louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04378205: Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium
Official title: Pulpal Blood Flow Changes Related to Using SuperElastic 0.018-inch Nickel Titanium as the First Orthodontic Alignment Archwire: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance
Keywords: Pulpal blood flow
Pfixed appliance
Alignment arch wire
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A split mouth study design was applied. Each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of 2 groups based on archwire sizes used. Group 1:- 0.014-inch and 0.018-inch NiTi Group 2:- 0.016-inch and 0.018-inch NiTi.
Primary purpose: TREATMENT

Brief summary: to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.

Detailed description: Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch.

Patients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).

Eligibility criteria: Inclusion Criteria:

* age 18-25 years
* Class I skeletal malocclusion
* Mild lower arches crowding.
* Contact point displacement less than 2 mm.
* No previous orthodontic treatment

Exclusion Criteria:

* Missing teeth
* Poor oral hygiene
* deep carious teeth
* history of previous trauma
* any medical conditions affecting blood vessels
* smokers

Primary outcomes:
measure: Pulpal blood flow changes
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Dental Faculty/Jordan university of Science and Technology Dental Teaching Clinics
Study officials:
affiliation: Jordan University of Science and Technology
name: Elham Abu Alhaija, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176305: Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
Official title: Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Thromboembolic event
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2010-08-06
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives.

Brief summary: The purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period.

Detailed description: Venous thromboembolism (VTE) still causes maternal death in the western world. The purpose of this study is to estimate the relative and absolute risk of VTE at different gestational ages in pregnant women compared to non-pregnant women.

All Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives are included.Non-pregnant women are controls.

Eligibility criteria: Inclusion Criteria:

* Danish woman at 15 to 49 years old in the period January 1995 through December 2005.
* Free of previous VTE and current use of oral contraceptives.

Exclusion Criteria:

* Previous VTE or current use of oral contraceptives.

Primary outcomes:
measure: Absolute incidence of thromboembolic event
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06189105: Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial
Official title: Testing the Efficacy and Safety of Niacinamide Cosmetic Preparation: A Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Hyperpigmentation
Dry Skin; Eczema
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Niacinamide in lower concentrations has been recognized as a cosmetic ingredient with hydrating properties. Therefore, aim was to test the efficacy and safety of niacinamide cosmetic preparation in A Randomized, Controlled Trial.

Detailed description: Skin hydration (as use of hydrating cosmetic ingredients) is one of the most interventions for healthy skin and skin barrier function. Therefore, cosmetic ingredients used for this purpose should be examined for their efficacy.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers who gave written informed consent

Exclusion Criteria:

* skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation

Primary outcomes:
measure: TEWL assessment with Courage Khazaka probe
timeFrame: through study completion, an average of 1 year
measure: Hydration assessment with corneometer probe
timeFrame: through study completion, an average of 1 year
measure: pigmentation assessment with mexameter probe
timeFrame: through study completion, an average of 1 year
measure: skin oiliness assessment with sebumeter probe
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: subjective opinion of participants
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
affiliation: USSM
name: Dario Leskur
role: STUDY_DIRECTOR
References:
Clinical trial NCT00414505: A Randomized Controlled Double Blinding Study of Intradermal Acupuncture Treatment on Obesity
Official title: Korea Institute of Oriental Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Wonkwang University
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2006-12-21
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intradermal acupuncture is effective and safe in the treatment of obesity.

Detailed description: Recently the Studies of auricular acupuncture or Common Acupuncture on obesity have been conducted. Saam acupuncture, the Korean unique acupuncture, is famous with its high efficacy but not established by the scientific way yet. Thus, we tried a double-blind study on the effect of sa-am acupuncture on obesity using intradermal acupuncture.

Eligibility criteria: Inclusion Criteria:

* BMI\>25, regular menstruation, volunteer

Exclusion Criteria:

* symptomatic obesity, acupuncture treatment within 3 months, \>120kg, pregnancy or breast-feeding, hemophilia, dementia, mental illness, arrhythmia, liver cirrhosis, renal failure, pace maker, diabete mellitus, tuberculosis, steroid taker,

Primary outcomes:
measure: Bio-body impedance methods
Secondary outcomes:
measure: Cholesterol, Triglycerides, HDL LDL cholesterol
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Wonkwang University Hospital
Study officials:
affiliation: Dept. of Acupuncture & Moxibustion, Wonkwang University Hospital
name: Sung-chul Kim, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06742905: Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)
Official title: Echocardiographic Acquisition With Geographic Separation of Patients and Sonographers With Roboot Assistance (EAGER)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Echocardiography
Keywords: Echocardiography
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Echocardiography is a cornerstone of modern cardiology management, but access in rural and remote areas is limited. We have developed a robot ("Edler" named after the originator of echocardiography) which enables a sonographer to complete an examination at a distance. This study seeks to compare the images obtained by both methods, the completeness of the exam over a feasible time, and to identify particular components of the exam that are difficult to obtain using the robot.

Detailed description: The EAGER study is an effectiveness and feasibility trial of robot -assisted echo.

Patients who have undergone a standard echo will be asked to have a repeat study with a different sonographer, working remotely, obtaining images using the robot. This study is limited to 1 hour and as many views as possible will be obtained. During the study, the remote sonographer and patient are in direct contact over a video link. Another person will be in the room with the patient and the patient will be instructed on the use of a stop switch which will disengage the robot if they feel uncomfortable.

The acquired images will be saved to the imaging cloud and interpreted by an imaging specialist blinded to the original echocardiogram. A side-by-side comparison will be undertaken for each view, and image quality and study completeness will be assessed.

Eligibility criteria: Inclusion Criteria:

* Having a conventional echocardiogram

Exclusion Criteria:

* Declined consent to undergo both examinations

Primary outcomes:
measure: Proportion complete
timeFrame: 1 hour
Secondary outcomes:
measure: Proportion complete
timeFrame: 1 hour
measure: Proportion diagnostic features correctly identified by robotic echo
timeFrame: 1 hour
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
Study officials:
References:
Clinical trial NCT06545305: Incidence and Risk Factors of Ocular Complications Among Patients With Homocystinuria
Official title: Incidence and Risk Factors of Ocular Complications Among Patients With Homocystinuria in Jeddah, Saudi Arabia: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Complications
Keywords: ocular complications
high myopia
Saudi Arabia
Classic Homocystinuria
Ectopia lentis
Lead sponsor: King Fahad Armed Forces Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-09
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient's records gathered from outpatient internal medicine and pediatric encounters. Six patients met study inclusion criteria. Demographic and clinical characteristics of patients were collected. Relevant clinical and ophthalmic assessments, as visual acuity, fundus examination, complications and surgery type were also obtained. Visual acuity, in-clinic dilated fundus examination, optical coherence tomography (OCT) angiography, macular OCT scan, and fundus photography were components of ophthalmic examinations. Fundus examination involved retinal inspection, visual acuity measured using tumbling E chart.

Brief summary: Background: Cysteine beta-synthase (CBS) deficiency, often known as classic homocystinuria (HCU), is an uncommon inborn mistake in methionine metabolism. Developmental delay, intellectual incapacity, skeletal and vascular symptoms, and ocular abnormalities are possible main clinical characteristics.

Objective: This study sought to describe the ocular anomalies that King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia, HCU patients presented with between 2018 and 2022.

Detailed description: This retrospective research included 6 HCU patients. Demographic and clinical characteristics of patients as age, gender, comorbidities were collected. Relevant clinical and ophthalmic assessments, like visual acuity, fundus examination findings, complications and type of surgery were also reported

Eligibility criteria: Inclusion Criteria:

* All patients from all age groups who were diagnosed with homocystinuria between 2018 and 2022 were included, regardless of whether the diagnosis was made biochemically (by exhibiting hyperhomocysteinaemia and hypermethioninaemia) or genetically (by discovering biallelic pathogenic mutations in the CBS gene)

Exclusion Criteria:

* Patients with incomplete investigations for various reasons

Primary outcomes:
measure: Autoref reading
timeFrame: After one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
Study officials:
affiliation: Pediatric Department, King Salman Medical city-Maternity and Children, Medina, Saudi Arabia
name: Hassan A Ahmed, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726505: Renal Mechanism of Action/Splay vs. TmG
Official title: Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes, NOS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-08-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Male and female subjects
* Age 18 to 65 years
* BMI 18 to 35 kg/m2
* Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
* No evidence of impaired renal function

Exclusion Criteria:

* Unwilling or unable to use an acceptable method of birth control
* Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
* Exposure to insulin
* Use of exclusionary concomitant medications
* Evidence of significant kidney disease or any other significant medical or psychiatric disorder

Primary outcomes:
measure: The change in urinary glucose excretion dynamics
timeFrame: after 7 days of treatment
Secondary outcomes:
measure: Differences in urinary glucose between healthy and diabetic subjects
timeFrame: at 7 days
measure: Changes in liver glucose production
timeFrame: at one day
measure: Glucose effects on tubular markers
timeFrame: at one day
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Of Texas Health Center At San Antonio
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06560905: Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
Official title: Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive PSMA-PET-CT
Primary purpose: DIAGNOSTIC

Brief summary: This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET/ CT.

Detailed description: The proposed 'Preoperative Planning PSMA-PET in Melanoma Surgery (PPPIMS)' trial is a Phase 2 study, investigating the ability of PSMA as a biomarker to accurately detect melanoma metastases in patients with palpable lymphadenopathy and oligometastatic melanoma. If proven to have diagnostic utility, it may allow more precise 3D lymphatic mapping and identification of tumour in intricate anatomical areas, resulting in more accurate surgical planning. A more precise delineation of nodal disease and metastasis will result in a more accurate and lesser surgical dissection, and consequent reduction in morbidity.

The PSMA-PET-CT will be compared with the standard-of-care imaging, FDG-PET-CT to evaluate utility of this approach. It is of note that FDG-PET CT has a high background FDG uptake normally seen in the brain and liver, and PSMA could potentially be a more favourable tracer if there is less background uptake.

Eligibility criteria: Inclusion Criteria:

* Males ≥18 years of age
* Biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging FDG PET-CT scan as part of routine clinical care and are scheduled for surgery for resection of the primary site

Exclusion Criteria:

* Patients unable to give voluntary written informed consent to participate in this study
* Patients not willing to complete all the study assessments
* Patients who are females
* Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.
* Patients who have or have previously been diagnosed with prostate cancer
* Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning
* Patients not fluent in English

Primary outcomes:
measure: PSMA PET-CT detection of melanoma metastases
timeFrame: 1 Year
Secondary outcomes:
measure: Compare FDG PET-CT & PSMA PET-CT
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Hesham Sayed Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02201498: Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE
Official title: A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Dental Caries
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Septodont
name: St. Justine's Hospital
First posted: 2014-07-28
Enrollment: 180
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.


Eligibility criteria: Inclusion Criteria:

* ASA I and II
* less than 1/3 of physiologic root resorption
* asymptomatic tooth (with no history of symptoms)
* no clinical or radiological sign of pathology
* vital tooth, with carious pulpal exposure
* hemostasis must be obtained simply with pressure in less than 5 min
* teeth restored with stainless steel crowns

Exclusion Criteria:

* more than 10 y.o.
* symptomatic tooth (presently or history of symptoms)
* previous pulpal treatment on the tooth
* necrotic pulp
* hyperemic pulp
* inadequate operative technique, defective restauration
* non diagnostic x-ray (pre or post treatment)

Primary outcomes:
measure: clinical success
timeFrame: 12 months post treatment
measure: radiographic success
timeFrame: 12 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT03981198: Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Official title: Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite
Lead sponsor: Soliton
Sponsor class: INDUSTRY
First posted: 2019-06-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite

Detailed description: To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).

Eligibility criteria: Inclusion Criteria:

* Female ages 18-65 years
* Participant seeking treatment of cellulite in the upper lateral thigh areas
* Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
* Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
* Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
* Participant is willing to participate in study and adhere to follow-up schedule
* Participant is able to read and comprehend English
* Participant has completed Informed Consent Form

Exclusion Criteria:

* Participant is pregnant or planning to become pregnant during the duration of the study
* Participant has a BMI \> 30
* Greater than 10% increase or decrease in body weight within past 6 months
* Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
* Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.)
* Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
* Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
* Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)

Primary outcomes:
measure: Incidence of SAEs
timeFrame: 18 weeks
measure: Treatment Tolerability
timeFrame: 18 Weeks
Secondary outcomes:
measure: Cellulite improvement
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
Study officials:
affiliation: Soliton
name: Christopher C Capelli, MD
role: STUDY_DIRECTOR
References: