louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06422468: Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring
Official title: Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Photoplethysmography
Single-lead Electrocardiography
Lead sponsor: Qompium NV
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF).


Eligibility criteria: Inclusion Criteria:

Inclusion criteria applicable for all groups:

* At least 18 years old
* Participants must have the ability to understand and provide written informed consent
* Participants must have the ability to understand Dutch

Group specific inclusion criteria:

Group 1: Healthy volunteers

* No cardiac conditions based on medical history.

Group 2: Cardiology patients

* Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF.
* Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction).

Exclusion Criteria:

* Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
* Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
* Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
* Persons that have a disability to perform the measurements according to the instructions for use
* Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

Primary outcomes:
measure: Identification of morphologic characteristics of smartphone generated signals
timeFrame: 1 day
Secondary outcomes:
measure: Evaluate the performance of the FibriCheck Algorithm
timeFrame: 1 day
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Pieter Vandervoort, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05864768: The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Official title: Experimental Gingivitis in Omnivores and Vegetarians/Vegans. The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Inflammation
Periodontal Diseases
Keywords: Experimental Gengivitis
Nutraceutical
Periodontal Inflammation
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diet can influence the body's healing and repair mechanisms. A dietary imbalance obviously cannot trigger periodontal disease in the absence of a primum movens, which is bacterial plaque. However, it can condition its severity and extent by altering the permeability of the oral mucosa, the effectiveness of the immune response and the reparative potential of the gingival tissues.

Nutraceuticals is the science that studies the effects of the so-called food-drug, i.e. those foods that contain substances capable of performing a pharmacological function, modifying the functions of the organism. In particular, some molecules that are assimilated through various foods are able to penetrate the cell nucleus and influence, through an epigenetic mechanism, the expression or otherwise of some genes. The aim of our controlled study is to understand whether a vegetarian/vegan diet can be considered as protective for periodontal health compared to an omnivorous diet. For this purpose, we used a test group of 22 omnivorous subjects and a control group of 22 vegetarian/vegan patients in which experimental gingivitis was induced.


Eligibility criteria: Inclusion Criteria:

* Optimal systemic health conditions
* Non-Smoking
* Absence of cardio-vascular pathologies
* Absence of pulmonary pathologies
* Non-diabetic
* Not pregnant
* FMPS \<20%
* FMBS \<20%
* Omnivorous or vegan/vegetarian diet for at least a year
* Absence of periodontitis

Exclusion Criteria:

* Smokers
* Presence of systemic pathologies
* Presence of cardio-vascular disease
* Presence of periodontitis
* FMPS\>20%
* FMBS\>20%
* Pregnant women
* Presence of blood pathologies
* Taking medicines (hydantoins, nifedipine or cyclosporine)
* Taking oral contraceptives
* Bacterial, viral or fungal infections
* Idiopathic gingival fibromatosis
* Mucocutaneous disorders
* Allergic reactions to toothpastes and mouthwashes

Primary outcomes:
measure: Eastman Interdental Bleeding Index
timeFrame: Four weeks
Secondary outcomes:
measure: Pocket Probing Depth
timeFrame: Four weeks
measure: Full Mouth Plaque Score
timeFrame: Four weeks
measure: Full Mouth Bleeding Score
timeFrame: Four weeks
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. D'Annunzio University
state: CH
Study officials:
affiliation: University G. D'Annunzio Chieti-Pescara
name: Michele Paolantonio, MD; DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00290368: Repeat Nasal Allergen Challenge
Official title: Assessment of Inflammatory Mediator and Cellular Changes Following Repeated Nasal Allergen Challenge in Subjects With Allergic Rhinitis Sensitive to Timothy Grass Pollen - a Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hayfever
Keywords: Nasal allergen challenge
Allergic rhinitis
Timothy grass pollen
inflammatory mediators
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2006-02-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Detailed description: This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years.
2. Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.

Exclusion Criteria:

1. Smokers (use of tobacco products in the previous 3 months).
2. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 \> 80% predicted at screening).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Heart & Lung Institute Clinical Studies Unit
Study officials:
affiliation: Imperial College London
name: Trevor T Hansel, FRCPath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06096168: Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
Official title: Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthropathy
Keywords: Total Hip Prosthesis Revision
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 120
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 subjects who needed a revision of total hip arthroplasty, implanted with a SAGITTA EVL-R revision femoral stem according to instructions for use, over a period of time between 31/01/2016 and 31/12/2018.

Brief summary: This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.

This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old at the time of surgery,
* Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2016 and 31/12/2018,
* Affiliated to French health insurance system

Exclusion Criteria:

* Patient who has not expressed consent for data collection and participation in the study,
* Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
* Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
* Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication

Primary outcomes:
measure: Survival rate at mid term follow-up
timeFrame: At 4/6 years after surgery
Secondary outcomes:
measure: Adverse events
timeFrame: From per operative period to 4/6 years after surgery
measure: Survival rates at mid term follow-up (by component)
timeFrame: At 4/6 years after surgery
measure: Survival rates at mid term follow-up (by etiology)
timeFrame: At 4/6 years after surgery
measure: Patient's satisfaction
timeFrame: At 4/6 years after surgery
measure: Oblivion of prosthesis
timeFrame: At 4/6 years after surgery
measure: Functional improvement
timeFrame: At 4/6 years after surgery
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Hospitalier de Rouen - Hôpital Charles Nicolle
state: Seine Maritime
Study officials:
References:
Clinical trial NCT00005768: Estrogen Modulation of Mood and Cognition Following Monoaminergic Depletion in Post-Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Menopause
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-06-02
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will examine whether estrogen administration in postmenopausal women can alter the response to changes in brain chemistry brought about by dietary manipulation. Women who are recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (\>70 yrs. of age) will take estrogen or placebo for three months. At the end of that time they will participate in three challenges using dietary techniques to briefly change the relative amounts of neurotransmitters in the brain that are believed to be related to mood regulation (serotonin, dopamine, and norepinephrine). Previous research has shown that these dietary manipulations can briefly produce negative changes in mood. The investigator hypothesizes that estrogen administration will blunt or buffer these negative effects in a quantifiable way. The investigator believes that this will provide a direct test of the ability of estrogen to meaningfully change the brain chemistry of mood in a clinically measurable and positive way. The proposed procedure will also allow assessment of the effects of estrogen on brain neurotransmitter systems after many years of very low estrogen levels.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* Non-smoker
* BMI \<30
* Healthy
* Without surgically-induced menopause
* Not on HRT or \>1 year post HRT
* Normal mammogram within last year
* No cardiovascular disease other than mild hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT00212368: Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Official title: Phase3,Open-label,Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wison's Disease
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.


Eligibility criteria: Inclusion Criteria:

* Wilson's disease(adult,infant,pregnant woman)

Exclusion Criteria:

* acute hepatitis
* malignant tumor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National MINAMIYOKOHAMA Hospital
name: Koudou Ishii, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05234268: Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in Cervical Radiculopathy
Official title: Comparative Effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in the Management of Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy. To compare the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy.

Detailed description: Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots near the spinal cord. Some factors that may increase the risk for developing cervical radiculopathy include age. The risk for cervical radiculopathy tends to increase with age. This study is based on three interventions (Manual Cervical traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active Strength Training) individually on three separate but equal groups of participants. It will determine the most effective intervention and which intervention is superior to the other for treating cervical radiculopathy and to assist future practitioners and researchers.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cervical radiculopathy due to muscle tightness or spasm (Diagnosed by Spurling's Test)
* Having complaint more than 2 months

Exclusion Criteria:

* Past history of cervical surgery
* Past history of cervical trauma
* Any inflammatory disease
* Tumor or Carcinoma
* Disco genic/ disc herniation or stenosis cause of radiculopathy.

Primary outcomes:
measure: Pain Relief by Visual Analogue Scale (VAS)
timeFrame: 4 weeks
measure: Activities of daily living by Neck Disability Index (NDI)
timeFrame: 4 Weeks
measure: Cervical Compression Test by Spurling's Test
timeFrame: 4 Weeks
Secondary outcomes:
measure: Cervical Range of motion by Goniometer
timeFrame: 4 Weeks
measure: Endurance of the deep flexors of the cervical spine by Cranio-cervical Flexion Test
timeFrame: 4 week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Quaid-e-Azam International Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maria Khalid, MSPT-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530668: Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI
Official title: Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective Monoamine Oxidase Inhibitors (MAOIs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression Anxiety Disorder
Keywords: Depression Disorder
Anxiety Disorder
intranasal esketamine
monoamine oxidase inhibitors (MAOIs)
MAOIs
antidepressants
ketamine
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject.having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.

Brief summary: There are already recently published data on the tolerability and efficacy of the combination of ketamine and/or esketamine with MAOIs. However, these reports are few and far between, and to our knowledge, there are no data involving intranasal esketamine.

Given the numerous interactions between MAOIs and other antidepressants, and the impossibility of combination, this pharmacological class is neglected. This is despite the fact that MAOIs are the only truly tri-aminergic drugs, that they have unparalleled efficacy in certain forms of resistant apathetic depression, and that new, more dietary permissive forms have appeared on the market. The arrival of antidepressants that can be combined with MAOIs, such as ketamine and esketamine, changes the situation and could offer a new treatment opportunity to many patients in a therapeutic impasse. For these opportunities to become a reality, sharing the clinical experience gained by specialized centers is essential.


Eligibility criteria: Inclusion criteria:

* Major subject.
* Having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.
* Not objecting to the reuse of their data for scientific research purposes.

Exclusion Criteria:

- Subject who has expressed opposition to the reuse of their data for scientific research purposes.

Primary outcomes:
measure: Number of adverse events for each patient
timeFrame: Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01660568: Gemcitabine in NK/T Cell Lymphoma
Official title: Gemcitabine in Pretreated/Refractory NK/T Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NK/T Cell Lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: relapsed or refractory NK/T cell lymphoma treated with gemcitabine conatining treatment

Brief summary: We retrospectively review patients with refractory or relapsed ENKL who received a gemcitabine-containing regimen


Eligibility criteria: Inclusion Criteria:

* NK/T cell lymphoma
* relapse or refractory disease
* gemcitabine containing treatment

Exclusion Criteria:

Primary outcomes:
measure: Overall response rate
timeFrame: 2012-May
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01797068: Patient Navigation for Medicaid Frequent ED Users
Official title: Patient Navigation to Improve Care and Reduce Costs for High Utilizers of the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Illness
Keywords: HEALTHCARE UTILIZATION
ED UTILIZATION
PRIMARY CARE UTILIZATION
PATIENT NAVIGATION
UNDERSERVED POPULATIONS
HEALTH DISPARITIES
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED) visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported health status, quality of life, access/barriers to care) among Medicaid patients who are high utilizers of the ED, as well as to identify best practices for engaging and providing healthcare services to underserved patients using patient navigation. This study will address needs that have been identified within the New Haven community and the local healthcare system, contribute to knowledge and literature surrounding the use of patient navigation to improve care for underserved patients and improve health system efficiency, and inform the design and development of programs that address these needs both locally and in other communities.


Eligibility criteria: Inclusion Criteria:

* 4-18 ED visits per year
* Frequent ED users
* age 18 to 62
* Medicaid insurance only
* Those living in the greater New Haven area (i.e. having a zip code that matches that)

Exclusion Criteria:

* the current visit for primary psychiatric or substance abuse
* more than 50% of all ED visits in the past year for primary psychiatric or substance abuse.

Primary outcomes:
measure: Number of ED visits
timeFrame: One Year
Secondary outcomes:
measure: Number of hospitalizations
timeFrame: One Year
measure: Number of outpatient visits
timeFrame: One Year
measure: Costs by analyzing global use with Medicaid claims data
timeFrame: One year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References: