louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06591884: Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus
Official title: Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Oral Erosive Lichen Planus
Keywords: Oral Lichen Planus
Tacrolimus
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 46
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: The goal of this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. The main questions it aims to answer are:

* Does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment?
* Which tacrolimus formulation can keep participants free of lesions for longer periods?

Researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective.

Participants will:

* Apply one of the proposed tacrolimus formulations twice a day for 1 month.
* Visit the clinic once every 2 weeks for checkups and tests, with follow-ups extending up to 3 months.


Eligibility criteria: Inclusion Criteria:

* individuals with a clinical and histopathological diagnosis of erosive/ulcerative/atrophic and symptomatic oral lichen planus, according to the criteria established by the American Academy of Oral and Maxillofacial Pathology

Exclusion Criteria:

* History of oral cancer;
* history of allergic reactions to tacrolimus or any other component of the formulas;
* history of organ transplant or have a systemic condition that induces significant immunosuppression;
* be pregnant or lactating.

Primary outcomes:
measure: Oral Disease Severity Score (ODSS) - 50%
timeFrame: 30 days
measure: VAS (visual analogical score) pain score - 50%
timeFrame: 30 days
Secondary outcomes:
measure: OHIP-14 quality of life score
timeFrame: 15-90 days
measure: Beck scale scores (anxiety levels)
timeFrame: 15-90 days
measure: hedonic scale satisfaction scores
timeFrame: 30-90 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Fernanda Visioli, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409379: Association Between Telomere Length and Cardiac Dysfunction
Official title: Association Between Relative Telomere Length and Severity of Cardiac Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Toxicity
Acute Leukemia
Childhood Cancer
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 300 eligible acute leukemia patients were anticipated to include in this study.

Brief summary: Compelling epidemiological evidence indicates that alterations of relative telomere length (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute leukemia (AL).The aim of this study was to explore association between RTL content in peripheral blood cells could be used as a risk predictor for severity of cardiac damage.


Eligibility criteria: Inclusion Criteria:

* 1. histological confirmed acute leukemia; 2. Preparing for chemotherapy;

Exclusion Criteria:

* 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.

Primary outcomes:
measure: Relative telomere length
timeFrame: From date of admission until the date of discharging from hospital, assessed up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Xiao-Fan Zhu
state: Tianjin
Study officials:
References:
Clinical trial NCT04679779: Virtual Reality in Children With Hemiparesis
Official title: Effect of Virtual Reality on Selective Motor Control and Upper Limb Functions in Children With Hemiparesis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: cerebral palsy
selective motor control
upper limb coordination
virtual reality
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control grouprecivedvDesigned occupational therapy programe including Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.

• study group will recieve Wii virtual reality games

1. Bowling
2. Frisbee
3. Basketball
4. Boxing
Primary purpose: TREATMENT

Brief summary: children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance

Detailed description: Twenty volunteer children diagnosed with hemiparetic cerebral palsy will be recruited from national institute of neuromotor system. they will be randomly assigned to intervention and control group.

Eligibility criteria: Inclusion Criteria:

* - Age between 7 and 11 years
* spasticity grade of 1+ or 2 on MAS
* level I and II on GMFCS
* level II and III on MACS
* Being able to cooperate and being motivated

Exclusion Criteria:

* visual or auditory problems Severe spasticity (an Ashworth spasticity score of 4 in any upper or lower extremities) Severe mental retardation surgeries for spasticity within the past 12 months, toxin injection within the past six months.
* Structural or fixed soft tissue deformities in the affected upper extremity

Primary outcomes:
measure: Selective voluntary motor control of upper extremity
timeFrame: 6 weeks
Secondary outcomes:
measure: Hand grip strength
timeFrame: 6 weeks
measure: - Upper limb function
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Egypt
Study officials:
affiliation: Cairo University
name: hoda eltalawy, professor
role: STUDY_CHAIR
affiliation: Cairo University
name: shorouk elshennawy, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: amira mahmoud, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03518879: ASTHMA-Educator Mobile Application Manage Asthma
Official title: The ASTHMA-Educator: A Novel Algorithmic Software Tool to Help Manage Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: informatics
asthma
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm proof of concept study to evaluate the impact of the ASTHMA-Educator on process and clinical outcomes
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use among adult asthma patients at Montefiore.

Detailed description: Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use through 2 phases: 1) Phase 1 = process outcomes evaluation with 30 patients); and 2) Phase 2 (longitudinal clinical evaluation with 40 patients receiving the intervention at baseline, 2 months, 4 months, and 6 months). The study's primary outcome is asthma control.

Eligibility criteria: Inclusion Criteria: Adults (\>18 years) with: (a) severe asthma (i.e. at least one asthma-related ED visit and/or hospitalization in the previous year); (b) access to a smartphone with short message service (SMS) capability; (c) English speaking; (d) able to give informed consent.

Exclusion Criteria: (a) use of oral corticosteroids in the 2 weeks prior to the baseline visit; (b) pregnancy; (c) severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol; and (d) patients that previously received the ASTHMAXcel application.

Primary outcomes:
measure: Change from baseline asthma control to 2, 4, and 6 months
timeFrame: Baseline, 2 months, 4 months, 6 months
Secondary outcomes:
measure: Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months
timeFrame: Baseline, immediately post-intervention, 2 months, 4 months, 6 months
measure: Patient satisfaction measured by the Client Satisfaction Questionnaire-8
timeFrame: Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months
measure: Time spent in using the mobile application
timeFrame: Immediately post-intervention at the baseline visit
measure: Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Asthma emergency department visits
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Asthma hospitalizations
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Asthma-related steroid courses
timeFrame: Baseline, 2 months, 4 months, 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sunit Jariwala
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06597279: Developing Tools for Dialysis Decision Support
Official title: Developing Tools for Dialysis Decision Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2024-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a non-randomized controlled trial using historical control as a comparator. It involves comparing outcomes from a group of participants receiving the current intervention with outcomes from a previously treated group (historical control) that did not receive the intervention.
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability.

Detailed description: This study employs a pre-post design to assess the impact of a web-based dialysis decision support tool on patients with advanced chronic kidney disease and their caregivers. Participants will complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit. Following the visit, participants will access the decision support tool, with follow-up support provided by the study coordinator. One to four weeks after the baseline visit, participants will complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Additionally, telephone interviews will be conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool.

Eligibility criteria: Inclusion Criteria:

1. Age \&gt;=65
2. Estimated GFR \&lt;25 ml/min/1.73m2
3. English speaking
4. Not a candidate for kidney transplant based on nephrologist assessment.

Family/caregiver inclusion criteria:

1. age \&gt;=21
2. English speaking

Exclusion Criteria:

a. Patients with cognitive impairment will be excluded; however their family member or caregiver is eligible to participate.

Primary outcomes:
measure: Treatment choice
timeFrame: 1 month
measure: Values treatment concordance
timeFrame: 1 month
measure: Confidence in treatment decision
timeFrame: 1 month
measure: Treatment choice
timeFrame: 1 month
measure: Decisional Conflict Scale (DCS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: U.S. Department of Veterans Affairs - Palo Alto Health Care System
state: California
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: U.S. Department of Veterans Affairs - Palo Alto Health Care System
name: Manjula Tamura, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06179979: PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.
Official title: PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with neurodegenerative diseases will be included: with mild cognitive disorder, Alzheimer's dementia and early temporal frontal degeneration.

Brief summary: Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study.

The validation in larger groups of patients, and the comparison between the different clinical syndromes included in the spectrum, will allow the diagnostic and prognostic potential of the tracer to be evaluated, with important consequences for the clinical management of patients.

In particular, the tracer could play a central role in the clinical management of patients with neurodegenerative diseases and cognitive impairment.

Numerous pharmacological trials are currently underway, worldwide, for the validation of anti-amyloid drugs. In the future we could think about early monitoring with imaging of the effectiveness of the treatment.

T he FDG PET technique can be of great help in obtaining relationships between radiation damage to the brain and possibly neurological and neuropsychological deficits associates.


Eligibility criteria: Inclusion Criteria:

* Alzheimer's diagnosis according to the diagnostic criteria in use.

Exclusion Criteria:

* current or previous treatments with neuroactive drugs;
* pregnancy or breastfeeding.

Primary outcomes:
measure: PET/CT with 11C-PiB to characterize amyloid protein deposits in patients with neurodegenerative diseases.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06077279: HCT Effect Among Patients With Psychotic Disorders
Official title: Effect of Horticultural Therapy Program on Psychological Wellbeing, Hope, and Social Adjustment Among Patients With Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Hope
Psychological Adjustment
Psychological Wellbeing
Horticulture Therapy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Horticulture therapy has been found to have positive effects on individuals with psychotic disorders, promoting social interaction, reducing social isolation, and improving cognitive function. Effectiveness of horticulture therapy in enhancing well-being, reducing symptoms, and facilitating social adjustment in this population

Detailed description: Horticulture therapy involves gardening and plant-related activities as a form of therapeutic intervention, enhance patient to be mindful to current environment and promote relaxation which can reduce symptoms such as anxiety, depression, and social isolation, improve cognitive function, and promote overall well-being .With this respect, there is an urgent need to find a sustainable and eco-friendly solution for this complex issue by returned to nature and utilizing the low cost and current resources at the same time to make a signification reduction in the psychotic disorder's symptoms

Eligibility criteria: Inclusion and exclusionCriteria:

did not undergo any other intervention during the HT program used in the study, just routine care in hospital -

Primary outcomes:
measure: Effect of Horticultural Therapy Program on hope level among patients with psychotic disorders
timeFrame: three months
measure: Effect of Horticultural Therapy Program on psychological wellbeing level among patients with psychotic
timeFrame: three months
measure: Effect of Horticultural Therapy Program on social adjustment level among patients with psychotic
timeFrame: three month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
Clinical trial NCT04007679: Pain Neuroscience Education in Students
Official title: The Effects of Pain Neuroscience Education in Undergraduate Physiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Educational Problems
Keywords: pain neuroscience education
chronic pain
physiotherapy students
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study was designed to evaluate the effect of a 70-minute Pain neuroscience education (PNE) session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain.

Detailed description: To investigate the effect of a 70 minute pain neuroscience education session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain. This study was a single-center, cross-sectional study on the pain knowledge of students in a four-year physiotherapy program and their beliefs and attitudes about patients with back pain.Students were eligible to participate if they were enrolled at physiotherapy undergraduate program at Kütahya Health Sciences University Faculty of Health Sciences. Individuals were excluded if they had previously received in depth-teaching on pain neuroscience. The study was completed with 156 students from different classes (first, second, and third year of the program) who agreed to participate in the study. All participants were informed about the study and signed informed consent forms. Pain neurophysiology questionnaire and Pain Attitudes and Beliefs Scale for Physiotherapists were used to assess pain knowladge and attitudes and beliefs. After recording their demographic information, the participants completed the Neuroscience of Pain Questionnaire (NPQ) and Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) at three time points: pre-PNE, immediately post-PNE, and 6 months after PNE.

Eligibility criteria: Inclusion Criteria:

* participants who study in physiotherapy.
* willing to participate

Exclusion Criteria:

* Individuals in years 4 were excluded.
* participants who received an in-depth session about pain previously.

Primary outcomes:
measure: Neurophysiology of Pain Questionnaire (NPQ)
timeFrame: Baseline and six months
Secondary outcomes:
measure: Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: KutahyaMSU
state: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Cihan AKSOY, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01930279: Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood
Official title: Effect of Sleep Deprivation on Expression of T Cell Markers in Peripheral Blood of Medical Residents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Deprivation
Keywords: T cell markers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical residnets

Brief summary: Sleep deprivation was found to affect many organs including the immune system and predisposing for various health consequences including diabetes hypertension infections and increase in neoplastic diseases.

Subjects will be evaluated for immune parameters in peripheral blood test following a regular nigh sleep and compared with a test performed following a night shift in which they slept less than 3 hours.

Each participant will serve as its own control.

Detailed description: Overall Study Design and Plan

1. Subjects will be bled on the day of the experiment between 8and 9 AM.
2. Blood tubes will be tested for T cell markers, serum cytokines levels, and other immune parameters by western blots.
3. The first tube will be tested on the day of experiment.
4. The second tube will kept in the lab and will be tested 24 hours later.
5. The third tube will be kept in the pocket of the subject and be tested 24 hours later.
6. The fourth tube will be kept in the pocket of another subject and will be tested 24 hours later.
7. The subject will be tested again following 24 hours.
8. Each subject will be tested twice following a regular 6-8 hours of sleep, and following an on call duty in which he slept less than 3 hours.

Eligibility criteria: Inclusion Criteria:

Male and female ages 18-40 signed confirmed consent no evidence of chronic disease or chronic medications

Exclusion Criteria:

Any type of acute infection or other acute illness

Primary outcomes:
measure: surface markers of T cell as assessed by FACS
timeFrame: 6 months
measure: serum cytokine levels
timeFrame: 6 months
measure: immune parameters to be assessed by western including STAT proteins
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: