louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05402384: AVTX-801 D-galactose Supplementation in SLC35A2-CDG
Official title: Evaluation of Efficacy and Safety of D-galactose Supplementation in SLC35A2-CDG, a Disorder of Hypogalactosylation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Rare Diseases Clinical Research Network
name: Children's Hospital of Philadelphia
First posted: 2022-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of AVTX-801 in subjects with SLC35A2-CDG


Eligibility criteria: Inclusion Criteria

* Molecular confirmation of SLC35A2 genetic variant
* Age \> 1 month
* Presence of seizures, chronic vomiting, chronic constipation, or chronic diarrhea
* A parent or legal guardian must be available and willing to provide consent on behalf of minor subjects or adult subjects who are unable to give informed consent due to developmental disabilities.
* Use of contraception in females \> age 8 years
* Previously performed eye exam within last year

Exclusion Criteria

* Aldolase-B deficiency
* Galactosemia
* Hemolytic uremic syndrome
* Hemoglobin \< 7 mg/dL
* LFTs \> 3x ULN
* Previously experienced severe AEs from oral galactose (severe diarrhea, vomiting, constipation, galactosuria, or increased liver glycogen storage)
* Other history of galactose intolerance as determined by the investigator
* Currently treated with ketogenic diet
* Current enrollment in another trial involving investigational compounds
* Ongoing dietary D-galactose supplementation
* Use of investigational compounds
* Pregnancy

Primary outcomes:
measure: Number of major motor seizure frequency
timeFrame: 28 days
measure: Number of vomiting episodes
timeFrame: 28 days
measure: Bristol Stool Form Scale (BSFS)
timeFrame: average daily 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eva Morava-Kozicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00740584: Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
Official title: Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
HSV-2 Genital Herpes
Keywords: Prevention
Lead sponsor: Starpharma Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2008-08-25
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.


Eligibility criteria: Inclusion Criteria:

* Healthy women aged 18-45 with regular menstrual cycles, free from sexually transmitted infections and using adequate contraception

Exclusion Criteria:

* Any condition, including genital conditions, sexually transmitted infection, menopause, and/or allergies that would make the study participant unsuitable for the study.
* Pregnancy or breast-feeding

Primary outcomes:
measure: HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)
timeFrame: at 3 hours
Secondary outcomes:
measure: Number of Participants With Adverse Experiences
timeFrame: Approximately 13 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
Study officials:
References:
citation: Price CF, Tyssen D, Sonza S, Davie A, Evans S, Lewis GR, Xia S, Spelman T, Hodsman P, Moench TR, Humberstone A, Paull JR, Tachedjian G. SPL7013 Gel (VivaGel(R)) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. PLoS One. 2011;6(9):e24095. doi: 10.1371/journal.pone.0024095. Epub 2011 Sep 15.
Clinical trial NCT05800184: Finnish Imaging of Shoulder Trauma
Official title: Finnish Imaging of Shoulder Trauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Pain
Shoulder Injuries
Rotator Cuff Tears
Glenoid Labrum Tear
Keywords: Shoulder
Injury
Rotator Cuff
Magnetic resonance Imaging
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2023-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from a population based sample (FIMAGE study participants) who sustain a shoulder injury or sudden onset of significant shoulder symptoms within 2 years after the FIMAGE research visit.

Brief summary: The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)


Eligibility criteria: Inclusion Criteria:

* Ambulatory
* Participated in the FIMAGE
* Baseline MRI from FIMAGE study available

Exclusion Criteria:

* Contraindications to MRI
* Previous shoulder joint replacement
* Previous rotator cuff surgery

Primary outcomes:
measure: Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI)
timeFrame: At baseline
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: At baseline
measure: Constant -Murley Score
timeFrame: At baseline
Secondary outcomes:
measure: Subjective Shoulder Value (SSV)
timeFrame: At baseline
measure: Pain NRS
timeFrame: At baseline
Other outcomes:
measure: Clinical Shoulder Examination
timeFrame: At baseline
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
Clinical trial NCT00926484: Tooth Mousse and Fluoride in Dentin Hypersensitivity Treatment
Official title: Combined Tooth Mousse and Fluoride Varnish in Dentin Hypersensitivity Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentin Hypersensitivity
Keywords: Dentin hypersensitivity
Tooth Mousse
fluoride varnish
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2009-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 26
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries progression. Whether CPP-ACP can act synergistically with fluorine in the dentin hypersensitivity treatment is unknown. The aim of this study was to assess the effect of CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.


Eligibility criteria: Inclusion Criteria:

* subjects with a minimum of three cervical hypersensitive teeth at both sides of the dental arch

Exclusion Criteria:

* dentin hypersensitivity caused by caries lesions
* fracture of restoration
* chipped teeth
* marginal gaps
* post-operative sensitivity
* cracked-tooth syndrome, and which were confirmed by periapical radiographs and teeth with cervical fillings

Primary outcomes:
measure: ANOVA
timeFrame: June 2008
Secondary outcomes:
measure: T-test
timeFrame: June 2008
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xuejin Tao, Doctor
role: STUDY_CHAIR
References:
citation: Kowalczyk A, Botulinski B, Jaworska M, Kierklo A, Pawinska M, Dabrowska E. Evaluation of the product based on Recaldent technology in the treatment of dentin hypersensitivity. Adv Med Sci. 2006;51 Suppl 1:40-2.
Clinical trial NCT04636684: Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
Official title: Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyloidosis
Keywords: ATTR aortic valve amyloidosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cardiac amyloidosis is a restrictive cardiomyopathy with a potentially severe prognosis that can be life-threatening. It is linked in the vast majority of cases to a light chain deposition of immunoglobulin or transthyretin. Although myocardial involvement is predominant, other locations are possible: the atrioventricular conduction system, coronary arteries and valve leaflets. In systematic histological analyzes, deposits of amyloidosis infiltrating the aortic valve have been reported with a frequency of up to 74% for degenerative RA. The nature of these deposits has never been established because the immunostaining carried out all remained negative, probably due to decalcification prior to cutting. Currently, these deposits are considered to be local degenerative phenomena without clinical repercussions. However, the use of bone scintigraphy has shown a high prevalence, between 14 and 16%, of ATTR cardiac amyloidosis in patients with severe RA. The diagnosis of ATTR amyloidosis has been proven histologically in a few patients. Sequencing of the TTR gene has shown that they are mainly wild forms. In fact, the prevalence of transthyretin mutations in our local cohort is 20%.

The objective of this study is to determine by proteomic analysis based on mass spectrometry, the prevalence of ATTR aortic valve amyloidosis in patients undergoing surgical valve replacement for degenerative aortic stenosis.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Degenerative aortic stenosis
* Aortic valve replacement surgery
* Signature of the informed consent form

Exclusion Criteria:

* Non-degenerative aortic stenosis: bicuspid, rheumatic disease, aortic regurgitation
* Persons under a system of legal protection for adults (guardianship, curatorship, etc.)
* Pregnant women

Primary outcomes:
measure: prevalence rate of valvular ATTR amyloidosis
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy
timeFrame: 1 year
measure: percentage of wild ATTR myocardial amyloidosis
timeFrame: 1 year
measure: percentage of mutated ATTR myocardial amyloidosis
timeFrame: 1 year
measure: Prevalence of types of amyloidosis other than ATTR
timeFrame: 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: university hospital center Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Magali COLOMBAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01503684: Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome
Official title: Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-01-04
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube.

Brief summary: In this proposal, the investigators wish to investigate, identify and validate potential biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.

Detailed description: In this proposed project, we will focus on the identification of potential biomarkers in EBC with ability to predict development of multi-organ failure. Currently, no tools could be used to evaluate the effect of mitochondrial dysfunction in sepsis. All the human studies discussing mitochondrial dysfunction in sepsis use tissue biopsies as study materials. Repeated tissue biopsy is invasive and not applicable. EBC could be collected non-invasively and conveniently. A study has demonstrated the use of metabolomic technologies in mitochondrial diseases. We believe that the metabolomic biomarkers of EBC could be used to demonstrate mitochondrial dysfunction in lungs and respiratory tracts of septic patients. Such metabolomic biomarkers may also reflect similar on-going mitochondrial dysfunction in other organ systems, and could potentially become a novel diagnostic tool and a therapeutic target in future sepsis therapy.

Eligibility criteria: Inclusion Criteria:

* above 20 years old
* admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube

Exclusion Criteria:

* pregnant
* active malignancy
* in an immunosuppressed status such as HIV disease, neutropenia, being treated with immunosuppressive agents
* expected to have an unavoidable very short life expectancy after admission, i.e., \< 3 days

Primary outcomes:
measure: Development and severity of sepsis
timeFrame: 28 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
measure: Response to treatment and progression of organ failure
timeFrame: 28 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jih-Shuin Jerng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00588484: Ultrasound-based Intima-Media Thickness Measurements
Official title: Determination of the Precision and Clinical Utility of Ultrasound-based Intima-Media Thickness Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Intima Media Thickness
Keywords: Carotid artery
Common carotid artery
Measurement
Ultrasound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 128
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 75 Men and 75 women, ages 35-65, being seen either at the Mayo Clinic Cardiovascular Clinic, or having an appointment for a carotid duplex ultrasound.

Brief summary: Develop a standard technique and demonstrate adequate precision for measurement of intima-media thickness (IMT) for routine clinical use.

Detailed description: IMT is measured using software to analyze ECG-gated US image sequences acquired using a standard protocol. Two sonographers acquire images and measure IMT for 100 vessels. IMT technique standard deviation (SD) is determined by assuming normally distributed measurements, and dividing the SD of the 100 (paired) IMT differences by sqrt(2). This SD will be taken as measures of precision of the IMT technique.

Eligibility criteria: Inclusion Criteria:

* Must have an appointment at either the Cardiovascular Health Clinic or scheduled for a carotid ultrasound.

Exclusion Criteria:

* Carotid endarterectomy,carotid stenting, carotid repair, less than 45 degree range of motion in the neck, and/or cannot lie flat on back.
* Participants Enrolled who are found after imaging not to exhibit a \~1cm long common carotid far wall region free of focal plaque in which to measure IMT will not have their data analyzed further.

Primary outcomes:
measure: The primary statistical endpoint for this study is to determine the standard deviation and 95% confidence interval of IMT measurements obtained using our standard method.
timeFrame: Four years
Secondary outcomes:
measure: Standard deviation and 95% confidence interval of our IMT measurement method considering data subsets with variable US image quality levels, and different levels of image plane correlation.
timeFrame: Two years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicholas J. Hangiandreou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06385184: Social & QoL Behaviors in Parkinson's Disease
Official title: Social Behaviors and Quality of Life in Individuals With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes both 40+ year old adults with Parkinson's disease and 40+ year old neurotypical adults

Brief summary: Adults with Parkinson's Disease experience an array of challenges and changes in daily living, behaviors, and functioning throughout the progression of their condition. The investigators want to learn more about the effects of Parkinson's Disease on individuals' social behavior and quality of life (QoL) compared to people of the same age without Parkinson's Disease.


Eligibility criteria: Parkinson's disease group

Inclusion Criteria:

* Have been diagnosed with Parkinsons Disease by a healthcare professional
* Are at least 40 years old

Exclusion Criteria:

* Possess a diagnosis of autism or any other developmental disability (e.g., Down syndrome)

Neurotypical group

Inclusion Criteria:

* Are at least 40 years old

Exclusion Criteria:

* Have been diagnosed with Parkinson's disease by a healthcare professional
* Possess a diagnosis of autism or any other developmental disability (e.g., Down syndrome)

Primary outcomes:
measure: Subjective Quality of Life
timeFrame: through study completion, an average of 1 year
measure: Social Behavior
timeFrame: through study completion, an average of 1 year
measure: Activities of Daily Living
timeFrame: through study completion, an average of 1 year
measure: Mental Health
timeFrame: through study completion, an average of 1 year
measure: Cognition
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Gregory Wallace, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05031884: Vision-based Ultrasonic Robot Autonomous Scanning Research
Official title: Vision-based Ultrasonic Robot Autonomous Scanning Research
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ultrasound Therapy; Complications
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers are encouraged in the study.

Brief summary: MGIR3-US is a remote scanning robot which can perform ultrasound exam. The aim of the study is to evaluate the feasibility and the application of MGIR3-US.


Eligibility criteria: Inclusion Criteria:

* patients who agree using MGIR3 to do ultrasonic examinations
* age from 18 to 65

Exclusion Criteria:

* Patients who has trauma on the inspection site or on the body surface
* Pregnant patients.
* Patients who are afraid of MGIR3-US

Primary outcomes:
measure: The degree of satisfaction in participants
timeFrame: from 2021.08 to 2024.08
Secondary outcomes:
measure: The degree of satisfaction in doctors
timeFrame: from 2021.08 to 2024.08
measure: the lesion inspection rate
timeFrame: from 2021.08 to 2024.08
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: the third affiated hosptial of Sun Yat-sun University
name: Jie Ren, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971984: Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel
Official title: Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia Alpha
Hemolytic Anemia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 50
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of 50 children that underwent workup due to hemolytic anemia and were further diagnosis as suffering from clinical alpha thalassemia.

Brief summary: The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations.

Detailed description: Fifty children and adolescents diagnosed as having alpha thalassemia will be studied, the clinical characteristics and hematology analysis will be summarized.

Eligibility criteria: Inclusion Criteria:

* All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center

Exclusion Criteria:

* None

Primary outcomes:
measure: Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Study officials:
References: