louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01147549: Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers
Official title: An Open-Label, Single-Centre, Phase I Study to Assess the Excretion, Metabolism and Plasma Pharmacokinetics Following a Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ADME
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 4
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to characterise the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of \[14C\]AZD9668.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedure
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Exposed to radiation levels above background of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life
* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Primary outcomes:
measure: Percentage of radioactive dose recovered in urine and faeces and total balance
timeFrame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
measure: Concentration of total radioactivity in blood and plasma
timeFrame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
measure: Plasma concentrations of AZD9668
timeFrame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
measure: Metabolite profiling and identification in plasma and excreta
timeFrame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
measure: PK of AZD9668 (Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR )
timeFrame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Secondary outcomes:
measure: Adverse Events
timeFrame: Adverse events collected prior to treatment and after treatment including follow up.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Wilmington
name: Chris O'Brien
role: STUDY_DIRECTOR
affiliation: Quintiles Drug Research Unit, United Kingdom
name: Tim Mant, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06140849: Evaluation of Artificial Intelligence Models for Diagnosis of Anterior Open Bite Malocclusion
Official title: Evaluation of Artificial Intelligence Models for Diagnosis of Anterior Open Bite Malocclusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Artificial Intelligence
Open Bite
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Future University in Egypt
First posted: 2023-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient with anterior open bite of any type and severity will be included in the study

Brief summary: Building artificial intelligence models for diagnosis of anterior open bite malocclusion

Detailed description: The study aims at creating artificial intelligence models, with the input being the pre-treatment photographs and radiographs of open bite patients that are routinely taken for diagnosis and treatment planning. The output of the AI model will be the type and phenotype of anterior open bite. The photographs and radiographs with highest quality will be arranged in certain standardized templates to facilitate the machine learning process.

Eligibility criteria: Inclusion Criteria:

* anterior open bite

Exclusion Criteria:

* craniofacial syndromes, previous orthodontic treatment, poor quality records

Primary outcomes:
measure: the efficiency of artificial intelligence (AI) model in diagnosis of anterior open bite
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Orthodontic Department, Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo
name: Yehya Mostafa, DDS., PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06166849: Clinical Evaluation of an Experimental Remineralization Product
Official title: Clinical Study of Tooth Enamel Remineralization Using DoReMin Product
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: White Spot Lesion
Keywords: white spot lesion
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
Collaborators: name: Iuliu Hatieganu University of Medicine and Pharmacy
First posted: 2023-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.


Eligibility criteria: Inclusion Criteria:

* At least two incipient carious lesions on the buccal or oral surface of a permanent tooth. Neighbouring teeth should not be in two different groups. There is no maximum amount of lesions.
* Active caries lesion
* Patient at risk of caries
* Vital teeth

Exclusion Criteria:

* Pregnancy
* Enamel detachment at the site of investigation
* Allergies (DoReMin)
* Chronic diseases

Primary outcomes:
measure: White Spot Measurement
timeFrame: Baseline to 1 Year
measure: ICDAS II visual scoring system (Codes)
timeFrame: Baseline to 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Iuliu Hatieganu, University of Medicine and Pharmacy
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
name: Ada Delean, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05267249: Revascularisation of Autotransplanted Teeth
Official title: Revascularisation of Autotransplanted Teeth - Retrospective Analysis of a Novel Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Disease
Pulp Canal Obliteration
Keywords: Autotransplantation, Apicoectomy, Revascularisation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Retrospective Analysis of a Study cohort that experienced autotransplantation of mature teeth with simultaneous root end resection

Note: The study was registered on Clinicaltrials.gov after termination of study.


Eligibility criteria: Inclusion Criteria:

* Male and female consenting and judicious young people and adults
* Written consent of the participant and, if applicable, of the legal guardian after education
* Planned tooth transplantation with advanced or completed root growth

Exclusion Criteria:

* Contraindications for magnetic resonance imaging (MRI): (pronounced metal restorations, running orthodontics with metal, fixed appliance in the target jaw)
* Current or past antiresorptive therapy with bisphosphonates
* Further anamnestic general or local risk situation, among others: Anti-angiogenic therapy, History of local radiation therapy, severe coagulation disorder, unadjusted diabetes mellitus, malignant diseases
* Acute gingivitis or advanced periodontitis
* Participation in an ongoing drug trial (various drugs may distort the result, such as bisphosphonates, cortisone, chemotherapeutics, angiogenesis inhibitors)
* heavy smokers (\> 10 per day)
* Acute or chronic infections (osteomyelitis) at the surgical site
* metabolic diseases (diabetes, hyperparathyroidism, osteomalacia)
* Severe kidney dysfunction, severe liver disease
* Patients with high-dose corticosteroid therapy
* prolonged corticosteroid or radiotherapy in the oral cavity
* autoimmune diseases
* Pregnant or breastfeeding women

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
measure: Revascularisation
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Petra Rugani, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jakse N, Ruckenstuhl M, Rugani P, Kirnbauer B, Sokolowski A, Ebeleseder K. Influence of Extraoral Apicoectomy on Revascularization of an Autotransplanted Tooth: A Case Report. J Endod. 2018 Aug;44(8):1298-1302. doi: 10.1016/j.joen.2018.04.016. Epub 2018 Jun 20.
Clinical trial NCT04783649: Clinical Validation of Cervical Cancer Screening Methods
Official title: Clinical Validation of Cervical Cancer Screening Methods in St. Petersburg, Russia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Cervical Dysplasia
Human Papilloma Virus
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25-65 year-old women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities.

Brief summary: This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests.

Detailed description: Cervical cytology practices are different across the world. While the Pap test became the cornerstone of the highly-effective cervical cancer screening in the countries that initially implemented population-based programs in the 60s and the 70s, alternative staining techniques were implemented in the Soviet Union. The tradition to apply other staining techniques than conventional Pap test remained unchanged in the national screening program implemented in the 2010s in Russia. As a new alternative option HPV testing showed effectiveness in screening women older than 30. The acceptable sensitivity and specificity of a screening test are crucial in population-based screening, that is why validation against "the gold standard" should be the first step in the process of program implementation. The objective of this study is to evaluate alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests in the population of 25-65 yo women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities referred to a primary screening test.

Eligibility criteria: Inclusion Criteria:

Age between 25 and 65 years old Referral to colposcopy or to a primary screening test Signed informed consent

Exclusion Criteria:

Prior history of malignancy or cervical dysplasia Prior history of cervical dysplasia

Primary outcomes:
measure: Sensitivity
timeFrame: 24 months
measure: Specificity
timeFrame: 24 months
Secondary outcomes:
measure: HPV prevalence by type
timeFrame: 24 months
measure: Cervical dysplasia prevalence
timeFrame: 24 months
Other outcomes:
measure: Safety of cervical smear
timeFrame: 24 months
measure: Safety of colposcopy and biopsy
timeFrame: 24 months
Locations:
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov National Medical Research Center of Oncology
Study officials:
References:
Clinical trial NCT05843149: Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain
Official title: Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 6
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: A randomized controlled trial for patients with chronic low back pain with two treatment arms and one waiting list control group. Primary outcome is pain intensity on VAS.


Eligibility criteria: Inclusion Criteria:

* pre-existing and specialist confirmed diagnosis of chronic low back pain for at least 3 months prior to inclusion
* Average pain intensity with at least 40 mm on the VAS from 0 to 100 mm and pain on at least 5 of 7 weekdays in the last 3 months.

Exclusion criteria:

* Regular own exercise practice for the treatment of back pain (including yoga and other interventions)
* Invasive spinal procedures within the past 6 weeks or planned within the next 10 weeks
* Acute disc herniation (diagnosed within the last 3 months)
* Congenital deformities of the lumbar spine
* Rheumatoid arthritis
* Fibromyalgia
* Ankylosing spondylitis
* Severe comorbidities
* Pregnancy/lactation
* Current participation in another clinical trial

Primary outcomes:
measure: Change from baseline in average pain intensity in previous week
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline for back pain specific disability
timeFrame: 3 months, 6 months
measure: Change from baseline in average pain intensity in previous week
timeFrame: 6 months
measure: Change from baseline in pain bothersomeness in previous week
timeFrame: 3 months, 6 months
measure: Change from baseline in pain medication use in the previous week
timeFrame: 3 months, 6 months
measure: Change from baseline for health related quality of life
timeFrame: 3 months, 6 months
measure: Change from baseline for pain self-efficacy
timeFrame: 3 months, 6 months
measure: Change from baseline for work productivity
timeFrame: 3 months, 6 months
measure: Change from baseline for anxiety and depression
timeFrame: 3 months, 6 months
Other outcomes:
measure: Number of participants with adverse events as a measure of safety and treatment adherence
timeFrame: 3 months, 6 months
measure: Treatment adherence (class/session attendance)
timeFrame: 3 months, 6 months
measure: App via mobile phones
timeFrame: 3 times daily within baseline and 6 months
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT06181149: Auditory Prediction and Error Evaluation in the Speech of Individuals Who Stutter
Official title: Auditory Prediction and Error Evaluation in the Speech of Individuals Who Stutter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Subjects
Stuttering, Developmental
Keywords: stuttering
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-12-26
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Stuttering negatively impacts communication and reduces the overall quality of life and well-being of individuals who stutter. This study will provide a strong foundation for developing neural and behavioral interventions for stuttering. Participants will be asked to name pictures, read words/sentences silently or aloud, and listen to speech and nonspeech sounds while their speech, muscle, and brain signals are collected. Some participants may also receive brain stimulation while reading and speaking.


Eligibility criteria: Inclusion Criteria:

* being a monolingual, native speaker of American English
* absence of developmental, psychological, neurological, or communication disorders (other than developmental stuttering) as confirmed by a certified research SLP
* normal (age-appropriate) binaural pure-tone hearing threshold (0.5-4k Hz; ≤25 dB HL for younger than 70 years, and ≤35 dB HL for older than 70 years)
* not taking any medications that affect the central nervous system
* absence of safety contra-indication for tDCS, TMS and MRI (for adults)
* scoring at the 20th percentile or higher on standardized speech-language tests (for children)

Exclusion Criteria:

-

Primary outcomes:
measure: Change in brain activity before and during speaking
timeFrame: within each session of the study that may last up to 2 hours
measure: change in speech when participants experience auditory errors
timeFrame: within each session of the study that may last up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
city: Seattle
country: United States
facility: Univeristy of Washington
state: Washington
Study officials:
References:
Clinical trial NCT00935649: PinPointe FootLaser for the Treatment of Onychomycosis
Official title: Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infected Toenails
Onychomycosis
Keywords: Toenail Fungus
PinPointe
FootLaser
Onychomycosis
Fungal nails
Lead sponsor: PathoLase, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

Detailed description: The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.

Eligibility criteria: Inclusion Criteria:

* Volunteers of either sex,
* 18-80 years of age,
* Both great toes with clinical signs of infection.
* Positive KOH or culture test

Exclusion Criteria:

* Existing or history of cancer/skin malignancy,
* Use of oral antifungal agents in past 6 months,
* Use of topical antifungal agents in past 1 month,
* Loss of protective sensation in either foot,
* Infection involving lunula of either great toe,
* Longitudinal streaks/spikes of either great toenail,
* Distal nail thickness \> 2 mm of either great toe,
* Prior surgical treatment of either great toe in past 12 months,
* Participation in another medical device/pharmaceutical study,
* Condition that investigator determines makes it unsafe for subject to participate,
* Pregnancy, breastfeeding or plans to become pregnant.

Primary outcomes:
measure: Nail Bed Clearing
timeFrame: 48 weeks
Secondary outcomes:
measure: Mycology
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Laser Center
state: New York
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: London
country: Canada
facility: Mediprobe Research Inc
state: Ontario
Study officials:
affiliation: PathoLase, Inc.
name: David M Harris, PhD
role: STUDY_DIRECTOR
affiliation: Dermatology Associates
name: Bernard Goffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04784949: PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars
Official title: Outcome of PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars With Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: PRF
Vital pulp therapy
pulpotomy
bioceramics
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: permanent molar with symptomatic irreversible pulpitis
Primary purpose: TREATMENT

Brief summary: this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars with irreversible pulpitis


Eligibility criteria: Inclusion Criteria:

* spontaneous, lingering pain exacerbated by hot and cold , and/or radiating pain
* Responded to cold and electric pulp testing

Exclusion Criteria:

* pain on palpation, percussion,
* mobility or swelling
* peridontall widening
* Teeth with marginal periodontitis or crestal bone loss
* resorption
* calcified canals

Primary outcomes:
measure: Change in postoperative pain
timeFrame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
measure: Change in swelling
timeFrame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
measure: Change in Mobility
timeFrame: 24 hours, 48 hours, 1 week, every 3 months for 12 months
Secondary outcomes:
measure: calcific like bridge
timeFrame: 12 month
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of dentistry Fayoum University
Study officials:
References:
citation: Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand. 2013 Jan;71(1):130-6. doi: 10.3109/00016357.2011.654251. Epub 2012 Feb 20.
citation: Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20.