louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02243046: The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
Official title: The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Plaque and Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 162
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: This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.


Eligibility criteria: Inclusion Criteria

1. Subjects, ages 18-70, inclusive.
2. Availability for the six-month duration of the clinical research study.
3. Good General health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Antibiotic use any time during the one-month period prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Dental prophylaxis during the past two weeks prior to baseline examinations.
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome.
11. An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Pregnant or lactating subjects.

Primary outcomes:
measure: Gingivitis Scores
timeFrame: Baseline
measure: Gingivitis Scores
timeFrame: 3 months (from Baseline)
measure: Gingivitis Scores
timeFrame: 6 months (from Baseline)
measure: Dental Plaque Scores
timeFrame: Baseline
measure: Dental Plaque Scores
timeFrame: 3 months (from Baseline)
measure: Dental Plaque Scores
timeFrame: 6 months (from Baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Spa Dental
Study officials:
References:
Clinical trial NCT06887946: Effectiveness of Medical Coaching in Enhancing Periodontal Health and Lifestyle
Official title: Effectiveness of Medical Coaching in Enhancing Periodontal Health and Lifestyle: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Medical Coaching
Periodontitis
Stress
gingival health
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Periodontitis is a chronic inflammatory disease that adversely influences the supporting tissues of the teeth. It is primarily characterized by the accumulation of bacterial plaque and the host immune response. Traditional periodontal therapy emphasizes the central roles of both oral hygiene education and risk factor management; however, maintaining a long-term optimal behavioral compliance remains challenging.

The purpose of this Randomized Controlled Trial is to assess how effective is Medical Coaching on Oral Health (MCOH) in improving plaque control (PCR) and gingival health (GBI) in patients with periodontitis after one month, in comparison to traditional oral hygiene instructions (OHI).

Detailed description: The baseline assessments included periodontal status, PCR, GBI (describe the achronym) and a systematic questionnaire on lifestyle factors (smoking, alcohol, food, exercise, sleep, and stress). The intervention group received tailored MCOH sessions that comprised goal-setting, emotional hurdle assessment and action planning, whereas the control group received conventional OHI.

Eligibility criteria: Inclusion Criteria:

* Periodontitis Patients

Exclusion Criteria:

* Patients who do not wish to participate in the study.

Primary outcomes:
measure: Plaque Control Record (PCR) .
timeFrame: 30 days
measure: Gingival Bleeding Index (GBI)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Anna Antonacci
Study officials:
affiliation: University of Bari Aldo Moro
name: Giuseppe D'Albis Dr, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227746: A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib
Keywords: Advanced gastro-intestinal stromal tumors
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-10-25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian patients with advanced gastro-intestinal stromal tumors (GIST) treated with imatinib.

Brief summary: Imatinib is the current standard treatment for advanced GIST. Previous studies have shown that GIST genotype was associated with treatment outcomes with exon 11 having superior outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response rate was higher at when imatinib was given at 800mg daily compared with the standard dose of 400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response in metastatic GISTs is intriguing, more information is needed before mutation testing is adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate, overall survival does not appear to be better with high-dose therapy. The investigators propose to conduct a retrospective analysis of mutational analysis on patients with GIST and determine the relationship between patient response and imatinib dose.


Eligibility criteria: Inclusion Criteria:

1. Histologic diagnosis of advanced stage or metastatic GIST
2. Asian patient (as defined by the investigator)
3. First line treatment with imatinib
4. Availability of tumor samples for kit mutation analysis
5. Availability of tumor response rate and or time to progression data

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: Tornillo L, Terracciano LM. An update on molecular genetics of gastrointestinal stromal tumours. J Clin Pathol. 2006 Jun;59(6):557-63. doi: 10.1136/jcp.2005.031112.
citation: Heinrich MC, Corless CL, Duensing A, McGreevey L, Chen CJ, Joseph N, Singer S, Griffith DJ, Haley A, Town A, Demetri GD, Fletcher CD, Fletcher JA. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003 Jan 31;299(5607):708-10. doi: 10.1126/science.1079666. Epub 2003 Jan 9.
Clinical trial NCT05885269: Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata
Official title: Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alopecia Areata
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (\>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value \<0.05 as significant, was used.


Eligibility criteria: Inclusion Criteria:

* Patients age 20 to 50 years
* Both male and female
* Duration of illness less than 2 months
* those who never received any treatment before

Exclusion Criteria:

* Patients having duration of alopecia greater than 2 months
* Atypical alopecia areata i.e., Alopecia universalis etc
* Hypersensitivity history to topical corticosteroids or tacrolimus
* patients taking any systemic immune suppression
* pregnancy/lactation

Primary outcomes:
measure: The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Danyal Sajjad
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT00461669: Hip Fracture Characterization With Ultrasound Exam
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Keywords: hip
fracture
ultrasound
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Hip fractures are usually classified according to their X-ray as subcapital, pertrochanteric. We examine hip fractures with ultrasound in order to characterize the fractures with several parameters.


Eligibility criteria: Inclusion Criteria:

* patients over 50 years with x rays showing a hip fracture

Exclusion Criteria:

* previous fracture or surgical intervention in the hip
* fracture over 3 days old
* pregnancy
* flexion contracture of hip

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Alon Burg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02918669: Study to Investigate the Long Term Survivorship of Coflex
Official title: Study to Investigate the Long Term Survivorship of Coflex CT Study: Sub-Analysis of 24 Month Spinous Process Fractures Via Post-60 Month CT Scan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fractures
Lead sponsor: Paradigm Spine
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.

Detailed description: This is a prospective, multi-center, single-arm, radiographic evaluation of all coflex IDE patients who presented with a spinous process fracture at 24 months as identified by independent radiographic review (using X-ray or CT). All patients were enrolled and followed through 60 months under the IDE and extended follow-up protocol.

The specific objective of this CT Study is to perform a sub-analysis of the patients with 24 month spinous process fracture(s) via a CT scan at post-60 months. A CT Scan will be performed and analyzed by an independent radiographic review lab for evidence of fracture or healing at the long term timepoint.

Eligibility criteria: Inclusion Criteria:

* Participant in coflex IDE Study
* Willing and able to give informed consent
* Spinous process fracture identified by site and/or radiographic lab at 24 months

Exclusion Criteria:

* Subjects who died, were withdrawn or withdrew consent to participate in the study
* Subjects who are pregnant, or planning to become pregnant, during the course of this study
* Subjects who have cancer, whether active or in remission

Primary outcomes:
measure: Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan
timeFrame: Post-60 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Paradigm Spine
name: Hal Mathews, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02289469: PictureRx: Improving Medication Safety in Health Disparity Populations
Official title: PictureRx: Improving Medication Safety in Health Disparity Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Reconciliation
Lead sponsor: PictureRx, LLC
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2014-11-13
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medication safety is an important concern in hospital Emergency Departments (EDs), which provide approximately 136 million patient visits annually in the US. An accurate list of the patient's medications is often needed to inform medical decision-making. Moreover, health care facilities are required to provide patients with an accurate, reconciled list of their medications upon completion of the visit. However, for 37-87% of patients in the ED, errors are present in the documented medication list, and patients often leave without an updated list of their medications or a good understanding of their self-care instructions. This increases the risk of harmful adverse drug events. Health disparity populations, who are more likely to seek care in EDs and who more often have difficulty providing a complete medication history, are disproportionately affected.

Health information technology has the potential to improve medication safety in this setting. PictureRx is an internet-based platform designed to improve medication management in vulnerable populations. It allows users to generate illustrated medication lists in an easily-understood, patient-centered format, in either English or Spanish. The investigators have developed a process for importing prescription fill data from the Surescripts Medication History service, which covers 96% of US pharmacies, into the PictureRx platform. The investigators are developing a mobile tablet PC-based medication history platform that receives and processes the Surescripts data, as well as prompts verification and additional information about the medication regimen.

This trial will assess the effect of the PictureRx medication history platform on the accuracy and efficiency of the medication reconciliation process, as well as patient understanding and satisfaction, in hospital Emergency Departments.


Eligibility criteria: Inclusion Criteria:

* Prescribed one or more prescription medications

Exclusion Criteria:

* Too ill to complete informed consent process

Primary outcomes:
measure: Number of Participants With Changes/Updates in Medication List
timeFrame: 1 day
Secondary outcomes:
measure: Patient Understanding
timeFrame: 1 week
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnatti
state: Ohio
Study officials:
affiliation: PictureRx, LLC
name: Dane Boyington, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03820869: The Effect Of Occupational Therapy On Sensory-Based Feeding Problems
Official title: The Effect Of Occupational Therapy On Sensory-Based Feeding Problems Of Children Wth Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding Disorder
Autism Spectrum Disorder
Sensory Integration Disorder (Disorder)
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 18
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.

Detailed description: Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.

Eligibility criteria: Inclusion Criteria:

* ASD
* Feeding problems

Primary outcomes:
measure: Dunn Sensory Profile
timeFrame: 8 weeks
Secondary outcomes:
measure: BAMBİ
timeFrame: 8 weeks
measure: STEP
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00520169: Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine
Official title: A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: bioavailability
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Detailed description: To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.

Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* under 18 years

Primary outcomes:
measure: ketamine pharmacokinetics
timeFrame: multiple
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Javelin Pharmaceuticals
state: Massachusetts
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02832869: Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation
Official title: Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation Scale
Adenoma Detection Rate
Keywords: Polyp detection rate
Adenoma detection rate
Boston Bowel Preparation Scale
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by Wechat or short message service (SMS) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced education groups received additional education via reminders by Wechat or SMS 2 days before colonoscopy. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.


Eligibility criteria: Inclusion Criteria:

* aged 18-80 years
* can access to Wechat themselves or through close family members living in the same household

Exclusion Criteria:

* inpatients
* pregnancy
* breast feeding
* history of colorectal surgery
* patients allergic to PEG-ELS based laxatives

Primary outcomes:
measure: Quality of bowel preparation using Boston Bowel Preparation Scale
timeFrame: 1 day
Secondary outcomes:
measure: polyp detection rate
timeFrame: 1 day
measure: Patient compliance using a pre-procedure questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Kang X, Zhao L, Leung F, Luo H, Wang L, Wu J, Guo X, Wang X, Zhang L, Hui N, Tao Q, Jia H, Liu Z, Chen Z, Liu J, Wu K, Fan D, Pan Y, Guo X. Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Mar;14(3):429-435.e3. doi: 10.1016/j.cgh.2015.09.038. Epub 2015 Oct 20.
citation: Lee YJ, Kim ES, Choi JH, Lee KI, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy. 2015 Nov;47(11):1018-27. doi: 10.1055/s-0034-1392406. Epub 2015 Jul 16.