louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02320162: School-based Oral Health Education Program Using Experiential Learning
Official title: "School-based Oral Health Education Program Using Experiential Learning or Traditional Lecturing in Children and Adolescents: a Clinical Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Gingivitis
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 351
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this project was to compare the effectiveness of experiential learning (EL) and traditional lecturing (TL) school-based oral health education on the oral health knowledge, attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old Greek children. Thee hundred and fifty children were selected from three areas of Greece. Information on oral health knowledge, attitude and behaviour were obtained using a questionnaire. Dental plaque was recorded using a modified hygiene index, gingivitis was assessed using the simplified gingival index and dental caries was measured by recording the number of Decayed, Missing and Filled teeth (DMFT) using the British Association for the Study of Community Dentistry (BASCD) criteria. All children were examined by two calibrated dentists, using a World Health Organisation (WHO) periodontal probe and artificial light. Questionnaires were delivered and clinical examinations were performed at baseline and at 6 and 18 months post-intervention. The EL oral health educational program was implemented by teachers using the program's manual.


Eligibility criteria: Inclusion Criteria:

* 10 and 13 year-old children
* For the EL group, students were recruited from schools that had teachers previously trained in EL
* Students recruited for the TL group attended schools of the same geographical location as students in the EL group

Exclusion Criteria:

* Contributory medical history

Primary outcomes:
measure: Change from baseline in dental plaque, gingivitis and caries at 6 and 18 months in 350 children
timeFrame: baseline, 6 and 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dental School, University of Athens
name: Constantine Oulis, DDS,MS,PhD
role: STUDY_CHAIR
References:
citation: Angelopoulou MV, Kavvadia K, Taoufik K, Oulis CJ. Comparative clinical study testing the effectiveness of school based oral health education using experiential learning or traditional lecturing in 10 year-old children. BMC Oral Health. 2015 Apr 28;15:51. doi: 10.1186/s12903-015-0036-4.
Clinical trial NCT02962362: Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
Official title: A Prospective Multi-center Data Collection to Assess the Exactech Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred (100) subjects enrolled up to 4 sites. All subjects will be screened, enrolled and evaluated prospectively and be followed for up to two years. In the event a subject is enrolled and does not have surgery, additional patients may be screened and enrolled to reach the 100 subjects.

Brief summary: Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).

Detailed description: The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.

Eligibility criteria: Inclusion Criteria:

* Patient requires a primary Optetrak Logic Total Knee Arthroplasty
* Patient is skeletally mature with no obvious mechanical defect
* Patient is mentally capable of completing follow-up visits
* Patient is 18 years of age or greater at time of surgery
* Patient will be available for follow-up out to 2 years
* Patient has consented to participate in the clinical study

Exclusion Criteria:

* Patient has a mental or physical condition that may invalidate evaluation of the data
* Patient is a prisoner
* Surgery is contraindicated according to the applicable product package insert
* Patient has a local or systemic infection
* Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
* Patient is pregnant

Primary outcomes:
measure: Hospital for Special Surgery knee score (HSS)
timeFrame: 24 Months
measure: Oxford Knee Score (OKS)
timeFrame: 24 Months
measure: Knee Society Score (KSS)
timeFrame: 24 Months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Exatech, Inc.
state: Florida
Study officials:
References:
Clinical trial NCT03590262: Effect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes
Official title: Effect of Metformin as add-on Therapy on Glycemic Control and Other Diabetes-Related Outcomes in Type 1 Diabetic Patients:a Open-label,Self-control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Metformin
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of metformin as add-on therapy on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

Detailed description: Design An open-label, add-on, self-control clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 20 participants with type 1 diabetes, aged 18-60 years, will be recruited and treated with metformin as add-on therapy with insulin for 12 weeks.

Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention .

Eligibility criteria: Inclusion Criteria:

type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；

Exclusion Criteria:

pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs

Primary outcomes:
measure: Change of hemoglobin A1c in percentage
timeFrame: 3 months
Secondary outcomes:
measure: Change of weight in kilograms
timeFrame: 3 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: associate chief physician
name: Fengyi Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05770362: Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays
Official title: Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lifestyle-related Condition
COVID-19 Pandemic
Children With Developmental Delays
Keywords: COVID-19 pandemic
lifestyle
sleep
children with developmental delays
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 260
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital in Taiwan.

Brief summary: To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan.

Detailed description: Two hundred and sixty children with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital will be included. The lifestyle questionnaire will evaluate the lifestyle changes of children with developmental delays during home isolation and release from home isolation during the COVID-19 pandemic in Taiwan. The parents of children with developmental delays will fill out the questionnaire.

Eligibility criteria: Inclusion Criteria:

* children diagnosed with developmental delays

Exclusion Criteria:

* children without developmental delays

Primary outcomes:
measure: sleeping quality change by lifestyle questionnaire
timeFrame: during and after home isolation through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02028962: Computer Tailored Program for Smoking Cessation Among Romanian Adults
Official title: Development, Implementation and Evaluation of a Computer Tailored Program for Smoking Cessation Among Romanian Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Smoking
Keywords: Smoking cessation
Romanian adults
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 640
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The research aim is the development, implementation and evaluation of the first computer tailored smoking cessation progam for Romanian adult smokers. It will be implemented among smokers from Romania aged 20-60 years. The participants will beneficiate of tailored information received in letters generated by using sophisticated computer algorithms, allowing the creation of highly individualized messages that address each individual's unique needs, motivations and beliefs related to smoking .

Program implementation will comprise of :

1. ''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
2. development of the ''message library'' that contains all education messages that may be needed
3. development of an ''algorithm'', a set of decision rules that evaluates the diagnosis, selects and generates messages tailored to the specific needs of the individual user
4. generating of personalized letters for each participant
5. sending of theses personalized letters to the participants. The participants will receive three personalized letters during a period of six months after registration into the program.

The effects of the program will be evaluated with a randomized controlled trial which will assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy and quiting attempts at 6 months after the enrolment into the program.

A process evaluation will assess participants' opinion about the program.


Eligibility criteria: Inclusion Criteria:

* smokers (smoked in the last 7 days)who intend to quit smoking in the next 6 months

Exclusion Criteria:

* non-smokers
* smokers who do not intend to quit smoking in the next 6 months

Primary outcomes:
measure: abstinence from smoking in the last 7 days
timeFrame: baseline and 6 months after
Secondary outcomes:
measure: quiting attempts in the last 6 months
timeFrame: baseline and 6 months after
measure: smoking related attitudes
timeFrame: baseline and six months after
measure: self-eficacy in quiting smoking
timeFrame: baseline and 6 months after
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Iuliu Hatieganu University of Medicine and Pharmacy
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
name: Lucia M Lotrean, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05030662: Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty
Official title: National Taipei University of Nursing and Health Sciences
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Arthroplasty
Replacement
Knee Osteoarthritis
Keywords: total knee arthroplasty
Walking stick exercise
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether the effect of "hiking poles exercise" on lower extremity muscular strength, knee range of motion, and quality of life in elderly patients underwent total knee arthroplasty

Detailed description: This is a longitudinal-experimental study. The data collection and analysis are in a single-blind manner. The study will be undertaken in the Department Orthopaedics of En Chu Kong hospital (approximate 500-bed regional teaching hospital). All patients who meet the inclusion criteria are admitted for primary total knee arthroplasty and assigned to control group or intervention group randomly. The 44 patients in the control group received routine guidance of " Rehabilitation and precautions for artificial knee replacement ". In addition to the routine guidance, the 44 patients in the intervention group received educations of " hiking poles exercise " on the day before surgery and before discharge, as well as a follow-up call at least once a week after discharge.

Eligibility criteria: Minimum Age: 60 years Maximum Age: 85years Gender-Based: All Accepts Healthy Volunteers:No

Criteria:

Inclusion Criteria:

* Age between 60 and 85 years
* Informed consent
* Receipt of elective unilateral primary knee arthroplasty surgery.

Exclusion Criteria:

* Non-degenerative arthritis, including rheumatoid arthritis, or traumatic arthritis
* Patients receiving rehabilitation simultaneously
* Patients with other musculoskeletal or neurological problems, including fractures, Parkinsonism, cerebrovascular events, or patients with multiple comorbidities
* Cancer patients receive chemotherapy
* Patients with the peri-operative complication that has an adverse effect on outcomes,for example: intra-operative fractures, thromboembolism, peri-operative infections, or phlebitis

Primary outcomes:
measure: Total knee arthroplasty of Quality of life
timeFrame: for three months
Secondary outcomes:
measure: lower limb muscle power
timeFrame: for three months
measure: knee range of motion
timeFrame: for three months
Other outcomes:
measure: participant characteristics
timeFrame: on the day before surgery
Locations:
city: New Taipei City
country: Taiwan
facility: TAIWAN
Study officials:
affiliation: none,specify Unaffiliated
name: Yu Hua Chou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810862: Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
Official title: A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: African American children
Lead sponsor: Children's Hospital of Michigan
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2008-12-18
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.


Eligibility criteria: Inclusion Criteria:

* African American children aged 2 to 17 years
* mild to moderate atopic dermatitis

Exclusion Criteria:

* m-EASI less than 3 at baseline
* allergy to Elidel or components
* use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
* previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
* active skin infections.
* immunocompromised patients.
* previous history of skin cancer or lymphoma
* any hypopigmentation in study areas
* pregnant or breastfeeding
* participation in another investigational trial

Primary outcomes:
measure: Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis
timeFrame: at baseline, one week and three weeks following treatment initiation
Secondary outcomes:
measure: modified IGA score
timeFrame: at baseline, one week and three weeks following initiation of therapy
measure: hypopigmentation scale score
timeFrame: baseline, one and three weeks following initiation of treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05411562: COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations
Official title: On-Demand Point-of-Care SARS-CoV-2 Genomic Sequencing to Support Nosocomial Outbreak Investigations: A Prospective Molecular Epidemiology Study in Montreal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Molecular Sequence Variation
Nosocomial Infection
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-06-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthcare workers in the institution during the study period.

Brief summary: This is a tertiary care hospital-based prospective molecular epidemiology study in Montreal, Canada. When nosocomial transmission was suspected by local infection control teams' investigations, SARS-CoV-2 viral genomic sequencing was performed locally for all putative outbreak cases and contemporary controls. Molecular and conventional epidemiology data were confronted in real time to improve understanding of COVID-19 transmission and reinforce or adapt prevention measures.

Detailed description: This study will include infected healthcare workers (HCW) and patients for whom a nosocomial infection in CHUM is suspected. The CHUM laboratory is responsible for COVID-19 diagnostic testing in all eligible HCW and patients. After initial diagnosis on standard PCR testing, samples are maintained at -80. Viral RNA is extracted and next-generation sequencing of the viral genome is performed using Nanopore long read sequencing platform. Preliminary data suggest that SARS-CoV-2 has a "molecular clock" of 2 single nucleotide polymorphism (SNP) per month. The analysis and between-isolate comparaison of those SNP among epidemiologically related cases will allow to support or refute the hypothesis of person to person nosocomial transmission. All infected patients will be matched 1:1 with contemporary community cases to provide a viral genome back catalog and better contextualize molecular epidemiology analyses. Molecular clusters will be reported to infection prevention and control teams and resulting interventions will be monitored.

Eligibility criteria: Inclusion Criteria:

* Hospitalized in the institution during the study period
* Healthcare workers in the institution during the study period

Exclusion Criteria:

* None

Primary outcomes:
measure: Outbreak control measures improvement
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Simon Grandjean Lapierre, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01445262: Drug Use Investigation for XYZAL®
Official title: Drug Use Investigation for XYZAL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-03
Enrollment: 10728
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese male and female subjects without age restriction who were considered appropriate to prescribe levocetirizine tablet according to the prescribing information were eligible for this surveillance study.

Brief summary: This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets before.


Eligibility criteria: Inclusion Criteria:

* Must be the first time for taking levocetirizine tablet

Exclusion Criteria:

* As this is PMS study, there are no exclusion criteria.

Primary outcomes:
measure: The number of adverse events in Japanese subjects treated with levocetirizine tablets
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: