder (GAD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: General Anxiety Disorder
Keywords: anxiety
Lead sponsor: Engrail Therapeutics INC
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD


Eligibility criteria: Key Inclusion Criteria:

* Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive
* Diagnosed with GAD according to the DSM-V, confirmed by MINI
* Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2

Key Exclusion Criteria:

* Clinically predominant psychiatric diagnosis other than GAD per the MINI
* Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
* Ingested prohibited medication within 5 half-lives prior to Day 1
* Current or recent moderate or severe substance use disorder as assessed by the MINI
* Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial
* Has significant progressive disorders or unstable medical conditions
* Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study

Primary outcomes:
measure: Safety and tolerability
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research
state: UK
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
affiliation: Engrail Therapeutics INC
name: Kimberly Vanover, PhD
role: STUDY_DIRECTOR
References: