louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02739373: Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
Official title: Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Severe Sepsis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to measure the amount of study drug (BMS-986189) in the blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a single dose.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy, males and females, 18 to 55 years of age, inclusive
* Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive
* Women of childbearing potential (WOCBP) must have negative serum pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to start of study drug

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder
* History of autoimmune disease
* Any known skin condition that would affect subcutaneous dosing
* Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV -1 and HIV -2 antibody

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 to Day 30
measure: Time of maximum observed concentration (Tmax)
timeFrame: Day 1 to Day 30
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T))
timeFrame: Day 1 to Day 30
measure: Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Day 1 to Day 30
measure: Half Life (T-HALF)
timeFrame: Day 1 to Day 30
measure: Total Body Clearance (CLT/F)
timeFrame: Day 1 to Day 30
measure: Apparent volume of distribution at steady state (Vss/F)
timeFrame: Day 1 to Day 30
measure: Deaths leading to discontinuation
timeFrame: Day 1 to Day 30
measure: Adverse events (AEs) leading to discontinuation
timeFrame: Day 1 to Day 30
measure: Serious adverse events (SAEs) leading to discontinuation
timeFrame: Day 1 to Day 30
measure: Lab abnormalities leading to discontinuation
timeFrame: Day 1 to Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Indiana
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04828473: Green Light Effect on Sleep
Official title: Green Light Effect on Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Lead sponsor: The Green Light Study Center
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: single group assessment
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improved sleep quality in healthy subjects.

This is a within-subject study design that examines NBGL effects on sleep onset, sleep fractures (i.e., how many times per night the subjects wake up), total sleep duration, and sleep quality using high-resolution assessments. To complete the study, each participant will complete a 30-day, daily sleep diary while using white light (i.e., being in regular room light) during the last 2 hours of their waking period. This period will be defined as the baseline/control arm of the study. After completing this phase 1, subjects will receive a lamp designed to emit the narrow band of green light and again be asked to complete a 30-day, daily sleep diary, but this timer while using the NBGL light (i.e., being in what appears green light) during the last 2 hours of their waking period. This period will be defined as the active arm of the study. After completing this phase 2,

Detailed description: Sleep quality will be assessed using the Consensus sleep diary \[Carney et al., (2012)\] The consensus sleep diary: Standardizing prospective sleep self-monitoring, Sleep Vol.35, No.2, pp.287-302\], the latter of which captures total sleep time, sleep latency, wake after sleep onset, number of awakenings, quality, sleep efficiency, and trouble staying awake.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers who wish to improve their sleep quality

Exclusion Criteria:

* Subjects diagnosed with sleep disorders and are currently on medications and/or devices that aid their sleep ( eg trazadone as medication, CPAP)

Primary outcomes:
measure: narrow band green light and sleep
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Green Light Sleep Study Center
state: Florida
Study officials:
References:
Clinical trial NCT00502073: Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria:

* Intraocular or refractive surgery in the study eye within 3 months prior to study start
* Unwilling to discontinue use of contact lenses during the run-in and duration of the study
* Pregnancy or lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangor
country: United States
facility: Eye Center Northeast
state: Maine
Study officials:
affiliation: Sirion Therapeutics
name: Roger Vogel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04929873: Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology
Official title: Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perfusion; Complications
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: transdynation for real-time pressure monitoring
Primary purpose: SUPPORTIVE_CARE

Brief summary: Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology.

Detailed description: It is proposed to monitor VA-ECMO arterial end side branch circulation in real time through a set of monitoring equipment, guide clinical adjustment, improve lower limb re-perfusion, reduce the occurrence of lower limb ischemia, in order to achieve the goal of early detection, early prevention and early treatment, and provide reference and theoretical basis for clinical practice.

Monitoring techniques are divided into two parts: A. monitoring equipment (connecting transdiotic monitoring pressure on va-ECMO side branches cycle); B.to guide clinical adjustment by monitoring pressure (average arterial pressure).

Eligibility criteria: Inclusion Criteria:

* Age: adult patients ≥ 18 years of age;
* signed ECMO informed consent;
* femur vein VA-ECMO treatment;
* agreed to establish VA-ECMO side branch cycle;
* informed consent to this study.

Exclusion Criteria:

* a completely closed double lower limb venously before surgery;
* amputee

Primary outcomes:
measure: Incidence of ischemia Incidence of ischemia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZhejiangU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Fei Zeng
role: STUDY_CHAIR
References:
Clinical trial NCT03508973: Sculptra for Décolletage Crepiness and Wrinkling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Décolletage
Lead sponsor: Skin Laser & Surgery Specialists
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.


Eligibility criteria: Inclusion Criteria:

* Female volunteer
* Aged from 40-70 years on the day of screening
* No known medical conditions that may interfere with study participation
* Moderate to severe crepiness and wrinkling of the décolletage
* Willingness to not use any products on their décolleté for the duration of the study
* Read, understand, and sign informed consent forms
* Willingness to sign photography release form
* Willing and able to comply with all follow-up requirements
* Willingness to undergo a series of three Sculptra injections, 2-3 months apart, in their décolletage

Exclusion Criteria:

* Any significant skin disease at treatment area
* Any medical condition which could interfere with the treatment
* Inability or unwillingness to follow the treatment schedule
* Inability or unwillingness to sign the informed consent
* History of poor wound healing
* History of keloid formation
* History of HIV, hepatitis, immuno-compromised
* Pregnant or lactating
* Previous use of deep chemical peels on the treatment area
* Previous injections of Sculptra in the décolletage
* Known hypersensitivity to Sculptra or any of its ingredients
* Previous laser or light based treatments to the treatment area 6 months prior to the screening visit

Primary outcomes:
measure: Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale
timeFrame: Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03090373: The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters
Official title: The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Baacterial Colonization
Urinary Tract Infections
Keywords: Catheter
UTI's
Lead sponsor: Rosenblum, Jonathan I., DPM
Sponsor class: INDIV
Collaborators: name: Nanovibronix
First posted: 2017-03-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double blinded, randomized controlled trial. All involved will be blinded as to whether the supplied UroShield device is active or a sham.
Primary purpose: PREVENTION

Brief summary: This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.

Detailed description: This is a double blinded Randomized controoled trial of 30 days duration. The trial device is the Uroshield, SAW device which is an externally applied device attached to the external portion of the urinary catheter.

Subjects will be randomized to a control group and the treatment group. The control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham UroShield device. The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device.

At baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. These numbers will be evaluated to see if there is a difference between the active and sham devices.

Eligibility criteria: Inclusion Criteria:

* Currently being treated with an indwelling urinary catheter for at least 30 days.
* Ability to sign informed consent or have someone authorized to sign informed consent.

Exclusion Criteria:

* Currently being treated for an active Urinary Tract infection.
* Previous treatment with Surface Acoustic Waves.

Primary outcomes:
measure: Bacterial Colonization
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Elmsford
country: United States
facility: NanoVibronix
state: New York
Study officials:
References:
Clinical trial NCT00487773: Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
Official title: Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
children
inhaled glucocorticosteroids
bone metabolism
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2007-06-19
Enrollment: 96
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Detailed description: Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory character of disease. All iGCS are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. The purpose of trial is to check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Eligibility criteria: Inclusion Criteria:

* Allergic only to house dust mites
* Never treated chronically (longer than at least 3 months) with anti-asthmatic drugs
* Newly-diagnosed or non-treated asthma
* Must be able to inhale drugs

Exclusion Criteria:

* Other allergic diseases requiring treatment with glucocorticosteroids
* Other chronic diseases
* Asthma exacerbation
* Pregnancy

Primary outcomes:
measure: Markers of bone metabolism (from serum and urine)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Symptoms score (based on PAQLQ), spirometry
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Pediatrics and Allergy, Medical University of Lodz
Study officials:
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Malgorzata Olszowiec-Chlebna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Iwona Stelmach, MD, PhD, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04837573: Feasibility & Acceptability of a Virtual Sister Circle Intervention for Black Women With Depressive Symptoms
Official title: Evaluating the Feasibility and Acceptability of a Therapeutically-Grounded Virtual Sister Circle Intervention for Black Women With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Depression
Keywords: Sister Circle
Black Women
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility and acceptability of a protocol for middle- and older-aged Black women with depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* Identify as Black or African American
* Identify as female
* Age 40 years and older
* Community-dwelling
* Self-report of experiencing depressive symptoms
* Ability to commit to the 8-week intervention
* Access to Zoom
* Speak and read English

Exclusion Criteria:

* Have a diagnosis of bipolar, but is not taking medication for the condition
* Experiencing psychosis

Primary outcomes:
measure: Recruitment, completion, and retention rates of participants
timeFrame: 16 weeks
measure: Assess Acceptability according to the Theoretical Framework of Acceptability
timeFrame: 16 weeks
Secondary outcomes:
measure: Changes in Perceived Stress Scale (PSS) from baseline at 8 weeks and 16 weeks
timeFrame: baseline, 8 weeks, 16 weeks
measure: Changes in Positive and Negative Affect Schedule (PANAS) Scale from baseline at 8 weeks and 16 weeks
timeFrame: baseline, 8 weeks, 16 weeks
measure: Changes in Acceptance and Action Questionnaire II (AAQ-II) from baseline at 8 weeks and 16 weeks
timeFrame: baseline, 8 weeks, 16 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kia Skrine Jeffers, PhD, RN, PHN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179373: Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Official title: Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Detailed description: Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.

Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2

Ages: 50-85 Genders: both

Eligibility criteria: Inclusion Criteria:

1. Men and women aged 50-85.
2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
3. Scored below 24 on the MMSE.
4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
5. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
6. Gave their oral and written consent to participate in the trial.

Exclusion criteria:

1. An additional neurological or psychiatric disorder.
2. Severe personality disorder.
3. Uncontrolled hypertension.
4. History of epilepsy, seizure, or heat convulsion.
5. History of epilepsy or seizure in first degree relatives.
6. History of head injury or stroke.
7. History of metal implants in the head (except dental fillings).
8. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps.
9. History of migraines in the last six months.
10. History of drug or alcohol abuse.
11. Inadequate communication with examiner.
12. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
13. Inability to sign a consent form.

Primary outcomes:
measure: cognitive functioning score by ADAS-COG
timeFrame: 4 months
Secondary outcomes:
measure: Global advancement score by CGI-C
timeFrame: 4 months
measure: Frontal lobe functioning score by FAB
timeFrame: 4 months
measure: Daily activity score by ADL
timeFrame: 4 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Merchav Clinics
Study officials:
References: