louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02069574: Diagnosis of Periodontal Disease Using Genetic Marker in Saliva
Official title: Identification of Novel Periodontal Disease Biomarkers Using microRNA Expression in Saliva
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the present study is to identify the novel periodontal disease biomarkers using differentially expressed microRNA in the saliva. The severity of chronic periodontal diseases and the time of pre- and post-treatment are major classification criteria. The obtained data will secure the foundation for the development of a new non-invasive diagnostic methods for early diagnosis \& prognosis prediction of periodontal disease.


Eligibility criteria: Inclusion Criteria:

A. Severe Periodontal Disease

* Patients with chronic severe periodontitis
* Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
* subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing

A. Moderate Periodontal Disease

* Patients with chronic moderate periodontitis
* Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
* subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing

C. Healthy Control

* Healthy periodontal patients ( more than 20 permanent teeth are present , in all parts of deep periodontal pockets measuring 4mm or less, and height is 2mm or less clinical attachment person)
* subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing

Exclusion Criteria:

* Received periodontal treatment within the last six months
* recently taken antibiotics within 3 months if you need a prescription antibiotic prophylaxis
* taking the drug can affect periodontal status for a long period of time
* pregnant or breastfeeding
* In case of oral inflammatory mucosal disease (Lichen planus, etc.)
* A history of alcoholism or drug abuse if
* other special systemic disease (high blood pressure)
* ages under 18

Primary outcomes:
measure: Expression level of MicroRNAs using Microarray
timeFrame: Change from Baseline in expression level of MicroRNAs at 1,6,12 months
Secondary outcomes:
measure: Expression level of cytokines using multiple cytokine analysis
timeFrame: Change from Baseline in expression level of cytokines at 1,6,12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
Study officials:
affiliation: Asan Medical Center
name: Su-Hwan Kim, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02597374: EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE)
Official title: Exploration du système Des Neurones-miroirs Par Enregistrement EEG du Rythme mu Chez l'Enfant Atteint de lésion cérébrale unilatérale Lors d'Action, d'Observation et d'Imagination d'Action du Membre supérieur. " Action-Observation-EEG "
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Child
Keywords: Electroencephalography
mu rhythm
Sensorimotor Cortex
Unilateral Cerebral Palsy
Child
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-11-05
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.


Eligibility criteria: Inclusion Criteria:

* unilateral cerebral injury
* hemiplegia

Exclusion Criteria:

* visual or mental or cognitive impairment
* no health insurance

Primary outcomes:
measure: Change measures of mu rhythm desynchronization (i.e. alpha band power) before the action execution or action observation and after the action execution or action observation
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
Study officials:
affiliation: University Hospital, Angers
name: NGUYEN THE TICH Sylvie, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06880874: A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)
Official title: A Clinical Study to Evaluate the Relative Bioavailability of Enlicitide Formulations in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.


Eligibility criteria: Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
* Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
* Has history of cancer (malignancy)
* Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 24 hours post dose
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Maximum Plasma Concentration (Cmax) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 14 days
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 8 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion ( Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01106274: The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy
Official title: Study of the Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bullous Keratopathy
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown potential to improve the signs and symptoms of bullous keratopathy .The objective of this study is to demonstrate the effects of C3R to treat bullous keratopathy.


Eligibility criteria: Inclusion Criteria:

* patients with bollous keratopathy

Exclusion Criteria:

* corneal scarring or contemporary eye disease affecting VA were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03740074: Personal Activity Intelligence (PAI) Pilot
Official title: Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Diabetes
Hypertension
Dyslipidemias
Cardiovascular Diseases
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective pilot
Primary purpose: TREATMENT

Brief summary: Pilot study to evaluate the use of the Personal Activity Intelligence (PAI) score in a clinical setting.

Detailed description: This is a pilot project to evaluate the feasibility of a larger study to evaluate the effectiveness of Personal Activity Intelligence (PAI) score in patients with chronic disease, as an adjunct to lifestyle medical therapy.

The PAI score is a proprietary formula developed by PAI Health (PH) to aid physical fitness. A PAI score calculation uses biometrics obtained via a device that measures heart rate and steps. For this study, Mio Slice, a commercial wrist worn device will be utilized to obtain data which will be linked to a smart phone. Data from the smart phone app will be accessed by PAI Health. Feedback information will be given to the participants to encourage increased physical activity.

The short-term aim of this study is to evaluate the logistics of utilizing PAI in the patient setting.

The data obtained from this study will be utilized to devise a larger study to evaluate the utility of PAI in patients with chronic disease who are receiving lifestyle medical therapy.

Eligibility criteria: Inclusion Criteria:

* Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
* Participants must own a smart phone and feel comfortable managing apps on their smart phone.
* Participants must be willing and able to register online with PAI Health (PH)
* Participants must be willing to wear a wrist device around the clock, except when charging or bathing for 12 weeks.
* Participants must have at least one of the following diagnoses:
* overweight / obesity
* diabetes or prediabetes
* hypertension or pre-hypertension
* abnormal lipids
* cardiovascular disease

Exclusion Criteria:

* Patients with angina or poor exercise tolerance, based on the evaluation by the PI, will be excluded from the study.

Primary outcomes:
measure: App utility
timeFrame: 12 weeks
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Diastolic blood pressure
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Personal Activity Intelligence (PAI) Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: David S Drozek, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06614374: Fish Oil for Cognitive Function, Sleep Quality, and Bone Density
Official title: Effects of N-3 Fatty Acids on Cognitive Function, Sleep Quality, and Bone Mineral Density in Diabetic Patients: an Ancillary Study of the Precision Nutritional Management for Diabetes (PNMD) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Sleep
Bone Mineral Density
Keywords: Fish oil
Omega-3 fatty acids
cognitive function
sleep quality
bone density
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 415
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. This ancillary study is being conducted among PNMD participants and will examine whether fish oil supplements affect A) cognitive function, B) sleep quality, and C) bone mineral density. Cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants. The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone density.


Eligibility criteria: Inclusion Criteria:

1) diagnosed type 2 diabetes according to WHO diagnostic criteria or those on the use of diabetic medications; 2) between 40 and 75 years old (postmenopausal women); 3) have never used n-3 PUFA supplements before or have stopped using them for more than six months.

Exclusion Criteria:

1) type 1 diabetes; 2) coronary heart disease, stroke, cancer, hepatic or kidney disease; 3) pregnancy or lactation; 4) allergy to fish; 5) have participated in other clinical trials in the last three months.

Primary outcomes:
measure: Bone mineral density
timeFrame: Baseline and 1 year
measure: Sleep quality
timeFrame: Baseline and 1 year
measure: Cognitive function
timeFrame: Baseline and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Lanxi Red Cross Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT02558374: Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Official title: A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
3. Post-washout intraocular pressure \>20mmHg and \<30mmHg in 1 or both eyes at 2 qualification visits
4. Corrected visual acuity equivalent to 20/200
5. Able to give informed consent and follow study instructions

Exclusion Criteria:

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
3. Unmedicated intraocular pressure ≥30mmHg
4. Use of more than 2 ocular hypotensive medications within 30 days of screening
5. Known hypersensitivity to any component of the formulation
6. Previous glaucoma surgery or refractive surgery
7. Ocular trauma within 6 months prior to screening
8. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
9. Recent or current ocular infection or inflammation in either eye
10. Used ocular medication in either eye of any kind within 30 days of screening
11. Mean central corneal thickness \>620µm at screening
12. Any abnormality preventing reliable applanation tonometry of either eye
13. Clinically significant abnormalities in lab tests at screening
14. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
15. Clinically significant systemic disease
16. Participation in any investigational study within 60 days prior to screening
17. Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening
18. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Primary outcomes:
measure: IOP (Intraocular Pressure)
timeFrame: 3 months
Secondary outcomes:
measure: Extent of Exposure
timeFrame: 6 months
Other outcomes:
Locations:
city: Bedminster
country: United States
facility: Aerie Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Aerie Pharmaceuticals, Inc
name: Theresa Heah, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00578474: A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
Official title: Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Media
Keywords: Acute otitis media
Tympanostomy tubes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 911
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.


Eligibility criteria: Inclusion Criteria:

* 6 months to 12 years old
* Ear tubes in one or both ears
* Ear drainage visible by the parent / guardian
* Ear drainage less than 21 days
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have non-tube otorrhea
* Patient may not have had otic surgery other than tube placement in the last year
* Patient may not be a menarchal female
* Diabetic patients are not eligible
* Patient may not have any disease or condition that would negatively affect the conduct of the study
* Patient may not require any other systemic antimicrobial therapy during the study
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patient may not be pre-disposed to neurosensory hearing loss
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age related
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Clinical cure rate at the test of cure visit as determined by the investigator
timeFrame: From baseline
Secondary outcomes:
measure: Time to cessation of otorrhea
timeFrame: From baseline
measure: Microbiological outcome
timeFrame: From baseline
measure: Treatment failures
timeFrame: From baseline
Other outcomes:
Locations:
Study officials:
affiliation: 1-888-451-3937
name: Contact Alcon Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01432574: Study of Gardasil in Mid-Adult Males (MAM)
Official title: A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Human Papillomavirus
Keywords: HPV
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-09-13
Enrollment: 150
Sex: MALE
Minimum age (years): 27
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effectiveness of the research study vaccine, Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human Papillomavirus \[HPV\] infection in men (HIM) Study.

Detailed description: The MAM Study is a prospective pilot intervention trial to investigate patterns of human papillomavirus (HPV) vaccine immunogenicity in men, aged 27-45 years, in which the men will receive Gardasil. Gardasil was administered at 0, 2, and 6 months. Blood was drawn at 0 and 7 months to provide a quadrivalent HPV antibody serologic profile. Participants also completed surveys via computer-assisted interviews (CASI) at Day 1 and Month 7 to record sexual behavior.

Our overall goal is to test the efficacy of Gardasil to reduce HPV 6, 11, 16, 18 persistent infection among men at the external genital epithelium, anal canal, and oral cavity, and to reduce lesions caused by these HPV types at the external genital epithelium and anal canal. The purpose of this Phase II trial is to establish the immunogenicity of Gardasil among mid-adult men and to establish the infrastructure with which to build the larger Phase III trial in the future.

Eligibility criteria: Inclusion Criteria:

* Men that have completed 4 years of follow-up in the on-going international prospective natural history study of HPV in men (The HIM Study)
* Willing to comply with 4 scheduled visits within a 7-month period

Exclusion Criteria:

* Have received an HPV vaccine
* Have a prior diagnosis of penile or anal cancers
* Have a prior diagnosis of high grade anal intraepithelial neoplasia
* Have been diagnosed with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
* Have a history of anaphylaxis to vaccines
* Have known impairment of the immune system
* Have received any blood products within 6 months of enrollment

Primary outcomes:
measure: Percentage of Participants Seropositive at Month 7
timeFrame: 7 Months
Secondary outcomes:
measure: Change in Antibody Titers
timeFrame: Points: Day 1 and Month 7
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Cuernavaca
country: Mexico
facility: National Institute of Public Health, Mexico
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Anna Giuliano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: