louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06669026: The Proposed Study Aims to Investigate the Impact of Adjunctive Vitamin D Gel Application on Gingival Crevicular Fluid Levels of Alkaline Phosphatase and Interleukin-8 in Periodontitis Patients Undergoing Phase 1 Periodontal Therapy. By Elucidating the Molecular Mechanisms Underlying the Therapeutic
Official title: Therapeutic Efficacy of Local Vitamin D Drug as an Adjunct to Mechanical Debridement in the Treatment of Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Pocket
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Group 1: vitamin D3-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement.

* Group 2: vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.
* Group 3: placebo gel as an adjunct to mechanical debridement.
* Group 4: only mechanical debridement.
Primary purpose: TREATMENT

Brief summary: The proposed study aims to investigate the impact of adjunctive vitamin D gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. By elucidating the molecular mechanisms underlying the therapeutic effects of vitamin D, this research seeks to contribute to the development of more effective treatment strategies for periodontitis.


Eligibility criteria: Inclusion Criteria:

* Patients with attachment loss 3-4 mm
* periodontal pocket ≤ 5 mm

Exclusion Criteria:

* - Patients with sensitivity to the medication used in the study.
* Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study.
* Patients with systemic diseases.
* Pregnant and lactating females.
* Smokers and tobacco chewers.
* Patients not compliant with oral hygiene procedures.

Primary outcomes:
measure: Periodontal Assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Interleukin 8
timeFrame: 8 weeks
measure: alkaline phosphatase
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alaaeldin Ahmed Taha
Study officials:
References:
Clinical trial NCT01449526: A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design
Official title: A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be myopic, and wear contact lenses in each eye.
* Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion Criteria:

* Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with any grade 2 or greater finding during the slit lamp examination.
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who are allergic to any component in the study care products.

Primary outcomes:
measure: Visual Acuity (VA)
timeFrame: 4 visits over 3 months
Secondary outcomes:
measure: Slit Lamp > Grade 2
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen, OD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01263626: Cough Monitoring Study
Official title: Monitoring Cough Device - Step 1 and 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough
Reflux
Keywords: Cough
Chronic Cough
Reflux
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the ENT or GI clinics at Vanderbilt Medical Center with a chief complaint of chronic cough will be eligible for participation in this study. Patients who meet eligibility requirements will be able to participate regardless of sex, social status, or ethnicity.

Brief summary: The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.

Cough is an important defense mechanism of the respiratory tract. The presence of chronic cough may indicate the presence of underlying diseases, including reflux. Despite the increased number of patients suffering from cough in the ENT and GI practice, to date, there has been no method/device to objectively assess the frequency of cough episodes in a given patient.

PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an innovative device that is able to record cough episodes and then automatically detect and count them with the help of a specific software program. This study will assess the accuracy of this novel cough monitoring and counting technology and validate potential clinical use in patients with chronic cough.


Eligibility criteria: Inclusion Criteria:

Arm 1: healthy volunteers:

1. Male and female volunteers 18 years of age and older
2. No history of chronic or acute cough and throat clearing
3. Ability to read a 5th grade script written in English for approximately 20 minutes

Arm 2: patients:

1. Male and female volunteers 18 years of age and older
2. Cough as chief complaint
3. Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint
4. pH testing for standard of care purposes

Exclusion Criteria:

* Subjects who are not able to give informed consent

Primary outcomes:
measure: Accuracy of Cough Device
timeFrame: 24 hours post device placement
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael Vaezi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Francis DO, Slaughter JC, Ates F, Higginbotham T, Stevens KL, Garrett CG, Vaezi MF. Airway Hypersensitivity, Reflux, and Phonation Contribute to Chronic Cough. Clin Gastroenterol Hepatol. 2016 Mar;14(3):378-84. doi: 10.1016/j.cgh.2015.10.009. Epub 2015 Oct 19.
Clinical trial NCT05138926: Effect of Spinal Manipulation on Electromyography of the Masseter Muscle
Official title: Immediate Effect of High Speed and Low Amplitude Cervical Manipulation on the Electromyographic Activity of the Masseter Muscle, in a Physiotherapy Students at the University of the Americas. a Clinical Trial, Single Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism
Muscle Disorder
Lead sponsor: University of Americas
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research Problem: To know the immediate effects of high speed and low amplitude cervical manipulation on the electromyographic activity of the masseter muscles of physiotherapy students at the University of the Americas Course objective: To compare the immediate effects of high-speed, low-amplitude cervical manipulation on the electromyographic activity of the masseter muscles versus a placebo intervention in kinesiology students at the University of the Americas.

Specific objectives: To describe the changes in the electromyographic activity of the masseter muscles of the high-speed cervical manipulation group in students of the physiotherapy school of the University of the Americas of the Santiago Centro campus.

To describe the changes in the electromyographic activity of the masseter muscles of the placebo group in students of the physiotherapy school of the University of the Americas of the Santiago Centro campus.

Methodology: Single-blind, randomized clinical trial. Expected results: Significant differences are expected between the intervention group and the control group. This is reflected in a decrease in electromyographic activity in the masseter muscles after high-speed cervical manipulation.


Eligibility criteria: Inclusion Criteria:

* Male and female physiotherapy students over 18 years of age who regularly attend face-to-face classes who have a mobility pass and a health declaration.
* Students who read and sign the informed consent.

Exclusion Criteria:

* Orthognathic surgery.

  * Recent head and neck injury or fracture (equal to or less than 3 months)
  * Dental or medical diagnosis of mandibular disorder or manifest facial pain.
  * Contraindication (red flag) to perform high speed and low amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)

Primary outcomes:
measure: Electromyography of the masseter muscle before intervention
timeFrame: baseline
measure: Electromyography of the masseter muscle after the intervention
timeFrame: 5 minute after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Universidad de las Americas
state: Santiago
Study officials:
References:
Clinical trial NCT06362226: Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management
Official title: Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Periorbital Burns
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 10
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 purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.


Eligibility criteria: Inclusion Criteria:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Mechanism of Injury including explosion, thermal, electrical
* Clinical diagnosis of periorbital burn wound
* Second degree or less periorbital or lid bur
* No previous surgical treatment for wound management
* Partial Deep thickness Periorbital burn
* Partial Thickness Burn
* Superficial Burn
* Periocular lesions with globe involvement

Exclusion Criteria:

* Recent surgical intervention for wound
* Full Thickness and or "Third degree Burns"
* Imprisoned Inmates
* Chemical Burn
* Pregnant women
* Individuals whom are not adults \>18 years of age

Primary outcomes:
measure: Comparison of wound healing time
timeFrame: 12 months
measure: Comparison of infection rate
timeFrame: 12 months
measure: Comparison of complication rates
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of pain level
timeFrame: 12 months
measure: Comparison of quality of life
timeFrame: 12 months
measure: Comparison of cosmetic outcome through the Vancouver scar scale (VSS)
timeFrame: 12 months
measure: Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Nikisha Richards, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05548426: Linezolid for Syphilis Pilot Study
Official title: Pilot Study of Linezolid for Early Syphilis Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Syphilis
Keywords: Linezolid
Treponema pallidum
Penicillin
Early Syphilis
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Universidad Peruana Cayetano Heredia
name: The University of Texas Health Science Center, Houston
First posted: 2022-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.

Detailed description: This will be a randomized, open-label, non-comparative, adaptive pilot trial to evaluate the efficacy of linezolid 600mg orally, twice a day, for five or ten days, using a contemporaneous historical control group benzathine penicillin G (single dose of 2.4 million units) in participants with and without HIV infection.

In total, 24 participants will be enrolled across multiple clinical sites in the United States. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) at 1 month, 3 months, and 6 months.

Study findings may identify an efficacious alternative syphilis treatment to penicillin that is effective for people living with HIV. Study findings may also help address the crisis of penicillin shortages, difficulty in administration, and offer options for those with penicillin allergy.

Eligibility criteria: Inclusion Criteria:

* 16 years of age or older
* Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
* Able to provide informed consent
* For PLHIV: on treatment for HIV-infection and most recent viral load \<200 copies/mL or most recent CD4 T-cell count \>350 cells/mL

Exclusion Criteria:

* Pregnancy or a positive pregnancy test on the day of enrollment
* Participants who receive certain psychotropic medications, e.g., MAO inhibitors, SNRIs, SSRIs
* Patients showing signs and symptoms of neurosyphilis
* Serofast RPR titer
* Recent (\<7 days) or concomitant antimicrobial therapy with azithromycin, doxycycline, ceftriaxone, cefixime, or other beta lactam antibiotics (e.g. amoxicillin)
* Linezolid or penicillin allergy

Primary outcomes:
measure: Response to Treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Howard Brown Health
state: Illinois
city: Jackson
country: United States
facility: Open Arms HealthCare Center
state: Mississippi
Study officials:
affiliation: University of Southern California
name: Jeffrey D Klausner, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852826: Evaluation of a Hemostatic and Sealing Agent to Prevent Surgical Complications After Axillary Lymphadenectomy
Official title: Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seroma
Keywords: axillary seroma
axillary lymphadenectomy
morbidity
morbidity postlymphadenectomy
Lymphadenectomy
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 60
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: This study was intended to assess the value of a hemostatic and sealing agent, a collagen sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for decreasing occurrence of seroma after axillary lymphadenectomy.


Eligibility criteria: Inclusion Criteria:

* Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion Criteria:

* Patients that did not want to participate in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario "Virgen de la Arrixaca"
Study officials:
name: Antonio Piñero, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770626: A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients
Official title: A Pilot Study to Determine the Effectiveness of Bioelectrical Impedance Analysis as a Clinical Assessment Tool of Nutrition Status in Glioblastoma Multiforme Patients (The BEAM Study [BIA Effectiveness as Assessment Tool for Glioblastoma Multiforme (GBM) Patients])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Brain Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study is designed to evaluate how the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis can predict the progression and outcomes of disease.

Detailed description: The purpose of this study is to monitor the nutritional status of (Glioblastoma Multiforme)GBM patients for one year. We will look at the relationships between phase angle determined by Bioelectrical Impedance Analysis (BIA), nutrition assessment by Subjective Global Assessment and serum albumin, the type of microbes present in the gut, the participant's DNA information, and tumor progression. We will also compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry of the people with GBM and the people without.

Eligibility criteria: Inclusion Criteria:

* Subjects must be at least 19 years of age.
* Subjects must have a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme).
* Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

* Subjects with implanted pacemakers or defibrillators.
* Subjects who are pregnant.
* Subjects with edema.
* Subjects with an amputated extremity.

Primary outcomes:
measure: To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients
timeFrame: Participants will be followed every 3 months up to 12 months
Secondary outcomes:
measure: To compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry
timeFrame: At initial visit until end of study.Participants will be followed for duration average of every 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Louis B Nabors, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03352726: A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
Official title: An Open-label Phase I Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peanut Allergy
Keywords: EPIT
Epicutaneous
Immunotherapy
Viaskin
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2017-11-24
Enrollment: 27
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study aims to assess the biological potency of the In-House Reference Preparation (IHRP) of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic subjects.


Eligibility criteria: Main Inclusion Criteria:

* Male or female subjects aged between 12-50 years
* Physician-diagnosed peanut allergy
* Subject currently following a strict peanut-free diet
* Documented history of positive test to peanut-specific IgE (ImmunoCAP system) \>0.7 kU/L
* Positive peanut SPT with a largest wheal diameter ≥ 8 mm

Main Exclusion Criteria:

* Uncontrolled asthma
* Peanut allergen immunotherapy whatever the route, either ongoing or previously started and having lasted more than one month (\>30 days)
* Topical use of steroids within the past 14 days prior to the Screening SPT
* Inability to discontinue short-acting antihistamines
* Atopic dermatitis, eczema or urticaria on the areas to be tested

Primary outcomes:
measure: Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)
timeFrame: 1 day to 2 weeks
Secondary outcomes:
measure: Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
timeFrame: Throughout the study (1 day to 2 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: