louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05518019: An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus
Official title: An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Fear
Stress
Low Mood
Sleep
Keywords: Anxiety
Fear
Stress
Low Mood
Sleep
Focus
Calmness
Lead sponsor: Prima CBD
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be administered once daily. It is hypothesized that this supplement will lead to improvements in sleep, focus, and stress. Previous research supports that CBD supplementation provides support to the endocannabinoid system, allowing the brain to better control negative psychological outcomes like fear, stress, and negative mood states.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsules per day).
* Must be in general good health (e.g., no long term health issues that would impact your participation.
* Moderate self-reported issues with stress, mood, focus, and sleep.

Exclusion Criteria:

* Current use of selective serotonin reuptake inhibitors or prescription medication for the treatment of depression or anxiety and have not been on a stable dose for more than 60 days.
* Currently receiving other psychotherapeutic treatment for anxiety or depression.
* Diagnosed anxiety or depression
* BMI over 40
* Known allergic reactions that would require the use of an epi-pen
* Females who are pregnant or breastfeeding.

Primary outcomes:
measure: Change in stress and anxiety as measured by questionnaires.
timeFrame: 2 months
measure: Change in mood as measured by questionnaire
timeFrame: 2 months
Secondary outcomes:
measure: Change in sleep quality and quantity as measured by digital wearable devices and by self-report
timeFrame: 2 months
Other outcomes:
measure: Change in overall well-being as measured by self-report and questionnaires.
timeFrame: 2 months
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03564119: A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Official title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Keywords: papulopustular rosacea
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 372
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: To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

Detailed description: In this Phase 3, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

Eligibility criteria: Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 18 years of age and older.
3. Participants must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
5. Have 2 nodules or less.

Exclusion Criteria:

1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Primary outcomes:
measure: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
timeFrame: Baseline through Week 12
measure: Change From Baseline in Inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Sol-Gel
state: New York
Study officials:
References:
Clinical trial NCT06885619: Prediction of Left Ventricular Adverse Remodeling and Major Adverse Cardiovascular Events in Patients with Acute Myocardial Infarction Though Plasma Multiomics Analysis.
Official title: Prediction of Left Ventricular Adverse Remodeling and Major Adverse Cardiovascular Events in Patients with Acute Myocardial Infarction Though Plasma Multiomics Analysis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myocardial Infarction (AMI)
Left Ventricular Remodeling
Major Adverse Cardiovascular Event
Plasma Multi-Omics
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Institute of Biophysics, Chinese Academy of Sciences
First posted: 2025-03-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes individuals diagnosed with acute myocardial infarction (MI), selected by the site personnel according to predefined inclusion criteria. The cohort comprises 1,000 patients, whose baseline clinical characteristics and plasma biomarkers will be assessed.

Brief summary: To identify plasma multi-omics biomarkers that predict left ventricular adverse remodeling (LVAR) and major adverse cardiovascular events (MACE) in patients with acute myocardial infarction, and to investigate the molecular pathways linked to LVAR and MACE.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Diagnosis of AMI (STEMI or NSTEMI) confirmed by clinical criteria, electrocardiogram (ECG), and cardiac biomarkers (e.g., troponin).
3. Willingness to provide informed consent.

Exclusion Criteria:

1. Prior surgery or trauma.
2. Renal failure with glomerular filtration \<30 ml/min.

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 2025-1-1 to 2027-12-31
Secondary outcomes:
measure: adverse cardiac remodeling
timeFrame: 2025-1-1 to 2027-12-31
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University.
state: Beijing
Study officials:
affiliation: Beijing Anzhen hospital, Capital Mediacl University.
name: Xu Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Biophysics, Chinese Academy of Sciences
name: Tanxi Cai, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05216718: Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe
Official title: Prospective Randomized Controlled Study on Mini-flap Bilateral Axillo-breast Approach Robotic Thyroidectomy : Effect on Postoperative Pain and Sensation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Keywords: Mini-flap
Bilateral axillo-breast approach
Da vinci
Robot-assisted thyroid surgery
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, a randomized controlled study was conducted between two groups of 40 recipients of conventional flap during BABA robotic-thyroidectomy and 40 recipients of Mini-flap method during BABA robotic-thyroidectomy. In this study, we tried to determine whether the use of Mini-flap can reduce sensory loss and pain after BABA robotic-thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* subjects who will have thyroid surgery
* subjects who has no evidence of lymph node metastasis on palpation and imaging (cN0)
* subjects who has thyroid nodule under 4cm (\<cT2)
* subjects who has no distant metastasis (M0)

Exclusion Criteria:

* subjects who has clinical evidence of lymph node metastasis (cN1a or cN1b)
* subjects who has both thyroid nodule
* subjects who underwent any radiotherapy on neck
* subjects who has primary hyperparathyroidism
* subjects who underwent head and neck surgery
* subjects who disagree to do this trial

Primary outcomes:
measure: Change from baseline in pain, as measured by the Visual Analog Score(VAS)
timeFrame: 2, 24, 48, 72 hours after surgery
measure: change from baseline in pain, as measured by the number of analgesics uses
timeFrame: 2, 24, 48, 72 hours after surgery
measure: change from baseline in Sensory change, as measured by the monofilaments
timeFrame: 1 day before surgery, 1, 3 months after surgery
Secondary outcomes:
measure: Incidence of vocal cord palsy
timeFrame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
measure: change from baseline in Hypoparathyroidism, as measured by parathyroid hormone level
timeFrame: before surgery, 1 day after surgery, 2, 6 weeks after surgery, 6 month, 1year after surgery
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong sik Bae
Study officials:
References:
Clinical trial NCT03378518: Evaluation of Effectiveness of Blue Code Team After In-hospital Cardiopulmonary Arrest
Official title: Evaluation of Effectiveness of Blue Code Team After In-hospital Cardiopulmonary Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In-hospital Cardiac Arrest
Keywords: In-hospital Cardiac Arrest, mortality
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were coded blue due to in-hospital cardiac arrest between January 1, 2016 and December 31, 2016.

Brief summary: This study aimed to retrospectively examine patients evaluated by the Code Blue team on a Code Blue call in our hospital between 2016-2017.

Primary outcome: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2016-2017.

Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.

Detailed description: This study aimed to retrospectively examine patients evaluated by the Code Blue team on a Code Blue call in our hospital between 20016 and 2017.

Primary outcome: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2016-2017.Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients throughout the whole hospital for whom a Code Blue form was completed and who were evaluated by the Code Blue team on a Code Blue call.

Eligibility criteria: Inclusion criteria:

-Patients intervened by code blue team

Exclusion criteria:

* Cardiac arrest in the anesthesiology and reanimation intensive care unit
* Cardiac arrest in the newborn intensive care unit
* Out-of-hospital cardiac arrest

Primary outcomes:
measure: Blue code notification form
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Training and Research Hospital
Study officials:
affiliation: Aydin Adnan Menderes University
name: sinan yılmaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02767518: Prehabilitation for Aortic Repair Patients
Official title: Does Prehabilitation Prior to Thoracic Aortic Repair Improve Quality of Care?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Aneurysm
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 2-group study comparing the effect of a "prehabilitation" program to usual care on quality of life and clinical outcomes in patients undergoing elective repair of their thoracic aorta.

Detailed description: Patients undergoing elective repair of their thoracic aortic aneurysm will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.

Eligibility criteria: Inclusion Criteria:

* Age 21 years or older
* Diagnosis of thoracic aortic disease with scheduled repair
* Medical clearance from cardiothoracic surgeon
* Ability to provide informed consent
* Regular use of a smartphone or personal computer

Exclusion Criteria:

* Conditions that limit walking to a severe degree
* Current participation in regular physical activity program
* Acute aortic dissection
* Recent coronary artery disease events
* Inability to speak and read English

Primary outcomes:
measure: Feasibility of recruiting and enrolling
timeFrame: 1 year
Secondary outcomes:
measure: Acceptability
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Bo Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03036241: Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae)
Official title: Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (Dialysis Fistulae)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Restenosis, Vascular Graft
Dialysis Related Complications
Keywords: drug-eluting balloon,
target lesion revascularization (TLR)
restenosis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in dialysis fistulae.

Detailed description: Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in dialysis fistulae and drug-eluting devices might be beneficial in this field as well.

In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.

The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.

Eligibility criteria: Inclusion Criteria:

* Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria:

* Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy

Primary outcomes:
measure: TLR
timeFrame: 12 months
measure: Occlusion of access
timeFrame: 12 months
Secondary outcomes:
measure: Primary assisted patency
timeFrame: 12 months
measure: Death
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Hospital, dept of vascular surgery
name: Maarit Venermo, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorkman P, Weselius EM, Kokkonen T, Rauta V, Alback A, Venermo M. Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study). Scand J Surg. 2019 Mar;108(1):61-66. doi: 10.1177/1457496918798206. Epub 2018 Sep 5.
Clinical trial NCT01736241: A Study of LY3053102 in Healthy Participants
Official title: A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3053102 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).


Eligibility criteria: Inclusion Criteria:

* Normal blood pressure
* Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
* Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m\^2), inclusive, at screening

Exclusion Criteria:

* Had known allergies to LY3053102 or related compounds
* Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
* Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids
* Heavy smokers (more than 10 cigarettes a day)

Primary outcomes:
measure: Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs
timeFrame: Baseline through Day 31
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102
timeFrame: Time 0 to 168 hours after study drug administration on Day 1
measure: PK: Observed Maximum Drug Concentration (Cmax) of LY3053102
timeFrame: Time 0 to 168 hours after study drug administration on Day 1
measure: Number of Participants Who Developed Anti-LY3053102 Antibodies
timeFrame: Baseline, up to Day 31
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06832241: Cognitive Load Assessment of Helicopter Pilots in Training
Official title: ÉVALUATION DE LA CHARGE COGNITIVE DES PILOTES D'HÉLICOPTÈRES EN FORMATION "ECCOLicoF"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cognitive Impairment
Situational Anxiety
Skills, Coping
Keywords: Cognitive load
Military helicopter pilots
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Military helicopter pilots trainees

Brief summary: The aim of this study is to identify the effect of the increase of the situation demands, with or without a thread, on military helicopter pilot's cognitive load, depending on their skills acquisition (at the beginning, midway and end of training course). This study is carried out on a simulator, in virtual reality and allows to identify the moments of cognitive load enhancement and the associated indicators such as subjective, physiological and behavioural indicators. Recommendations will be done to go towards an individualization of the lessons during the pilots education, by anticipating an overload which has a deleterious effect on learning.


Eligibility criteria: Inclusion Criteria:

* Being a trainee at the Instructional center of helicopter crews
* Being more than 18 years old
* Being insured under the French social security system
* Having the bases to pilot helicopters
* Having signed the non-opposition form

Exclusion Criteria:

* Being minor or an incapacitated adult
* Being in a motor handicap situation
* Having a cardiac pathology
* Having a visual pathology that is uncorrected by glasses or lens
* Having a bad audition
* Having a psychiatric disorder, a neurologic or organic disorder requiring a medical treatment
* Taking psychotropics
* Drinking more than 28 units of alcohol per week
* Being epileptic

Primary outcomes:
measure: Subjective level of cognitive load
timeFrame: It is completed during 5 minutes after each of the six scenarios
Secondary outcomes:
measure: Objective level of cognitive load
timeFrame: It is measured during each of the six scenarios lasting around 5 minutes
measure: Subjective level of anxiety
timeFrame: It is measured during 1 minute after each of the six scenarios
measure: Objective level of anxiety
timeFrame: It is measured during each of the six scenarios lasting around 5 minutes
measure: Subjective level of fatigue
timeFrame: It is measured during 1 minute before each of the six scenarios
Other outcomes:
Locations:
Study officials:
affiliation: IRBA, 1 place Valérie André, 91 223 Brétigny-sur-Orge cedex
name: Julie ALBENTOSA
role: STUDY_CHAIR
References: