louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00569075: Apoptic Biomarkers of Periodontal Disease
Official title: Apoptotic Biomarkers of Periodontal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: Apoptic biomarkers
Early detection periodontitis
Gingival crevicular fluid
Healthy subjects
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy adults with healthy gums or those with periodontitis

Brief summary: The goal of this study is to facilitate early diagnosis of gum disease. Proteins associated with cell death will be isolated from gum pockets of diseased and healthy patients and evaluated.

Detailed description: Early detection of the progression of periodontitis is difficult because it typically relies on comparisons of clinical measurements made with a calibrated probe and nonstandardized radiographs over time. Both methods detect periodontal breakdown only after it has occurred. Therefore, considerable emphasis has been placed on identifying more specific and sensitive methods to diagnose and detect periodontal disease progression. The overall goal of this project is to determine whether specific apoptosis-associated proteins, specifically fibronectin (FN) fragments, caspase-3, soluble Fas, and soluble Fas ligand, sampled from gingival crevicular fluid (GCF) can be used as markers for periodontal disease progression.

Eligibility criteria: Inclusion Criteria:

* Adults over age of 18
* Healthy or diagnosis of periodontitis

Exclusion Criteria:

* Active treatment with anti-inflammatory agents such as NSAIDs or steroids and pregnant females

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yvonne Kapila, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04981275: A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
Official title: A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Onegevity Health
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland, Baltimore
First posted: 2021-07-28
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, ages 18-40, living in the USA (except for NY, NJ, RI, MD, SD, ND, or HI), who have not been using hormonal therapy for at least 3 months and without other significant health issues or medications affecting hormones. Women must be previously diagnosed with PCOS or considered Healthy and not currently pregnant or nursing. Women will be referred to the study by their Physician or word of mouth.

Brief summary: The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS.

Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with PCOS or Women who are considered Healthy
* 18-40 years old
* Residing in the USA, except for exclusion states
* Have not been using hormonal therapy for at least 3 months

Exclusion Criteria:

* Women using hormonal therapy within the last 3 months
* Diagnosed with other significant health conditions or using medications that will affect hormone levels
* Residing in NY, NJ, MD, RI, ND, SD, or HI
* Pregnant or nursing

Primary outcomes:
measure: Phenotype differences in vaginal microbiome
timeFrame: Samples to be collected on any day once per participant within 30 days of enrollment
measure: Phenotype differences in gut microbiome
timeFrame: Samples to be collected once on any day per participant within 30 days of enrollment
measure: Phenotype differences in blood biomarkers
timeFrame: Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment
measure: Phenotype differences in DNA
timeFrame: Samples to be collected once per participant within 30 days of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Chris D'Adamo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Chris Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295670: Pediatric Difficult Intubation
Official title: Can the Vividtrac Laryngoscope Rival the Miller Laryngoscope for Child Tracheal Intubation During Chest Compression in a Manikin? A Randomized Crossover Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation
Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* Paramedic student

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: 1 day
Secondary outcomes:
measure: Success of intubation
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovie
Study officials:
References:
Clinical trial NCT02159170: Cortical Representation of Hyperalgesia Induced by Nerve Growth Factor
Official title: Cortical Representation of NGF-induced Hyperalgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-inflammatory Neuropathic Pain
Healthy Subjects
Keywords: Use of NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2014-06-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and hyperalgesia are not yet understood in this group of patients. The investigators plan to use NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic resonance imaging and resting state network analysis.


Eligibility criteria: Inclusion Criteria:

* no acute or chronic disease
* no acute or chronic pain
* age: 18-60 years
* male
* no medication use

Exclusion Criteria:

* metallic parts in the body
* claustrophobia
* drug or substance abuse

Primary outcomes:
measure: Changes in activation of the pain processing and resting state networks
timeFrame: baseline to one week
Secondary outcomes:
measure: Changes in pain intensity, unpleasentness and suffering ratings
timeFrame: baseline to one week
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
affiliation: Medical Faculty Mannheim, Heidelberg University
name: Herta Flor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594970: A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).


Eligibility criteria: Inclusion Criteria:

* Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* None

Primary outcomes:
measure: Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, Week 6, Week 12
measure: Overall Percent Change From Baseline in IOP
timeFrame: Baseline, Week 6, Week 12
Other outcomes:
measure: Change From Baseline in Hyperemia Severity in the Study Eye
timeFrame: Baseline, Week 12
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160.
Clinical trial NCT06025370: Pressures During Prone Positions in Healthy Volunteers
Official title: Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Healthy Volunteer
Pressure Mapping
ARDS
Prone Position
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS). Despite the benefits of PP, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours.

There are 2 PP techniques:

1. Positioning with arms alongside the body
2. Swimmer's position At present, no study compares or has compared prospectively, the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores, nor on secondary effects in intensive care.

Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces. The investigators have acquired a pressure-measuring device, a mattress topper which is attached to the resuscitation mattress and which, connected to a PC, provides a live display of the pressures between the patient and the mattress.

The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers, which would enable them to obtain the world's first data on the real pressures generated during PP.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Major volunteer

Exclusion Criteria:

* Volunteers with cervical mobility problems preventing them from rotating their head 90°
* Volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction.
* Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test).
* Volunteer not affiliated to a French social security system
* Volunteer protected by law

Primary outcomes:
measure: Skin/Bed pressures
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
state: Centre Val De Loire
Study officials:
affiliation: CHU ORLEANS
name: Guillaume FOSSAT, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03109470: The Durability of Early RA Disease Control After Tocilizumab Withdrawal: A Canadian Experience
Official title: The Durability of Early RA Disease Control After Tocilizumab Withdrawal: A Canadian Experience
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis
Keywords: Tocilizumab
Early Rheumatoid Arthritis
Observational
Canadian
Lead sponsor: Pope Research Corporation
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2017-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients withdrawing first-line tocilizumab and/or methotrexate therapy due to therapeutic response during the FUNCTION (WA19926) study that have agreed to provide informed consent will be enrolled in this study.

Brief summary: Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients who were treated with Tocilizumab to require treatment with another biologic medication.


Eligibility criteria: Inclusion Criteria:

* Completed 2 years in the FUNCTION (WA19926) trial
* Patient has provided written informed consent and is willing to comply with the requirements of this study protocol

Exclusion Criteria:

* Requirement for immediate treatment with a biologic therapy following completion of the FUNCTION (WA19926) trial as per treating physician judgement.
* Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of RA

Primary outcomes:
measure: Rate of Biologic Treatment
timeFrame: 2 years
Secondary outcomes:
measure: Treatment after completion of FUNCTION study
timeFrame: Baseline
measure: Rate of requiring treatment intensification
timeFrame: 2 years
measure: Change in functional status
timeFrame: 2 years
measure: Work productivity
timeFrame: 2 years
measure: Healthcare Utilization
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Pope Research Corp.
name: Janet E Pope, MD, MPH, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: JSS Medical Research Inc.
name: John S Sampalis, BSc, BA, MSc, PHD, FACE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666470: Quality of Life of Patients With a History of Drug Allergy in Thailand
Official title: Quality of Life of Patients With a History of Drug Allergy in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: Quality of life
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2012-08-16
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai patients with a history of drug allergy

Brief summary: Quality of life of patients with a history of drug allergy in Thailand will be studied.

Detailed description: Thai patients with a history of drug allergy will be evaluated for their quality of life based on drug hypersensitivity quality of life questionnaire (DrHy-Q; Thai version) and The World Health Organization Quality of Life instrument (WHOQOL-BREF-THAI)

Eligibility criteria: Inclusion Criteria:

* Have a history of drug allergy
* At least 18 years of age

Exclusion Criteria:

* Not be able to understand Thai language

Primary outcomes:
measure: The quality of life of Thai patients with a history of drug allergy evaluating by DrHy-Q (Thai version)
timeFrame: 1 year
Secondary outcomes:
measure: The correlation between DrHy-Q (Thai version) and WHOQOL-BREF-THAI
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138670: Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark
Official title: Complications Following Pacemaker or ICD Implantation in Denmark
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pacemaker
Defibrillators, Implantable
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 5500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Danish patients receiving a cardiac device (pacemaker, cardiac resynchronization therapy (CRT) or implantable defibrillator cardioverter (ICD)), or undergoing a reoperation from May 2010 to April 2011.

Brief summary: This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.

Detailed description: This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD)implantation. Furthermore validation af the Danish Pacemaker and ICD Register will be conducted.

Eligibility criteria: Inclusion Criteria:

* patients receiving a cardiac device (pacemaker, cardiac resynchronization therapy (CRT) or implantable defibrillator cardioverter (ICD)), or undergoing a reoperation

Exclusion Criteria:

* none

Primary outcomes:
measure: complication rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
Study officials:
affiliation: Aarhus Universitetshospital, Skejby
name: Rikke E Kirkfeldt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02099370: Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients
Official title: A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Tecfidera(R)
Oral medication
Adherence
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2014-03-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample of Multiple Sclerosis patients started on Tecfidera

Brief summary: The investigators are measuring the adherence rates of an oral MS drug that is to be administered twice-daily. The investigators would like to observe any patterns that might indicate factors that greatly affect adherence.


Eligibility criteria: Inclusion Criteria:

* Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information \[PHI\]).
* Aged 18 at the time of informed consent.
* Must have a relapsing form of MS.
* Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

* Progressive form of MS
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Female subjects considering becoming pregnant while in the study.
* Female subjects who are currently pregnant or breast-feeding.
* Unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol.
* Any other reason that, in opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.

Primary outcomes:
measure: adherence rates to Tecfidera
timeFrame: over one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Carol and Frank Morsani Center for Advanced Healthcare
state: Florida
Study officials:
References:
Clinical trial NCT03898570: Distributed Registry
Official title: Distributed Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms
Patient Compliance
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults with an iPhone 5s or higher who can read English

Brief summary: The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.


Eligibility criteria: Inclusion Criteria:

1. Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure.
2. Patients with smartphones (iOS or Android) with unlimited data plans.
3. Patients who agree to remote surveillance

Exclusion Criteria:

1. Patients unwilling to download a research study app.
2. Data plans which are not unlimited.

Primary outcomes:
measure: Patient Reported Outcomes (PROs) using mobile app
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Veterans Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Oliver O Aalami, MD
role: PRINCIPAL_INVESTIGATOR
References: