louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05957926: Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration
Official title: Evaluation the Effect of Hyaluronic Acid With Hydroxyapatite Versus Hydroxyapatite Alone on Bone Regeneration Following Enucleation of Mandibular Odontogenic Cyst (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Loss
Bone Lesion
Keywords: bone regenerarion
bone graft
hydroxyapatite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of hyaluronic acid with hydroxyapatite versus hydroxyapatite alone on bone regeneration following enucleation of mandibular odontogenic cyst.

Detailed description: During cyst enucleation , There's resultant decrease in bone density especially in large defects .Therefore, it may be needed for a bone grafts and bone regenerative materials to improve quality of bone .The rationale is to evaluate hyaluronic acid with hydroxyapatite as a bone quality improvement material following cyst enucleation, which would provide significant bone regeneration. Hydroxyapatite is inorganic component of bone tissue used as bone graft, scaffolds, filler and cement for repair and regeneration of bone defect , and it is stimulate bone remodeling by generating surface active moieties or cell signaling process while Hyaluronic acid and it's derivatives has been widely used for bone regeneration and it has a good potential for osteogenesis and mineralization

Eligibility criteria: Inclusion Criteria:

* Patient in need of cyst removal .
* Both genders aged between 18-50 years .
* Size of lesion is ≤ 4 cm .
* Patients free from any systemic disease that may affect bone healing .

Exclusion criteria :

* Heavy smokers , alcohol intake .
* Poor oral hygiene .
* Patient with systemic disease that may affect bone healing .
* Pregnant women.
* Patient who are currently or have been under treatment using chemotherapy or radiotherapy
* Uncooperative patient .

Primary outcomes:
measure: Bone density
timeFrame: 6 months
Secondary outcomes:
measure: postoperative pain
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
citation: Zhao N, Wang X, Qin L, Zhai M, Yuan J, Chen J, Li D. Effect of hyaluronic acid in bone formation and its applications in dentistry. J Biomed Mater Res A. 2016 Jun;104(6):1560-9. doi: 10.1002/jbm.a.35681. Epub 2016 Apr 9.
citation: Scariot R, da Costa DJ, Rebellato NL, Muller PR, Gugisch RC. Treatment of a large dentigerous cyst in a child. J Dent Child (Chic). 2011 Jul;78(2):111-4.
citation: AboulHosn M, Noujeim Z, Nader N, Berberi A. Decompression and Enucleation of a Mandibular Radicular Cyst, Followed by Bone Regeneration and Implant-Supported Dental Restoration. Case Rep Dent. 2019 Jan 9;2019:9584235. doi: 10.1155/2019/9584235. eCollection 2019.
Clinical trial NCT00224926: The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation
Official title: The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinea Capitis
Keywords: Tinea Capitis
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2005-09-23
Enrollment: 446
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preschool aged children

Brief summary: To explore carrier and infection status of T.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. The general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.The global outcome of this investigation is to reveal potential new drug targets designed to improve treatment outcomes in these children.

Detailed description: Tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in approximately 1 in 20 children at any point in time with an equal number of children serving as carriers of the fungal pathogen. Despite the widespread nature of the disease, the natural course of the infection remains incompletely described. The study will be driven by the following hypothesis: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.

A fungal scalp culture will be acquired from all participants using a brush culture technique. Samples will be collected once a month over a two year time period.

Eligibility criteria: Inclusion Criteria:

* Preschool aged children will be eligible.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hosptials and Clinics
name: Susan Rahman, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01400126: Ultrapure Water System for Hemodialysis Therapy
Official title: The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for
Hemodialysis.
The Rate of Adverse Events Such as Hypotension During Hemodialysis Therapy With Ultra Pure Water
System as Compared to Conventional Water System.
Keywords: Ultrapure water,hemodialysis, CRP, blood pressure
Lead sponsor: Tel Aviv Medical Center
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 150
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: Chronic hemodialysis patients

Brief summary: We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure water) in comparison with the use of conventional water which are used in most dialysis units worldwide. To the best of our knowledge prospective data in that field is sparse.

Detailed description: In observational studies, the use of very pure dialysis solution has been suggested to reduce the plasma level of CRP, IL-6 ; to improve the response to anemia to erythropoietin therapy ; to promote better nutrition as evidenced by increase in plasma albumin value , estimated dry body weight, midarm muscle circumference and urea-nitrogen appearance rate; to reduce plasma level of β2-microglobulin and pentosidine ; to dely carpal tunnel syndrome ; to slow the loss of residual renal function; and to lower cardiovascular morbidity.The aim of this study is to prospectively evaluate the effect of dialysis performed with ultra-pure water (UPW)in comparison with dialysis with the use of conventional water system. Patients enrolled into this study will be evaluated at initial period of one month treated with conventional water system (-30 to 0 days). Then water system will be switched to ultra-pure water system with the use of filter added to the dialysis machine (Gambro). After switching to UPW system the patients will be followed for a period of one year (days 0-365). Primary end point will be change in CRP. Additional parameters: Blood pressure, adverse events during dialysis, hemoglobin levels and white-blood cell counts.

Eligibility criteria: Inclusion Criteria:

1. chronic hemodialysis therapy thrice weekly \> 3 months of therapy
2. Signed an informed consent -

Exclusion Criteria:

1. Enrolled to other study
2. Ongoing infection -

Primary outcomes:
measure: CRP
timeFrame: 13 months
Secondary outcomes:
measure: blood pressure
timeFrame: 13 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06656026: Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A
Official title: A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Influenza a
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules


Eligibility criteria: Inclusion Criteria:

1. Subjects and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
2. Male or female subjects aged ≥ 2 to ≤17 years at the time of signing the informed consent form.
3. Subjects with a diagnosis of influenza virus infection confirmed by all of the following:

   * Positive rapid antigen test (RAT) for influenza with nasal or throat swabs;
   * The time interval between the onset of symptoms and enrollment is 72 hours or less;
   * Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present

Exclusion Criteria:

1. Subjects with severe influenza virus infection；
2. Subjects with any medical history in gastrointestinal that interferes with the absorption of drugs；
3. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment；
4. Have received any other investigational products within 3 months prior to dosing；
5. Positive urine pregnancy test；
6. Subjects with concurrent infections requiring antimicrobial therapy；
7. Subjects who are considered inappropriate for the study by the investigator.

Primary outcomes:
measure: Plasma concentrations of ZSP1273
timeFrame: DAY1~5
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: DAY1~29
measure: Time to alleviation of influenza symptoms (duration of influenza)
timeFrame: DAY1~29
measure: Percentage of subjects with virus titer detected
timeFrame: DAY1~29
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT02927626: Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma
Official title: Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.


Eligibility criteria: Inclusion Criteria:

1. Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
2. Ages Eligible for Study: ≤75 years old;
3. TCM syndrome is deficiency of both Qi and Yin;
4. Confirmed of CHB;
5. Surgery cannot be allowed;
6. Informed consent from the patient.

Exclusion Criteria:

1. Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
2. Serious problem of heart, lung, or kidney with severe dysfunction;
3. Pregnant or child breast feeding women;
4. Mental or cognitive disorders;
5. Participating in other drug trials;
6. Who are allergic to the study drug.

Primary outcomes:
measure: Survival rate
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 2 years
measure: quality of life(QOL)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhiyun Yang
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital
name: Zhiyun Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06522126: The Effects of Progressive Relaxation Exercise
Official title: The Effects of Progressive Relaxation Exercise on Life Satisfaction, Anxiety, and Psychological Well-being in Students Experiencing Premenstrual Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Progressive Relaxation Exercise
Exercise
Relation, Interpersonal
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome.

Methods: This randomized controlled trial was conducted with students who were enrolled in a university in the east of Türkiye, studying at the undergraduate levels outside the field of health, and experiencing premenstrual syndrome. The sample of the research consisted of 162 students (Exercise group 81 participants; Control group 81 participants). The Personal Information Form, Premenstrual Syndrome Scale (PMSS), Life Satisfaction Scale (LSS), Beck Anxiety Scale (BAS), and Psychological Well-Being Scale (PWBS) were used to collect data. Women in the exercise group underwent eight sessions of relaxation exercises, once a week for 8 weeks. In addition, for eight weeks after the first exercise, the participants exercised at home, at least twice a week, outside of the training. The PMSS, LSS, BAS, and PWBS were applied as post-tests to the participants in both groups, 8 weeks after the pre-tests.


Eligibility criteria: Inclusion Criteria:

* Those who scored 111 points or more on the Premenstrual Syndrome Scale,
* were married or single at the time of the research,
* did not have children.

Exclusion Criteria:

* those who were pregnant or postpartum,
* those who were diagnosed with any psychiatric disease according to the records,
* those who did not perform relaxation exercises outside of the training.

Primary outcomes:
measure: Premenstrual Syndrome Scale (PMSS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Life Satisfaction Scale (LSS)
timeFrame: 8 weeks
Other outcomes:
measure: Beck Anxiety Scale (BAS)
timeFrame: 8 weeks
Locations:
city: Malatya
country: Turkey
facility: Esra Sabanci Baransel
Study officials:
References:
Clinical trial NCT04137926: A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease
Official title: Shanghai Mental Health Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 360
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AD, MCI due to AD and Normal Control
Primary purpose: DIAGNOSTIC

Brief summary: The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. \[18F\]-AV-45 plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD. Next, a pilot intervention study on APP/PS1 transgenic mice will be promoted based on miRNAs gene regulation.


Eligibility criteria: Inclusion Criteria:

* 2011 NIA-AA criteria of MCI due to AD or AD

Exclusion Criteria:

* Non AD dementia

Primary outcomes:
measure: the diagnostic accuracy of biomarkers for MCI due to AD
timeFrame: 2 years
measure: Neropsychological test battery
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Psychogeriatrics，Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02062866: Evaluation of Purse-String Closure Vs Second Intention
Official title: Intradermal Purse-String Closure Vs Second Intention Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Closure Techniques
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare healing time, scar size, aesthetic outcome, and complication rates following second intention healing or purse string closure of surgical wounds on the trunk or extremities. This study, will allow surgeons to make informed decisions on whether purse string closure is superior to that of second intention healing and thus worth considering or inferior and not worth performing.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Willing to return for follow-up visits
* Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the trunk and extremities (including the shin, hands, and feet)

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Unwilling to return for follow-up
* Pregnant women
* Wounds less than 8 mm in length
* Wounds on the head, neck or digits
* Patients in which primary linear closure is recommended

Primary outcomes:
measure: Assessment of Scar on the Patient and Observer Scar Assessment Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Dept. of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313.
Clinical trial NCT04219566: Vestibular Nerve Stimulation to Improve Sleep
Official title: Pilot Study to Demonstration of Safety and Efficacy of VeSTAL Sleep Device in Human Subjects: Randomized Study of VeSTAL Compared to Sham Control as a Means of Improving Sleep as Determined by ISI Scores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep
Sleep Disorders, Circadian Rhythm
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: RD Gardi Medical College
name: Compliance Solutions Ltd.
First posted: 2020-01-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings

The purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).


Eligibility criteria: Inclusion Criteria:

* Adults
* Both genders
* Ages 18-24 years inclusive
* Score above 14 in the insomnia severity index questionnaire
* Willingness to participate in the study.

Exclusion Criteria:

* Use sleep medication
* Ear problems
* Under any kind of treatment
* Practicing sleep improving techniques
* Any other significant health-related problems.

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI) Scores
timeFrame: Day 0, Day 7, Day 14, Day 21, Day 28
Secondary outcomes:
measure: EEG Assessment
timeFrame: Day 0, Day 28
measure: Depression Anxiety Stress Scales (DASS) Assessment
timeFrame: Day 0, Day 7, Day 14, Day 21, Day 28
measure: WHO Quality of Life (WHOQOL) Assessment
timeFrame: Day 0, Day 7, Day 14, Day 21, Day 28
Other outcomes:
Locations:
city: Ujjain
country: India
facility: RD Gardi Medical College
state: Madhya Pradesh
Study officials:
affiliation: RD Gardi Medical College
name: Sai Sailesh
role: PRINCIPAL_INVESTIGATOR
References: