louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05091060: Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Official title: Erchonia and InnerScope, Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms

Detailed description: The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing temporary relief of tinnitus symptoms in adults 18 years and older.

Eligibility criteria: Inclusion Criteria:

* Subjective tinnitus
* Tonal tinnitus.
* Constant tinnitus on-going at least half the time over at least the past 6 months.
* Willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration.
* Willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation.
* 18 years of age or older
* Primary language is English

Exclusion Criteria:

* Objective tinnitus
* Atonal, pulsatile, intermittent, or occasional tinnitus
* Severe or profound hearing loss in one or both ears
* Current or prior surgically removed acoustic neuroma
* Consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days:

NSAIDS (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates Lasix and other "loop" diuretics "mycin" antibiotics such as vancomycin quinine and related drugs Chemotherapy agents such as cis-platin

* Acute or chronic vertigo/dizziness
* Ménière's disease
* Prior stapendectomy
* Prior mastoidectomy
* Auditory nerve tumor (acoustic neuroma), current or surgically removed in the past
* Active infection/wound/external trauma to the areas to be treated with the laser
* Medical, physical or other contraindications for, or sensitivity to, light therapy
* Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
* Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements

Primary outcomes:
measure: Total Score on the Tinnitus Handicap Inventory (THI).
timeFrame: Baseline and 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Kathy Amos
state: California
Study officials:
References:
Clinical trial NCT01167660: Non Invasive Measurement of Coagulation in Term and Preterm Neonates
Official title: Non Invasive Measurement of Coagulation in Term and Preterm Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Coagulation Tests
Keywords: Coagulation tests
Neonates
Non invasive
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 120
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term and preterm babies born in Meir Medical Center

Brief summary: The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.

Detailed description: Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood.

Eligibility criteria: Inclusion Criteria:

* Newborn babies - term and preterm
* Written parental informed consent

Exclusion Criteria:

* Congenital anomalies / chromosomal abnormalities

Primary outcomes:
measure: Reliability of the non-invasive ThM device.
timeFrame: From birth up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Ita Litmanovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949960: DMT210 Topical Gel in the Treatment of Atopic Dermatitis
Official title: DMT210 Topical Gel in the Treatment of Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Dermatitis, Atopic
Skin Diseases, Eczematous
Hypersensitivity
Immune System Diseases
Lead sponsor: Dermata Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Male or female 12 years or older
* Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement
* Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline

Primary outcomes:
measure: ADSI (Atopic Dermatitis Severity Index) score of each Target lesion
timeFrame: Day 28
Secondary outcomes:
measure: Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion
timeFrame: Day 28
measure: Investigator Global Assessment (IGA) of the Treatment Area
timeFrame: Day 28
Other outcomes:
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: Day 28
Locations:
city: Houston
country: United States
facility: Dermata Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Dermata Investigational Site
state: Virginia
Study officials:
affiliation: Dermata Therapeutics
name: Christopher Nardo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05777460: Mid- and Long-term Outcomes of Custom-made Aortic Devices
Official title: Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Diseases
Thoracic Aortic Aneurysm
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients that underwent Thoracic Endovascular Aortic Repair (TEVAR) in the period 2015-2023 with the Custom Relay® Multi-Feature™ Terumo Aortic will be included in the analysis.

Brief summary: This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.


Eligibility criteria: Inclusion Criteria:

* Thoracic Aortic Disease

Exclusion Criteria:

* Urgent/Emergent treatment

Primary outcomes:
measure: Overall Mortality
timeFrame: 3 years
measure: Aortic-related mortality
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT02045160: A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
Official title: A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumocystis Jirovecii Pneumonia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are treated in the National Taiwan University Hospital

Brief summary: In this study, we aim to investigate the incidence of the adverse reactions, the effectiveness and the gene polymorphism associated with the plasma level of sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole, sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.


Eligibility criteria: Inclusion Criteria:

* males and females aged 20 years or older
* using oral or intravenous form of sulfamethoxazole-trimethoprim

Exclusion Criteria:

* patients who are under 20 years of age

Primary outcomes:
measure: High performance liquid chromatography for drug plasma concentration
timeFrame: Participants will be followed for the duration of the treatment course, an expected average of 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: TW
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: TW
Study officials:
References:
Clinical trial NCT03386760: Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
Official title: Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tattoo; Pigmentation
Keywords: tattoo
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.

The aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed picosecond laser and to compare it to a nanosecond laser for treating black tattoos.

In a first phase of the study 10 patients with black tattoos will be treated with increasing fluencies of the picosecond laser to the optimal parameters in terms of efficacy and tolerance.

In a second phase, 10 additional subjects with black tattoos will be treated after central randomization on half of the tattoo with the picosecond laser (with the parameters determined in the first phase) and the other half treated with a nanosecond laser.


Eligibility criteria: Inclusion Criteria:

* Black tattoos with surface between 10 and 100 cm²
* Skin type I to VI

Exclusion Criteria:

* Childbearing age women
* Active dermatosis located on the tattoo
* Personal history of hypertrophic scars or keloids
* Pigmentary or vascular lesions located on the tattoo
* Subject taking oral steroid or retinoid or have any risk of delayed healing problems
* Acquired or hereditary conditions that could leead to a delayed healing
* Allergy to xylocaine, prilocaine or lidocaine

Primary outcomes:
measure: Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures
timeFrame: 2 month after the end of laser utilisation
Secondary outcomes:
measure: Evaluation of Pain with EVA test
timeFrame: 2 months after one session of laser utilisation
measure: Evaluation of tolerance
timeFrame: 2 months after one session of laser utilisation
measure: satisfaction evaluation of depigmanetation tattoo
timeFrame: 2 months after one session of laser utilisation
measure: Skin biopsies
timeFrame: immediately after treatment
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Dermatologie - Hôpital Archet
Study officials:
References:
Clinical trial NCT06305260: LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40
Official title: The LOTUS Trial: Lumbar Ultrasound Utility in Obstetric Patients With BMI > 40
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity, Morbid
Labor Pain
Keywords: Labor Epidural
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are:

* Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
* Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English Speaking
* BMI (Body Mass Index) \> 40
* Ability to provide informed consent and verbally disclose their medical history

Exclusion Criteria:

* History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement
* Patients with platelet counts \<70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.
* Minors
* Adults unable to make their own decisions or with cognitive issues or developmental delays
* Prisoners

Primary outcomes:
measure: Epidural Redirects
timeFrame: Day of Epidural
Secondary outcomes:
measure: Total time to epidural space
timeFrame: Day of Epidural
measure: Number of attempts at a different level
timeFrame: Day of Epidural
measure: Epidural replacement rate
timeFrame: Day of Epidural
measure: Patient satisfaction
timeFrame: 24 hours post-epidural
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04859660: Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Official title: Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Retention Postoperative
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Women 18-80 undergoing outpatient minimally invasive hysterectomy

Exclusion Criteria:

* Inability to provide informed consent
* Bladder malignancy
* Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
* Plan for sling or anterior repair

Primary outcomes:
measure: Time to Spontaneous Void
timeFrame: 8 weeks
Secondary outcomes:
measure: Time to Discharge From the Post-anesthesia Care Unit
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center- Phoenix
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center- Tucson
state: Arizona
Study officials:
References:
Clinical trial NCT06751160: Comparative Effects of Dry Needling Versus Soft Tissue Mobilization on Hamstring Tightness
Official title: Comparative Effects of Dry Needling Versus Soft Tissue Mobilization on Hamstring Tightness in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hamstring Tightness
Chronic Low-back Pain
Keywords: Chronic Low Back Pain
Disability
Dry Needling
Hamstring Tightness
Soft Tissue Mobilization
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hamstring tightness is considered as the inability to achieve knee extension greater than 160 degrees while hip is flexed at 90 degrees. When low back pain (LBP) persists for 12 weeks or longer, it is termed as chronic low back pain. The objective of study is to see the effect of dry needling versus soft tissue mobilization on hamstring muscle on pain, range of motion and functionality in patients with chronic low back pain.

Detailed description: A randomized clinical trial will be conducted at Hameed Latif Medical Centre through non probability convenient sampling technique on 30 subjects which will be divided into two groups' 15 subjects in group A and 15 subjects in group B through computer generated software for Randomization. Both groups will be conventional therapy and spinal mobilization (posterior anterior glide) of grade 1 and 2 (3 sets of 6 repetitions) as baseline treatment. Group A was will be dry needling and Group B will be Soft Tissue Mobilization.

Eligibility criteria: Inclusion Criteria:

* Reduction in active knee extension test \>25
* Current back pain between 4 to 6 on Numeric Pain Rating scale
* Low back pain for at least 12weeks0r 6 months

Exclusion Criteria:

* Subjects using anticoagulants and having vascular diseases
* Subjects with needle phobia and allergic to metals
* Subjects with cognitive impairment
* History of fracture in lumbar region
* History of systemic diseases e.g. cancer or systemic joint pathologies
* History of congestive heart failure in past 24 months
* Subjects have used medications like narcotics or Muscle relaxants 30 days before enrolment into study

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Oswestry Disability index (Urdu)
timeFrame: 4 weeks
measure: Inclinometer
timeFrame: 4 weeks
measure: Active Knee Extension Test
timeFrame: 4 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hameed Latif Medical Centre
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ali Raza, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03460860: Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of An Oral Supplement Containing Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Wrinkles
Lead sponsor: United Laboratories
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the clinical efficacy of a combination of Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin anti-aging properties. Specifically, the investigators aim to determine the increase in hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs of photoaging, particularly facial fine lines.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals age 30 to 60 years old
* Fitzpatrick Skin Type I-IV
* Crow's Feet Wrinkle Scale Class 1-2
* Subjects willing to provide written informed consent

Exclusion Criteria:

* Use of topical or oral anti-aging drug therapy 1 month prior to the study
* History of allergy to cosmetics and anti-aging drugs
* History of photosensitivity reactions
* Any current or past medical condition, including seizures and stroke
* History of pigmentation disorder such as but not limited to vitiligo and leukoderma
* Immunocompromised state
* Pregnant or lactating (pregnancy kit will be used to check)
* Patients who have undergone laser, radiofrequency, peeling, and other procedural therapies for anti-aging in the month prior to the study.
* Patients with current inflammatory or infectious skin disease on the face, or history of such in the month prior to the study.
* Patients taking OCDs and other photosensitizing drugs (e.g. tetracycline).
* Not willing to provide informed consent

Primary outcomes:
measure: Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.
timeFrame: 12 weeks
measure: Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: PDC Building, 1440 Taft Avenue
state: Metro Manila
Study officials:
References: