louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04218188: Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer
Official title: Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinical Decision-Making
Early Detection of Cancer
Keywords: pH-responsive chitosan
Cancer stem-like cell
Cell detachment ratio
Prognostic factor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: At the discretion of the professional attending physician, the lung cancer patients who need to undergo resection of lung lesions.

Brief summary: Biomaterial-based cell culture models have been gaining increasing attention as potential therapeutic strategies. The purpose of this project is to evaluate whether the cell detachment ratio on pH-responsive chitosan could be correlated with the overall survival in lung cancer patients. Through controllable cell-material interaction, this project has the intention to develop an alternative tool for both early diagnosis and accurate prognosis in cancer therapeutics.


Eligibility criteria: Inclusion Criteria:

* Lung cancer patient between 20-70 years old who need surgery for the resection of lung lesions.
* Willing to sign the consent form under the informed consent.

Exclusion Criteria:

* Vulnerable subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Primary outcomes:
measure: The correlation between the cell detachment ratio and the overall survival
timeFrame: 5-year follow-up after tumor resection
Secondary outcomes:
measure: The analyses of the detached cells by specific markers
timeFrame: About one week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Biomedical Engineering, National Taiwan University
name: Tai-Horng Young, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04141488: Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis
Official title: Examining The Efficacy Of Scapular Exercises On Pain, Muscle Activation And Function İn Patients With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Lateral Epicondylitis
electromyography
pain
scapula
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2019-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: TREATMENT

Brief summary: We aimed to investigate the effect of scapular exercises on pain and functioning in patients with lateral epicondylitis to achieve a more accurate result by using little-used EMG between scapula and elbow muscles in the literature besides ongoing classical measurements and evaluations.

Detailed description: Thirty patients who participated in the study were randomly divided into two groups. First group (n=15), conventional physiotherapy program and exercise, second group (n=15), in addition to the conventional physiotherapy program and exercises, scapula exercises were applied. Patients were evaluated before and after treatment by VAS, algometer, hand dynamometer, EMG, UEFS, PRTEE and DASH questionnaires.

Eligibility criteria: Inclusion Criteria:

* Cases diagnosed with lateral epicondylitis by the physician and decided to receive conservative treatment
* Not receiving NSAID or other medical treatment
* Untreated Lateral Epicondylitis for the last 6 months
* Cases with age range 18-75
* Patients with pain and tenderness for at least 3 months

Exclusion Criteria:

* People with pacemakers or cardiac arrhythmias
* Tumoral disease
* Pregnant women
* Head and neck, elbow, scapula joint pathologies
* Acute infection
* Nerve or nerve root compression
* Other musculoskeletal problems

Primary outcomes:
measure: Pain Severity Assessment
timeFrame: Change from baseline pain severity of Lateral Epicondylitis at week 6.
measure: Muscle Activation Assessment
timeFrame: Change from baseline EMG activation of the forearm extensor muscles at week 6.
measure: Functional Level Assessment
timeFrame: Change from baseline functional level score at week 6.
measure: Functionality Assessment
timeFrame: Change from baseline functionality score at week 6.
Secondary outcomes:
measure: Grip Force Assessment
timeFrame: Change from baseline grip force score at week 6.
measure: Pressure Pain Threshold Assessment
timeFrame: Change from baseline Pressure Pain Threshold score at week 6.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bayram Kapsigay
state: Maltepe
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Bitlis Eren University
name: Bayram Kapsigay, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05584878: Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions
Official title: Clinical and Topographic Evaluation of the Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions (a Randomized Controlled Clinical Trial and In-vitro Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The modern concept in caries treatment focuses on the non-invasive approach and on the biomimetic remineralization of early non-cavitated white spot carious lesions. Recently developed biomimetic scaffolds attempt to remineralize the dental tissues and are more regenerative than reparative.


Eligibility criteria: Inclusion Criteria:

* Patients who at least have 1 white spot lesion.
* No systemic diseases or taking any medication affecting salivary flow.
* Patients with good oral hygiene measures.
* Patients with moderate caries risk assessment.
* Post orthodontic WSLs with International Caries Detection and Assessment System (ICDAS II) scoring criteria (1-2).

Exclusion Criteria:

* Participant in another trial.
* Developmental non carious lesion (enamel hypoplasia and dental fluorosis).
* Presence of abnormal oral disease, or medically compromised patients.
* Participants who had evidence of reduced salivary flow or significant tooth wear.
* Allergy to milk products or other drug allergies.

Primary outcomes:
measure: Change in DIAGNOdent values
timeFrame: Baseline, 1 month, 3 months , 6 months, 9 months, 12 months
measure: change in ICDAS scores
timeFrame: Baseline, 1 month, 3 months , 6 months, 9 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00613678: Exercise Plus Activity Strategy Training for Osteoarthritis
Official title: Exercise Plus Activity Strategy Training for Older Adults With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: pain
activities of daily living
symptoms
self-management
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 54
Sex: ALL
Minimum age (years): 62
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: To study the effects of two different rehabilitation programs for people with osteoarthritis of the hip or knee.

Hypothesis 1: Participants who received Activity Stratgey Training will report less pain and physical disability at 8-weeks and 6-months follow-up.

Hypothesis 2: Participants who receive Activity Strategy Training will have a greater increase in physical activity as measured by a wrist-worn accelerometer.

Hypothesis 3: Participants who receive Activity Stratgey Training will report greater improvements in health-related quality of life.

Detailed description: We are testing the effectiveness of a targeted intervention for older adults with hip and/or knee osteoarthritis (LE-OA) using an occupational therapy treatment approach to promote activity engagement. We believe that it is necessary to tailor this intervention to the specific needs of older adults with LE-OA. Based on the literature, exercise is a necessary component of an intervention for older adults with LE-OA. However, this should also be coupled with an Activity Strategy Training (AST) component designed to promote lifestyle changes and thus more lasting effects. The AST component is based on occupational therapy principles and will include behavioral and environmental strategies to increase activity engagement.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 62 years
* Meet ACR clinical criteria for either hip or knee OA
* Ambulatory (with or without assistance)
* Requiring assistance or report difficulty in \>=1/4 activities of daily living
* Ability to speak English

Exclusion Criteria:

* Knee/hip surgery within the previous 9 mos.
* Current participation in physical/occupational therapy
* Any contraindication to exercise activities
* Cognitive impairment
* Inability to provide informed consent

Primary outcomes:
measure: Self-reported pain
timeFrame: Baseline, Post-intervention (8-wks), and 6-mos follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Institute of Gerontology
state: Michigan
Study officials:
affiliation: University of Michigan, Institute of Gerontology
name: Susan L Murphy, ScD, OTR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy SL, Strasburg DM, Lyden AK, Smith DM, Koliba JF, Dadabhoy DP, Wallis SM. Effects of activity strategy training on pain and physical activity in older adults with knee or hip osteoarthritis: a pilot study. Arthritis Rheum. 2008 Oct 15;59(10):1480-7. doi: 10.1002/art.24105.
Clinical trial NCT00965978: A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
Official title: A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Keywords: ONO-5920
YM529
Minodronic Acid
Food Effect
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharma USA Inc
First posted: 2009-08-26
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.


Eligibility criteria: Inclusion Criteria:

* Post menopausal women (at least 2 years after menopause)
* Body weight: more than 40.0 Kg and less than 70.0 Kg
* BMI: more than 17.6 and less than 30.0

Exclusion Criteria:

* Receives investigational drug within 120 day before the study
* Blood donation before the study
* With abnormal laboratory values

Primary outcomes:
measure: Pharmacokinetic parameter of ONO-5920/YM529
timeFrame: For 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03710278: The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
Official title: The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis
Encephalitis
Guillain-Barré
Subarachnoid Hemorrhage
Intracranial Neoplasm
Intracranial CNS Disorder
Lead sponsor: Spartanburg Regional Healthcare System
Sponsor class: OTHER
Collaborators: name: Edward Via Virginia College of Osteopathic Medicine
First posted: 2018-10-18
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient 12 years or older

Brief summary: The purpose of this study is to proof and investigate the effectiveness and safety of the invented device named "Human Lumbar Puncture Assist Device (LPat)" as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation if the LP need to be done under fluoroscopy, and need to obtain none traumatic tap for better CSF analysis.

Detailed description: "Human Lumbar Puncture Assist Device (LPat)" was invented as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation.

Eligibility criteria: Inclusion Criteria:

Patients age 12 years and older who need lumbar puncture (LP) for diagnostic purposes or patients already underwent LP but failed to obtain Cerebrospinal Fluids i.e. "Unsuccessful Tap"

Exclusion Criteria:

Patients younger than 12 years of age

Primary outcomes:
measure: Successful Lumbar Puncture
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Spartanburg Reginal Heathcare System
state: South Carolina
Study officials:
References:
Clinical trial NCT02012478: Using a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.
Official title: The Impact of a Motivational Interviewing (MI) Informed Text Messaging (SMS) Program Tailored to Level of Patient Activation on Glycemic Control in a Population of Poorly Controlled Diabetic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes Mellitus
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Center for Healthcare Improvement and Patient Safety
name: Leonard Davis Institute
First posted: 2013-12-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite advances in medical therapy for diabetes, significant numbers of patients fail to achieve adequate blood glucose control. Diabetic patients who engage in more self-care behaviors have better glycemic control, as measured by HbA1C. Patient "activation", defined as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the performance of these self-care behaviors.

There is a growing literature on diabetes behavioral change interventions; however interventions are often developed and implemented without consideration of patients readiness to engage in lifestyle changes. Additionally, patient-tailored interventions require intensive clinical and financial resources, making them difficult to integrate into clinical practice. Mobile text messaging (SMS) programs have been successfully used to promote smoking cessation, alcohol cessation, and weight loss in diverse patient populations. SMS interventions for diabetes have also been developed, but they have been designed primarily to provide feedback on blood glucose management, rather than to motivate behavioral change. The few studies that included motivational content as a primary feature, did not tailor their intervention to a patient's readiness for change or rigorously describe their motivational intervention, and show limited efficacy.

To address these concerns, we will perform a three-month randomized controlled pilot study to develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to patient level of activation for patients with poorly controlled type II diabetes.


Eligibility criteria: Inclusion Criteria:

* age 18 or older
* type II diabetes
* poorly controlled diabetes (HbA1C \>8 x 2 measurements, with goal \< 8)

Exclusion Criteria:

* pregnancy
* non-English speaking or reading

Primary outcomes:
measure: hemoglobin A1C
timeFrame: three months
Secondary outcomes:
measure: PAM scale
timeFrame: 3 months
Other outcomes:
measure: Summary of Diabetes Self-Care Activities
timeFrame: 3 months
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Judith Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03953378: CD73+ Th1.17 in Rheumatoid Arthritis and Psoriatic Arthritis
Official title: Presence and Impact of CD73+ Th1.17 and of the CD39/CD73/Adenosine Cascade in Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 41
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: Patients with chronic inflammatory rheumatism RA and PsA types with or without background therapy at the inclsuion

Brief summary: Prospective study to investigate the correlation between CD39/CD73 expression by the different T lymphocyte subpopulations in the blood and synovial fluid (if available) into patients with chronic inflammatory rheumatism RA and PsA types, with the rheumatic activity, the background therapy (with Methotrexate (MTX)) and the response to this treatment.

Detailed description: Th1.17 compose a recently described subset of highly polyfunctional and thus potentially more harmful CD4+ effector T cells (Teff) than classical Th17 as they co-produce interferon-γ (IFN-γ) and interleukin-17A (IL-17A). For this reason, Th1.17 rise increasing interest in RA and PsA since they seem involved in their pathophysiology. Hyper activation of Teff in RA and PsA results partly from a deficiency in regulatory mechanisms of Teff's pro-inflammatory functions. The ecto-nucleotidase CD73 delineates Teff enriched in Th1.17 features and acts as a regulatory mechanism for these pro-inflammatory cells. Considering that MTX, usually used as first line treatment of RA and PsA, increases extracellular concentrations of adenosine monophasphate (AMP) and immunosuppressive adenosine, the investigators hypothesized that CD4+CD73+ T cell effector population enriched in Th1.17 and Th17 cells may participate in the pathogenicity of RA and PsA but also in the resistance to MTX treatment through the specific expression of CD73 essential for Ado generation and which is down-regulated on proliferating T cells.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients naive to biologics
* Patients with RA fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria
* Patients with PsA fulfilling the Classification for PsA (CASPAR) criteria

Exclusion Criteria:

* None

Primary outcomes:
measure: CD73 expression on T helper lymphocyte subpopulations
timeFrame: At inclusion
measure: CD73 expression on T helper lymphocyte subpopulations
timeFrame: 3 months
measure: CD73 expression on T helper lymphocyte subpopulations
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Rhumatologie, Centre Hospitalier Lyon-Sud (HCL)
Study officials:
References:
Clinical trial NCT01305278: The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy
Official title: The Efficacy of Balance Gaming as an Adjunct to Vestibular Rehabilitation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vestibular Diseases
Disturbance; Balance, Labyrinth
Keywords: Balance
Rehabilitation
Vestibular
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 7
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: Patients with a unilateral vestibular loss often complain of dizziness and imbalance. Movement usually increases these symptoms often resulting in patients avoiding these movements, causing further limitations in their activities of daily living. Vestibular Rehabilitation (VR) involves a series of adaptation and balance exercises to improve symptoms of postural stability. There is evidence that stroke patients gain benefit in their rehabilitation from using gaming consoles (Nintendo Wii Balance) and we believe that similar advantages can be shown for balance patients. We plan a 3 arm study. As there is a considerable wait list for VR, the first arm will receive a Wii console and instructions to use it on the wait list and during VR. The second arm will receive a Wii console and instructions at the end of the waiting list and will use it during VR only and the control group will receive no Wii. All will spend the same time on the wait list and will receive identical assessments and VR

Detailed description: None required

Eligibility criteria: Inclusion Criteria:

* Unilateral vestibular loss
* Uncompensated
* Present for \>6 months

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: Dizziness Handicap Index
timeFrame: t=0 (at initial assessment)
measure: Dizziness Handicap Index
timeFrame: t=6 weeks
measure: Dizziness Handicap Index
timeFrame: t=12 weeks
measure: Dizziness Handicap Index
timeFrame: t=18 weeks
Secondary outcomes:
measure: Modified Clinical Test of Sensory Interaction on Balance
timeFrame: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
measure: Activity Specific Balance Confidence Scale
timeFrame: t=0 (at initial assessment), t=6 weeks, t=12 weeks, t=18 weeks
measure: Dynamic Gait Index score
timeFrame: t=0 (at initial assessment), t=12 weeks, t=18 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: John A Rutka, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References: