louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05202093: Eight Week Clinical Study to Investigate Reduction of Extrinsic Tooth Stain by Electric Toothbrush
Official title: Eight Week Clinical Study to Investigate Reduction of Extrinsic Tooth Stain by Electric Toothbrush
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Bleaching
Keywords: Controlled Clinical Trial
electric toothbrush
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen Yunding Information Technology Co., Ltd.
First posted: 2022-01-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study was to compare the effects of reduction of extrinsic stains between a commercially available Oclean electric toothbrush and Oral B manual toothbrush.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-70 years old
* Good general health
* Could attend the clinical examinations during the 4 week study period
* Possessing \>20 natural permanent teeth that were uncrowned or heavily filled with restorative materials, excluding third molars
* Having a whole-mouth mean tooth stain score of more than 1.5 according to the Lobene index.

Exclusion Criteria:

* Severe oral diseases, chronic disease or allergic to the trial products
* Advanced periodontal diseases
* Females who are pregnant or lactating
* Taking part in other clinical trials
* Taking part in orthodontic treatment or wearing removable denture
* Fluorosis or tetracycline teeth
* Receiving prophylaxis during the previous 3 months or tooth whitening treatment during the past 6 months.

Primary outcomes:
measure: Lobene Stain Index of Stain Extent Scores 4 Weeks After Toothbrush Use
timeFrame: 4 weeks after toothbrush use
measure: Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use
timeFrame: 4 weeks after toothbrush use
measure: Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use
timeFrame: 4 weeks after toothbrush use
measure: Lobene Stain Index of Stain Extent Scores 8 Weeks After Toothbrush Use
timeFrame: 8 weeks after toothbrush use
measure: Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use
timeFrame: 8 weeks after toothbrush use
measure: Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use
timeFrame: 8 weeks after toothbrush use
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hongchun Liu
state: Guangdong
Study officials:
affiliation: Guanghua School of Stomatology, Sun Yat-sen University
name: Hongchun Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03354793: Endometriosis and Risk of Obstetric Complications
Official title: Impact of Endometriosis on the Risk of Obstetric Complications in Spontaneous Pregnancy: a Multicentric Italian Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Pregnancy Complications
Lead sponsor: Endometriosis Treatment Italian Club
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2017-11-28
Enrollment: 844
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All continuous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria

Brief summary: The aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis

Detailed description: All women followed up for a surgical or clinical/sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis, completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or clinical/sonographic evaluation excluded endometriosis.

Eligibility criteria: Inclusion Criteria:

* 30 to 50 years old women with at least one previous spontaneous pregnancy \> 12 weeks with surgical or clinical/sonographic diagnosis of endometriosis or in whom surgical or clinical/sonographic evaluation ruled out endometriosis

Exclusion Criteria:

* Pregnancy achieved by assisted reproductive techniques
* Pregnancy terminated before 12 gestational weeks
* Twin pregnancy
* Preexisting hypertension
* Lupus like anti-coagulant
* Non corrected uterine malformation
* Recurrent abortion

Primary outcomes:
measure: Pre-term delivery
timeFrame: 2 years
Secondary outcomes:
measure: Placenta praevia
timeFrame: 2 years
Other outcomes:
measure: Intra uterine Growth Restriction
timeFrame: 2 years
measure: HELLP syndrome
timeFrame: 2 years
Locations:
Study officials:
affiliation: Endometriosis Treatment Italian Club
name: Nicola Berlanda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berlanda N, Alio W, Angioni S, Bergamini V, Bonin C, Boracchi P, Candiani M, Centini G, D'Alterio MN, Del Forno S, Donati A, Dridi D, Incandela D, Lazzeri L, Maiorana A, Mattei A, Ottolina J, Orenti A, Perandini A, Perelli F, Piacenti I, Pino I, Porpora MG, Scaramuzzino S, Seracchioli R, Solima E, Somigliana E, Venturella R, Vercellini P, Vigano P, Vignali M, Zullo F, Zupi E; Endometriosis Treatment Italian Club (ETIC). Impact of endometriosis on obstetric outcome after natural conception: a multicenter Italian study. Arch Gynecol Obstet. 2022 Jan;305(1):149-157. doi: 10.1007/s00404-021-06243-z. Epub 2021 Oct 8.
Clinical trial NCT05836493: Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Official title: Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - patients operated for non-valvular procedures (e.g. coronary artery bypass)

Brief summary: Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (\>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).


Eligibility criteria: Inclusion Criteria:

* cardiac surgery treatment of TR, isolated or in conjunction with other procedures on the left heart
* patients operated on between January 1998 and December 2004

Exclusion Criteria:

Primary outcomes:
measure: Mortality
timeFrame: through study completion, a minimum of 15 years
Secondary outcomes:
measure: Reintervention
timeFrame: through study completion, a minimum of 15 years
measure: TR recurrence
timeFrame: through study completion, a minimum of 15 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT01395693: Performance of the Salt Lake Mask System
Official title: Assessment of the Performance of the Salt Lake Mask System as a Patient Interface in the Provision of Positive Airway Pressure (PAP) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.

Detailed description: Sleep-disordered breathing (SDB) is a significant direct cause of morbidity and mortality, as well as being a significant indirect cause of morbidity and mortality impacting greatly upon health and quality of life when left untreated. Positive Airway Pressure (PAP) therapy is an effective and proven form of medical treatment for many types of SDB.

In order for PAP therapy to be effective, patient interfaces(masks) need to be both effective in their delivery of this treatment and accepted by prospective and current patients for use. This study will investigate the ability of the Salt Lake mask system to act effectively as a patient interface in PAP therapy, and its ability to be accepted by patients.

Eligibility criteria: Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients using the Swift FX mask system
* Patients who can trial the mask for 7 nights
* Patients who have used PAP therapy for a minimum of 6 months.

Exclusion Criteria:

* Patients not willing to give written informed consent
* Patients who can not read and comprehend English
* Patients using an inappropriate mask system
* Patients using Bilevel flow generators
* Patients who are pregnant
* Patients who are unable to comply with the protocol
* Patients who have used PAP therapy for less than 6 months.

Primary outcomes:
measure: Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.
timeFrame: 1 week
Secondary outcomes:
measure: Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly
timeFrame: 1 week
measure: Subjectively Assessed Levels of Skin Markings
timeFrame: 1 week
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed Ltd
state: New South Wales
Study officials:
affiliation: ResMed
name: Klaus Schindhelm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391893: Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation
Official title: Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A treatment protocol using oral and IV diltiazem has been implemented. We will compare admission rates, time to heart rate control, and hypotension between the protocol group and patients receiving traditional treatments for atrial fibrillation with rapid ventricular response
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.


Eligibility criteria: Inclusion Criteria:

* Heart rate \>125
* Systolic BP\>110
* Atrial Fibrillation/Flutter confirmed on ECG.
* Meets observation unit requirements (performs certain ADL's (acts of daily living)
* Age\>18.

Exclusion Criteria:

* Wolf-Parkinson-White syndrome
* ST Elevation Myocardial Infarction
* Pregnant
* Clinical diagnosis of Sepsis,
* Decompensated HF
* allergy to Diltiazem
* provider discretion
* clinical need for cardioversion

Primary outcomes:
measure: Admission Rate
timeFrame: 1 days
measure: Treatment Success at 3 Hours
timeFrame: 3 hours
Secondary outcomes:
measure: Rate of Hypotension
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Matthew Hysell
state: Michigan
Study officials:
References:
Clinical trial NCT02492893: Yoga Intervention for Substance Use and ART Adherence in Community Reentry
Official title: Yoga Intervention for Substance Use and Antiretroviral Therapy Adherence in Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Related Disorders
HIV
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Peter McManus Charitable Trust
name: National Coalition of Independent Scholars
First posted: 2015-07-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with HIV and a substance use disorder who are reentering the community from prison or jail face the dual risks of relapse and interruptions in adherence to antiretroviral therapy (ART) medication. This mixed-methods randomized controlled trial will compare the stress, substance use and ART adherence outcomes of participants in a 12-session, 90-minute weekly yoga group intervention with participants in a treatment as usual control group. All participants are re-entering the community, have HIV and experience substance use challenges.


Eligibility criteria: Inclusion Criteria:

* have HIV
* experience substance use challenges, within one year of reentry from prison or jail

Primary outcomes:
measure: Stress: Perceived Stress Scale (self-report)
timeFrame: 3 months
measure: Substance use: Time Line Follow Back (self-report)
timeFrame: 3 months
Secondary outcomes:
measure: Antiretroviral therapy adherence: prescription refill (pharmacy data)
timeFrame: 3 months
measure: Heart rate: sphygmomanometer
timeFrame: 3 months
measure: Blood pressure: sphygmomanometer
timeFrame: 3 months
measure: Viral load: blood test
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02399293: Computer-based Attention Training in Patients With Acquired Brain Injury
Official title: Computer-based Attention Training in Patients With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: Cognitive training
Cognitive rehabilitation
Acquired brain injury
N-back
Visual Search
Cognitive transfer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Hammel Neurocenter
First posted: 2015-03-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with acquired brain injury and non-impaired subjects.


Eligibility criteria: Inclusion criteria:

* subjects should be able to do both task at level at the time of recruitment
* Informed consent
* (for brain injured patients) training must not interfere with treatment as usual.
* (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.

Primary outcomes:
measure: Change from baseline Raven's advanced progressive matrices at the end of training
timeFrame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Secondary outcomes:
measure: Change from baseline WAIS-III Working Memory Index at the end of training
timeFrame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
measure: Change from baseline WAIS-III Processing Speed Index at the end of training
timeFrame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
measure: Change from baseline Operation Span at the end of training
timeFrame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
measure: Change from baseline Stroop color-text interference at the end of training
timeFrame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
measure: Change from baseline AMPS at the end of training
timeFrame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Other outcomes:
Locations:
Study officials:
affiliation: Hammel Neurocenter
name: Jonas Lindeløv, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002793: Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
Official title: Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis
Keywords: pancreatitis
early stage
mini-invasive abdominal drainage
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2013-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to standardized the process of mini-invasive abdominal draniage of SAP in early stage.To determine the indications and occasion.

Detailed description: Pancreatitis associated ascetic fluids(PAAF) gather with the beginning of SAP and induced IAP(intra-abdominal pressure) increasement.With an excess of 12mmHg ,IAP presents as IAH(intra-abdominal hypertension) and when a ≥20mmHg IAP accompanied with at least one organ's dysfunction it is ACS(abdominal compartment syndrome).Previous recommended theraphy of ACS is laparotomy.However,with inherited advantages such as ease-to-operate and minimal invassiveness, early stage mini-invasive abdominal drainage therapies , for example, percutaneous catheter drainage(PCD) instructed by ultrasound or CT ,have shown a promised future in recent years. It is reported that patients acquired PCD decreased 81% in operation rate compared to those who did not and had lower mortality rate. Whereas, the operation flow of early stage mini-invasive abdominal drainage remains controversial, and whose validity calls for evidence from large-scale clinical trials.

Eligibility criteria: Inclusion Criteria:

1.Diagnosis of pancreatitis 2.Onset of abdominal pain within 72h 3.Moderate severe or severe AP according to Atlanta criteria revisited in 2012 4.Intravesical pressure≥20cmH2O 4.CT images:acute peripancreatic liquid collection

-

Exclusion Criteria:

1.Pregnancy 2.Heart function: NYHA \>II 3.Pacemaker implantation 4.COPD 5.CKD 6.Pre-existing disease with life expectancy \< 3 months 7.CT images:No acute peripancreatic liquid collection 8.Intravesical pressure\>25cmH2O 9.At least one organ'S newly emerged dysfunction

-

Primary outcomes:
measure: Rates of ACS in 28 days since outbreaks
timeFrame: 28 days
Secondary outcomes:
measure: Rates of surgical interfere, MODS or death in 6 months since outbreaks
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin
state: Shanghai
Study officials:
affiliation: Emergency intensive care unit of Ruijin Hospital
name: erzhen Chen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00940693: Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)
Official title: Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder with Hyperactivity
Duloxetine
Adult
ADDH
ADHD
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2009-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 duloxetine is an effective treatment of attention deficit disorder in adults.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ADHD of at least moderate intensity
* Able to give consent
* Able to swallow capsules

Exclusion Criteria:

* Allergic or do not tolerate duloxetine
* Under psychotherapy for ADHD
* Taking a medication that interacts with duloxetine, including all psychotropic medication
* Treated with medication for ADHD
* Unstable medical condition
* Severe renal insufficiency
* Liver insufficiency
* Substance/alcool abuse or dependency in the last 6 months
* Pregnancy, nursing or inadequate contraceptive methods
* Suicide or homicide risk
* Organic brain syndrome
* Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder

Primary outcomes:
measure: Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.
timeFrame: baseline and week 6
Secondary outcomes:
measure: Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults
timeFrame: baseline and week 6
measure: Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects.
timeFrame: baseline and week 6
measure: Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.
timeFrame: baseline and week 6
measure: Impact of duloxetine on Quality of life in adults with ADHD
timeFrame: baseline and week 6
measure: Impact of duloxetine on executive functions and cognitive performances in adults with ADHD
timeFrame: baseline and week 6
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Valérie Tourjman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. doi: 10.1177/1087054708326109. Epub 2009 Apr 9.