louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05037721: Effects of Gargling With Green Tea on Oral Health of Stroke Patients
Official title: Oral Health Initiative With Green Tea,Gargling,Oral Health for Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Health
Keywords: green tea
gargling
oral health
stroke patients
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-09-08
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 1. Compare the effects of gargling with green tea on the oral health of stroke patients?
2. Compare whether gargling with green tea can reduce halitosis in stroke patients?
3. Compare whether gargling with green tea can reduce plaque index in stroke patients?

Detailed description: Before the intervention of green tea mouthwash, patients in the experimental group and the control group were tested for oral health status, bad breath and plaque degree, and received routine brushing guidelines. Patients in the experimental group received green tea mouthwash intervention twice a day for 7 day

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients over 20 years of age with acute cerebral stroke admitted by medical institutions.
* Stroke patients diagnosed by medical institutions were treated with the National Institute of Health Stroke Scale; NIHSS) score is 5-15, which is a moderate degree of stroke
* Able to perform mouthwash.
* Those who have passed the three-stage swallowing function screening.
* Those with stable medical condition.

Exclusion Criteria:

* Those who of medical institutes in the diagnosis of severe alzheimer.(ICD-10 code： G30.9)
* Those who severe mental retardation.
* Those has a history of mental illness.
* Those has unable to clearly express their wishes.
* Those has full mouth teeth less than six.
* Those has in the past more than a month use mouthwash.
* Those has treatment of the patients with gingivitis and periodontal disease, oral antibiotics or anti-fungal drugs.
* Those has unable to cooperate or applicable except of assessment tools.

Primary outcomes:
measure: The participants assess the patient's oral health status by the oral health assessment tool scale.
timeFrame: to evaluate the seventh day after use green tea gargle
Secondary outcomes:
measure: The participants assess the patient's degree of halitosis by the portable breath meter.
timeFrame: to evaluate the seventh day after use green tea gargle
measure: The participants assess the patient's the degree of dental plaque with the modified plaque index of "Turesky".
timeFrame: to evaluate the seventh day after use green tea gargle
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Li ya-wen
state: Beitou District
Study officials:
affiliation: member
name: Li ya-wen
role: STUDY_DIRECTOR
References:
Clinical trial NCT02844621: Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults
Official title: Comparison of Gut Microbiota Composition and Systemic Inflammatory Markers Prior to and Post-Proton Pump Inhibitor Use in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effects of a common over-the-counter medication, omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.

Detailed description: This study aims to enroll 25 healthy subjects from San Antonio, Texas and the surrounding area. Study participants will be asked to provide a blood and stool sample at baseline, complete a 14-day course of omeprazole (Prilosec®), and then complete a follow-up blood and stool sample.

Eligibility criteria: Inclusion Criteria:

* Age 60 years or older

Exclusion Criteria:

* No prior major gastrointestinal surgery
* No chronic daily use or any use within the past two months of the following medications: antibiotics, proton pump inhibitors, other acid reflux medications, probiotics, anti-inflammatory medications, anti-diarrhea medications, laxatives, anti-depressants, anti-anxiety medications, steroids, metformin, or biologic/immune modulating drugs

Primary outcomes:
measure: Change in fecal microbiota diversity following omeprazole use
timeFrame: 14 days
Secondary outcomes:
measure: Change in interleukin inflammatory markers following omeprazole use
timeFrame: 14 days
measure: Change in tumor necrosis factor-alpha following omeprazole use
timeFrame: 14 days
measure: Change in insulin-like growth factor-1 due following omeprazole use
timeFrame: 14 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: First Outpatient Research Unit, Medical Arts and Research Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Kelly R Reveles, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01496521: Chemoprevention of Esophageal Squamous Cell Carcinoma (ESCC) With Aspirin and Tea Polyphenols
Official title: Chemoprevention of Esophageal Squamous Cell Carcinoma With Aspirin and Tea Polyphenols: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell
Keywords: Aspirin
polyphenols
Chemoprevention
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this double-blind, randomized controlled clinical trial. Research project is planned to recruit 10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China, which has been known as a high incidence region of ESCC. All the participants receive endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained lesions (USLs). The location and size of each USL will be recorded followed by collecting biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months. Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six months and the second at 3 or 5 years later). The primary outcome measure was occurrence of high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the participants and adverse events.


Eligibility criteria: Inclusion Criteria:

1. age 40 to 60 years;
2. Lugol's chromoendoscopy showing at least one USL 1 cm or larger containing mild to moderate dysplasia and chronic inflammation;
3. subject neither pregnant nor intending to become pregnant during the study.

Exclusion Criteria:

1. current non-steroidal anti-inflammatory drugs (NSAID) therapy;
2. major intercurrent illness;
3. pregnancy;
4. invasive carcinoma;
5. any condition that could be worsened by aspirin or tea polyphenols.

Primary outcomes:
measure: occurrence of high grade dysplasia and invasive ESCC
timeFrame: at six months
Secondary outcomes:
measure: the mortality of the participants
timeFrame: The first interval will be at six months and the second at 3 or 5 years later.
measure: Number of participants with adverse events.
timeFrame: The first interval will be at six months and the second at 3 or 5 years later.
measure: occurrence of high grade dysplasia and invasive ESCC
timeFrame: at 3 or 5 years later
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Shu-Tian Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05379621: Socio-economic, Meteorological and Environmental Factors Associated With the Incidence of COVID-19
Official title: Socio-economic, Meteorological and Environmental Factors Associated With the Incidence of COVID-19 in the Alpes-Maritimes and the City of Nice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 28377
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of legal age or not residing in the Alpes Maritimes department between 03/01/2021 and 14/02/2021, i.e. 1078729 inhabitants in the Alpes Maritimes, including 342979 in the city of Nice

Brief summary: Socio-demographic factors in relation to the diagnosis of COVID cases are increasingly mentioned in the role of transmission, but unfortunately with a small number of conclusive publications on French data. Our objective is to analyse the distribution of cases according to these factors and their possible role during the first 6 weeks of 2021 when the Alpes Maritimes was the department with the highest incidence rate. The collaboration between ARS06 and the Public Health Department in the field of COVID-19 has made it possible to have a departmental bulletin for monitoring the evolution of the epidemic (incidence, screening, hospitalisation). Knowledge of the socio-demographic, meteorological and environmental factors associated with the transmission of SARS-CoV2 would make it possible to reflect on how to act on these factors and to implement a public health policy.


Eligibility criteria: Inclusion Criteria:

Any person, adult or not, residing in the Alpes-Maritimes between 03/01/2021 and 14/02/2021 with a COVID-19 diagnosis.

Exclusion Criteria:

Non resident in the Alpes-Maritimes

Primary outcomes:
measure: Weekly incidence rate of COVID-19 in the Alpes-Maritimes during the study period.
timeFrame: Between 03/01/2021 and 14/02/2021
Secondary outcomes:
measure: Weekly incidence rate of COVID-19 in the Alpes-Maritimes during the study period according to participants' social and economic factors
timeFrame: Between 03/01/2021 and 14/02/2021
measure: Weekly incidence rate of COVID-19 in the Alpes-Maritimes during the study period according to climatic factors
timeFrame: Between 03/01/2021 and 14/02/2021
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References:
Clinical trial NCT04070521: EEG Monitoring in the Emergency Department
Official title: Observational Study of EEG Monitoring of Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Drug Overdose
Substance Abuse
Alcohol Abuse
Keywords: Electroencephalogram
Opioids
Alcohol
Benzodiazepines
Alpha-2 agonists
Propofol
Ketamine
Marijuana
Neuromechanisms of intoxicants
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2019-08-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse.

Brief summary: This study seeks to investigate whether drug effects in suspected overdose patients could be identified using the electroencephalogram (EEG). From previous work it is known that different classes of anesthetic drugs have specific "EEG signatures" related to the drug mechanisms. Many of the drugs of abuse that are frequently encountered in overdose patients are similar or identical to anesthetic drugs. The hypothesis for this study is that the EEG could be used to characterize the brain effects of intoxicants using EEG in the ED setting. Such monitoring could one day help clinicians and first responders at the point-of-care make more informed decisions to improve the care of overdose patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse

Exclusion Criteria:

* Hemodynamic instability or other acute medical condition for which the primary treating team does not thing it would be appropriate or safe for the study staff to approach the patient
* The patient has an overt head trauma or deformity of the face which would preclude application of the forehead EEG monitoring lead
* The patient has dermatological issues or skin conditions on the forehead
* The patient has known dementia and/or mental impairment
* The patient is a prisoner
* The patient is an employee or student at one of the study sites.

Primary outcomes:
measure: Electroencephalogram (EEG)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Patrick L Purdon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04330521: Impact of the Coronavirus (COVID-19) on Patients With Cancer
Official title: Impact of the Coronavirus (COVID-19) on Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
COVID-19
Keywords: Coronavirus
COVID-19
Cancer
Life Change Events
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are diagnosed with any cancer diagnosis . We plan to enroll as many patients as possible in the survey portion of the study - we have no limitation of the numbers and do not require a specific number to participate although we hope to achieve at least 50 participants who fill out the survey.

Among survey participants, we plan to enroll 18-30 participants in semi-structured telephone interviews. These participants will be randomly selected among those who filled out the survey.

The research procedures are as followed:

1. Survey: An online survey link will include questions regarding the impact patients with cancer are experiencing during the coronavirus outbreak.
2. Semi-structured Interviews (18-30 participants): For those participants who state that they would like to participate in an interview, a random sample will be contacted.

Brief summary: The purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.

Detailed description: The global spread of coronavirus (COVID-19) is affecting cancer patients and their treatments. Cancer patients are among those at high risk of developing serious illness from an infection because their immune systems are often weakened by cancer and its treatments. Due to the growing coronavirus outbreak, patients clinic visits are being cancelled and many are facing social isolation and strict restrictions on their daily lives. We want to evaluate the impact of the coronavirus on the patient's well-being and their cancer care by assessing the delays in their medical care and any other unmet needs. We have created a survey that is available online for any patient with cancer to fill out voluntarily regarding their experiences to date. The survey is available at: https://stanforduniversity.qualtrics.com/jfe/form/SV_ctKS6ZSMYdEYoXX

Eligibility criteria: Inclusion Criteria:

1. The patients must be 18 years or older.
2. Patients who opt in to complete the survey.
3. Patients must have the capacity to verbally consent for the interview.

Exclusion Criteria:

1.Patients who under the age of 18 years old.

Primary outcomes:
measure: Number of participants who fill out the survey and participate in the semi-structured interviews.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT00836602: Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Official title: Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Men and women (not of child bearing potential) ages 18 to 45
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Women of child bearing potential
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

Primary outcomes:
measure: Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
timeFrame: 8 times within 27 days of the first dose
Secondary outcomes:
measure: Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)
timeFrame: After each dose panel
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05002621: Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
Official title: Exploratory Investigation of Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Asthma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will involve twenty adult (≥18yo) individuals with a diagnosis of severe eosinophilic asthma (SEA) who have been prescribed mepolizumab during their course of routine clinical care.

Brief summary: The purpose of this study is to identify gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA), and to determine the composition of immune cells present in the microenvironment of individuals with SEA after initiation of mepolizumab.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Diagnosis of SEA by a health care provider
* History of an absolute eosinophil count ≥ 300/mm\^3
* Prescription for mepolizumab provided during course of routine clinical care but mepolizumab not yet started

Exclusion Criteria:

* Age \< 18 years old.
* Pregnancy.
* Currently using or have used within 3 months of the initial baseline visit any biologic or immunomodulatory therapy with the exception of #3.
* Currently using or any prior use of rituximab.
* History of upper/lower respiratory tract infection or asthma exacerbation within the previous four weeks of the first baseline visit.
* Any prior history of malignancy, autoimmune disease, or immune deficiency.
* Any other significant medical issue as determined by the principal investigator.

Primary outcomes:
measure: Expressed gene transcripts
timeFrame: Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab
measure: Composition of immune cell subsets
timeFrame: Baseline and 4, 8, and 12 weeks post-initiation of mepolizumab
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thanai Pongdee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00781521: Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
Official title: A Pilot, Multicenter, Open Label, Non Comparative Study of the Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children With Tympanostomy Tubes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 6 months of age to \<12 years of age
* weight = or \>4.5 kg
* Patent tympanostomy tube(s) in the affected ear(s)
* Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin

Exclusion Criteria:

* Non-bacterial otic infection
* Known or suspected hypersensitivity to ofloxacin
* Cystic fibrosis
* HIV infection
* Neutropenia
* Receiving immunosuppressive therapy

Primary outcomes:
measure: Sponsor determined clinical cure of otitis media
timeFrame: 7 days
measure: Sponsor determined microbiological cure of otitis media
timeFrame: 7 days
Secondary outcomes:
measure: Investigator determined clinical cure
timeFrame: 7 days
measure: Overall per-subject microbiological outcome
timeFrame: 7 days
measure: Overall per pathogen microbiological outcome
timeFrame: 7 days
measure: sign and symptoms of otitis media
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References: