louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06287060: Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining
Official title: BLEACHING EFFECT OF STRAWBERRY EXTRACT VERSUS HYDROGEN PEROXIDE IN PATIENTS WITH EXRINSIC STAINING A RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bleaching Effect and Postoperative Sensitivity of Strawberry Extract
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 40
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: with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity.

Detailed description: The whitening effect of strawberry is due to the presence of malic acid, which acts as a natural astringent to remove surface discoloration. The ellagic acid content in strawberry is ranging from 0.43 to 4.64 mg/g dry weight. The more amount of ellagic acid will produce more potential OH clusters as a powerful oxidizer thus make the more effective bleaching process. Ellagic acid releases the OH and H radicals which will react with the tooth enamel organic molecules and disrupt the electron conjugation, as well as changing the energy absorption in the tooth enamel organic molecules to form smaller organic molecules with a lighter color. Ellagic acid has an OH cluster, not COOH cluster like any other acids. The electronegativity of the OH group will be easier to break and react with the organic molecules of tooth enamel.

Eligibility criteria: Inclusion Criteria:

Participant inclusion criteria:

1. At least 18 years old.
2. Good general and oral health.
3. six present maxillary anterior teeth.

Tooth inclusion criteria:

1. yellowing of teeth due to age.
2. stains due to coffee or tea.
3. light tetracycline stain.

   * Exclusion Criteria:

participant exclusion criteria:

1. patients undergoing radiotherapy or chemotherapy.
2. Pregnant females or breast feeders.
3. Bruxism and patients who reported tooth sensitivity.

Tooth exclusion criteria:

1. Hypoplastic enamel.
2. carious lesion.
3. sensitive recession area or sensitive tooth.
4. Amalgam staining.
5. Non vital tooth.
6. Discolration due to pulp trauma or necrosis.
7. presence of non carious cervical lesion.

Primary outcomes:
measure: Bleaching effect of strawberry extract versus Hydrogen peroxide.
timeFrame: immediately , one week and one month after application.
Secondary outcomes:
measure: post operative sensitivity.
timeFrame: immediately after bleaching agent removal , 24 hours after application.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03722160: Clinical Study of the Solo Tympanostomy Tube Device
Official title: Clinical Study of the Solo Tympanostomy Tube Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ear Infection
Otitis Media
Lead sponsor: AventaMed DAC
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Detailed description: The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.

Eligibility criteria: Inclusion Criteria:

* Listed for bilateral tympanostomy tube insertion

Exclusion Criteria:

* Anatomy that precludes sufficient visualisation of both the left and right eardrum
* Narrow ear canals
* Anatomy that precludes safe access to both the left and right eardrum
* Membrane \>25% sclerosis
* Congenital or craniofacial abnormalities
* No available baseline audiometry and tympanometry

Primary outcomes:
measure: Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device
timeFrame: Intra-operative
measure: Rate of Adverse Events
timeFrame: Intra-operative, 2-6 weeks post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo-Garofolo
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
Study officials:
affiliation: Queen's Medical Center
name: Matija Daniel
role: STUDY_CHAIR
References:
Clinical trial NCT03871660: Flash Glucose Measurement in Patients on Total Parenteral Nutrition
Official title: What Happens to Frequently Measured Glucose Measures in Patients, Both With and Without Diabetes, Who Are Receiving Total Parenteral Nutrition (TPN).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Total Parenteral Nutrition
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: IV nutrition is a means of providing all the nutritional requirements of people who have severe bowel disease. At least 10% of people on longer term IV nutrition also have diabetes and IV nutrition includes delivering glucose directly to large veins. Unsurprisingly this causes elevated blood glucose levels, particularly in people with diabetes. This can make treatment of hyperglycaemia more challenging. As a result this study aims to use a flash glucose monitoring device, the FreeStyle Libre pro, to investigate what happens to glucose levels in patients receiving IV nutrition. We will look at this trend in 5 patients with diabetes and 5 patients without diabetes receiving IV nutrition.


Eligibility criteria: Inclusion Criteria:

* Participants receiving TPN in Leeds with or without diabetes

Exclusion Criteria:

* Patients not receiving TPN
* Patients who do not speak English
* Patients who are unable to give consent

Primary outcomes:
measure: Hyperglycaemia
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Diabetes, Endocrinology and General Medcine Department St James Hospital
state: West Yorkshire
Study officials:
References:
Clinical trial NCT04519060: Eye Shields for Infants After Dilated Exam
Official title: An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Newborn, Disease
Pain
Retinopathy of Prematurity
Eye Diseases
Keywords: eye shield
eye protector
eye patch
eye mask
phototherapy
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 106
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

Detailed description: Neonatal eye examinations are the standard of best practice in pediatrics. In the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. There is anecdotal and clinical evidence that infants experience stress after eye dilation. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

Eligibility criteria: Inclusion Criteria:

* Chronological age 0-12 months
* Infants who require dilated eye exams
* Parent or legal guardian consent/permission granted

Exclusion Criteria:

* More than a two-week interval between dilated eye exams
* Prior or ongoing medical treatment or therapy for the eye(s)
* Functional blindness diagnosed by eye exam

Primary outcomes:
measure: Number of stress events
timeFrame: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Secondary outcomes:
measure: Number of stress events amongst covariates
timeFrame: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
References:
Clinical trial NCT00762060: Multicenter Infection Surveillance Study Following Colorectal Procedures
Official title: Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Infection
Keywords: colorectal surgery
Lead sponsor: Halyard Health
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical patients Colorectal procedures

Brief summary: This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.

Detailed description: This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal procedures.

Eligibility criteria: Inclusion Criteria:

* Men and women, \>18 years of age;
* Scheduled for elective colon procedure;
* Ability to complete patient survey questionnaires;
* Provision of informed consent

Exclusion Criteria:

* Patients with a prior allergic reaction to Morphine, Demerol, Dilaudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
* Procedures for hemorrhoids;
* Inability to perform follow up assessments

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days postoperative
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Average 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Piedmont Medical Center
name: Jay Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175160: Predictability of the Ability to Perform an Emergency Stop
Official title: Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Total Knee Arthroplasty
Keywords: Driver reaction time
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.


Eligibility criteria: Inclusion Criteria:

* 18-85 y
* valid driving license
* male and female
* right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
* capability to walk with or without a walking stick

Exclusion Criteria:

* myocardial infarction/Apoplexia \< 6 months
* Total knee arthroplasty \<5 weeks
* New York Heart Association 3/4
* lacking drivers' license
* peripheric sensomotor deficit \<3/5 British Medical Research Council
* new fracture of the lower extremity or spine
* systemic or metastasised Cancer
* drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Tilidin)

Primary outcomes:
measure: Correlation of knee functionality and braking performance
timeFrame: Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Orthopaedics
Study officials:
affiliation: University Hospital Tuebingen
name: Ulf K Hofmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hau R, Csongvay S, Bartlett J. Driving reaction time after right knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):89-92. doi: 10.1007/s001670050192.
Clinical trial NCT02136160: Population-based Intervention to Promote Health in Elementary Schools
Official title: Rakuns: Setting-based Prevention Program to Promote Positive Experiences in Health Promoting Lifestyle Choices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion
Keywords: elementary school
children
health promotion
teachers
prevention
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Child Health Foundation
name: Johnson & Johnson Citizenship Trust, in cooperation with Johnson & Johnson GmbHInitiative Rückenwirbel e.V., Gmund
name: Platform for Diet and Physical activity e.V. (peb)
First posted: 2014-05-12
Enrollment: 249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Primary purpose: PREVENTION

Brief summary: Population based intervention at elementary school setting aimed at contributing, to a major extent, to health education and health promotion for children aged approximately 5-10 years in Germany. Health education units with theoretical and practical exercises for use by teachers, children, and parents addresses physical activity, sedentary behavior, relaxation, nutrition, personal hygiene and body awareness.

Main questions of the pilot are:

Does health promotion take on an important role in primary schools? How do teachers evaluate training materials, homepage, content and framework conditions? How do teachers assess the efficiency of teaching units?

Detailed description: The program is based on actual cognitions and methods of the early education science. In the pilot phase study part (3/2013-5/2013) the investigators evaluated 210 classes of five states in Germany: NRW, Thüringen, Berlin, Sachsen-Anhalt, Schleswig-Holstein.

The long-term aim of this project is to provide an innovative concept based on current concepts in social studies and science that addresses health education of pupils in elementary schools.

Eligibility criteria: Inclusion Criteria:

* teacher of intervention-school

Exclusion Criteria:

* absence of consent to participate

Primary outcomes:
measure: Change of health related behaviour due to intervention
timeFrame: After 6 weeks of intervention period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06622460: VET Evaluation: Healthy
Official title: Experimental Evaluation of the Virtual Eggs Test on Healthy Participants
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant&#39;Anna di Pisa
First posted: 2024-10-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study involving healthy participants aims to validate the Virtual Eggs Test (VET) as a tool for measuring hand dexterity and grip force control. This part of the study focuses on determining the test's reliability and validity in a population without motor impairments. Healthy participants will perform the VET using both their dominant and non-dominant hands across two sessions. The purpose is to establish baseline performance metrics for comparison with stroke patients and to assess the test's usability in clinical settings.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 85 years.
* No motor deficits.
* Adequate cognitive and language abilities to understand the experiment and follow instructions.
* Signed informed consent.

Exclusion Criteria:

* Significant visual or oculomotor impairments.
* Comorbidities or disabilities that may interfere with the study, such as multiple sclerosis, Parkinson's disease, or muscle tone disorders.
* Cardiopulmonary or circulatory pathologies.
* Pregnancy or breastfeeding.
* Psychiatric comorbidities.
* Difficulty understanding the Italian language.
* Lack of cooperation.
* Consumption of alcohol or diuretics before the test

Primary outcomes:
measure: Threshold from the Virtual Eggs Test (VET)
timeFrame: First Session (Test)
measure: Threshold from the Virtual Eggs Test (VET)
timeFrame: Second Session (Re-Test)
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Fondazione Don Carlo Gnocchi ONLUS
Study officials:
References:
Clinical trial NCT02609360: Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming
Official title: Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Acute Respiratory Failure
ARDS
ECMO
Lung transplantation
Acid-Base Equilibrium
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Crystalloid solutions modify acid-base equilibrium according to their electrolyte composition. Moreover, it has been suggested that these alterations are generated by the difference between the solution strong ion difference (SID) and the plasma bicarbonate level. An increased risk of acute kidney injury and renal replacement therapy has been associated to the infusion of chloride rich crystalloids. This study aims to compare, in patients with acute respiratory failure undergoing ECMO support, the effects on acid-base status and renal function of crystalloids commonly employed for circuit priming to a balanced solution created with a SID equal to patients' bicarbonate level.


Eligibility criteria: Inclusion Criteria:

* Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria:

* None

Primary outcomes:
measure: Variation in Acid-Base Equilibrium (Base Excess)
timeFrame: First 24 hours after ECMO start
Secondary outcomes:
measure: Variation in Acid-Base Equilibrium (pH)
timeFrame: First 24 hours after ECMO start
measure: Variation in Renal Function
timeFrame: First 24 hours after ECMO start
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Pietro Caironi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04919460: Research on Optimization and Evaluation of Oral Cancer Screening Methods
Official title: Research on Optimization and Evaluation of Oral Cancer Screening Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Oral Cancer
Keywords: Oral cancer
Screening Method
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected.

Detailed description: An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. That is, inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed. This is also the commonly used screening method for oral cancer now; (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. That is, toluidine blue staining is performed at the same time as the inspection and palpation of the oral cavity and neck of the screening object. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected. Finally, we will carry out prospective controlled population studies in high-risk areas and non-high-risk areas to further evaluate the effectiveness and feasibility of screening method after selection.

Eligibility criteria: Inclusion Criteria:

* aged 40-69 years old.

Exclusion Criteria:

* No.

Primary outcomes:
measure: The rate of participants being detected as positive
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: