louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03679988: Prevalence of Oral Mucosal Alterations in Mucocutaneous Ocular Disorders
Official title: Prevalence of Oral Mucosal Alterations in a Sample of Egyptian Patients With Mucocutaneous Ocular Disorders: A Hospital Based Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Disease
Muco-Cutaneo-Ocular Syndrome
Keywords: oral health status
oral findings
oral manifestations
patient with mucocutaneous ocular disorders
mucocutaneous ocular disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-09-21
Enrollment: 380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of adult patients diagnosed with mucocutanous oculer disorders attending to Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University will be enrolled in the study in a consecutive order.

Brief summary: The patients will be selected from the pool of the Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University. For each eligible participant, a full history will be obtained followed by thorough clinical examination.


Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with one of the mucocutaneous disorder.
* Patient who will agree to participate in the study.
* Patients who will accept to sign the informed consent.

Exclusion Criteria:

* Patients not physically able to participate in survey or clinical oral examination.

Primary outcomes:
measure: Identifying and recording oral mucosal alterations
timeFrame: 10 min
Secondary outcomes:
measure: Identifying the oral health-related quality of life: OHIP-14
timeFrame: 10 min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06517888: Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Official title: A Phase 1/2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals with Unilateral Vestibular Schwannoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Vestibular Schwannoma
Keywords: Vestibular schwannoma
Hearing loss
Acoustic neuroma
anti-VEGF
Lead sponsor: Akouos, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2024-07-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.


Eligibility criteria: Criteria for Inclusion:

1. Presence of unilateral, progressive vestibular schwannoma.
2. Vestibular schwannoma larger than 2 mm.
3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.
4. Able and willing to comply with all trial requirements, including willingness to participate in a separate long term follow-up study after completion of this trial.

Criteria for Exclusion:

1. Prior diagnosis of NF2 and/or bilateral vestibular schwannoma.
2. Prior surgery or radiation therapy for vestibular schwannoma.
3. Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear.
4. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear.
5. Prior participation in a clinical trial with an investigational drug within six months prior to administration (Day 0), or any prior participation in a gene therapy clinical trial.

Primary outcomes:
measure: Frequency of Adverse Events (AEs)
timeFrame: through trial completion, approximately one year
Secondary outcomes:
measure: Tumor Volume
timeFrame: through trial completion, approximately one year
measure: Performance of Akouos Delivery Device
timeFrame: through trial completion, approximately one year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt Bill Wilkerson Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Akouos, Inc.
name: Kathy Reape, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03087188: Inhalation Therapy in Ambulant and Hospitalized Patient Using Available Film Sequences From the Internet
Official title: Inhalation Therapy in Ambulant and Hospitalized Patient Using Available Film Sequences From the Internet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Lung Disease
COPD
Asthma
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in need of inhalative therapy due to obstructive lung disease, COPD, or asthma bronchial

Brief summary: There are different therapy strategies for patients suffering on obstructive lung disease like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of these strategies includes inhalative drugs, e.g. ß2-mimetics, anticholinergic drugs, or glucocorticoids, which are indicated often and which can be used with different inhalation devices. Dry powder inhalators, and dosieraerosol are used the most in clinical routine. Further strategies in treating obstructive lung disease are innovative systems like Respimat or systems with liquid inhalation. However, the success of the therapy depends on the correct application technique. In the clinical routine a high error rate was observed. Consequently, the initiative of the German league of respiratory tracts published internet-based film sequences in order to demonstrate how to use an inhalator correctly. These films are available in the internet for everyone and can be watched as often as needed in order to improve technique and facilitate training.

Therefore, in this study we aim to evaluate the following aspects:

* amount of wrong applications in ambulant and hospitalized patients (wrong in terms of lack of knowledge on how to use the inhalator or incorrect utilization)
* amount of correct applications in patients who had first used the inhalator incorrectly but improved technique by watching the film sequences
* evaluation of learning success within 2 weeks to 2 months (follow-up visit in the ambulance)


Eligibility criteria: Inclusion Criteria:

* male and female patients indicated for inhalative treatment with ß2-mimetics, inhalative steroids, anticholinergic drugs, or a combination of these drugs
* patient was already trained on how to use the inhalator before participating in the study
* age \> 18
* obtained written consent

Exclusion Criteria:

* patients who are incapable to consent or are unable to understand the scope of the trial
* patients who indicate that they do not know how to use the inhalator

Primary outcomes:
measure: Correct utilization of inhalator
timeFrame: Day of Screening and follow-up visit (2-8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: University Hospital RWTH Aachen
name: Tobias Müller, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02541188: Genotype and Phenotype in Early Onset Breast Cancer in Young Women on the Two Shores of the Mediterranean Sea
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Breast cancer
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 460
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients have or have had a breast cancer diagnosed before 40 years old in two shores of the Mediterranean sea (France, lgeria, Marocco, Egypt, Tunisia)

Brief summary: Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (\< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations.

Detailed description: The object of this study is to compare the genotypic and phenotypic differences between south and north shore of the mediterranean sea.

Eligibility criteria: Inclusion Criteria:

* Patient have or have had a breast cancer diagnosed before 40 years old
* Breast cancer proven by histology
* BRCA1/2 analysis proposed, realized, ongoing
* Women \>18 years old
* Patient with insurance
* Patient informed and no-opposed

Exclusion Criteria:

* Patient have or have had a breast cancer diagnosed after 40 years old
* Patient requiring tutorship or guardianship
* Adult patient protected by law

Primary outcomes:
measure: Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1)
timeFrame: The day of inclusion
measure: Genetic analysis of Breast Cancer susceptibility gene 2 (BRCA 2)
timeFrame: The day of inclusion
Secondary outcomes:
measure: Analysis TNM grade
timeFrame: The day of inclusion
measure: Analysis histoprognostic grade Scarf Bloom and Richardson (SBR)
timeFrame: The day of inclusion
measure: analysis of hormone receptor ER
timeFrame: The day of inclusion
measure: growth factors analysis (Ki 67)
timeFrame: The day of inclusion
measure: analysis of HER2
timeFrame: The day of inclusion
measure: analysis of hormone receptor PR
timeFrame: The day of inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: Oncogenetic Unit -CHU de Montpellier
name: Pascal PUJOL, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586388: Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy
Official title: Pilot Study on the Efficacy and Safety of an Oral Desensitization Protocol at the Onset of Food Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity, Milk
Keywords: Hypersensitivity, Milk
Cow's Milk
Immunotherapy
Infant
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 73
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%.

The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions.

Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited.

The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.


Eligibility criteria: Inclusion Criteria:

• children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels)

Exclusion Criteria:

* children with not IgE-mediated clinical manifestations
* children with a known immunodeficiency

Primary outcomes:
measure: number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance
timeFrame: 6 months
Secondary outcomes:
measure: Clinical reactions experienced by children at home
timeFrame: 6 months
measure: Serum levels of specific IgE
timeFrame: 6 months
measure: Serum levels of specific IgG4
timeFrame: 6 months
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Laura Badina, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Burlo Garofolo
name: Giorgio Longo, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo
name: Egidio Barbi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01566188: Vascular Impact of Omega-3 in Metabolic Syndrome
Official title: Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Metabolic Syndrome
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Female and male patients with treated essential hypertension (blood pressure values\<140/90 mmHg under antihypertensive treatment).
* Presence of at least two of the following criteria of the metabolic syndrome: abdominal girth \>102 cm in men or \>88 cm in women, HDL-C\<0.4 g/L in men or \<0.5 g/L in women, fasting triglyceride \>1.5 g/L (or specific treatment for these lipid abnormalities), fasting glucose \>1.10 g/L.

Exclusion Criteria:

* Secondary hypertension, myocardial infarction, coronary artery disease, cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or fasting glucose\>1.26 g/L) or renal failure (MDRD \< 50 ml/min)
* Severe hypercholesterolemia (total cholesterol \> 2.5 g/l), alcohol or drug abuse, toxicomania, or clinically significant abnormalities in other current biological parameters.

Primary outcomes:
measure: Brachial artery flow-mediated dilatation
timeFrame: 6 months after omega-3 supplementation
Secondary outcomes:
measure: Aortic stiffness
timeFrame: 6 months after omega-3 supplementation
Other outcomes:
Locations:
city: Fleury-Mérogis
country: France
facility: Mahes Hospital
city: Paris
country: France
facility: George Pompidou European Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Toulouse
country: France
facility: Rangueil University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Robinson Joannides, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01261988: Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
Official title: A Single Center, Feasibility Study Using Healthy Volunteers to Assess the Safety and Adhesive Performance of the VIPER System When Compared to the Esteem™ Cut to Fit One Piece Closed End Pouch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ostomy
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 70 years of age (inclusive) at the time of randomization
* Willing and able to provide written informed consent and HIPAA Waiver
* An appropriate candidate for participation with unbroken non-irritated abdominal skin
* Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol
* Willing to adhere to the scheduled study visits
* Good manual dexterity and be able to take care of their abdominal area independently
* Be willing and able to record the required study data in a specified format

Exclusion Criteria:

* A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure.
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
* Subjects with any chronic allergies requiring the use of prescription medication
* History of skin disease affecting abdominal area
* Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen
* Active case of eczema, dermatitis, psoriasis
* Pregnant or lactating females.
* Subject currently enrolled in another investigational study
* Possesses extensive knowledge about either product (ie employees that re members or extended members of the Core Team work in ostomy research and development, or ostomy division sales and marketing )

Primary outcomes:
measure: Safety: Related Events
timeFrame: 17 hours
measure: Efficacy: Device Fall-Offs
timeFrame: 17 hours
measure: Efficacy: Device Fall-Offs
timeFrame: 17 hours
measure: Safety: Skin Reactions
timeFrame: 17 hours
Secondary outcomes:
measure: Adhesive
timeFrame: 1 hour
measure: Ease of Removal
timeFrame: 17 hours
measure: Security
timeFrame: 17 hours
Other outcomes:
Locations:
city: Jobstown
country: United States
facility: Susan Bell, RN, MSN, CWOCN
state: New Jersey
Study officials:
affiliation: ConvaTec Inc.
name: Qing Li, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03648788: A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe
Official title: A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mixed Dyslipidemia
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient diagnosed with mixed dyslipidemia

Brief summary: Post-marketing surveillance of Rosuvastatin/Ezetimibe

Detailed description: This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Eligibility criteria: Inclusion Criteria:

* The patient who is first prescribed and administered Rosuvastatin/Ezetimibe

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* The patients with severe renal impairment

Primary outcomes:
measure: Incidence of adverse event after this drug administration in general medical practice
timeFrame: 24 weeks
measure: Incidence of serious adverse event after this drug administration in general medical practice
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00415688: Lifestyle Modification for Obesity-Related Type 2 Diabetes
Official title: A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Overweight
Obesity
Keywords: lifestyle modification
weight loss
hyperglycemia
hypoglycemic agents
Lead sponsor: Robert C. Atkins Foundation
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 90
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: Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus for at least one year
* hgba1c \> 6.0
* BMI from 27-50 kg/m2

Exclusion Criteria:

* Unstable medical condition
* Serious medical condition
* AST or ALT \> 100
* Serum creatinine \> 1.5

Primary outcomes:
measure: Hemoglobin A1c
Secondary outcomes:
measure: Body weight
measure: Serum lipoproteins
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Eric C Westman, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: