louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03785769: Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement
Official title: Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Universidade Ibirapuera
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.


Eligibility criteria: Inclusion Criteria:

* Patients with carious lesion of occlusoproximais in primary molars

Exclusion Criteria:

* Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
* Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.

Primary outcomes:
measure: Survival of restorations
timeFrame: 24 months
Secondary outcomes:
measure: Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration
timeFrame: Immediately after the restoration and 24 months
measure: Cost-efficacy
timeFrame: 24 months.
measure: Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale
timeFrame: Immediately after the treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Tamara Kerber Tedesco
state: SP
Study officials:
References:
Clinical trial NCT03953469: Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate
Official title: Investigating the Short-term Effects of Passiflora Incarnate and Mobile Audio-guided Meditation on Blood Pressure and Heart Rate in Naturopathic Medical Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Rate Fast
Blood Pressure
Keywords: passionflower
heart rate
blood pressure
Lead sponsor: University of Bridgeport
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to study the effects of one-time acute dosing of a solid extract of Passiflora incarnata, also known as Passionflower, on blood pressure and heart rate in students. Our hypothesis is that blood pressure levels and heart rates will decrease significantly in response to Passiflora incarnata.


Eligibility criteria: Inclusion Criteria: all University of Bridgeport students are invited to participate

Exclusion Criteria:

1. Those taking hypertensive medication
2. Those taking anti-anxiety medication, including MAOI medication
3. Those taking blood-thinning medication
4. Those who are pregnant
5. Those who could be pregnant
6. Those who will have surgery 2 weeks before the research date
7. Those who are scheduled to have surgery 2 weeks after the research date
8. Those who have consumed caffeine, food/tyramine containing foods, stimulant medication, cold medicine, decongestant medicine, antihistamine medicine, cough suppressants, alcoholic beverages, or stimulant energy drinks within 2 hours before the study period.

Primary outcomes:
measure: Change in blood pressure between baseline and 15 minutes
timeFrame: 15 minutes
measure: Change in heart rate between baseline and 15 minutes
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Bridgeport
name: Kimberly Sanders, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02546869: A Single-Arm Study to Evaluate Administration of Lebrikizumab by Participants or Caregivers in the Home Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multi-center, single-arm study is designed to evaluate clinical experience of participants (or caregivers) administering lebrikizumab at home in participants with asthma. Eligible participants will receive four doses of subcutaneous (SC) lebrikizumab every 4 weeks (q4w) up to Week 12. Primary analysis visit occurs at Week 13. After study treatment, all participants will complete a 12 week safety follow up. All participants will get training for the administartion of lebrikizumab using the device.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 75 years at Week -1
* Asthma diagnosis for greater than or equal to (\>=) 12 months prior to Week -1
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) of \>=40% predicted at Week -1 or Week 0 (Day 1; prior to entering treatment phase), based on an established spirometry reference equations
* Competent and willing, as determined by the investigator, to independently administer lebrikizumab at home. The investigator needs to confirm that the participant (or caregiver) will be able to follow the instructions to administer lebrikizumab
* Able and willing to take home the pre-filled syringes of lebrikizumab at the conclusion of Week 0 (Day 1) and store these according to the requirements highlighted within the Instructions for Use (IFU) document.

Exclusion Criteria:

* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Hospitalization for any reason, including acute exacerbation event, within 4 weeks prior to Week -1 or during the screening period
* Infection that required hopitalization, treatment with intravenous (IV) or intramuscular antibiotics within 4 weeks and oral antibiotics within 2 weeks prior to Week -1 or during screening
* Taken part in a previous clinical trial of lebrikizumab and discontinued from the trial prematurely or discontinued study drug prematurely due to an adverse event

Primary outcomes:
measure: Percentage of participants with adherence to each planned home administration
timeFrame: up to Week 13
Secondary outcomes:
measure: Percentage of participants who reported device complaints
timeFrame: up to Week 13
measure: Serum lebrikizumab concentration at Weeks 13 and 24
timeFrame: Week 13 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00793169: Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Official title: Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Keywords: squamous cell carcinoma of the head or neck
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a cross-sectional study of 20 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck requiring Mohs micrographic surgery.

Brief summary: The primary objective of this study is to (1) determine whether local injection of lidocaine used during Mohs surgery will elevate serum lidocaine concentrations to a level that could cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine occur after intralesional anesthesia on the face and neck. This study is a cross-sectional study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck requiring Mohs micrographic surgery. The study will consist of a brief questionnaire and blood draws during their Moh's surgical procedure.


Eligibility criteria: Inclusion Criteria

* Age: 18-75
* Basal cell carcinoma or squamous cell carcinoma of the head or neck
* Subjects are in good health
* Subjects that have the willingness and the ability to understand and provide informed consent for the use of their blood and communicate with the investigator

Exclusion Criteria

* Lidocaine sensitivity
* Bleeding disorder
* Pregnancy
* Medical conditions which would impair hepatic blood flow: congestive heart failure, liver dysfunction, peripheral vascular disease.
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness

Primary outcomes:
measure: The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alam M, Ricci D, Havey J, Rademaker A, Witherspoon J, West DP. Safety of peak serum lidocaine concentration after Mohs micrographic surgery: a prospective cohort study. J Am Acad Dermatol. 2010 Jul;63(1):87-92. doi: 10.1016/j.jaad.2009.08.046. Epub 2010 May 11.
Clinical trial NCT01726569: Post-operative Satisfaction With Glaucoma Surgery Trial
Official title: A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
educational intervention
post-operative satisfaction
knowledges
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1. Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.
2. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.
3. Investigate the effect factors of postoperative satisfaction.

Detailed description: Glaucoma is the leading cause irreversible blindness worldwide, but only less than 10% glaucoma patients were diagnosed in the country of Asia areas. In the country of China, patients who are low educational level and less known acknowledgement and information have less known glaucoma. In the help of the government and some international non-governmental organizations(NGOs), a lot of people in the country know the cataract, and the operability of cataract is increase. Because vision loss usually development after operation for glaucoma. If patients did not understand this, they may be not only do not accept operation, but also affect operability of cataract. We hope the educational intervention for glaucoma can increase the degree of satisfaction in glaucoma patients.

Eligibility criteria: Inclusion Criteria:

* age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy

Exclusion Criteria:

* patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia

Primary outcomes:
measure: postoperative satisfaction rate in both group
timeFrame: after surgery up to 6 weeks
Secondary outcomes:
measure: knowledge about glaucoma
timeFrame: before surgery and after surgey 1 week and 6 weeks
measure: willingness to recommend surgery
timeFrame: after surgery 1 week and 6 weeks
measure: personality in both groups
timeFrame: Baseline (before surgery)
measure: intraocular pressure and visual acuity in both groups
timeFrame: before surgery and after surgery 1week and 6 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS
name: Nathan Congdon, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492868: Sinusitis in Children and the Nasopharyngeal Microbiome
Official title: My Nose Study: Sinusitis in Children and How Virus Infections Promote Secondary Bacterial Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Keywords: sinusitis
upper respiratory infection
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-12-15
Enrollment: 323
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children

Brief summary: The purpose of this study is to investigate the relationship between viral infections of the upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the risk of acute bacterial sinusitis over a one year period. The investigators will determine the incidence of acute bacterial sinusitis post viral upper respiratory infection and identify the viral antecedent infections and other risk factors which predispose to infection and ultimately design strategies to reduce the burden of disease and antimicrobial resistance.


Eligibility criteria: Inclusion Criteria:

* Children 4 to 7 years of age
* Healthy
* English-speaking parent/guardian -

Exclusion Criteria:

* Any underlying condition which would predispose them to the development of sinusitis including congenital or acquired immunodeficiencies
* Craniofacial abnormalities
* Cystic fibrosis
* Allergic rhinitis or a previous episode of chronic sinusitis.

Primary outcomes:
measure: Incidence of acute bacterial sinusitis in children 49 to 84 months of age (which is the peak age incidence of sinusitis) as a complication of an antecedent viral upper respiratory infection.
timeFrame: Over a 1 year time frame
Secondary outcomes:
measure: Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis.
timeFrame: Over a 1 year time frame
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Pediatrics at 20 S. Park St
state: Wisconsin
city: Madison
country: United States
facility: UW Health West Towne Pediatrics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02189668: Non-operative Management of Pediatric Appendicitis With an Appendicoltih
Official title: Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Appendicitis
Keywords: Appendicitis
Non-operative
Children
Appendicolith
fecalith
Pediatrics
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

Detailed description: This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Eligibility criteria: Inclusion Criteria:

* Age : 7-17 years
* Abdominal pain \</= 48hours prior to receiving antibiotics
* White Blood Cell Count \>5 but \< 18
* US or CT confirmed early appendicitis plus:

  * US: \</=1.1 cm in diameter, presence of appendicolith
  * CT: \</= 1.1cm in diameter, presence of appendicolith

Exclusion Criteria:

* Positive urine pregnancy test
* Pain \> 48 hours prior to first antibiotic dose
* Diffuse peritonitis
* History of chronic intermittent abdominal pain
* White Blood Cell count ≤ 5 or ≥ 18
* Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Primary outcomes:
measure: Number of Participants That Did Not Have an Appendectomy
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Complicated Appendicitis
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Peter C Minneci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031. Epub 2014 Apr 13.
citation: Mahida JB, Lodwick DL, Nacion KM, Sulkowski JP, Leonhart KL, Cooper JN, Ambeba EJ, Deans KJ, Minneci PC. High failure rate of nonoperative management of acute appendicitis with an appendicolith in children. J Pediatr Surg. 2016 Jun;51(6):908-11. doi: 10.1016/j.jpedsurg.2016.02.056. Epub 2016 Mar 2.
Clinical trial NCT04143568: Circulating Progenitor Cells Levels in Periodontal Disease Patients
Official title: Analysis of Circulating Progenitor Cells Levels in Periodontal Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disease
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 167
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 79 healthy subjects, 88 patients with CP. Lipid profile and levels of CD133 and C-reactive protein (CRP) were evaluated.

Brief summary: Recently, a key role played in the ethiology of periodontitis has been highlighted by a subtype of stem cells derived from bone marrow, the circulating endothelial progenitor cells (EPCs). EPCs possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. Among the main markers for the analysis of EPCs levels are CD34+, CD133+ and the kinase insert domain-containing receptor (KDR). CD34+ and CD133+ originate from hematopoietic stem cell antigens whereas KDR is a specific marker of endothelial cells. More specifically, CD34+ and CD133+/ KDR+ allows less mature and mature EPCs to be evaluated.

Detailed description: The aim of the present study was to investigate the association between endothelial progenitor cells (EPCs) levels subtype (CD133+/KDR+), in patients with periodontitis.

Furthermore, the objective was to determine if the periodontal status influenced CD133+/KDR+ levels.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives

  * Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
  * Status of pregnancy or lactation
  * Previous history of excessive drinking
  * Allergy to local anaesthetic
  * Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Evaluation of endothelial progenitor cells level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
References: