louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02928289: Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)
Official title: Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Open-Angle Glaucoma
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-10
Enrollment: 29
Sex: ALL
Minimum age (years): 22
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 safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG) in the study eye.
* Pseudophakic with Posterior Chamber IOL (PCIOL)
* Able and willing to attend follow up visits for two years post-operative
* Able and willing to sign informed consent

Exclusion Criteria:

* Phakia or aphakia
* Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) \[Subjects with one prior SLT application (\>3 months prior to screening) or prior ECP (performed \> 12 months prior to screening) can be enrolled\].
* Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
* Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
* Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)
* Participation in any clinical trial ≤ 30 days prior to screening

Primary outcomes:
measure: Mean change in diurnal IOP (Measured in mm Hg)
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP
timeFrame: 12 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Orange
country: United States
facility: Coastal Vision Medical Group
state: California
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
Study officials:
References:
citation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Clinical trial NCT05378789: Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review
Official title: Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nap
Keywords: nap; ICU; nurse; Shift work
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published.

This study will also explore : the factors favouring or hindering the implementation of this strategy and its maintenance over time through a concomitant sociological qualitative study, the evolution over time of the parameters of perceived nocturnal sleepiness and the immediate impact of the realization of naps on this sleepiness and the evolution over time of the medium-term impact with the help of questionnaires exploring various dimensions concerning the working conditions and health (somatic health, stress, psychosocial risks, evaluation of the working environment).


Eligibility criteria: Inclusion Criteria:

* Paramedic working 12 hours alternating day and night in the ICU department of the Vendee departmental hospital center.

Exclusion Criteria:

* Pregnant woman.
* Caregiver with knowledge of a scheduled departure from the ICU within 2 months after the start of the project.
* Caregiver refusing to participate in the project.

Primary outcomes:
measure: Nap appropriation
timeFrame: 12 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: Centre hospitalier départemental Vendee
Study officials:
affiliation: Centre hospitalier departemental Vendée
name: Mélanie ROUGIER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02882789: IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers
Official title: A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LigaChem Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-30
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary

• To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose


Eligibility criteria: Inclusion Criteria:

1. Healthy Male between 19 and 39 years of age at the time of screening
2. Subjects with body mass index (BMI) between 19 and 27 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy
2. History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.

Primary outcomes:
measure: To assess Peak Plasma Concentration(Cmax) of LCB01-0371
timeFrame: through study completion per patient, an average of 8 days (+ - 1 D)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bae KS
Study officials:
References:
citation: Cho YS, Lim HS, Han S, Yoon SK, Kim H, Cho YL, Nam HS, Bae KS. Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371. Clin Ther. 2019 Jan;41(1):92-106. doi: 10.1016/j.clinthera.2018.11.009. Epub 2018 Dec 15.
Clinical trial NCT06673589: Brain-to-brain Synchrony in Ss With Different Levels of Social Interaction
Official title: Brain-to-brain Synchrony as a Mechanism of Field Effects of Consciousness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Social Dynamics
Keywords: Consciousness
Hyper-scanning
Social Neuroscience
Lead sponsor: Maharishi International University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adult population that practices TM

Brief summary: Brain-to-brain synchrony will be measured between pairs of subjects with different levels of similarity of DNA and social interactions

Detailed description: Brain-to-brain synchrony will be measured in five pairs of identical twins, five pairs who are good friends and from the same region of a country, and five pairs of strangers from different countries when they practice Transcendental Meditation practice

Eligibility criteria: Inclusion Criteria:

* healthy fit the cohort criteria practice TM

Exclusion Criteria:

* mental or physical issue

Primary outcomes:
measure: Brain-to-Brain Synchrony
timeFrame: 20 minute TM
Secondary outcomes:
measure: Tracing of depth of meditation (This is a graphic measure.)
timeFrame: after 20 minute meditation
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Maharishi International University
state: Iowa
city: Fairfield
country: United States
facility: Maharishi International University
state: Iowa
Study officials:
affiliation: Maharishi International Uniersity
name: Fred Travis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02444689: EMPower: Electronic Media Powering Positive Health Changes in Youth
Official title: EMPower: Electronic Media Powering Positive Health Changes in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Prehypertension
Overweight
Obesity
Hypertrophy, Left Ventricular
Keywords: Blood pressure
Cardiovascular disease
Children
Adolescent
Pediatrics
End-organ damage
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-05-14
Enrollment: 91
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
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 of a technology-based behavioral Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean clinic systolic BP), and heart size (LVM) in comparison to standard care.


Eligibility criteria: Inclusion Criteria:

* Overweight or Obese
* Speaks English

Exclusion Criteria:

* No smart phone / smart phone data plan
* Not willing to send/ receive text messages or download and use the study applications
* Neurological impairment/ developmental delay
* New / changes in anti-hypertensive medication or medication known to affect blood pressure within the last 6 months
* Prior diagnosis of congenital heart disease or cancer
* Pregnancy
* Taking medication with weight gain as a side effect
* Taking medications for weight loss/ participation in another weight loss program

Primary outcomes:
measure: Change in adiposity as measured by change in BMI z-score
timeFrame: 6 months from date of randomization
Secondary outcomes:
measure: Change in clinic systolic blood pressure
timeFrame: 6 months from date of randomization
measure: Change in left ventricular mass index
timeFrame: 6 months from date of randomization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tammy M Brady, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715789: COGNITIVE BEHAVIOURAL THERAPY FOR TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
Official title: EFFECT OF COGNITIVE BEHAVIOURALTHERAPY IN TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: graded eposure and activity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial controled study with double blind procedures for (main investigator) for treatment interventions and (research assistance) for assessment interventions.
Primary purpose: TREATMENT

Brief summary: To explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain.

Detailed description: Studies suggest that patients with LBP benefited when standard rehabilitation approaches were supplemented with graded exercise . There is adequate information to allow clinical implementation of graded exercise by physical therapists, In contrast, there is less information available for physical therapy implementation of graded exposure. LBP rehabilitation based on graded exposure principles Therefore, the purpose of this study is to review the available evidence for graded exposure and to describe physical therapy application of graded exposure for patients enrolled in clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Patient's age between 25-40 years.
2. Patients have persistent Chronic Non-specific LBP for at least 3 months with or without leg pain. Leg pain won't exceeds mechanical behaviors.
3. Score of 24 fear avoidance questionnaire.
4. Symptoms of hypersensitivity, secondary punctate or pressure hyperalgesia and fear of movement as a central sensitization symptoms

Exclusion Criteria:

* 1-History of previous back surgery. 2- History of previous hip, knee or ankle surgeries. 3- Systemic inflammatory diseases. 4-Tumors. 5-Red flags of back pain 6-Patients with disc pathology and radicular pain 7- spinal fracture or spinal surgery 8- systemic disease or TB of spine widespread constant non-specific pain disorder, pain without a clear mechanical behavior

Primary outcomes:
measure: Arabic ODI for function
timeFrame: 5 minutes
Secondary outcomes:
measure: Numerical rating scale
timeFrame: 5 minutes
measure: Tape measurement
timeFrame: 5 minutes
measure: Fear avoidance belief questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
References:
Clinical trial NCT00476489: Does Topical Steroid Treatment Impair the Adrenal Function?
Official title: Low Dose (1mcg) ACTH Stimulation Test for Assessment of the Hypothalamo-Pituitary- Adrenal Axis in Patients Treated With Topical Corticosteroids
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothalamus-Pituitary-Adrenal Axis Assessement
Topical Steroid Therapy in Chronic Skin Diseases
Keywords: secondary adrenal insuffiency
hypothalamus-pituitary-adrenal axis impairement
topical steroids
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.

Detailed description: Adrenocortical suppression is a potential complication of systemic corticosteroid treatement but also of non systemic therapy like topical therapy.

The normalcy of hypothalamic-pituitary-adrenal axis ( HPA axis) of patients with chronic skin diseases like atopic dermatitis, pemphigus or psoriasis which are treated with topical steroids, will be assessed with the low dose (1mcg) adrenocortocotropin ( ACTH) stimulation test. During this test serum cortisol levels are measured before, 30 and 60 mn after intravenous administration of 1mcg of ACTH (synacthen).The results will be compared with age and sex matched subjects with normal HPA axis as assessed by low dose ACTH stimulation test.

Eligibility criteria: Inclusion Criteria:

* patients receiving daily topical steroids for at least two weeks on 10% or more of body surface.

Exclusion Criteria:

* patients treated with any form of corticosteroids except topical steroids.
* patients with known pituitary disease
* pregnant patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: Avraham Ishay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01883089: Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
Official title: Ambivalence Model of Craving: Re-examining the Drinking-craving Relationship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study combines both clinical trial and daily process methodology to examine the dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e., craving) and drinking behaviors in those diagnosed with an Alcohol Use Disorder (AUD) prior to, during, and after receiving a brief alcohol intervention. It is hypothesized that daily avoidance inclinations will significantly moderate the effect of daily approach inclinations on drinking behaviors, and that significant increases in avoidance inclinations will be observed prior to treatment entry, followed by significant decreases in approach inclinations during treatment.


Eligibility criteria: Inclusion Criteria:

* current diagnosis of alcohol dependence
* live within commuting distance of the program site,
* regular access to a phone to call into an IVR system and
* provide informed consent

Exclusion Criteria:

* acute psychosis or severe cognitive impairment
* current or previous treatment for an alcohol use disorder within the past 6 months,
* taking medications that may modify alcohol use,
* current drug use diagnosis other than nicotine or marijuana abuse,
* lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures, and
* legally mandated to attend treatment

Primary outcomes:
measure: Drinks per day
timeFrame: participants will be followed for the duration of the study, an expected average of 90 days
Secondary outcomes:
measure: Approach inclinations
timeFrame: participants will be followed for the duration of the study, an expected average of 90 days
measure: Avoidance inclinations
timeFrame: participants will be followed for the duration of the study, an expected average of 90 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Robert C Schlauch, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709289: Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne Vulgaris: a Prospective Study
Official title: Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 40
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: To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.

Detailed description: To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.

Eligibility criteria: Inclusion Criteria:

* (1) Patients diagnosed with moderate to severe acne and graded grade III-IV according to Investigator's Global Assessment (IGA) ;
* (2) Patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives;
* (3) Patients who read the instructions and were willing to follow the program requirements.

Exclusion Criteria:

* (1) Patients who had a history of photosensitive diseases;
* (2) Patients who had Modified-PDT;
* (3) Patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks;
* (4) Female patients who were pregnant or lactating.

Primary outcomes:
measure: The clearance rate of lesions
timeFrame: 1 week after treatment
Secondary outcomes:
measure: Assessment of adverse effects
timeFrame: up to 7 days after treatment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Lei Shi
state: Shanghai
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Xiuli Wang, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01927289: DBRCT on the Effect of Grip Strength in Brachial Plexus vs Distal Forearm Nerve Blocks
Official title: A Double-blind Randomized Controlled Trial Between Ultrasound-guided Brachial Plexus and Distal Peripheral Nerve Blocks for Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Mobility
Keywords: Ultrasound
supraclavicular block
distal forearm block
Grip Strength
Satisfaction
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
First posted: 2013-08-22
Enrollment: 14
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: This is a double-blind prospective randomized control trial. The primary hypothesis is that the preservation of motor function is superior in distal forearm blocks compared to supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's satisfaction, rate of block success, onset and duration of block.


Eligibility criteria: Inclusion criteria:

1. American Society of Anesthesiologists physical status I to III
2. Aged 18 and above
3. Able to provide own consent
4. Elective ambulatory surgery in the hand with an expected surgical time of less than 15 minutes that is normally performed with a peripheral nerve block covering the median and ulnar nerve distributions and intravenous sedation without general anesthesia

Exclusion criteria:

1) Surgery outside the median and ulnar nerve distribution in the hand 2) Bilateral surgery 3) body mass index of more than 45 kg/m2 (higher chance of failure) 4) neck or clavicle deformities 5) infection at the injection site 6) existing neurologic disease 7) insulin dependent diabetes 8) Diabetes with peripheral neuropathy or end organ damage 9) allergy to LA agents 10) coagulopathy 11) Past surgery on the same upper limb 12) Any other contraindication to supraclavicular block or forearm blocks 13) Contraindication to monitored anesthesia care with peripheral nerve block as the mode of anesthesia.

-

Primary outcomes:
measure: Grip Strength
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: UNM
name: Nicholas Lam, MD
role: PRINCIPAL_INVESTIGATOR
References: