louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03989479: Effectiveness of T-shaped Toothbrush
Official title: The Effectiveness of T-shaped Toothbrush in Plaque Removal and Maintaining Gingival Health Among Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Keywords: toothbrush
plaque removal
gingival health
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated the effectiveness of two manual toothbrushes, the T-shaped toothbrush (Denson™, Malaysia) and a conventional toothbrush (Kid's Soft Toothbrush, Colgate) in removing plaque and maintaining gingival health among 8-10-year old children.

Brushing demonstration was provided at baseline and reinforced at 2 weeks and 1 month interval.Plaque scores and gingival scores were measured at 2 weeks and 1 month and 3 months

Detailed description: T-shaped toothbrush (Denson™, Malaysia) was introduced that is designed to efficiently clean and reduce gingival inflammation. Unlike most common conventional manual toothbrush, this new toothbrush was designed to employ a vertical motion on all tooth surfaces which simulates the natural up and down movement of the hand, suggesting that this makes the brushing process to be more controlled and stable.

One hundred and ten participants were assigned randomly to conventional toothbrush (Kid's Soft Toothbrush, Colgate) as a control group, while another half were assigned the T-shaped toothbrush (Denson™, Malaysia) as an experimental group.

Gingival status was scored using the Loe and Silness Gingival Index 25. The amount of plaque was scored using the modified Quigley and Hein Plaque Index (TQHI) 26. Both indices were recorded at 6 sites around all the teeth (mesiobuccal, midbuccal, distobuccal, mesiopalatal, midpalatal, distopalatal). All teeth were included except teeth with prosthetic crowns or cervical restorations.

One hundred children completed the study.

Eligibility criteria: Inclusion Criteria:

* good systemic health
* normal motor and cognitive development

Exclusion Criteria:

* acute intraoral lesion
* history of antibiotic and/ or antiseptic therapy in the past one month
* interproximal caries or restorations
* 3 or more missing teeth in one quadrant

Primary outcomes:
measure: Plaque score
timeFrame: 3 months
measure: Gingival status
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Dentistry, University of Malaya
name: Shani Ann Mani, MDS
role: STUDY_CHAIR
References:
citation: Mamat N, Mani SA, Danaee M. T-shaped toothbrush for plaque removal and gingival health in children: a randomized controlled trial. BMC Oral Health. 2022 Apr 7;22(1):113. doi: 10.1186/s12903-022-02137-x.
Clinical trial NCT00614679: A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia
Official title: A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End-Stage Renal Disease
Hemodialysis Catheter-associated Infection
Keywords: biofilm
catheter lock solution
catheter salvage
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.


Eligibility criteria: Inclusion Criteria:

* Adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures.

Exclusion Criteria:

* Patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to NAC or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.

Primary outcomes:
measure: Treatment success within 90 days
timeFrame: 90 days
Secondary outcomes:
measure: catheter salvage
timeFrame: 90 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
References:
citation: Aslam S, Trautner BW, Ramanathan V, Darouiche RO. Pilot trial of N-acetylcysteine and tigecycline as a catheter-lock solution for treatment of hemodialysis catheter-associated bacteremia. Infect Control Hosp Epidemiol. 2008 Sep;29(9):894-7. doi: 10.1086/590192.
Clinical trial NCT03381079: Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia
Official title: Posterior Scleral Reinforcement for Adults With High Myopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: High Myopia
Posterior Scleral Reinforcement
Adults
Axial Elongation
Myopia Progression
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.


Eligibility criteria: Inclusion Criteria:

* Cycloplegic spherical equivalent less than -6.0 D
* Myopia progression greater than 1.0 D per year
* Normal IOP, no strabismus or any other ocular pathological changes
* no any other ocular or systematic diseases that may affect refractive development

Exclusion Criteria:

* Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
* Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing

Primary outcomes:
measure: Cycloplegic autorefraction
timeFrame: 2 years
measure: Axial length
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 2 years
measure: Visual acuity
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Tongren Eye Center, Beijing Tongren Hospital
name: Ningli Wang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01619579: Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
Official title: Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Pain
Non-Invasive
Arthritis
Rheumatoid Disease
Lead sponsor: Avacen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
name: San Diego Veterans Healthcare System
First posted: 2012-06-14
Enrollment: 22
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: TREATMENT

Brief summary: Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain.


Eligibility criteria: Inclusion Criteria:

* Fibromyalgia diagnosis
* Over the age of 18
* Understands English
* Not pregnant/planning to become pregnant
* Average pain of 4 or greater over the last week (10 point scale)
* Fibromyalgia pain lasting longer than 6 months

Exclusion Criteria:

* Pregnant/Planning to become pregnant
* Major unstable psychiatric illness
* Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months

Primary outcomes:
measure: Widespread Pain Index (WPI) Score After 4 Weeks Treatment
timeFrame: 4 Weeks
measure: Tender Point Count (TPC) After 4 Weeks Treatment
timeFrame: 4 Weeks
measure: Symptom Severity (SS) Score After 4 Weeks Treatment
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: VA San Diego
state: California
Study officials:
References:
Clinical trial NCT04167579: STS & ACC Foundation's Transcutaneous Valve Therapy (TVT) Registry Foundation's Transcutaneous Valve Therapy (TVT) Registry
Official title: The Society of Thoracic Surgeons and American College of Cardiology Foundation's Transcutaneous Valve Therapy (TVT) Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transcutaneous Valve Therapies
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Brief summary: The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.

Detailed description: The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.

The secondary aim of the TVT Registry is to serve as a scalable data infrastructure forpost market studies.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Exclusion Criteria:

-

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events
timeFrame: 30 days from procedure
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
measure: Major adverse cardiac and cerebrovascular events
timeFrame: 1 year from procedure
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoah Memorial Hospital Presbyterian
state: California
Study officials:
References:
Clinical trial NCT04856579: Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
Official title: Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicocele
Infertility, Male
Keywords: Male infertility
Varicocele
Cystatin C
Endoglin
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Varicocele is a major contributor in male infertility. The improvement of sperm parameters after varicocelectomy supports this contribution. The pathophysiological mechanisms of varicocele-induced male infertility are still under investigation. Cystatin C (Cys C) and endoglin are secreted glycoproteins that recently linked to several cellular changes common in varicocele like apoptosis and autophagy.

Detailed description: Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele

Eligibility criteria: Inclusion Criteria:

* Infertile men
* Varicocele
* Poor sperm parameters

Exclusion Criteria:

* Men with systemic diseases
* Infertile men due to other causes than varicocele

Primary outcomes:
measure: The Quality of Semen
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha Faculty of Medecine
city: Banhā
country: Egypt
facility: Benha Faculty of Medicine
Study officials:
References:
Clinical trial NCT04093479: Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation
Official title: Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Obesity During Childbirth
Labor; Arrested Active Phase
Keywords: labor
obesity
oxytocin
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2019-09-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage.

Brief summary: The aim of this study is to examine the associations between maternal BMI and levels of oxytocin in maternal plasma during augmentation with oxytocin during first stage of labor in term pregnancy.

Detailed description: A translational prospective experimental study in the delivery ward in Linköping. The study population will include women in two BMI groups (underweight/normal weight and overweight/obese) during first stage of labor with singleton full term pregnancy and cephalic presentation.The BMI is calculated from weight and height registered at the first antenatal visit around week 8-12. At the delivery ward, if the women are in need of labor augmentation with oxytocin infusion, a peripheral venous catheter will be placed in the contralateral arm from the arm where oxytocin will be administrated. The oxytocin infusion will be prepared to a concentration of 10 mU/ml and will be given according to a standardized protocol or to an infusion level giving maximum of 5 uterine contractions per 10 minutes. Blood samples for measuring plasma levels of oxytocin will be taken prior to start and before every increase in the rate of oxytocin infusion. The blood samples will be collected through the first stage of labor.

Eligibility criteria: Inclusion Criteria:

Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage.

Exclusion Criteria:

Not participating in other studies at the delivery ward

Primary outcomes:
measure: maternal BMI, were weight and height will be combined to report BMI in kg/m^2
timeFrame: eight hours
measure: level of oxytocin in plasma during oxytocin infusion
timeFrame: eight hours
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Obstetrics
Study officials:
affiliation: Linkoeping University
name: Marie Blomberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04331379: Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate
Official title: Effectiveness of Nasal-alar Elevator (NE) Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.


Eligibility criteria: Inclusion Criteria:

* Infants with age range from 1-30 days.
* Unilateral complete cleft lip and alveolus.
* Medically free subjects.
* Both males and females.
* Cleft gap more than 10 mm.

Exclusion Criteria:

* Patients older than 30 days.
* Syndromic patients with other defects in addition to cleft lip and palate.
* Patients with bilateral cleft lip and palate.
* Incomplete Cleft lip.
* Patient with previous surgical lip repair or adhesion.
* Patients with previous presurgical infant orthopedic treatment.
* Medically compromised patients.
* Cleft gap distance less than 10mm

Primary outcomes:
measure: Nasal Esthetics
timeFrame: 3 months
measure: Maxillary arch changes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02675179: EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor.
Official title: EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor: Comparative Single-center Prospective Study - PELVIC-EOS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.

Detailed description: The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.

To answer this objective, the study will be a prospective, monocentric, open clinical trial, comparing the radio-pelvimetry realized with EOS technique, to the spiral CT. Measures are performed in the 3 months following the obstructed delivery.

Eligibility criteria: Inclusion Criteria:

* Patients who gave birth at the CHU Saint-Etienne
* Patients having an indication of pelvimetry
* Patients who delivered singleton pregnancy in cephalic presentation at term
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Patients with no wish of further pregnancy
* Patients with another cause of dystocia during labor
* Patients with a significant number (\>2) of radiological examinations in the year before

Primary outcomes:
measure: Diameter of the basin
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Céline CHAULEUR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04443179: Brain Imaging in Babies Study
Official title: Brain Imaging and Infant Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Neurodevelopmental Conditions
COVID-19
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 790
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: The aims of the BIBS Study

The Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby's brain develops from before birth, up until 3-4 years of age. Working with children from a variety of backgrounds and communities, the investigators use a combination of state-of-the-art diagnostic tools such as MRI scans alongside traditional behavioural assessments to capture the earliest information on infant brain development.

The focus of the BIBS study

MRI scanning is a safe way of producing detailed images using strong magnetic fields and radio waves. It does not use X-ray. Along with learning more about brain development in general, the investigators also try to identify features that may in future help predict whether a child will or will not develop traits of conditions such as Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this may help target useful interventions early on, helping children who are most in need.

Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have been given ethical approval to include testing for this infection in the mothers and children participating in the study. This may provide an opportunity to better understand how mother and baby respond to infections. The investigators particularly welcome mothers who have had a positive COVID-19 test during their pregnancy to join the study.


Eligibility criteria: Inclusion Criteria:

* Pregnant mothers with and without confirmed COVID-19
* Infants with and without an immediate family history of Autism Spectrum and neurodevelopmental conditions
* Based in England, UK

Exclusion Criteria:

* based on further screening

Primary outcomes:
measure: Neurodevelopmental Outcomes
timeFrame: 3-4 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References: