louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03563469: Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth
Official title: Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth Stains
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 73
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian children 4-6 years old with black stained teeth.

Brief summary: Black stains (BS) are type of extrinsic discoloration of the tooth. It's characterized as dark lines or an incomplete coalescence of dark dots found mostly on cervical third of the crown. Most studies worldwide found that children with the black stained teeth have low caries prevalence. A study on Brazilian population also suggested that black stains might be protective factor against development of dental caries. A study reported that chromogenic bacteria were proposed as etiological factor in production of black stains.The most common microbiological composition of BS was found to be Actinomycetes. Dental examination and saliva samples collection will be done for black stained teeth children of outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. This research adopts null hypothesis; it assumes that there is no effect on dental caries experience in children with black stained teeth.


Eligibility criteria: Inclusion Criteria:

* Patients with black stained teeth who were reported to outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University ranging in age between 4-6 years.
* With primary dentition.
* Both sexes will be included.
* Cooperative children.

Exclusion Criteria:

* Having oral disease (such as peridotites, salivary gland disorder, and oral mucosal disease).
* Having autoimmune disease.
* Receiving any antibiotic treatment in the past three months.
* Parents refuse to sign the consent

Primary outcomes:
measure: Salivary bacterial level
timeFrame: 6 months
Secondary outcomes:
measure: Dental caries experience
timeFrame: 6 months
measure: Salivary pH level
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00933569: Dermacyd Silver Floral (Lactic Acid) - Acceptability.
Official title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility criteria: Inclusion criteria:

* Integral vaginal mucosa in the product analysis region
* Use the same category of cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.
timeFrame: From the treatment start to the end of the study (treatment period 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02552069: Tritanium® Study in Japan
Official title: The Verification Study on the Early Fixation/ Stability of Tritanium Cup
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis of the Femoral Head
Lead sponsor: Stryker Japan K.K.
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis

Brief summary: The purpose of this study is to evaluate early fixation and stability of the Tritanium cup. It is expected that the Tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.


Eligibility criteria: Inclusion Criteria:

1. Patient is a candidate for a primary Total Hip Arthroplasty (THA).
2. Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis.
3. Patient whose age is 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 40.
4. Patient who is or may be pregnant female.
5. Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy), which limits ability to evaluate the safety and efficacy of the device.
7. Patient who is immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device.
8. Patients who is judged ineligible with specific reason by primary doctor.

Primary outcomes:
measure: Change in implantation position(angle) of the cup
timeFrame: Baseline, intraoperative, 3 months, 6 months and 12 months
Secondary outcomes:
measure: Change in Japanese Orthopaedic Association (JOA) score
timeFrame: Baseline, 3 months, 6months and 12 months
measure: Change in Quality of Life as assessed by Euro QOL 5 Dimension (EQ-5D)
timeFrame: Pre-operation, 3 months, 6months and 12 months
Other outcomes:
Locations:
city: Izumisano
country: Japan
facility: RINKU General Medical Center
state: Osaka
Study officials:
affiliation: Stryker Japan
name: Yasuyuki Inatsugu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03770169: Validation of Patient Reported Outcome Measures for Use in Vulvodynia
Official title: Validation of Patient Reported Outcome Measures for Use in Vulvodynia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvodynia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred by clinicians

Brief summary: The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia


Eligibility criteria: Inclusion Criteria:

* Fluent in understanding, speaking and reading US-English
* Have vulvodynia with pain for at least 6 months

Exclusion Criteria:

* Clinically significant history of alcohol/drug abuse or dependence within the last 2 years

Primary outcomes:
measure: Validation of mVPAQ
timeFrame: 1 week
measure: Validation of mFSFI
timeFrame: 1 week
measure: Validation of Pain on Intercourse Numeric Rating Scale (NRS)
timeFrame: 1 week
Secondary outcomes:
measure: Vulvar pain NRS
timeFrame: 1 week
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Washington
country: United States
facility: Center for Vulvovaginal Disorders
state: District of Columbia
city: Omaha
country: United States
facility: Omaha OB-GYN Associates, PC
state: Nebraska
city: New York
country: United States
facility: The Center for Vulvovaginal Disorders
state: New York
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02925169: Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging
Official title: Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child
Keywords: Subglottis, cricoid, airway shape, CT imaging
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2016-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children less than 12 months of age

Brief summary: Cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.

This study using imaging modality (2D CT images) is done to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Detailed description: Using imaging modalities (CT, MRI), the funnel-shape of the airway in children has been questioned and subglottis rather than cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.

This is the first study using imaging modality (2D CT images) to determine the airway shape and dimensions in neonates and infants. The purpose of this investigation was to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Eligibility criteria: Inclusion Criteria:

* Neonates and infants.

Exclusion Criteria:

Patients with tracheostomy, tracheo-esophageal fistulas lung collapse mediastinal masses diaphragmatic hernias chest masses intubated patients patients, preterm infants syndromic patients patients with primary lung diseases

Primary outcomes:
measure: Shape of airway in neonates and infants
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: King Fahad Medical City
name: Tariq Wani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wani TM, Bissonnette B, Rafiq Malik M, Hayes D Jr, Ramesh AS, Al Sohaibani M, Tobias JD. Age-based analysis of pediatric upper airway dimensions using computed tomography imaging. Pediatr Pulmonol. 2016 Mar;51(3):267-71. doi: 10.1002/ppul.23232. Epub 2015 Jun 17.
citation: Sellars I, Keen EN. Laryngeal growth in infancy. J Laryngol Otol. 1990 Aug;104(8):622-5. doi: 10.1017/s0022215100113416.
citation: Litman RS, Weissend EE, Shibata D, Westesson PL. Developmental changes of laryngeal dimensions in unparalyzed, sedated children. Anesthesiology. 2003 Jan;98(1):41-5. doi: 10.1097/00000542-200301000-00010.
Clinical trial NCT05876169: How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
Official title: How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Orthognathic Surgery
Cleft Lip and Palate
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. The results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. We will have blinded evaluation of outcomes.

Detailed description: Consecutive patients referred to department of Oral and Maxillofacial Surgery, Umeå University Hospital for corrective maxillofacial-mandibular surgery, will offer opportunity to be included in the study. Expected number of patients: 20 - 25 patients annually. Blinded evaluation will be pre-operative and during follow-up 8 weeks and 18 months after surgical correction.

Eligibility criteria: Inclusion Criterias:

* Patients accepted for orthognathic surgery due to jaw discrepancies.
* Patients given their consent for participation

Exclusion Criterias:

* Patients with syndromes
* Patients not given their consent for participation
* Patients unable to follow instructions due to lack of knowledge in Swedish and/or English language

Primary outcomes:
measure: Change in Kinematic outcome variables
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
measure: Change in Kinematic outcome variables
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
measure: Change in Kinematic outcome variables
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
measure: Change in Kinematic outcome variables
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
measure: Change in Kinematic outcome variables
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
measure: Change in Electromyography (EMG)
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
measure: Change in Maximum voluntary occlusal bite force (MVOBF)
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
measure: Change in Occlusal contact area
timeFrame: Preoperatively, postoperatively 8 weeks, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Faculty of Medicine, Department of Odontology, Umeå University
Study officials:
References:
Clinical trial NCT04877769: Bronchopulmonary PK of AT-527 (R07496998)
Official title: A Phase 1, Open-label, Randomized Study in Healthy Subjects to Assess the Bronchopulmonary Pharmacokinetics, Safety and Tolerability of AT-527, a Potential Treatment for COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)


Eligibility criteria: Inclusion Criteria:

* Subjects must agree to use birth control, as required by the protocol.
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Concentrations of AT-527 in epithelial lining fluid
timeFrame: 4-5 hours after last dose and 11-12 hours after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Atea Study Site
Study officials:
References:
Clinical trial NCT06298669: Biventricular Versus Right Ventricular Pacing
Official title: Selection of Cardiac Resynchronization Therapy Pacing Modalities in Patients Supported by LVADs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Left Ventricular Assist Device (LVAD)
Cardiac resynchronization therapy (CRT)
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.

Detailed description: Heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. However, minimal research documents the utility of these two modalities in unison. There have been recent investigations comparing Biventricular (BiV) versus right ventricular (RV) pacing suggesting better exercise performance and decreased left ventricular (LV) volumes with RV pacing. This discovery contrasts with prior meta-analysis that reports no difference between LVAD patients with and without CRT including mortality and hospitalizations. Investigators aim to compare BiV pacing and RV pacing in LVAD patients with CRT on patient's exercise tolerance and frequency of tachyarrhythmias. Additionally, research is required to form a conclusion on the role of CRT in LVAD patients.

Eligibility criteria: Inclusion Criteria:

* Patients with both an LVAD and CRT device with functional leads
* Age 18 years and older
* Ability to walk
* Ability to sign consent

Exclusion Criteria:

* Patients with permanent atrial fibrillation
* Patients who are pacemaker dependent
* Patients with sustained ventricular tachycardia

Primary outcomes:
measure: 6 Minute Walk Test Performance
timeFrame: Baseline visit; Three-month visit
Secondary outcomes:
measure: EQ-5D-3L Quality of Life Score
timeFrame: Baseline visit
measure: Serum NT-PRO-BNP
timeFrame: Baseline visit; Three-month visit
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT02373969: Thromboelastogram During Total Knee Replacement
Official title: Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Procedures, Tranexamic Acid
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As described in eligibility criteria

Brief summary: Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.

Detailed description: The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.

Eligibility criteria: Inclusion Criteria:

* Osteoarthrosis
* TKR operation elective
* ASA I-III

Exclusion Criteria:

* TKR due to any reason but osteoarthrosis
* known coagulation problems
* platelets \< 100,000/DcL
* Hb \< 12 g%
* past thrombo-embolic event
* treatment with aspiring during last week
* treatment with NSAID's during last 48 hours
* malignancy
* known allergy to tranexamic acid
* general anesthesia

Primary outcomes:
measure: Change in coagulation status during and after surgery compared to pre-surgery
timeFrame: During and after surgery compared to pre-surgery
measure: Change in fibrinolytic activity during and after surgery compared to pre-surgery
timeFrame: During and after surgery compared to pre-surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: